1
00:00:05,436 --> 00:00:07,671
GOOD AFTERNOON, EVERYONE.

2
00:00:07,671 --> 00:00:10,374
THANK YOU TODAY FOR JOINING US

3
00:00:10,374 --> 00:00:12,643
FOR THIS VERY TIMELY AND

4
00:00:12,643 --> 00:00:13,244
IMPORTANT MEETING.

5
00:00:13,244 --> 00:00:15,746
I'D LIKE TO THANK ALL OF YOU AS

6
00:00:15,746 --> 00:00:21,485
WELL AS THE CO-CHAIRS, DR.

7
00:00:21,485 --> 00:00:24,989
CHRISTINA REDWIG AND DR. SUSAN

8
00:00:24,989 --> 00:00:27,057
RAMAN AND WORKING GROUP MEMBERS

9
00:00:27,057 --> 00:00:28,592
FOR THEIR PARTICIPATION IN THIS

10
00:00:28,592 --> 00:00:30,227
ESSENTIAL WORK.

11
00:00:30,227 --> 00:00:33,430
ONE OF MY MISSIONS AND AREAS OF

12
00:00:33,430 --> 00:00:35,933
FOCUS AS DIRECTOR OF NICHD HAS

13
00:00:35,933 --> 00:00:38,002
BEEN TO PROTECT PREGNANT WOMEN

14
00:00:38,002 --> 00:00:42,473
THROUGH RESEARCH INSTEAD OF FROM

15
00:00:42,473 --> 00:00:42,740
RESEARCH.

16
00:00:42,740 --> 00:00:44,708
PREGNANT AND LACTATING PEOPLE

17
00:00:44,708 --> 00:00:46,877
AND CLINICIANS ARE FORCED TO

18
00:00:46,877 --> 00:00:49,146
MAKE DECISIONS WHETHER TO TREAT

19
00:00:49,146 --> 00:00:50,381
PREEXISTING OR EMERGING MILLION

20
00:00:50,381 --> 00:00:54,852
CONDITIONS, DESPITE THE LACK OF

21
00:00:54,852 --> 00:00:55,519
ADEQUATE SCIENTIFIC KNOWLEDGE

22
00:00:55,519 --> 00:00:58,789
REGARDING SAFETY AND EFFICACY OF

23
00:00:58,789 --> 00:01:00,224
TREATMENTS IN PREGNANT PEOPLE.

24
00:01:00,224 --> 00:01:03,827
NICHD WAS PROUD TO LEAD THE

25
00:01:03,827 --> 00:01:05,362
ORIGINAL TASK FORCE ON RESEARCH

26
00:01:05,362 --> 00:01:09,667
SPECIFIC TO PREGNANT WOMEN AND 

27
00:01:09,667 --> 00:01:11,101
LACTATING WOMEN OR PRGLAC,

28
00:01:11,101 --> 00:01:12,603
COMMITTED TO ENSURING PREGNANT

29
00:01:12,603 --> 00:01:14,038
AND LACTATING PEOPLE ARE

30
00:01:14,038 --> 00:01:17,675
INCLUDED IN RESEARCH AND HAVE

31
00:01:17,675 --> 00:01:19,643
THE INFORMATION THAT THEY NEED

32
00:01:19,643 --> 00:01:21,945
TO MAKE DECISIONS ABOUT THEIR

33
00:01:21,945 --> 00:01:23,247
OWN CARE.

34
00:01:23,247 --> 00:01:25,382
IN 2018 THE ORIGINAL PRGLAC TASK

35
00:01:25,382 --> 00:01:28,719
FORCE RELEASED A SET OF

36
00:01:28,719 --> 00:01:31,055
RECOMMENDATIONS AND THEN IN 2020

37
00:01:31,055 --> 00:01:34,858
THEY RELEASED AN IMPLEMENTATION

38
00:01:34,858 --> 00:01:35,092
PLAN.

39
00:01:35,092 --> 00:01:39,229
IN THE THREE YEARS SINCE PRGLAC

40
00:01:39,229 --> 00:01:40,564
ISSUED ITS IMPLEMENTATION PLAN,

41
00:01:40,564 --> 00:01:43,167
NICHD AND OTHER NUMEROUS FEDERAL

42
00:01:43,167 --> 00:01:48,439
AGENCIES HAVE BEEN HARD AT WORK

43
00:01:48,439 --> 00:01:48,872
IMPLEMENTING THESE 

44
00:01:48,872 --> 00:01:49,440
RECOMMENDATIONS.

45
00:01:49,440 --> 00:01:54,244
FOR EXAMPLE, NICHD CREATED THE

46
00:01:54,244 --> 00:01:55,446
MATERNAL AND PEDIATRIC PRECISION

47
00:01:55,446 --> 00:01:58,615
IN THERAPEUTICS HUB, OTHERWISE

48
00:01:58,615 --> 00:02:01,018
KNOWN AS MPRINT, TO COORDINATE,

49
00:02:01,018 --> 00:02:04,755
PRESENT, AND EXPAND THE

50
00:02:04,755 --> 00:02:06,957
AVAILABLE KNOWLEDGE, TOOLS AND

51
00:02:06,957 --> 00:02:08,258
EXPERTISE IN MATERNAL AND

52
00:02:08,258 --> 00:02:09,126
PEDIATRIC THERAPEUTICS.

53
00:02:09,126 --> 00:02:12,196
IT SERVES AS A NATIONAL RESOURCE

54
00:02:12,196 --> 00:02:16,133
FOR CONDUCTING AND FOSTERING

55
00:02:16,133 --> 00:02:18,335
THERAPEUTICS FOCUSED RESEARCH

56
00:02:18,335 --> 00:02:19,336
INCLUDING TRIALS IN OBSTETRICS,

57
00:02:19,336 --> 00:02:20,170
LACTATION, AND PEDIATRICS.

58
00:02:20,170 --> 00:02:22,373
YOU'RE GOING TO HEAR MORE ABOUT

59
00:02:22,373 --> 00:02:25,008
THESE EFFORTS IN FUTURE

60
00:02:25,008 --> 00:02:25,776
MEETINGS.

61
00:02:25,776 --> 00:02:29,380
ONE OF THE ORIGINAL PRGLAC

62
00:02:29,380 --> 00:02:30,781
RECOMMENDATIONS WAS ESTABLISH

63
00:02:30,781 --> 00:02:32,349
AND ADVISORY COMMITTEE TO

64
00:02:32,349 --> 00:02:35,419
MONITOR AND REPORT ON

65
00:02:35,419 --> 00:02:37,287
IMPLEMENTATION OF THE

66
00:02:37,287 --> 00:02:39,123
RECOMMENDATIONS, UPDATING

67
00:02:39,123 --> 00:02:41,125
REGULATIONS AND GUIDANCE, AS

68
00:02:41,125 --> 00:02:42,326
APPLICABLE, REGARDING THE

69
00:02:42,326 --> 00:02:44,728
INCLUSION OF PREGNANT WOMEN AND

70
00:02:44,728 --> 00:02:47,564
LACTATING WOMEN IN CLINICAL

71
00:02:47,564 --> 00:02:49,967
RESEARCH.

72
00:02:49,967 --> 00:02:51,168
THE MOST RECENT PRGLAC

73
00:02:51,168 --> 00:02:54,371
RECOMMENDATIONS STATED THAT ONCE

74
00:02:54,371 --> 00:02:56,206
A CHARTER EXPIRES IN 2021,

75
00:02:56,206 --> 00:02:58,842
ANOTHER COMMITTEE WITH A SIMILAR

76
00:02:58,842 --> 00:03:01,044
RANGE OF EXPERTISE SHOULD BE

77
00:03:01,044 --> 00:03:03,781
ESTABLISHED TO ENSURE THAT THE

78
00:03:03,781 --> 00:03:05,983
STEPS RECOMMENDED BY PRGLAC ARE

79
00:03:05,983 --> 00:03:09,586
IMPLEMENTED AND PROGRESS IS

80
00:03:09,586 --> 00:03:10,020
MONITORED.

81
00:03:10,020 --> 00:03:10,654
THIS PARTICULAR RECOMMENDATION

82
00:03:10,654 --> 00:03:14,057
IS WHY WE'RE ALL HERE TODAY.

83
00:03:14,057 --> 00:03:17,127
BY SERVING ON THIS WORKING GROUP

84
00:03:17,127 --> 00:03:19,096
OF THE NATIONAL ADVISORY CHILD

85
00:03:19,096 --> 00:03:21,532
HEALTH AND HUMAN DEVELOPMENT

86
00:03:21,532 --> 00:03:23,734
COUNCIL, YOU ARE FULFILLING THIS

87
00:03:23,734 --> 00:03:24,301
RECOMMENDATION.

88
00:03:24,301 --> 00:03:27,571
AND ARE HELPING TO MONITOR

89
00:03:27,571 --> 00:03:29,440
IMPLEMENTATION EFFORTS, AND YOU

90
00:03:29,440 --> 00:03:31,875
WILL REPORT ON PROGRESS TOWARDS

91
00:03:31,875 --> 00:03:32,743
PRGLAC'S VISION.

92
00:03:32,743 --> 00:03:34,578
I WANT TO BE CLEAR WHILE THIS

93
00:03:34,578 --> 00:03:37,214
GROUP CAME OUT OF THE ORIGINAL

94
00:03:37,214 --> 00:03:39,850
PRGLAC, WE ARE NOT HERE NOW TO

95
00:03:39,850 --> 00:03:41,819
EXTEND THEIR WORK.

96
00:03:41,819 --> 00:03:46,190
WE ARE UNIQUELY FOCUSED ON

97
00:03:46,190 --> 00:03:48,926
TRACKING IMPLEMENTATION ON THE

98
00:03:48,926 --> 00:03:51,328
ORIGINAL 15 RECOMMENDATIONS.

99
00:03:51,328 --> 00:03:51,962
THE IMPLEMENTATION WORKING GROUP

100
00:03:51,962 --> 00:03:56,233
WILL HEAR FROM A RANGE OF

101
00:03:56,233 --> 00:03:56,733
AGENCIES AND NON-FEDERAL

102
00:03:56,733 --> 00:03:59,436
PARTNERS OVER THE SERIES OF YOUR

103
00:03:59,436 --> 00:03:59,903
MEETINGS.

104
00:03:59,903 --> 00:04:01,738
AS YOU HEAR ABOUT THEIR EFFORTS,

105
00:04:01,738 --> 00:04:06,109
I URGE YOU TO CRITICALLY EXAMINE

106
00:04:06,109 --> 00:04:08,412
THE IMPLEMENTATION PLAN AND HOW

107
00:04:08,412 --> 00:04:10,848
THIS IS REFLECTED IN FEDERAL

108
00:04:10,848 --> 00:04:11,081
EFFORTS.

109
00:04:11,081 --> 00:04:16,420
I HOPE THAT YOU LEARN ABOUT THE

110
00:04:16,420 --> 00:04:17,387
NUMEROUS SUCCESSFUL INITIATIVES

111
00:04:17,387 --> 00:04:20,257
UNDERWAY, AND THAT YOU UNCOVER

112
00:04:20,257 --> 00:04:21,859
BARRIERS TO IMPLEMENTATION, AS

113
00:04:21,859 --> 00:04:24,761
WELL AS PUTTING FORWARD

114
00:04:24,761 --> 00:04:27,397
RECOMMENDATIONS TO FACILITATE

115
00:04:27,397 --> 00:04:28,899
CONTINUED IMPLEMENTATION OF

116
00:04:28,899 --> 00:04:29,466
PRGLAC.

117
00:04:29,466 --> 00:04:31,535
TODAY'S MEETING WILL FOCUS ON

118
00:04:31,535 --> 00:04:35,472
TWO OF THE RECOMMENDATIONS

119
00:04:35,472 --> 00:04:36,907
SPECIFICALLY.

120
00:04:36,907 --> 00:04:39,843
THESE ARE RECOMMENDATIONS 12 AND

121
00:04:39,843 --> 00:04:40,811
13.

122
00:04:40,811 --> 00:04:43,447
RECOMMENDATION 12 WAS TO UTILIZE

123
00:04:43,447 --> 00:04:44,648
AND IMPROVE EXISTING RESOURCES

124
00:04:44,648 --> 00:04:47,718
FOR DATA TO INFORM THE EVIDENCE

125
00:04:47,718 --> 00:04:50,020
AND PROVIDE A FOUNDATION FOR

126
00:04:50,020 --> 00:04:54,525
RESEARCH ON PREGNANT WOMEN AND

127
00:04:54,525 --> 00:04:56,493
LACTATING WOMEN.

128
00:04:56,493 --> 00:05:02,199
RECOMMENDATION 13 WAS TO 

129
00:05:02,199 --> 00:05:03,734
OPTIMIZE REGISTRIES FOR

130
00:05:03,734 --> 00:05:04,501
PREGNANCY AND LACTATION.

131
00:05:04,501 --> 00:05:06,570
I'LL BE POPPING IN AND OUT TODAY

132
00:05:06,570 --> 00:05:08,772
BECAUSE I'M IN PARALLEL MEETINGS

133
00:05:08,772 --> 00:05:10,073
THIS AFTERNOON BUT I VERY MUCH

134
00:05:10,073 --> 00:05:11,375
LOOK FORWARD TO YOUR FINAL

135
00:05:11,375 --> 00:05:13,410
REPORT AND TO YOUR FINDINGS.

136
00:05:13,410 --> 00:05:15,746
I WANT TO THANK YOU ALL

137
00:05:15,746 --> 00:05:17,614
SINCERELY FOR YOUR TIME AND

138
00:05:17,614 --> 00:05:19,816
SERVICE TO THIS VERY IMPORTANT

139
00:05:19,816 --> 00:05:20,584
WORKING GROUP.

140
00:05:20,584 --> 00:05:23,520
I'LL NOW HAND THE VIRTUAL FLOOR

141
00:05:23,520 --> 00:05:26,924
OVER TO EMMA CARPENTER, WHO WILL

142
00:05:26,924 --> 00:05:28,959
GUIDE US THROUGH THE SUBSEQUENT

143
00:05:28,959 --> 00:05:29,226
SPEAKERS.

144
00:05:29,226 --> 00:05:32,262
THANK YOU ALL VERY MUCH.

145
00:05:32,262 --> 00:05:39,503
 

146
00:05:39,503 --> 00:05:46,510
>> I'M EMMA CARPENTER, THE
STAFF

147
00:05:46,510 --> 00:05:47,644
COORDINATOR, LOOKING FORWARD TO

148
00:05:47,644 --> 00:05:49,179
DIVING INTO THE TASK.

149
00:05:49,179 --> 00:05:50,714
BEFORE I INTRODUCE THE

150
00:05:50,714 --> 00:05:54,518
CO-CHAIRS, I'D LIKE TO GO OVER A

151
00:05:54,518 --> 00:05:55,085
COUPLE HOUSEKEEPING ITEMS.

152
00:05:55,085 --> 00:05:56,153
>> EMMA, I CAN'T HEAR YOU

153
00:05:56,153 --> 00:05:59,556
EITHER, CAN YOU TURN UP YOUR

154
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VOLUME PLEASE.

155
00:05:59,923 --> 00:06:02,826
>> YES, UH-HUH.

156
00:06:02,826 --> 00:06:09,299
IS THAT A LITTLE BIT BETTER?

157
00:06:09,299 --> 00:06:10,834
>> A LITTLE, YES.

158
00:06:10,834 --> 00:06:13,036
>> IT'S UP ALL THE WAY,
I'M SO

159
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SORRY.

160
00:06:15,439 --> 00:06:21,445
 

161
00:06:21,445 --> 00:06:27,150
 

162
00:06:27,150 --> 00:06:30,454
I'M HOPEFUL THAT IS AS GOOD AS I

163
00:06:30,454 --> 00:06:32,322
CAN DO, AS LOUD AS IT CAN GET.

164
00:06:32,322 --> 00:06:35,492
I'D LIKE TO GO OVER HOUSEKEEPING

165
00:06:35,492 --> 00:06:37,761
ITEMS. 

166
00:06:37,761 --> 00:06:40,597
SO FIRST OF ALL, FOR THE

167
00:06:40,597 --> 00:06:42,366
DURATION OF THE MEETING KEEP

168
00:06:42,366 --> 00:06:45,102
YOUR CAMERA ON, MICROPHONE ON

169
00:06:45,102 --> 00:06:47,304
MUTE UNLESS YOU'RE PRESENTING OR

170
00:06:47,304 --> 00:06:47,838
SPEAKING.

171
00:06:47,838 --> 00:06:48,472
IN THE QUESTION-AND-ANSWER

172
00:06:48,472 --> 00:06:49,806
SESSIONS FEEL FREE TO COME OFF

173
00:06:49,806 --> 00:06:52,109
AND USE THE CHAT FUNCTION OR

174
00:06:52,109 --> 00:06:56,913
CAMERA AND COME OFF MUTE.

175
00:06:56,913 --> 00:06:59,549
JUST A REMINDER THIS IS A PUBLIC

176
00:06:59,549 --> 00:07:02,586
MEETING, WE'RE BROADCASTING VIA

177
00:07:02,586 --> 00:07:04,254
NIH VIDEO CARS, SO I JUST WANT

178
00:07:04,254 --> 00:07:05,689
YOU TO BE AWARE OF THAT.

179
00:07:05,689 --> 00:07:07,424
AND THAT IS PART OF WHY WE'VE

180
00:07:07,424 --> 00:07:10,527
ASKED YOU TO KEEP YOUR CAMERAS

181
00:07:10,527 --> 00:07:12,162
OFF, SO FOLKS LIVE ARE NOT

182
00:07:12,162 --> 00:07:13,130
JUMPING BETWEEN CAMERAS.

183
00:07:13,130 --> 00:07:16,967
FINALLY I WANT TO NOTE A COUPLE

184
00:07:16,967 --> 00:07:18,068
OF MEMBERS HAVE DISCLOSED

185
00:07:18,068 --> 00:07:19,202
POTENTIAL CONFLICTS OF INTEREST.

186
00:07:19,202 --> 00:07:22,339
GIVEN THE SCOPE OF THE WORKING

187
00:07:22,339 --> 00:07:23,640
GROUP AND SPECIFIC TOPICS WE'RE

188
00:07:23,640 --> 00:07:24,341
DISCUSSING TODAY WE DO NOT

189
00:07:24,341 --> 00:07:26,943
BELIEVE THEY WILL NEED TO RECUSE

190
00:07:26,943 --> 00:07:29,012
THEMSELVES FROM THIS

191
00:07:29,012 --> 00:07:29,346
CONVERSATION.

192
00:07:29,346 --> 00:07:32,616
WITH THAT, I WILL HAND THE

193
00:07:32,616 --> 00:07:36,553
VIRTUAL FLOOR OVER TO THE

194
00:07:36,553 --> 00:07:38,188
CO-CHAIRS OF THIS WORKING GROUP.

195
00:07:38,188 --> 00:07:41,491
THANK YOU FOR YOUR LEADERSHIP. 

196
00:07:41,491 --> 00:07:46,063
OVER TO YOU. 

197
00:07:46,063 --> 00:07:48,699
>> THANK YOU, EMMA.

198
00:07:48,699 --> 00:07:50,834
AND I'LL GET STARTED.

199
00:07:50,834 --> 00:07:59,309
AND I'LL TRANSITION OVER TO YOU.

200
00:07:59,309 --> 00:08:00,610
I WORK FOR NOVARTIS

201
00:08:00,610 --> 00:08:02,479
PHARMACEUTICALS, GLOBAL HEAD OF

202
00:08:02,479 --> 00:08:03,613
PEDIATRIC AND MATERNAL HEALTH

203
00:08:03,613 --> 00:08:03,980
POLICY.

204
00:08:03,980 --> 00:08:06,983
I'M ONE OF THE CO-CHAIRS FOR

205
00:08:06,983 --> 00:08:08,752
THIS IMPLEMENTATION WORKING

206
00:08:08,752 --> 00:08:09,419
GROUP OF NICCHD.

207
00:08:09,419 --> 00:08:13,123
I'M HONORED TO BE HERE TODAY AND

208
00:08:13,123 --> 00:08:20,230
HUMBLED TO REPRESENT MEMBERS OF

209
00:08:20,230 --> 00:08:21,631
THE ORIGINAL PRGLAC, TO EVALUATE

210
00:08:21,631 --> 00:08:22,866
IMPLEMENTATION TO DATE OF 15

211
00:08:22,866 --> 00:08:23,366
RECOMMENDATIONS.

212
00:08:23,366 --> 00:08:25,368
SO IF WE CAN GO TO THE NEXT

213
00:08:25,368 --> 00:08:28,004
SLIDE PLEASE.

214
00:08:28,004 --> 00:08:31,608
I WILL WALK US THROUGH SOME SAME

215
00:08:31,608 --> 00:08:34,344
INFORMATION THAT DR. BIANCHI

216
00:08:34,344 --> 00:08:35,979
JUST DISCUSSED, JUST TO

217
00:08:35,979 --> 00:08:36,747
REEMPHASIZE SOME CRITICAL

218
00:08:36,747 --> 00:08:37,914
FACTORS FOR WHAT OUR SCOPE OF

219
00:08:37,914 --> 00:08:41,384
WORK WILL BE OVER THE COURSE OF

220
00:08:41,384 --> 00:08:42,853
THE NEXT FEW MONTHS.

221
00:08:42,853 --> 00:08:47,023
SO, AS WAS LAID OUT, THIS WORK

222
00:08:47,023 --> 00:08:50,861
COMES AND WAS ESTABLISHED IN THE

223
00:08:50,861 --> 00:08:51,428
114th CONGRESS, THROUGH THE

224
00:08:51,428 --> 00:08:53,997
21ST CENTURY CURES ACT WHERE AT

225
00:08:53,997 --> 00:08:56,833
WHEN THE 21ST CENTURY CURES WAS

226
00:08:56,833 --> 00:08:58,969
SIGNED INTO LAW IT WAS DESIGNED

227
00:08:58,969 --> 00:08:59,836
TO ACCELERATE MEDICAL PRODUCT

228
00:08:59,836 --> 00:09:00,937
DEVELOPMENT AND BRING NEW

229
00:09:00,937 --> 00:09:02,706
INNOVATION AND ADVANCES TO

230
00:09:02,706 --> 00:09:04,341
PATIENTS WHO NEED THEM.

231
00:09:04,341 --> 00:09:07,410
CLEARLY, ONE OF THE COMPONENTS

232
00:09:07,410 --> 00:09:10,914
OF THE 21ST CENTURY CURES ACT

233
00:09:10,914 --> 00:09:12,415
INCLUDED ENSURING THAT WE

234
00:09:12,415 --> 00:09:14,050
IDENTIFY AND ADDRESS GAPS IN

235
00:09:14,050 --> 00:09:15,585
KNOWLEDGE, REGARDING SAFE AND

236
00:09:15,585 --> 00:09:16,686
EFFECTIVE THERAPIES OF VACCINES

237
00:09:16,686 --> 00:09:20,791
FOR PREGNANT WOMEN AND LACTATING

238
00:09:20,791 --> 00:09:20,991
WOMEN.

239
00:09:20,991 --> 00:09:23,927
IN THE ORIGINAL ORGANIZATION OF

240
00:09:23,927 --> 00:09:26,096
THE PRGLAC, MULTIPLE SECTORS

241
00:09:26,096 --> 00:09:29,266
WERE REPRESENTED, INCLUDING

242
00:09:29,266 --> 00:09:31,568
MULTIPLE AGENCIES, SOCIETIES,

243
00:09:31,568 --> 00:09:34,538
THE INDUSTRY, ACADEMIA,

244
00:09:34,538 --> 00:09:36,940
NON-PROFIT ORGANIZATIONS, AND WE

245
00:09:36,940 --> 00:09:39,376
WERE VERY WELL ORGANIZED AND LED

246
00:09:39,376 --> 00:09:41,878
BY THE NICHD.

247
00:09:41,878 --> 00:09:43,847
IN 2018, THE DELIVERABLE WAS

248
00:09:43,847 --> 00:09:45,816
PROVIDED TO CONGRESS, WHICH

249
00:09:45,816 --> 00:09:48,785
INCLUDED A REPORT THAT HAD 15

250
00:09:48,785 --> 00:09:49,753
RECOMMENDATIONS TO PROMOTE THE

251
00:09:49,753 --> 00:09:51,354
INCLUSION OF PREGNANT WOMEN AND

252
00:09:51,354 --> 00:09:55,025
LACTATING WOMEN IN CLINICAL

253
00:09:55,025 --> 00:09:55,559
TRIALS.

254
00:09:55,559 --> 00:09:58,862
A COMPONENT OF THE

255
00:09:58,862 --> 00:10:00,497
RECOMMENDATIONS WAS REQUEST TO

256
00:10:00,497 --> 00:10:02,165
EXTEND THE PRGLAC CHARTER SO WE

257
00:10:02,165 --> 00:10:05,635
COULD CONTINUE OUR WORK TO

258
00:10:05,635 --> 00:10:06,970
DEVELOP IMPLEMENTATION GUIDANCE.

259
00:10:06,970 --> 00:10:11,975
AND THEN IN 2020, THE

260
00:10:11,975 --> 00:10:14,311
IMPLEMENTATION PLAN WAS ALSO

261
00:10:14,311 --> 00:10:15,278
PRESENTED.

262
00:10:15,278 --> 00:10:16,913
NEXT SLIDE PLEASE.

263
00:10:16,913 --> 00:10:19,216
SO DR. BIANCHI LAID OUT THERE

264
00:10:19,216 --> 00:10:21,318
WERE 15 RECOMMENDATIONS THAT

265
00:10:21,318 --> 00:10:24,020
CAME THROUGH THE PRGLAC.

266
00:10:24,020 --> 00:10:26,122
THIS PICTOGRAM INCLUDES ALL 15

267
00:10:26,122 --> 00:10:29,092
OF THE RECOMMENDATIONS, PART OF

268
00:10:29,092 --> 00:10:31,494
THAT ORIGINAL WORK THAT WAS

269
00:10:31,494 --> 00:10:34,130
DELIVERED BY THE PRGLAC.

270
00:10:34,130 --> 00:10:37,033
OF THESE 15 RECOMMENDATIONS,

271
00:10:37,033 --> 00:10:39,603
THERE WAS A CENTRAL THEME, THE

272
00:10:39,603 --> 00:10:40,937
CENTRAL THEME OF ALL

273
00:10:40,937 --> 00:10:44,774
RECOMMENDATIONS WAS NEED TO

274
00:10:44,774 --> 00:10:46,943
REALLY ALTER THE SCIENTIFIC

275
00:10:46,943 --> 00:10:49,246
CULTURISM SHOWING SIGNIFICANTLY

276
00:10:49,246 --> 00:10:50,347
LIMITED ASCERTAINMENT OF

277
00:10:50,347 --> 00:10:54,718
KNOWLEDGE OF THERAPEUTIC SAFETY

278
00:10:54,718 --> 00:10:55,919
EFFECTIVENESS FOR PREGNANT WOMEN

279
00:10:55,919 --> 00:10:57,020
AND LACTATING WOMEN.

280
00:10:57,020 --> 00:11:00,390
IF YOU LOOK ACROSS THE 15

281
00:11:00,390 --> 00:11:02,259
RECOMMENDATIONS THERE WERE SOME

282
00:11:02,259 --> 00:11:03,226
THEMES, APPROXIMATELY NINE

283
00:11:03,226 --> 00:11:06,529
THEMES YOU COULD FIND INTERWOVEN

284
00:11:06,529 --> 00:11:09,032
AMIDST THESE RECOMMENDATIONS.

285
00:11:09,032 --> 00:11:11,434
THESE INCLUDED LEVERAGING

286
00:11:11,434 --> 00:11:14,070
EXPANDED EXISTING FEDERAL

287
00:11:14,070 --> 00:11:15,038
PROGRAMS, OR NETWORKS;

288
00:11:15,038 --> 00:11:17,908
DEVELOPING SYSTEMATIC PLAN TO

289
00:11:17,908 --> 00:11:20,944
DIRECT DATA IN PREGNANT WOMEN OR

290
00:11:20,944 --> 00:11:23,046
LACTATING WOMEN; DEVELOP

291
00:11:23,046 --> 00:11:24,114
RESEARCH TOOLS AND STRATEGIES;

292
00:11:24,114 --> 00:11:26,116
CONSIDER TRIAL DESIGNS OPTIMAL

293
00:11:26,116 --> 00:11:30,253
FOR PREGNANT WOMEN AND LACTATING

294
00:11:30,253 --> 00:11:33,556
WOMEN; UTILIZE REGISTRIES AND

295
00:11:33,556 --> 00:11:35,058
DATA SOURCES; ESTABLISH

296
00:11:35,058 --> 00:11:35,592
PRIORITIZATION PROCESS FOR

297
00:11:35,592 --> 00:11:41,298
THERAPEUTICS IN  PREGNANCY AND

298
00:11:41,298 --> 00:11:49,940
LACTATION; TO ADDRESS

299
00:11:49,940 --> 00:11:50,774
INCENTIVES.

300
00:11:50,774 --> 00:11:52,575
FOSTER NEED TO INCLUDE IN

301
00:11:52,575 --> 00:11:54,444
RESEARCH; AND TO CREATE

302
00:11:54,444 --> 00:11:54,911
PARTNERSHIPS.

303
00:11:54,911 --> 00:11:57,948
WHAT WE'LL BE DOING IS GOING

304
00:11:57,948 --> 00:12:00,250
FURTHER IN DETAIL TO EVALUATE

305
00:12:00,250 --> 00:12:02,652
THEN HOW THE IMPLEMENTATION

306
00:12:02,652 --> 00:12:03,620
PLANS SUPPORTING THESE

307
00:12:03,620 --> 00:12:04,421
RECOMMENDATIONS ARE PROGRESSING

308
00:12:04,421 --> 00:12:05,388
TO DATE.

309
00:12:05,388 --> 00:12:13,830
IF WE CAN GO TO THE NEXT SLIDE

310
00:12:13,830 --> 00:12:14,531
PLEASE.

311
00:12:14,531 --> 00:12:16,900
NEXT SLIDE PLEASE.

312
00:12:16,900 --> 00:12:20,971
SO, DR. BIANCHI NOTED, THE 

313
00:12:20,971 --> 00:12:22,272
CREATION OF THIS WORKING GROUP

314
00:12:22,272 --> 00:12:24,140
IS THE RESULT OF ONE OF THE

315
00:12:24,140 --> 00:12:27,110
RECOMMENDATIONS IN THE ORIGINAL

316
00:12:27,110 --> 00:12:27,610
PRGLAC PLAN.

317
00:12:27,610 --> 00:12:30,280
AND THIS IS THE CONGRESSIONAL

318
00:12:30,280 --> 00:12:32,048
LANGUAGE THAT SUPPORTED THE

319
00:12:32,048 --> 00:12:33,383
FORMATION OF THIS PARTICULAR

320
00:12:33,383 --> 00:12:34,684
GROUP, AND WHAT YOU SEE IN THE

321
00:12:34,684 --> 00:12:36,586
TEXT OF THE SLIDE IS A COUPLE

322
00:12:36,586 --> 00:12:39,823
KEY THINGS I'D LIKE TO HIGHLIGHT

323
00:12:39,823 --> 00:12:42,559
FOR YOU AND WAYS TO MONITOR AND

324
00:12:42,559 --> 00:12:44,094
REPORT ON IMPLEMENTING

325
00:12:44,094 --> 00:12:47,163
RECOMMENDATIONS, UPDATING

326
00:12:47,163 --> 00:12:48,031
REGULATIONS, AND GUIDANCE,

327
00:12:48,031 --> 00:12:49,566
SPECIFICALLY TO THE POPULATION

328
00:12:49,566 --> 00:12:52,502
OF PREGNANT WOMEN AND LACTATING

329
00:12:52,502 --> 00:12:52,702
WOMEN.

330
00:12:52,702 --> 00:12:53,937
AND OUR COMMITTEE WILL DIRECT

331
00:12:53,937 --> 00:12:57,874
THE SECRETARY TO SUBMIT A REPORT

332
00:12:57,874 --> 00:12:59,409
TO CONGRESS OUTLINING THE

333
00:12:59,409 --> 00:13:01,611
PROGRESS TO DATE.

334
00:13:01,611 --> 00:13:03,580
SO, WE ARE -- IF WE CAN GO TO

335
00:13:03,580 --> 00:13:07,951
THE NEXT SLIDE -- SERVING AS A

336
00:13:07,951 --> 00:13:09,686
WORKING GROUP THAT AGREED TO

337
00:13:09,686 --> 00:13:11,988
DRAFT ULTIMATELY THE REPORT ON

338
00:13:11,988 --> 00:13:18,428
PROGRESS, THAT WILL BE REPORTED

339
00:13:18,428 --> 00:13:20,630
TO THE NICCHD COUNCIL, THE

340
00:13:20,630 --> 00:13:22,932
COUNCIL THEN PROVIDES UNDER THE

341
00:13:22,932 --> 00:13:25,235
GUIDANCE UNDER THE DIRECTOR,

342
00:13:25,235 --> 00:13:27,637
FROM THERE THIS REPORT WILL BE

343
00:13:27,637 --> 00:13:30,040
PROVIDED TO CONGRESS.

344
00:13:30,040 --> 00:13:32,776
NEXT SLIDE PLEASE.

345
00:13:32,776 --> 00:13:35,412
WE DO HAVE A KEY SET OF

346
00:13:35,412 --> 00:13:35,945
OBJECTIVES.

347
00:13:35,945 --> 00:13:37,480
AS NOTED, WE WERE FORMED UNDER

348
00:13:37,480 --> 00:13:40,116
RECOMMENDATION 15 OF THE PRGLAC

349
00:13:40,116 --> 00:13:41,084
REPORT.

350
00:13:41,084 --> 00:13:45,688
AND OUR WORKING GROUP WILL DO A

351
00:13:45,688 --> 00:13:48,091
NUMEROUS SET OF REVIEWS.

352
00:13:48,091 --> 00:13:50,060
WE'RE GOING TO REVIEW LARGELY

353
00:13:50,060 --> 00:13:52,695
PUBLICLY AVAILABLE MATERIALS

354
00:13:52,695 --> 00:13:55,298
PERTAINING TO IMPLEMENTATION

355
00:13:55,298 --> 00:13:56,299
PROGRESS, SPEAKERS FROM RELEVANT

356
00:13:56,299 --> 00:13:58,268
FEDERAL AGENCIES AND/OR

357
00:13:58,268 --> 00:13:59,469
NON-FEDERAL ENTITIES WILL BE

358
00:13:59,469 --> 00:14:02,772
INVITED TO COME AND DISCUSS ANY

359
00:14:02,772 --> 00:14:05,075
PROGRESS TO DATE ON

360
00:14:05,075 --> 00:14:05,708
IMPLEMENTATION PLAN.

361
00:14:05,708 --> 00:14:07,677
THEY CAN ALSO OUTLINE BARRIERS

362
00:14:07,677 --> 00:14:11,081
THAT THEY ARE FACED WITH, OR

363
00:14:11,081 --> 00:14:12,382
THEY CAN OUTLINE EXISTING

364
00:14:12,382 --> 00:14:14,017
PROGRAMS THAT ARE IN PLACE THAT

365
00:14:14,017 --> 00:14:16,419
CAN BE UTILIZED TO ADDRESS SOME

366
00:14:16,419 --> 00:14:17,487
OF THESE RECOMMENDATIONS.

367
00:14:17,487 --> 00:14:21,357
WHAT WE WILL DO THEN IS REPORT

368
00:14:21,357 --> 00:14:22,559
THE FINDINGS TO THE NICHD

369
00:14:22,559 --> 00:14:24,294
COUNCIL AS OUTLINED IN THE

370
00:14:24,294 --> 00:14:25,762
PREVIOUS SLIDE, AND THE REPORT

371
00:14:25,762 --> 00:14:30,333
WILL BE SUBMITTED TO CONGRESS.

372
00:14:30,333 --> 00:14:34,804
THE REPORT WILL INCLUDE OR WILL

373
00:14:34,804 --> 00:14:35,572
OUTLINE IMPLEMENTATION PROGRESS,

374
00:14:35,572 --> 00:14:37,107
INCLUDING RECOMMENDATIONS TO

375
00:14:37,107 --> 00:14:37,907
FACILITATE THE IMPLEMENTATION,

376
00:14:37,907 --> 00:14:41,044
WHERE IT'S NECESSARY FOR US TO

377
00:14:41,044 --> 00:14:42,245
PROVIDE THAT GUIDANCE.

378
00:14:42,245 --> 00:14:45,115
AND/OR WE COULD ALSO BE

379
00:14:45,115 --> 00:14:47,383
INCLUDING SOME RECOMMENDATIONS

380
00:14:47,383 --> 00:14:49,352
FOR RECONSIDERATION OF ELEMENTS

381
00:14:49,352 --> 00:14:52,622
OF SPECIFIC RECOMMENDATIONS OR

382
00:14:52,622 --> 00:14:56,793
RECOMMENDATIONS THEMSELVES.

383
00:14:56,793 --> 00:15:02,732
NEXT SLIDE PLEASE.

384
00:15:02,732 --> 00:15:05,135
WE HAVE AN AMBITIOUS TIMELINE.

385
00:15:05,135 --> 00:15:05,902
WE'RE HERE IN THE FIRST

386
00:15:05,902 --> 00:15:07,237
LEFT-HAND SIDE OF THE SLIDE

387
00:15:07,237 --> 00:15:10,740
SECTION, WHERE WE'RE DOING OUR

388
00:15:10,740 --> 00:15:11,274
INFORMATION GATHERING

389
00:15:11,274 --> 00:15:14,577
DISCUSSIONS, AND BECAUSE TWO

390
00:15:14,577 --> 00:15:15,545
MEETINGS ARE VIRTUAL WE'LL HAVE

391
00:15:15,545 --> 00:15:18,181
QUITE A BIT OF OUR PREP WORK

392
00:15:18,181 --> 00:15:20,350
DONE OFFLINE, PREPARING SO WE'RE

393
00:15:20,350 --> 00:15:22,018
ABLE TO REALLY PROCESS THE

394
00:15:22,018 --> 00:15:23,653
INFORMATION BEING PRESENTED TO

395
00:15:23,653 --> 00:15:25,722
US, BY THE INVITED SPEAKERS.

396
00:15:25,722 --> 00:15:28,791
WE'LL HAVE OUR THIRD MEETING IN

397
00:15:28,791 --> 00:15:29,759
PERSON IN MARCH.

398
00:15:29,759 --> 00:15:32,495
IN MARCH AND APRIL OF NEXT YEAR

399
00:15:32,495 --> 00:15:34,063
THE REPORT WILL BE DRAFTED, AND

400
00:15:34,063 --> 00:15:36,766
ALL OF US IN THE WORKING GROUP

401
00:15:36,766 --> 00:15:40,270
WILL BE REVIEWING, PROVIDING

402
00:15:40,270 --> 00:15:41,838
RECOMMENDATIONS FOR EDITING,

403
00:15:41,838 --> 00:15:43,806
ADDITIONS, AND THAT REPORT WILL

404
00:15:43,806 --> 00:15:46,009
BE FINALIZED, PRESENTED TO THE

405
00:15:46,009 --> 00:15:48,077
NICHD COUNCIL, THE REPORT

406
00:15:48,077 --> 00:15:49,012
FINALIZED IN JULY, AND PROVIDED

407
00:15:49,012 --> 00:15:49,846
TO CONGRESS.

408
00:15:49,846 --> 00:15:55,385
SO IT'S A VERY, VERY AMBITIOUS

409
00:15:55,385 --> 00:15:56,085
TIMELINE.

410
00:15:56,085 --> 00:15:58,354
NEXT SLIDE PLEASE.

411
00:15:58,354 --> 00:16:01,224
SO, SUE AND I HAVE BEEN MEETING

412
00:16:01,224 --> 00:16:02,525
OFFLINE WITH THE EXCELLENT NICHD

413
00:16:02,525 --> 00:16:05,395
STAFF TO TRY AND ORGANIZE THIS

414
00:16:05,395 --> 00:16:07,430
QUITE SIGNIFICANT SCOPE OF WORK

415
00:16:07,430 --> 00:16:10,400
FOR OUR GROUP TO TAKE ON, AND TO

416
00:16:10,400 --> 00:16:11,634
SUCCESSFULLY DELIVER ON.

417
00:16:11,634 --> 00:16:13,803
WE THOUGHT THE BEST WAY TO

418
00:16:13,803 --> 00:16:14,904
HANDLE ALL OF THE INFORMATION

419
00:16:14,904 --> 00:16:16,873
THAT WILL BE REPORTED TO US

420
00:16:16,873 --> 00:16:19,809
WOULD BE TO CLUSTER SOME OF THE

421
00:16:19,809 --> 00:16:23,846
COMMON THEMES TOGETHER INTO FIVE

422
00:16:23,846 --> 00:16:24,280
OVERARCHING TOPICS.

423
00:16:24,280 --> 00:16:26,282
SO, WE AS A WORKING GROUP

424
00:16:26,282 --> 00:16:30,887
DISCUSSED EACH OF THESE FIVE

425
00:16:30,887 --> 00:16:34,958
TOPICS, FOLLOWING PROVISION OF

426
00:16:34,958 --> 00:16:36,359
INSIGHTS FROM THE RELEVANT

427
00:16:36,359 --> 00:16:37,260
INVITED SPEAKERS REPORTING ON

428
00:16:37,260 --> 00:16:39,529
PROGRESS TO DATE.

429
00:16:39,529 --> 00:16:40,430
THE FIVE CLUSTERS INCLUDE

430
00:16:40,430 --> 00:16:43,600
CLUSTER A ON CONDUCT OF CLINICAL

431
00:16:43,600 --> 00:16:45,802
RESEARCH AND TRIALS; CLUSTER B

432
00:16:45,802 --> 00:16:48,204
ON EDUCATION, OUTREACH, TRAINING

433
00:16:48,204 --> 00:16:51,074
AND CAREER DEVELOPMENT; CLUSTER

434
00:16:51,074 --> 00:16:55,078
C ON POLICY, REGULATORY ISSUES

435
00:16:55,078 --> 00:16:55,979
AND LIABILITY; CLUSTER D

436
00:16:55,979 --> 00:16:59,048
REGISTRIES AND REAL WORLD DATA;

437
00:16:59,048 --> 00:17:01,684
AND CLUSTER E, NOVEL DRUG

438
00:17:01,684 --> 00:17:04,387
DISCOVERY AND DEVELOPMENT.

439
00:17:04,387 --> 00:17:06,356
NEXT SLIDE PLEASE.

440
00:17:06,356 --> 00:17:09,659
AND THEN THIS IS OUR WORK PLAN

441
00:17:09,659 --> 00:17:11,861
WHERE WE WILL WORK THROUGH EACH

442
00:17:11,861 --> 00:17:13,229
OF THE DIFFERENT CLUSTERS.

443
00:17:13,229 --> 00:17:16,532
TODAY AS YOU'RE WELL PREPARED

444
00:17:16,532 --> 00:17:20,270
FOR, WE WILL BE -- AFTER WE'VE

445
00:17:20,270 --> 00:17:22,372
COMPLETED OUR OVERVIEW OF PRGLAC

446
00:17:22,372 --> 00:17:26,909
VERSION 1.70 WE'LL MOVE TO D,

447
00:17:26,909 --> 00:17:29,012
REGISTRIES AND REAL WORLD DATA.

448
00:17:29,012 --> 00:17:31,514
IN JANUARY MEETING 2 WE'LL

449
00:17:31,514 --> 00:17:33,716
DISCUSS CLUSTERS A AND E AND

450
00:17:33,716 --> 00:17:34,917
CLUSTER C.

451
00:17:34,917 --> 00:17:35,885
AND IN OUR FACE-TO-FACE MEETING

452
00:17:35,885 --> 00:17:37,754
IN MARCH WE'LL BE DISCUSSING

453
00:17:37,754 --> 00:17:39,622
PROGRESS TO DATE ON CLUSTER B.

454
00:17:39,622 --> 00:17:42,692
AND SO I THINK THIS TAKES US TO

455
00:17:42,692 --> 00:17:43,760
TODAY'S AGENDA.

456
00:17:43,760 --> 00:17:46,829
I'LL TURN THINGS OVER TO SUE.

457
00:17:46,829 --> 00:17:50,099
>> THANK YOU, CHRISTINA.

458
00:17:50,099 --> 00:17:53,836
SO, AS CHRISTINA MENTIONED, OUR

459
00:17:53,836 --> 00:18:04,314
FIRST MEETING IS CLUSTER  D,

460
00:18:04,580 --> 00:18:07,083
BOTH RECOMMENDATIONS CENTER ON

461
00:18:07,083 --> 00:18:08,184
THE COLLECTION, ORGANIZATION,

462
00:18:08,184 --> 00:18:10,586
AND UTILIZATION OF REAL WORLD

463
00:18:10,586 --> 00:18:11,421
DATA.

464
00:18:11,421 --> 00:18:13,122
OUR PLANNING TEAM DISCUSSED THE

465
00:18:13,122 --> 00:18:15,825
LIKELY OWNERS OF THESE

466
00:18:15,825 --> 00:18:17,994
ACTIVITIES, AND WE IDENTIFIED

467
00:18:17,994 --> 00:18:19,429
THE OFFICE OF THE NATIONAL

468
00:18:19,429 --> 00:18:20,863
COORDINATOR IN CENTER FOR

469
00:18:20,863 --> 00:18:21,964
MEDICARE AND MEDICAID SERVICES,

470
00:18:21,964 --> 00:18:24,233
THE FDA, AND THE NIH.

471
00:18:24,233 --> 00:18:26,769
AND SO WE'RE FORTUNATE ENOUGH TO

472
00:18:26,769 --> 00:18:28,971
HAVE STEPHANIE GARCIA FROM ONC

473
00:18:28,971 --> 00:18:33,476
JOINING US TODAY, ALONG WITH 

474
00:18:33,476 --> 00:18:39,048
DOCTORS TRISH BRIGHT AND LEILA

475
00:18:39,048 --> 00:18:41,517
TAHEEN AND DR. VANCE AND CHIN

476
00:18:41,517 --> 00:18:42,085
FROM NICHD.

477
00:18:42,085 --> 00:18:43,720
WHERE WE'D LIKE TO LAND AT THE

478
00:18:43,720 --> 00:18:46,589
END OF THE TIME TOGETHER IN

479
00:18:46,589 --> 00:18:49,325
MARCHING IS AN UNDERSTANDING

480
00:18:49,325 --> 00:18:51,928
WHICH RECOMMENDATIONS HAVE BEEN

481
00:18:51,928 --> 00:18:53,896
FULFILLED, WE'LL CODE AS GREEN;

482
00:18:53,896 --> 00:18:55,131
WHICH RECOMMENDATIONS ARE IN

483
00:18:55,131 --> 00:18:57,667
PROGRESS OR PLANNED, BUT HAVE A

484
00:18:57,667 --> 00:19:00,603
CLEARLY DEFINED OWNER OR OWNERS

485
00:19:00,603 --> 00:19:01,704
AROUND SUFFICIENT EVIDENCE

486
00:19:01,704 --> 00:19:03,406
POINTING TO A TIMELINE FOR THEIR

487
00:19:03,406 --> 00:19:04,741
EXECUTION, AND THOSE WILL BE

488
00:19:04,741 --> 00:19:07,276
CODED IN YELLOW.

489
00:19:07,276 --> 00:19:07,944
AND FINALLY WHICH

490
00:19:07,944 --> 00:19:09,145
RECOMMENDATIONS HAVEN'T SEEN ANY

491
00:19:09,145 --> 00:19:10,880
REAL GAINS.

492
00:19:10,880 --> 00:19:12,181
AND THIS CATEGORY COULD INCLUDE

493
00:19:12,181 --> 00:19:15,385
ACTIVITIES THAT HAVE BEEN

494
00:19:15,385 --> 00:19:17,987
OUTSOURCED OR COMPLETED EYE

495
00:19:17,987 --> 00:19:19,422
OTHER GROUPS OR PERHAPS NO

496
00:19:19,422 --> 00:19:20,857
LONGER MAKE SENSE TO PURSUE.

497
00:19:20,857 --> 00:19:23,025
THIS DIAGRAM WILL SERVE AS THE

498
00:19:23,025 --> 00:19:24,694
FRAMEWORK ON WHICH WE'LL

499
00:19:24,694 --> 00:19:25,762
CONSTRUCT OUR REPORT.

500
00:19:25,762 --> 00:19:27,630
THERE IS ONE MORE COLOR THAT WE

501
00:19:27,630 --> 00:19:29,265
HOPE NOT TO NEED, BUT IS

502
00:19:29,265 --> 00:19:31,667
AVAILABLE TO US, AND THAT IS

503
00:19:31,667 --> 00:19:32,135
WHITE.

504
00:19:32,135 --> 00:19:35,071
AND THAT WOULD MEAN THAT WE

505
00:19:35,071 --> 00:19:37,373
HAVEN'T ASSEMBLED THE ADEQUATE

506
00:19:37,373 --> 00:19:39,108
INFORMATION TO MAKE A

507
00:19:39,108 --> 00:19:40,910
DETERMINATION ABOUT THAT

508
00:19:40,910 --> 00:19:41,644
RECOMMENDATION STATUS.

509
00:19:41,644 --> 00:19:43,045
THAT ALSO MEANS THAT OUR GROUP

510
00:19:43,045 --> 00:19:45,114
WILL NEED TO DO ADDITIONAL WORK

511
00:19:45,114 --> 00:19:47,583
OFFLINE TO IDENTIFY THE CORRECT

512
00:19:47,583 --> 00:19:49,419
DATA SOURCES AND REVIEW THE

513
00:19:49,419 --> 00:19:50,420
MATERIALS THEY PROVIDE US SO

514
00:19:50,420 --> 00:19:54,223
THAT WE CAN MOVE THAT INTO A

515
00:19:54,223 --> 00:19:56,359
DEFINITIVE DETERMINATION.

516
00:19:56,359 --> 00:19:57,960
NEXT SLIDE PLEASE.

517
00:19:57,960 --> 00:19:59,495
SO, HOW WE PLAN TO ATTACK THE

518
00:19:59,495 --> 00:20:01,464
CHALLENGES BY WORKING THROUGH

519
00:20:01,464 --> 00:20:04,200
OUR ASSESSMENT OF PROGRESS MADE.

520
00:20:04,200 --> 00:20:05,268
THE SUBRECOMMENDATIONS, SO YOU

521
00:20:05,268 --> 00:20:12,074
CAN SEE ON THIS PICTOGRAPH WE'VE

522
00:20:12,074 --> 00:20:13,609
BROKEN OUT RECOMMENDATION 1 INTO

523
00:20:13,609 --> 00:20:14,210
FIVE MAIN SUBRECOMMENDATIONS.

524
00:20:14,210 --> 00:20:17,380
IF YOU DO THE MATH IN YOUR HEAD,

525
00:20:17,380 --> 00:20:19,415
WE'RE TALKING ABOUT 40

526
00:20:19,415 --> 00:20:20,116
SUBRECOMMENDATIONS OVER THE

527
00:20:20,116 --> 00:20:22,385
COURSE OF FOUR HALF DAYS THAT

528
00:20:22,385 --> 00:20:23,820
WE'RE TOGETHER, WHICH IS A LOT

529
00:20:23,820 --> 00:20:26,222
OF GROUND TO COVER, IN A

530
00:20:26,222 --> 00:20:28,724
RELATIVELY SMALL PERIOD OF TIME.

531
00:20:28,724 --> 00:20:31,027
AND BECAUSE OF THE DOMAINS THAT

532
00:20:31,027 --> 00:20:33,196
ARE RELEVANT TO EACH GUEST

533
00:20:33,196 --> 00:20:35,164
SPEAKER WILL VARY, WE ALSO DON'T

534
00:20:35,164 --> 00:20:36,732
HAVE THE LUXURY OF HAVING THEM

535
00:20:36,732 --> 00:20:39,368
PRESENT IN THE ORDER THAT WE

536
00:20:39,368 --> 00:20:41,003
FIND THE RECOMMENDATIONS AND

537
00:20:41,003 --> 00:20:42,972
IMPLEMENTATION PLAN DOCUMENT.

538
00:20:42,972 --> 00:20:45,174
SO, IT WILL YOUR RESPONSIBILITY

539
00:20:45,174 --> 00:20:48,211
AS WORKING GROUP MEMBERS TO

540
00:20:48,211 --> 00:20:48,945
FAMILIARIZE YOURSELF WITH

541
00:20:48,945 --> 00:20:49,846
RECOMMENDATIONS WE'RE COVERING

542
00:20:49,846 --> 00:20:52,281
IN ANY GIVEN MEETING AHEAD OF

543
00:20:52,281 --> 00:20:54,016
TIME AND RECORD YOUR THOUGHTS

544
00:20:54,016 --> 00:20:54,884
ACROSS THE RELEVANT

545
00:20:54,884 --> 00:20:55,985
RECOMMENDATIONS AS WE HEAR FROM

546
00:20:55,985 --> 00:20:58,488
OUR SPEAKERS.

547
00:20:58,488 --> 00:21:00,356
I'M I'VE GOT A MATRIX IN FRONT

548
00:21:00,356 --> 00:21:02,592
OF ME TO TAKE NOTES AS WE MOVE

549
00:21:02,592 --> 00:21:04,961
THROUGH OUR SPEAKERS TODAY.

550
00:21:04,961 --> 00:21:06,062
RECOMMENDATION 12, WE'LL BE

551
00:21:06,062 --> 00:21:08,030
CONSIDERING PROGRESS MADE IN THE

552
00:21:08,030 --> 00:21:11,200
AREA OF EHR SYSTEMS, COMMON DATA

553
00:21:11,200 --> 00:21:12,535
ELEMENTS, DATABASE AND REGISTRY

554
00:21:12,535 --> 00:21:14,470
INFRASTRUCTURE, AND REAL WORLD

555
00:21:14,470 --> 00:21:16,772
DATA ANALYTICS.

556
00:21:16,772 --> 00:21:18,975
NEXT SLIDE PLEASE.

557
00:21:18,975 --> 00:21:20,710
FOR RECOMMENDATION 13, WE'LL

558
00:21:20,710 --> 00:21:22,044
DRILL DEEPER INTO THE REGISTRY

559
00:21:22,044 --> 00:21:25,114
SPACE AND FOCUS ON PROGRESS MADE

560
00:21:25,114 --> 00:21:27,950
AS RELATED TO STANDARDS,

561
00:21:27,950 --> 00:21:29,585
TRANSPARENCY, CONSTRUCTION, AND

562
00:21:29,585 --> 00:21:30,086
ACCESS.

563
00:21:30,086 --> 00:21:31,320
SO THE OPERATIVE PHRASE TO KEEP

564
00:21:31,320 --> 00:21:34,957
IN MIND AS WE WORK THROUGH THE

565
00:21:34,957 --> 00:21:35,925
RECOMMENDATIONS IS

566
00:21:35,925 --> 00:21:37,727
IMPLEMENTATION PROGRESS, DR.

567
00:21:37,727 --> 00:21:39,529
BIANCHI MENTIONED WE'RE NOT

568
00:21:39,529 --> 00:21:42,365
REFRAMING OR REVISING THE

569
00:21:42,365 --> 00:21:42,732
RECOMMENDATIONS.

570
00:21:42,732 --> 00:21:43,799
WE'RE SIMPLY EVALUATING WHETHER

571
00:21:43,799 --> 00:21:45,468
AND TO WHAT EXTENT THEY HAVE

572
00:21:45,468 --> 00:21:46,769
BEEN ADDRESSED.

573
00:21:46,769 --> 00:21:49,805
SO, AS YOU LISTEN TO SPEAKERS,

574
00:21:49,805 --> 00:21:52,108
START CATALOGING THE ACTIVITIES

575
00:21:52,108 --> 00:21:54,076
IN THEIR RESPECTIVE

576
00:21:54,076 --> 00:21:55,044
SUBRECOMMENDATION CATEGORIES, I

577
00:21:55,044 --> 00:21:56,812
WOULD ALSO ENCOURAGE YOU TO JOT

578
00:21:56,812 --> 00:21:57,813
DOWN ANY THOUGHTS OR QUESTIONS

579
00:21:57,813 --> 00:22:00,216
THAT YOU HAVE FOR THE SPEAKERS,

580
00:22:00,216 --> 00:22:01,951
AND PREPARE TO POST THEM IN THE

581
00:22:01,951 --> 00:22:03,553
CHAT, IF YOU FIND THEY HAVE NOT

582
00:22:03,553 --> 00:22:06,122
BEEN RESOLVED AT THE END OF THE

583
00:22:06,122 --> 00:22:06,422
DISCUSSION.

584
00:22:06,422 --> 00:22:07,757
SUGGESTING THAT WE RELY HEAVILY

585
00:22:07,757 --> 00:22:10,259
ON THE CHAT FEATURE, NOT ONLY TO

586
00:22:10,259 --> 00:22:11,360
FACILITATE EFFICIENCY DURING THE

587
00:22:11,360 --> 00:22:13,362
MEETING BUT ALSO TO KEEP A

588
00:22:13,362 --> 00:22:14,897
WORKING RECORD OF THE

589
00:22:14,897 --> 00:22:17,199
INFORMATION THE COMMITTEE WANTS

590
00:22:17,199 --> 00:22:18,601
TO SEE, IN THE EVENT OUR TIME

591
00:22:18,601 --> 00:22:21,003
RUNS SHORT AND ADDITIONAL

592
00:22:21,003 --> 00:22:21,637
OFFLINE REVIEW OR DELIBERATIONS

593
00:22:21,637 --> 00:22:23,306
WILL BE REQUIRED.

594
00:22:23,306 --> 00:22:26,576
AS WE GO ALONG YOU MIGHT

595
00:22:26,576 --> 00:22:27,777
IDENTIFY OTHER ENTITIES

596
00:22:27,777 --> 00:22:28,544
ADDRESSING THESE

597
00:22:28,544 --> 00:22:30,513
RECOMMENDATIONS, AND WE WANT TO

598
00:22:30,513 --> 00:22:31,614
CAPTURE THOSE OBSERVATIONS AS

599
00:22:31,614 --> 00:22:33,049
WELL BECAUSE WE MAY NEED TO

600
00:22:33,049 --> 00:22:35,117
REACH OUT TO THOSE ENTITIES IF

601
00:22:35,117 --> 00:22:37,520
WE FEEL MORE OR ADDITIONAL

602
00:22:37,520 --> 00:22:38,955
INFORMATION IS NEEDED.

603
00:22:38,955 --> 00:22:41,691
FINALLY, EVEN THOUGH WE'RE NOT

604
00:22:41,691 --> 00:22:42,124
TASKED WITH MAKING

605
00:22:42,124 --> 00:22:44,093
RECOMMENDATIONS WE MAY HAVE

606
00:22:44,093 --> 00:22:45,728
KNOWLEDGE OF OR CONCERN ABOUT

607
00:22:45,728 --> 00:22:47,363
MAJOR BARRIERS THAT WOULD

608
00:22:47,363 --> 00:22:48,664
PREVENT A RECOMMENDATION FROM

609
00:22:48,664 --> 00:22:50,566
BEING REALIZED, WE WANT TO

610
00:22:50,566 --> 00:22:52,201
CAPTURE THAT DISCUSSION AS WELL.

611
00:22:52,201 --> 00:22:53,936
SO I'M GOING TO STOP HERE AND

612
00:22:53,936 --> 00:22:55,705
OPEN THE FLOOR TO QUESTIONS THAT

613
00:22:55,705 --> 00:22:58,007
YOU MAY HAVE FOR CHRISTINA OR

614
00:22:58,007 --> 00:23:00,710
MYSELF ABOUT OUR ROLE OR THE

615
00:23:00,710 --> 00:23:02,612
PROGRESS, BEFORE WE ACTUALLY GET

616
00:23:02,612 --> 00:23:05,314
READY AND GET UNDERWAY.

617
00:23:05,314 --> 00:23:08,184
 

618
00:23:08,184 --> 00:23:09,585
>> I JUST WANTED TO SAY I
THINK

619
00:23:09,585 --> 00:23:12,989
IT'S GREAT THAT YOU CLARIFIED

620
00:23:12,989 --> 00:23:15,057
THAT WE'RE NOT GOING TO CHANGE

621
00:23:15,057 --> 00:23:18,694
ANY OF THE ALREADY ESTABLISHED

622
00:23:18,694 --> 00:23:19,061
RECOMMENDATIONS.

623
00:23:19,061 --> 00:23:21,397
>> THANK YOU, ALLISON.

624
00:23:21,397 --> 00:23:26,769
 

625
00:23:26,769 --> 00:23:29,205
>> ANY OTHER QUESTIONS FOR

626
00:23:29,205 --> 00:23:29,839
CHRISTINA OR MYSELF?

627
00:23:29,839 --> 00:23:31,841
THEY CAN ALWAYS GO IN THE CHAT

628
00:23:31,841 --> 00:23:32,675
AS WELL.

629
00:23:32,675 --> 00:23:34,243
BOTH CHRISTINA AND I WILL BE

630
00:23:34,243 --> 00:23:35,745
MONITORING THE CHAT THROUGHOUT

631
00:23:35,745 --> 00:23:37,079
THE AFTERNOON AS WE'RE

632
00:23:37,079 --> 00:23:39,682
MODERATING THESE SESSIONS.

633
00:23:39,682 --> 00:23:44,520
 

634
00:23:44,520 --> 00:23:44,787
ALL RIGHT.

635
00:23:44,787 --> 00:23:46,155
HEARING NONE, CHRISTINA, I'LL

636
00:23:46,155 --> 00:23:48,557
ASK YOU DO WE NEED TO TAKE A

637
00:23:48,557 --> 00:23:52,028
QUICK STRETCH BREAK OR GET

638
00:23:52,028 --> 00:23:52,261
STARTED?

639
00:23:52,261 --> 00:23:55,031
>> MY RECOMMENDATION WOULD
BE TO

640
00:23:55,031 --> 00:23:55,297
JUMP IN.

641
00:23:55,297 --> 00:23:56,098
>> OKAY.

642
00:23:56,098 --> 00:23:58,434
LET'S GO.

643
00:23:58,434 --> 00:24:04,407
 

644
00:24:04,407 --> 00:24:09,879
 

645
00:24:09,879 --> 00:24:11,614
 

646
00:24:11,614 --> 00:24:12,848
HOPEFULLY EVERYBODY HAS ENOUGH

647
00:24:12,848 --> 00:24:13,716
ENERGY AND NUTRITION ON BOARD TO

648
00:24:13,716 --> 00:24:15,484
GET US THROUGH THE FIRST ROUND

649
00:24:15,484 --> 00:24:17,453
OF SPEAKERS.

650
00:24:17,453 --> 00:24:19,121
WITH A HEAVY LIFTING BEGINNING

651
00:24:19,121 --> 00:24:21,090
NOW, STAY ALERT, BE PREPARED,

652
00:24:21,090 --> 00:24:23,125
PLEASE STAY WITH US.

653
00:24:23,125 --> 00:24:25,761
THIS FIRST SESSION WE'LL BE

654
00:24:25,761 --> 00:24:26,962
HEARING PRIMARILY FROM

655
00:24:26,962 --> 00:24:27,963
REPRESENTATIVES OF NICHD, BOTH

656
00:24:27,963 --> 00:24:30,599
SPEAKERS WILL BE TOUCHING ON

657
00:24:30,599 --> 00:24:31,233
ELEMENTS OF RECOMMENDATIONS 12

658
00:24:31,233 --> 00:24:34,303
AND 13, SO I WOULD ENCOURAGE YOU

659
00:24:34,303 --> 00:24:37,239
TO HAVE SUBRECOMMENDATIONS CLOSE

660
00:24:37,239 --> 00:24:38,574
AT HAND WHICH WOULD HELP YOU

661
00:24:38,574 --> 00:24:40,109
ORGANIZE YOUR THOUGHTS AND

662
00:24:40,109 --> 00:24:40,376
QUESTIONS.

663
00:24:40,376 --> 00:24:42,078
AGAIN, HAVE THEM IN FRONT OF

664
00:24:42,078 --> 00:24:43,479
YOU, START TAKING NOTES.

665
00:24:43,479 --> 00:24:44,680
LET'S FIGURE OUT WHAT WE'RE

666
00:24:44,680 --> 00:24:46,348
HEARING FROM OUR SPEAKERS.

667
00:24:46,348 --> 00:24:47,750
PLEASE, PLEASE, PLEASE MAKE

668
00:24:47,750 --> 00:24:49,652
LIBERAL USE OF THE CHAT FEATURE

669
00:24:49,652 --> 00:24:51,053
FOR QUESTIONS.

670
00:24:51,053 --> 00:24:55,324
IF THEY REMAIN UNADDRESSED AFTER

671
00:24:55,324 --> 00:24:56,325
THE SPEAKERS CONCLUDE.

672
00:24:56,325 --> 00:24:58,194
AS THOUGHTS COME TO MIND LET'S

673
00:24:58,194 --> 00:25:00,362
HEAR THAT SPEAKER THROUGH

674
00:25:00,362 --> 00:25:01,197
COMPLETELY, THEN POST ADDITIONAL

675
00:25:01,197 --> 00:25:03,632
QUESTIONS IN THE CHAT.

676
00:25:03,632 --> 00:25:08,571
RIGHT NOW LEADING OFF WILL BE

677
00:25:08,571 --> 00:25:10,906
KATIE VANCE.

678
00:25:10,906 --> 00:25:11,507
TAKE IT AWAY.

679
00:25:11,507 --> 00:25:13,642
>> I'M GOING TO SHARE MY
SCREEN.

680
00:25:13,642 --> 00:25:17,546
GIVE ME A SECOND.

681
00:25:17,546 --> 00:25:23,586
 

682
00:25:23,586 --> 00:25:28,624
 

683
00:25:28,624 --> 00:25:31,160
I'M GOING TO PRESENT WORK TO

684
00:25:31,160 --> 00:25:32,461
LEVERAGE LARGE DATASETS,

685
00:25:32,461 --> 00:25:35,297
INCLUDING REAL WORLD EVIDENCE,

686
00:25:35,297 --> 00:25:40,169
I'M KATIE VANCE, PROGRAM OFFICER

687
00:25:40,169 --> 00:25:45,608
IN OBSTETRIC AND PEDIATRIC

688
00:25:45,608 --> 00:25:47,176
FARMOLOGY AND THERAPEUTICS

689
00:25:47,176 --> 00:25:47,610
BRANCH.

690
00:25:47,610 --> 00:25:53,716
RESEARCH FOR PREGNANT AND

691
00:25:53,716 --> 00:25:55,117
LACTATING AND POSTPARTUM

692
00:25:55,117 --> 00:25:58,020
POPULATIONS CONTINUES TO LAG.

693
00:25:58,020 --> 00:25:59,321
THIS SUMMER NICHD SURVEYED

694
00:25:59,321 --> 00:26:01,724
PROGRAM OFFICERS AND KEY NIH

695
00:26:01,724 --> 00:26:04,293
STAKEHOLDERS IN MATERNAL AND

696
00:26:04,293 --> 00:26:05,027
PEDIATRIC PHARMACOLOGY AND

697
00:26:05,027 --> 00:26:05,361
THERAPEUTICS.

698
00:26:05,361 --> 00:26:08,798
ONE OF THE QUESTIONS WE ASKED

699
00:26:08,798 --> 00:26:11,467
WAS WHAT THEY PERCEIVE TO BE

700
00:26:11,467 --> 00:26:17,306
MAJOR CHALLENGES FOR PROGRESS 

701
00:26:17,306 --> 00:26:18,741
FOR THESE PATIENT POPULATIONS.

702
00:26:18,741 --> 00:26:21,143
THEY IDENTIFY A NUMBER OF

703
00:26:21,143 --> 00:26:22,444
CHALLENGES, INCLUDING ETHICAL

704
00:26:22,444 --> 00:26:24,847
CONCERNS, LACK OF PATIENT

705
00:26:24,847 --> 00:26:27,149
PARTICIPATION IN RESEARCH,

706
00:26:27,149 --> 00:26:29,051
SAMPLE COLLECTION METHODOLOGIES,

707
00:26:29,051 --> 00:26:31,353
NEED FOR NOVEL STUDY DESIGNS,

708
00:26:31,353 --> 00:26:34,390
SHORTAGE IN RESEARCH WORK FORCE,

709
00:26:34,390 --> 00:26:37,660
LACK OF APPROPRIATE PRE-CLINICAL

710
00:26:37,660 --> 00:26:37,893
MODELS.

711
00:26:37,893 --> 00:26:38,861
THE MAJOR TAKEHOME MESSAGE FROM

712
00:26:38,861 --> 00:26:40,930
THE SURVEY OF OUR NIH

713
00:26:40,930 --> 00:26:43,866
STAKEHOLDERS IS THAT WE NEED

714
00:26:43,866 --> 00:26:45,067
NOVEL METHODOLOGIES INCLUDING

715
00:26:45,067 --> 00:26:48,237
UTILIZATION OF EXISTING LARGE

716
00:26:48,237 --> 00:26:50,573
DATASETS TO PROMOTE INNOVATION

717
00:26:50,573 --> 00:26:53,409
AND RESEARCH FOR PREGNANT AND

718
00:26:53,409 --> 00:26:54,810
LACTATING AND POSTPARTUM

719
00:26:54,810 --> 00:26:55,144
PERSONS.

720
00:26:55,144 --> 00:26:57,446
THERE'S BEEN A LOT OF GROWING

721
00:26:57,446 --> 00:26:59,315
MOMENTUM AND REAL WORLD DATA AND

722
00:26:59,315 --> 00:27:01,951
REAL WORLD EVIDENCE ACROSS

723
00:27:01,951 --> 00:27:03,085
SCIENCE AND MEDICINE.

724
00:27:03,085 --> 00:27:05,988
THAT'S DRIVEN BY A NUMBER OF

725
00:27:05,988 --> 00:27:06,422
FACTORS.

726
00:27:06,422 --> 00:27:10,159
THERE ARE EMERGING AI/ML AND

727
00:27:10,159 --> 00:27:10,793
OTHER TECHNOLOGIES THAT

728
00:27:10,793 --> 00:27:11,794
FACILITATE THE EXTRACTION OF

729
00:27:11,794 --> 00:27:16,599
DATA AND ANALYSES OF THESE DATA.

730
00:27:16,599 --> 00:27:17,366
RECENT LEGISLATION INCLUDING

731
00:27:17,366 --> 00:27:20,769
21ST CENTURY CURES ACT OF 2016

732
00:27:20,769 --> 00:27:23,172
WHICH HAS BEEN ENACTED, THE 21ST

733
00:27:23,172 --> 00:27:26,809
CENTURY CURES ACT WAS DESIGNED

734
00:27:26,809 --> 00:27:28,644
ACCELERATE MEDICAL PRODUCT

735
00:27:28,644 --> 00:27:30,312
DEVELOPMENT AND BRING INNOVATION

736
00:27:30,312 --> 00:27:31,747
FASTER AND MORE EFFICIENTLY.

737
00:27:31,747 --> 00:27:33,916
THE FDA HAS A REAL WORLD

738
00:27:33,916 --> 00:27:36,452
EVIDENCE PROGRAM AND NUMBER OF

739
00:27:36,452 --> 00:27:37,486
GUIDANCE DOCUMENTS SURROUNDING

740
00:27:37,486 --> 00:27:39,688
THE USE OF REAL WORLD DATA AND

741
00:27:39,688 --> 00:27:41,790
REAL WORLD EVIDENCE TO GUIDE

742
00:27:41,790 --> 00:27:43,092
REGULATORY DECISION MAKING FOR

743
00:27:43,092 --> 00:27:47,229
DRUGS AND OTHER BIOLOGICAL

744
00:27:47,229 --> 00:27:47,696
PRODUCTS.

745
00:27:47,696 --> 00:27:49,565
THE 2023 DATA MANAGEMENT AND

746
00:27:49,565 --> 00:27:53,369
SHARING POLICY IS GOING TO BE

747
00:27:53,369 --> 00:27:54,603
VERY IMPORTANT TO THE

748
00:27:54,603 --> 00:27:55,905
GENERATIONS OF LARGE DATASETS AS

749
00:27:55,905 --> 00:27:58,874
WELL AS SECONDARY USE OF LARGE

750
00:27:58,874 --> 00:27:59,174
DATASETS.

751
00:27:59,174 --> 00:28:01,377
WE'LL SEE A LOT OF DATA

752
00:28:01,377 --> 00:28:03,445
AVAILABLE COMING UP IN THE NEXT

753
00:28:03,445 --> 00:28:04,446
FEW YEARS FOR THE RESEARCH

754
00:28:04,446 --> 00:28:06,548
COMMUNITY TO USE AND LEVERAGE TO

755
00:28:06,548 --> 00:28:11,387
FIND NEW DISCOVERIES, NEW 

756
00:28:11,387 --> 00:28:13,555
TREATMENTS, NEW CURES.

757
00:28:13,555 --> 00:28:15,424
AND THEN THERE'S BEEN A RECENT

758
00:28:15,424 --> 00:28:21,430
DEMONSTRATION OF THE UTILITY OF 

759
00:28:21,430 --> 00:28:25,501
REAL WORLD EVIDENCE, IN 2021EN

760
00:28:25,501 --> 00:28:27,703
APPROVED FOR USE, USING REAL

761
00:28:27,703 --> 00:28:30,539
WORLD EVIDENCE, DATA CAN BE USED

762
00:28:30,539 --> 00:28:31,407
TO IDENTIFY TREATMENTS FOR

763
00:28:31,407 --> 00:28:32,074
PATIENTS.

764
00:28:32,074 --> 00:28:34,810
IN THE LAST FEW YEARS NICHD DATA

765
00:28:34,810 --> 00:28:37,212
SCIENCE PORTFOLIO AND REAL WORLD

766
00:28:37,212 --> 00:28:39,081
EVIDENCE PORTFOLIO HAVE BEEN

767
00:28:39,081 --> 00:28:39,315
GROWING.

768
00:28:39,315 --> 00:28:42,818
THIS IS A SNAPSHOT OF SOME OF

769
00:28:42,818 --> 00:28:44,586
THE AWARDED COMPETING GRANTS

770
00:28:44,586 --> 00:28:46,755
INVOLVING DATA SCIENCE OR REAL

771
00:28:46,755 --> 00:28:50,592
WORLD EVIDENCE STUDIES IN

772
00:28:50,592 --> 00:28:51,493
PREGNANT, LACTATING, POSTPARTUM

773
00:28:51,493 --> 00:28:52,127
PERSONS SINCE 2013.

774
00:28:52,127 --> 00:28:56,598
YOU CAN SEE A BIG UPTICK IN THE

775
00:28:56,598 --> 00:28:59,335
NUMBER OF AWARDS NICHD HAS MADE,

776
00:28:59,335 --> 00:29:03,272
AND DATA SCIENCE AND REAL WORLD

777
00:29:03,272 --> 00:29:04,473
EVIDENCE PORTFOLIO.

778
00:29:04,473 --> 00:29:10,045
WE WANT TO CONTINUE THIS

779
00:29:10,045 --> 00:29:13,215
MOMENTUM AND ENCOURAGE

780
00:29:13,215 --> 00:29:14,450
EXTRAMURAL COMMUNITY TO LEVERAGE

781
00:29:14,450 --> 00:29:15,851
LARGE DATASETS AND WE'RE DOING

782
00:29:15,851 --> 00:29:19,121
THAT IN A NUMBER OF DIFFERENT

783
00:29:19,121 --> 00:29:19,788
WAYS.

784
00:29:19,788 --> 00:29:25,594
WE ARE ISSUES FUNDING

785
00:29:25,594 --> 00:29:26,695
ANNOUNCEMENTS, RECRUITING NEW

786
00:29:26,695 --> 00:29:28,564
PROGRAMS, WORKING WITH EXISTING

787
00:29:28,564 --> 00:29:30,332
PROGRAMS, WORKING WITH OTHER NIH

788
00:29:30,332 --> 00:29:31,633
PARTNERS TO HAVE TRANS-NIH

789
00:29:31,633 --> 00:29:32,601
COLLABORATION TO ENCOURAGE

790
00:29:32,601 --> 00:29:33,702
EXTRAMURAL COMMUNITIES TO

791
00:29:33,702 --> 00:29:35,037
LEVERAGE DATASETS, AND WE'RE

792
00:29:35,037 --> 00:29:37,539
ALSO RELYING ON OUR NICHD

793
00:29:37,539 --> 00:29:38,140
RESOURCES.

794
00:29:38,140 --> 00:29:42,244
SO TODAY I'M GOING TO SHARE A

795
00:29:42,244 --> 00:29:45,881
FEW OF THESE EFFORTS NICHD HAS

796
00:29:45,881 --> 00:29:50,152
USED TO PROMOTE USE MUCH REAL 

797
00:29:50,152 --> 00:29:53,322
WORLD DATA AND EVIDENCE FOR

798
00:29:53,322 --> 00:29:54,823
PREGNANT, LACTATING, POSTPARTUM

799
00:29:54,823 --> 00:29:55,391
PERSONS.

800
00:29:55,391 --> 00:29:57,126
FIRST IS TRANSLATIONAL RESEARCH

801
00:29:57,126 --> 00:29:58,327
IN MATERNAL AND PEDIATRIC

802
00:29:58,327 --> 00:30:08,837
PHARMACOLOGY AND THEY ARE -- 

803
00:30:09,938 --> 00:30:11,507
THERAPEUTIC OPPORTUNITIES,

804
00:30:11,507 --> 00:30:16,879
STARTED IN 2009, REVISED IN 2023

805
00:30:16,879 --> 00:30:21,383
TO FOCUS ON PRGLAC

806
00:30:21,383 --> 00:30:21,917
RECOMMENDATIONS, INCLUDING

807
00:30:21,917 --> 00:30:23,519
ENCOURAGEMENT TO SUBMIT FOR

808
00:30:23,519 --> 00:30:26,288
FUNDING ANNOUNCEMENTS FOCUS ON

809
00:30:26,288 --> 00:30:27,589
DEVELOPMENT OF NOVEL

810
00:30:27,589 --> 00:30:30,559
GENERALIZABLE TOOLS, MODELS,

811
00:30:30,559 --> 00:30:31,660
OTHER TECHNOLOGIES, AND THE

812
00:30:31,660 --> 00:30:33,362
SPECIFIC REQUEST THAT WE HAD

813
00:30:33,362 --> 00:30:35,097
WITH THESE FUNDING ANNOUNCEMENTS

814
00:30:35,097 --> 00:30:36,698
WAS ENCOURAGING INVESTIGATORS TO

815
00:30:36,698 --> 00:30:37,833
SUBMIT APPLICATIONS RELATED TO

816
00:30:37,833 --> 00:30:39,501
THINGS LIKE MACHINE LEARNING

817
00:30:39,501 --> 00:30:42,971
MODELS THAT INCORPORATE LARGE

818
00:30:42,971 --> 00:30:43,972
DATASETS LIKE MULTI-OMICS OR

819
00:30:43,972 --> 00:30:46,275
CLINICAL DATA, TO SUBMIT

820
00:30:46,275 --> 00:30:47,976
APPLICATIONS FOR MODELS THAT

821
00:30:47,976 --> 00:30:49,211
UTILIZE REAL WORLD DATA.

822
00:30:49,211 --> 00:30:52,481
TOOLS AND OTHER RESOURCES THAT

823
00:30:52,481 --> 00:30:54,016
UTILIZE PHARMACO EPIDATA, AND

824
00:30:54,016 --> 00:30:56,752
OTHER METHODOLOGIES SUCH AS

825
00:30:56,752 --> 00:31:02,124
AI/ML OR NLP POOLS TO FACILITATE

826
00:31:02,124 --> 00:31:05,627
DATA EXTRACTION, HARMONIZATION,

827
00:31:05,627 --> 00:31:06,095
AND INTEROPERABILITY,

828
00:31:06,095 --> 00:31:06,829
INCREASINGLY MORE USED IN THE

829
00:31:06,829 --> 00:31:08,597
RESEARCH COMMUNITY AND WE WOULD

830
00:31:08,597 --> 00:31:10,566
LIKE TO LEVERAGE TECHNOLOGIES

831
00:31:10,566 --> 00:31:14,369
AND CAPABILITIES FOR OUR PATIENT

832
00:31:14,369 --> 00:31:15,804
POPULATIONS OF INTEREST.

833
00:31:15,804 --> 00:31:16,772
THERE ARE THREE APPLICATIONS

834
00:31:16,772 --> 00:31:19,074
THAT I WOULD LIKE TO TALK ABOUT.

835
00:31:19,074 --> 00:31:23,545
THREE AWARDS THAT WE HAVE FUNDED

836
00:31:23,545 --> 00:31:25,314
THROUGH OUR TRANSLATIONAL

837
00:31:25,314 --> 00:31:30,152
RESEARCH PARS THAT SPECIFICALLY

838
00:31:30,152 --> 00:31:32,121
DEAL WITH LEVERAGING HR, CLAIMS,

839
00:31:32,121 --> 00:31:34,289
OTHER REAL WORLD DATA AND REAL

840
00:31:34,289 --> 00:31:38,560
WORLD EVIDENCE IN PREGNANT,

841
00:31:38,560 --> 00:31:39,094
LACTATING, AND POSTPARTUM

842
00:31:39,094 --> 00:31:42,598
PERSONS, FIRST IS THE BOOST-HP

843
00:31:42,598 --> 00:31:43,031
STUDY.

844
00:31:43,031 --> 00:31:46,768
IT WAS AWARDED TO DR. JUDITH

845
00:31:46,768 --> 00:31:48,504
MARO, AND THIS PARTICULAR AWARD

846
00:31:48,504 --> 00:31:51,006
USES PRIVATE AND PUBLIC CLAIMS

847
00:31:51,006 --> 00:31:55,310
DATA TO EVALUATE THE ASSOCIATION

848
00:31:55,310 --> 00:32:01,183
BETWEEN PREGNANCY LOSS AND 

849
00:32:01,183 --> 00:32:01,750
TERATOGENIC RISK, THREAT

850
00:32:01,750 --> 00:32:03,352
EXPOSURE, EVALUATING EXPOSURES

851
00:32:03,352 --> 00:32:04,853
AND OUTCOMES SIMULTANEOUSLY.

852
00:32:04,853 --> 00:32:06,889
AND THE LONG-TERM GOAL OF THE

853
00:32:06,889 --> 00:32:09,625
AWARD IS TO BUILD A REUSABLE

854
00:32:09,625 --> 00:32:11,393
SCALABLE APPROACH AND

855
00:32:11,393 --> 00:32:12,227
INFRASTRUCTURE TO ACCELERATE

856
00:32:12,227 --> 00:32:14,096
EVIDENCE GENERATION ON THE

857
00:32:14,096 --> 00:32:17,399
SAFETY AND EFFECTIVENESS OF 

858
00:32:17,399 --> 00:32:20,235
MEDICATION USE DURING PREGNANCY.

859
00:32:20,235 --> 00:32:22,738
THE NEXT AWARD THAT WAS GIVEN

860
00:32:22,738 --> 00:32:26,808
OUT THIS SUMMER WAS DR. BEJAN,

861
00:32:26,808 --> 00:32:28,310
AND IT'S THE LEVERAGE ARTIFICIAL

862
00:32:28,310 --> 00:32:29,444
INTELLIGENCE METHODS AND

863
00:32:29,444 --> 00:32:31,613
ELECTRONIC HEALTH RECORDS FOR

864
00:32:31,613 --> 00:32:32,714
PEDIATRIC PHARMACOVIGILANCE.

865
00:32:32,714 --> 00:32:37,419
A MAJOR PART OF THIS AWARD IS TO

866
00:32:37,419 --> 00:32:41,657
EVALUATE THE IMPACT OF DRUG

867
00:32:41,657 --> 00:32:43,759
EXPOSURE BEFORE AND DURING

868
00:32:43,759 --> 00:32:45,761
PREGNANCY ON PEDIATRIC OUTCOMES.

869
00:32:45,761 --> 00:32:48,997
SO THIS PARTICULAR AWARD HAS A

870
00:32:48,997 --> 00:32:50,199
VERY LARGE COMPONENT ABOUT THE

871
00:32:50,199 --> 00:32:55,170
IMPACT OF DRUGS ON PREGNANCY.

872
00:32:55,170 --> 00:32:56,905
FINALLY THE MATERNAL COVID-19

873
00:32:56,905 --> 00:32:59,007
VACCINATION AND LACTATION

874
00:32:59,007 --> 00:33:01,710
OUTSOME STUDY BY DR. KRISTIN

875
00:33:01,710 --> 00:33:03,912
PALMER, THE INVESTIGATORS WILL

876
00:33:03,912 --> 00:33:05,781
USE EHR RECORDS LINKED WITH

877
00:33:05,781 --> 00:33:07,282
STATE IMMUNIZATION RECORDS

878
00:33:07,282 --> 00:33:08,083
ACROSS MULTIPLE HEALTH SYSTEMS,

879
00:33:08,083 --> 00:33:13,188
AND THEY ARE GOING TO LOOK AT

880
00:33:13,188 --> 00:33:16,258
HOW MATERNAL VACCINATION IMPACTS

881
00:33:16,258 --> 00:33:18,927
INFANT GROWTH, INFANT CARE,

882
00:33:18,927 --> 00:33:21,530
OTHER PREGNANCY AND POSTNATAL

883
00:33:21,530 --> 00:33:22,331
THINGS, MASTITIS, BREASTFEEDING

884
00:33:22,331 --> 00:33:27,102
STATUS, AND THE GOAL IS TO

885
00:33:27,102 --> 00:33:29,838
COLLECT DATA AND INFORMATION

886
00:33:29,838 --> 00:33:32,874
BOTH TO SUPPORT VACCINATION

887
00:33:32,874 --> 00:33:35,644
DURING PREGNANCY AS WELL AS TO

888
00:33:35,644 --> 00:33:37,813
MITIGATE SOME FEAR RELATED TO

889
00:33:37,813 --> 00:33:39,047
VACCINATION DURING PREGNANCY.

890
00:33:39,047 --> 00:33:41,883
THESE ARE SOME EXAMPLES OF SOME

891
00:33:41,883 --> 00:33:43,085
INVESTIGATOR-INITIATED

892
00:33:43,085 --> 00:33:44,853
APPLICATIONS THAT WERE SUBMITTED

893
00:33:44,853 --> 00:33:47,389
TO A FUNDING ANNOUNCEMENT AT

894
00:33:47,389 --> 00:33:49,124
NICHD UTILIZING REAL WORLD DATA

895
00:33:49,124 --> 00:33:50,559
AND REAL WORLD EVIDENCE.

896
00:33:50,559 --> 00:33:53,729
NEXT I'D LIKE TO TALK ABOUT SOME

897
00:33:53,729 --> 00:33:55,364
EXISTING PROGRAMS, DR. BIANCHI

898
00:33:55,364 --> 00:33:56,698
ALREADY MENTIONED THE MPRINT

899
00:33:56,698 --> 00:33:56,865
HUB.

900
00:33:56,865 --> 00:33:58,433
I'D LIKE TO COVER A LITTLE BIT

901
00:33:58,433 --> 00:34:01,837
OF THE WORK THE MPRINT HUB IS

902
00:34:01,837 --> 00:34:02,170
DOING.

903
00:34:02,170 --> 00:34:04,473
SO, IT WAS ESTABLISHED TO

904
00:34:04,473 --> 00:34:07,075
CATALYZE RESEARCH IN MATERNAL

905
00:34:07,075 --> 00:34:09,945
AND PEDIATRIC PRECISION

906
00:34:09,945 --> 00:34:10,379
THERAPEUTICS.

907
00:34:10,379 --> 00:34:12,981
IT'S COMPRISED OF DATA MODEL

908
00:34:12,981 --> 00:34:13,482
KNOWLEDGE AND RESEARCH

909
00:34:13,482 --> 00:34:16,285
COORDINATION CENTER, AS WELL AS

910
00:34:16,285 --> 00:34:18,186
VANDERBILT AND UCSD CENTERS OF

911
00:34:18,186 --> 00:34:18,754
EXCELLENCE.

912
00:34:18,754 --> 00:34:24,159
REAL WORLD EVIDENCE IS A

913
00:34:24,159 --> 00:34:25,727
CROSS-CUTTING CONCERN ACROSS ALL

914
00:34:25,727 --> 00:34:26,561
OF OUR THREE CENTERS.

915
00:34:26,561 --> 00:34:28,630
FOR THE SAKE OF TIME, I'M JUST

916
00:34:28,630 --> 00:34:30,799
GOING TO FOCUS ON THE WORK THAT

917
00:34:30,799 --> 00:34:36,505
THE CARE C.C. IS DOING IN REAL

918
00:34:36,505 --> 00:34:42,444
WORLD EVIDENCE.

919
00:34:42,444 --> 00:34:46,148
THE FIRST CORE FOR THE KRCC IS

920
00:34:46,148 --> 00:34:47,883
OUR REAL WORLD EVIDENCE CORE.

921
00:34:47,883 --> 00:34:49,851
THE REAL WORLD EVIDENCE CORE

922
00:34:49,851 --> 00:34:52,821
USES REAL WORLD DATA RESOURCES

923
00:34:52,821 --> 00:34:54,356
TO CHARACTERIZE, STUDY, ADDRESS

924
00:34:54,356 --> 00:34:57,125
RESEARCH QUESTIONS RELATED TO

925
00:34:57,125 --> 00:34:58,527
MATERNAL AND PEDIATRIC

926
00:34:58,527 --> 00:35:00,162
PHYSIOLOGY, PHARMACOLOGY,

927
00:35:00,162 --> 00:35:01,163
CLINICAL OUTCOMES, THE ULTIMATE

928
00:35:01,163 --> 00:35:05,867
GOAL IS TO ENHANCE DRUG SAFETY

929
00:35:05,867 --> 00:35:06,401
AND EFFICACY.

930
00:35:06,401 --> 00:35:08,370
NOW, OFTEN MOTHERS AND INFANTS

931
00:35:08,370 --> 00:35:09,705
ARE TREATED AT MORE THAN ONE

932
00:35:09,705 --> 00:35:11,473
HOSPITAL, EVEN MORE THAN ONE

933
00:35:11,473 --> 00:35:12,107
HOSPITAL SYSTEM.

934
00:35:12,107 --> 00:35:14,376
AND SO WE KNOW THAT IT'S VERY

935
00:35:14,376 --> 00:35:16,678
DIFFICULT TO TRACK MATERNAL AND

936
00:35:16,678 --> 00:35:19,414
CHILD DYADS FROM PREGNANCY

937
00:35:19,414 --> 00:35:20,282
THROUGHOUT ADULTHOOD.

938
00:35:20,282 --> 00:35:23,685
THE CORE IS DEVELOPING A LINKAGE

939
00:35:23,685 --> 00:35:25,420
ALGORITHM FOR MATERNAL INFANT

940
00:35:25,420 --> 00:35:28,190
RECORDS THAT WILL FACILITATE

941
00:35:28,190 --> 00:35:30,258
RESEARCHERS IN EVALUATION OF

942
00:35:30,258 --> 00:35:32,894
ASSOCIATION BETWEEN MATERNAL

943
00:35:32,894 --> 00:35:34,329
EXPOSURE AND LONG-TERM PEDIATRIC

944
00:35:34,329 --> 00:35:37,065
OUTCOMES, EVEN WHEN THE MOTHER

945
00:35:37,065 --> 00:35:38,800
AND CHILD ARE TREATED ACROSS

946
00:35:38,800 --> 00:35:41,737
DIFFERENT HEALTH SYSTEMS.

947
00:35:41,737 --> 00:35:43,605
THE ULTIMATE GOAL OF THE SCORE

948
00:35:43,605 --> 00:35:46,775
TO CREATE A CURATED

949
00:35:46,775 --> 00:35:55,450
MATERNAL-PEDIATRIC DATA MART.

950
00:35:55,450 --> 00:35:57,619
DATA WILL INCLUDE INFORMATION

951
00:35:57,619 --> 00:35:59,154
RELEVANT TO UNDERSTAND DRUG

952
00:35:59,154 --> 00:36:01,123
DISPOSITION AND RESPONSE, AND AS

953
00:36:01,123 --> 00:36:02,791
WELL AS SUPPORT DRUG DEVELOPMENT

954
00:36:02,791 --> 00:36:08,029
AND THERAPEUTICS AND MATERNAL

955
00:36:08,029 --> 00:36:09,898
AND PEDIATRIC POPULATIONS.

956
00:36:09,898 --> 00:36:15,837
ANOTHER CORE OF THE KRCC IS

957
00:36:15,837 --> 00:36:17,572
KNOWLEDGE BASE AND PORTAL CORE

958
00:36:17,572 --> 00:36:18,774
LED BY DR. LI.

959
00:36:18,774 --> 00:36:20,409
ONE THING WE HEAR IS WE KNOW THE

960
00:36:20,409 --> 00:36:22,277
DATA ARE OUT THERE BUT WE JUST

961
00:36:22,277 --> 00:36:24,679
DON'T KNOW WHERE TO FIND IT.

962
00:36:24,679 --> 00:36:27,949
AND ONE OF THE GOALS FOR THIS

963
00:36:27,949 --> 00:36:29,718
PARTICULAR CORE IS TO DEVELOP A

964
00:36:29,718 --> 00:36:32,320
KNOWLEDGE BASE OF DATA AND

965
00:36:32,320 --> 00:36:36,825
RESOURCES, RELATED TO MATERNAL

966
00:36:36,825 --> 00:36:44,499
AND PEDIATRIC THERAPEUTICS, 

967
00:36:44,499 --> 00:36:46,768
INCLUDING PHARMACOKINETICS,

968
00:36:46,768 --> 00:36:48,003
PHARMACODYNAMICS, PEDIATRIC

969
00:36:48,003 --> 00:36:48,870
ONTOGENY WITH PREGNANCY AND

970
00:36:48,870 --> 00:36:49,237
LACTATION.

971
00:36:49,237 --> 00:36:52,574
WHAT THE CORE IS GOING TO DO IS

972
00:36:52,574 --> 00:36:53,475
INTEGRATE DATA SOURCES PUBLICLY

973
00:36:53,475 --> 00:36:56,745
AVAILABLE AND IT'S GOING TO HELP

974
00:36:56,745 --> 00:36:58,380
OUR RESEARCH COMMUNITY ASSESS

975
00:36:58,380 --> 00:37:00,248
THE QUALITY, RELIABILITY, AS

976
00:37:00,248 --> 00:37:06,855
WELL AS GAPS IN EVIDENCE,

977
00:37:06,855 --> 00:37:08,023
SUPPORT TRANSLATIONAL RESEARCH.

978
00:37:08,023 --> 00:37:09,891
I THINK THIS IS GOING TO GO A

979
00:37:09,891 --> 00:37:11,860
LONG WAY TO SHOWING RESEARCH

980
00:37:11,860 --> 00:37:13,295
COMMUNITY WHAT'S OUT THERE, AND

981
00:37:13,295 --> 00:37:17,432
WHAT ELSE WE NEED TO FIND OUT.

982
00:37:17,432 --> 00:37:19,100
 

983
00:37:19,100 --> 00:37:24,172
NOW I'D LIKE TO TALK ABOUT A NEW

984
00:37:24,172 --> 00:37:25,907
PROGRAM, SO THE IMPROVE PROGRAM

985
00:37:25,907 --> 00:37:28,043
MATERNAL HEALTH RESEARCH CENTERS

986
00:37:28,043 --> 00:37:32,347
OF EXCELLENCE INITIATED THIS

987
00:37:32,347 --> 00:37:33,114
YEAR.

988
00:37:33,114 --> 00:37:34,950
THESE ARE TEN RESEARCH CENTERS,

989
00:37:34,950 --> 00:37:38,587
DATA INNOVATION AND COORDINATION

990
00:37:38,587 --> 00:37:39,354
HUB.

991
00:37:39,354 --> 00:37:40,989
AND IMPLEMENTATION SCIENCE HUB.

992
00:37:40,989 --> 00:37:42,624
TOGETHER THESE INSTITUTIONS WILL

993
00:37:42,624 --> 00:37:45,126
WORK TOGETHER TO DESIGN AND

994
00:37:45,126 --> 00:37:48,396
IMPLEMENT RESEARCH PROJECTS TO

995
00:37:48,396 --> 00:37:50,065
ADDRESS BIOLOGICAL BEHAVIORAL,

996
00:37:50,065 --> 00:37:53,235
ENVIRONMENTAL, SOCIOCULTURAL AND

997
00:37:53,235 --> 00:37:54,035
STRUCTURAL FACTORS THAT AFFECT

998
00:37:54,035 --> 00:37:54,669
PREGNANCY-RELATED COMPLICATIONS

999
00:37:54,669 --> 00:37:55,537
AND DEATH.

1000
00:37:55,537 --> 00:37:57,606
WE'LL FOCUS ON POPULATIONS THAT

1001
00:37:57,606 --> 00:37:58,373
EXPERIENCE HEALTH DISPARITIES

1002
00:37:58,373 --> 00:38:01,977
INCLUDING RACIAL AND ETHNIC

1003
00:38:01,977 --> 00:38:03,044
MINORITIES, ECONOMICALLY

1004
00:38:03,044 --> 00:38:04,079
CHALLENGED DISADVANTAGED

1005
00:38:04,079 --> 00:38:05,146
POPULATIONS, THOSE LIVING IN

1006
00:38:05,146 --> 00:38:07,782
UNDERSERVED RURAL AREAS, SEXUAL

1007
00:38:07,782 --> 00:38:09,985
AND GENDER MINORITY POPULATIONS,

1008
00:38:09,985 --> 00:38:11,653
AND PEOPLE WITH DISABILITIES.

1009
00:38:11,653 --> 00:38:14,155
AND THE CENTER I'D LIKE TO FOCUS

1010
00:38:14,155 --> 00:38:17,459
ON TODAY IS THE DATA INNOVATION

1011
00:38:17,459 --> 00:38:19,828
AND COORDINATION CENTER.

1012
00:38:19,828 --> 00:38:21,329
THE DATA HUB WILL DO A LOT OF

1013
00:38:21,329 --> 00:38:25,000
WORK IN THE REAL WORLD EVIDENCE

1014
00:38:25,000 --> 00:38:26,501
AND LARGE DATASET SPACE.

1015
00:38:26,501 --> 00:38:28,169
SO THEY WILL FACILITATE

1016
00:38:28,169 --> 00:38:29,804
HARMONIZATION WITH EXISTING

1017
00:38:29,804 --> 00:38:34,409
LARGE SCALE RESEARCH EFFORTS.

1018
00:38:34,409 --> 00:38:35,844
AND DATA TYPES THAT THESE

1019
00:38:35,844 --> 00:38:38,146
CENTERS AND DATA COORDINATION

1020
00:38:38,146 --> 00:38:40,081
HUB WILL WORK WITH INCLUDE REAL

1021
00:38:40,081 --> 00:38:43,485
WORLD DATA SUCH AS ELECTRONIC

1022
00:38:43,485 --> 00:38:46,321
HEALTH RECORDS, CLAIMS DATA,

1023
00:38:46,321 --> 00:38:51,259
PATIENT REGISTRIES, VITAL

1024
00:38:51,259 --> 00:38:53,028
STATISTICS AND SURVEILLANCE,

1025
00:38:53,028 --> 00:38:55,330
HOUSEHOLD SURVEYS, CENSUS DATA

1026
00:38:55,330 --> 00:38:56,731
AND SO FORTH.

1027
00:38:56,731 --> 00:38:59,034
THE INNOVATION AND COORDINATION

1028
00:38:59,034 --> 00:39:01,436
HUB WILL UTILIZE EXISTING

1029
00:39:01,436 --> 00:39:03,638
STANDARDS, AND FACILITATE

1030
00:39:03,638 --> 00:39:04,606
EXTRACTION AND TRANSFORMATION OF

1031
00:39:04,606 --> 00:39:06,942
DATA AS WELL AS DEVELOP METHODS

1032
00:39:06,942 --> 00:39:10,412
TO EXTRACT REAL WORLD DATA FROM

1033
00:39:10,412 --> 00:39:11,846
EHR RECORDS, PREDICTION AND RISK

1034
00:39:11,846 --> 00:39:14,049
ASSESSMENT, AS WELL AS DEVELOP

1035
00:39:14,049 --> 00:39:17,285
OTHER METHODOLOGIES USING AI/ML

1036
00:39:17,285 --> 00:39:19,054
AND DATA SCIENCE APPROACHES,

1037
00:39:19,054 --> 00:39:22,657
WITH EMPHASIS ON APPROACHES THAT

1038
00:39:22,657 --> 00:39:23,858
HAVE BALANCED ETHICAL CONCERNS

1039
00:39:23,858 --> 00:39:27,462
FOR THESE TOOLS SO WE DON'T

1040
00:39:27,462 --> 00:39:28,863
EXACERBATE ALREADY EXISTING

1041
00:39:28,863 --> 00:39:29,631
HEALTHCARE DISPARITIES.

1042
00:39:29,631 --> 00:39:32,300
AND WE'RE ALSO GOING TO PROVIDE

1043
00:39:32,300 --> 00:39:33,635
EXPERTISE AND INFRASTRUCTURE

1044
00:39:33,635 --> 00:39:38,306
NEEDED FOR DATA MANAGEMENT

1045
00:39:38,306 --> 00:39:39,307
INCLUDING STANDARDIZED

1046
00:39:39,307 --> 00:39:40,508
ACQUISITION, HARMONIZATION,

1047
00:39:40,508 --> 00:39:42,377
QUALITY ROLE, TIMELY

1048
00:39:42,377 --> 00:39:44,779
DISSEMINATION AND PUBLIC

1049
00:39:44,779 --> 00:39:45,513
ACCESSIBILITY TO THESE DATA,

1050
00:39:45,513 --> 00:39:46,748
IMPORTANT FOR US TO BE ABLE TO

1051
00:39:46,748 --> 00:39:48,583
COLLECT THE DATA IN A WAY THAT

1052
00:39:48,583 --> 00:39:50,018
MAKES IT REASONABLE AS WELL AS

1053
00:39:50,018 --> 00:39:53,355
TO SHARE THE DATA FOR FUTURE

1054
00:39:53,355 --> 00:39:54,823
USE.

1055
00:39:54,823 --> 00:39:58,793
 

1056
00:39:58,793 --> 00:40:01,096
I'D NEXT LIKE TO TOUCH ON

1057
00:40:01,096 --> 00:40:01,997
TRANS-NIH COLLABORATIONS THAT

1058
00:40:01,997 --> 00:40:04,265
NICHD IS WORKING ON RIGHT NOW

1059
00:40:04,265 --> 00:40:09,204
THAT PROMOTE THE USE OF LARGE

1060
00:40:09,204 --> 00:40:09,471
DATASETS.

1061
00:40:09,471 --> 00:40:13,375
THE FIRST I'D LIKE TO SPEAK

1062
00:40:13,375 --> 00:40:15,143
ABOUT IS HUMAN GENETICS

1063
00:40:15,143 --> 00:40:15,410
AMPLIFIER.

1064
00:40:15,410 --> 00:40:19,481
THIS IS A SOFTWARE PLATFORM AND

1065
00:40:19,481 --> 00:40:21,249
INFRASTRUCTURE THAT AGGREGATES,

1066
00:40:21,249 --> 00:40:23,518
INTEGRATES, ANALYZES LARGE HUMAN

1067
00:40:23,518 --> 00:40:24,719
GENETIC AND GENOMIC DATASETS.

1068
00:40:24,719 --> 00:40:26,788
IT'S A SERIES OF KNOWLEDGE

1069
00:40:26,788 --> 00:40:29,324
PORTALS THAT ALLOW THE PUBLIC TO

1070
00:40:29,324 --> 00:40:32,394
IDENTIFY NEW DRUG TARGETS,

1071
00:40:32,394 --> 00:40:34,462
BIOMARKERS, OTHER BIOLOGICAL

1072
00:40:34,462 --> 00:40:39,501
PARADIGMS, AND RECENTLY THE

1073
00:40:39,501 --> 00:40:40,468
REPRODUCTIVE SYSTEM KNOWLEDGE

1074
00:40:40,468 --> 00:40:41,569
PORTAL BECAME AVAILABLE AND THE

1075
00:40:41,569 --> 00:40:45,306
GOAL OF THESE PORTALS IS TO HELP

1076
00:40:45,306 --> 00:40:47,075
RESEARCHERS ANSWER THE QUESTION,

1077
00:40:47,075 --> 00:40:48,710
THE HUMAN GENETIC AND GENOMIC

1078
00:40:48,710 --> 00:40:49,611
RESULTS PROVIDE EVIDENCE ABOUT

1079
00:40:49,611 --> 00:40:51,546
THE INVOLVEMENT OF THE GENE OF

1080
00:40:51,546 --> 00:40:53,281
INTEREST IN A DISEASE TRAIT, SO

1081
00:40:53,281 --> 00:40:55,917
THIS IS A COLLABORATION THAT WE

1082
00:40:55,917 --> 00:40:59,621
HAVE WORKED WITH, IT'S A

1083
00:40:59,621 --> 00:41:00,622
PUBLIC/PRIVATE PARTNERSHIP

1084
00:41:00,622 --> 00:41:02,057
COLLABORATION, OTHER INSTITUTES

1085
00:41:02,057 --> 00:41:04,125
FNIH, AND OTHER INDUSTRY

1086
00:41:04,125 --> 00:41:05,360
PARTNERS HAVE WORKED TOGETHER

1087
00:41:05,360 --> 00:41:06,461
AND VERY EXCITED ABOUT THE

1088
00:41:06,461 --> 00:41:10,799
RECENT RELEASE OF THE 

1089
00:41:10,799 --> 00:41:12,333
REPRODUCTIVE SYSTEM KNOWLEDGE

1090
00:41:12,333 --> 00:41:12,567
PORTAL.

1091
00:41:12,567 --> 00:41:13,301
ANOTHER PROGRAM THAT I'D LIKE TO

1092
00:41:13,301 --> 00:41:17,372
MAKE YOU AWARE OF IS THE

1093
00:41:17,372 --> 00:41:19,207
COMPLEMENT ANIMAL RESEARCH AND

1094
00:41:19,207 --> 00:41:20,308
EXPERIMENTATION, COMPLEMENTARY

1095
00:41:20,308 --> 00:41:20,542
PROGRAM.

1096
00:41:20,542 --> 00:41:23,344
RIGHT NOW THE NIH IS CONDUCTING

1097
00:41:23,344 --> 00:41:25,246
PLANNING ACTIVITIES TO INFORM A

1098
00:41:25,246 --> 00:41:30,618
POTENTIAL COMMON FUND PROGRAM

1099
00:41:30,618 --> 00:41:32,153
CALLED COMPLEMENT-ARIE TO

1100
00:41:32,153 --> 00:41:32,687
CATALYZE DEVELOPMENT

1101
00:41:32,687 --> 00:41:33,988
STANDARDIZATION VALIDATION AND

1102
00:41:33,988 --> 00:41:38,293
USE OF NEW APPROACH METHODS.

1103
00:41:38,293 --> 00:41:41,096
SOMETIMES ALSO CALLED NOVEL

1104
00:41:41,096 --> 00:41:41,663
ALTERNATIVE METHODOLOGIES,

1105
00:41:41,663 --> 00:41:41,996
NAMs.

1106
00:41:41,996 --> 00:41:44,299
AND ONE OF THE METHODOLOGIES

1107
00:41:44,299 --> 00:41:48,336
THEY ARE PROMOTING IS IN SILICO

1108
00:41:48,336 --> 00:41:49,237
MODELS, SO COMPUTATIONAL MODELS

1109
00:41:49,237 --> 00:41:51,539
BUILT WITH REAL WORLD EVIDENCE

1110
00:41:51,539 --> 00:41:53,208
OR OTHER COMPLEX DATASETS.

1111
00:41:53,208 --> 00:41:55,009
NICHD HAS REPRESENTATION ON THE

1112
00:41:55,009 --> 00:41:57,212
WORKING GROUP, AND HAS MADE SURE

1113
00:41:57,212 --> 00:42:02,350
THAT PREGNANT PERSONS AND 

1114
00:42:02,350 --> 00:42:04,219
REPRODUCTIVE HEALTH ARE

1115
00:42:04,219 --> 00:42:04,519
REPRESENTED.

1116
00:42:04,519 --> 00:42:05,353
THEY LAUNCHED A CHALLENGE IN

1117
00:42:05,353 --> 00:42:07,489
EARLY NOVEMBER THAT ENDS IN

1118
00:42:07,489 --> 00:42:10,658
JANUARY, SELECTING UP TO 20

1119
00:42:10,658 --> 00:42:12,861
PRIZE WINNERS TO DEMONSTRATE

1120
00:42:12,861 --> 00:42:15,463
WAYS TO CONDUCT BASIC RESEARCH

1121
00:42:15,463 --> 00:42:21,903
UNCOVER DISEASE  MECHANISM, INTO

1122
00:42:21,903 --> 00:42:27,275
DISEASE METHODS AND PRACTICE.

1123
00:42:27,275 --> 00:42:31,646
THE LAST TRANS-NIH COLLABORATION

1124
00:42:31,646 --> 00:42:34,849
IS THE CONSORTIUM N-PERC TO

1125
00:42:34,849 --> 00:42:37,152
IMPROVE CHILD HEALTH, RESEARCH

1126
00:42:37,152 --> 00:42:37,685
COLLABORATION.

1127
00:42:37,685 --> 00:42:41,356
BUT RECENTLY APPROVED THE

1128
00:42:41,356 --> 00:42:42,757
ESTABLISHMENT OF A SUBGROUP

1129
00:42:42,757 --> 00:42:50,532
FOCUSING ON PEDIATRIC AND

1130
00:42:50,532 --> 00:42:58,006
MATERNAL PHARMACOLOGY, OFTEN

1131
00:42:58,006 --> 00:43:04,546
VERY MUCH LINKED.

1132
00:43:04,546 --> 00:43:05,313
LEVERAGING DATASETS,

1133
00:43:05,313 --> 00:43:07,515
REPOSITORIES, AND DATA SCIENCE,

1134
00:43:07,515 --> 00:43:09,250
MAKING A NICE TRANS-NIH EFFORT,

1135
00:43:09,250 --> 00:43:10,885
A SPACE TO COMMUNICATE AND

1136
00:43:10,885 --> 00:43:11,986
COLLABORATION, COME UP WITH

1137
00:43:11,986 --> 00:43:17,225
IDEAS TO HELP IMPROVE THE HEALTH

1138
00:43:17,225 --> 00:43:20,295
OF PREGNANT, LACTATING, AND

1139
00:43:20,295 --> 00:43:20,728
POSTPARTUM PERSONS.

1140
00:43:20,728 --> 00:43:22,597
FINALLY I'D LIKE TO TALK ABOUT A

1141
00:43:22,597 --> 00:43:25,233
RESOURCE WE HAVE HERE AT NICHD,

1142
00:43:25,233 --> 00:43:25,433
DASH.

1143
00:43:25,433 --> 00:43:27,735
I'M SURE MANY IF NOT ALL OF YOU

1144
00:43:27,735 --> 00:43:29,904
ARE FAMILIAR WITH DASH.

1145
00:43:29,904 --> 00:43:31,573
THIS IS OUR CENTRALIZED

1146
00:43:31,573 --> 00:43:32,540
REPOSITORY FOR SHARING

1147
00:43:32,540 --> 00:43:36,744
DE-IDENTIFIED HUMAN DATA AND

1148
00:43:36,744 --> 00:43:39,147
BIOSPECIMENS FOR STUDIES FUNDED

1149
00:43:39,147 --> 00:43:40,982
FROM NICHD.

1150
00:43:40,982 --> 00:43:45,153
AT THE MOMENT THE DASH CONTAINS 

1151
00:43:45,153 --> 00:43:47,455
MORE THAN 210 STUDIES, MORE THAN

1152
00:43:47,455 --> 00:43:49,324
50 STUDY TOPICS, HAS APPROVED

1153
00:43:49,324 --> 00:43:54,028
MORE THAN 600 DATA REUSE

1154
00:43:54,028 --> 00:43:55,496
REQUESTS FROM 16 COUNTRIES

1155
00:43:55,496 --> 00:43:56,531
RESULTING IN NEARLY 100

1156
00:43:56,531 --> 00:44:01,002
PUBLICATIONS, AND WE CONTINUE TO

1157
00:44:01,002 --> 00:44:03,771
IMPROVE DASH TO MODERNIZE, MAKE

1158
00:44:03,771 --> 00:44:06,574
SURE WE MAXIMIZE THE FAIRNESS OF

1159
00:44:06,574 --> 00:44:10,311
OUR DATA SO THE FUNDABILITY,

1160
00:44:10,311 --> 00:44:11,946
ACCESSIBILITY, INTEROPERABILITY

1161
00:44:11,946 --> 00:44:15,683
AND REUSABILITY OF DATA IN DASH.

1162
00:44:15,683 --> 00:44:18,453
THE ULTIMATE GOAL OF NICHD'S

1163
00:44:18,453 --> 00:44:21,489
EFFORTS AND THE REAL WORLD DATA

1164
00:44:21,489 --> 00:44:25,860
AND REAL WORLD EVIDENCE BASE ARE

1165
00:44:25,860 --> 00:44:26,127
MANY-FOLD.

1166
00:44:26,127 --> 00:44:28,029
WE WOULD LIKE TO EXPAND ACCESS

1167
00:44:28,029 --> 00:44:30,665
TO DATA AND GROW OUR DATA

1168
00:44:30,665 --> 00:44:32,967
ECOSYSTEM, AND BY DOING SO WE

1169
00:44:32,967 --> 00:44:36,671
CAN IDENTIFY NOVEL THERAPEUTIC

1170
00:44:36,671 --> 00:44:39,107
TARGETS, NOVEL BIOMARKERS,

1171
00:44:39,107 --> 00:44:41,075
DEVELOP TOOLS, ALGORITHMS,

1172
00:44:41,075 --> 00:44:42,410
SOFTWARE, AND ULTIMATELY INFORM

1173
00:44:42,410 --> 00:44:44,345
LEARNING HEALTH SYSTEMS AND

1174
00:44:44,345 --> 00:44:45,647
IMPROVE REPRODUCTIVE HEALTH

1175
00:44:45,647 --> 00:44:51,586
OUTCOMES FOR OUR PATIENT

1176
00:44:51,586 --> 00:44:51,886
POPULATIONS.

1177
00:44:51,886 --> 00:44:53,788
THANK YOU FOR YOUR TIME AND

1178
00:44:53,788 --> 00:44:55,423
OPPORTUNITY TO PRESENT NICHD'S

1179
00:44:55,423 --> 00:44:56,691
EFFORTS, AND LEVERAGING LARGE

1180
00:44:56,691 --> 00:44:58,593
DATASETS AND REAL WORLD DATA.

1181
00:44:58,593 --> 00:44:59,527
THANK YOU SO MUCH.

1182
00:44:59,527 --> 00:45:00,995
>> KATIE, THANK YOU VERY
MUCH.

1183
00:45:00,995 --> 00:45:03,197
WE WILL HOLD QUESTIONS UNTIL WE

1184
00:45:03,197 --> 00:45:04,599
GET THROUGH OUR NEXT

1185
00:45:04,599 --> 00:45:06,367
PRESENTATION.

1186
00:45:06,367 --> 00:45:12,040
SO I'D LIKE TO INVITE DR. CHEN.

1187
00:45:12,040 --> 00:45:13,808
>> THERE ARE SOME
CLARIFICATION

1188
00:45:13,808 --> 00:45:15,009
QUESTIONS ASKED, WONDERING IF IT

1189
00:45:15,009 --> 00:45:19,580
MAKES SENSE TO DO THOSE NOW.

1190
00:45:19,580 --> 00:45:23,751
>> I THINK WE CAN HOLD
THOSE AND

1191
00:45:23,751 --> 00:45:25,720
MAKE THOSE BROADER BY WAY OF

1192
00:45:25,720 --> 00:45:33,094
WHAT THEY ARE ASKING, AND USE 

1193
00:45:33,094 --> 00:45:35,830
THOSE TO STIMULATE DISCUSSION.

1194
00:45:35,830 --> 00:45:41,202
>> A COUPLE WERE SPECIFIC
TO

1195
00:45:41,202 --> 00:45:42,737
STUDIES MENTIONED, BE AWARE.

1196
00:45:42,737 --> 00:45:47,175
>> DR. CHINN?

1197
00:45:47,175 --> 00:45:52,580
>> GOOD AFTERNOON. 

1198
00:45:52,580 --> 00:45:55,183
I'M TALKING TODAY ABOUT THE

1199
00:45:55,183 --> 00:45:55,917
PATIENT CENTERS OUTCOMES

1200
00:45:55,917 --> 00:46:03,624
RESEARCH PROJECT TRUST FUND

1201
00:46:03,624 --> 00:46:05,493
PROJECT PROPOSAL, THE MORBIDITY

1202
00:46:05,493 --> 00:46:09,430
AND MORTALITY ELECTRONIC HEALTH

1203
00:46:09,430 --> 00:46:12,600
RECORD DATA INFRASTRUCTURE

1204
00:46:12,600 --> 00:46:16,104
PROJECT CONDUCTED HERE AT NICHD

1205
00:46:16,104 --> 00:46:18,473
WITH LEADS THAT I'M PRESENTING

1206
00:46:18,473 --> 00:46:24,212
FOR TODAY, AND ALLISONER IS 

1207
00:46:24,212 --> 00:46:25,413
ALISON CERNICH.

1208
00:46:25,413 --> 00:46:27,148
THIS SPEAK TO RECOMMENDATION 12,

1209
00:46:27,148 --> 00:46:28,783
DESIGN HEALTH RECORD SYSTEMS TO

1210
00:46:28,783 --> 00:46:32,954
LINK MOTHER AND INFANT RECORDS.

1211
00:46:32,954 --> 00:46:34,255
IN THIS PRESENTATION I'LL TALK

1212
00:46:34,255 --> 00:46:38,526
ABOUT THE PROJECT AND STANDARDS

1213
00:46:38,526 --> 00:46:40,928
OVERVIEW AND ADDITIONAL

1214
00:46:40,928 --> 00:46:42,897
COMPONENT THAT WE SEE CALLED

1215
00:46:42,897 --> 00:46:44,866
MATERNAL HEALTH LINK, GOING INTO

1216
00:46:44,866 --> 00:46:50,571
DETAIL WITH THAT.

1217
00:46:50,571 --> 00:46:54,108
NEXT SLIDE PLEASE.

1218
00:46:54,108 --> 00:47:02,383
IN COLLABORATION WITH THE CDC, 

1219
00:47:02,383 --> 00:47:03,051
NLM, NATIONAL COORDINATOR

1220
00:47:03,051 --> 00:47:05,219
OFFICE, WE DECIDED TO PROPOSE TO

1221
00:47:05,219 --> 00:47:08,423
CREATE NEW DATA LINKAGES THAT

1222
00:47:08,423 --> 00:47:11,259
ALLOW FOR RESEARCH WITH THE

1223
00:47:11,259 --> 00:47:14,195
EFFECT OF PREGNANCY RISK FACTORS

1224
00:47:14,195 --> 00:47:16,831
ON PREGNANCY-RELATED HEALTH

1225
00:47:16,831 --> 00:47:18,800
OUTCOMES AND EFFECTS,

1226
00:47:18,800 --> 00:47:20,101
COMPLICATIONS DURING PREGNANCY,

1227
00:47:20,101 --> 00:47:22,503
LONGER-TERM POST PREGNANCY

1228
00:47:22,503 --> 00:47:25,606
HEALTH OUTCOMES.

1229
00:47:25,606 --> 00:47:27,675
WAYS TO COLLECT AND SHARE DATA

1230
00:47:27,675 --> 00:47:30,511
NEEDED TO ANALYZE HOW A WOMAN OR

1231
00:47:30,511 --> 00:47:36,984
BIRTHING PERSON OR PREGNANT AND

1232
00:47:36,984 --> 00:47:38,853
POSTPARTUM PERSON'S LONGITUDINAL

1233
00:47:38,853 --> 00:47:40,922
HISTORY, SOCIOECONOMIC STATUS,

1234
00:47:40,922 --> 00:47:42,657
DEMOGRAPHIC CHARACTERISTICS

1235
00:47:42,657 --> 00:47:44,258
AFFECT OUTCOMES FOR BIRTHING

1236
00:47:44,258 --> 00:47:50,298
PERSON OR THE  POSTPARTUM AND

1237
00:47:50,298 --> 00:47:51,499
PREGNANT INDIVIDUAL OR INFANT OR

1238
00:47:51,499 --> 00:47:52,100
INFANTS.

1239
00:47:52,100 --> 00:47:53,468
WE DEVELOPED A WAY TO

1240
00:47:53,468 --> 00:47:56,471
STANDARDIZE AND APPROACH TO LINK

1241
00:47:56,471 --> 00:47:57,538
ELECTRONIC HEALTH RECORDS AND

1242
00:47:57,538 --> 00:47:58,873
ELECTRONIC HEALTH DATA ON

1243
00:47:58,873 --> 00:48:01,375
MATERNAL AND INFANT HEALTH USE

1244
00:48:01,375 --> 00:48:03,044
FOR STUDYING IMPACTS OF THEIR

1245
00:48:03,044 --> 00:48:06,514
OUTCOMES OR MEDICAL CONDITIONS

1246
00:48:06,514 --> 00:48:07,115
AND INTERVENTIONS.

1247
00:48:07,115 --> 00:48:10,585
AND OUT OF THIS PROJECT WE

1248
00:48:10,585 --> 00:48:13,955
PRODUCED AN IMPLEMENTATION 

1249
00:48:13,955 --> 00:48:19,127
GUIDE, A FINAL HL7 OR A HEALTH

1250
00:48:19,127 --> 00:48:21,729
LEVEL 7 PUBLISHED STANDARD AND

1251
00:48:21,729 --> 00:48:22,630
DISTRIBUTED TO PARTNERS,

1252
00:48:22,630 --> 00:48:26,000
PUBLICLY AVAILABLE, AND WE

1253
00:48:26,000 --> 00:48:26,701
PILOTED THE STANDARD OR

1254
00:48:26,701 --> 00:48:28,536
IMPLEMENT GUIDE USING THE OPEN

1255
00:48:28,536 --> 00:48:31,172
SOURCE TOOL WHICH IS THAT

1256
00:48:31,172 --> 00:48:32,607
MATERNAL HEALTH THAT I MENTIONED

1257
00:48:32,607 --> 00:48:35,676
IN THE PREVIOUS SLIDE.

1258
00:48:35,676 --> 00:48:39,046
NEXT SLIDE PLEASE.

1259
00:48:39,046 --> 00:48:41,115
SO, THE LONGITUDINAL MATERNAL

1260
00:48:41,115 --> 00:48:45,286
AND INFANT HEALTH INFORMATION

1261
00:48:45,286 --> 00:48:48,656
FOR RESEARCH FHIR OR LET ME GET

1262
00:48:48,656 --> 00:48:53,528
THAT ACRONYM FOR YOU.

1263
00:48:53,528 --> 00:48:55,796
THE HEALTH CARE INTEROPERABILITY

1264
00:48:55,796 --> 00:48:57,465
RESOURCES, THE STANDARD FOR

1265
00:48:57,465 --> 00:49:00,201
EXCHANGING HEALTH CARE

1266
00:49:00,201 --> 00:49:02,703
INFORMATION AND HL7, FOR HEALTH

1267
00:49:02,703 --> 00:49:05,106
LEVEL 7, THE INTERNATIONAL

1268
00:49:05,106 --> 00:49:06,507
STANDARD FOR COMMUNICATING

1269
00:49:06,507 --> 00:49:09,076
ACROSS THE ELECTRONIC HEALTH

1270
00:49:09,076 --> 00:49:10,578
RECORDS AND MEDICAL RECORDS.

1271
00:49:10,578 --> 00:49:13,981
WE DECIDED TO CREATE THIS

1272
00:49:13,981 --> 00:49:14,949
FRAMEWORK AND THIS

1273
00:49:14,949 --> 00:49:17,285
IMPLEMENTATION GUIDE TO LINK THE

1274
00:49:17,285 --> 00:49:19,587
RECORDS TOGETHER, AND CREATE

1275
00:49:19,587 --> 00:49:21,222
THIS TOOL FOR RESEARCHERS, WE

1276
00:49:21,222 --> 00:49:24,859
USE TWO SPECIFIC USE CASES TO DO

1277
00:49:24,859 --> 00:49:25,526
THAT.

1278
00:49:25,526 --> 00:49:27,361
ONE IS ON HYPERTENSIVE DISORDERS

1279
00:49:27,361 --> 00:49:30,765
OF PREGNANCY, AND THE OTHER IS

1280
00:49:30,765 --> 00:49:32,166
PREGNANCY-ASSOCIATED MATERNAL

1281
00:49:32,166 --> 00:49:34,268
DEATHS, BECAUSE WE WANTED TO

1282
00:49:34,268 --> 00:49:36,204
LOOK AT SEVERE MATERNAL

1283
00:49:36,204 --> 00:49:41,142
MORBIDITY AS WELL AS MATERNAL

1284
00:49:41,142 --> 00:49:44,645
MORTALITY.

1285
00:49:44,645 --> 00:49:45,613
NEXT SLIDE PLEASE.

1286
00:49:45,613 --> 00:49:49,050
THIS PROJECT TOOK PLACE OVER A

1287
00:49:49,050 --> 00:49:50,885
2-YEAR PERIOD WHICH SOUNDS LIKE

1288
00:49:50,885 --> 00:49:54,722
A LONG TIME BUT FROM START TO

1289
00:49:54,722 --> 00:49:58,526
FINISH IT WAS AMAZINGLY RAPID.

1290
00:49:58,526 --> 00:50:01,896
SO WE STARTED IN 2021,

1291
00:50:01,896 --> 00:50:04,098
SOCIALIZING IMPLEMENTATION GUIDE

1292
00:50:04,098 --> 00:50:06,100
THAT WAS DEVELOPED AT HL7

1293
00:50:06,100 --> 00:50:09,370
WORKING GROUP MEETINGS AND WE

1294
00:50:09,370 --> 00:50:14,609
HAD A PHENOMENAL CONTRACTOR WITH

1295
00:50:14,609 --> 00:50:16,377
THIS PROCESS, THE CONSULTANT, WE

1296
00:50:16,377 --> 00:50:20,848
STARTED WITH THE PROJECT 

1297
00:50:20,848 --> 00:50:22,049
PROPOSAL, PROJECT SCOPE,

1298
00:50:22,049 --> 00:50:22,783
SOCIALIZING, INTRODUCED IT,

1299
00:50:22,783 --> 00:50:24,552
LOOKING FOR A RESPONSIBLE TORE.

1300
00:50:24,552 --> 00:50:26,087
WE WERE SPONSORED IN THE PUBLIC

1301
00:50:26,087 --> 00:50:29,023
HEALTH WORKING GROUP.

1302
00:50:29,023 --> 00:50:30,858
AND THEN THE NEXT CAME, THE

1303
00:50:30,858 --> 00:50:33,761
ITERATIVE PROCESS OF THE

1304
00:50:33,761 --> 00:50:38,032
IMPLEMENTATION GUIDE. 

1305
00:50:38,032 --> 00:50:39,367
SO WE RECEIVED FEEDBACK,

1306
00:50:39,367 --> 00:50:40,768
ENVIRONMENTAL SCAN, SAW WHAT

1307
00:50:40,768 --> 00:50:42,303
OTHER IMPLEMENTATION GUIDES WHY

1308
00:50:42,303 --> 00:50:44,171
AVAILABLE THAT WERE SIMILAR, HOW

1309
00:50:44,171 --> 00:50:46,474
WE OVERLAP, WHAT ARE WE ADDING,

1310
00:50:46,474 --> 00:50:49,210
THOSE SORTS OF THINGS,

1311
00:50:49,210 --> 00:50:49,777
STAKEHOLDER ENGAGEMENT,

1312
00:50:49,777 --> 00:50:52,613
TECHNICAL EXPERT PANEL WHICH

1313
00:50:52,613 --> 00:50:55,449
CONSISTED OF FEDERAL EXPERTS AS

1314
00:50:55,449 --> 00:50:57,218
WELL AS NON-FEDERAL EXPERTS AND

1315
00:50:57,218 --> 00:51:02,089
FEEDBACK FROM CONNECT-A-THONS,

1316
00:51:02,089 --> 00:51:03,224
VALIDATED COMMENTS, ANOTHER WAY

1317
00:51:03,224 --> 00:51:04,859
OF GETTING INPUT AND FEEDBACK

1318
00:51:04,859 --> 00:51:09,130
FROM THE EXPERTS IN THIS HL7

1319
00:51:09,130 --> 00:51:10,564
GUIDANCE, AND NON-VALID

1320
00:51:10,564 --> 00:51:12,099
COMMENTS, WHICH IS INFORMATION

1321
00:51:12,099 --> 00:51:16,937
AND FEEDBACK FROM PEERS, AS WELL

1322
00:51:16,937 --> 00:51:19,674
AS REPRESENTATIVES OF OTHER

1323
00:51:19,674 --> 00:51:23,277
SOURCES OF EXPERTISE.

1324
00:51:23,277 --> 00:51:27,548
SO WE GATHERED THAT FEEDBACK TO

1325
00:51:27,548 --> 00:51:29,183
INFORM IMPLEMENTATION GUIDE.

1326
00:51:29,183 --> 00:51:30,918
LIKE I SAID, WE VALIDATE THIS

1327
00:51:30,918 --> 00:51:37,591
PROCESS, WE USE THAT INFORMATION

1328
00:51:37,591 --> 00:51:39,627
TO FULLY DEVELOP IMPLEMENTATION

1329
00:51:39,627 --> 00:51:43,264
GUIDE IN JANUARY 2023 WE WERE

1330
00:51:43,264 --> 00:51:45,833
ABLE TO SEEK HL7 APPROVALS FOR

1331
00:51:45,833 --> 00:51:47,468
THE PUBLICATION OF THE

1332
00:51:47,468 --> 00:51:48,803
IMPLEMENTATION GUIDE WHICH IS IN

1333
00:51:48,803 --> 00:51:51,305
THE PUBLIC DOMAIN.

1334
00:51:51,305 --> 00:51:53,941
NEXT SLIDE PLEASE.

1335
00:51:53,941 --> 00:51:55,710
NEXT SLIDE PLEASE.

1336
00:51:55,710 --> 00:51:57,144
SO, FOR PILOTING ON THE ORIGINAL

1337
00:51:57,144 --> 00:52:00,081
START OF THE PROJECT WE THOUGHT

1338
00:52:00,081 --> 00:52:01,849
WE WOULD BE ABLE TO PILOT

1339
00:52:01,849 --> 00:52:04,452
THROUGH SEVERAL USE CASES LIKE I

1340
00:52:04,452 --> 00:52:06,454
SAID WE HAD TWO BUT I THINK WE

1341
00:52:06,454 --> 00:52:10,191
DEVELOPED A TOTAL OF EIGHT.

1342
00:52:10,191 --> 00:52:11,125
THAT CAME NOT FEASIBLE FOR WHAT

1343
00:52:11,125 --> 00:52:13,027
WE WERE DOING FOR THIS PROJECT

1344
00:52:13,027 --> 00:52:18,165
SO WE ROUNDED DOWN TO TWO USE

1345
00:52:18,165 --> 00:52:19,033
CASES.

1346
00:52:19,033 --> 00:52:22,970
AND I WANT TO EMPHASIZE THAT

1347
00:52:22,970 --> 00:52:26,040
THIS WAS A SIGNIFICANT

1348
00:52:26,040 --> 00:52:27,108
MILESTONE, THAT'S THE EXACT

1349
00:52:27,108 --> 00:52:33,247
LANGUAGE ON THE SLIDE BUT IT WAS

1350
00:52:33,247 --> 00:52:34,782
TRULY SIGNIFICANT, FIRST

1351
00:52:34,782 --> 00:52:35,349
LONGITUDINAL INFORMATION FOR

1352
00:52:35,349 --> 00:52:36,417
RESEARCH IMPLEMENTATION GUIDE.

1353
00:52:36,417 --> 00:52:38,519
WE WERE LINKING THE MATERNAL

1354
00:52:38,519 --> 00:52:40,154
RECORD WITH THE INFANT RECORD,

1355
00:52:40,154 --> 00:52:43,324
LINKING THE MATERNAL RECORD WITH

1356
00:52:43,324 --> 00:52:46,360
THE MATERNAL RECORDS FROM

1357
00:52:46,360 --> 00:52:47,395
PREVIOUS AND CONTINUOUS,

1358
00:52:47,395 --> 00:52:49,797
CREATING A LONGITUDINAL HISTORY

1359
00:52:49,797 --> 00:52:53,501
OF THE BIRTHING PERSON AND THE

1360
00:52:53,501 --> 00:52:55,069
PREGNANT AND POSTPARTUM PERSON

1361
00:52:55,069 --> 00:53:00,508
AND LINKING TO THE INFANT

1362
00:53:00,508 --> 00:53:01,942
OUTCOMES.

1363
00:53:01,942 --> 00:53:03,244
HOWEVER, WE CREATED THIS

1364
00:53:03,244 --> 00:53:04,678
DOCUMENT, PUT IT IN THE PUBLIC

1365
00:53:04,678 --> 00:53:06,313
DOMAIN BUT IT'S ONLY AS GOOD AS

1366
00:53:06,313 --> 00:53:07,081
ADOPTION RATE.

1367
00:53:07,081 --> 00:53:08,616
YOU CAN HAVE A DOCUMENT THAT

1368
00:53:08,616 --> 00:53:10,384
JUST SITS OUT THERE AND GOES

1369
00:53:10,384 --> 00:53:11,786
UNUSED, THAT'S NOT SOMETHING WE

1370
00:53:11,786 --> 00:53:13,654
WANTED FOR THIS PROJECT SO WE

1371
00:53:13,654 --> 00:53:18,159
HAD TO IDENTIFY TOOLS AND

1372
00:53:18,159 --> 00:53:19,126
STRATEGIES TO CREATE A PROJECT

1373
00:53:19,126 --> 00:53:22,730
THAT WOULD BE USED BROADLY AND

1374
00:53:22,730 --> 00:53:24,265
AS ACCESSIBLE.

1375
00:53:24,265 --> 00:53:27,334
SO IN THE ADOPTION, WITH OUR

1376
00:53:27,334 --> 00:53:30,404
CONTRACT PARTNERS, WE PILOTED AN

1377
00:53:30,404 --> 00:53:33,374
AUTOMATION AND STANDARD TOOL

1378
00:53:33,374 --> 00:53:34,775
USING MATERNAL HEALTH LINK, AND

1379
00:53:34,775 --> 00:53:36,811
WE'LL GO INTO THAT IN THE NEXT

1380
00:53:36,811 --> 00:53:37,211
COUPLE SLIDES.

1381
00:53:37,211 --> 00:53:39,046
THIS IS ALSO A UNIQUE PRODUCT

1382
00:53:39,046 --> 00:53:42,416
THAT WAS PRODUCED OUT OF THIS

1383
00:53:42,416 --> 00:53:45,519
PROJECT FOR RESEARCH DATA

1384
00:53:45,519 --> 00:53:45,820
ACQUISITION.

1385
00:53:45,820 --> 00:53:48,889
AND THIS IS AN OPEN SOURCE

1386
00:53:48,889 --> 00:53:49,757
MEASURE BASED APPLICATION,

1387
00:53:49,757 --> 00:53:51,192
MATERNAL HEALTH LINK PROVIDES

1388
00:53:51,192 --> 00:53:53,060
DATA ACCESS AND FLEXIBILITY TO

1389
00:53:53,060 --> 00:53:53,727
ACCOMMODATE RESEARCHERS' NEEDS

1390
00:53:53,727 --> 00:53:54,695
OVER TIME.

1391
00:53:54,695 --> 00:53:57,198
SO THIS HELPS THE RESEARCHER USE

1392
00:53:57,198 --> 00:53:59,066
THE IMPLEMENTATION GUIDE AND

1393
00:53:59,066 --> 00:54:00,100
MAKES IT EASIER.

1394
00:54:00,100 --> 00:54:02,770
NEXT SLIDE PLEASE.

1395
00:54:02,770 --> 00:54:05,406
 

1396
00:54:05,406 --> 00:54:09,243
SO MATERNAL HEALTH WAS ADOPTED

1397
00:54:09,243 --> 00:54:12,179
FROM AN EXISTING TOOL THAT ALSO

1398
00:54:12,179 --> 00:54:14,114
USED OPEN FHIR APPLICATION FOR

1399
00:54:14,114 --> 00:54:18,452
PUBLIC HEALTH, AND THIS WAS DONE

1400
00:54:18,452 --> 00:54:23,591
UNDER A CDC CONTRACT, AND THIS

1401
00:54:23,591 --> 00:54:24,225
CONNECTS SECURELY TO ELECTRONIC

1402
00:54:24,225 --> 00:54:25,326
HEALTH RECORDS, WHAT WE WERE

1403
00:54:25,326 --> 00:54:30,397
TRYING TO DO VIA STANDARD OPEN 

1404
00:54:30,397 --> 00:54:32,132
APPLICATION PROGRAMMING

1405
00:54:32,132 --> 00:54:33,100
INTERFACE API, FULL DISCLOSURE

1406
00:54:33,100 --> 00:54:38,372
THAT PART IS OUT OF MIGHT 

1407
00:54:38,372 --> 00:54:40,007
H AVE -- OUT OF MY EXPERTISE AND

1408
00:54:40,007 --> 00:54:42,076
DOMAIN SO I CAN'T ANSWER

1409
00:54:42,076 --> 00:54:45,012
QUESTIONS ON THE TECHNICAL

1410
00:54:45,012 --> 00:54:46,547
ASPECT, BUT THE APPLICATION

1411
00:54:46,547 --> 00:54:52,753
EXTRACTS DATA, EVALUATES DATA

1412
00:54:52,753 --> 00:54:53,521
USING PRE-DEFINED AND SUBMITS

1413
00:54:53,521 --> 00:54:54,989
DATA TO THIS NETWORK.

1414
00:54:54,989 --> 00:54:59,727
NEXT SLIDE PLEASE. 

1415
00:54:59,727 --> 00:55:05,232
SO WHAT WE DO WITH CONTRACTORS,

1416
00:55:05,232 --> 00:55:09,169
CUSTOMIZE THIS EXISTING TOOL FOR

1417
00:55:09,169 --> 00:55:10,704
THE TOOL CALLED MATERNAL HEALTH

1418
00:55:10,704 --> 00:55:11,505
LINK.

1419
00:55:11,505 --> 00:55:15,075
WE PROPOSE PILOTING WITH A

1420
00:55:15,075 --> 00:55:15,709
HEALTH INFORMATION EXCHANGE TO

1421
00:55:15,709 --> 00:55:17,044
AUTOMATE DATA COLLECTION.

1422
00:55:17,044 --> 00:55:18,712
THIS PROCESS TOOK A BIT OF TIME

1423
00:55:18,712 --> 00:55:21,448
BECAUSE WE HAD TO FIND DATA THAT

1424
00:55:21,448 --> 00:55:23,217
FIT THE PARTICULAR CRITERIA FOR

1425
00:55:23,217 --> 00:55:27,454
THE USE CASES THAT HAD THE

1426
00:55:27,454 --> 00:55:29,356
APPROPRIATE INFORMATION IN IT

1427
00:55:29,356 --> 00:55:30,724
AND THAT COULD -- THAT WE COULD

1428
00:55:30,724 --> 00:55:31,725
HAVE ACCESS TO.

1429
00:55:31,725 --> 00:55:32,726
THIS IS SOMETHING THAT TOOK

1430
00:55:32,726 --> 00:55:38,632
QUITE A BIT OF TIME AND

1431
00:55:38,632 --> 00:55:39,967
PERSISTENCE TO FIND THE VIABLE

1432
00:55:39,967 --> 00:55:41,035
DATASET WE COULD USE.

1433
00:55:41,035 --> 00:55:44,104
WE WERE VERY GRATEFUL TO USE

1434
00:55:44,104 --> 00:55:46,540
THIS HIE, AND WE DEVELOPED

1435
00:55:46,540 --> 00:55:48,275
MEASURES TO SUPPORT DATA

1436
00:55:48,275 --> 00:55:53,347
COLLECTION FOR COHORT POPULATION

1437
00:55:53,347 --> 00:55:57,585
SO WE USED SIMPLISTIC

1438
00:55:57,585 --> 00:55:59,653
PARAMETERS, TWO USE CASES, ONE

1439
00:55:59,653 --> 00:56:02,823
ON MATERNAL MORTALITY SO DEATH

1440
00:56:02,823 --> 00:56:05,359
WITHIN ONE YEAR OR 365 DAYS OF

1441
00:56:05,359 --> 00:56:08,729
END OF A PREGNANCY, AND THEN

1442
00:56:08,729 --> 00:56:10,598
ALSO THE HYPERTENSIVE DISORDERS

1443
00:56:10,598 --> 00:56:15,102
OF PREGNANCY, SO PREGNANT PERSON

1444
00:56:15,102 --> 00:56:18,472
AND PROBABLY POSTPARTUM PERSON

1445
00:56:18,472 --> 00:56:19,673
WITH DIAGNOSED HYPERTENSIVE

1446
00:56:19,673 --> 00:56:22,977
DISORDERS OF PREGNANCY.

1447
00:56:22,977 --> 00:56:27,114
NEXT SLIDE PLEASE.

1448
00:56:27,114 --> 00:56:27,448
 

1449
00:56:27,448 --> 00:56:30,851
THIS IS A GRAPHIC DEVELOPED TO

1450
00:56:30,851 --> 00:56:34,021
MAKE VISUAL AND TANGIBLE KIND OF

1451
00:56:34,021 --> 00:56:35,656
HOW THE MATERNAL HEALTH LINK

1452
00:56:35,656 --> 00:56:37,491
COMMUNICATES WITH THE DATABASE

1453
00:56:37,491 --> 00:56:40,027
AND WITH THE RESEARCHERS AND

1454
00:56:40,027 --> 00:56:40,260
THINGS.

1455
00:56:40,260 --> 00:56:41,895
YOU CAN SEE WE HAVE THIS HEALTH

1456
00:56:41,895 --> 00:56:42,863
INFORMATION EXCHANGE.

1457
00:56:42,863 --> 00:56:45,132
WE HAVE A USER INTERFACE IN THE

1458
00:56:45,132 --> 00:56:47,701
BLUE BOX ON THE LEFT, WHERE YOUR

1459
00:56:47,701 --> 00:56:49,670
RESEARCHERS ARE SITTING, THEY

1460
00:56:49,670 --> 00:56:52,740
USE THIS INTERFACE, WE HAVE

1461
00:56:52,740 --> 00:56:54,942
IMPLEMENTATION GUIDES, THIS

1462
00:56:54,942 --> 00:56:59,079
MEASURE LOGIC, WE PRESCRIBE FROM

1463
00:56:59,079 --> 00:57:02,282
THE RESEARCHER THE PARAMETERS

1464
00:57:02,282 --> 00:57:03,817
LIKE 365 DAYS EXPERIENCE OF

1465
00:57:03,817 --> 00:57:05,152
MATERNAL DEALT AND THEN, YOU

1466
00:57:05,152 --> 00:57:07,121
KNOW, THEY PUT IN THEIR

1467
00:57:07,121 --> 00:57:10,391
INFORMATION, THEY HIT SUBMIT,

1468
00:57:10,391 --> 00:57:12,593
THAT INFORMATION TO THE HEALTH

1469
00:57:12,593 --> 00:57:17,097
INFORMATION EXCHANGE DATABASE, 

1470
00:57:17,097 --> 00:57:18,399
AUTHENTICATED, BACK TO THE MA

1471
00:57:18,399 --> 00:57:20,034
TERRIBLE HEALTH LINK WHICH

1472
00:57:20,034 --> 00:57:23,303
PRODUCES THE REPORT WHICH YOU

1473
00:57:23,303 --> 00:57:24,438
SEE FOR THE RESEARCHERSER, THEN

1474
00:57:24,438 --> 00:57:27,708
YOU SEE THE DOTTED LIKE IN BOX

1475
00:57:27,708 --> 00:57:28,676
4, RESEARCHERS AND PARTNERS AS

1476
00:57:28,676 --> 00:57:29,276
THEY BEGIN.

1477
00:57:29,276 --> 00:57:31,111
WE USE THIS INFORMATION TO MAKE

1478
00:57:31,111 --> 00:57:32,112
ASSESSMENTS WHAT WE NEED TO KNOW

1479
00:57:32,112 --> 00:57:35,382
AND HOW WE CAN MOVE FORWARD AS

1480
00:57:35,382 --> 00:57:39,153
WE MAKE NEW DISCOVERIES FOR

1481
00:57:39,153 --> 00:57:41,622
INTERVENTIONS AND PREVENTION FOR

1482
00:57:41,622 --> 00:57:43,757
SEVERE MATERNAL MORBIDITY AND

1483
00:57:43,757 --> 00:57:44,024
MORTALITY.

1484
00:57:44,024 --> 00:57:47,628
NEXT SLIDE PLEASE.

1485
00:57:47,628 --> 00:57:49,329
THIS IS PART OF THE PILOTING

1486
00:57:49,329 --> 00:57:51,899
THAT WE TALKED ABOUT WITH THE

1487
00:57:51,899 --> 00:57:55,269
MATERNAL HEALTH LINK, SO LIKE I

1488
00:57:55,269 --> 00:58:00,107
SAID WE DEFINED CRITERIA, FOUND

1489
00:58:00,107 --> 00:58:06,547
THAT HIE, THANKS TO DILIGENCE OF

1490
00:58:06,547 --> 00:58:08,315
DR. SHAKTURA, THAT'S A BIT OF

1491
00:58:08,315 --> 00:58:10,484
BUSINESS ASPECT OF PILOTING THIS

1492
00:58:10,484 --> 00:58:10,951
PROJECT.

1493
00:58:10,951 --> 00:58:19,560
AND THEN GOING DOWN A LITTLE 

1494
00:58:19,560 --> 00:58:22,062
BIT, THERE'S A PILOT REPORT,

1495
00:58:22,062 --> 00:58:22,963
TECHNICAL ASSISTANCE, THINGS

1496
00:58:22,963 --> 00:58:23,230
LIKE THAT.

1497
00:58:23,230 --> 00:58:23,630
NEXT SLIDE PLEASE.

1498
00:58:23,630 --> 00:58:30,838
ON THE SUCCESS OF THE PROJECT.

1499
00:58:30,838 --> 00:58:39,179
WE FOUND THAT A SUCCESSFUL

1500
00:58:39,179 --> 00:58:40,681
HANDSHAKE, MEANING THE

1501
00:58:40,681 --> 00:58:43,851
PARAMETERS WERE ABLE TO BE USED

1502
00:58:43,851 --> 00:58:44,418
PROPERLY, THEY COMMUNICATED

1503
00:58:44,418 --> 00:58:46,720
PROPERLY, WE WERE ABLE TO

1504
00:58:46,720 --> 00:58:50,958
SUCCESSFULLY PRESENT THE DATA WE

1505
00:58:50,958 --> 00:58:56,563
NEED-- LINK THE DATA WE NEEDED

1506
00:58:56,563 --> 00:58:58,098
TO LINK, ACCOMMODATING

1507
00:58:58,098 --> 00:58:58,966
RESEARCHERS, AUTOMATING THE

1508
00:58:58,966 --> 00:59:01,702
QUERIES AND SETTING UP ALL THESE

1509
00:59:01,702 --> 00:59:05,739
THINGS AND CREATING THE RESULTS 

1510
00:59:05,739 --> 00:59:11,245
THAT CAN BE EASILY INTERPRETED.

1511
00:59:11,245 --> 00:59:12,212
NEXT SLIDE PLEASE.

1512
00:59:12,212 --> 00:59:14,081
SO AGAIN THIS IS THE LITTLE BIT

1513
00:59:14,081 --> 00:59:17,584
OF THAT PROCESS. 

1514
00:59:17,584 --> 00:59:18,552
NOW, WHEN THIS WAS PRESENTED

1515
00:59:18,552 --> 00:59:23,824
BEFORE THEY HAD AN AUTOMATED

1516
00:59:23,824 --> 00:59:24,925
DATA VISUALIZATION TO SHOW THAT

1517
00:59:24,925 --> 00:59:26,794
WAS TOO LONG TO DEMONSTRATE FOR

1518
00:59:26,794 --> 00:59:30,063
THIS GROUP IN THIS PRESENTATION.

1519
00:59:30,063 --> 00:59:33,233
BUT THERE IS A RECORDED

1520
00:59:33,233 --> 00:59:34,334
DEMONSTRATION THAT IF THIS GROUP

1521
00:59:34,334 --> 00:59:36,236
WOULD LIKE TO SEE IT, PROBABLY

1522
00:59:36,236 --> 00:59:39,706
COULD BE MADE AVAILABLE.

1523
00:59:39,706 --> 00:59:41,675
NEXT SLIDE PLEASE.

1524
00:59:41,675 --> 00:59:45,212
SO FUTURE RECOMMENDATIONS, NEXT

1525
00:59:45,212 --> 00:59:47,281
SLIDE.

1526
00:59:47,281 --> 00:59:50,551
ONE IS NOT ON THIS PAGE BUT I

1527
00:59:50,551 --> 00:59:52,886
WOULD LIKE TO EMPHASIZE WE USE

1528
00:59:52,886 --> 00:59:55,622
THIS FOR TWO USE CASES, AND WE

1529
00:59:55,622 --> 01:00:00,227
WOULD LIKE TO MAKE SURE THAT THE

1530
01:00:00,227 --> 01:00:01,528
IMPLEMENTATION GUIDE AND TOOLING

1531
01:00:01,528 --> 01:00:05,199
CAN BE MADE SO THAT IT IS USE

1532
01:00:05,199 --> 01:00:06,233
CASE AGNOSTIC.

1533
01:00:06,233 --> 01:00:08,335
SO THAT IT'S NOT SPECIFIC TO

1534
01:00:08,335 --> 01:00:10,404
HYPERTENSION, THAT IT'S NOT

1535
01:00:10,404 --> 01:00:11,471
SPECIFIC TO MATERNAL MORTALITY,

1536
01:00:11,471 --> 01:00:14,007
BUT THAT WE MAKE SOMETHING THAT

1537
01:00:14,007 --> 01:00:15,909
CAN BE USED FOR DUAL INCIDENTS

1538
01:00:15,909 --> 01:00:18,512
AND I THINK RIGHT NOW THE

1539
01:00:18,512 --> 01:00:20,647
GUIDANCE IS THERE BUT WE NEED TO

1540
01:00:20,647 --> 01:00:22,015
MAKE SURE THAT THEY CAN BE

1541
01:00:22,015 --> 01:00:26,486
TESTED IN ALL OF THOSE DOMAINS.

1542
01:00:26,486 --> 01:00:28,722
ALSO, TO USE A REAL RESEARCH

1543
01:00:28,722 --> 01:00:33,327
STUDY IS A GOAL OF THIS, TEST

1544
01:00:33,327 --> 01:00:34,728
THE SCALABILITY, LARGER VOLUME

1545
01:00:34,728 --> 01:00:34,962
DATA.

1546
01:00:34,962 --> 01:00:38,465
I'M NOT SURE WITH THE VOLUME OF

1547
01:00:38,465 --> 01:00:41,401
THE NEW YORK HIE WE CAN'T TO

1548
01:00:41,401 --> 01:00:42,636
SCALE THAT UP.

1549
01:00:42,636 --> 01:00:44,171
WE'RE LOOKING AT NATIONAL LEVEL

1550
01:00:44,171 --> 01:00:45,305
DATA, HOSPITAL LEVEL DATA, AND

1551
01:00:45,305 --> 01:00:49,743
SO IF WE NEED TO MAKE SURE THIS

1552
01:00:49,743 --> 01:00:51,712
IS APPROPRIATE FOR ALL DATA.

1553
01:00:51,712 --> 01:00:53,780
AND DATA FROM MULTIPLE SOURCES,

1554
01:00:53,780 --> 01:00:58,919
THIS IS ONE HIE BUT WE WANT TO

1555
01:00:58,919 --> 01:01:00,888
MAKE SURE THAT EPIC IN NEW YORK

1556
01:01:00,888 --> 01:01:05,058
CAN TALK TO A DIFFERENT SYSTEM

1557
01:01:05,058 --> 01:01:06,593
IN CALIFORNIA.

1558
01:01:06,593 --> 01:01:10,964
AND THAT WORKERS  CAN BE LINKED

1559
01:01:10,964 --> 01:01:11,665
TOGETHER FOR LONGITUDINAL

1560
01:01:11,665 --> 01:01:15,135
HISTORY AND TO LINK TO INFANT

1561
01:01:15,135 --> 01:01:17,771
AND INFANTS BORN IN DIFFERENT

1562
01:01:17,771 --> 01:01:18,472
LOCATIONS.

1563
01:01:18,472 --> 01:01:24,878
AND WE WANT TO ENHANCE THIS

1564
01:01:24,878 --> 01:01:25,412
SECURITY.

1565
01:01:25,412 --> 01:01:26,947
EXACTLY.

1566
01:01:26,947 --> 01:01:27,948
SOMEONE PUT IN THE CHAT EPIC

1567
01:01:27,948 --> 01:01:38,492
ANDER IS  AND SERNA DON'T TALK 

1568
01:01:43,430 --> 01:01:46,099
TO EACH OTHER.

1569
01:01:46,099 --> 01:01:52,673
THEY ALL WANT TO SEE THESE

1570
01:01:52,673 --> 01:01:55,075
THINGS, IMPROVEMENTS IN MATERNAL

1571
01:01:55,075 --> 01:01:55,776
HEALTH.

1572
01:01:55,776 --> 01:01:58,812
SO WE WERE SURPRISED AND

1573
01:01:58,812 --> 01:02:00,113
FORTUNATE AND BENEFITED FROM

1574
01:02:00,113 --> 01:02:01,982
HAVING THEM PRESENT ON THE SAME

1575
01:02:01,982 --> 01:02:09,756
DAY, IN OUR WORKING GROUP.

1576
01:02:09,756 --> 01:02:11,391
WE ALSO WANT TO MAKE SURE THIS

1577
01:02:11,391 --> 01:02:12,926
IS SOMETHING THAT STAYS UP TO

1578
01:02:12,926 --> 01:02:14,661
DATE SO WE WANT TO MAKE SURE

1579
01:02:14,661 --> 01:02:17,631
IT'S CONTINUALLY USED AND ALSO

1580
01:02:17,631 --> 01:02:18,932
DEVELOP THIS MATERNAL TOOLKIT

1581
01:02:18,932 --> 01:02:21,601
EVEN FURTHER.

1582
01:02:21,601 --> 01:02:22,102
NEXT SLIDE.

1583
01:02:22,102 --> 01:02:27,007
AND SO WITH THAT I WILL TURN IT

1584
01:02:27,007 --> 01:02:29,343
BACK OVER TO OUR -- TO SUE AND

1585
01:02:29,343 --> 01:02:31,311
THANK YOU, EMMA.

1586
01:02:31,311 --> 01:02:36,416
I WANT TO ACKNOWLEDGE OUR ONC

1587
01:02:36,416 --> 01:02:37,351
TEAM, THE CDC, NLM, NATIONAL

1588
01:02:37,351 --> 01:02:39,386
LIBRARY OF MEDICINE, CENTERS FOR

1589
01:02:39,386 --> 01:02:40,454
DISEASE CONTROL AND PREVENTION,

1590
01:02:40,454 --> 01:02:48,929
THE OFFICE OF THE NATIONAL 

1591
01:02:48,929 --> 01:02:50,998
COORDINATOR, OUR PROLIFIC

1592
01:02:50,998 --> 01:02:57,571
PROGRAM OFFICER, AND THE

1593
01:02:57,571 --> 01:03:00,007
LEADERSHIP OF NIKITA SHAKTURA

1594
01:03:00,007 --> 01:03:00,874
AND ALISON CERNICH.

1595
01:03:00,874 --> 01:03:03,243
>> WE'LL TAKE QUESTIONS
FOR 

1596
01:03:03,243 --> 01:03:08,348
KATIE AND JUANITA NOW. 

1597
01:03:08,348 --> 01:03:09,983
I WANT TO BROADEN, A PROFESSOR

1598
01:03:09,983 --> 01:03:12,753
IS ASKING ABOUT DATA SOURCES AND

1599
01:03:12,753 --> 01:03:15,155
WHETHER THE SCOPE IS U.S. OR

1600
01:03:15,155 --> 01:03:18,959
INTERNATIONAL, CAN YOU SPEAK TO

1601
01:03:18,959 --> 01:03:19,159
THAT?

1602
01:03:19,159 --> 01:03:19,760
>> SURE.

1603
01:03:19,760 --> 01:03:21,962
FOR THE AWARDS I SPOKE ABOUT

1604
01:03:21,962 --> 01:03:23,864
EARLIER TODAY THOSE R01s AND

1605
01:03:23,864 --> 01:03:25,999
R21s ARE UNITED STATES DATA

1606
01:03:25,999 --> 01:03:26,433
SOURCES.

1607
01:03:26,433 --> 01:03:29,436
WE DO HAVE WITHIN OUR PORTFOLIO

1608
01:03:29,436 --> 01:03:31,471
APPLICATIONS THAT UTILIZE REAL

1609
01:03:31,471 --> 01:03:32,372
WORLD DATA FROM INTERNATIONAL

1610
01:03:32,372 --> 01:03:33,073
DATA SOURCES.

1611
01:03:33,073 --> 01:03:35,008
THEY JUST HAPPEN TO BE WITH

1612
01:03:35,008 --> 01:03:37,411
PEDIATRICS AT THE MOMENT.

1613
01:03:37,411 --> 01:03:39,713
CERTAINLY NEED TO BROADEN OUR

1614
01:03:39,713 --> 01:03:41,348
SCOPE THERE TO INCLUDE PREGNANT

1615
01:03:41,348 --> 01:03:42,682
AND LACTATING PERSONS AS WELL.

1616
01:03:42,682 --> 01:03:44,751
YES, THE ONES THAT I SPOKE ABOUT

1617
01:03:44,751 --> 01:03:47,621
TODAY ARE UNITED STATES DATA

1618
01:03:47,621 --> 01:03:47,854
SOURCES.

1619
01:03:47,854 --> 01:03:49,022
>> THANKS, KATIE.

1620
01:03:49,022 --> 01:03:51,858
AND A QUESTION ABOUT COVID

1621
01:03:51,858 --> 01:03:52,926
STUDDIES SPECIFICALLY BUT I'LL

1622
01:03:52,926 --> 01:03:56,029
BROADEN AND THINK IN THE CONTEXT

1623
01:03:56,029 --> 01:04:01,401
OF ARE WE TRACKING PREGNANCY

1624
01:04:01,401 --> 01:04:08,308
EXCLUSIONS IN FEDERALLY FUNDED

1625
01:04:08,308 --> 01:04:08,542
STUDIES?

1626
01:04:08,542 --> 01:04:09,709
>> THERE'S PROBABLY
SOMEBODY WHO

1627
01:04:09,709 --> 01:04:11,578
CAN SPEAK TO THAT BETTER BUT I

1628
01:04:11,578 --> 01:04:12,813
THINK THAT'S SOMETHING THAT WE

1629
01:04:12,813 --> 01:04:16,650
AS AN INSTITUTE HAVE LOOKED AT

1630
01:04:16,650 --> 01:04:23,723
TO SEE IF PREGNANCY IS USED AS

1631
01:04:23,723 --> 01:04:24,157
EXCLUSION CRITERIA.

1632
01:04:24,157 --> 01:04:25,926
BUT I'M PROBABLY NOT THE EXPERT.

1633
01:04:25,926 --> 01:04:28,328
THAT'S A BROADER QUESTION THAN

1634
01:04:28,328 --> 01:04:30,063
JUST UTILIZATION OF REAL WORLD

1635
01:04:30,063 --> 01:04:31,398
DATA AND REAL WORLD EVIDENCE.

1636
01:04:31,398 --> 01:04:33,366
YES, IT'S A VERY IMPORTANT TOPIC

1637
01:04:33,366 --> 01:04:34,434
FOR THE INSTITUTE.

1638
01:04:34,434 --> 01:04:36,103
WE DO LARGELY SEE THAT AS

1639
01:04:36,103 --> 01:04:36,970
INCLUSION CRITERIA FOR THESE

1640
01:04:36,970 --> 01:04:37,537
STUDIES.

1641
01:04:37,537 --> 01:04:40,707
THEY ARE OFT EVERYBODY EXCLUDED

1642
01:04:40,707 --> 01:04:41,174
FROM STUDIES.

1643
01:04:41,174 --> 01:04:41,808
>> THANKS.

1644
01:04:41,808 --> 01:04:42,642
AGAIN, WE'LL TAKE OTHER

1645
01:04:42,642 --> 01:04:47,247
QUESTIONS IN THE CHAT OR IF YOU

1646
01:04:47,247 --> 01:04:55,722
WANT TO COME OFF CAMERA, RACHEL?

1647
01:04:55,722 --> 01:04:57,891
>> HI, QUESTION FOR DR.
CHINN.

1648
01:04:57,891 --> 01:05:02,696
I WANT TO SAY IT'S AMAZING HOW

1649
01:05:02,696 --> 01:05:06,433
FAR WE'VE COME WITH ELECTRONIC

1650
01:05:06,433 --> 01:05:08,301
MEDICAL RECORDS.

1651
01:05:08,301 --> 01:05:09,636
MY QUESTION THAT REALLY HAS BEEN

1652
01:05:09,636 --> 01:05:15,909
ON MY MIND WE'VE MET WITH OCR

1653
01:05:15,909 --> 01:05:22,015
BUT A LOT OF CONCERNS ABOUT THE 

1654
01:05:22,015 --> 01:05:24,084
SAFETY AND SECURITY OF

1655
01:05:24,084 --> 01:05:25,852
INFORMATION SHARED IN THE

1656
01:05:25,852 --> 01:05:27,154
MEDICAL RECORD AND MOST

1657
01:05:27,154 --> 01:05:30,223
CONVERSATIONS HAVE BEEN MORE

1658
01:05:30,223 --> 01:05:32,058
SPECIFIC TO -- IN THE CLINICAL

1659
01:05:32,058 --> 01:05:35,228
SETTINGS BUT I'M CURIOUS ABOUT

1660
01:05:35,228 --> 01:05:38,965
IF THIS HAS COME UP IN THE

1661
01:05:38,965 --> 01:05:40,367
RESEARCH STEPS WHAT STEPS HAVE

1662
01:05:40,367 --> 01:05:41,701
BEEN TOGETHER, IF THAT'S

1663
01:05:41,701 --> 01:05:42,669
SOMETHING WE SHOULD THINK ABOUT

1664
01:05:42,669 --> 01:05:46,072
TO MAKE SURE WE'RE ABLE TO GET

1665
01:05:46,072 --> 01:05:49,943
THE DATA BUT IT NOT BE MISUSED.

1666
01:05:49,943 --> 01:05:50,443
THANK YOU.

1667
01:05:50,443 --> 01:05:51,111
>> THANK YOU.

1668
01:05:51,111 --> 01:05:53,847
YES, THAT HAS COME UP MULTIPLE

1669
01:05:53,847 --> 01:05:54,047
TIMES.

1670
01:05:54,047 --> 01:05:57,584
AS WE MENTIONED, REAL WORLD

1671
01:05:57,584 --> 01:05:59,653
TECHNICAL PANELS, I BELIEVE

1672
01:05:59,653 --> 01:06:02,856
THERE WAS ACOG REPRESENTATION ON

1673
01:06:02,856 --> 01:06:12,799
THE PANEL, THAT QUESTION HAS 

1674
01:06:12,799 --> 01:06:14,201
COME UP -- PRE-DOBBS, SO MANY

1675
01:06:14,201 --> 01:06:18,171
THINGS HAPPENED, THINGS CHANGE 

1676
01:06:18,171 --> 01:06:20,674
QUICKLY BUT THAT'S SOMETHING

1677
01:06:20,674 --> 01:06:22,542
THAT WE ARE GENERALLY HAVE ON

1678
01:06:22,542 --> 01:06:25,845
OUR RADAR IN THE DATA SPACE.

1679
01:06:25,845 --> 01:06:31,952
OUR WORK IN THE POPULATION 

1680
01:06:31,952 --> 01:06:32,819
DYNAMICS BRANCH AT NICHD, A LOT

1681
01:06:32,819 --> 01:06:34,454
OF DATA COLLECTIONS AS WELL,

1682
01:06:34,454 --> 01:06:37,757
THAT'S CERTAINLY SOMETHING DATA

1683
01:06:37,757 --> 01:06:40,160
PRIVACY THAT'S COME UP.

1684
01:06:40,160 --> 01:06:42,128
DOBBS-RELATED AND NOT.

1685
01:06:42,128 --> 01:06:44,664
THE OTHER THING IS THAT HAS COME

1686
01:06:44,664 --> 01:06:46,733
UP MULTIPLE TIMES IS DATA

1687
01:06:46,733 --> 01:06:47,767
SECURITY.

1688
01:06:47,767 --> 01:06:49,669
YOU CAN HAVE TWO PUBLIC USE

1689
01:06:49,669 --> 01:06:52,005
DATASETS AND WHEN YOU LINK THEM

1690
01:06:52,005 --> 01:06:56,176
TOGETHER, YOU NOW HAVE ENOUGH

1691
01:06:56,176 --> 01:06:56,943
INFORMATION FOR DISCLOSURE,

1692
01:06:56,943 --> 01:07:00,580
THAT'S ANOTHER WAY THE DATA

1693
01:07:00,580 --> 01:07:02,315
PRIVACY COULD COMPROMISE DATA.

1694
01:07:02,315 --> 01:07:04,084
THESE THINGS HAVE COME UP

1695
01:07:04,084 --> 01:07:04,851
INDEPENDENT OF THE TECHNICAL

1696
01:07:04,851 --> 01:07:07,687
EXPERT PANEL BUT ALSO HAVE COME

1697
01:07:07,687 --> 01:07:11,725
UP IN DISCUSSION WITH THE

1698
01:07:11,725 --> 01:07:12,926
TECHNICAL EXPERT PANEL.

1699
01:07:12,926 --> 01:07:16,963
SOLUTIONS ARE NOT AS PLENTIFUL

1700
01:07:16,963 --> 01:07:20,800
AS ACKNOWLEDGMENT THESE THINGS

1701
01:07:20,800 --> 01:07:22,569
WILL EXIST.

1702
01:07:22,569 --> 01:07:25,405
I'M NOT SURE WHAT THE DIRECTION

1703
01:07:25,405 --> 01:07:29,542
OF THE POLICIES ARE GOING FOR

1704
01:07:29,542 --> 01:07:30,443
THAT.

1705
01:07:30,443 --> 01:07:34,748
I CAN SAY WE'VE DEFINITELY 

1706
01:07:34,748 --> 01:07:36,383
ACKNOWLEDGED, WE'VE DISCUSSED

1707
01:07:36,383 --> 01:07:38,118
PUTTING DISCLAIMERS, WHICH IS

1708
01:07:38,118 --> 01:07:40,420
CERTAINLY NOT ENOUGH, BUT IT IS

1709
01:07:40,420 --> 01:07:42,822
MAKING PEOPLE AWARE THAT THESE

1710
01:07:42,822 --> 01:07:45,091
RISKS ARE AVAILABLE WHEN YOU

1711
01:07:45,091 --> 01:07:46,459
LINK DATA.

1712
01:07:46,459 --> 01:07:49,529
AS FAR AS OTHER HEALTH

1713
01:07:49,529 --> 01:07:54,768
INFORMATION RELATED TO WOMEN AND

1714
01:07:54,768 --> 01:07:56,536
POSTPARTUM AND PREGNANCY, IT'S

1715
01:07:56,536 --> 01:07:58,805
ON OUR RADAR, BUT I'M NOT SURE

1716
01:07:58,805 --> 01:08:03,410
THAT A SOLUTION TO KIND OF THAT

1717
01:08:03,410 --> 01:08:04,477
DATA PRIVACY BECAUSE THE

1718
01:08:04,477 --> 01:08:06,046
INFORMATION IS CHANGING AS WE

1719
01:08:06,046 --> 01:08:08,782
HAVE THESE DISCUSSIONS.

1720
01:08:08,782 --> 01:08:09,649
 

1721
01:08:09,649 --> 01:08:13,386
>> THANK YOU, JUANITA.

1722
01:08:13,386 --> 01:08:13,586
JANET?

1723
01:08:13,586 --> 01:08:15,755
 

1724
01:08:15,755 --> 01:08:16,756
>> THANK YOU.

1725
01:08:16,756 --> 01:08:19,326
THANK YOU FOR SUCH WONDERFUL

1726
01:08:19,326 --> 01:08:21,494
PRESENTATIONS, VERY THOUGHT

1727
01:08:21,494 --> 01:08:21,761
PROVOKING.

1728
01:08:21,761 --> 01:08:24,998
I'M GOING DIRECT MY QUESTION TO

1729
01:08:24,998 --> 01:08:30,670
DR. VANCE, REGARDING THE IMPROVE

1730
01:08:30,670 --> 01:08:30,870
STUDY.

1731
01:08:30,870 --> 01:08:33,740
YOU MENTIONED YOU WANT TO

1732
01:08:33,740 --> 01:08:35,608
PROMOTE MATERNAL HEALTH EQUITY

1733
01:08:35,608 --> 01:08:39,779
AND YOU'RE STUDYING EHR AND

1734
01:08:39,779 --> 01:08:41,781
CLAIMS DATA, EQUITY VARIABLES

1735
01:08:41,781 --> 01:08:45,151
CAN BE CHALLENGING AND LARGE

1736
01:08:45,151 --> 01:08:48,855
DATA SOURCES POORLY RECORDED 

1737
01:08:48,855 --> 01:08:50,290
AND/OR LARGELY MISSING.

1738
01:08:50,290 --> 01:08:51,591
HOW ARE YOU APPROACHING THAT?

1739
01:08:51,591 --> 01:08:52,759
I'D BE INTERESTED IN YOUR

1740
01:08:52,759 --> 01:08:55,862
THOUGHTS SINCE THIS IS A BIG

1741
01:08:55,862 --> 01:08:56,596
ISSUE WITH LARGE DATA.

1742
01:08:56,596 --> 01:08:58,031
THANK YOU.

1743
01:08:58,031 --> 01:08:59,032
>> ABSOLUTELY.

1744
01:08:59,032 --> 01:09:02,302
IT IS A LARGE ISSUE.

1745
01:09:02,302 --> 01:09:04,704
THE IMPROV PORTFOLIO IS NOT IN

1746
01:09:04,704 --> 01:09:06,439
MY PORTFOLIO, THERE ARE PROBABLY

1747
01:09:06,439 --> 01:09:07,674
OTHERS WHO CAN SPEAKER TO THIS A

1748
01:09:07,674 --> 01:09:08,641
LITTLE BIT BETTER.

1749
01:09:08,641 --> 01:09:12,045
I DO KNOW THE DATA HUB, THERE

1750
01:09:12,045 --> 01:09:14,447
ARE -- IT'S A PROBLEM.

1751
01:09:14,447 --> 01:09:17,050
IT'S A PROBLEM BOTH IN PATIENT

1752
01:09:17,050 --> 01:09:18,818
ACCESS TO CARE AND WHEN THEY

1753
01:09:18,818 --> 01:09:20,353
HAVE LIMITATIONS TO ACCESS TO

1754
01:09:20,353 --> 01:09:23,089
CARE AND BIAS WAS CARE, THERE'S

1755
01:09:23,089 --> 01:09:25,058
ALSO BIASES RELATED TO THE DATA

1756
01:09:25,058 --> 01:09:27,127
THAT ARE AVAILABLE AND THE DATA

1757
01:09:27,127 --> 01:09:29,195
THAT WE CAN GENERATE FROM REAL

1758
01:09:29,195 --> 01:09:30,630
WORLD DATA.

1759
01:09:30,630 --> 01:09:32,065
WHAT IS A CONCERN?

1760
01:09:32,065 --> 01:09:35,902
HOPKINS IS THE AWARDEE FOR THIS

1761
01:09:35,902 --> 01:09:37,404
PARTICULAR DATA HUB, THE DATA

1762
01:09:37,404 --> 01:09:40,140
INNOVATION HUB FOR CENTERS OF

1763
01:09:40,140 --> 01:09:40,607
EXCELLENCE.

1764
01:09:40,607 --> 01:09:44,644
SO, THEY DO HAVE A PLAN TO

1765
01:09:44,644 --> 01:09:47,747
ADDRESS THESE CONCERNS AND TRY

1766
01:09:47,747 --> 01:09:52,218
TO MITIGATE THEM USING

1767
01:09:52,218 --> 01:09:52,986
COMPUTATIONAL AND OTHER

1768
01:09:52,986 --> 01:09:55,288
METHODOLOGIES, BUT I CAN'T SPEAK

1769
01:09:55,288 --> 01:09:56,256
TO THE SPECIFICS, BECAUSE I'M

1770
01:09:56,256 --> 01:10:03,229
NOT THE PROGRAM OFFICER FOR THE 

1771
01:10:03,229 --> 01:10:05,265
AWARD, THERE WILL BE BIASES WITH

1772
01:10:05,265 --> 01:10:06,332
UTILIZATION OF REAL WORLD DATA.

1773
01:10:06,332 --> 01:10:07,667
>> THANK YOU VERY MUCH.

1774
01:10:07,667 --> 01:10:10,103
>> THANK YOU, KATIE.

1775
01:10:10,103 --> 01:10:12,705
JUANITA, WE'VE GOT A FAIR AMOUNT

1776
01:10:12,705 --> 01:10:17,544
OF CONVERSATION IN THE CHAT

1777
01:10:17,544 --> 01:10:19,179
THAT'S ASKING ABOUT NON-HIE

1778
01:10:19,179 --> 01:10:23,516
RELATED DATABASES, SO PRIVATE

1779
01:10:23,516 --> 01:10:24,217
PAYER DATABASES, OTHER

1780
01:10:24,217 --> 01:10:27,454
GOVERNMENT-RELATED  DATABASES.

1781
01:10:27,454 --> 01:10:30,223
CAN YOU SPEAK TO THAT?

1782
01:10:30,223 --> 01:10:30,857
>> THE U.S. DEPARTMENT OF
HEALTH

1783
01:10:30,857 --> 01:10:33,259
AND HUMAN SERVICES OFFICE FOR

1784
01:10:33,259 --> 01:10:34,494
WOMEN'S HEALTH HAS PUBLISHED AN

1785
01:10:34,494 --> 01:10:38,431
ARTICLE ON MATERNAL HEALTH USING

1786
01:10:38,431 --> 01:10:40,967
THE PREMIER DATA, I THINK THAT

1787
01:10:40,967 --> 01:10:41,935
INCLUDES DATA LINKAGES, NOT SURE

1788
01:10:41,935 --> 01:10:45,138
HOW IT FITS WITH OUR PROJECT.

1789
01:10:45,138 --> 01:10:49,943
WE'VE HAD SOME CONVERSATIONS,

1790
01:10:49,943 --> 01:10:53,546
REGARDING KAISER I'M NOT SURE

1791
01:10:53,546 --> 01:10:55,114
THAT WE HAD KAISER COME IN AND

1792
01:10:55,114 --> 01:10:56,616
SEE ABOUT THE DATA LINKAGE.

1793
01:10:56,616 --> 01:10:58,151
THAT ONE I CAN'T REMEMBER.

1794
01:10:58,151 --> 01:11:03,089
AND THEN THE OTHER -- I'M NOT

1795
01:11:03,089 --> 01:11:05,258
FAMILIAR WITH TRINET, THAT ONE

1796
01:11:05,258 --> 01:11:08,027
I'M NOT FAMILIAR WITH.

1797
01:11:08,027 --> 01:11:10,430
BUT THERE'S SOME PUBLICATIONS IN

1798
01:11:10,430 --> 01:11:15,134
THE PUBLIC DOMAIN ON PREMIER

1799
01:11:15,134 --> 01:11:17,003
DATA, PARTICULARLY AROUND THE

1800
01:11:17,003 --> 01:11:19,506
HYPERTENSION LINKAGES.

1801
01:11:19,506 --> 01:11:21,274
 

1802
01:11:21,274 --> 01:11:23,009
SO, YEAH, I'M NOT FAMILIAR

1803
01:11:23,009 --> 01:11:23,343
ENOUGH.

1804
01:11:23,343 --> 01:11:26,946
BUT WE CAN TAKE THOSE QUESTIONS

1805
01:11:26,946 --> 01:11:30,250
DOWN AND HOPEFULLY GET SOME 

1806
01:11:30,250 --> 01:11:31,317
SUFFICIENT ANSWERS FOR YOU.

1807
01:11:31,317 --> 01:11:35,054
>> MAYBE TO EXTEND THAT

1808
01:11:35,054 --> 01:11:36,589
QUESTION, JUANITA, HAVE THERE

1809
01:11:36,589 --> 01:11:42,595
BEEN ENOUGH CONVERSATION WAS

1810
01:11:42,595 --> 01:11:45,131
VARIOUS HIEs THAT YOU HAVE A

1811
01:11:45,131 --> 01:11:47,867
SENSE OF LOGISTICAL OR

1812
01:11:47,867 --> 01:11:49,736
CONTRACTUAL CHALLENGES TRYING TO

1813
01:11:49,736 --> 01:11:51,671
EXPAND THIS INITIATIVE?

1814
01:11:51,671 --> 01:11:52,238
>> YES.

1815
01:11:52,238 --> 01:11:55,875
SO, IN THE PRESENTATION I

1816
01:11:55,875 --> 01:11:59,145
MENTIONED KIND OF PERSISTENCE OF

1817
01:11:59,145 --> 01:12:02,115
DR. SHAKTUR IN SECURING THE

1818
01:12:02,115 --> 01:12:05,919
HEALTH INFORMATION EXCHANGE DATA

1819
01:12:05,919 --> 01:12:06,920
AND ACCESS, AND I BREEZED

1820
01:12:06,920 --> 01:12:10,957
THROUGH A SLIDE THAT HAD SOME OF

1821
01:12:10,957 --> 01:12:14,227
THAT CONTRACTUAL NEGOTIATIONS.

1822
01:12:14,227 --> 01:12:16,563
THIS IS SOMETHING THAT WE SHOULD

1823
01:12:16,563 --> 01:12:18,431
HAVE ANSWERED A LITTLE BIT

1824
01:12:18,431 --> 01:12:21,935
BETTER, SOME OF THE CHALLENGES

1825
01:12:21,935 --> 01:12:23,403
THAT ARISE WITH THAT IN

1826
01:12:23,403 --> 01:12:25,638
ACCESSING THESE DATA, I THINK WE

1827
01:12:25,638 --> 01:12:27,707
THOUGHT IT WOULD BE EASIER THAN

1828
01:12:27,707 --> 01:12:28,474
WHAT IT WAS.

1829
01:12:28,474 --> 01:12:31,978
AND SO I DO THINK THAT IS

1830
01:12:31,978 --> 01:12:34,280
SOMETHING THAT CAN BE EXPANDED

1831
01:12:34,280 --> 01:12:38,217
UPON FOR HOW WE DEVELOP THIS,

1832
01:12:38,217 --> 01:12:39,852
SCALE THIS UP, FOR A LARGER

1833
01:12:39,852 --> 01:12:41,854
SCALE IN OUR FUTURE DIRECTIONS,

1834
01:12:41,854 --> 01:12:43,189
BECAUSE THAT IS SOMETHING WE

1835
01:12:43,189 --> 01:12:44,023
WANT TO DO.

1836
01:12:44,023 --> 01:12:47,093
SO I THINK YOU RAISE AN

1837
01:12:47,093 --> 01:12:47,961
EXCELLENT POINT THERE, AND

1838
01:12:47,961 --> 01:12:50,797
THAT'S DEFINITELY SOMETHING THAT

1839
01:12:50,797 --> 01:12:53,099
WE'VE HAD CONVERSATIONS ABOUT

1840
01:12:53,099 --> 01:12:55,602
BECAUSE THERE WERE CHALLENGES

1841
01:12:55,602 --> 01:12:59,138
THAT WERE UNANTICIPATED IN

1842
01:12:59,138 --> 01:13:03,176
ACCESSING THESE DATA BECAUSE WE 

1843
01:13:03,176 --> 01:13:04,911
CONTACTED MULTIPLE HIEs.

1844
01:13:04,911 --> 01:13:06,012
>> THANK YOU.

1845
01:13:06,012 --> 01:13:07,880
MAYBE ONE MORE QUESTION FOR

1846
01:13:07,880 --> 01:13:08,314
KATIE.

1847
01:13:08,314 --> 01:13:11,050
THE FACT THERE ARE A NUMBER OF

1848
01:13:11,050 --> 01:13:12,151
FUNDING OPPORTUNITIES THAT FALL

1849
01:13:12,151 --> 01:13:13,786
UNDER THE HEADING OF MATERNAL

1850
01:13:13,786 --> 01:13:18,591
AND PEDIATRIC, CAN YOU GIVE US A

1851
01:13:18,591 --> 01:13:20,126
SENSE HOW MANY APPLICATIONS AND

1852
01:13:20,126 --> 01:13:22,228
WHAT PERCENT OF FUNDING IS GOING

1853
01:13:22,228 --> 01:13:24,063
MATERNAL ROUTE VERSUS PEDIATRIC

1854
01:13:24,063 --> 01:13:24,297
ROUTE?

1855
01:13:24,297 --> 01:13:26,366
ARE WE GETTING UPTAKE BY OUR

1856
01:13:26,366 --> 01:13:28,334
MATERNAL RESEARCH PARTNERS?

1857
01:13:28,334 --> 01:13:29,602
>> WE ARE.

1858
01:13:29,602 --> 01:13:31,537
YEAH, WE ARE.

1859
01:13:31,537 --> 01:13:32,705
MY GENERAL IMPRESSION IS THAT WE

1860
01:13:32,705 --> 01:13:35,174
PROBABLY DO A LITTLE BIT BETTER

1861
01:13:35,174 --> 01:13:39,846
IN THE PEDIATRIC SPACE.

1862
01:13:39,846 --> 01:13:42,382
OUR BRANCH, OPPT IN PARTICULAR,

1863
01:13:42,382 --> 01:13:47,086
DID A DETAILED ANALYSIS OF OUR

1864
01:13:47,086 --> 01:13:48,221
PORTFOLIO LAST YEAR AND WE DID

1865
01:13:48,221 --> 01:13:49,922
SEE PROBABLY MORE IN THE

1866
01:13:49,922 --> 01:13:50,490
PEDIATRIC SPACE.

1867
01:13:50,490 --> 01:13:51,457
I FEEL LIKE IN THE LAST TWO

1868
01:13:51,457 --> 01:13:53,960
YEARS OF THE INTEREST IN

1869
01:13:53,960 --> 01:13:56,162
MATERNAL SPACE HAS GROWN.

1870
01:13:56,162 --> 01:13:58,898
WE'RE GETTING MORE APPLICATIONS

1871
01:13:58,898 --> 01:14:00,700
THAT ARE TRULY PREGNANCY

1872
01:14:00,700 --> 01:14:06,105
RELATED, OR THEY ARE DYADS.

1873
01:14:06,105 --> 01:14:07,140
MATERNAL-CHILD OUTCOME, MATERNAL

1874
01:14:07,140 --> 01:14:08,341
FETAL OUTCOME.

1875
01:14:08,341 --> 01:14:15,348
I THINK THERE'S MOVEMENT IN THE

1876
01:14:15,348 --> 01:14:16,282
SPACE, GROWING INTEREST,

1877
01:14:16,282 --> 01:14:19,385
PROBABLY LARGELY DUE TO THE

1878
01:14:19,385 --> 01:14:20,153
PRGLAC WORK FORCE.

1879
01:14:20,153 --> 01:14:23,990
I THINK THERE NEEDS TO BE MORE

1880
01:14:23,990 --> 01:14:26,426
OUTREACH FOR OUR INVESTIGATORS

1881
01:14:26,426 --> 01:14:27,727
TO SORT OF INCREASE THE NUMBER

1882
01:14:27,727 --> 01:14:34,667
OF APPLICATIONS THAT WE GET. 

1883
01:14:34,667 --> 01:14:44,077
WE'RE WORKING ON IT.

1884
01:14:44,077 --> 01:14:46,913
>> DO WE HAVE OTHER
QUESTIONS

1885
01:14:46,913 --> 01:14:50,016
RELATED PROGRESS MADE TOWARD 

1886
01:14:50,016 --> 01:14:51,184
SOME OF THESE RECOMMENDATIONS?

1887
01:14:51,184 --> 01:14:52,285
WE'VE GOT ANOTHER QUESTION HERE,

1888
01:14:52,285 --> 01:14:55,254
WHAT EFFORTS ARE MADE TO ENSURE

1889
01:14:55,254 --> 01:14:57,657
THE AVAILABLE LINKED DATA IS

1890
01:14:57,657 --> 01:15:00,159
REPRESENTATIVE NATIONALLY?

1891
01:15:00,159 --> 01:15:01,828
 

1892
01:15:01,828 --> 01:15:06,532
MAYBE THIS IS TO JUANITA?

1893
01:15:06,532 --> 01:15:11,671
 

1894
01:15:11,671 --> 01:15:14,307
>> SO IT'S HARD TO LINK

1895
01:15:14,307 --> 01:15:15,174
NATIONALLY REPRESENTATIVE DATA

1896
01:15:15,174 --> 01:15:19,312
WHEN PULLING OUT OF THESE DATA

1897
01:15:19,312 --> 01:15:19,712
SOURCES.

1898
01:15:19,712 --> 01:15:20,279
TYPICALLY VITAL STATISTICS,

1899
01:15:20,279 --> 01:15:23,616
THINGS LIKE THAT ARE USED FOR

1900
01:15:23,616 --> 01:15:24,817
NATIONALLY REPRESENTATIVE DATA,

1901
01:15:24,817 --> 01:15:33,159
ON OUR -- SO THIS IS KIND OF ONE

1902
01:15:33,159 --> 01:15:35,661
OF THOSE, LARGE AMOUNT DATA, BUT

1903
01:15:35,661 --> 01:15:37,864
I CAN SAY THAT I WAS A LITTLE

1904
01:15:37,864 --> 01:15:39,699
BIT SURPRISED SOME OF THE

1905
01:15:39,699 --> 01:15:41,134
INFORMATION MISSING IN THE

1906
01:15:41,134 --> 01:15:42,635
ELECTRONIC HEALTH RECORDS AT THE

1907
01:15:42,635 --> 01:15:43,803
RATE WHICH THEY WERE SO

1908
01:15:43,803 --> 01:15:46,572
SOMETIMES REPRESENTATION IS HARD

1909
01:15:46,572 --> 01:15:47,240
TO ASCERTAIN.

1910
01:15:47,240 --> 01:15:50,309
FOR INSTANCE RACE AND ETHNICITY

1911
01:15:50,309 --> 01:15:52,278
WAS NOT ALWAYS INDICATED IN THE

1912
01:15:52,278 --> 01:15:53,479
ELECTRONIC HEALTH RECORDS, AS

1913
01:15:53,479 --> 01:15:57,416
WELL AS IT WAS DIFFICULT TO GET

1914
01:15:57,416 --> 01:15:58,851
SOME OF THE DEMOGRAPHIC DATA

1915
01:15:58,851 --> 01:16:00,920
THAT WE HAD ANTICIPATED WHEN WE

1916
01:16:00,920 --> 01:16:03,222
FIRST PROPOSED THIS PROJECT, BUT

1917
01:16:03,222 --> 01:16:06,359
EVEN DOWN TO GESTATIONAL AGE, WE

1918
01:16:06,359 --> 01:16:09,595
FOUND SOME MISSINGNESS THAT WAS

1919
01:16:09,595 --> 01:16:09,896
UNEXPECTED.

1920
01:16:09,896 --> 01:16:12,398
SO IT'S SOMETHING ON THE RADAR.

1921
01:16:12,398 --> 01:16:13,833
WE'VE HAD REPRESENTATIVES FROM

1922
01:16:13,833 --> 01:16:17,003
THE NATIONAL CENTER FOR HEALTH

1923
01:16:17,003 --> 01:16:18,771
STATISTICS, AS WELL AS CDC.

1924
01:16:18,771 --> 01:16:21,474
AND SO THIS IS A PART OF THEIR

1925
01:16:21,474 --> 01:16:23,042
RADAR, ON THEIR RADAR FOR

1926
01:16:23,042 --> 01:16:24,210
WORKING ON THIS PROJECT.

1927
01:16:24,210 --> 01:16:27,146
BUT IT IS SOMETHING THAT IS TOP

1928
01:16:27,146 --> 01:16:29,482
OF MIND.

1929
01:16:29,482 --> 01:16:31,450
LET ME SEE.

1930
01:16:31,450 --> 01:16:33,319
YES, THAT'S A PART OF ONE OF THE

1931
01:16:33,319 --> 01:16:34,620
THINGS THAT WE'RE TRYING TO

1932
01:16:34,620 --> 01:16:36,823
FIGURE OUT AS WELL SO WE HAD A

1933
01:16:36,823 --> 01:16:41,894
PRESENTATION ON KIND OF THE DATA

1934
01:16:41,894 --> 01:16:43,729
LINKAGES TO ELECTRONIC HEALTH

1935
01:16:43,729 --> 01:16:45,164
RECORDS TO THE CENSUS DATA AND

1936
01:16:45,164 --> 01:16:47,066
THINGS LIKE THAT SO WE COULD TRY

1937
01:16:47,066 --> 01:16:50,403
TO PUT IN SOME OF THIS TYPE OF

1938
01:16:50,403 --> 01:16:53,372
INFORMATION AND THERE'S A

1939
01:16:53,372 --> 01:16:55,775
WONDERFUL PAPER OUT THERE BY

1940
01:16:55,775 --> 01:16:57,076
BARBARA ATLAS, WE HAD HER COME

1941
01:16:57,076 --> 01:17:01,447
IN AND GIVE A TALK AS WELL.

1942
01:17:01,447 --> 01:17:04,517
AND SOME OF THE CHALLENGES AND

1943
01:17:04,517 --> 01:17:06,219
SUCCESSES WITH THOSE TYPES OF

1944
01:17:06,219 --> 01:17:06,552
DATA LINKAGE.

1945
01:17:06,552 --> 01:17:07,987
>> KATIE, THIS IS A FAIR

1946
01:17:07,987 --> 01:17:11,390
QUESTION TO YOU AS WELL, WHEN WE

1947
01:17:11,390 --> 01:17:12,391
LOOK THROUGH YOUR PORTFOLIO, HOW

1948
01:17:12,391 --> 01:17:16,896
MUCH OF WHAT WE'RE SEEING IS

1949
01:17:16,896 --> 01:17:19,932
FOCUSED ON UNDERREPRESENTED

1950
01:17:19,932 --> 01:17:21,133
POPULATIONS, UNDERREPRESENTED

1951
01:17:21,133 --> 01:17:23,102
GEOGRAPHIC REGIONS?

1952
01:17:23,102 --> 01:17:23,970
ARE THEY REPRESENTED EFFECTIVELY

1953
01:17:23,970 --> 01:17:25,972
IN THE FUNDING THAT'S GOING OUT

1954
01:17:25,972 --> 01:17:27,707
THE DOOR?

1955
01:17:27,707 --> 01:17:30,309
>> SO I THINK WE CAN
ALWAYS DO

1956
01:17:30,309 --> 01:17:31,077
BETTER.

1957
01:17:31,077 --> 01:17:33,946
YOU KNOW, YOU DO SEE OFTEN THE

1958
01:17:33,946 --> 01:17:36,015
MAJOR PLAYERS ARE THE ONES

1959
01:17:36,015 --> 01:17:39,085
SUBMITTING THESE APPLICATIONS

1960
01:17:39,085 --> 01:17:39,886
AND GETTING FUNDED.

1961
01:17:39,886 --> 01:17:41,454
THEY ARE WHO YOU'RE EXPECTED TO

1962
01:17:41,454 --> 01:17:42,154
BE.

1963
01:17:42,154 --> 01:17:44,257
I THINK WE'RE GETTING BETTER IN

1964
01:17:44,257 --> 01:17:48,594
TERMS OF OF MAKING SURE THAT WE

1965
01:17:48,594 --> 01:17:50,463
RECRUIT PATIENT POPULATIONS AS

1966
01:17:50,463 --> 01:17:51,697
WELL AS INVESTIGATORS FROM

1967
01:17:51,697 --> 01:17:52,832
UNDERSERVED COMMUNITIES.

1968
01:17:52,832 --> 01:17:54,300
I KNOW THAT'S ONE OF THE THINGS

1969
01:17:54,300 --> 01:17:57,203
WE TRACK FOR THE TRANSITIONAL

1970
01:17:57,203 --> 01:17:58,905
RESEARCH PAR FOR EXAMPLE.

1971
01:17:58,905 --> 01:18:02,642
AND SO I DO THINK IT IS A

1972
01:18:02,642 --> 01:18:02,875
CONCERN.

1973
01:18:02,875 --> 01:18:04,710
I THINK WE AS A COMMUNITY CAN DO

1974
01:18:04,710 --> 01:18:09,949
A BETTER JOB MAKING SURE THAT WE

1975
01:18:09,949 --> 01:18:11,183
ACCESS UNDERSERVE AND

1976
01:18:11,183 --> 01:18:15,454
UNDERPRIVILEGED PATIENTS AS WELL

1977
01:18:15,454 --> 01:18:17,423
AS THE SCIENTISTS AN CLINICIANS

1978
01:18:17,423 --> 01:18:19,959
WHO CARE FOR THEM BUT I DO THINK

1979
01:18:19,959 --> 01:18:20,459
THAT WE'RE IMPROVING.

1980
01:18:20,459 --> 01:18:24,130
>> THANK YOU BOTH FOR TWO

1981
01:18:24,130 --> 01:18:24,897
WONDERFUL PRESENTATIONS,

1982
01:18:24,897 --> 01:18:26,299
CHRISTINA, ANYTHING ELSE WE WANT

1983
01:18:26,299 --> 01:18:28,401
TO TOUCH ON IN THE FIRST

1984
01:18:28,401 --> 01:18:29,035
SESSION?

1985
01:18:29,035 --> 01:18:33,105
>> IT'S A RELATIVELY MINOR

1986
01:18:33,105 --> 01:18:34,941
CLARIFICATION QUESTION, JUANITA.

1987
01:18:34,941 --> 01:18:36,809
THE LAST SLIDE FUTURE

1988
01:18:36,809 --> 01:18:38,911
RECOMMENDATIONS, TRYING TO

1989
01:18:38,911 --> 01:18:39,745
UNPACK THE WORD

1990
01:18:39,745 --> 01:18:40,146
"RECOMMENDATION."

1991
01:18:40,146 --> 01:18:42,949
ARE THESE ON A WISH LIST OR

1992
01:18:42,949 --> 01:18:44,717
THESE ARE INTENTIONAL AND

1993
01:18:44,717 --> 01:18:47,219
PLANNED ACTIVITIES THAT WILL BE

1994
01:18:47,219 --> 01:18:49,855
MOVING FORWARD?

1995
01:18:49,855 --> 01:18:54,126
 

1996
01:18:54,126 --> 01:18:57,496
>> I WAS TRYING TO LOOK AT
THE

1997
01:18:57,496 --> 01:18:58,831
LAST SLIDE.

1998
01:18:58,831 --> 01:19:01,367
PROBABLY SHOULD SAY FUTURE WISH

1999
01:19:01,367 --> 01:19:02,735
LIST INSTEAD OF RECOMMENDATIONS.

2000
01:19:02,735 --> 01:19:04,837
I WOULD SAY MORE OF A WISH LIST,

2001
01:19:04,837 --> 01:19:07,340
AND AS FUNDING BECOMES AVAILABLE

2002
01:19:07,340 --> 01:19:10,309
WE'LL CHECK THESE THINGS OFF.

2003
01:19:10,309 --> 01:19:13,379
SCALABILITY IS DEFINITELY ONE,

2004
01:19:13,379 --> 01:19:15,214
WE HAVE ANOTHER CONNECT-A-THON

2005
01:19:15,214 --> 01:19:20,152
THAT WE'RE WORKING ON, I'M NOT A

2006
01:19:20,152 --> 01:19:23,122
HUGE PLAYER SO, YES, TO BOTH.

2007
01:19:23,122 --> 01:19:24,323
THESE ARE RECOMMENDATIONS, THESE

2008
01:19:24,323 --> 01:19:26,258
ARE WISH LISTS, AND THESE ARE

2009
01:19:26,258 --> 01:19:28,894
THINGS WE'RE ACTIVELY WORKING ON

2010
01:19:28,894 --> 01:19:29,929
TO MOVE FORWARD ON.

2011
01:19:29,929 --> 01:19:31,630
>> AND MY ONLY OTHER
QUESTION,

2012
01:19:31,630 --> 01:19:34,934
IT'S FOR BOTH OF YOU, WE'VE

2013
01:19:34,934 --> 01:19:39,205
LIMITED CAPACITY TO INVITE

2014
01:19:39,205 --> 01:19:40,506
SPEAKERS, ALL THE THINGS

2015
01:19:40,506 --> 01:19:41,841
HAPPENING WITHIN THE UNITED

2016
01:19:41,841 --> 01:19:42,074
STATES.

2017
01:19:42,074 --> 01:19:43,275
ARE THERE OTHER AGENCIES YOU

2018
01:19:43,275 --> 01:19:46,445
FEEL WE SHOULD HAVE SIMILAR

2019
01:19:46,445 --> 01:19:47,513
CONVERSATIONS WITH TO UNDERSTAND

2020
01:19:47,513 --> 01:19:50,383
SIMILAR ACTIVITIES THAT ARE

2021
01:19:50,383 --> 01:19:51,217
TAKING PLACE?

2022
01:19:51,217 --> 01:19:53,986
OR DO YOU FEEL THIS IS A

2023
01:19:53,986 --> 01:19:56,856
REPRESENTATIVE EXAMPLE OF THE

2024
01:19:56,856 --> 01:19:59,258
TYPES OF ACTIVITIES TAKING PLACE

2025
01:19:59,258 --> 01:20:00,993
TO ADDRESS RECOMMENDATIONS LAID

2026
01:20:00,993 --> 01:20:03,763
OUT, THE DIFFERENCE SUBPARTS OF

2027
01:20:03,763 --> 01:20:04,230
THE RECOMMENDATION 12?

2028
01:20:04,230 --> 01:20:08,267
>> I THINK THE OFFICE OF

2029
01:20:08,267 --> 01:20:09,769
NATIONAL COORDINATOR AND THE --

2030
01:20:09,769 --> 01:20:11,137
BECAUSE THEY HAVE -- KATIE

2031
01:20:11,137 --> 01:20:12,438
MENTIONED THEM AS WELL.

2032
01:20:12,438 --> 01:20:14,173
THEY ARE VERY INTEGRAL IN THIS

2033
01:20:14,173 --> 01:20:19,545
SPACE BECAUSE THEY SET THE

2034
01:20:19,545 --> 01:20:21,280
STANDARDS.

2035
01:20:21,280 --> 01:20:23,716
AND THEN GUIDANCE, I APOLOGIZE,

2036
01:20:23,716 --> 01:20:29,288
BUT I ALSO WOULD SAY THE PATIENT

2037
01:20:29,288 --> 01:20:30,823
CENTERS OUTCOME RESEARCH TRUST

2038
01:20:30,823 --> 01:20:32,925
FUND BECAUSE THEY FUNDED OUR

2039
01:20:32,925 --> 01:20:34,260
PROJECT BUT THEY FUND MULTIPLE

2040
01:20:34,260 --> 01:20:36,462
PROJECTS IN THIS SPACE.

2041
01:20:36,462 --> 01:20:39,598
>> THANK YOU.

2042
01:20:39,598 --> 01:20:39,799
KATIE?

2043
01:20:39,799 --> 01:20:45,838
>> I THINK THOSE ARE
EXCELLENT

2044
01:20:45,838 --> 01:20:48,774
SUGGESTION, THE ONLY OTHER TO 

2045
01:20:48,774 --> 01:20:50,843
ADD IS THE CDC, IMPORTANT THINGS

2046
01:20:50,843 --> 01:20:51,210
TO SHARE.

2047
01:20:51,210 --> 01:20:52,178
>> WE'LL HEAR FROM SOME OF
THEM

2048
01:20:52,178 --> 01:20:53,612
IN THE NEXT SESSION, A PERFECT

2049
01:20:53,612 --> 01:20:54,914
SETUP TO THE NEXT SESSION OF

2050
01:20:54,914 --> 01:21:00,152
SPEAKERS AS WELL.

2051
01:21:00,152 --> 01:21:00,786
BACK TO YOU.

2052
01:21:00,786 --> 01:21:01,787
>> IF WE'VE GOT NO OTHER

2053
01:21:01,787 --> 01:21:03,556
QUESTIONS IN THE CHAT WE'LL TAKE

2054
01:21:03,556 --> 01:21:06,192
THIS OPPORTUNITY TO TAKE A QUICK

2055
01:21:06,192 --> 01:21:07,893
BREAK, A QUICK TEN-MINUTE BREAK.

2056
01:21:07,893 --> 01:21:10,563
I'D LIKE TO THANK KATIE AND

2057
01:21:10,563 --> 01:21:11,730
JUANITA FOR TWO EXCELLENT

2058
01:21:11,730 --> 01:21:12,364
PRESENTATIONS.

2059
01:21:12,364 --> 01:21:22,908
AND WE WILL BE BACK AT -- I'M

2060
01:21:22,908 --> 01:21:31,550
SORRY  12:30 CENTRAL TIME, 1:30

2061
01:21:31,550 --> 01:21:34,086
EASTERN TIME AND KATIE AND

2062
01:21:34,086 --> 01:21:35,287
JUANITA WILL JOIN US LATER.

2063
01:21:35,287 --> 01:21:37,631
WE'LL SEE EVERYBODY IN TEN
MINUTES.

2064
01:21:37,631 --> 01:21:39,366
FOR THE SECOND SESSION WE'RE

2065
01:21:39,366 --> 01:21:42,569
GOING TO FOLLOW THE SAME

2066
01:21:42,569 --> 01:21:45,205
CONSTRUCT IN THE PREVIOUS

2067
01:21:45,205 --> 01:21:45,639
SESSION.

2068
01:21:45,639 --> 01:21:49,676
WE'LL THRILLED TO HAVE SPEAK TO

2069
01:21:49,676 --> 01:21:50,711
PROVIDE THEIR INSIGHTS ON

2070
01:21:50,711 --> 01:21:53,113
PROGRESS TO DATE FOR OUR CLUSTER

2071
01:21:53,113 --> 01:21:55,415
DAY TOPICS FOR TODAY.

2072
01:21:55,415 --> 01:21:57,184
WE'LL START WITH STEFFI GARCIA

2073
01:21:57,184 --> 01:21:58,919
FROM OFFICE OF THE NATIONAL

2074
01:21:58,919 --> 01:21:59,686
COORDINATOR FOR HEALTH

2075
01:21:59,686 --> 01:22:00,187
INFORMATION TECHNOLOGY.

2076
01:22:00,187 --> 01:22:06,126
THANKS SO MUCH FOR BEING WITH US

2077
01:22:06,126 --> 01:22:06,326
TODAY.

2078
01:22:06,326 --> 01:22:08,762
>> THANK YOU FOR THE
INVITATION.

2079
01:22:08,762 --> 01:22:10,731
I'M EXCITED TO PRESENT TO THIS

2080
01:22:10,731 --> 01:22:13,734
GROUP AND HOPE YOU'LL FIND THE

2081
01:22:13,734 --> 01:22:16,136
MATERIAL USEFUL AND INTERESTING.

2082
01:22:16,136 --> 01:22:18,972
AND I'LL JUMP RIGHT IN, ASSUMING

2083
01:22:18,972 --> 01:22:23,710
EVERYONE CAN HEAR ME OKAY.

2084
01:22:23,710 --> 01:22:25,546
SO-- GREAT, THANK YOU.

2085
01:22:25,546 --> 01:22:27,948
SO MY NAME IS STEPHANIE GARCIA,

2086
01:22:27,948 --> 01:22:30,250
A BRANCH BRIEF IN THE OFFICE OF

2087
01:22:30,250 --> 01:22:32,219
THE NATIONAL COORDINATOR FOR

2088
01:22:32,219 --> 01:22:34,822
HEALTH I.T.

2089
01:22:34,822 --> 01:22:40,327
TODAY I'M GOING OVER USCDI+ FOR

2090
01:22:40,327 --> 01:22:41,962
MATERNAL HEALTH IN PARTNERSHIP

2091
01:22:41,962 --> 01:22:45,699
WITH NICHD, AND AIM TO

2092
01:22:45,699 --> 01:22:48,168
DEMONSTRATE THOUSAND THIS CAN

2093
01:22:48,168 --> 01:22:49,636
SUPPORT IMPLEMENTATIONS OF 12

2094
01:22:49,636 --> 01:22:57,177
AND 13, AS MADE BY THE TASK

2095
01:22:57,177 --> 01:22:57,644
FORCE.

2096
01:22:57,644 --> 01:22:59,913
SO, HERE IS THE AGENDA.

2097
01:22:59,913 --> 01:23:04,618
A BRIEF OVERVIEW OF ONC AND OUR

2098
01:23:04,618 --> 01:23:08,021
ROLE WITHIN HHS AND MOVE TO

2099
01:23:08,021 --> 01:23:10,624
USCDI, PROVIDING THE FRAMEWORK

2100
01:23:10,624 --> 01:23:13,160
FOR UNDERSTANDING USCDI+.

2101
01:23:13,160 --> 01:23:15,462
AND THEN I'LL SPEAK ABOUT THE

2102
01:23:15,462 --> 01:23:18,966
DRAFT DATA LIST HOW THIS WORK

2103
01:23:18,966 --> 01:23:21,168
SERVES AS A STARTING POINT TO

2104
01:23:21,168 --> 01:23:22,436
MEET PARTS OF RECOMMENDATION 12

2105
01:23:22,436 --> 01:23:32,913
AND 13 AND WRAP UP WITH NEXT

2106
01:23:33,814 --> 01:23:34,648
STEPS.

2107
01:23:34,648 --> 01:23:39,653
ONC WAS FOUNDED IN 2004 BY

2108
01:23:39,653 --> 01:23:41,722
EXECUTIVE O, TO ADVANCE NATIONAL

2109
01:23:41,722 --> 01:23:45,359
GOALS FOR BETTER AND SAFER

2110
01:23:45,359 --> 01:23:48,328
HEALTH CARE THROUGH

2111
01:23:48,328 --> 01:23:49,630
INTRAPROBABLY NATIONWIDE HEALTH

2112
01:23:49,630 --> 01:23:50,364
I.T. INFRASTRUCTURE.

2113
01:23:50,364 --> 01:23:57,471
IN 2009 CONGRESS PASSED THE ACT,

2114
01:23:57,471 --> 01:24:00,240
PROMOTED ADOPTION AND USE OF

2115
01:24:00,240 --> 01:24:02,109
HEALTH I.T.

2116
01:24:02,109 --> 01:24:05,345
THIS IS FOUNDATION FOR 

2117
01:24:05,345 --> 01:24:06,146
PROLIFERATION ACROSS THE HEALTH

2118
01:24:06,146 --> 01:24:07,881
CARE INDUSTRY.

2119
01:24:07,881 --> 01:24:10,083
I'M GOING TO PAUSE AND ASK CAN

2120
01:24:10,083 --> 01:24:12,586
YOU SEE THE SLIDES OR ARE YOU

2121
01:24:12,586 --> 01:24:13,353
SEEING MY NOTES?

2122
01:24:13,353 --> 01:24:15,989
>> WE CAN SEE YOUR SLIDES.

2123
01:24:15,989 --> 01:24:16,256
THANK YOU.

2124
01:24:16,256 --> 01:24:19,693
>> OKAY.

2125
01:24:19,693 --> 01:24:21,228
THANK YOU.

2126
01:24:21,228 --> 01:24:24,197
SO, IN 2016, CONGRESS THEN

2127
01:24:24,197 --> 01:24:25,632
PASSED THE 21ST CENTURY CURES

2128
01:24:25,632 --> 01:24:25,933
ACT.

2129
01:24:25,933 --> 01:24:28,769
WHICH WE'RE FAMILIAR WITH, AIMS

2130
01:24:28,769 --> 01:24:29,403
TO ENCOURAGE, PROMOTE, LEVERAGE

2131
01:24:29,403 --> 01:24:31,305
EXISTING HEALTH I.T. AND EHRs

2132
01:24:31,305 --> 01:24:35,242
ACROSS THE HEALTH CARE INDUSTRY;

2133
01:24:35,242 --> 01:24:41,715
VALUE RESEARCH AND BETTER CARE. 

2134
01:24:41,715 --> 01:24:43,250
HITECH IN 2009 PROVIDED THE

2135
01:24:43,250 --> 01:24:45,018
FOUNDATION THROUGH ADOPTION AND

2136
01:24:45,018 --> 01:24:49,289
NOW WITH THE CURES ACT ONC'S

2137
01:24:49,289 --> 01:24:51,358
POSITION TO LEVERAGE THE

2138
01:24:51,358 --> 01:24:52,225
FOUNDATION.

2139
01:24:52,225 --> 01:24:54,094
OVER TIME, ONC IDENTIFIED

2140
01:24:54,094 --> 01:24:55,963
SEVERAL MECHANISMS WHICH ARE IN

2141
01:24:55,963 --> 01:24:58,131
THE BULLETED LIST BELOW, THAT

2142
01:24:58,131 --> 01:25:01,868
DEPEND ON STANDARDIZED DATA TO

2143
01:25:01,868 --> 01:25:06,039
CREATE THAT INTEROPEARABLE

2144
01:25:06,039 --> 01:25:09,710
HEALTH I.T. INFRASTRUCTURE.

2145
01:25:09,710 --> 01:25:13,113
 

2146
01:25:13,113 --> 01:25:17,184
NOW JUMPING INTO USCDI, THE U.S.

2147
01:25:17,184 --> 01:25:24,524
CORE FOR DATA INTEROPERABILITY

2148
01:25:24,524 --> 01:25:26,593
SHOULD BE AVAILABLE

2149
01:25:26,593 --> 01:25:26,960
ELECTRONICALLY.

2150
01:25:26,960 --> 01:25:28,562
THIS BASELINE ALONG WITH

2151
01:25:28,562 --> 01:25:35,469
GUIDANCE REGARDING APPLICABLE 

2152
01:25:35,469 --> 01:25:36,670
VOCABULARY STANDARDS FOR A

2153
01:25:36,670 --> 01:25:38,839
VARIETY OF USE CASES INCLUDING

2154
01:25:38,839 --> 01:25:41,274
TREATMENT, PAYMENT, POST MARKET

2155
01:25:41,274 --> 01:25:42,042
SURVEILLANCE, RESEARCH AND

2156
01:25:42,042 --> 01:25:44,211
PUBLIC HEALTH.

2157
01:25:44,211 --> 01:25:45,545
THERE'S AN ANNUAL WELL-DEFINED

2158
01:25:45,545 --> 01:25:47,080
PROCESS FOR INCORPORATION OF NEW

2159
01:25:47,080 --> 01:25:50,017
DATA ELEMENTS AND CLASSES INTO

2160
01:25:50,017 --> 01:25:51,785
USCDI, AND THIS PROCESS IS

2161
01:25:51,785 --> 01:25:54,521
BASICALLY A WAY FOR ONC TO

2162
01:25:54,521 --> 01:25:57,457
SIGNAL TO INDUSTRY WHERE THE

2163
01:25:57,457 --> 01:25:58,558
HEALTH I.T. CERTIFICATION

2164
01:25:58,558 --> 01:26:00,093
REQUIREMENTS ARE LIKELY TO GO IN

2165
01:26:00,093 --> 01:26:01,294
THE FUTURE.

2166
01:26:01,294 --> 01:26:05,332
THIS ALSO HELPS WITH

2167
01:26:05,332 --> 01:26:06,867
PRIORITIZING STANDARDS

2168
01:26:06,867 --> 01:26:07,167
DEVELOPMENT.

2169
01:26:07,167 --> 01:26:08,201
POLICY PERSPECTIVE THE ABILITY

2170
01:26:08,201 --> 01:26:12,139
TO ADD NEW DATA ELEMENTS ON

2171
01:26:12,139 --> 01:26:13,140
ANNUAL EXPECTED BASIS HAS

2172
01:26:13,140 --> 01:26:14,341
INCREDIBLE IMPACT BECAUSE WE'RE

2173
01:26:14,341 --> 01:26:17,077
ABLE TO RESPOND TO OUR

2174
01:26:17,077 --> 01:26:19,479
CONSTANTLY DEVELOPING AREAS OF

2175
01:26:19,479 --> 01:26:21,882
HEALTH WITH EMPHASIS ON HEALTH

2176
01:26:21,882 --> 01:26:22,983
EQUITY OUTSIDE REGULATORY

2177
01:26:22,983 --> 01:26:23,517
CYCLES.

2178
01:26:23,517 --> 01:26:26,920
SO, FOR EXAMPLE, THE FIRST

2179
01:26:26,920 --> 01:26:29,990
VERSION OF USCDI IS ADOPTED AS A

2180
01:26:29,990 --> 01:26:31,725
STANDARD IN THE ONC CURES FINAL

2181
01:26:31,725 --> 01:26:34,361
ACT RULES, THE RULE WAS

2182
01:26:34,361 --> 01:26:35,662
PUBLISHED IN 2020 AND

2183
01:26:35,662 --> 01:26:36,763
CERTIFICATION REQUIREMENTS WERE

2184
01:26:36,763 --> 01:26:41,368
EXPECTED TO BE ADHERED TO IN

2185
01:26:41,368 --> 01:26:41,668
2022.

2186
01:26:41,668 --> 01:26:43,870
HOWEVER, ALTHOUGH THAT TOOK TWO

2187
01:26:43,870 --> 01:26:45,839
YEARS TO HAVE IT RECOGNIZED A

2188
01:26:45,839 --> 01:26:49,810
STANDARD IN ALL, WE HAVE

2189
01:26:49,810 --> 01:26:52,546
CONTINUED TO EVOLVE USCDI WITH

2190
01:26:52,546 --> 01:26:53,413
VERSION 4 CLOSING COMMENT PERIOD

2191
01:26:53,413 --> 01:26:56,183
IN SEPTEMBER OF THIS YEAR.

2192
01:26:56,183 --> 01:26:58,151
THE UPDATES REQUIRE ONLY MODEST

2193
01:26:58,151 --> 01:27:01,755
DEVELOPMENT BURDEN ON HEALTH

2194
01:27:01,755 --> 01:27:05,592
I.T. MODULES, CREATE MODEST 

2195
01:27:05,592 --> 01:27:06,560
IMPLEMENTATION BURDEN, AND

2196
01:27:06,560 --> 01:27:08,195
RESULT IN MODEST AND AGGREGATE

2197
01:27:08,195 --> 01:27:12,699
LIFT FOR ALL NEW DATA ELEMENTS

2198
01:27:12,699 --> 01:27:13,500
COMBINED.

2199
01:27:13,500 --> 01:27:17,270
AS COORDINATING OFFICE CHARGED

2200
01:27:17,270 --> 01:27:17,838
WITH PROMOTING NATIONWIDE

2201
01:27:17,838 --> 01:27:19,372
INFORMATION EXCHANGE WE'VE BEEN

2202
01:27:19,372 --> 01:27:21,441
WORKING WITH HHS COLLEAGUES

2203
01:27:21,441 --> 01:27:24,945
ACROSS OPERATING DIVISIONS TO

2204
01:27:24,945 --> 01:27:27,447
SUPPORT ADOPTION AT USCDI BY ALL

2205
01:27:27,447 --> 01:27:28,448
HHS PROGRAMS AS WELL.

2206
01:27:28,448 --> 01:27:30,083
SITTING IN THE OFFICE OF THE

2207
01:27:30,083 --> 01:27:32,152
SECRETARY, THIS IS A REALLY NICE

2208
01:27:32,152 --> 01:27:34,788
PURVIEW AND ABILITY TO WORK

2209
01:27:34,788 --> 01:27:35,789
ACROSS THE OPERATING DIVISIONS.

2210
01:27:35,789 --> 01:27:38,625
AGAIN, ALL OF THIS IS WITH THE

2211
01:27:38,625 --> 01:27:41,461
INTENT OF CREATING THAT

2212
01:27:41,461 --> 01:27:43,864
INTRAOPERABLE FOUNDATION FOR

2213
01:27:43,864 --> 01:27:51,438
HEALTH INFORMATION.

2214
01:27:51,438 --> 01:27:53,206
THE FIRST THREE VERSIONS, YOU'RE

2215
01:27:53,206 --> 01:27:55,609
MORE THAN WELCOME TO GOOGLE

2216
01:27:55,609 --> 01:27:58,345
USCDI AND FIND MORE INFORMATION

2217
01:27:58,345 --> 01:28:01,047
AS WELL AS THE VERSION 4.

2218
01:28:01,047 --> 01:28:03,683
JUST TO SUM UP, USCDI

2219
01:28:03,683 --> 01:28:04,551
ESTABLISHED CONSISTENT BASELINE

2220
01:28:04,551 --> 01:28:06,653
OF HARMONIZED DATA ELEMENTS THAT

2221
01:28:06,653 --> 01:28:10,157
CAN BE BROADLY REUSED ACROSS USE

2222
01:28:10,157 --> 01:28:11,124
CASES, INCLUDING THOSE OUTSIDE

2223
01:28:11,124 --> 01:28:12,792
OF PATIENT CARE AND PATIENT

2224
01:28:12,792 --> 01:28:16,163
ACCESS, SO AS WE'RE DISCUSSING

2225
01:28:16,163 --> 01:28:19,432
TODAY FOR RESEARCH PURPOSES.

2226
01:28:19,432 --> 01:28:22,636
UPDATE BASED ON ANNUAL PROCESS

2227
01:28:22,636 --> 01:28:24,271
WITH MULTIPLE CRITERIA INCLUDING

2228
01:28:24,271 --> 01:28:26,339
MATURITY OF THE STANDARD, AS

2229
01:28:26,339 --> 01:28:30,110
WELL AS PUBLIC AND INDUSTRY

2230
01:28:30,110 --> 01:28:30,977
PRIORITIES.

2231
01:28:30,977 --> 01:28:35,982
AND JUST TO REITERATE, USCDI

2232
01:28:35,982 --> 01:28:40,487
ASSURANCE ONLY THE MOST

2233
01:28:40,487 --> 01:28:42,122
IMPORTANT DATA ELEMENTS AND

2234
01:28:42,122 --> 01:28:43,323
DIRECTLY TIED TO MEASURABLE

2235
01:28:43,323 --> 01:28:44,958
IMPROVEMENTS ARE ADDED ON AN

2236
01:28:44,958 --> 01:28:49,596
ANNUAL BASIS.

2237
01:28:49,596 --> 01:28:54,134
NOW WE'LL DISCUSS THE USCDI+ FOR

2238
01:28:54,134 --> 01:28:55,435
MATERNAL HEALTH DATASET.

2239
01:28:55,435 --> 01:28:59,940
BUILDING OFF OF THAT USCDI

2240
01:28:59,940 --> 01:29:01,141
FRAMEWORK, USCDI+ ESTABLISHES

2241
01:29:01,141 --> 01:29:03,009
DATA FACTS AND IMPLEMENT

2242
01:29:03,009 --> 01:29:04,411
GUIDANCE TO HARMONIZE AND ALIGN

2243
01:29:04,411 --> 01:29:08,615
DATA NEEDS FOR AGENCY PARTNERS.

2244
01:29:08,615 --> 01:29:11,351
USCDI+ IS AN EXTENSION AND

2245
01:29:11,351 --> 01:29:12,752
COMPLEMENT TO USCDI, AND WE'VE

2246
01:29:12,752 --> 01:29:14,955
BEEN WORKING WITH HHS PARTNERS

2247
01:29:14,955 --> 01:29:20,293
TO IDENTIFY DATA NEEDS ACROSS 

2248
01:29:20,293 --> 01:29:22,162
AND OUTSIDE OF HHS SPECIFIED

2249
01:29:22,162 --> 01:29:22,729
AREAS.

2250
01:29:22,729 --> 01:29:23,697
TODAY DISCUSSING MATERNAL

2251
01:29:23,697 --> 01:29:24,898
HEALTH, FOR EXAMPLE.

2252
01:29:24,898 --> 01:29:27,968
THIS WILL GIVE PARTNERS ABILITY

2253
01:29:27,968 --> 01:29:30,237
TO POINT TO GUIDANCE AS THEY

2254
01:29:30,237 --> 01:29:32,038
LOOK FOR INFORMATION ON HOW TO

2255
01:29:32,038 --> 01:29:35,308
BEST COLLECT OR EXCHANGE DATA.

2256
01:29:35,308 --> 01:29:37,644
AND WHEN IMPLEMENTING DATA

2257
01:29:37,644 --> 01:29:40,480
STANDARDS FOR THOSE ACTIVITIES.

2258
01:29:40,480 --> 01:29:42,315
THE USCDI PLUS LAUNCHED IN FALL

2259
01:29:42,315 --> 01:29:44,618
OF 2021 AND SINCE THEN THERE'S

2260
01:29:44,618 --> 01:29:46,253
BEEN INCREASING INTEREST IN THE

2261
01:29:46,253 --> 01:29:49,456
MODEL IN A FEW AREAS SO WE

2262
01:29:49,456 --> 01:29:52,492
WORKED WITH CDC, CMS, HRSA, NIH

2263
01:29:52,492 --> 01:29:56,029
TO ADVANCE DIFFERENT

2264
01:29:56,029 --> 01:29:58,832
PROGRAMMATIC AREAS, LISTED HERE.

2265
01:29:58,832 --> 01:30:00,500
AND THE MATERNAL HEALTH DOMAIN

2266
01:30:00,500 --> 01:30:02,669
WAS IDENTIFIED AS AN AREA OF

2267
01:30:02,669 --> 01:30:04,304
FOCUS WITHIN THE CONTEXT OF THE

2268
01:30:04,304 --> 01:30:08,141
DISCUSSION REGARDING PUBLIC

2269
01:30:08,141 --> 01:30:12,746
HEALTH DATASETS WITH CDC AND TO

2270
01:30:12,746 --> 01:30:13,613
SUPPORT ONC PARTNERED WITH NICHD

2271
01:30:13,613 --> 01:30:17,317
TO BEGIN ESTABLISHING THE DATA

2272
01:30:17,317 --> 01:30:19,085
LIFT, AND STAKEHOLDERS AND PILOT

2273
01:30:19,085 --> 01:30:20,387
PARTNERS TO ENSURE THAT IS

2274
01:30:20,387 --> 01:30:24,891
DEVELOPED OVER TIME WITH USER

2275
01:30:24,891 --> 01:30:25,659
FEEDBACK.

2276
01:30:25,659 --> 01:30:28,828
JUST A FEW INCREMENTAL OVER

2277
01:30:28,828 --> 01:30:31,598
TIME, THE TRANSPARENT ESTABLISH

2278
01:30:31,598 --> 01:30:33,967
COLLABORATIVE PROCESS, WEIGHING

2279
01:30:33,967 --> 01:30:36,836
BOTH ANTICIPATED BENEFITS AND

2280
01:30:36,836 --> 01:30:38,371
INDUSTRY IMPACTS, USCDI+ WILL

2281
01:30:38,371 --> 01:30:40,240
MERIT A SIMILAR PROCESS

2282
01:30:40,240 --> 01:30:41,641
ESTABLISH DATA ELEMENTS AND

2283
01:30:41,641 --> 01:30:42,842
IMPLEMENTATION GUIDANCE TO

2284
01:30:42,842 --> 01:30:44,311
HARMONIZE AND ALIGN DATA NEEDS

2285
01:30:44,311 --> 01:30:48,982
FOR PARTNERS.

2286
01:30:48,982 --> 01:30:49,115
 

2287
01:30:49,115 --> 01:30:51,818
THE U.S. CDI+ MATERNAL SET

2288
01:30:51,818 --> 01:30:54,354
FOCUSED ON ESTABLISH CORE

2289
01:30:54,354 --> 01:30:56,856
DATASET, AS NECESSARY FOR HIGH

2290
01:30:56,856 --> 01:30:58,258
QUALITY EQUITABLE OUTCOMES

2291
01:30:58,258 --> 01:31:00,593
SUPPORTING PUBLIC HEALTH

2292
01:31:00,593 --> 01:31:04,964
INITIATIVES AND MATERNAL HEALTH

2293
01:31:04,964 --> 01:31:07,133
RESEARCH, THE INTENT TO EXPAND

2294
01:31:07,133 --> 01:31:09,769
AS NEED, CONDUCT PILOT TESTING,

2295
01:31:09,769 --> 01:31:11,538
AND EVENTUALLY SEEING ADOPTION

2296
01:31:11,538 --> 01:31:12,839
BY RELEVANT STAKEHOLDERS.

2297
01:31:12,839 --> 01:31:15,008
THE GOAL TO DEVELOP SOMETHING

2298
01:31:15,008 --> 01:31:17,310
THAT HHS PROGRAM OFFICES CAN USE

2299
01:31:17,310 --> 01:31:19,279
AND POINT TO, AS THIS IS THE

2300
01:31:19,279 --> 01:31:23,016
DATA THAT SHOULD BE

2301
01:31:23,016 --> 01:31:25,652
ELECTRONICALLY AVAILABLE WHEN

2302
01:31:25,652 --> 01:31:27,420
PROVIDING CARE OR INSTITUTING

2303
01:31:27,420 --> 01:31:29,422
PUBLIC HEALTH INITIATIVES OR

2304
01:31:29,422 --> 01:31:32,125
CONDUCTING RESEARCH WITHIN THE

2305
01:31:32,125 --> 01:31:32,459
POPULATION.

2306
01:31:32,459 --> 01:31:34,327
WE WERE INITIALLY THINKING ABOUT

2307
01:31:34,327 --> 01:31:35,929
OUR INCLUSION AND EXCLUSION

2308
01:31:35,929 --> 01:31:38,365
CRITERIA FOR THIS CURRENT DRAFT

2309
01:31:38,365 --> 01:31:39,532
DATASET, IN THREE AREAS.

2310
01:31:39,532 --> 01:31:41,201
WE LOOKED AT IMPORTANCE FOR

2311
01:31:41,201 --> 01:31:43,803
PROMOTING HIGH QUALITY CARE AND

2312
01:31:43,803 --> 01:31:45,672
ADDRESSING CARE GAPS, LIKELIHOOD

2313
01:31:45,672 --> 01:31:49,175
OF DATA AVAILABILITY THROUGH

2314
01:31:49,175 --> 01:31:49,743
DOCUMENTATION, AND POTENTIAL

2315
01:31:49,743 --> 01:31:50,477
IMPLEMENTATION BURDEN.

2316
01:31:50,477 --> 01:31:53,546
SO YOU'LL SEE THAT ALIGNS

2317
01:31:53,546 --> 01:31:57,851
CLOSELY WITH THE USCDI CRITERIA

2318
01:31:57,851 --> 01:31:59,352
AS WELL.

2319
01:31:59,352 --> 01:32:02,522
OUR INITIAL REVIEW INCLUDED

2320
01:32:02,522 --> 01:32:05,492
INPUTS AND RESOURCE LISTED HERE.

2321
01:32:05,492 --> 01:32:07,160
WE SCOPED DIFFERENT RESOURCES

2322
01:32:07,160 --> 01:32:08,228
BOTH ACROSS HHS AND OUTSIDE THE

2323
01:32:08,228 --> 01:32:09,696
DEPARTMENT AS WELL.

2324
01:32:09,696 --> 01:32:11,831
AND THE RESULTING DRAFT DATASET

2325
01:32:11,831 --> 01:32:13,266
REFLECTS DATA ELEMENTS

2326
01:32:13,266 --> 01:32:14,167
IDENTIFIED THROUGH THESE INPUTS,

2327
01:32:14,167 --> 01:32:16,336
MANY OF WHICH ARE TIED TO

2328
01:32:16,336 --> 01:32:19,072
FEDERAL PROGRAMS AND OTHER

2329
01:32:19,072 --> 01:32:20,707
NATIONAL INITIATIVES.

2330
01:32:20,707 --> 01:32:23,209
ALSO, GIVEN ONC ROLE AS

2331
01:32:23,209 --> 01:32:25,412
COORDINATOR WE'VE MET WITH

2332
01:32:25,412 --> 01:32:26,045
VARIOUS FEDERAL PARTNERS AND

2333
01:32:26,045 --> 01:32:28,581
WE'RE HELD TWO PUBLIC LISTENING

2334
01:32:28,581 --> 01:32:31,651
SESSIONS WITH INVITED EXTERNAL

2335
01:32:31,651 --> 01:32:34,687
PARTNERS TO GATHER ADDITIONAL

2336
01:32:34,687 --> 01:32:36,122
FEEDBACK FROM CERTAIN SPECIFIC

2337
01:32:36,122 --> 01:32:37,690
MATTER AREAS, WE'VE ALSO

2338
01:32:37,690 --> 01:32:39,659
PARTNERED WITH THREE PILOT SITES

2339
01:32:39,659 --> 01:32:43,930
TO GATHER ON THE GROUND

2340
01:32:43,930 --> 01:32:44,564
FEEDBACK, MOSTLY AROUND

2341
01:32:44,564 --> 01:32:46,366
FEASIBILITY, HAD THEM LOOK AT

2342
01:32:46,366 --> 01:32:49,369
DATA LIFT AND TELL US WHAT DATA

2343
01:32:49,369 --> 01:32:51,438
ON THE LIST WAS CURRENTLY

2344
01:32:51,438 --> 01:32:55,842
AVAILABLE TO THEM, AND EVEN WHAT

2345
01:32:55,842 --> 01:32:58,011
IT LOOKED LIKE, WHAT THE GENERAL

2346
01:32:58,011 --> 01:32:59,345
PERCENTAGES OR ESTIMATES THE

2347
01:32:59,345 --> 01:33:01,080
DATA WAS AVAILABLE FROM THE

2348
01:33:01,080 --> 01:33:05,785
VARIOUS SOURCES THAT THEY MAY 

2349
01:33:05,785 --> 01:33:07,420
HAVE HAD ACCESS TO.

2350
01:33:07,420 --> 01:33:09,522
DURING THE FEEDBACK SESSIONS WE

2351
01:33:09,522 --> 01:33:10,857
ASKED THE SAME QUESTIONS, SO ARE

2352
01:33:10,857 --> 01:33:13,693
THESE THE RIGHT DATA CLASSES AND

2353
01:33:13,693 --> 01:33:15,228
ELEMENTS, ARE WE MISSING

2354
01:33:15,228 --> 01:33:17,330
ANYTHING, IS THE DATA ELEMENT

2355
01:33:17,330 --> 01:33:18,631
LIKELY TO CONTRIBUTE THE GOALS

2356
01:33:18,631 --> 01:33:21,234
WE HAD SET FORWARD IN TERMS OF

2357
01:33:21,234 --> 01:33:24,304
HIGH QUALITY CARE, AND EQUITABLE

2358
01:33:24,304 --> 01:33:26,406
CARE, THEY ASKED ABOUT

2359
01:33:26,406 --> 01:33:29,542
IMPLEMENTATION BURDEN AND DATA

2360
01:33:29,542 --> 01:33:29,876
AVAILABILITY.

2361
01:33:29,876 --> 01:33:33,713
AND ALSO WHETHER THERE WAS ANY

2362
01:33:33,713 --> 01:33:35,682
PARTICULAR ISSUES WITH

2363
01:33:35,682 --> 01:33:36,616
ELECTRONICALLY EXTRACTING THE

2364
01:33:36,616 --> 01:33:38,751
DATA AND ABOUT HOW MUCH

2365
01:33:38,751 --> 01:33:44,757
DEVELOPER TIME WOULD BE NEEDED.

2366
01:33:44,757 --> 01:33:46,726
AGAIN, I PUT THIS SLIDE IN SO

2367
01:33:46,726 --> 01:33:49,662
YOU CAN ALSO SEE SOME OF THE

2368
01:33:49,662 --> 01:33:51,764
GROUPS OF PARTNERS THAT WE'VE

2369
01:33:51,764 --> 01:33:55,602
MET WITH, SO HHS PROGRAMS,

2370
01:33:55,602 --> 01:33:57,203
HEALTH CARE PROVIDERS, VARIOUS

2371
01:33:57,203 --> 01:33:59,873
TYPES, I.T. DEVELOPERS, PUBLIC

2372
01:33:59,873 --> 01:34:02,675
HEALTH EXPERTS AND RESEARCHERS.

2373
01:34:02,675 --> 01:34:05,378
 

2374
01:34:05,378 --> 01:34:07,080
WE RECENTLY MOVED TO AN ONLINE

2375
01:34:07,080 --> 01:34:14,087
PLATFORM TO HOUSE THIS AND OTHER

2376
01:34:14,087 --> 01:34:15,622
USCDI+ SETS, LAUNCHING IN A FEW

2377
01:34:15,622 --> 01:34:19,759
WEEKS, IT WILL BE ANNOUNCED ON

2378
01:34:19,759 --> 01:34:20,527
HEALTHIT.GOV WITH A COMMENT

2379
01:34:20,527 --> 01:34:21,828
PERIOD FOR THIS DATA LIST THAT

2380
01:34:21,828 --> 01:34:23,563
WILL OPEN AT A LATER DATE, AND

2381
01:34:23,563 --> 01:34:27,333
AS I MENTIONED IT WILL BE PART

2382
01:34:27,333 --> 01:34:30,370
OF THE REFINEMENT OF THE

2383
01:34:30,370 --> 01:34:30,603
DATASET.

2384
01:34:30,603 --> 01:34:33,006
SINCE WE CAN'T LOOK AT IT TODAY

2385
01:34:33,006 --> 01:34:35,875
I'LL GIVE AN OVERVIEW AND A HIGH

2386
01:34:35,875 --> 01:34:38,444
LEVEL PREVIEW OF WHAT THE DATA

2387
01:34:38,444 --> 01:34:40,380
ELEMENT -- WHAT THE DATA LIST

2388
01:34:40,380 --> 01:34:42,649
CONSISTS OF.

2389
01:34:42,649 --> 01:34:45,218
THERE ARE ABOUT 153 DATA

2390
01:34:45,218 --> 01:34:46,753
ELEMENTS, AS YOU CAN SEE A BIG

2391
01:34:46,753 --> 01:34:50,456
PORTION OF THEM ARE ACTUALLY

2392
01:34:50,456 --> 01:34:51,758
FROM THE USCDI DATASET WHICH IS

2393
01:34:51,758 --> 01:34:53,426
GREAT BECAUSE THAT MEANS THAT

2394
01:34:53,426 --> 01:34:56,262
DATA IS LIKELY ALREADY AVAILABLE

2395
01:34:56,262 --> 01:34:58,231
AND SHOULD BE ELECTRONICALLY

2396
01:34:58,231 --> 01:35:00,099
ABLE TO BE ELECTRONICALLY

2397
01:35:00,099 --> 01:35:00,967
EXCHANGED.

2398
01:35:00,967 --> 01:35:03,469
WE ALSO FOUND THAT IN THE

2399
01:35:03,469 --> 01:35:05,672
CREATION OF THE VARIOUS DOMAINS

2400
01:35:05,672 --> 01:35:07,974
WITHIN USCDI PLUS THERE WAS

2401
01:35:07,974 --> 01:35:08,408
OVERLAP.

2402
01:35:08,408 --> 01:35:10,476
SO NAMELY THERE WAS OVERLAP WITH

2403
01:35:10,476 --> 01:35:12,912
THE PUBLIC HEALTH DOMAIN, CANCER

2404
01:35:12,912 --> 01:35:14,347
DOMAIN, QUALITY DOMAIN.

2405
01:35:14,347 --> 01:35:16,749
THIS LETS US KNOW A COUPLE

2406
01:35:16,749 --> 01:35:19,252
THINGS, THAT THERE ARE VARIOUS

2407
01:35:19,252 --> 01:35:22,956
DATA ELEMENTS AND CLASSES WITHIN

2408
01:35:22,956 --> 01:35:25,792
THE DATA LIST THAT SHOULD BE OF

2409
01:35:25,792 --> 01:35:26,926
SUBSTANTIAL MATURITY LEVEL.

2410
01:35:26,926 --> 01:35:29,429
IT CAN ALSO TELL US THAT THEY

2411
01:35:29,429 --> 01:35:31,598
MAY NOT BE AT A SUBSTANTIAL

2412
01:35:31,598 --> 01:35:35,234
MATURITY LEVEL BUT THERE'S A

2413
01:35:35,234 --> 01:35:37,203
NEED ACROSS MULTIPLE DOMAINS AND

2414
01:35:37,203 --> 01:35:38,071
AREAS TO STANDARDIZE SOMETHING

2415
01:35:38,071 --> 01:35:41,674
SO THERE'S A GAP THERE IN MORE

2416
01:35:41,674 --> 01:35:42,675
THAN JUST MATERNAL HEALTH.

2417
01:35:42,675 --> 01:35:46,613
AND THEN I DID ALSO WANT TO

2418
01:35:46,613 --> 01:35:47,747
HIGHLIGHT THAT FOR MATERNAL

2419
01:35:47,747 --> 01:35:49,248
HEALTH DATASET THERE ARE UNIQUE

2420
01:35:49,248 --> 01:35:51,317
ELEMENTS THAT ARE OBVIOUSLY NOT

2421
01:35:51,317 --> 01:35:54,621
IN USCDI OR IN OTHER DOMAINS,

2422
01:35:54,621 --> 01:35:57,023
AND SOME EXAMPLES I'VE INCLUDED

2423
01:35:57,023 --> 01:36:00,860
HERE ARE THINGS LIKE DATA CLASS

2424
01:36:00,860 --> 01:36:02,929
AND ELEMENT FOR DEPRESSION,

2425
01:36:02,929 --> 01:36:03,463
ANXIETY, HEMORRHAGIC RISK

2426
01:36:03,463 --> 01:36:05,465
SCREEN, ALSO LOOKING AT THINGS

2427
01:36:05,465 --> 01:36:10,403
THAT MAY INDICATE HIGH RISK FOR

2428
01:36:10,403 --> 01:36:11,270
PERINATAL REFERRAL, HYPERTENSIVE

2429
01:36:11,270 --> 01:36:13,239
DISORDERS SPECIFIC TO PREGNANCY,

2430
01:36:13,239 --> 01:36:17,644
METHOD OF CONTRACEPTION AND SOME

2431
01:36:17,644 --> 01:36:18,645
OTHER PREGNANCY-RELATED

2432
01:36:18,645 --> 01:36:20,680
INFORMATION.

2433
01:36:20,680 --> 01:36:21,914
BECAUSE OF THE FOCUS AREA OF THE

2434
01:36:21,914 --> 01:36:23,850
GROUP I DID TAKE A LOOK AT THE

2435
01:36:23,850 --> 01:36:26,719
DATASET AND PROVIDED SOME

2436
01:36:26,719 --> 01:36:28,454
ADDITIONAL EXAMPLES OF OTHER

2437
01:36:28,454 --> 01:36:31,090
DATA ELEMENTS THAT WE CURRENTLY

2438
01:36:31,090 --> 01:36:34,727
HAVE IN THE DATASET, AND NAMELY

2439
01:36:34,727 --> 01:36:36,663
THERE WERE -- I INCLUDED SOME

2440
01:36:36,663 --> 01:36:41,367
SAMPLES OF THE TYPE OF DATA

2441
01:36:41,367 --> 01:36:43,336
ELEMENTS LISTED FOR MEDICATION

2442
01:36:43,336 --> 01:36:44,804
INFORMATION GATHERING, RELATED

2443
01:36:44,804 --> 01:36:49,709
TO PHARMACY NOTE IN THE

2444
01:36:49,709 --> 01:36:51,244
RECOMMENDATION, BIRTH OUTCOME, I

2445
01:36:51,244 --> 01:36:53,212
INCLUDED SOME DATA ELEMENTS

2446
01:36:53,212 --> 01:36:55,248
RELATED TO -- THAT WOULD BE

2447
01:36:55,248 --> 01:36:57,283
COLLECTED IN THAT, YOU KNOW,

2448
01:36:57,283 --> 01:36:59,052
PERIOD RIGHT AFTER DELIVERY, AND

2449
01:36:59,052 --> 01:37:04,957
THEN IN TERMS OF TRYING TO

2450
01:37:04,957 --> 01:37:06,926
IDENTIFY POTENTIAL EQUITY TYPE

2451
01:37:06,926 --> 01:37:09,328
DATA, I'VE INCLUDED THINGS LIKE

2452
01:37:09,328 --> 01:37:10,897
ETHNICITY, TRIBAL AFFILIATION,

2453
01:37:10,897 --> 01:37:14,067
AND RACE.

2454
01:37:14,067 --> 01:37:16,769
I WILL NOTE CURRENTLY WE DON'T

2455
01:37:16,769 --> 01:37:18,638
HAVE LACTATION SPECIFIC ELEMENTS

2456
01:37:18,638 --> 01:37:19,839
BUT I'LL HIGHLIGHT THAT'S, FOR

2457
01:37:19,839 --> 01:37:21,374
EXAMPLE, ONE PLACE I WOULD

2458
01:37:21,374 --> 01:37:23,476
WELCOME SUBJECT MATTER EXPERTISE

2459
01:37:23,476 --> 01:37:25,211
FROM THIS GROUP TO PROVIDE

2460
01:37:25,211 --> 01:37:26,846
DURING THE COMMENT PERIOD SO WE

2461
01:37:26,846 --> 01:37:29,048
CAN CONTINUE TO EXPAND AND

2462
01:37:29,048 --> 01:37:31,651
REFINE THE DATASETS.

2463
01:37:31,651 --> 01:37:38,124
 

2464
01:37:38,124 --> 01:37:39,859
THE LAST TOPIC I'M GOING TO

2465
01:37:39,859 --> 01:37:45,431
TOUCH ON ARE MOTHER AND INFANT

2466
01:37:45,431 --> 01:37:46,866
LINKAGES.

2467
01:37:46,866 --> 01:37:49,068
THROUGH A VARIETY OF ACTIVITIES

2468
01:37:49,068 --> 01:37:52,872
ONC HAS BEEN LOOKING AT MOM AND

2469
01:37:52,872 --> 01:37:54,774
INFANT LINKAGES FOR A LITTLE BIT

2470
01:37:54,774 --> 01:37:56,509
OF TIME NOW.

2471
01:37:56,509 --> 01:38:00,113
AND WE FOUND THE APPROACH VARIES

2472
01:38:00,113 --> 01:38:01,614
SIGNIFICANTLY ACCORDING TO

2473
01:38:01,614 --> 01:38:04,617
TECHNOLOGY DEVELOPER AND ALSO

2474
01:38:04,617 --> 01:38:07,153
DATA HOLDER.

2475
01:38:07,153 --> 01:38:08,154
SO SOME MAINTAIN PERSISTENT

2476
01:38:08,154 --> 01:38:09,555
LINKS BETWEEN MOM AND BABY

2477
01:38:09,555 --> 01:38:10,857
WITHIN THEIR SYSTEM AND THAT

2478
01:38:10,857 --> 01:38:12,492
LINK IS THEN ONLY BROKEN ONCE

2479
01:38:12,492 --> 01:38:15,561
THE DATA IS SHARED OUTSIDE OF

2480
01:38:15,561 --> 01:38:16,896
THE SYSTEM.

2481
01:38:16,896 --> 01:38:19,398
OTHERS DO NOT LINK RECORDS AT

2482
01:38:19,398 --> 01:38:19,565
ALL.

2483
01:38:19,565 --> 01:38:21,601
AND STILL OTHERS TAKE A

2484
01:38:21,601 --> 01:38:23,136
DIFFERENT APPROACH BY CREATING A

2485
01:38:23,136 --> 01:38:24,670
SEPARATE ENCOUNTER THAT'S JUST

2486
01:38:24,670 --> 01:38:27,173
SPECIFIC TO THE BIRTH, AND THEN

2487
01:38:27,173 --> 01:38:29,442
THEY ONLY HAVE MOM'S MAIDEN NAME

2488
01:38:29,442 --> 01:38:31,110
NOTED ON THE BABY RECORD.

2489
01:38:31,110 --> 01:38:34,413
IN TERMS OF LINKING RECORDS, IT

2490
01:38:34,413 --> 01:38:36,582
DEPENDS ON THE ENTITY BUT THERE

2491
01:38:36,582 --> 01:38:38,451
ARE THREE GENERAL APPROACHES

2492
01:38:38,451 --> 01:38:41,387
THAT WE HAVE FOUND.

2493
01:38:41,387 --> 01:38:43,589
SO, FIRST USING SOME SORT OF AN

2494
01:38:43,589 --> 01:38:45,424
ALGORITHM OR MANUALLY LOOKING AT

2495
01:38:45,424 --> 01:38:48,060
DATA TO INDICATE WHETHER RECORDS

2496
01:38:48,060 --> 01:38:49,395
SHOULD BE LINKED.

2497
01:38:49,395 --> 01:38:51,798
AND OFTEN TAKE APPROACHING USED

2498
01:38:51,798 --> 01:38:53,566
IN PATIENT MATCHING TO IDENTIFY

2499
01:38:53,566 --> 01:38:55,301
POTENTIAL LINKS, AND DATA THAT

2500
01:38:55,301 --> 01:38:58,504
ARE USED TYPICALLY TO DO THIS

2501
01:38:58,504 --> 01:39:00,139
INCLUDE INFANT DATA, SORRY,

2502
01:39:00,139 --> 01:39:03,876
INFANT DATA AT BIRTH, NEXT OF

2503
01:39:03,876 --> 01:39:04,944
KIN INFORMATION, MOTHER'S

2504
01:39:04,944 --> 01:39:05,945
DEMOGRAPHIC.

2505
01:39:05,945 --> 01:39:09,549
ANOTHER WAY TO LINK IS

2506
01:39:09,549 --> 01:39:11,617
IDENTIFIED AS A SYSTEM TRIGGER,

2507
01:39:11,617 --> 01:39:14,487
SO IT WILL GENERATE A FAMILY

2508
01:39:14,487 --> 01:39:16,355
HISTORY FOR THE BABY WHEN THERE

2509
01:39:16,355 --> 01:39:18,691
IS SOME SORT OF REQUEST FOR THE

2510
01:39:18,691 --> 01:39:21,527
BABY'S INFORMATION AND THEN MOM

2511
01:39:21,527 --> 01:39:22,829
WILL INEVITABLY SHOW UP IN THE

2512
01:39:22,829 --> 01:39:23,830
FAMILY HISTORY.

2513
01:39:23,830 --> 01:39:28,201
AND THEN THE LAST TWO THAT I'VE

2514
01:39:28,201 --> 01:39:30,837
INCLUDED HERE ARE WAYS TO LINK

2515
01:39:30,837 --> 01:39:35,842
RECORDS BY USING PORTIONS OF AN

2516
01:39:35,842 --> 01:39:36,242
EXCHANGE MESSAGE.

2517
01:39:36,242 --> 01:39:39,979
SO THE FIRST ONE IS USING HL7

2518
01:39:39,979 --> 01:39:44,083
FHIR, AND THERE ARE THREE

2519
01:39:44,083 --> 01:39:46,118
OPTIONS WHICH SHOULD DEPEND ON

2520
01:39:46,118 --> 01:39:47,887
THE SPECIFIC USE CASE.

2521
01:39:47,887 --> 01:39:51,190
ABOUT THERE IS SOMETHING CALLED

2522
01:39:51,190 --> 01:39:55,127
RELATED PERSON, WHICH WILL LINK

2523
01:39:55,127 --> 01:39:56,662
MOM AND BABY PRETTY

2524
01:39:56,662 --> 01:39:57,530
PERSISTENTLY.

2525
01:39:57,530 --> 01:40:00,066
THERE'S ANOTHER CHOICE WHICH IS,

2526
01:40:00,066 --> 01:40:02,335
AGAIN, USING AN ENCOUNTER SUCH

2527
01:40:02,335 --> 01:40:04,437
AS LINKING MOM AND BABY THROUGH

2528
01:40:04,437 --> 01:40:06,639
THE SPECIFIC ENCOUNTER OF THE

2529
01:40:06,639 --> 01:40:09,709
BIRTH, AND THEN AS I MENTIONED

2530
01:40:09,709 --> 01:40:11,978
EARLIER USING THE FHIR RESOURCE

2531
01:40:11,978 --> 01:40:12,645
FAMILY MEMBER HISTORY WHICH

2532
01:40:12,645 --> 01:40:15,681
WOULD BE USED IN AN INSTANCE

2533
01:40:15,681 --> 01:40:18,117
AGAIN WHEN BABY'S INFORMATION IS

2534
01:40:18,117 --> 01:40:21,220
BEING PULLED UP AND THE MOTHER'S

2535
01:40:21,220 --> 01:40:23,256
INFORMATION COMES UP IN THE

2536
01:40:23,256 --> 01:40:25,658
FAMILY MEMBER HISTORY.

2537
01:40:25,658 --> 01:40:28,494
THEN WE ALSO FOUND THAT THERE IS

2538
01:40:28,494 --> 01:40:37,470
AN OPPORTUNITY TO USE THE HL7 V2

2539
01:40:37,470 --> 01:40:38,137
PATIENT IDENTIFICATION SEGMENT.

2540
01:40:38,137 --> 01:40:39,272
AT THIS TIME I UNFORTUNATELY

2541
01:40:39,272 --> 01:40:42,174
DON'T HAVE A LOT OF INSIGHT

2542
01:40:42,174 --> 01:40:43,943
INTO, YOU KNOW, HOW OFTEN EACH

2543
01:40:43,943 --> 01:40:46,579
OF THESE ARE USED.

2544
01:40:46,579 --> 01:40:50,182
BUT I CAN SAY THAT THEY DID COME

2545
01:40:50,182 --> 01:40:51,584
UP DURING OUR STAKEHOLDER

2546
01:40:51,584 --> 01:40:55,888
HEARINGS AND PARTNER FEEDBACK

2547
01:40:55,888 --> 01:40:59,125
SESSIONS, AND HL7 ONES IN

2548
01:40:59,125 --> 01:40:59,725
PARTICULAR ARE IDENTIFIED AS

2549
01:40:59,725 --> 01:41:00,459
CANDIDATES, VIABLE CANDIDATES

2550
01:41:00,459 --> 01:41:04,497
FOR USE IN MOM AND BABY LINKING.

2551
01:41:04,497 --> 01:41:07,033
 

2552
01:41:07,033 --> 01:41:09,435
TO WRAP UP, I WANT TO CLOSE BY

2553
01:41:09,435 --> 01:41:12,071
SAYING THAT THE WORK THAT WE'RE

2554
01:41:12,071 --> 01:41:13,606
DOING IN USCDI+ FOR MATERNAL

2555
01:41:13,606 --> 01:41:15,808
FALLS WITHIN THE LARGER

2556
01:41:15,808 --> 01:41:18,644
WHEELHOUSE OF ONC EFFORTS IN

2557
01:41:18,644 --> 01:41:20,212
USHERING TOWARD HEALTH I.T.

2558
01:41:20,212 --> 01:41:21,747
ALIGNMENT ACROSS DEPARTMENT OF

2559
01:41:21,747 --> 01:41:22,048
HHS.

2560
01:41:22,048 --> 01:41:24,684
THERE ARE A SERIES OF MECHANISMS

2561
01:41:24,684 --> 01:41:26,585
THAT ONC HAS BEEN ESTABLISHENING

2562
01:41:26,585 --> 01:41:28,754
THAT ARE WORKING TO BRING

2563
01:41:28,754 --> 01:41:31,023
ALIGNMENT IN HOW THE DEPARTMENT

2564
01:41:31,023 --> 01:41:32,558
PURCHASES AND USES HEALTH I.T.

2565
01:41:32,558 --> 01:41:36,295
SO THAT WE'RE ALL USING A

2566
01:41:36,295 --> 01:41:37,697
STANDARDS-BASED APPROACH TO

2567
01:41:37,697 --> 01:41:39,131
COLLECTING AND USING THE DATA

2568
01:41:39,131 --> 01:41:43,736
WHICH IS THAT FOUNDATION OF AN

2569
01:41:43,736 --> 01:41:44,337
INTEROPERABLE INFRASTRUCTURE.

2570
01:41:44,337 --> 01:41:46,706
YOU MAY HAVE SEEN THE LANGUAGE

2571
01:41:46,706 --> 01:41:49,175
ONC IS WORKING TO INCORPORATE

2572
01:41:49,175 --> 01:41:51,944
INTO HHS PROGRAMS.

2573
01:41:51,944 --> 01:41:53,479
AND OTHER WAYS WE ARE, AGAIN,

2574
01:41:53,479 --> 01:41:57,516
TRYING TO MAXIMIZE THE USE OF

2575
01:41:57,516 --> 01:41:58,050
ONC-APPROVED STANDARDS AND

2576
01:41:58,050 --> 01:42:00,886
AUTHORITIES, AND ALSO ALWAYS

2577
01:42:00,886 --> 01:42:04,623
LOOKING FOR PARTNERS WHO ARE

2578
01:42:04,623 --> 01:42:07,360
READY TO TAKE ON, YOU KNOW,

2579
01:42:07,360 --> 01:42:08,427
IMPLEMENTING DATASET, LETTING US

2580
01:42:08,427 --> 01:42:10,796
KNOW IF WE'RE MISSING ANYTHING

2581
01:42:10,796 --> 01:42:13,165
IN THERE, AND, YOU KNOW, AGAIN

2582
01:42:13,165 --> 01:42:14,667
THAT FEASIBILITY QUESTION IS A

2583
01:42:14,667 --> 01:42:16,635
REALLY IMPORTANT ONE FOR US.

2584
01:42:16,635 --> 01:42:18,170
SO THAT WE ARE BUILDING AN

2585
01:42:18,170 --> 01:42:21,007
ON-RAMP TO MAKE SURE THAT WE

2586
01:42:21,007 --> 01:42:23,409
EVENTUALLY GET THERE WITHOUT

2587
01:42:23,409 --> 01:42:24,744
MAKING PEOPLE FEEL LIKE THEY ARE

2588
01:42:24,744 --> 01:42:27,146
PUSHED BEFORE THEY ARE READY.

2589
01:42:27,146 --> 01:42:28,681
SO I THINK THAT THE ONLY OTHER

2590
01:42:28,681 --> 01:42:31,417
THING I WANT TO MENTION IS THAT,

2591
01:42:31,417 --> 01:42:33,686
AGAIN, THAT WINDOW OF FEEDBACK

2592
01:42:33,686 --> 01:42:37,623
ON THE DATASET WILL BE OPEN,

2593
01:42:37,623 --> 01:42:39,492
HOPEFULLY SOMETIME NEXT YEAR.

2594
01:42:39,492 --> 01:42:41,527
IF YOU HAVEN'T SIGNED UP FOR THE

2595
01:42:41,527 --> 01:42:42,561
ONC NEWSLETTER, NOW WOULD BE A

2596
01:42:42,561 --> 01:42:43,429
GREAT TIME.

2597
01:42:43,429 --> 01:42:45,631
YOU CAN CHECK OUT OUR WEBSITE

2598
01:42:45,631 --> 01:42:48,467
FOR RELEVANT UPDATES AND

2599
01:42:48,467 --> 01:42:51,771
INFORMATION. 

2600
01:42:51,771 --> 01:42:53,072
THANK YOU.

2601
01:42:53,072 --> 01:42:54,273
>> THANK YOU, STEPHANIE.

2602
01:42:54,273 --> 01:42:56,409
VERY WISE TO REMIND EVERYONE

2603
01:42:56,409 --> 01:42:59,011
ABOUT THE PUBLIC CONSULTATION

2604
01:42:59,011 --> 01:43:02,148
OPPORTUNITY, SO SIGN UP FOR THE

2605
01:43:02,148 --> 01:43:02,948
NEWSLETTER, I COULDN'T AGREE

2606
01:43:02,948 --> 01:43:04,550
MORE WITH THAT APPROACH.

2607
01:43:04,550 --> 01:43:07,420
WE HAVE TIME, I WANT TO SEE ARE

2608
01:43:07,420 --> 01:43:08,387
THERE ANY CLARIFICATION

2609
01:43:08,387 --> 01:43:10,489
QUESTIONS THAT ANYONE HAS FOR

2610
01:43:10,489 --> 01:43:10,856
STEPHANIE.

2611
01:43:10,856 --> 01:43:12,958
WE'LL GET INTO A BROADER

2612
01:43:12,958 --> 01:43:13,559
QUESTION-AND-ANSWER AT THE END

2613
01:43:13,559 --> 01:43:15,828
OF THE SESSION BUT I WANT TO

2614
01:43:15,828 --> 01:43:17,129
MAKE SURE WE DON'T MISS

2615
01:43:17,129 --> 01:43:18,697
CLARIFICATION QUESTIONS BASED ON

2616
01:43:18,697 --> 01:43:21,300
WHAT WAS PRESENTED.

2617
01:43:21,300 --> 01:43:25,037
 

2618
01:43:25,037 --> 01:43:28,107
SEEING NO HANDS COMING UP, I

2619
01:43:28,107 --> 01:43:33,045
THINK WHAT WE CAN DO, TRISH AND

2620
01:43:33,045 --> 01:43:33,779
LEILA, MOVE TO YOU.

2621
01:43:33,779 --> 01:43:38,484
>> I'LL GO AHEAD AND I
WILL

2622
01:43:38,484 --> 01:43:38,951
SHARE MY SCREEN.

2623
01:43:38,951 --> 01:43:41,454
>> I CAN HEAR YOU CLEARLY.

2624
01:43:41,454 --> 01:43:43,856
>> GOOD.

2625
01:43:43,856 --> 01:43:44,390
ALL RIGHT.

2626
01:43:44,390 --> 01:43:49,862
AND LET ME GO HERE. 

2627
01:43:49,862 --> 01:43:53,265
>> PERFECT.

2628
01:43:53,265 --> 01:43:53,532
VERY NICE.

2629
01:43:53,532 --> 01:43:55,468
>> THANK YOU I'M TRISH
BRIGHT

2630
01:43:55,468 --> 01:43:57,536
WITH THE FDA'S CENTER FOR DRUG

2631
01:43:57,536 --> 01:43:58,971
EVALUATION AND RESEARCH.

2632
01:43:58,971 --> 01:44:01,507
I WORK WITH THE SENTINEL SYSTEM

2633
01:44:01,507 --> 01:44:02,775
IN PARTICULAR.

2634
01:44:02,775 --> 01:44:05,644
SO I WAS ASKED TO SPEAK TO USE

2635
01:44:05,644 --> 01:44:06,745
OF NOVEL DATA RESOURCES AND

2636
01:44:06,745 --> 01:44:08,581
WE'LL JUMP INTO THAT.

2637
01:44:08,581 --> 01:44:10,549
FIRST I WANT TO JUST EXPLAIN

2638
01:44:10,549 --> 01:44:13,619
WHAT THE SENTINEL SYSTEM IN IN

2639
01:44:13,619 --> 01:44:21,160
CASE PEOPLE HAVE LESS

2640
01:44:21,160 --> 01:44:21,727
FAMILIARARITY.

2641
01:44:21,727 --> 01:44:23,229
CDER'S SYSTEM, ARI,

2642
01:44:23,229 --> 01:44:24,230
CONGRESSIONALLY MANDATED TO HAVE

2643
01:44:24,230 --> 01:44:28,234
THIS STOOD UP.

2644
01:44:28,234 --> 01:44:30,569
IT INVOLVES ELECTRONIC HEALTH

2645
01:44:30,569 --> 01:44:32,872
CARE DATA, TYPICALLY INSURANCE

2646
01:44:32,872 --> 01:44:34,073
CLAIMS, SOME INTEGRATED WITH

2647
01:44:34,073 --> 01:44:34,273
EHR.

2648
01:44:34,273 --> 01:44:36,375
WE HAVE A COMMON DATA MODEL,

2649
01:44:36,375 --> 01:44:40,846
DISTRIBUTED NETWORK OF DATA

2650
01:44:40,846 --> 01:44:42,481
PARTNERS. 

2651
01:44:42,481 --> 01:44:44,917
AND PRE-DEFINED PARAMETERIZE

2652
01:44:44,917 --> 01:44:45,551
REUSABLE QUERYING TOOLS, OFF THE

2653
01:44:45,551 --> 01:44:47,520
SHELF PROGRAMMING SO WE HAVE

2654
01:44:47,520 --> 01:44:48,954
PROGRAMS THAT ARE DONE THAT

2655
01:44:48,954 --> 01:44:50,923
ADDRESS SOME BASE QUESTIONS THAT

2656
01:44:50,923 --> 01:44:52,558
WE LIKE TO ASK, PULL THEM AND

2657
01:44:52,558 --> 01:44:55,628
REUSE THEM.

2658
01:44:55,628 --> 01:44:56,862
AND QUALITY ASSURANCE PROCESS.

2659
01:44:56,862 --> 01:45:01,100
I JUMPED AHEAD A LITTLE BIT.

2660
01:45:01,100 --> 01:45:07,406
OKAY, SO, WE'LL LOOK AT THE

2661
01:45:07,406 --> 01:45:09,175
MIDDLE COMMON FIRST, COMMON DATA

2662
01:45:09,175 --> 01:45:10,609
FORMAT.

2663
01:45:10,609 --> 01:45:14,747
WE GATHER INFORMATION ON

2664
01:45:14,747 --> 01:45:15,514
ENROLLMENT, DEMOGRAPHICS,

2665
01:45:15,514 --> 01:45:19,318
ENCOUNTER, DISPENSING, LAB

2666
01:45:19,318 --> 01:45:20,119
TESTS, VITAL SIGNS, ACROSS

2667
01:45:20,119 --> 01:45:21,153
DIFFERENT DATA PARTNERS.

2668
01:45:21,153 --> 01:45:23,489
IF WE JUMP TO THE RIGHT-HAND

2669
01:45:23,489 --> 01:45:25,457
SIDE HERE IF WE HAVE A QUESTION

2670
01:45:25,457 --> 01:45:27,793
AT FDA WE CAN DESIGN A STUDY TO

2671
01:45:27,793 --> 01:45:29,428
USE DATABASES.

2672
01:45:29,428 --> 01:45:36,535
WE HAVE A SENTINEL CENTER THAT

2673
01:45:36,535 --> 01:45:38,204
DROPS IN PROGRAMMING FORMAT WITH

2674
01:45:38,204 --> 01:45:39,505
PARAMETERS, QUERIES ARE

2675
01:45:39,505 --> 01:45:40,673
DISTRIBUTED TO EACH APPLICABLE

2676
01:45:40,673 --> 01:45:42,341
DATA PARTNER, AND YOU'LL SEE

2677
01:45:42,341 --> 01:45:43,542
THAT DONE HERE, REPRESENTING

2678
01:45:43,542 --> 01:45:45,211
DIFFERENT DATA PARTNERS IN OUR

2679
01:45:45,211 --> 01:45:45,444
NETWORK.

2680
01:45:45,444 --> 01:45:47,713
WE HAVE 14 AND DO HAVE SOME

2681
01:45:47,713 --> 01:45:49,381
KAISERS IN HERE, THAT WAS A

2682
01:45:49,381 --> 01:45:50,683
PRIOR QUESTION.

2683
01:45:50,683 --> 01:45:52,651
SO THE DATA PARTNERS MAINTAIN

2684
01:45:52,651 --> 01:45:54,053
PHYSICAL AND OPERATIONAL CONTROL

2685
01:45:54,053 --> 01:45:55,588
OVER THEIR DATA, STAYS BEHIND

2686
01:45:55,588 --> 01:45:57,590
THEIR FIRE WALL.

2687
01:45:57,590 --> 01:45:59,692
DATA PARTNERS EXECUTE

2688
01:45:59,692 --> 01:46:00,659
STANDARDIZED QUERIES AGAINST

2689
01:46:00,659 --> 01:46:03,662
THEIR OWN DATA FORMATTED AND

2690
01:46:03,662 --> 01:46:07,466
RETURN RESULTS TO THE CENTER

2691
01:46:07,466 --> 01:46:10,636
OPERATIONS, SENTINEL OPERATIONS

2692
01:46:10,636 --> 01:46:11,036
CENTER.

2693
01:46:11,036 --> 01:46:18,844
THE SENTINEL CENTER GIVES

2694
01:46:18,844 --> 01:46:19,278
AGGREGATED RESULTS,

2695
01:46:19,278 --> 01:46:20,679
DE-IDENTIFIED, PRESERVING

2696
01:46:20,679 --> 01:46:22,214
PRIVACY.

2697
01:46:22,214 --> 01:46:24,617
AND IN THE MOTHER-INFANT LINKAGE

2698
01:46:24,617 --> 01:46:26,485
TABLE WAS ADDED TO THE DATA

2699
01:46:26,485 --> 01:46:27,686
MODEL IN 2018.

2700
01:46:27,686 --> 01:46:29,555
AND I HAVE UP HERE NEAR THE TOP

2701
01:46:29,555 --> 01:46:32,825
JUST A LINK IN CASE ANYBODY IS

2702
01:46:32,825 --> 01:46:35,461
INTERESTED, YOU CAN GO THERE AND

2703
01:46:35,461 --> 01:46:37,563
SEE AND GET THEM YOURSELF.

2704
01:46:37,563 --> 01:46:43,802
WE DO HAVE A SAS PACKAGING

2705
01:46:43,802 --> 01:46:44,069
AVAILABLE.

2706
01:46:44,069 --> 01:46:47,273
IT HAS TO BE IN THE FORM OF THE

2707
01:46:47,273 --> 01:46:47,906
SENTINEL COMMON DATA MODEL BUT

2708
01:46:47,906 --> 01:46:50,509
THEN YOU CAN USE IT.

2709
01:46:50,509 --> 01:46:52,211
SO THERE'S 10.8 MILLION LINKED

2710
01:46:52,211 --> 01:46:54,079
DELIVERIES IN OUR DATA.

2711
01:46:54,079 --> 01:46:57,783
AND WE SHOW THAT DELIVERIES HERE

2712
01:46:57,783 --> 01:46:59,551
OVER TIME, AND THIS GREEN

2713
01:46:59,551 --> 01:47:04,690
SECTION IS WHEN WE UPLOAD

2714
01:47:04,690 --> 01:47:05,758
INCLUDED MEDICAID DATA, I'LL

2715
01:47:05,758 --> 01:47:08,294
TALK MORE ABOUT THAT LATER, BUT

2716
01:47:08,294 --> 01:47:10,596
IT'S A RICH RESOURCE THAT ADDS A

2717
01:47:10,596 --> 01:47:14,099
LOT OF PREGNANCY AND INFANT

2718
01:47:14,099 --> 01:47:14,433
DATA.

2719
01:47:14,433 --> 01:47:15,734
THIS IS JUST ANOTHER LINK FOR

2720
01:47:15,734 --> 01:47:17,469
YOU IN CASE PEOPLE HAVE AN

2721
01:47:17,469 --> 01:47:20,673
INTEREST WHERE THERE'S TRAINING

2722
01:47:20,673 --> 01:47:22,941
ON USING THE SENTINEL SYSTEM.

2723
01:47:22,941 --> 01:47:27,379
SO YOU CAN PUT IN THE LINK OR

2724
01:47:27,379 --> 01:47:28,881
FDA AND 2023 SENTINEL PUBLIC

2725
01:47:28,881 --> 01:47:31,050
TRAINING AND IT WILL POP UP IN

2726
01:47:31,050 --> 01:47:31,784
THE SEARCH ENGINE.

2727
01:47:31,784 --> 01:47:33,452
THE QUESTION I WAS ASKED TO

2728
01:47:33,452 --> 01:47:35,888
SPEAK TO IS USING NOVEL DATA

2729
01:47:35,888 --> 01:47:38,057
RESOURCES TO SUPPORT LARGE POST

2730
01:47:38,057 --> 01:47:39,024
MARKETING OBSERVATIONAL STUDIES

2731
01:47:39,024 --> 01:47:42,895
TO EVALUATE THE SAFETY OF

2732
01:47:42,895 --> 01:47:44,296
MEDICATION CLASSES DURING

2733
01:47:44,296 --> 01:47:45,731
PREGNANCY.

2734
01:47:45,731 --> 01:47:47,032
I CROSSED OUT SECTIONSES BECAUSE

2735
01:47:47,032 --> 01:47:49,034
WE SHALL NOT USING IN THE

2736
01:47:49,034 --> 01:47:52,171
CONTEXT OF PREGNANCIES, WE'RE

2737
01:47:52,171 --> 01:47:54,239
NOT USING DATABASE STUDIES TO

2738
01:47:54,239 --> 01:47:55,541
STUDY EFFECTIVENESS.

2739
01:47:55,541 --> 01:47:59,178
IN DATABASE STUDIES WE'RE NOT 

2740
01:47:59,178 --> 01:48:00,179
CURRENTLY LOOKING AT LACTATION.

2741
01:48:00,179 --> 01:48:02,581
SO WE'RE USING IT THOUGH.

2742
01:48:02,581 --> 01:48:04,683
SO HERE IS AN EXAMPLE OF

2743
01:48:04,683 --> 01:48:05,651
ASSESSMENT FOR PRE-MARKET

2744
01:48:05,651 --> 01:48:05,884
REVIEW.

2745
01:48:05,884 --> 01:48:08,287
IF WE JUMP TO THE LEFT-HAND SIDE

2746
01:48:08,287 --> 01:48:11,223
HERE, THE CONCERN WAS THAT

2747
01:48:11,223 --> 01:48:12,658
EMBRYO FETAL MALFORMATIONS WERE

2748
01:48:12,658 --> 01:48:14,727
IN ANIMAL STUDIES.

2749
01:48:14,727 --> 01:48:19,031
FDA WAS THINKING RISK EVALUATION

2750
01:48:19,031 --> 01:48:24,403
AND MITIGATION STRATEGY, A REMS

2751
01:48:24,403 --> 01:48:27,573
PROGRAM SHOULD BE REQUIRED, WE

2752
01:48:27,573 --> 01:48:28,574
ESTIMATED HEART FAILURE IN

2753
01:48:28,574 --> 01:48:31,410
REPRODUCTIVE AGE WOMEN AND

2754
01:48:31,410 --> 01:48:32,511
CHARACTERIZE MEDICATION USE

2755
01:48:32,511 --> 01:48:34,012
AMONG PREGNANCIES WITH HEART

2756
01:48:34,012 --> 01:48:34,480
FAILURE.

2757
01:48:34,480 --> 01:48:36,115
WE COULDN'T STUDY THE ACTUAL USE

2758
01:48:36,115 --> 01:48:38,083
OF THIS MEDICATION BECAUSE IT

2759
01:48:38,083 --> 01:48:39,518
WAS STILL PRE-MARKET.

2760
01:48:39,518 --> 01:48:41,620
SO WE FOUND HEART FAILURE WAS

2761
01:48:41,620 --> 01:48:44,323
RARE AMONG WOMEN OF REPRODUCTIVE

2762
01:48:44,323 --> 01:48:45,190
AGE.

2763
01:48:45,190 --> 01:48:46,625
AND THE POTENTIAL EMBRYO TOXIC

2764
01:48:46,625 --> 01:48:47,960
HEART FAILURE MEDICATION USE

2765
01:48:47,960 --> 01:48:50,462
DURING PREGNANCY WAS RARE.

2766
01:48:50,462 --> 01:48:52,231
THIS INFORMATION CONTRIBUTED TO

2767
01:48:52,231 --> 01:48:53,766
FDA DETERMINATION THAT LABELING

2768
01:48:53,766 --> 01:48:55,067
WOULD PROVIDE SUFFICIENT

2769
01:48:55,067 --> 01:48:57,236
INFORMATION TO ASSURE BENEFITS

2770
01:48:57,236 --> 01:48:58,670
OUTWEIGHED THE RISK.

2771
01:48:58,670 --> 01:49:01,106
HERE'S ANOTHER STUDY THAT WAS

2772
01:49:01,106 --> 01:49:10,282
DONE, RISK OF CONGENITAL CARDIAC

2773
01:49:10,282 --> 01:49:11,250
MALFORMATION FOLLOWING DISCERN

2774
01:49:11,250 --> 01:49:11,617
USE.

2775
01:49:11,617 --> 01:49:14,153
YOU CAN FIND IT ON THE SENTINEL

2776
01:49:14,153 --> 01:49:15,988
SITE, CLICK ON THESE THINGS IF

2777
01:49:15,988 --> 01:49:18,157
YOU WANT TO SEE IT.

2778
01:49:18,157 --> 01:49:19,491
WE'RE ACTIVELY USING IT BUT

2779
01:49:19,491 --> 01:49:21,493
THERE'S A LOT MORE THAT COULD BE

2780
01:49:21,493 --> 01:49:23,529
DONE AND ALL OF THIS IS AN

2781
01:49:23,529 --> 01:49:23,796
EVOLUTION.

2782
01:49:23,796 --> 01:49:25,697
SO, WHAT I'M GOING TO SHOW YOU

2783
01:49:25,697 --> 01:49:27,800
NEXT IS THAT SOME OF THE

2784
01:49:27,800 --> 01:49:28,967
LIMITATIONS AROUND IT.

2785
01:49:28,967 --> 01:49:32,905
ONE OF THE ISSUES IS RIGHT NOW

2786
01:49:32,905 --> 01:49:36,108
WE ARE ANCHORING ON LIVE BIRTHS.

2787
01:49:36,108 --> 01:49:37,309
STUDYING MATERNAL EXPOSURE WE

2788
01:49:37,309 --> 01:49:39,178
ALSO WANT TO KNOW ABOUT OUTCOMES

2789
01:49:39,178 --> 01:49:40,913
THAT WEREN'T LIFE BIRTHS AND

2790
01:49:40,913 --> 01:49:42,214
SAFETY, BECAUSE WE'RE STILL

2791
01:49:42,214 --> 01:49:43,749
WORKING ON THAT PROGRAMMING AND

2792
01:49:43,749 --> 01:49:44,783
TOOLS DON'T HAVE THEM AVAILABLE

2793
01:49:44,783 --> 01:49:46,618
RIGHT NOW BUT WE'RE ABOUT TO

2794
01:49:46,618 --> 01:49:47,619
HAVE THEM DONE.

2795
01:49:47,619 --> 01:49:51,190
WHEN WE WENT AND LOOKED AT THE

2796
01:49:51,190 --> 01:49:52,191
SENTINEL SYSTEM WE WOULD LIKE

2797
01:49:52,191 --> 01:49:53,625
WHEN THERE'S A MARKET

2798
01:49:53,625 --> 01:49:54,593
APPLICATION BEING APPROVED, NO,

2799
01:49:54,593 --> 01:49:56,028
THE SYSTEM ISN'T GOING TO

2800
01:49:56,028 --> 01:49:57,796
CAPTURE THAT BECAUSE IT DOESN'T

2801
01:49:57,796 --> 01:50:00,532
CAPTURE THE ENTIRETY OF THE

2802
01:50:00,532 --> 01:50:01,934
OUTCOMES WE'RE INTERESTED IN.

2803
01:50:01,934 --> 01:50:03,802
SO WHAT I'M GOING TO SHOW HERE

2804
01:50:03,802 --> 01:50:05,437
AT THE TOP THERE'S INFORMATION

2805
01:50:05,437 --> 01:50:06,638
ON ANOTHER ARTICLE THAT TALKS

2806
01:50:06,638 --> 01:50:09,141
ABOUT USE OF THE SENTINEL SYSTEM

2807
01:50:09,141 --> 01:50:12,478
AND THEY HAVE ABOUT A PARAGRAPH 

2808
01:50:12,478 --> 01:50:14,413
OR TWO ABOUT PREGNANCY.

2809
01:50:14,413 --> 01:50:16,448
THERE IS THIS TABLE, IT SHOWS

2810
01:50:16,448 --> 01:50:22,387
THE DISTRIBUTION OF THE SAFETY

2811
01:50:22,387 --> 01:50:24,022
CONCERNS, BUT DECIDED THE THERE

2812
01:50:24,022 --> 01:50:27,426
ARE TOOLS IN THE SENTINEL SYSTEM

2813
01:50:27,426 --> 01:50:29,394
NOT SUFFICIENT TO ADDRESS THE

2814
01:50:29,394 --> 01:50:30,929
OUTCOME OF INTEREST, STILL

2815
01:50:30,929 --> 01:50:31,830
CAPTURE THE HEALTH OUTCOME.

2816
01:50:31,830 --> 01:50:34,967
THERE COULD BE OTHER REASONS WHY

2817
01:50:34,967 --> 01:50:36,935
WE COULDN'T USE SENTINEL,

2818
01:50:36,935 --> 01:50:38,003
CO-VARIATES OR POPULATION WE

2819
01:50:38,003 --> 01:50:39,805
COULDN'T CAPTURE BUT THIS IS

2820
01:50:39,805 --> 01:50:41,874
FOCUSED ON HEALTH OUTCOMES, AND

2821
01:50:41,874 --> 01:50:45,377
I'M SHARING BECAUSE THE TOP ROW

2822
01:50:45,377 --> 01:50:45,811
IS PREGNANCY.

2823
01:50:45,811 --> 01:50:48,547
WE WANT TO LOOK AT THE GAMUT OF

2824
01:50:48,547 --> 01:50:49,548
POTENTIAL SAFETY OUTCOMES

2825
01:50:49,548 --> 01:50:50,682
ASSOCIATED WITH MEDICAL EXPOSURE

2826
01:50:50,682 --> 01:50:54,786
TO MOM ON THE MOM AND THE BABY.

2827
01:50:54,786 --> 01:50:56,121
IT'S INSUFFICIENT BUT THAT COULD

2828
01:50:56,121 --> 01:50:57,656
BE EVOLVING AND CHANGING BECAUSE

2829
01:50:57,656 --> 01:50:59,291
WE DO HAVE NEW PROGRAMMING

2830
01:50:59,291 --> 01:51:03,562
THAT'S BECOMING AVAILABLE TO US.

2831
01:51:03,562 --> 01:51:05,430
IN ADDITION, WE HAVE

2832
01:51:05,430 --> 01:51:08,033
PRESCRIPTION DRUG USER FEES,

2833
01:51:08,033 --> 01:51:10,002
KNOWN AS PDUFA FEES, TO SUPPORT

2834
01:51:10,002 --> 01:51:11,537
THE FDA.

2835
01:51:11,537 --> 01:51:12,104
THERE'S A COMMITMENT LETTER.

2836
01:51:12,104 --> 01:51:15,173
ON THE RIGHT-HAND SIDE IS A

2837
01:51:15,173 --> 01:51:18,110
SECTION, BUT PART OF THE PDUFA

2838
01:51:18,110 --> 01:51:19,978
7, OUR MOST RECENT COMMITMENT,

2839
01:51:19,978 --> 01:51:21,647
FOCUSED ON PREGNANCY SAFETY.

2840
01:51:21,647 --> 01:51:23,849
WE SAID WE COULD CONDUCT FIVE

2841
01:51:23,849 --> 01:51:24,616
DEMONSTRATION PROJECTS TO

2842
01:51:24,616 --> 01:51:27,352
ADDRESS GAPS IN KNOWLEDGE ABOUT

2843
01:51:27,352 --> 01:51:28,320
PERFORMANCE CHARACTERISTICS OF

2844
01:51:28,320 --> 01:51:29,221
DIFFERENT STUDY DESIGNS.

2845
01:51:29,221 --> 01:51:32,758
WE NEEDED TO HAVE THIS COMPLETED

2846
01:51:32,758 --> 01:51:34,459
BY 2027 TO HELP INFORM A

2847
01:51:34,459 --> 01:51:36,528
FRAMEWORK THE FDA WILL USE

2848
01:51:36,528 --> 01:51:37,396
AROUND POST-MARKETING SAFETY.

2849
01:51:37,396 --> 01:51:40,365
AND THIS IS JUST SHOWING WHAT

2850
01:51:40,365 --> 01:51:43,101
THREE OF THOSE DEMONSTRATION

2851
01:51:43,101 --> 01:51:46,171
PROJECTS INVOLVE. 

2852
01:51:46,171 --> 01:51:47,406
COMPARING PREGNANCY REGISTRY

2853
01:51:47,406 --> 01:51:47,973
STUDIES, VERSUS ELECTRONIC

2854
01:51:47,973 --> 01:51:50,108
HEALTH RECORD STUDIES AND

2855
01:51:50,108 --> 01:51:51,843
LOOKING AT SIGNAL DETECTION AND

2856
01:51:51,843 --> 01:51:52,844
SIGNAL EVALUATION.

2857
01:51:52,844 --> 01:51:54,713
BOTTOM ONE HERE IS LOOKING AT

2858
01:51:54,713 --> 01:52:00,586
SINGLE ARM SAFETY STUDIES VERSUS

2859
01:52:00,586 --> 01:52:02,020
ELECTRONIC HEALTH CARE DATABASE

2860
01:52:02,020 --> 01:52:03,155
TO UNDERSTAND WHAT COMPLEMENT

2861
01:52:03,155 --> 01:52:04,957
APPROACHES AND HOW TO USE THEM

2862
01:52:04,957 --> 01:52:09,494
IS BEST IN THE POST MARKET SPACE

2863
01:52:09,494 --> 01:52:10,896
ABOUT PREGNANCY SAFETY.

2864
01:52:10,896 --> 01:52:13,432
SO WE'VE RECENTLY HAD A WORKSHOP

2865
01:52:13,432 --> 01:52:17,469
ON SEPTEMBER 18 AND 19 ABOUT

2866
01:52:17,469 --> 01:52:20,038
OPTIMIZING THE USE OF PREGNANCY

2867
01:52:20,038 --> 01:52:20,639
SAFETY STUDIES.

2868
01:52:20,639 --> 01:52:22,541
AND YOU'LL FIND THE LINK TO THAT

2869
01:52:22,541 --> 01:52:24,977
INFORMATION DOWN HERE AT THE

2870
01:52:24,977 --> 01:52:26,178
BOTTOM, MATERIALS ARE LOCATED

2871
01:52:26,178 --> 01:52:26,378
HERE.

2872
01:52:26,378 --> 01:52:28,080
YOU CAN GO IN AND LISTEN TO THE

2873
01:52:28,080 --> 01:52:30,248
ENTIRE WORKSHOP IF YOU WANT SO

2874
01:52:30,248 --> 01:52:33,185
THAT'S AVAILABLE TO YOU.

2875
01:52:33,185 --> 01:52:35,821
SO, THE SECOND QUESTION, SUBPART

2876
01:52:35,821 --> 01:52:37,456
QUESTION POSED, NOVEL DATA

2877
01:52:37,456 --> 01:52:38,890
SOURCES TO SUPPORT STUDIES

2878
01:52:38,890 --> 01:52:40,626
ACROSS MULTIPLE DRUGS USING THE

2879
01:52:40,626 --> 01:52:41,393
SAME INFRASTRUCTURE TO CONSERVE

2880
01:52:41,393 --> 01:52:43,261
RESOURCES AND YES WE DO THAT.

2881
01:52:43,261 --> 01:52:46,098
WE USE OUR COMMON DATA MODEL TO

2882
01:52:46,098 --> 01:52:47,733
LOOK AT STUDY CLASS EFFECTS.

2883
01:52:47,733 --> 01:52:49,368
I PUT AN EXAMPLE, THE LINK AT

2884
01:52:49,368 --> 01:52:51,003
THE BOTTOM FOR PEOPLE

2885
01:52:51,003 --> 01:52:51,536
INTERESTED.

2886
01:52:51,536 --> 01:52:53,438
AND WE HAVEN'T DONE THIS IN THE

2887
01:52:53,438 --> 01:52:55,741
CONTEXT OF PREGNANCY SAFETY BUT

2888
01:52:55,741 --> 01:53:00,445
WE DO USE THE  SENTINEL SYSTEM

2889
01:53:00,445 --> 01:53:00,979
IN GENERAL.

2890
01:53:00,979 --> 01:53:04,049
I WANTED TO TALK ABOUT MEDICAID

2891
01:53:04,049 --> 01:53:07,219
DATA BECAUSE THIS IS MORE RECENT

2892
01:53:07,219 --> 01:53:07,419
WORK.

2893
01:53:07,419 --> 01:53:10,722
WITHIN THE U.S. FDA'S SENTINEL

2894
01:53:10,722 --> 01:53:11,923
SYSTEM, THE LINKAGE OF MOTHER

2895
01:53:11,923 --> 01:53:14,426
AND INFANT DATA IS CRITICAL FOR

2896
01:53:14,426 --> 01:53:15,193
ASSESSMENT OF MEDICATION SAFETY

2897
01:53:15,193 --> 01:53:17,629
DURING PREGNANCY.

2898
01:53:17,629 --> 01:53:21,433
AND MEDICAID DATA IS THE NEW

2899
01:53:21,433 --> 01:53:24,736
TRANSFORMED MEDICAID STATISTICAL

2900
01:53:24,736 --> 01:53:28,240
INFORMATION SYSTEM, T-MSIS, 

2901
01:53:28,240 --> 01:53:32,377
CONVERTED INTO THE SENTINEL

2902
01:53:32,377 --> 01:53:34,246
COMMON DATA MODEL, INITIAL

2903
01:53:34,246 --> 01:53:35,280
LINKAGE WAS PERFORMED, OBJECTIVE

2904
01:53:35,280 --> 01:53:38,283
TO HAVE THE MOST ACCURATE

2905
01:53:38,283 --> 01:53:39,051
LINKAGE, BOTH ASSOCIATED WITH

2906
01:53:39,051 --> 01:53:40,585
THE SAME JURISDICTION, BUT

2907
01:53:40,585 --> 01:53:42,354
DELIVERY RECORD AND INFANT

2908
01:53:42,354 --> 01:53:45,390
RECORD MUST HAVE THE SAME CASE

2909
01:53:45,390 --> 01:53:49,327
NUMBER IDENTIFIER, A

2910
01:53:49,327 --> 01:53:53,398
STATE-ASSIGNED NUMBER OFTEN A 

2911
01:53:53,398 --> 01:53:55,367
PROXY FOR FAMILY IDENTIFIER,

2912
01:53:55,367 --> 01:53:57,736
CLOSE TO DELIVERY DATE.

2913
01:53:57,736 --> 01:54:00,005
I'M GOING THROUGH THIS QUICKLY.

2914
01:54:00,005 --> 01:54:02,908
YOU CAN SEE A DEPICTION OF

2915
01:54:02,908 --> 01:54:04,476
LINKAGE.

2916
01:54:04,476 --> 01:54:06,945
61% OF MOTHER DELIVERY RECORDS

2917
01:54:06,945 --> 01:54:09,648
IN THE MEDICAID AND CHIP DATA

2918
01:54:09,648 --> 01:54:12,517
COULD BE LINKED BUT THEY HIDE

2919
01:54:12,517 --> 01:54:12,818
VARIABILITY.

2920
01:54:12,818 --> 01:54:17,022
FOR EXAMPLE, 34 OF THE 

2921
01:54:17,022 --> 01:54:18,857
JURISDICTIONS LINKAGE RATE WAS

2922
01:54:18,857 --> 01:54:23,462
OVER 75%, SEVEN WERE UNDER 15%.

2923
01:54:23,462 --> 01:54:24,996
I'M GOING TO SHOW MORE

2924
01:54:24,996 --> 01:54:26,965
GRANULARITY ABOUT THE DATA.

2925
01:54:26,965 --> 01:54:29,134
I'M NOT THE ONE WHO DID THE

2926
01:54:29,134 --> 01:54:30,469
LINKAGE AND WORKED ON THIS

2927
01:54:30,469 --> 01:54:31,636
PROJECT.

2928
01:54:31,636 --> 01:54:36,041
THIS WORK IS LED BY DR. JUDY

2929
01:54:36,041 --> 01:54:40,112
MARO, ONE OF THE NICHD WINNERS

2930
01:54:40,112 --> 01:54:42,714
PRESENTED EARLIER, IN AN EARLIER

2931
01:54:42,714 --> 01:54:43,048
PRESENTATION.

2932
01:54:43,048 --> 01:54:46,551
SO THE TOP ROW HERE IS ALASKA.

2933
01:54:46,551 --> 01:54:49,521
SO YOU'LL SEE ALASKA HAS THE

2934
01:54:49,521 --> 01:54:50,822
GREEN CHECKS, SIGNIFY THE TEAM

2935
01:54:50,822 --> 01:54:53,258
WENT THROUGH AND FOUND IT WAS

2936
01:54:53,258 --> 01:54:55,861
REALLY COMPLETE AND SOLID DATA

2937
01:54:55,861 --> 01:54:56,528
ACROSS ALL YEARS.

2938
01:54:56,528 --> 01:54:58,597
BUT YOU HAVE TO BE CAREFUL ABOUT

2939
01:54:58,597 --> 01:55:00,465
WHAT YOU'RE GETTING BECAUSE THE

2940
01:55:00,465 --> 01:55:02,434
RED INDICATE WHERE THE TEAM

2941
01:55:02,434 --> 01:55:03,401
IDENTIFIED A PROBLEM AND THE

2942
01:55:03,401 --> 01:55:04,770
NUMBERS WE DON'T HAVE TO FOCUS

2943
01:55:04,770 --> 01:55:07,439
ON TOO MUCH, THE LETTERS, THESE

2944
01:55:07,439 --> 01:55:08,774
ARE SIGNIFYING THE TEAM CODE OF

2945
01:55:08,774 --> 01:55:11,276
WHAT TYPE OF PROBLEM IT WAS.

2946
01:55:11,276 --> 01:55:12,944
IN ALABAMA THEY LOOKED AND SAID

2947
01:55:12,944 --> 01:55:15,680
NO, THIS DATA IS NOT COMPLETE.

2948
01:55:15,680 --> 01:55:16,782
WE CAN'T USE IT.

2949
01:55:16,782 --> 01:55:18,950
SO WE'RE NOT USING ANY OF THAT.

2950
01:55:18,950 --> 01:55:20,919
BUT THERE IS A LOT OF

2951
01:55:20,919 --> 01:55:21,219
VARIABILITY.

2952
01:55:21,219 --> 01:55:24,189
WE HAVE ARKANSAS, THE FIRST TWO

2953
01:55:24,189 --> 01:55:27,092
YEARS, 2004, 2015, A YEAR WHERE

2954
01:55:27,092 --> 01:55:28,960
THEY WERE ONBOARDING THE SYSTEM

2955
01:55:28,960 --> 01:55:30,796
SO STATES YOU'LL SEE SOME

2956
01:55:30,796 --> 01:55:33,732
ONBOARDED EARLIER THAN OTHERS.

2957
01:55:33,732 --> 01:55:34,633
STARTING IN 2016, IT WASN'T THAT

2958
01:55:34,633 --> 01:55:37,469
GOOD BUT THEN IN THE OTHER YEARS

2959
01:55:37,469 --> 01:55:38,770
IT WAS ACCEPTABLE.

2960
01:55:38,770 --> 01:55:41,173
BUT NOT FOR THIS CMC,

2961
01:55:41,173 --> 01:55:42,407
COMPREHENSIVE MANAGED CARE IN

2962
01:55:42,407 --> 01:55:45,143
ONE PARTICULAR YEAR.

2963
01:55:45,143 --> 01:55:46,545
SO I THINK THE MORAL, YOU HAVE

2964
01:55:46,545 --> 01:55:47,746
TO BE CAREFUL AND WORK WITH

2965
01:55:47,746 --> 01:55:48,947
PEOPLE WHO KNOW THE DATA AND

2966
01:55:48,947 --> 01:55:50,816
HAVE LOOKED AT IT CAREFULLY AND

2967
01:55:50,816 --> 01:55:52,350
DONE THESE KIND OF QUALITY

2968
01:55:52,350 --> 01:55:52,684
CHECKS.

2969
01:55:52,684 --> 01:55:54,886
BECAUSE IF YOU JUST TOOK THE

2970
01:55:54,886 --> 01:55:58,056
DATA AT FACE VALUE, SORT OF

2971
01:55:58,056 --> 01:56:00,458
GARBAGE IN, GARBAGE OUT, SO

2972
01:56:00,458 --> 01:56:01,560
MOVING ON, THE JURISDICTIONS

2973
01:56:01,560 --> 01:56:04,529
WITH GREATER THAN FIVE YEARS OF

2974
01:56:04,529 --> 01:56:06,064
INCLUSION MEDICAID DATA WERE 33.

2975
01:56:06,064 --> 01:56:08,466
WITH LESS THAN FOUR YEARS WERE

2976
01:56:08,466 --> 01:56:08,967
16.

2977
01:56:08,967 --> 01:56:10,869
JURISDICTIONS WITH ANY INCLUSION

2978
01:56:10,869 --> 01:56:11,436
WERE 4.

2979
01:56:11,436 --> 01:56:13,872
AND THIS IS WHERE IF YOU WANT TO

2980
01:56:13,872 --> 01:56:15,373
GO TO THE LINK THAT DESCRIBES

2981
01:56:15,373 --> 01:56:17,242
THE PROJECT, IT DOESN'T HAVE THE

2982
01:56:17,242 --> 01:56:19,110
RESULTS THAT I SHOWED YOU BUT

2983
01:56:19,110 --> 01:56:21,413
DOES DESCRIBE THE PROJECT.

2984
01:56:21,413 --> 01:56:23,715
SO, FROM FDA'S CENTER FOR DRUG

2985
01:56:23,715 --> 01:56:24,583
EVALUATION AND RESEARCH

2986
01:56:24,583 --> 01:56:29,621
EXPERIENCE WHAT HAS BEEN DONE IN

2987
01:56:29,621 --> 01:56:34,459
FDA'S SENTINEL SYSTEM THAT MIGHT

2988
01:56:34,459 --> 01:56:36,661
ALIGN WITH RECOMMENDATION 12,

2989
01:56:36,661 --> 01:56:38,763
10.8 MOTHER AND INFANT LINKED.

2990
01:56:38,763 --> 01:56:40,265
LACTATION IS NOT ADDRESSED

2991
01:56:40,265 --> 01:56:41,032
THROUGH DATABASE STUDIES.

2992
01:56:41,032 --> 01:56:43,201
WE'RE SORTING THROUGH THE BEST

2993
01:56:43,201 --> 01:56:44,436
PRACTICES FOR USING

2994
01:56:44,436 --> 01:56:46,504
COMPLEMENTARY DATA SOURCES FOR

2995
01:56:46,504 --> 01:56:47,372
POST-MARKET SAFETY ASSESSMENT

2996
01:56:47,372 --> 01:56:49,708
AND THE PROGRAMMING TOOLS ARE

2997
01:56:49,708 --> 01:56:53,845
STILL EVOLVING AND DEVELOPING.

2998
01:56:53,845 --> 01:56:56,348
THE MEDICATE DATA IS RICH,

2999
01:56:56,348 --> 01:56:58,783
QUALITY AND CAPTURE DIFFERS BY

3000
01:56:58,783 --> 01:56:59,217
STATE

3001
01:56:59,217 --> 01:57:00,752
WHAT RESOURCES, POLICY CHANGE,

3002
01:57:00,752 --> 01:57:02,187
REGULATIONS ARE NEEDED?

3003
01:57:02,187 --> 01:57:03,722
I INCLUDED THE LINK TO THE

3004
01:57:03,722 --> 01:57:06,658
WORKSHOP BECAUSE WE SPENT TWO

3005
01:57:06,658 --> 01:57:08,293
DAYS TALKING, IF ANYBODY WANT A

3006
01:57:08,293 --> 01:57:09,728
DEEP DIVE INTO FDA CURRENT

3007
01:57:09,728 --> 01:57:12,564
THINKING THEY CAN GO AND WATCH

3008
01:57:12,564 --> 01:57:12,797
THAT.

3009
01:57:12,797 --> 01:57:18,503
AND SO WITH THAT I'LL END. 

3010
01:57:18,503 --> 01:57:20,438
>> THANKS SO MUCH, TRISH.

3011
01:57:20,438 --> 01:57:21,873
I THINK OUR WORK GROUP MEMBERS

3012
01:57:21,873 --> 01:57:23,508
SHOULD HAVE RECEIVED THOSE LINKS

3013
01:57:23,508 --> 01:57:26,578
AS PART OF THEIR PRE-READ, SO

3014
01:57:26,578 --> 01:57:28,980
ANYTHING THAT'S IN THESE SLIDES

3015
01:57:28,980 --> 01:57:29,848
YOU WILL RECEIVE SOME OF THE

3016
01:57:29,848 --> 01:57:31,383
SLIDES AT THE COMPLETION OF THE

3017
01:57:31,383 --> 01:57:33,218
MEETING BUT YOU SHOULD AT LEAST

3018
01:57:33,218 --> 01:57:34,753
HAVE THESE LINKS AVAILABLE FROM

3019
01:57:34,753 --> 01:57:36,187
THE PREVIOUS MEETING.

3020
01:57:36,187 --> 01:57:39,157
I DO WANT TO MAKE SURE BEFORE WE

3021
01:57:39,157 --> 01:57:42,027
MOVE TO LEILA, ARE THERE

3022
01:57:42,027 --> 01:57:43,461
QUESTIONS FOR CLARIFICATION FOR

3023
01:57:43,461 --> 01:57:45,030
TRISH BASED ON HER PRESENTATION

3024
01:57:45,030 --> 01:57:47,198
TODAY?

3025
01:57:47,198 --> 01:57:52,437
 

3026
01:57:52,437 --> 01:57:54,072
NOT SEEING ANYONE, I'M ASKING --

3027
01:57:54,072 --> 01:57:59,577
WAIT, THERE IS A QUESTION.

3028
01:57:59,577 --> 01:58:00,779
DR. CHARO?

3029
01:58:00,779 --> 01:58:01,246
>> THAT WAS TERRIFIC.

3030
01:58:01,246 --> 01:58:03,515
THANK YOU SO VERY MUCH.

3031
01:58:03,515 --> 01:58:05,684
I JUST WONDER IF YOU COULD SAY A

3032
01:58:05,684 --> 01:58:06,885
FEW WORDS ABOUT THE STATES SLOW

3033
01:58:06,885 --> 01:58:08,420
TO IMPLEMENT OR DIDN'T IMPLEMENT

3034
01:58:08,420 --> 01:58:10,422
AT ALL FROM YOUR LAST SLIDE,

3035
01:58:10,422 --> 01:58:13,692
WHAT WERE THE REASONS OR THE

3036
01:58:13,692 --> 01:58:14,559
OBSTACLES AND IS THERE SOME

3037
01:58:14,559 --> 01:58:16,194
REASON TO THINK IT'S GOING TO

3038
01:58:16,194 --> 01:58:17,729
IMPROVE IN THE FUTURE?

3039
01:58:17,729 --> 01:58:18,930
>> YEAH, IT'S HARD TO SAY

3040
01:58:18,930 --> 01:58:20,999
BECAUSE I WASN'T THE ONE WHO DID

3041
01:58:20,999 --> 01:58:21,166
IT.

3042
01:58:21,166 --> 01:58:23,969
WITH THE ONES SLOW, I WOULDN'T

3043
01:58:23,969 --> 01:58:25,170
BE TOO WORRIED BECAUSE THEY WERE

3044
01:58:25,170 --> 01:58:26,638
GIVEN TWO YEARS TO TRANSITION,

3045
01:58:26,638 --> 01:58:28,340
IT MAY HAVE BEEN HOW THEY

3046
01:58:28,340 --> 01:58:29,874
PRIORITIZED OR FUNDED FOR THAT

3047
01:58:29,874 --> 01:58:30,075
YEARS.

3048
01:58:30,075 --> 01:58:32,944
MORE CONCERNING IS WHEN YOU HIT

3049
01:58:32,944 --> 01:58:36,214
THE BLIPS LATER ON SEEING THE

3050
01:58:36,214 --> 01:58:38,049
RED LETTERS LATER BECAUSE THAT'S

3051
01:58:38,049 --> 01:58:40,685
SYSTEMS UP AND GOING AND

3052
01:58:40,685 --> 01:58:44,189
SOMETHING WENT WRONG.

3053
01:58:44,189 --> 01:58:46,391
SOMETIMES THE REASONS ARE REALLY

3054
01:58:46,391 --> 01:58:47,492
KIND OF STRANGE, LIKE, FOR

3055
01:58:47,492 --> 01:58:48,460
EXAMPLE, THERE'S SOME STATES

3056
01:58:48,460 --> 01:58:50,595
WHERE THEY FOUND THEY HAVE THE

3057
01:58:50,595 --> 01:58:52,397
UNIQUE FAMILY IDENTIFIER,

3058
01:58:52,397 --> 01:58:53,832
THERE'S SOME STATES, SOME

3059
01:58:53,832 --> 01:58:54,899
JURISDICTIONS WHERE THEY START

3060
01:58:54,899 --> 01:58:56,434
REISSUING THAT TO DIFFERENT

3061
01:58:56,434 --> 01:58:59,404
FAMILIES, WHICH THROWS OFF THE

3062
01:58:59,404 --> 01:59:00,005
LINKAGE.

3063
01:59:00,005 --> 01:59:02,574
SOMETIMES THE ISSUES WERE

3064
01:59:02,574 --> 01:59:04,676
ELIGIBILITY, SOMETIMES GETTING

3065
01:59:04,676 --> 01:59:06,511
STRANGE TEMPORAL SEQUENCE OF

3066
01:59:06,511 --> 01:59:07,512
PEOPLE GETTING MEDICATIONS

3067
01:59:07,512 --> 01:59:09,481
BEFORE THEY WERE FORMALLY

3068
01:59:09,481 --> 01:59:10,582
ENROLLED, A FEW STRANGE THINGS

3069
01:59:10,582 --> 01:59:11,649
LIKE THAT, THOSE WERE SORT OF

3070
01:59:11,649 --> 01:59:13,318
THE REASONS THE TEAM WOULD SAY

3071
01:59:13,318 --> 01:59:14,719
THIS DOESN'T MAKE LOGICAL SENSE,

3072
01:59:14,719 --> 01:59:17,288
THIS ISN'T DATA WE CAN USE.

3073
01:59:17,288 --> 01:59:19,557
WILL THEY GET BETTER?

3074
01:59:19,557 --> 01:59:20,759
I WOULD HOPE SO.

3075
01:59:20,759 --> 01:59:22,293
AND I THINK WITH TIME THEY

3076
01:59:22,293 --> 01:59:24,829
PROBABLY WOULD BUT, AGAIN, WE

3077
01:59:24,829 --> 01:59:27,232
DID SEE SOME THAT SEEM SOLID AND

3078
01:59:27,232 --> 01:59:29,467
THEN THEY HAD ERRORS JUMP IN.

3079
01:59:29,467 --> 01:59:31,703
>> THANKS VERY MUCH.

3080
01:59:31,703 --> 01:59:32,070
>> UH-HUH.

3081
01:59:32,070 --> 01:59:34,005
>> AND REBECCA, YOUR HAND
IS UP

3082
01:59:34,005 --> 01:59:35,440
FOR A CLARIFICATION QUESTION AS

3083
01:59:35,440 --> 01:59:38,610
WELL.

3084
01:59:38,610 --> 01:59:38,743
 

3085
01:59:38,743 --> 01:59:39,911
>> SORRY.

3086
01:59:39,911 --> 01:59:41,246
MY COMPUTER WAS SLOW.

3087
01:59:41,246 --> 01:59:43,982
THIS IS PROBABLY AN IGNORANT

3088
01:59:43,982 --> 01:59:44,282
QUESTION.

3089
01:59:44,282 --> 01:59:47,986
ONCE YOU ALL DO THE STUDIES WITH

3090
01:59:47,986 --> 01:59:49,554
SENTINEL, WHAT'S THE NEXT STEP

3091
01:59:49,554 --> 01:59:50,755
THERE, DOES THAT GO BACK TO

3092
01:59:50,755 --> 01:59:52,924
LABELING OR DO YOU PUT OUT

3093
01:59:52,924 --> 01:59:54,259
RESEARCH STUDIES, KIND OF HOW

3094
01:59:54,259 --> 01:59:59,064
DOES THAT INFORMATION THEN GET

3095
01:59:59,064 --> 02:00:00,098
TO CLINICIANS, PATIENTS?

3096
02:00:00,098 --> 02:00:00,298
YEAH.

3097
02:00:00,298 --> 02:00:01,566
>> IT'S A GOOD QUESTION.

3098
02:00:01,566 --> 02:00:04,069
ALL OF OUR STUDIES THAT WE DO

3099
02:00:04,069 --> 02:00:05,937
ARE POSTED ON OUR WEBSITE SO

3100
02:00:05,937 --> 02:00:07,272
PEOPLE CAN SEE THEM.

3101
02:00:07,272 --> 02:00:08,473
TYPICALLY THE REASON WE'RE DOING

3102
02:00:08,473 --> 02:00:10,875
A STUDY IS BECAUSE WE'RE TRYING

3103
02:00:10,875 --> 02:00:12,210
TO ANSWER A REGULATORY QUESTION

3104
02:00:12,210 --> 02:00:13,511
POSED WITHIN THE FDA.

3105
02:00:13,511 --> 02:00:14,913
SO MAYBE A REVIEW TEAM THAT HAS

3106
02:00:14,913 --> 02:00:16,948
A QUESTION AND THEY WANT US TO

3107
02:00:16,948 --> 02:00:19,284
ADDRESS SOMETHING OR A SAFETY

3108
02:00:19,284 --> 02:00:20,552
QUESTION, MAYBE IDENTIFIED IN

3109
02:00:20,552 --> 02:00:21,386
LITERATURE, PEOPLE WANT TO SEE

3110
02:00:21,386 --> 02:00:22,887
IF THIS IS REALLY DONE.

3111
02:00:22,887 --> 02:00:25,290
WE DO THE STUDY AND FEED IT BACK

3112
02:00:25,290 --> 02:00:25,857
TO THERAPEUTIC DIVISION

3113
02:00:25,857 --> 02:00:26,925
RESPONSIBLE FOR THAT.

3114
02:00:26,925 --> 02:00:28,426
AND THEN THEY MAKE A DECISION,

3115
02:00:28,426 --> 02:00:30,295
DO THEY WANT TO TAKE REGULATORY

3116
02:00:30,295 --> 02:00:32,297
ACTION, SOMETIMES IT COULD BE A

3117
02:00:32,297 --> 02:00:33,164
COMMUNICATION TO THE PUBLIC,

3118
02:00:33,164 --> 02:00:35,166
SOMETIMES IT COULD BE A LABELING

3119
02:00:35,166 --> 02:00:35,400
CHANGE.

3120
02:00:35,400 --> 02:00:36,668
WE HAVE ABOUT 12 LABELING

3121
02:00:36,668 --> 02:00:38,770
CHANGES AT THIS POINT THAT

3122
02:00:38,770 --> 02:00:40,505
INCLUDE SENTINEL DATA.

3123
02:00:40,505 --> 02:00:41,906
SOMETIMES IT'S CONSIDERING FOR

3124
02:00:41,906 --> 02:00:44,042
APPROVAL OF A NEW MEDICATION.

3125
02:00:44,042 --> 02:00:46,111
WE DID STUDIES RELATED TO

3126
02:00:46,111 --> 02:00:50,815
PAXLOVID BEFORE IT WAS APPROVED,

3127
02:00:50,815 --> 02:00:53,551
OR OFTEN OVERLOOKED MOST OF THE

3128
02:00:53,551 --> 02:00:55,854
TIME WE GET REASSURING SAFETY

3129
02:00:55,854 --> 02:00:57,489
INFORMATION, SO THE TEAM DECIDES

3130
02:00:57,489 --> 02:00:59,991
NO REGULATORY ACTION IS NEEDED.

3131
02:00:59,991 --> 02:01:00,291
>> HELPFUL.

3132
02:01:00,291 --> 02:01:03,194
THANK YOU. 

3133
02:01:03,194 --> 02:01:03,695
>> THANK YOU.

3134
02:01:03,695 --> 02:01:07,098
>> THANK YOU VERY MUCH FOR
THE

3135
02:01:07,098 --> 02:01:07,432
PRESENTATION.

3136
02:01:07,432 --> 02:01:10,001
WE'LL BRING YOU BACK FOR THE

3137
02:01:10,001 --> 02:01:10,969
QUESTION-AND-ANSWER ONCE LEILA

3138
02:01:10,969 --> 02:01:11,836
COMPLETED HER PRESENTATION.

3139
02:01:11,836 --> 02:01:14,772
>> SOUNDS GOOD, THANK YOU.

3140
02:01:14,772 --> 02:01:21,779
>> NEXT WE'LL INVITE DR.
SAHIM.

3141
02:01:21,779 --> 02:01:23,681
>> I'M IN THE DIVISION OF

3142
02:01:23,681 --> 02:01:24,582
PEDIATRICS AND MATERNAL HEALTH,

3143
02:01:24,582 --> 02:01:29,454
OFFICE OF NEW DRUGS IN CDER.

3144
02:01:29,454 --> 02:01:32,857
SLIGHTLY DIFFERENT DIVISION THAN

3145
02:01:32,857 --> 02:01:33,958
TRISH BUT WE COLLABORATE ON A

3146
02:01:33,958 --> 02:01:35,326
LOT OF PROJECTS TOGETHER.

3147
02:01:35,326 --> 02:01:39,731
SO THANK YOU SO MUCH FOR THE

3148
02:01:39,731 --> 02:01:43,268
OPPORTUNITY TO PRESENT TODAY. 

3149
02:01:43,268 --> 02:01:52,544
NEXT SLIDE PLEASE. 

3150
02:01:52,544 --> 02:01:54,078
I'LL FDA SPEAKERS HAVE TO

3151
02:01:54,078 --> 02:01:56,281
PRESENT THIS DISCLAIMER AS PARTS

3152
02:01:56,281 --> 02:01:57,482
OF OUR PRESENTATION, SO IT'S

3153
02:01:57,482 --> 02:02:00,418
IMPORTANT FOR ME TO NOTE THAT

3154
02:02:00,418 --> 02:02:01,219
THIS PRESENTATION TODAY REFLECTS

3155
02:02:01,219 --> 02:02:02,921
MY PERSONAL VIEWS AND NOT THE

3156
02:02:02,921 --> 02:02:07,225
OFFICIAL POSITION OF THE FDA.

3157
02:02:07,225 --> 02:02:09,460
NEXT SLIDE PLEASE.

3158
02:02:09,460 --> 02:02:10,862
SO, THE OBJECTIVES OF MY TALK

3159
02:02:10,862 --> 02:02:15,667
ARE TO PROVIDE A LITTLE BIT OF

3160
02:02:15,667 --> 02:02:17,735
BACKGROUND INFORMATION ON KIND

3161
02:02:17,735 --> 02:02:22,874
OF THE REGULATORY PATHWAY FOR

3162
02:02:22,874 --> 02:02:26,945
DRUG APPROVALS, AND HOW WE HAVE

3163
02:02:26,945 --> 02:02:28,146
CERTAIN AUTHORITIES REGARDING

3164
02:02:28,146 --> 02:02:29,581
PREGNANCY REGISTRIES IN

3165
02:02:29,581 --> 02:02:30,315
POST-APPROVAL SETTING, AND THEN

3166
02:02:30,315 --> 02:02:33,084
I'M GOING TO TALK A LITTLE BIT

3167
02:02:33,084 --> 02:02:35,687
ABOUT FDA EFFORTS SUPPORTING

3168
02:02:35,687 --> 02:02:37,255
PRGLAC RECOMMENDATION 13.

3169
02:02:37,255 --> 02:02:40,191
NEXT SLIDE PLEASE.

3170
02:02:40,191 --> 02:02:42,160
SO, IN TERMS OF BACKGROUND

3171
02:02:42,160 --> 02:02:44,796
INFORMATION, OF COURSE THIS IS

3172
02:02:44,796 --> 02:02:45,463
ALL INFORMATION THAT YOU'RE

3173
02:02:45,463 --> 02:02:47,031
AWARE OF.

3174
02:02:47,031 --> 02:02:48,499
THERE ARE APPROXIMATELY 5.5

3175
02:02:48,499 --> 02:02:50,602
APPROXIMATELY PREGNANCIES IN THE

3176
02:02:50,602 --> 02:02:51,903
U.S. EVERY YEAR.

3177
02:02:51,903 --> 02:02:53,705
AND OF COURSE, THE REASON WE'RE

3178
02:02:53,705 --> 02:02:57,842
ALL HERE FOR THIS MEETING IS

3179
02:02:57,842 --> 02:02:59,277
BECAUSE PREGNANT INDIVIDUALS MAY

3180
02:02:59,277 --> 02:03:04,716
NEED TREATMENT FOR CHRONIC OR

3181
02:03:04,716 --> 02:03:07,552
ACUTE CONDITIONS, AND SO IT'S

3182
02:03:07,552 --> 02:03:09,220
ALSO UNDERSTOOD THAT PREGNANT

3183
02:03:09,220 --> 02:03:09,954
INDIVIDUALS HAVE HISTORICALLY

3184
02:03:09,954 --> 02:03:12,624
BEEN LEFT OUT OF DRUG

3185
02:03:12,624 --> 02:03:14,125
DEVELOPMENT TRIALS FOR VARIOUS

3186
02:03:14,125 --> 02:03:14,459
REASONS.

3187
02:03:14,459 --> 02:03:16,227
THERE ARE CURRENTLY SOME EFFORTS

3188
02:03:16,227 --> 02:03:18,229
THAT WE'RE INVOLVED IN TO

3189
02:03:18,229 --> 02:03:20,265
ADDRESS THIS, BUT I THINK THAT'S

3190
02:03:20,265 --> 02:03:21,799
STILL A HUGE EFFORT THAT'S GOING

3191
02:03:21,799 --> 02:03:27,038
TO TAKE A LONG TIME. 

3192
02:03:27,038 --> 02:03:29,974
SO, WHAT HAPPENS IS THAT

3193
02:03:29,974 --> 02:03:31,276
PHARMACEUTICAL COMPANIES SUBMIT

3194
02:03:31,276 --> 02:03:33,278
DRUG APPLICATIONS TO THE FDA,

3195
02:03:33,278 --> 02:03:37,415
AND THEN WHEN DRUGS ARE APPROVED

3196
02:03:37,415 --> 02:03:39,951
THEY ARE ONLY APPROVED WITH

3197
02:03:39,951 --> 02:03:41,152
CLINICAL REPRODUCTIVE DATA TO

3198
02:03:41,152 --> 02:03:43,421
INFORM SAFETY AND PREGNANCY.

3199
02:03:43,421 --> 02:03:44,856
SO THE CURRENT PARADIGM IS THAT

3200
02:03:44,856 --> 02:03:48,793
HUMAN DATA ARE THEN NEEDED TO

3201
02:03:48,793 --> 02:03:49,794
INFORM THE PRESCRIPTION DRUG

3202
02:03:49,794 --> 02:03:51,095
LABELING, TO INFORM CLINICAL

3203
02:03:51,095 --> 02:03:53,131
CARE, AND THESE DATA ARE

3204
02:03:53,131 --> 02:03:55,867
COLLECTED IN THE POST-APPROVAL

3205
02:03:55,867 --> 02:03:56,100
SETTING.

3206
02:03:56,100 --> 02:03:59,337
AT THE TIME OF NEW DRUG APPROVAL

3207
02:03:59,337 --> 02:04:01,072
FDA COULD ISSUE POST-MARKETING

3208
02:04:01,072 --> 02:04:05,043
REQUIREMENTS TO CONDUCT

3209
02:04:05,043 --> 02:04:06,044
PREGNANCY SAFETY STUDIES.

3210
02:04:06,044 --> 02:04:07,111
NEXT SLIDE PLEASE.

3211
02:04:07,111 --> 02:04:11,082
SO, I WANTED TO TALK A LITTLE

3212
02:04:11,082 --> 02:04:12,383
BIT ABOUT FDA'S AUTHORITIES

3213
02:04:12,383 --> 02:04:15,286
BECAUSE THIS SETS THE STAGE FOR

3214
02:04:15,286 --> 02:04:18,623
DISCUSSION LATER ON IN TERMS OF

3215
02:04:18,623 --> 02:04:20,925
SOME OF PRGLAC RECOMMENDATIONS

3216
02:04:20,925 --> 02:04:23,127
FOR THE COMMITTEE TO UNDERSTAND

3217
02:04:23,127 --> 02:04:24,329
WHAT ARE WITHIN FDA'S

3218
02:04:24,329 --> 02:04:25,263
AUTHORITIES TO KIND OF, YOU

3219
02:04:25,263 --> 02:04:30,435
KNOW, TO IMPLEMENT SOME OF THESE

3220
02:04:30,435 --> 02:04:30,802
RECOMMENDATIONS.

3221
02:04:30,802 --> 02:04:38,476
PREGNANCY SAFETY STUDIES CAN BE

3222
02:04:38,476 --> 02:04:41,779
REQUIRED UNDER SESSION 505O 3 OF

3223
02:04:41,779 --> 02:04:43,381
THE FD & C ACT.

3224
02:04:43,381 --> 02:04:48,086
IN CBER THEY ISSUE AS

3225
02:04:48,086 --> 02:04:49,287
POST-MARKETING COMMITMENTS,

3226
02:04:49,287 --> 02:04:49,487
PMCs.

3227
02:04:49,487 --> 02:04:52,256
FDA HAS BEEN ISSUING TWO TYPES

3228
02:04:52,256 --> 02:04:54,592
OF PREGNANCY REQUIREMENTS, A

3229
02:04:54,592 --> 02:04:57,628
PREGNANCY REGISTRY AND

3230
02:04:57,628 --> 02:04:59,030
COMPLEMENTARY DATABASE STUDY,

3231
02:04:59,030 --> 02:05:04,302
AND THIS IS HAPPENING IN CDER.

3232
02:05:04,302 --> 02:05:05,503
NEXT SLIDE PLEASE.

3233
02:05:05,503 --> 02:05:08,239
SO, I'M GOING TO MOVE ON TO TALK

3234
02:05:08,239 --> 02:05:11,109
ABOUT FDA EFFORTS SUPPORTING

3235
02:05:11,109 --> 02:05:13,277
PRGLAC RECOMMENDATION 13

3236
02:05:13,277 --> 02:05:13,611
SPECIFICALLY.

3237
02:05:13,611 --> 02:05:18,649
NEXT SLIDE PLEASE.

3238
02:05:18,649 --> 02:05:20,718
SO PRGLAC RECOMMENDATION 13A IS

3239
02:05:20,718 --> 02:05:22,353
RECOMMENDATION TO CREATE USER

3240
02:05:22,353 --> 02:05:25,656
FRIENDLY PREGNANCY REGISTRY FOR

3241
02:05:25,656 --> 02:05:26,824
REGISTRY LISTING.

3242
02:05:26,824 --> 02:05:28,926
AND THEN UNDER THIS

3243
02:05:28,926 --> 02:05:30,228
RECOMMENDATION SUBPART, A IS

3244
02:05:30,228 --> 02:05:32,196
TO -- RECOMMENDATION TO IDENTIFY

3245
02:05:32,196 --> 02:05:33,831
ELEMENTS NEEDED FOR REGISTRY

3246
02:05:33,831 --> 02:05:39,337
LISTING AND THEN B TO DEVELOP A

3247
02:05:39,337 --> 02:05:43,708
PUBLIC/PRIVATE PARTNERSHIP TO

3248
02:05:43,708 --> 02:05:46,544
HOST A AND LACTATION REGISTRY

3249
02:05:46,544 --> 02:05:47,245
LISTING WEB PAGE.

3250
02:05:47,245 --> 02:05:51,149
IN TERMS OF WHAT FDA IS DOING

3251
02:05:51,149 --> 02:05:53,518
MAINTAINING A FDA REGISTRY

3252
02:05:53,518 --> 02:05:56,287
WEBSITE ONLY LIMITED TO PRODUCTS

3253
02:05:56,287 --> 02:05:57,355
APPROVED BY FDA.

3254
02:05:57,355 --> 02:06:01,325
AND SO THERE IS AN EXISTING

3255
02:06:01,325 --> 02:06:05,363
PROCESS THAT FDA IMPLEMENTS IN

3256
02:06:05,363 --> 02:06:09,734
TERMS OF STANDARD ELEMENTS TO 

3257
02:06:09,734 --> 02:06:12,570
LIST THE PREGNANCY REGISTRY, SO

3258
02:06:12,570 --> 02:06:14,338
WHEN SPONSORS SUBMIT THEIR STUDY

3259
02:06:14,338 --> 02:06:15,273
PROTOCOLS FOR PREGNANCY

3260
02:06:15,273 --> 02:06:17,708
REGISTRIES TO FDA THEY ARE

3261
02:06:17,708 --> 02:06:21,012
REVIEWED BY FDA, AND THEN WE

3262
02:06:21,012 --> 02:06:22,547
SEND BACK RECOMMENDATIONS TO THE

3263
02:06:22,547 --> 02:06:24,649
COMPANY, ADVISING THE COMPANY TO

3264
02:06:24,649 --> 02:06:27,718
LIST THEIR PREGNANCY REGISTRY ON

3265
02:06:27,718 --> 02:06:29,554
THIS PREGNANCY WEB PAGE.

3266
02:06:29,554 --> 02:06:33,458
SO IN TERMS OF RECOMMENDATION B

3267
02:06:33,458 --> 02:06:34,725
DEVELOPING A PUBLIC/PRIVATE

3268
02:06:34,725 --> 02:06:39,397
PARTNERSHIP TO HOST THIS

3269
02:06:39,397 --> 02:06:41,165
PREGNANCY REGISTRY LISTING WEB

3270
02:06:41,165 --> 02:06:43,267
PAGE, FOR US IT'S, YOU KNOW,

3271
02:06:43,267 --> 02:06:44,802
FROM OUR PERSPECTIVE THIS

3272
02:06:44,802 --> 02:06:48,406
PREGNANCY REGISTRY WEB PAGE IS

3273
02:06:48,406 --> 02:06:50,808
SERVING OUR NEEDS IN TERMS OF

3274
02:06:50,808 --> 02:06:52,777
PRODUCTS THAT ARE APPROVED BY

3275
02:06:52,777 --> 02:06:54,946
FDA, AND SO I GUESS A QUESTION

3276
02:06:54,946 --> 02:06:57,048
FOR THE COMMITTEE IS, YOU KNOW,

3277
02:06:57,048 --> 02:07:00,051
ARE THERE OTHER NEEDS THAT CAN

3278
02:07:00,051 --> 02:07:01,452
BE ADDRESSED BY A PUBLIC/PRIVATE

3279
02:07:01,452 --> 02:07:05,389
PARTNERSHIP FOR OTHER TYPES OF 

3280
02:07:05,389 --> 02:07:07,992
REGISTRY LISTINGS THAT MAY BE

3281
02:07:07,992 --> 02:07:09,727
OUTSIDE OF FDA'S PURVIEW.

3282
02:07:09,727 --> 02:07:13,498
AND WE CAN TALK ABOUT THESE

3283
02:07:13,498 --> 02:07:17,335
QUESTIONS OR THESE ISSUES IN THE

3284
02:07:17,335 --> 02:07:17,969
 THE QUESTION-AND-ANSWER PERIOD

3285
02:07:17,969 --> 02:07:18,736
OR IN DISCUSSION.

3286
02:07:18,736 --> 02:07:21,706
WE CAN MOVE TO THE NEXT SLIDE

3287
02:07:21,706 --> 02:07:28,379
PLEASE. 

3288
02:07:28,379 --> 02:07:29,480
RECOMMENDATION 13B DEVELOP

3289
02:07:29,480 --> 02:07:32,316
REGISTRY STANDARDS AND COMMON

3290
02:07:32,316 --> 02:07:35,820
DATA ELEMENTS AND FACILITATE

3291
02:07:35,820 --> 02:07:39,090
INPUT WITH TRANSPARENT ACCESS TO

3292
02:07:39,090 --> 02:07:42,026
OBTAIN INFORMATION IN REAL TIME.

3293
02:07:42,026 --> 02:07:44,562
FDA PUBLISHED A GUIDANCE ON

3294
02:07:44,562 --> 02:07:49,033
SAFETY STUDIES FOR, AGAIN,

3295
02:07:49,033 --> 02:07:51,903
FDA-APPROVED MEDICAL PRODUCTS.

3296
02:07:51,903 --> 02:07:53,938
AND SO IN THIS GUIDANCE,

3297
02:07:53,938 --> 02:07:55,172
REGISTRY STANDARDS IN THE

3298
02:07:55,172 --> 02:07:58,376
DISCUSSION OF THE COMMON DATA

3299
02:07:58,376 --> 02:07:59,377
ELEMENTS ARE DESCRIBED.

3300
02:07:59,377 --> 02:08:01,779
THERE IS A TABLE AT THE END OF

3301
02:08:01,779 --> 02:08:02,980
THE GUIDANCE THAT DESCRIBES ALL

3302
02:08:02,980 --> 02:08:05,950
OF THE COMMON DATA ELEMENTS THAT

3303
02:08:05,950 --> 02:08:08,452
ARE REQUESTED AS PART OF A

3304
02:08:08,452 --> 02:08:09,887
PREGNANCY REGISTRY STUDY.

3305
02:08:09,887 --> 02:08:12,924
THIS GUIDANCE IS CURRENTLY BEING

3306
02:08:12,924 --> 02:08:14,025
UPDATED BASED ON PUBLIC

3307
02:08:14,025 --> 02:08:14,458
COMMENTS.

3308
02:08:14,458 --> 02:08:19,163
AND THEN THE ISSUE RELATED TO

3309
02:08:19,163 --> 02:08:20,598
REALTIME DATA COLLECTION, SO

3310
02:08:20,598 --> 02:08:22,700
DATA IS COLLECTED FROM PREGNANT

3311
02:08:22,700 --> 02:08:25,870
INDIVIDUALS IN REAL TIME THROUGH

3312
02:08:25,870 --> 02:08:27,505
THE USE OF APPS.

3313
02:08:27,505 --> 02:08:31,542
AND SO AGAIN FROM OUR

3314
02:08:31,542 --> 02:08:32,944
PERSPECTIVE WE FEEL THAT I GUESS

3315
02:08:32,944 --> 02:08:35,479
A QUESTION IS THAT ARE THERE

3316
02:08:35,479 --> 02:08:38,616
OTHER REGISTRIES OUTSIDE OF

3317
02:08:38,616 --> 02:08:40,751
FDA'S PURVIEW THAT NEED TO

3318
02:08:40,751 --> 02:08:43,187
ADDRESS COMMON DATA ELEMENTS.

3319
02:08:43,187 --> 02:08:45,690
NEXT SLIDE PLEASE.

3320
02:08:45,690 --> 02:08:48,759
AND THIS IS THE GUIDANCE THAT I

3321
02:08:48,759 --> 02:08:49,427
MENTIONED THAT'S CURRENTLY

3322
02:08:49,427 --> 02:08:49,961
UNDERGOING REVISION.

3323
02:08:49,961 --> 02:08:55,967
NEXT SLIDE PLEASE.

3324
02:08:55,967 --> 02:08:57,335
RECOMMENDATION 13C FACILITATE

3325
02:08:57,335 --> 02:09:00,671
ACCESS TO DATA AND TRANSPARENCY

3326
02:09:00,671 --> 02:09:05,977
OF INFORMATION AND REGISTRIES

3327
02:09:05,977 --> 02:09:10,214
USE ANTIRETROVIRAL AS A MODEL.

3328
02:09:10,214 --> 02:09:11,482
FDA SUPPORTS THIS

3329
02:09:11,482 --> 02:09:11,849
RECOMMENDATION.

3330
02:09:11,849 --> 02:09:16,087
WE AT THE PUBLIC WORKSHOP THAT

3331
02:09:16,087 --> 02:09:17,822
WE HELD IN SEPTEMBER, THIS ISSUE

3332
02:09:17,822 --> 02:09:20,891
CAME UP AS WELL AND WAS A TOPIC

3333
02:09:20,891 --> 02:09:25,162
FOR DISCUSSION. 

3334
02:09:25,162 --> 02:09:26,530
AND SO THE ANTIRETROVIRAL

3335
02:09:26,530 --> 02:09:28,132
PREGNANCY REGISTRY HAS DONE THIS

3336
02:09:28,132 --> 02:09:35,506
VERY SUCCESSFULLY AND IS A GREAT

3337
02:09:35,506 --> 02:09:40,878
MODEL BECAUSE IT INVOLVES 24

3338
02:09:40,878 --> 02:09:41,846
DIFFERENT MANUFACTURERS AND THAT

3339
02:09:41,846 --> 02:09:45,016
INCLUDES 61 BRAND NAME DRUGS,

3340
02:09:45,016 --> 02:09:47,385
THIS IS NOT A PREGNANCY REGISTRY

3341
02:09:47,385 --> 02:09:50,721
THAT IS ISSUED AS A

3342
02:09:50,721 --> 02:09:53,557
POST-MARKETING REQUIREMENT, SO

3343
02:09:53,557 --> 02:09:56,093
ALL OF THESE COMPANIES

3344
02:09:56,093 --> 02:09:59,597
COLLABORATE TOGETHER AND THIS

3345
02:09:59,597 --> 02:10:00,297
PREGNANCY REGISTRY PUBLISHES

3346
02:10:00,297 --> 02:10:04,201
THEIR RESULTS ON A PUBLIC-FACING

3347
02:10:04,201 --> 02:10:06,570
WEBSITE, EVERY SIX MONTHS.

3348
02:10:06,570 --> 02:10:10,808
AND SO THIS IS A SUCCESSFUL

3349
02:10:10,808 --> 02:10:12,076
MODEL, AND THEN I GUESS THE

3350
02:10:12,076 --> 02:10:14,045
QUESTION THAT WE HAVE AGAIN FOR

3351
02:10:14,045 --> 02:10:20,384
THE COMMITTEE IS THAT FROM OUR

3352
02:10:20,384 --> 02:10:22,453
PERSPECTIVE, THE DATA BELONG TO

3353
02:10:22,453 --> 02:10:25,322
THE MANUFACTURER THAT

3354
02:10:25,322 --> 02:10:26,057
MANUFACTURES THE INDIVIDUAL

3355
02:10:26,057 --> 02:10:27,825
DRUG, AND SO, YOU KNOW, WHERE

3356
02:10:27,825 --> 02:10:31,228
DOES THE AUTHORITY LIE TO

3357
02:10:31,228 --> 02:10:31,662
OPERATIONALIZE THIS

3358
02:10:31,662 --> 02:10:33,731
RECOMMENDATION?

3359
02:10:33,731 --> 02:10:35,833
I THINK WE ALL SUPPORT THIS.

3360
02:10:35,833 --> 02:10:38,769
BUT I GUESS WE NEED TO HAVE

3361
02:10:38,769 --> 02:10:42,073
FURTHER DISCUSSION AS TO HOW 

3362
02:10:42,073 --> 02:10:43,474
THIS CAN BE IMPLEMENTED ACROSS

3363
02:10:43,474 --> 02:10:44,175
THE BOARD. 

3364
02:10:44,175 --> 02:10:46,777
NEXT SLIDE PLEASE.

3365
02:10:46,777 --> 02:10:49,947
 

3366
02:10:49,947 --> 02:10:52,783
THE NEXT RECOMMENDATION IS

3367
02:10:52,783 --> 02:10:54,318
RECOMMENDATION 13D, DEVELOPING

3368
02:10:54,318 --> 02:10:56,187
DISEASE AND CONDITION FOCUSED

3369
02:10:56,187 --> 02:10:57,188
REGISTRIES, MOVING TOWARDS

3370
02:10:57,188 --> 02:10:58,689
SINGLE REGISTRY FOR ALL

3371
02:10:58,689 --> 02:11:01,792
THERAPEUTIC PRODUCTS WITH INPUT

3372
02:11:01,792 --> 02:11:03,094
FROM STAKEHOLDERS, BUILD

3373
02:11:03,094 --> 02:11:04,528
COLLABORATION BETWEEN THE

3374
02:11:04,528 --> 02:11:05,596
PUBLIC/PRIVATE PARTNERSHIP AND

3375
02:11:05,596 --> 02:11:06,430
OTHER INDUSTRY REPRESENTATIVES

3376
02:11:06,430 --> 02:11:08,365
TO WORK TOWARDS SINGLE REGISTRY

3377
02:11:08,365 --> 02:11:10,568
FOR THERAPEUTIC PRODUCTS USED BY

3378
02:11:10,568 --> 02:11:14,004
PREGNANT WOMEN AND LACTATING

3379
02:11:14,004 --> 02:11:17,775
WOMEN AND B, EXPAND USE OF

3380
02:11:17,775 --> 02:11:18,876
DISEASE OR CONDITION

3381
02:11:18,876 --> 02:11:20,211
POST-MARKETING STUDIES.

3382
02:11:20,211 --> 02:11:23,514
IN TERMS OF STATUS UPDATE, THIS

3383
02:11:23,514 --> 02:11:26,784
IS ANOTHER RECOMMENDATION THAT

3384
02:11:26,784 --> 02:11:28,753
FDA STRONGLY SUPPORTS.

3385
02:11:28,753 --> 02:11:33,924
WE KNOW FROM PRIOR EXPERIENCE

3386
02:11:33,924 --> 02:11:34,692
THAT DISEASE-BASED REGISTRIES

3387
02:11:34,692 --> 02:11:37,628
HAVE A TRACK RECORD IN TERMS OF

3388
02:11:37,628 --> 02:11:40,264
DATA COLLECTION COMPARED TO

3389
02:11:40,264 --> 02:11:41,699
SINGLE DRUG, SINGLE COMPANY

3390
02:11:41,699 --> 02:11:42,666
PREGNANCY REGISTRIES THAT

3391
02:11:42,666 --> 02:11:45,503
TYPICALLY TAKE 10 TO 15 YEARS TO

3392
02:11:45,503 --> 02:11:47,338
COLLECT DATA.

3393
02:11:47,338 --> 02:11:51,175
AND SO THIS IS WHERE WE ALL

3394
02:11:51,175 --> 02:11:53,577
ASPIRE TO, AND WE CONSISTENTLY

3395
02:11:53,577 --> 02:11:55,312
PROVIDE RECOMMENDATIONS TO

3396
02:11:55,312 --> 02:11:57,515
INDUSTRY WHEN WE RECEIVE

3397
02:11:57,515 --> 02:12:01,552
PREGNANCY REGISTRY PROTOCOLS, WE

3398
02:12:01,552 --> 02:12:04,722
CONSISTENTLY SEND BACK

3399
02:12:04,722 --> 02:12:06,791
RECOMMENDATIONS FOR SPONSORS TO

3400
02:12:06,791 --> 02:12:09,326
CONSIDER ALIGNING AND

3401
02:12:09,326 --> 02:12:12,062
COLLABORATING WITH OTHER

3402
02:12:12,062 --> 02:12:14,899
MANUFACTURERS TO CONDUCT A

3403
02:12:14,899 --> 02:12:15,666
DISEASE-BASED PREGNANCY

3404
02:12:15,666 --> 02:12:15,933
REGISTRY.

3405
02:12:15,933 --> 02:12:19,804
SO AT THE PUBLIC WORKSHOP THAT 

3406
02:12:19,804 --> 02:12:23,240
WE HELD IN SEPTEMBER, THIS TOPIC

3407
02:12:23,240 --> 02:12:26,510
WAS ALSO DISCUSSED.

3408
02:12:26,510 --> 02:12:30,548
THERE WAS A PRESENTATION BY

3409
02:12:30,548 --> 02:12:36,520
JESSICA ALBANO WHO OVERSEES THE

3410
02:12:36,520 --> 02:12:38,222
ANTIRETROVIRAL PREGNANCY

3411
02:12:38,222 --> 02:12:42,026
REGISTRY, AND SO SHE DESCRIBED 

3412
02:12:42,026 --> 02:12:46,964
HOW COMPLEX IT IS, HOW -- BUT 

3413
02:12:46,964 --> 02:12:49,466
THEY ARE SUCCESSFUL IN

3414
02:12:49,466 --> 02:12:50,601
DEVELOPING CONFIDENTIALITY

3415
02:12:50,601 --> 02:12:51,101
AGREEMENTS, DATA SHARING

3416
02:12:51,101 --> 02:12:52,102
AGREEMENTS, ET CETERA.

3417
02:12:52,102 --> 02:12:53,637
AND THIS IS ALSO DONE WITHOUT

3418
02:12:53,637 --> 02:12:57,675
ANY KIND OF PUBLIC FUNDING.

3419
02:12:57,675 --> 02:13:00,044
SO JUST WANTED TO BRING THAT TO

3420
02:13:00,044 --> 02:13:03,280
EVERYBODY'S ATTENTION THAT THIS 

3421
02:13:03,280 --> 02:13:08,085
IS A GREAT MODEL, BUT HOW DO WE

3422
02:13:08,085 --> 02:13:08,953
OPERATIONALIZE THESE

3423
02:13:08,953 --> 02:13:09,720
RECOMMENDATIONS?

3424
02:13:09,720 --> 02:13:13,657
I WANT TO RECOGNIZE TWO

3425
02:13:13,657 --> 02:13:16,093
COMMITTEE MEMBERS, TINA CHAMBERS

3426
02:13:16,093 --> 02:13:17,161
AND JANET HARDY, WERE

3427
02:13:17,161 --> 02:13:19,029
PARTICIPANTS AT THE FDA PUBLIC

3428
02:13:19,029 --> 02:13:21,332
WORKSHOP IN SEPTEMBER, SO THEY

3429
02:13:21,332 --> 02:13:23,934
WERE SPEAKERS AND THEY WERE

3430
02:13:23,934 --> 02:13:25,803
PANEL MEMBERS, AND SO THIS --

3431
02:13:25,803 --> 02:13:30,074
THESE RECOMMENDATIONS ARE VERY,

3432
02:13:30,074 --> 02:13:31,175
VERY COMPLEX, AND, YOU KNOW,

3433
02:13:31,175 --> 02:13:36,747
THEY ARE KIND OF MORE RELATED TO

3434
02:13:36,747 --> 02:13:37,448
POLICY ISSUES AND AUTHORITY

3435
02:13:37,448 --> 02:13:38,849
ISSUES, AND SO FORTH.

3436
02:13:38,849 --> 02:13:41,485
SO, IT'S A LITTLE BIT DIFFICULT

3437
02:13:41,485 --> 02:13:43,954
FOR, YOU KNOW, FOR US TO

3438
02:13:43,954 --> 02:13:46,323
DIRECTLY RESPOND TO SOME OF

3439
02:13:46,323 --> 02:13:47,958
THESE AND MAYBE THESE ARE SOME

3440
02:13:47,958 --> 02:13:50,794
OF THE RECOMMENDATIONS THAT MAY

3441
02:13:50,794 --> 02:13:53,330
END UP BEING RED DOT WHERE THERE

3442
02:13:53,330 --> 02:13:55,499
NEEDS FURTHER CONSIDERATION BY

3443
02:13:55,499 --> 02:13:57,601
THE COMMITTEE.

3444
02:13:57,601 --> 02:13:58,235
NEXT SLIDE PLEASE.

3445
02:13:58,235 --> 02:14:00,638
AND THAT'S THE END OF MY

3446
02:14:00,638 --> 02:14:00,971
PRESENTATION.

3447
02:14:00,971 --> 02:14:02,139
SO THANK YOU FOR YOUR ATTENTION

3448
02:14:02,139 --> 02:14:05,242
AND THANK YOU FOR THE

3449
02:14:05,242 --> 02:14:05,609
OPPORTUNITY. 

3450
02:14:05,609 --> 02:14:07,978
>> THANK YOU, LEYLA.

3451
02:14:07,978 --> 02:14:09,647
DOES ANYONE HAVE CLARIFICATION

3452
02:14:09,647 --> 02:14:13,083
FOR LEYLA BEFORE WE GO INTO THE

3453
02:14:13,083 --> 02:14:19,823
OPEN QUESTION-AND-ANSWER? 

3454
02:14:19,823 --> 02:14:22,660
NOT SEEING ANY HANDS I'LL JUMP

3455
02:14:22,660 --> 02:14:24,295
INTO LEYLA'S LAST COMMENT.

3456
02:14:24,295 --> 02:14:26,096
THANK YOU VERY MUCH, STEPHANIE

3457
02:14:26,096 --> 02:14:28,465
AND TRISH, FOR COMING UP ON

3458
02:14:28,465 --> 02:14:28,699
SCREEN.

3459
02:14:28,699 --> 02:14:33,037
YOU PREEMPTED MY NEXT COMMENT.

3460
02:14:33,037 --> 02:14:35,105
LEYLA RAISES AN IMPORTANT

3461
02:14:35,105 --> 02:14:37,074
COMMENT IN THE PRESENTATION, ONE

3462
02:14:37,074 --> 02:14:39,410
THAT'S FUNDAMENTAL TO SUE LAID

3463
02:14:39,410 --> 02:14:41,612
OUT HOW WE INTEND TO WORK WITH

3464
02:14:41,612 --> 02:14:43,547
YOU IN THINKING ABOUT THESE

3465
02:14:43,547 --> 02:14:45,983
RECOMMENDATIONS, WHERE WE MIGHT

3466
02:14:45,983 --> 02:14:48,585
NEED TO BE, SOME ADDITIONAL WORK

3467
02:14:48,585 --> 02:14:52,756
DONE FOR SOME RECOMMENDATIONS TO

3468
02:14:52,756 --> 02:14:54,325
ULTIMATELY BE PUT INTO PRACTICE.

3469
02:14:54,325 --> 02:14:56,427
SO I THINK THERE'S A REALLY

3470
02:14:56,427 --> 02:14:58,362
IMPORTANT COMMENT THAT'S RAISED

3471
02:14:58,362 --> 02:14:59,096
BY LEYLA THAT WE NEED TO THINK

3472
02:14:59,096 --> 02:15:03,067
ABOUT IN TERMS OF THE

3473
02:15:03,067 --> 02:15:04,034
STAKEHOLDERS ENGAGED, THE CALL

3474
02:15:04,034 --> 02:15:06,904
TO ACTION, WHERE TO DIRECTION

3475
02:15:06,904 --> 02:15:07,671
COMES FROM.

3476
02:15:07,671 --> 02:15:10,107
SUE, THERE ARE QUITE A HANDFUL

3477
02:15:10,107 --> 02:15:11,408
OF QUESTIONS IN THE Q&A.

3478
02:15:11,408 --> 02:15:13,043
I DO INVITE YOU TO COME ON

3479
02:15:13,043 --> 02:15:17,614
SCREEN TO ASK YOUR QUESTION.

3480
02:15:17,614 --> 02:15:19,350
I DO SEE WE HAVE DR. CHARO WHO

3481
02:15:19,350 --> 02:15:28,325
IS READY WITH THE FIRST ONE.

3482
02:15:28,325 --> 02:15:29,760
>> THANKS AGAIN, BOTH
TERRIFIC.

3483
02:15:29,760 --> 02:15:32,629
FOLLOWING UP ON THE POINT ABOUT

3484
02:15:32,629 --> 02:15:35,232
PROPRIETARY DATA AND DIFFICULTY

3485
02:15:35,232 --> 02:15:36,100
IN IMPLEMENTING SOMEBODY'S

3486
02:15:36,100 --> 02:15:38,202
RECOMMENDATIONS ON, YOU KNOW,

3487
02:15:38,202 --> 02:15:41,271
TRANSPARENCY BECAUSE OF THAT.

3488
02:15:41,271 --> 02:15:43,874
CAN YOU GIVE US ANY EXAMPLES OF

3489
02:15:43,874 --> 02:15:45,309
OTHER SITUATIONS IN WHICH THERE

3490
02:15:45,309 --> 02:15:48,912
WAS SOME KIND OF DEAL OR

3491
02:15:48,912 --> 02:15:51,015
ARRANGEMENT THAT RESULTED IN

3492
02:15:51,015 --> 02:15:52,549
COMPANIES ALLOWING FOR

3493
02:15:52,549 --> 02:15:54,518
TRANSPARENCY OF PROPRIETARY

3494
02:15:54,518 --> 02:15:54,718
DATA?

3495
02:15:54,718 --> 02:15:56,353
WONDERING IF THERE ARE LESSONS

3496
02:15:56,353 --> 02:15:58,889
TO BE LEARNED THERE TO EXTRACT

3497
02:15:58,889 --> 02:16:01,425
THAT INFORMATION FOR PUBLIC

3498
02:16:01,425 --> 02:16:01,692
SCRUTINY.

3499
02:16:01,692 --> 02:16:03,160
>> YEAH, THANKS FOR THAT

3500
02:16:03,160 --> 02:16:03,427
QUESTION.

3501
02:16:03,427 --> 02:16:05,362
SO I THINK THAT THE ONE EXAMPLE

3502
02:16:05,362 --> 02:16:08,399
WE'RE ALL FAMILIAR WITH IS IN

3503
02:16:08,399 --> 02:16:09,933
THE ANTIRETROVIRAL PREGNANCY

3504
02:16:09,933 --> 02:16:12,369
REGISTRY, I'M NOT FAMILIAR WITH

3505
02:16:12,369 --> 02:16:14,104
OTHER PREGNANCY REGISTRIES THAT

3506
02:16:14,104 --> 02:16:15,739
USE A SIMILAR MODEL WHERE THEY

3507
02:16:15,739 --> 02:16:16,507
SHARE THEIR DATA.

3508
02:16:16,507 --> 02:16:19,710
SO IT IS A VERY, VERY

3509
02:16:19,710 --> 02:16:22,413
COMPLICATED PROCESS BUT THE

3510
02:16:22,413 --> 02:16:23,747
ANTIRETROVIRAL PREGNANCY

3511
02:16:23,747 --> 02:16:25,182
REGISTRY FIGURED OUT A WAY TO DO

3512
02:16:25,182 --> 02:16:27,451
THIS, SO, YOU KNOW, MAYBE THAT'S

3513
02:16:27,451 --> 02:16:31,855
SOMETHING FOR THE COMMITTEE TO

3514
02:16:31,855 --> 02:16:33,290
CONSIDER, MAYBE HAVE THAT, THE

3515
02:16:33,290 --> 02:16:35,292
PERSON WHO RUNS THAT PREGNANCY

3516
02:16:35,292 --> 02:16:39,396
REGISTRY COME TALK TO THE 

3517
02:16:39,396 --> 02:16:41,598
COMMITTEE TO PROVIDE MAYBE SOME

3518
02:16:41,598 --> 02:16:42,299
RECOMMENDATIONS OR POTENTIAL

3519
02:16:42,299 --> 02:16:47,938
SOLUTIONS ON HOW THIS CAN BE

3520
02:16:47,938 --> 02:16:49,540
DONE.

3521
02:16:49,540 --> 02:16:51,008
HAPPY TO HEAR FROM OTHERS AS

3522
02:16:51,008 --> 02:16:53,844
WELL, OTHERS ON THE COMMITTEE

3523
02:16:53,844 --> 02:16:56,246
WHO HAVE EXPERIENCE WITH

3524
02:16:56,246 --> 02:16:57,347
PREGNANCY REGISTRIES, AND FROM

3525
02:16:57,347 --> 02:17:00,417
OUR INDUSTRY REPRESENTATIVES AS

3526
02:17:00,417 --> 02:17:05,889
WELL. 

3527
02:17:05,889 --> 02:17:09,693
>> JANET, YOUR HAND IS UP.

3528
02:17:09,693 --> 02:17:11,128
>> HI.

3529
02:17:11,128 --> 02:17:14,098
I WOULD LIKE TO RAISE THE POINT

3530
02:17:14,098 --> 02:17:24,775
FOLLOWING UP TO THE DISCUSSION 

3531
02:17:24,775 --> 02:17:25,676
THAT THE ANTIRETROVIRAL

3532
02:17:25,676 --> 02:17:30,180
RETROVIRAL EXAM STELLAR, WITH 20

3533
02:17:30,180 --> 02:17:31,815
YEARS OF DATA, VAST AMOUNT OF

3534
02:17:31,815 --> 02:17:34,785
DATA PROVIDING FOR MORE PRIVACY

3535
02:17:34,785 --> 02:17:37,721
AND IN TERMS OF TRANSPARENCY IF

3536
02:17:37,721 --> 02:17:40,457
YOU'RE RELEASING RESULTS EVERY

3537
02:17:40,457 --> 02:17:42,993
SIX MONTHS THERE'S SOME SAMPLE

3538
02:17:42,993 --> 02:17:44,728
SIZE TO ACTUALLY HAVE SOME

3539
02:17:44,728 --> 02:17:46,163
CONFIDENCE IN THOSE RESULTS.

3540
02:17:46,163 --> 02:17:49,433
AND THERE ARE NOT AT THIS TIME

3541
02:17:49,433 --> 02:17:52,503
TOO MANY OTHER REGISTRIES THAT

3542
02:17:52,503 --> 02:17:54,571
CAN SAFELY DO THAT, SO I THINK

3543
02:17:54,571 --> 02:17:58,642
THAT'S A GRAY AREA THAT WE

3544
02:17:58,642 --> 02:18:01,678
SHOULD BE CAREFUL ABOUT IN TERMS

3545
02:18:01,678 --> 02:18:03,447
OF MAKING RECOMMENDATIONS

3546
02:18:03,447 --> 02:18:04,748
BECAUSE WE SHOULDN'T EXPECT THAT

3547
02:18:04,748 --> 02:18:07,184
THOSE OTHER REGISTRIES ARE GOING

3548
02:18:07,184 --> 02:18:11,788
TO BE READY TO PROVIDE DATA

3549
02:18:11,788 --> 02:18:12,789
AND/OR RESULTS, GIVEN THEIR SIZE

3550
02:18:12,789 --> 02:18:22,833
AND STAGE. 

3551
02:18:22,833 --> 02:18:24,268
>> GOOD AFTERNOON.

3552
02:18:24,268 --> 02:18:25,669
THESE HAVE BEEN OUTSTANDING

3553
02:18:25,669 --> 02:18:25,903
TALKS.

3554
02:18:25,903 --> 02:18:28,739
AS SOMEONE WHO DEALS WITH ARV

3555
02:18:28,739 --> 02:18:30,274
SIDE I CAN TELL YOU WE'RE ALWAYS

3556
02:18:30,274 --> 02:18:33,110
ENTERING OUR PATIENTS INTO THE

3557
02:18:33,110 --> 02:18:34,211
ANTIRETROVIRAL REGISTRY, SO I

3558
02:18:34,211 --> 02:18:35,512
HAD A FEW QUESTIONS.

3559
02:18:35,512 --> 02:18:38,849
FIRST IS DO WE THINK ALLOWING

3560
02:18:38,849 --> 02:18:40,684
PHARMA TO DO THESE REGISTRIES

3561
02:18:40,684 --> 02:18:42,853
GIVE THEM A PASS TO DOING STUDY

3562
02:18:42,853 --> 02:18:43,320
ON THE POPULATION?

3563
02:18:43,320 --> 02:18:45,956
THAT WAS SORT OF MIGHT HAVE, YOU

3564
02:18:45,956 --> 02:18:47,491
KNOW, THINK/WORRY KIND OF THING.

3565
02:18:47,491 --> 02:18:50,894
THE OTHER IS FOR DISEASE-BASED

3566
02:18:50,894 --> 02:18:52,529
REGISTRIES, AND DEVELOPING ONE,

3567
02:18:52,529 --> 02:18:54,298
HOW IS THAT WHOLE COLLABORATION

3568
02:18:54,298 --> 02:18:57,134
BETWEEN PHARMA FOR THEIR PATENT

3569
02:18:57,134 --> 02:18:58,001
OR OFF-PATENT OR GENERIC DRUGS

3570
02:18:58,001 --> 02:19:00,837
SORT WHO HAVE IS GOING TO BE,

3571
02:19:00,837 --> 02:19:08,111
YOU KNOW, RESPONSIBLE, COLLATE

3572
02:19:08,111 --> 02:19:09,479
DATA, IT'S NOT MY DRUG ANYMORE,

3573
02:19:09,479 --> 02:19:12,149
I DON'T HAVE TO WORRY ABOUT IT.

3574
02:19:12,149 --> 02:19:14,318
ARV REGISTRY WE CAPTURE IN REAL

3575
02:19:14,318 --> 02:19:16,853
TIME NEW DRUGS BEING ADDED ALL

3576
02:19:16,853 --> 02:19:20,257
THE TIME BUT FOR THE CARDIOLOGY

3577
02:19:20,257 --> 02:19:23,093
TYPE OR NEUROTYPE REGISTRIES

3578
02:19:23,093 --> 02:19:24,428
THOSE ARE GENERIC DRUGS, HOW DO

3579
02:19:24,428 --> 02:19:34,905
WE GET OUR HANDS NDS AROUND

3580
02:19:38,709 --> 02:19:38,842
THAT?

3581
02:19:38,842 --> 02:19:40,477
>> SHARON IS ASKING A
GREAT

3582
02:19:40,477 --> 02:19:41,578
QUESTION, SHOULD BE ASKING OTHER

3583
02:19:41,578 --> 02:19:44,314
INDUSTRY RENTS  --

3584
02:19:44,314 --> 02:19:50,988
REPRESENTATIVES IF THEY WOULD 

3585
02:19:50,988 --> 02:19:54,391
LIKE TO SPEAK. 

3586
02:19:54,391 --> 02:19:56,593
>> IT'S QUIET OUT THERE.

3587
02:19:56,593 --> 02:20:00,230
>> I'M GOING TO STEP
OUTSIDE TO

3588
02:20:00,230 --> 02:20:01,798
THE CONVERSATION.

3589
02:20:01,798 --> 02:20:03,367
I THINK SHARON, YOU'RE ASKING

3590
02:20:03,367 --> 02:20:06,436
THE QUESTION THAT IS A VERY

3591
02:20:06,436 --> 02:20:09,706
APPROPRIATE QUESTION TO FOLLOW

3592
02:20:09,706 --> 02:20:11,008
FROM LEYLA'S COMMENT.

3593
02:20:11,008 --> 02:20:12,776
THE REALITY, IT'S NOT A SINGLE

3594
02:20:12,776 --> 02:20:14,511
STAKEHOLDER WHO NEEDS TO DO

3595
02:20:14,511 --> 02:20:16,480
THIS.

3596
02:20:16,480 --> 02:20:18,682
THIS IS A TRUE PUBLIC/PRIVATE

3597
02:20:18,682 --> 02:20:19,216
PARTNERSHIP OF RELEVANT

3598
02:20:19,216 --> 02:20:21,718
STAKEHOLDERS TO UNDERSTAND WHAT

3599
02:20:21,718 --> 02:20:22,986
THE NEED IS FOR THE DATA

3600
02:20:22,986 --> 02:20:24,721
COLLECTION, TO UNDERSTAND WHERE

3601
02:20:24,721 --> 02:20:27,157
THE PRIORITIES LIE, AND THEN TO

3602
02:20:27,157 --> 02:20:29,693
ENSURE JUST AS YOU'VE SAID WHAT

3603
02:20:29,693 --> 02:20:31,662
IS THE SAFE HARBOR FOR DATA

3604
02:20:31,662 --> 02:20:33,530
COLLECTION, DATA ANALYSIS, AND

3605
02:20:33,530 --> 02:20:35,065
THE SUSTAINABILITY INTO THE

3606
02:20:35,065 --> 02:20:37,601
FUTURE, SO I THINK IT'S A REALLY

3607
02:20:37,601 --> 02:20:39,536
IMPORTANT QUESTION, A VERY

3608
02:20:39,536 --> 02:20:41,505
RELEVANT SET OF QUESTIONS, AND I

3609
02:20:41,505 --> 02:20:42,939
THINK THIS IS PART OF THE

3610
02:20:42,939 --> 02:20:44,141
DISCUSSION THAT WE NEED TO THINK

3611
02:20:44,141 --> 02:20:46,209
ABOUT HOW DO WE WRITE THAT TO

3612
02:20:46,209 --> 02:20:48,945
CONGRESS WHAT'S NEEDED TO ENSURE

3613
02:20:48,945 --> 02:20:51,882
THAT WE CAN PROPERLY IMPLEMENT

3614
02:20:51,882 --> 02:20:52,816
THIS RECOMMENDATION.

3615
02:20:52,816 --> 02:20:54,751
>> I WAS THINKING THAT YOU
WERE

3616
02:20:54,751 --> 02:20:58,255
GOING TO GO BACK TO THE EARLIER

3617
02:20:58,255 --> 02:21:00,223
TODAY DIALOGUES ABOUT IF WE'RE

3618
02:21:00,223 --> 02:21:02,392
LOOKING AT THIS LARGE DATABASES

3619
02:21:02,392 --> 02:21:05,562
AND WE CAN CRITIQUE IT ON DRUGS

3620
02:21:05,562 --> 02:21:07,197
USED, OR CONDITIONS FOR DRUGS

3621
02:21:07,197 --> 02:21:10,834
USED, THAT WOULD BE KIND OF THE

3622
02:21:10,834 --> 02:21:14,871
NEXT LOW-HANGING FRUIT BIG STEP.

3623
02:21:14,871 --> 02:21:16,840
YOU KNOW, IF IT'S CARDIOLOGY

3624
02:21:16,840 --> 02:21:17,541
DRUGS OR NEURO-SEIZURE DRUGS,

3625
02:21:17,541 --> 02:21:20,577
AND THOSE ARE THE BIG BUCKET OF

3626
02:21:20,577 --> 02:21:21,545
DRUGS GIVEN TO PREGNANT

3627
02:21:21,545 --> 02:21:23,847
POPULATIONS, IS THAT THE NEXT

3628
02:21:23,847 --> 02:21:27,150
REGISTRY THAT WE WANT TO DO?

3629
02:21:27,150 --> 02:21:29,453
AND AMONGST THAT REGISTRY WHAT

3630
02:21:29,453 --> 02:21:31,822
ARE THE DRUGS, PATENT OR

3631
02:21:31,822 --> 02:21:32,756
OFF-PATENT THAT WE NEED TO

3632
02:21:32,756 --> 02:21:33,390
INVESTIGATE?

3633
02:21:33,390 --> 02:21:34,958
I DON'T THINK WE CAN DO THIS FOR

3634
02:21:34,958 --> 02:21:35,992
ALL THINGS.

3635
02:21:35,992 --> 02:21:38,729
I THINK THERE ARE ORPHAN

3636
02:21:38,729 --> 02:21:40,597
DISEASES, NOT ORPHAN DISEASES, I

3637
02:21:40,597 --> 02:21:42,699
DON'T WANT TO SAY HIV IS AN

3638
02:21:42,699 --> 02:21:44,101
ORPHAN DISEASE OR NOT BUT THERE

3639
02:21:44,101 --> 02:21:46,737
ARE FROM THE DATABASES THAT YOU

3640
02:21:46,737 --> 02:21:50,540
GUYS TALKED ABOUT EARLIER BIGGER

3641
02:21:50,540 --> 02:21:52,943
DISEASE CATEGORIES OR BIGGER

3642
02:21:52,943 --> 02:21:53,710
DRUGS/DISEASE CATEGORIES.

3643
02:21:53,710 --> 02:21:55,479
WHY IS IT WE CAN'T DO ANOTHER

3644
02:21:55,479 --> 02:21:56,913
PILOT PROJECT SIMILAR TO WHAT

3645
02:21:56,913 --> 02:21:59,316
YOU HAVE BEEN TALKING ABOUT, TO

3646
02:21:59,316 --> 02:22:00,183
SAY WHAT'S THE BIG DISEASE

3647
02:22:00,183 --> 02:22:02,819
CATEGORY, WHAT ARE THE DRUGS

3648
02:22:02,819 --> 02:22:03,820
INCLUDED IN THAT DISEASE

3649
02:22:03,820 --> 02:22:06,323
CATEGORY, THAT'S OUR NEXT STEP

3650
02:22:06,323 --> 02:22:07,891
ON THESE DATABASES.

3651
02:22:07,891 --> 02:22:09,526
YOU KNOW, PERHAPS I'M NOT IN THE

3652
02:22:09,526 --> 02:22:11,495
RIGHT SPACE.

3653
02:22:11,495 --> 02:22:13,029
>> SO THIS IS TRISH.

3654
02:22:13,029 --> 02:22:15,098
I CAN JUMP IN ON A FEW POINTS.

3655
02:22:15,098 --> 02:22:16,933
I THINK ONE OF THE QUESTIONS YOU

3656
02:22:16,933 --> 02:22:20,871
HAD ASKED WAS ABOUT SORT OF IF

3657
02:22:20,871 --> 02:22:21,972
COMPANIES DOING REGISTRY-BASED

3658
02:22:21,972 --> 02:22:23,373
STUDIES PASS ON A POPULATION

3659
02:22:23,373 --> 02:22:27,544
BASED STUDY AND I THINK LEYLA

3660
02:22:27,544 --> 02:22:29,312
CAN CORRECT ME, IN GUIDANCE THEY

3661
02:22:29,312 --> 02:22:31,381
RECOMMEND TWO TYPES, ONE BEING

3662
02:22:31,381 --> 02:22:32,549
REGISTRY, ONE BEING POPULATION

3663
02:22:32,549 --> 02:22:32,749
BASED.

3664
02:22:32,749 --> 02:22:34,885
I THINK THAT'S HAPPENING IN

3665
02:22:34,885 --> 02:22:35,152
PARALLEL.

3666
02:22:35,152 --> 02:22:37,087
ANOTHER QUESTION YOU HAD ABOUT

3667
02:22:37,087 --> 02:22:38,722
THE GENERICS, WE CAN AND DO DO

3668
02:22:38,722 --> 02:22:39,156
THAT IN SENTINEL.

3669
02:22:39,156 --> 02:22:44,394
I DON'T THINK WE'VE DONE  IT IN

3670
02:22:44,394 --> 02:22:46,396
PREGNANCY SAFETY BUT WE LOOK AT

3671
02:22:46,396 --> 02:22:46,963
GENERICS, IT DEPENDS ON THE

3672
02:22:46,963 --> 02:22:48,365
QUESTION BECAUSE IF WE LOOK AT

3673
02:22:48,365 --> 02:22:50,100
CLASS, WE'LL TAKE ALL THE DRUGS

3674
02:22:50,100 --> 02:22:52,736
AND FIND OUT WHAT THEY ARE.

3675
02:22:52,736 --> 02:22:53,937
SO DISEASE-BASED, THAT'S ONE OF

3676
02:22:53,937 --> 02:22:56,440
THE THINGS WE'VE BEEN THINKING

3677
02:22:56,440 --> 02:22:57,207
ABOUT DOING.

3678
02:22:57,207 --> 02:22:58,608
WE HAVE A COUPLE SORT OF AREAS

3679
02:22:58,608 --> 02:23:03,346
THAT WE LOOK AT IN DATABASES,

3680
02:23:03,346 --> 02:23:04,347
BUT BECAUSE OUR --

3681
02:23:04,347 --> 02:23:06,316
WHAT WE'VE BEEN LOOKING AT IS

3682
02:23:06,316 --> 02:23:08,251
THERE'S A SPECIFIC REGULATORY

3683
02:23:08,251 --> 02:23:10,253
QUESTION WE'RE BEING ASKED

3684
02:23:10,253 --> 02:23:11,455
ABOUT, OFTEN NECESSARILY CUT IN

3685
02:23:11,455 --> 02:23:13,990
THE CATEGORY OF THE DISEASE, BUT

3686
02:23:13,990 --> 02:23:14,958
DEPENDING WHAT THE QUESTION IS

3687
02:23:14,958 --> 02:23:17,694
WE MAY OR MAY NOT BE ABLE TO DO

3688
02:23:17,694 --> 02:23:18,829
THAT.

3689
02:23:18,829 --> 02:23:23,099
>> THANK YOU, TRISH.

3690
02:23:23,099 --> 02:23:24,835
SO, WHAT ABOUT LACTATION, IN THE

3691
02:23:24,835 --> 02:23:25,168
CHAT?

3692
02:23:25,168 --> 02:23:26,470
FROM THE THREE OF YOUR

3693
02:23:26,470 --> 02:23:29,306
PRESENTATIONS ARE YOU ABLE TO

3694
02:23:29,306 --> 02:23:31,408
GIVE SOME INSIGHTS INTO SIMILAR

3695
02:23:31,408 --> 02:23:32,943
QUESTIONS THAT COME REGARDING

3696
02:23:32,943 --> 02:23:36,246
HOW TO GENERATE THAT INFORMATION

3697
02:23:36,246 --> 02:23:38,782
FOR LACTATION?

3698
02:23:38,782 --> 02:23:39,950
>> THIS IS EMMA.

3699
02:23:39,950 --> 02:23:41,685
I ALSO CAN'T FIGURE OUT HOW TO

3700
02:23:41,685 --> 02:23:43,453
GET THE VIDEO WORKING SO I

3701
02:23:43,453 --> 02:23:44,554
APOLOGIZE FOR THAT.

3702
02:23:44,554 --> 02:23:49,059
WHEN I WAS LISTENING TO THESE

3703
02:23:49,059 --> 02:23:50,126
CONDITION DATABASE THINGS, THE

3704
02:23:50,126 --> 02:23:53,096
ONE THAT STRUCK ME AS BEING A

3705
02:23:53,096 --> 02:23:55,065
VERY COMMON PROBLEM WOULD BE NEW

3706
02:23:55,065 --> 02:23:58,201
DISORDERS IN THE POSTPARTUM

3707
02:23:58,201 --> 02:24:01,738
PERIOD AND SAFETY OF USING THOSE

3708
02:24:01,738 --> 02:24:03,273
MEDICATIONS, A COMMON CLINICAL

3709
02:24:03,273 --> 02:24:03,807
CONCERN.

3710
02:24:03,807 --> 02:24:05,675
I WAS CURIOUS SPECIFIC TO

3711
02:24:05,675 --> 02:24:05,942
LACTATION.

3712
02:24:05,942 --> 02:24:07,544
THANK YOU.

3713
02:24:07,544 --> 02:24:10,914
>> NO WORRIES.

3714
02:24:10,914 --> 02:24:12,883
>> I WANT TO CHIME IN TO
SAY

3715
02:24:12,883 --> 02:24:16,620
WHEN I MET WITH SUE AND EMMA,

3716
02:24:16,620 --> 02:24:19,155
THE FACT WE HADN'T INCLUDED

3717
02:24:19,155 --> 02:24:22,893
LACTATION IN THE DATASET WAS

3718
02:24:22,893 --> 02:24:23,159
APPARENT.

3719
02:24:23,159 --> 02:24:24,194
SO, WE HAVEN'T PUT -- THAT WAS

3720
02:24:24,194 --> 02:24:28,899
JUST A FEW WEEKS AGO.

3721
02:24:28,899 --> 02:24:31,635
WE HAVEN'T PUT ANY NEW DATA

3722
02:24:31,635 --> 02:24:33,069
ELEMENTS IN USCDI YET BUT ARE

3723
02:24:33,069 --> 02:24:35,672
HAPPY TO WORK WITH SUBJECT

3724
02:24:35,672 --> 02:24:36,773
MATTER EXPERTS ON WORKING THAT

3725
02:24:36,773 --> 02:24:37,007
IN.

3726
02:24:37,007 --> 02:24:40,377
AS FAR AS FHIR GOES, AS EXCHANGE

3727
02:24:40,377 --> 02:24:44,014
AND STANDARD, THERE ARE WAYS OF

3728
02:24:44,014 --> 02:24:45,982
INCLUDING LACTATION DATA FOR

3729
02:24:45,982 --> 02:24:47,517
EXCHANGE, SO THE CAPABILITIES

3730
02:24:47,517 --> 02:24:48,752
ARE PROFILED IN THE FHIR

3731
02:24:48,752 --> 02:24:52,022
RESOURCES. 

3732
02:24:52,022 --> 02:24:54,124
>> THANK YOU, STEPHANIE.

3733
02:24:54,124 --> 02:24:56,092
TRISH OR LEYLA, ANYTHING TO ADD?

3734
02:24:56,092 --> 02:24:57,193
>> SURE.

3735
02:24:57,193 --> 02:25:00,497
FDA ALSO HAS AUTHORITIES TO

3736
02:25:00,497 --> 02:25:02,132
ISSUE POSTPARTUM REQUIREMENTS

3737
02:25:02,132 --> 02:25:04,634
FOR LACTATION STUDIES, SO THAT'S

3738
02:25:04,634 --> 02:25:08,171
AN ACTIVE AREA FDA IS INVOLVED

3739
02:25:08,171 --> 02:25:10,907
IN TRYING TO FURTHER ADVANCE.

3740
02:25:10,907 --> 02:25:13,743
FDA'S PREGNANCY REGISTRY WEBSITE

3741
02:25:13,743 --> 02:25:16,546
WILL ALSO SOON BE LAUNCHING AN

3742
02:25:16,546 --> 02:25:20,650
ADDITIONAL WEBSITE THAT WILL BE

3743
02:25:20,650 --> 02:25:23,153
LISTING ALL LACTATION STUDIES

3744
02:25:23,153 --> 02:25:27,357
THAT FDA ISSUED AS

3745
02:25:27,357 --> 02:25:28,992
POST-MARKETING REQUIREMENTS, SO

3746
02:25:28,992 --> 02:25:30,193
THAT CONSUMERS, HEALTHCARE

3747
02:25:30,193 --> 02:25:32,028
PROVIDERS AND PATIENTS ARE AWARE

3748
02:25:32,028 --> 02:25:33,897
OF LACTATION STUDIES THAT ARE

3749
02:25:33,897 --> 02:25:34,931
ACTIVE AND ENROLLING PATIENTS

3750
02:25:34,931 --> 02:25:39,903
INTO THEIR STUDY. 

3751
02:25:39,903 --> 02:25:42,772
>> THANK YOU, LEYLA.

3752
02:25:42,772 --> 02:25:45,075
TRISH, ANYTHING TO ADD?

3753
02:25:45,075 --> 02:25:47,243
>> NO, I WOULD SAY LARGE

3754
02:25:47,243 --> 02:25:50,547
DATABASES IN GENERAL WHERE WE'RE

3755
02:25:50,547 --> 02:25:53,283
USING DATA FROM INSURANCE CLAIMS

3756
02:25:53,283 --> 02:25:54,184
DON'T CAPTURE LACTATION DATA

3757
02:25:54,184 --> 02:25:54,718
WELL.

3758
02:25:54,718 --> 02:25:59,089
ONE MIGHT BE ABLE TO LOOK FOR A

3759
02:25:59,089 --> 02:26:01,958
WHERE SOMEBODY GOT A PUMP, IN

3760
02:26:01,958 --> 02:26:04,894
THEORY, LET'S NARROW DOWN TO THE

3761
02:26:04,894 --> 02:26:06,329
SUBSET WHERE THEY USED CLAIMS

3762
02:26:06,329 --> 02:26:09,065
INSURANCE IN PUMPING BUT MY

3763
02:26:09,065 --> 02:26:09,833
CONCERN, AS AN EPIDEMIOLOGIST,

3764
02:26:09,833 --> 02:26:10,400
WHAT ARE YOU MISSING?

3765
02:26:10,400 --> 02:26:12,902
I DON'T THINK IT'S THE BEST

3766
02:26:12,902 --> 02:26:15,338
RESOURCE OR BEST APPROACH WITH

3767
02:26:15,338 --> 02:26:16,106
LACTATION STUDIES.

3768
02:26:16,106 --> 02:26:17,173
>> THANK YOU.

3769
02:26:17,173 --> 02:26:23,513
AND THERE'S A QUESTION IN THE 

3770
02:26:23,513 --> 02:26:24,714
CHAT REGARDING FDA ENGAGEMENT,

3771
02:26:24,714 --> 02:26:27,784
IF YOU WANT TO EXPAND ON YOUR

3772
02:26:27,784 --> 02:26:28,451
COMMENT OR QUESTION.

3773
02:26:28,451 --> 02:26:38,828
>> YES, THANK YOU TO THE

3774
02:26:38,828 --> 02:26:39,095
SPEAKERS.

3775
02:26:39,095 --> 02:26:41,164
I JUST HAD THE RECOMMENDATION

3776
02:26:41,164 --> 02:26:44,734
13, TO FACILITATE ACCESS TO DATA

3777
02:26:44,734 --> 02:26:45,969
AND TRANSPARENCY OF REGISTRIES,

3778
02:26:45,969 --> 02:26:49,673
THE SUGGESTION FROM THE ORIGINAL

3779
02:26:49,673 --> 02:26:53,710
PRGLAC IS TO USE THE ART

3780
02:26:53,710 --> 02:26:55,578
REGISTRY BUT I FEEL CLINICALLY

3781
02:26:55,578 --> 02:27:00,617
WHAT'S  MOST COMMON PEOPLE ARE

3782
02:27:00,617 --> 02:27:02,018
USING INFORMATION TO GUIDE

3783
02:27:02,018 --> 02:27:04,220
MEDICATION USE IN PREGNANCY, THE

3784
02:27:04,220 --> 02:27:14,664
NON-PROFIT HAS EMERGED AS 

3785
02:27:15,765 --> 02:27:16,800
EMERGED AS PRINCIPAL SOURCE.

3786
02:27:16,800 --> 02:27:20,970
IT SEEMS LIKE I WAS EXCITED TO

3787
02:27:20,970 --> 02:27:24,040
SEE THIS, RECOMMENDATION 13,

3788
02:27:24,040 --> 02:27:25,275
CURIOUS TO HAVE SPEAKERS COMMENT

3789
02:27:25,275 --> 02:27:27,210
ON POTENTIAL PARTNERSHIP OR IF

3790
02:27:27,210 --> 02:27:28,845
ONE ALREADY EXISTS.

3791
02:27:28,845 --> 02:27:29,579
THANK YOU.

3792
02:27:29,579 --> 02:27:33,983
>> I CAN START.

3793
02:27:33,983 --> 02:27:39,122
SO, WE ARE VERY AWARE BUT WE

3794
02:27:39,122 --> 02:27:41,991
DON'T ACTIVELY ENGAGE IN

3795
02:27:41,991 --> 02:27:42,292
DISCUSSIONS.

3796
02:27:42,292 --> 02:27:46,596
I MEAN, WE ATTEND ALL THE PDRP

3797
02:27:46,596 --> 02:27:53,169
MEETINGS AND HAVE INTERACTIONS

3798
02:27:53,169 --> 02:27:56,573
WITH THE REPERTOX STAFF AND

3799
02:27:56,573 --> 02:27:57,006
MEMBERS.

3800
02:27:57,006 --> 02:27:59,609
THE DATA, YOU KNOW, THE DATA

3801
02:27:59,609 --> 02:28:02,779
OWNED BY THE MANUFACTURERS SO

3802
02:28:02,779 --> 02:28:05,715
MAYBE THAT'S A CONSIDERATION TO

3803
02:28:05,715 --> 02:28:08,618
ENGAGE WITH MANUFACTURERS AS

3804
02:28:08,618 --> 02:28:10,887
WELL, BUT HAPPY TO ALSO CONSIDER

3805
02:28:10,887 --> 02:28:21,431
THE IDEA OF FURTHER ENGAGEMENT 

3806
02:28:21,831 --> 02:28:25,535
AND DISCUSSION WITH REPERTOX.

3807
02:28:25,535 --> 02:28:26,469
>> ANYTHING TO ADD?

3808
02:28:26,469 --> 02:28:27,270
>> NOTHING TO ADD.

3809
02:28:27,270 --> 02:28:29,939
>> TINA, YOU HAVE A HAND
UP?

3810
02:28:29,939 --> 02:28:31,674
>> THANK YOU.

3811
02:28:31,674 --> 02:28:34,043
TO AGREE WITH TRISH, I'M NOT

3812
02:28:34,043 --> 02:28:36,880
SURE HOW USEFUL LARGE DATA WOULD

3813
02:28:36,880 --> 02:28:39,482
BE FOR LACTATION STUDIES, OR HOW

3814
02:28:39,482 --> 02:28:42,719
MEANINGFUL THE DATA WOULD BE

3815
02:28:42,719 --> 02:28:44,120
GIVEN THE LARGE VARIABILITY ONE

3816
02:28:44,120 --> 02:28:45,855
WOMAN MAY HAVE IN OTHER

3817
02:28:45,855 --> 02:28:48,391
LACTATION PRACTICES OVER A SHORT

3818
02:28:48,391 --> 02:28:52,428
PERIOD OF TIME WOULD BE HARD TO

3819
02:28:52,428 --> 02:28:54,297
CAPTURE, OVER TO LEYLA YOU

3820
02:28:54,297 --> 02:29:00,436
MENTION ED FDA HAS AUTHORITY FOR

3821
02:29:00,436 --> 02:29:04,908
LACTATION STUDIES, COULD THAT BE

3822
02:29:04,908 --> 02:29:11,247
TIED INTO REGISTRIES FOR

3823
02:29:11,247 --> 02:29:13,550
EXPOSURE, MORE LACTATION

3824
02:29:13,550 --> 02:29:13,883
CAPTURED DATA?

3825
02:29:13,883 --> 02:29:14,184
THANK YOU.

3826
02:29:14,184 --> 02:29:18,154
>> YES, THANK YOU FOR THAT

3827
02:29:18,154 --> 02:29:20,456
SUGGESTION, JANET.

3828
02:29:20,456 --> 02:29:22,192
YES, WE'RE LOOKING INTO THAT.

3829
02:29:22,192 --> 02:29:25,662
YES, ALL OF THESE DISCUSSIONS GO

3830
02:29:25,662 --> 02:29:29,432
ON DURING THE REVIEW OF THE NDA

3831
02:29:29,432 --> 02:29:30,767
AND SO THAT'S SOMETHING THAT

3832
02:29:30,767 --> 02:29:34,137
WE'RE DISCUSSING.

3833
02:29:34,137 --> 02:29:34,604
THANKS.

3834
02:29:34,604 --> 02:29:37,841
>> THANK YOU.

3835
02:29:37,841 --> 02:29:43,313
AND A QUESTION IN THE CHAT, IF

3836
02:29:43,313 --> 02:29:46,182
YOU WANT TO COME OFF CAMERA AND

3837
02:29:46,182 --> 02:29:46,349
ASK.

3838
02:29:46,349 --> 02:29:47,984
>> I WANTED TO KNOW, I
THINK

3839
02:29:47,984 --> 02:29:50,486
I'VE PROBABLY ASKED THIS BEFORE,

3840
02:29:50,486 --> 02:29:52,222
BUT ONE OF THE CHALLENGES WE

3841
02:29:52,222 --> 02:29:54,858
FOUND MANY YEARS AGO NOW,

3842
02:29:54,858 --> 02:29:56,292
PROBABLY TEN YEARS AGO, ACCESS

3843
02:29:56,292 --> 02:29:58,795
TO GOOD DATA FROM THE

3844
02:29:58,795 --> 02:29:59,229
REGISTRIES.

3845
02:29:59,229 --> 02:30:01,331
SO JUST THINKING ABOUT HOW TO

3846
02:30:01,331 --> 02:30:03,833
MAKE THAT AS EASY AS POSSIBLE

3847
02:30:03,833 --> 02:30:05,068
FOR CLINICIANS AND PATIENTS WHO

3848
02:30:05,068 --> 02:30:08,238
MIGHT NEED TO ENGAGE IN SHARED

3849
02:30:08,238 --> 02:30:09,072
DECISION MAKING.

3850
02:30:09,072 --> 02:30:10,707
IT'S GREAT TO HAVE THE

3851
02:30:10,707 --> 02:30:11,841
INFORMATION IN ONE PLACE, I

3852
02:30:11,841 --> 02:30:13,610
STILL THINK I HAVE SOME CONCERNS

3853
02:30:13,610 --> 02:30:15,311
ABOUT HOW EASY IT IS TO ACCESS

3854
02:30:15,311 --> 02:30:19,482
SOME OF THAT DATA JUST GIVEN

3855
02:30:19,482 --> 02:30:21,017
IT'S NOT NECESSARILY OWNED, YOU

3856
02:30:21,017 --> 02:30:24,520
KNOW, BY FDA OR IS PUBLICLY

3857
02:30:24,520 --> 02:30:25,088
AVAILABLE NECESSARILY, IT'S

3858
02:30:25,088 --> 02:30:28,758
REALLY UP TO THE DRUG SPONSORS.

3859
02:30:28,758 --> 02:30:31,427
 

3860
02:30:31,427 --> 02:30:35,231
>> I THINK IT'S PROBABLY
MORE OF

3861
02:30:35,231 --> 02:30:39,135
A COMMENT THAN A QUESTION,

3862
02:30:39,135 --> 02:30:39,335
KATIE.

3863
02:30:39,335 --> 02:30:39,802
>> SURE IS.

3864
02:30:39,802 --> 02:30:43,139
>> ONE WE SHOULD CONTINUE
TO

3865
02:30:43,139 --> 02:30:47,744
DISCUSS WITHIN THE WORKING

3866
02:30:47,744 --> 02:30:49,379
GROUP, THE ISSUE THAT COULD

3867
02:30:49,379 --> 02:30:50,613
POTENTIALLY BE ADDRESSED BACK TO

3868
02:30:50,613 --> 02:30:52,048
CONGRESS ABOUT THE ACCESSIBILITY

3869
02:30:52,048 --> 02:30:54,784
OF THAT INFORMATION, YES.

3870
02:30:54,784 --> 02:30:55,885
VERY GOOD.

3871
02:30:55,885 --> 02:30:56,853
I SHARON, ATHINK WE ADDRESSED

3872
02:30:56,853 --> 02:30:58,488
YOUR QUESTION IN THE CHAT.

3873
02:30:58,488 --> 02:31:03,760
AND JULIE HAD A COMMENT

3874
02:31:03,760 --> 02:31:04,727
REGARDING COUNSELING PROGRAMS AS

3875
02:31:04,727 --> 02:31:06,262
A DATA POINT FOR LACTATION.

3876
02:31:06,262 --> 02:31:08,398
DO YOU WANT TO EXPAND ON THAT?

3877
02:31:08,398 --> 02:31:08,998
>> SURE.

3878
02:31:08,998 --> 02:31:16,973
LET ME GET MYSELF ON CAMERA TOO.

3879
02:31:16,973 --> 02:31:17,106
 

3880
02:31:17,106 --> 02:31:19,175
ACTUALLY, I ADDED A THOUGHT TO

3881
02:31:19,175 --> 02:31:20,910
THAT, JUST AS EVERYONE KEEPS

3882
02:31:20,910 --> 02:31:22,879
TALKING ABOUT HOW DIFFICULT IT

3883
02:31:22,879 --> 02:31:27,150
IS TO GET LACTATION DATA POINTS,

3884
02:31:27,150 --> 02:31:31,321
THE PEER COUNSELING PROGRAM, IF

3885
02:31:31,321 --> 02:31:32,488
WE'RE TALKING ABOUT MEDICATION,

3886
02:31:32,488 --> 02:31:34,691
THE DIETITIAN OR NURSE

3887
02:31:34,691 --> 02:31:39,729
PRACTITIONER ON STAFF OR DOCTOR,

3888
02:31:39,729 --> 02:31:41,931
BUT WIC, THE NETWORK IS NOT

3889
02:31:41,931 --> 02:31:42,999
NECESSARILY AS INTEGRATED AS

3890
02:31:42,999 --> 02:31:44,000
LET'S SAY A HOSPITAL SYSTEM

3891
02:31:44,000 --> 02:31:49,472
WOULD BE OR MAYBE LIKE A LARGE

3892
02:31:49,472 --> 02:31:51,441
SYSTEM, MORE INTEGRATED, EXCUSE

3893
02:31:51,441 --> 02:31:53,743
ME, OR LIKE A LARGE SYSTEM LIKE

3894
02:31:53,743 --> 02:31:54,210
KAISER.

3895
02:31:54,210 --> 02:32:02,919
ANOTHER THOUGHT I HAD AS WELL IS

3896
02:32:02,919 --> 02:32:05,688
POSSIBLY USING LactMed AS A

3897
02:32:05,688 --> 02:32:08,091
WAY TO GATHER DATA.

3898
02:32:08,091 --> 02:32:10,293
IN OTHER WORDS, IF THE ISSUE IS

3899
02:32:10,293 --> 02:32:13,997
TRYING TO FIGURE OUT THE 

3900
02:32:13,997 --> 02:32:15,198
LACTATION, WHO IS LACTATING, AND

3901
02:32:15,198 --> 02:32:16,632
WHEN, YOU MIGHT NOT BE ABLE TO

3902
02:32:16,632 --> 02:32:18,935
GATHER ALL OF THAT DATA BUT

3903
02:32:18,935 --> 02:32:20,670
COULD POSSIBLY GATHER DATA ON

3904
02:32:20,670 --> 02:32:22,305
HITS ON IT, IF THERE WAS LIKE A

3905
02:32:22,305 --> 02:32:29,212
LINK OR SOMETHING LIKE THAT, IF

3906
02:32:29,212 --> 02:32:30,947
A PRACTITIONER CLICKED THE LINK

3907
02:32:30,947 --> 02:32:32,548
TO REGISTER THEY LOOKED AT THIS

3908
02:32:32,548 --> 02:32:33,316
DRUG FOR A PATIENT.

3909
02:32:33,316 --> 02:32:35,451
I'M NOT A TECH PERSON.

3910
02:32:35,451 --> 02:32:37,653
MIGHT BE SOMETHING THAT INVOLVED

3911
02:32:37,653 --> 02:32:39,188
SOMETHING VERY TECHY, THE NIH IS

3912
02:32:39,188 --> 02:32:40,723
JUST ABOUT WORK, BUT IT IS A

3913
02:32:40,723 --> 02:32:46,529
THOUGHT BECAUSE IN LACTATION

3914
02:32:46,529 --> 02:32:47,630
CIRCUMSTANCES ALSO WE USE

3915
02:32:47,630 --> 02:32:50,900
LACTOBACILLUS  -- LactMed

3916
02:32:50,900 --> 02:32:51,467
THIS WEEK.

3917
02:32:51,467 --> 02:32:53,102
IF YOU LOOKED UP THIS DRUG CAN

3918
02:32:53,102 --> 02:32:55,038
YOU CLICK THIS AND PUT IN A FORM

3919
02:32:55,038 --> 02:32:59,542
HOW OLD IS THE BABY, IT MIGHT BE

3920
02:32:59,542 --> 02:33:04,013
ONE WAY TO GATHER INFORMATION.

3921
02:33:04,013 --> 02:33:05,014
>> THANK YOU, JULIE.

3922
02:33:05,014 --> 02:33:06,649
WE CAN PROBABLY HAVE MORE

3923
02:33:06,649 --> 02:33:07,283
DISCUSSION AROUND JULIE'S

3924
02:33:07,283 --> 02:33:10,820
COMMENT WHEN WE HAVE THE OPEN

3925
02:33:10,820 --> 02:33:11,220
SESSION FOLLOWING.

3926
02:33:11,220 --> 02:33:14,390
AND I SEE ONE MORE COMMENT IN

3927
02:33:14,390 --> 02:33:14,857
THE CHAT.

3928
02:33:14,857 --> 02:33:16,959
WOULD YOU LIKE TO COMMENT OFF

3929
02:33:16,959 --> 02:33:20,663
CAMERA AND ASK YOUR QUESTION?

3930
02:33:20,663 --> 02:33:22,532
 

3931
02:33:22,532 --> 02:33:24,700
IF NOT I'LL READ IT.

3932
02:33:24,700 --> 02:33:28,237
IS THERE A VALUE SUGGESTING

3933
02:33:28,237 --> 02:33:32,608
OTHER RESOURCES TO INVESTIGATE 

3934
02:33:32,608 --> 02:33:36,312
DATA HARMONIZATION FOR DATA

3935
02:33:36,312 --> 02:33:36,979
PREGNANCY RESEARCH.

3936
02:33:36,979 --> 02:33:37,346
THERE YOU ARE.

3937
02:33:37,346 --> 02:33:41,117
>> I'M GETTING TO MY
BUTTONS NOT

3938
02:33:41,117 --> 02:33:41,751
QUICKLY ENOUGH.

3939
02:33:41,751 --> 02:33:44,020
I THINK I WAS REFERRING TO ONE

3940
02:33:44,020 --> 02:33:45,788
OF THE EARLIER SPEAKERS THAT WAS

3941
02:33:45,788 --> 02:33:49,826
JUST TALKING ABOUT THE WHOLE

3942
02:33:49,826 --> 02:33:53,563
DATA HARMONIZATION PROCESS.

3943
02:33:53,563 --> 02:33:55,998
AND JUST WONDERING IF THERE IS A

3944
02:33:55,998 --> 02:33:58,267
VALUE TO CONNECTING WITH SOME

3945
02:33:58,267 --> 02:33:59,669
OTHER DATA HARMONIZATION WORK

3946
02:33:59,669 --> 02:34:02,205
THAT'S HAPPENED IN THE PREGNANCY

3947
02:34:02,205 --> 02:34:03,606
SPACE, PREGNANCY RESEARCH

3948
02:34:03,606 --> 02:34:03,940
SPECIFICALLY.

3949
02:34:03,940 --> 02:34:08,544
I'M PART OF A GLOBAL CONSORTIUM

3950
02:34:08,544 --> 02:34:12,148
THAT DEVELOPED A COMMON DATA

3951
02:34:12,148 --> 02:34:13,649
DICTIONARY FOR PREGNANCY

3952
02:34:13,649 --> 02:34:17,687
RESEARCH, STARTED OFF 

3953
02:34:17,687 --> 02:34:18,855
SPECIFICALLY TO PREECLAMPSIA BUT

3954
02:34:18,855 --> 02:34:19,856
EXPANDED TO COVER OTHER

3955
02:34:19,856 --> 02:34:21,624
PREGNANCY THINGS AND THAT MAKES

3956
02:34:21,624 --> 02:34:28,831
ME THINK ABOUT THE  MULTITUDE OF

3957
02:34:28,831 --> 02:34:29,799
PATIENT-DRIVEN REGISTRIES.

3958
02:34:29,799 --> 02:34:33,402
WE USE THE WORD REGISTRY TO

3959
02:34:33,402 --> 02:34:36,172
IMPLY IT IS OFTEN ONE THAT IS

3960
02:34:36,172 --> 02:34:38,808
HOSTED BY, LET'S SAY, A DRUG

3961
02:34:38,808 --> 02:34:42,879
MANUFACTURER OR SOMEBODY TO

3962
02:34:42,879 --> 02:34:44,380
CAPTURE POST MARKET DATA BUT

3963
02:34:44,380 --> 02:34:46,682
THERE ARE A HOST OF PATIENT

3964
02:34:46,682 --> 02:34:48,451
REGISTRIES AND I'M WONDERING IF

3965
02:34:48,451 --> 02:34:50,720
THERE'S ANY VALUE IN SORT OF

3966
02:34:50,720 --> 02:34:52,021
THINKING ABOUT WHAT ROLE THEY

3967
02:34:52,021 --> 02:34:54,891
COULD PLAY IN ALL OF THIS DATA

3968
02:34:54,891 --> 02:34:55,424
HARMONIZATION WORK.

3969
02:34:55,424 --> 02:34:59,662
SO JUST KIND OF SOME OPEN-ENDED

3970
02:34:59,662 --> 02:35:01,564
QUESTIONS ABOUT HOW MUCH FURTHER

3971
02:35:01,564 --> 02:35:05,368
WE MIGHT BE ABLE TO GO EXPANDING

3972
02:35:05,368 --> 02:35:08,871
INTO SOME OTHER SOURCES, DATA

3973
02:35:08,871 --> 02:35:09,105
SOURCES.

3974
02:35:09,105 --> 02:35:12,942
AND INITIATIVES LIKE DATA

3975
02:35:12,942 --> 02:35:13,276
HARMONIZATION.

3976
02:35:13,276 --> 02:35:13,876
>> THANK YOU

3977
02:35:13,876 --> 02:35:16,312
>> YEAH, I WOULD SAY WE'RE

3978
02:35:16,312 --> 02:35:21,017
DEFINITELY IN THE BEGINNING 

3979
02:35:21,017 --> 02:35:23,085
PHASES OF ESTABLISHING USCDI+

3980
02:35:23,085 --> 02:35:23,986
MATERNAL HEALTH DATASET, WE'RE

3981
02:35:23,986 --> 02:35:25,388
DEFINITELY OPEN TO ANY

3982
02:35:25,388 --> 02:35:26,923
ADDITIONAL RESOURCES THAT COULD

3983
02:35:26,923 --> 02:35:31,427
HELP BUILD OUT THAT LIST. 

3984
02:35:31,427 --> 02:35:32,161
>> EXCELLENT.

3985
02:35:32,161 --> 02:35:34,163
AND WE CAN TALK MORE ABOUT THIS

3986
02:35:34,163 --> 02:35:37,033
TOPIC TOO IN THE UPCOMING OPEN

3987
02:35:37,033 --> 02:35:37,466
SESSION.

3988
02:35:37,466 --> 02:35:42,905
I THINK MAYBE BEFORE WE GO TO

3989
02:35:42,905 --> 02:35:43,940
BREAK, SINCE WE ARE PROBABLY

3990
02:35:43,940 --> 02:35:45,541
EARLY, SINCE WE STARTED EARLY, I

3991
02:35:45,541 --> 02:35:48,778
WANT TO MAKE SURE, SUE, ANY

3992
02:35:48,778 --> 02:35:49,445
ADDITIONAL CLARIFYING QUESTIONS,

3993
02:35:49,445 --> 02:35:49,712
COMMENTS?

3994
02:35:49,712 --> 02:35:53,382
>> NOT FROM ME BUT
CHRISTINA, I

3995
02:35:53,382 --> 02:35:54,350
WONDER IF MAYBE YOU'LL INDULGE

3996
02:35:54,350 --> 02:35:59,522
ME AND WE CAN GET OUR

3997
02:35:59,522 --> 02:36:00,089
TEMPERATURE-TAKING EXERCISE

3998
02:36:00,089 --> 02:36:01,157
STARTED BEFORE THE BREAK.

3999
02:36:01,157 --> 02:36:03,025
TO GET PEOPLE'S BRAINS MOVING

4000
02:36:03,025 --> 02:36:04,327
AND THINKING ABOUT WHERE WE'RE

4001
02:36:04,327 --> 02:36:06,862
HEADED AFTER THE BREAK IF THAT'S

4002
02:36:06,862 --> 02:36:07,063
OKAY?

4003
02:36:07,063 --> 02:36:08,130
>> ABSOLUTELY.

4004
02:36:08,130 --> 02:36:09,265
>> GREAT.

4005
02:36:09,265 --> 02:36:14,370
SO, IF EMMA, COULD YOU PULL UP

4006
02:36:14,370 --> 02:36:18,074
OUR SLIDES FOR 12 AND HAVE 13

4007
02:36:18,074 --> 02:36:18,307
CUED UP?

4008
02:36:18,307 --> 02:36:18,574
>> YES.

4009
02:36:18,574 --> 02:36:21,143
>> ONE OF THE THINGS
CHRISTINA

4010
02:36:21,143 --> 02:36:23,846
AND I TALKED ABOUT AS WE HEAD

4011
02:36:23,846 --> 02:36:26,816
INTO THE LARGER DISCUSSION IS

4012
02:36:26,816 --> 02:36:29,318
CAN WE STREAMLINE THE SESSION

4013
02:36:29,318 --> 02:36:30,419
AND IDENTIFY RECOMMENDATIONS

4014
02:36:30,419 --> 02:36:33,055
THAT THE GROUP BY CONSENSUS

4015
02:36:33,055 --> 02:36:34,557
FEELS DON'T REQUIRE ANY

4016
02:36:34,557 --> 02:36:35,891
ADDITIONAL DISCUSSION, SO ARE

4017
02:36:35,891 --> 02:36:38,628
THERE ANY ELEMENTS OF

4018
02:36:38,628 --> 02:36:39,929
RECOMMENDATIONS 12 AND 13 THAT

4019
02:36:39,929 --> 02:36:41,998
YOU PROPOSE HAVE EITHER BEEN

4020
02:36:41,998 --> 02:36:44,300
FULFILLED AS OUTLINED IN THE

4021
02:36:44,300 --> 02:36:45,735
IMPLEMENTATION PLAN THAT WE

4022
02:36:45,735 --> 02:36:48,804
COULD CODE AS GREEN, OR HAVE

4023
02:36:48,804 --> 02:36:50,106
SUFFICIENT PLANNING AND MOMENTUM

4024
02:36:50,106 --> 02:36:53,075
BEHIND THEM THAT WE CAN CONSIDER

4025
02:36:53,075 --> 02:36:55,578
THEM IN PROCESS, SO CODED AS

4026
02:36:55,578 --> 02:36:55,878
YELLOW?

4027
02:36:55,878 --> 02:36:58,514
AND AT THIS POINT I'LL OPEN IT

4028
02:36:58,514 --> 02:37:01,917
UP TO THE COMMITTEE TO SEE IF

4029
02:37:01,917 --> 02:37:05,321
ANYBODY'S GOT ANY THOUGHTS OR

4030
02:37:05,321 --> 02:37:06,756
RECOMMENDATIONS ON ELEMENTS THAT

4031
02:37:06,756 --> 02:37:09,058
WE FEEL WE MAY HAVE ENOUGH

4032
02:37:09,058 --> 02:37:10,926
INFORMATION ON AND WE KNOW ARE

4033
02:37:10,926 --> 02:37:14,430
FAR ENOUGH ALONG THAT WE CAN

4034
02:37:14,430 --> 02:37:15,865
TRIAGE THEM AND GIVE US A LITTLE

4035
02:37:15,865 --> 02:37:18,801
BIT MORE DISCUSSION TIME FOR THE

4036
02:37:18,801 --> 02:37:19,268
OTHER ELEMENTS.

4037
02:37:19,268 --> 02:37:20,636
>> YEAH, AND I WOULD SAY
LET'S

4038
02:37:20,636 --> 02:37:24,173
HOLD THAT PART UNTIL AFTER THE

4039
02:37:24,173 --> 02:37:24,507
BREAK.

4040
02:37:24,507 --> 02:37:24,807
>> OKAY.

4041
02:37:24,807 --> 02:37:27,643
>> LET'S KICK OFF WITH
PROPOSALS

4042
02:37:27,643 --> 02:37:28,644
FROM OUR WORKING GROUP, THOSE

4043
02:37:28,644 --> 02:37:30,279
THEY THINK HAVE BEEN ADDRESSED,

4044
02:37:30,279 --> 02:37:32,148
SO THAT WE CAN MOVE ON AND FOCUS

4045
02:37:32,148 --> 02:37:36,085
ON THE ONES WHERE WE NEED

4046
02:37:36,085 --> 02:37:37,420
ADDITIONAL DISCUSSION, SINCE

4047
02:37:37,420 --> 02:37:40,723
WE'RE JUST AT 2:50.

4048
02:37:40,723 --> 02:37:41,324
>> THAT WORKS.

4049
02:37:41,324 --> 02:37:42,658
I'D LIKE FOLKS TO THINK ABOUT

4050
02:37:42,658 --> 02:37:44,860
THIS AND READY TO PROPOSE SOME

4051
02:37:44,860 --> 02:37:46,429
ITEMS WHEN WE GET BACK.

4052
02:37:46,429 --> 02:37:48,698
>> THANK YOU VERY MUCH, TO
THE

4053
02:37:48,698 --> 02:37:49,765
SPEAKERS FROM THIS SESSION.

4054
02:37:49,765 --> 02:37:53,369
THANK YOU ON BEHALF OF ALL OF US

4055
02:37:53,369 --> 02:37:53,602
HERE.

4056
02:37:53,602 --> 02:37:54,670
WE CERTAINLY APPRECIATE YOUR

4057
02:37:54,670 --> 02:37:56,038
PARTICIPATION AND THE WORK YOU

4058
02:37:56,038 --> 02:37:57,206
PUT INTO THE PRESENTATIONS.

4059
02:37:57,206 --> 02:37:59,408
WE'LL SEE YOU IN TEN MINUTES,

4060
02:37:59,408 --> 02:38:01,831
EVERYONE, AT 3 P.M., EASTERN.

4061
02:38:01,831 --> 02:38:03,365
>> WE'LL GET STARTED.

4062
02:38:03,365 --> 02:38:05,034
I KNOW BEFORE WE TURN THINGS

4063
02:38:05,034 --> 02:38:07,203
OVER TO SUE TO LEAD THE

4064
02:38:07,203 --> 02:38:10,039
DISCUSSION, I WANTED TO MAKE

4065
02:38:10,039 --> 02:38:14,777
SURE WE SEE REBECCA, YOU HAD A

4066
02:38:14,777 --> 02:38:15,444
COUPLE CLARIFYING QUESTIONS TO

4067
02:38:15,444 --> 02:38:15,644
RAISE.

4068
02:38:15,644 --> 02:38:17,613
>> THANK YOU SO MUCH.

4069
02:38:17,613 --> 02:38:20,683
JUST AS WE THINK ABOUT THE FINAL

4070
02:38:20,683 --> 02:38:25,387
REPORT, WE'RE GOING TO COLOR 

4071
02:38:25,387 --> 02:38:25,721
CODE THESE.

4072
02:38:25,721 --> 02:38:27,156
AND THEN WILL WE HAVE FURTHER

4073
02:38:27,156 --> 02:38:29,725
DISCUSSION ABOUT LIKE WHAT WE

4074
02:38:29,725 --> 02:38:31,861
THINK WE NEED TO PRIORITIZE AND

4075
02:38:31,861 --> 02:38:34,163
REPORT BACK TO CONGRESS, YOU

4076
02:38:34,163 --> 02:38:36,565
KNOW, FDA AND ONC ARE DOING

4077
02:38:36,565 --> 02:38:40,603
THIS, WE STILL NEED TO DO XYZ,

4078
02:38:40,603 --> 02:38:49,578
AS WE'RE THINKING ABOUT -- YES,

4079
02:38:49,578 --> 02:38:51,780
THAT'S MY QUESTION.

4080
02:38:51,780 --> 02:38:58,354
>> YES, MA'AMA,  - EMMY,
DO YOU

4081
02:38:58,354 --> 02:38:59,955
WANT TO SPEAK ABOUT THAT?

4082
02:38:59,955 --> 02:39:01,523
>> SURE.

4083
02:39:01,523 --> 02:39:02,157
CAN YOU HEAR ME?

4084
02:39:02,157 --> 02:39:07,763
>> YES.

4085
02:39:07,763 --> 02:39:09,632
>> OKAY.

4086
02:39:09,632 --> 02:39:10,065
GREAT.

4087
02:39:10,065 --> 02:39:13,469
FIRST, YES, WE'LL HAVE MORE TIME

4088
02:39:13,469 --> 02:39:15,104
TO DISCUSS THAN JUST THIS

4089
02:39:15,104 --> 02:39:15,404
AFTERNOON.

4090
02:39:15,404 --> 02:39:19,475
I WANT TO MAKE SURE, WAS THAT

4091
02:39:19,475 --> 02:39:20,175
PART OF YOUR QUESTION?

4092
02:39:20,175 --> 02:39:22,111
>> I GUESS, YOU KNOW, FOR
MANY

4093
02:39:22,111 --> 02:39:23,846
OF THESE, YEAH, SOME OF THE WORK

4094
02:39:23,846 --> 02:39:25,714
STARTED, THERE'S A LOT MORE WORK

4095
02:39:25,714 --> 02:39:26,482
TO DO.

4096
02:39:26,482 --> 02:39:28,017
IS THERE MORE THAN JUST A COLOR

4097
02:39:28,017 --> 02:39:30,853
CODING THAT WE CAN USE THAN TO

4098
02:39:30,853 --> 02:39:32,288
LIKE SEND OUR RECOMMENDATIONS

4099
02:39:32,288 --> 02:39:33,389
OVER AND SAY THIS IS WHAT WE

4100
02:39:33,389 --> 02:39:35,124
THINK IS THE NEXT STEP HERE?

4101
02:39:35,124 --> 02:39:36,892
>> MAYBE I CAN STEP IN.

4102
02:39:36,892 --> 02:39:45,334
THE REPORT WILL BE FARM MORE --

4103
02:39:45,334 --> 02:39:46,635
FAR MORE DETAILED THAN COLOR

4104
02:39:46,635 --> 02:39:47,236
CODING.

4105
02:39:47,236 --> 02:39:49,138
WHAT WILL GO BACK AS PART OF THE

4106
02:39:49,138 --> 02:39:51,140
REPORT IS A STATUS UPDATE WHERE

4107
02:39:51,140 --> 02:39:54,410
EVERYTHING IS, WHERE WE FEEL

4108
02:39:54,410 --> 02:39:54,977
ADDITIONAL COMMUNICATIONS

4109
02:39:54,977 --> 02:39:56,812
INITIATIVES NEED TO TAKE PLACE,

4110
02:39:56,812 --> 02:39:58,681
PUT THOSE RECOMMENDATIONS IN ON

4111
02:39:58,681 --> 02:40:00,649
BEHALF OF THE COMMITTEE, IF

4112
02:40:00,649 --> 02:40:01,850
THERE ARE ELEMENTS THAT WE FEEL

4113
02:40:01,850 --> 02:40:03,719
NEED TO BE PULLED OUT WE'LL MAKE

4114
02:40:03,719 --> 02:40:04,920
THOSE RECOMMENDATIONS AS WELL.

4115
02:40:04,920 --> 02:40:08,724
WE'RE JUST USING THE COLOR

4116
02:40:08,724 --> 02:40:13,529
CODING AS A FRAMEWORK FOR US TO

4117
02:40:13,529 --> 02:40:18,901
VISUALLY IDENTIFY WHERE WE ARE 

4118
02:40:18,901 --> 02:40:19,902
TO START THE COMMUNICATION.

4119
02:40:19,902 --> 02:40:23,272
>> IT'S MORE OF A CHEAT
SHEET TO

4120
02:40:23,272 --> 02:40:25,441
FOCUS IN A SHORT TIME FRAME TO

4121
02:40:25,441 --> 02:40:26,909
GO TO ENSURING WE'RE HAVING

4122
02:40:26,909 --> 02:40:28,510
BROADER DISCUSSION AROUND THOSE

4123
02:40:28,510 --> 02:40:32,881
ELEMENTS THAT CLEARLY NEED MORE

4124
02:40:32,881 --> 02:40:33,215
CONSIDERATION.

4125
02:40:33,215 --> 02:40:34,183
>> THANK YOU.

4126
02:40:34,183 --> 02:40:34,683
>> YOU'RE WELCOME.

4127
02:40:34,683 --> 02:40:42,958
>> WE HAVE ONE MORE

4128
02:40:42,958 --> 02:40:43,892
CLARIFICATION QUESTION.

4129
02:40:43,892 --> 02:40:45,160
>> I WAS CURIOUS, MANY
SPEAKERS

4130
02:40:45,160 --> 02:40:46,862
ARE STILL HERE WITH US NOW, SO

4131
02:40:46,862 --> 02:40:51,800
FOR THIS PORTION OF THE OPEN

4132
02:40:51,800 --> 02:40:56,005
DISCUSSION --

4133
02:40:56,005 --> 02:41:04,646
>> WE'VE LOST YOU. 

4134
02:41:04,646 --> 02:41:07,383
 

4135
02:41:07,383 --> 02:41:09,018
PUT YOUR QUESTION IN THE CHAT.

4136
02:41:09,018 --> 02:41:12,721
>> CAN WE ENGAGE THE
SPEAKERS

4137
02:41:12,721 --> 02:41:13,756
AND GET SOME ADDITIONAL

4138
02:41:13,756 --> 02:41:15,691
CLARIFICATION AND GO BACK AND

4139
02:41:15,691 --> 02:41:19,428
FORTH, WE MOST CERTAINLY CAN.

4140
02:41:19,428 --> 02:41:23,365
I MAY HAVE MISINTERPRETED.

4141
02:41:23,365 --> 02:41:25,768
DO WE HAVE HER BACK?

4142
02:41:25,768 --> 02:41:27,936
ALL THESE PICTURES ARE BOUNCING

4143
02:41:27,936 --> 02:41:29,171
ALL OVER THE PLACE.

4144
02:41:29,171 --> 02:41:31,473
>> THAT'S OKAY.

4145
02:41:31,473 --> 02:41:34,443
WE'LL MAKE SURE WHEN SHE COMES

4146
02:41:34,443 --> 02:41:35,744
BACK -- CLARIFICATION.

4147
02:41:35,744 --> 02:41:36,945
IT'S A GREAT TIME FOR US TO

4148
02:41:36,945 --> 02:41:38,914
TRANSITION THINGS OVER TO YOU,

4149
02:41:38,914 --> 02:41:49,391
SUE, TO LEAD US THROUGH THIS

4150
02:41:50,259 --> 02:41:50,759
EXERCISE TO FOCUS.

4151
02:41:50,759 --> 02:41:53,562
>> I'LL KICK US OFF AND
WE'LL

4152
02:41:53,562 --> 02:41:57,533
TAG TEAM WE'VE GOT TWO SLIDES,

4153
02:41:57,533 --> 02:42:01,703
THIS AND THE NEXT SLIDE, IF YOU

4154
02:42:01,703 --> 02:42:03,005
COULD TOGGLE BACK AND FORTH.

4155
02:42:03,005 --> 02:42:04,640
I WOULD LIKE TO TAKE PROPOSALS

4156
02:42:04,640 --> 02:42:06,608
FROM THE GROUP AS TO WHETHER OR

4157
02:42:06,608 --> 02:42:12,748
NOT WE BELIEVE ANY OF THESE HAVE

4158
02:42:12,748 --> 02:42:15,684
EITHER BEEN FULFILLED OR ARE FAR

4159
02:42:15,684 --> 02:42:17,019
ENOUGH ALONG WE REALLY

4160
02:42:17,019 --> 02:42:18,987
UNDERSTAND WHERE THE TRAJECTORY

4161
02:42:18,987 --> 02:42:25,794
IS THAT WE MAY NOT NEED A LOT OF

4162
02:42:25,794 --> 02:42:28,530
DISCUSSION AROUND THEM.

4163
02:42:28,530 --> 02:42:34,536
 

4164
02:42:34,536 --> 02:42:39,575
 

4165
02:42:39,575 --> 02:42:40,008
>> PROFESSOR CHARO?

4166
02:42:40,008 --> 02:42:42,945
>> A 12A BASED ON WHAT I
WAS

4167
02:42:42,945 --> 02:42:44,480
HEARING IT SOUNDS LIKE THE

4168
02:42:44,480 --> 02:42:48,083
DESIGNING OF SYSTEMS IS WELL

4169
02:42:48,083 --> 02:42:48,350
UNDERWAY.

4170
02:42:48,350 --> 02:42:49,852
THE COORDINATION AND CONVERGENCE

4171
02:42:49,852 --> 02:42:54,556
OF SYSTEMS IS NOT NECESSARILY 

4172
02:42:54,556 --> 02:42:55,657
VERY WELL UNDERWAY, AND I DON'T

4173
02:42:55,657 --> 02:42:56,758
KNOW IF THAT'S DIFFERENT THAN

4174
02:42:56,758 --> 02:42:59,695
DESIGN BUT THAT SEEMS TON  -- TO

4175
02:42:59,695 --> 02:43:00,896
BE PART OF THE PROBLEM, THEY ARE

4176
02:43:00,896 --> 02:43:03,298
NOT ABLE TO TALK TO ONE ANOTHER

4177
02:43:03,298 --> 02:43:04,099
OR SHARE INFORMATION ACROSS

4178
02:43:04,099 --> 02:43:06,935
SYSTEMS. 

4179
02:43:06,935 --> 02:43:09,138
>> YOU'RE SUGGESTING THAT
THIS

4180
02:43:09,138 --> 02:43:11,540
IS PERHAPS PARTIALLY -- HAS BEEN

4181
02:43:11,540 --> 02:43:15,811
PARTIALLY ADDRESSED WITH STILL 

4182
02:43:15,811 --> 02:43:16,378
SOME OUTSTANDING ISSUES?

4183
02:43:16,378 --> 02:43:18,213
>> YES, ONLY WORKING ON
HEALTH

4184
02:43:18,213 --> 02:43:19,748
RECORDS SYSTEMS IN THE UNITED

4185
02:43:19,748 --> 02:43:22,784
STATES, I WENT CRAZY TALKING

4186
02:43:22,784 --> 02:43:23,919
ABOUT WHY WE SHOULD PAY

4187
02:43:23,919 --> 02:43:25,287
ATTENTION TO OTHER COUNTRIES.

4188
02:43:25,287 --> 02:43:27,389
IF WE'RE FOCUS ON THE UNITED

4189
02:43:27,389 --> 02:43:29,024
STATES THERE HAVE BEEN A LOT OF

4190
02:43:29,024 --> 02:43:30,125
TOOLS DEVELOPED TO CREATE

4191
02:43:30,125 --> 02:43:32,094
LINKAGES BUT THEY ARE NOT ALL

4192
02:43:32,094 --> 02:43:33,529
THE SAME TOOLS, DIFFERENT TOOL

4193
02:43:33,529 --> 02:43:34,663
MAKERS CAME UP WITH DIFFERENT

4194
02:43:34,663 --> 02:43:38,233
SYSTEMS NOT ABLE TO THEN BE

4195
02:43:38,233 --> 02:43:40,102
AGGREGATED THE WAY WE WANT,

4196
02:43:40,102 --> 02:43:41,170
SLIGHTLY DIFFERENT THAN THE

4197
02:43:41,170 --> 02:43:42,804
DESIGN QUESTION, IT'S WHAT DO DO

4198
02:43:42,804 --> 02:43:44,506
YOU WITH DIFFERENT DESIGNS.

4199
02:43:44,506 --> 02:43:48,744
>> TO PARAPHRASE AND PULL
IN THE

4200
02:43:48,744 --> 02:43:49,411
CONVERSATION WITH ONC

4201
02:43:49,411 --> 02:43:52,447
COLLEAGUES, THE DESIGN IS THERE,

4202
02:43:52,447 --> 02:43:55,551
WELL UNDERWAY, LINK IS IMPERFECT

4203
02:43:55,551 --> 02:43:58,253
IN ALL SYSTEMS.

4204
02:43:58,253 --> 02:44:03,525
SOUNDS LIKE CONVERSATIONS ARE 

4205
02:44:03,525 --> 02:44:05,160
BEING HAD AROUND THIS, SO YOU'RE

4206
02:44:05,160 --> 02:44:08,030
PROPOSING THIS MIGHT BE ONE THAT

4207
02:44:08,030 --> 02:44:15,804
WOULD GET COLOR CODED THAT IS 

4208
02:44:15,804 --> 02:44:17,272
WHERE, ONGOING AND PLANNED?

4209
02:44:17,272 --> 02:44:17,439
>> .

4210
02:44:17,439 --> 02:44:19,942
>> I'M NOT SURE, I'LL HAVE
TO

4211
02:44:19,942 --> 02:44:21,510
LISTEN HOW PEOPLE DISTINGUISH

4212
02:44:21,510 --> 02:44:22,477
BETWEEN RED AND YELLOW, SOME

4213
02:44:22,477 --> 02:44:23,579
WHERE IN BETWEEN THERE.

4214
02:44:23,579 --> 02:44:25,013
ONE LAST THING AND I'LL STOP.

4215
02:44:25,013 --> 02:44:26,148
THERE WAS A QUESTION I ASKED IN

4216
02:44:26,148 --> 02:44:28,283
THE CHAT, I DON'T THINK IT GOT

4217
02:44:28,283 --> 02:44:30,919
ANY ATTENTION, ABOUT WHETHER

4218
02:44:30,919 --> 02:44:32,588
THERE'S ANY ABILITY TO ACCESS

4219
02:44:32,588 --> 02:44:34,957
NEWBORN BLOOD SPOTS AT THE STATE

4220
02:44:34,957 --> 02:44:37,259
HYGIENE LABS BECAUSE I DIDN'T

4221
02:44:37,259 --> 02:44:39,461
HEAR -- I COULD HAVE MISSED IT,

4222
02:44:39,461 --> 02:44:41,763
I DON'T THINK I HEARD ANYBODY

4223
02:44:41,763 --> 02:44:43,498
TALK ABOUT THE USE OF THAT

4224
02:44:43,498 --> 02:44:46,835
SOURCE OF MATERIAL FOR CREATING

4225
02:44:46,835 --> 02:44:49,204
LINKAGE BUT ALL CAN BE DNA TYPED

4226
02:44:49,204 --> 02:44:51,240
BUT I UNDERSTAND MAYBE PRIVACY

4227
02:44:51,240 --> 02:44:56,945
CEREBRAL CORTEXES OR -- PRIVACY

4228
02:44:56,945 --> 02:44:58,480
CONCERNS, BUT THAT'S A

4229
02:44:58,480 --> 02:45:09,024
RECONSIDERATION, A RED LIGHT ON 

4230
02:45:14,396 --> 02:45:15,097
THAT ONE ASPECT.

4231
02:45:15,097 --> 02:45:17,199
>> WE DON'T HAVE A CLEAR

4232
02:45:17,199 --> 02:45:18,367
RECOMMENDATION OF SOMETHING WE

4233
02:45:18,367 --> 02:45:20,035
WANT TO TRIAGE, SOUNDS LIKE YOU

4234
02:45:20,035 --> 02:45:23,639
WANT ADDITIONAL DISCUSSION. 

4235
02:45:23,639 --> 02:45:24,506
IS THERE ANY ADDITIONAL COMMENT

4236
02:45:24,506 --> 02:45:34,383
THAT HAS TO BE HAD ABOUT THE

4237
02:45:34,383 --> 02:45:39,521
STATEWIDE DRIED BLOODSPOT?

4238
02:45:39,521 --> 02:45:41,056
>> I'M FROM CDC.

4239
02:45:41,056 --> 02:45:44,459
WE'RE STILL OFF FROM GETTING

4240
02:45:44,459 --> 02:45:48,030
BLOODSPOT SAMPLES IN ANY

4241
02:45:48,030 --> 02:45:49,464
CENTRALIZED SYSTEM.

4242
02:45:49,464 --> 02:45:50,899
SO, I WOULD -- THAT WOULD BE

4243
02:45:50,899 --> 02:45:54,569
YEARS IN THE FUTURE FROM MY

4244
02:45:54,569 --> 02:45:54,870
PERSPECTIVE.

4245
02:45:54,870 --> 02:45:59,541
>> THANK YOU VERY MUCH.

4246
02:45:59,541 --> 02:46:01,977
>> I'LL JUMP IN REAL
QUICK.

4247
02:46:01,977 --> 02:46:04,780
MY COLLEAGUE FROM CDC, WE HAVE

4248
02:46:04,780 --> 02:46:06,982
WORKED WITH THE SAFETY UTAH,

4249
02:46:06,982 --> 02:46:08,617
PROBABLY THE FURTHEST ALONG IN

4250
02:46:08,617 --> 02:46:10,786
TRYING TO GET THAT INFORMATION

4251
02:46:10,786 --> 02:46:11,486
ELECTRONICALLY AVAILABLE, AND

4252
02:46:11,486 --> 02:46:21,163
THERE'S STILL A WAYS TO GO.

4253
02:46:21,163 --> 02:46:22,864
>> THANK YOU.

4254
02:46:22,864 --> 02:46:29,304
>> REMEMBER, EVERYONE,
FOCUS ON

4255
02:46:29,304 --> 02:46:30,105
THE SUBCOMPONENTS, SO

4256
02:46:30,105 --> 02:46:33,041
RECOMMENDATION 12A HAD THREE

4257
02:46:33,041 --> 02:46:33,608
SUBCOMPONENTS.

4258
02:46:33,608 --> 02:46:36,745
WE SHOULD BE LOOKING AT BASED ON

4259
02:46:36,745 --> 02:46:41,016
WHAT WE HEARD TOGETHER, THESE

4260
02:46:41,016 --> 02:46:42,651
PARTICULAR PIECES DON'T HAVE TO

4261
02:46:42,651 --> 02:46:44,419
BE COMPLETE, HAVE THEY BEEN

4262
02:46:44,419 --> 02:46:46,588
ACTIONED AND HAS WORK BEEN MADE

4263
02:46:46,588 --> 02:46:48,123
TOWARD IT, IT'S RELEVANT FOR US

4264
02:46:48,123 --> 02:46:51,727
TO RAISE ADDITIONAL PIECES ABOUT

4265
02:46:51,727 --> 02:46:54,162
IT'S BEING ACTIONED BUT THE

4266
02:46:54,162 --> 02:46:55,797
INTEROPERABILITY, THE ABILITY TO

4267
02:46:55,797 --> 02:46:58,967
SPEAK BETWEEN MAY STILL REQUIRE

4268
02:46:58,967 --> 02:46:59,968
ADDITIONAL FOCUS SO I THINK THAT

4269
02:46:59,968 --> 02:47:03,338
WOULD BE A PART OF WHAT WE WOULD

4270
02:47:03,338 --> 02:47:05,440
THINK ABOUT BUT GO BACK TO THE

4271
02:47:05,440 --> 02:47:06,641
TOOLS THAT WE PROVIDED AS

4272
02:47:06,641 --> 02:47:09,378
PREVIOUS, THEY ARE GOING TO BE

4273
02:47:09,378 --> 02:47:10,479
HELPFUL IN UNDERSTANDING

4274
02:47:10,479 --> 02:47:17,252
INDIVIDUAL ELEMENTS OF THE

4275
02:47:17,252 --> 02:47:17,619
RECOMMENDATIONS.

4276
02:47:17,619 --> 02:47:18,620
>> GREAT RECOMMENDATION.

4277
02:47:18,620 --> 02:47:19,988
I WOULD RECOMMEND EVERYBODY OPEN

4278
02:47:19,988 --> 02:47:21,490
THAT DOCUMENTS UP, HAVE IT SIDE

4279
02:47:21,490 --> 02:47:22,824
BY SIDE NEXT TO THE ZOOM.

4280
02:47:22,824 --> 02:47:24,793
THERE ARE HANDS UP FOR

4281
02:47:24,793 --> 02:47:25,494
CLARIFICATION QUESTIONS.

4282
02:47:25,494 --> 02:47:26,862
I DON'T WANT TO ADDRESS THOSE

4283
02:47:26,862 --> 02:47:27,095
NOW.

4284
02:47:27,095 --> 02:47:29,831
I WANT TO SEE IF WE'RE ABLE TO

4285
02:47:29,831 --> 02:47:31,733
TRIAGE ANY OF THESE

4286
02:47:31,733 --> 02:47:33,769
RECOMMENDATIONS BEFORE WE GET

4287
02:47:33,769 --> 02:47:37,539
INTO MUCH BROADER DISCUSSION 

4288
02:47:37,539 --> 02:47:40,075
ABOUT ALL OF THEM.

4289
02:47:40,075 --> 02:47:41,176
SHARON, I'M TRUSTING YOU'RE

4290
02:47:41,176 --> 02:47:42,711
PROPOSING ONE TO BE TRIAGED.

4291
02:47:42,711 --> 02:47:45,280
>> I WAS LOOKING AT 12C
NOVEL

4292
02:47:45,280 --> 02:47:46,081
DATA RESOURCES.

4293
02:47:46,081 --> 02:47:48,683
WHEN I THINK ABOUT GRANTS,

4294
02:47:48,683 --> 02:47:51,019
CONTRACTS OUT THERE, WHAT'S

4295
02:47:51,019 --> 02:47:53,088
HAPPENING WITH THOSE, THOSE ARE

4296
02:47:53,088 --> 02:47:54,289
NOVEL DATA RESOURCES, SO I WANT

4297
02:47:54,289 --> 02:47:56,825
TO SAY THEY MAY NOT HAVE THE

4298
02:47:56,825 --> 02:47:58,894
RIGHT ANSWERS BUT SOUNDS LIKE

4299
02:47:58,894 --> 02:48:01,496
THAT PATHWAY IS WORKING.

4300
02:48:01,496 --> 02:48:02,798
YOU'VE GIVEN PEOPLE DOLLARS TO

4301
02:48:02,798 --> 02:48:04,599
DO THE WORK.

4302
02:48:04,599 --> 02:48:05,534
THEY HAVE OUTLINED CREATIVE

4303
02:48:05,534 --> 02:48:06,468
SOLUTIONS HOW THEY ARE GOING TO

4304
02:48:06,468 --> 02:48:07,869
DO THE WORK.

4305
02:48:07,869 --> 02:48:09,738
I DON'T WANT TO SAY THEY ARE THE

4306
02:48:09,738 --> 02:48:11,373
RIGHT ANSWERS BUT AT LEAST WHEN

4307
02:48:11,373 --> 02:48:13,475
I THINK ABOUT USING NOVEL DATA

4308
02:48:13,475 --> 02:48:14,109
RESOURCES IT SOUNDS LIKE YOU'RE

4309
02:48:14,109 --> 02:48:15,777
IN THE RIGHT PLACE SO I DON'T

4310
02:48:15,777 --> 02:48:18,447
WANT TO SAY IT'S FULFILLED.

4311
02:48:18,447 --> 02:48:20,382
I THINK IT'S MORE OF A YELLOW

4312
02:48:20,382 --> 02:48:21,249
THAN A GREEN.

4313
02:48:21,249 --> 02:48:27,622
BUT IT'S NOT A RED.

4314
02:48:27,622 --> 02:48:29,691
YOU HAVE A PLAN.

4315
02:48:29,691 --> 02:48:32,327
SOUNDS LIKE IT'S ROLLING ALONG.

4316
02:48:32,327 --> 02:48:36,031
>> SHARON IS PROPOSING
TRIAGING

4317
02:48:36,031 --> 02:48:38,233
12C.

4318
02:48:38,233 --> 02:48:39,034
I'M TURNING TO CHRISTINA FOR A

4319
02:48:39,034 --> 02:48:42,504
HIGH LEVEL VIEW OF THE

4320
02:48:42,504 --> 02:48:43,738
SUPPLEMENTS FOR 12C AND LET'S

4321
02:48:43,738 --> 02:48:46,208
SEE IF WE GET ENDORSEMENT FROM

4322
02:48:46,208 --> 02:48:47,742
THE WORKING GROUP.

4323
02:48:47,742 --> 02:48:54,449
>> FOR 12C TWO
SUBCOMPONENTS,

4324
02:48:54,449 --> 02:48:55,550
LARGE OBSERVATIONAL STUDIES,

4325
02:48:55,550 --> 02:48:57,953
MEDICATIONS CLASSES IN PREGNANCY

4326
02:48:57,953 --> 02:48:59,588
AND LACTATION, AND SUPPORT

4327
02:48:59,588 --> 02:49:01,456
STUDIES ACROSS MULTIPLE DRUGS

4328
02:49:01,456 --> 02:49:06,928
USING THE SAME INFRASTRUCTURE TO

4329
02:49:06,928 --> 02:49:07,829
CONSERVE RESOURCES.

4330
02:49:07,829 --> 02:49:10,665
>> IS THERE A GENERAL

4331
02:49:10,665 --> 02:49:16,338
ENDORSEMENT FROM THE WORKING

4332
02:49:16,338 --> 02:49:18,106
GROUP THAT THAT'S UNDERWAY?

4333
02:49:18,106 --> 02:49:20,942
>> I WOULD AGREE THAT'S
ONGOING.

4334
02:49:20,942 --> 02:49:21,943
IN YELLOW.

4335
02:49:21,943 --> 02:49:24,079
WITH THE EXCEPTION OF EFFICACY.

4336
02:49:24,079 --> 02:49:27,749
I DIDN'T HEAR A LOT ABOUT

4337
02:49:27,749 --> 02:49:28,016
EFFICACY.

4338
02:49:28,016 --> 02:49:32,687
I HEARD A LOT ABOUT SAFETY.

4339
02:49:32,687 --> 02:49:33,488
THAT'S JUST MY OPINION.

4340
02:49:33,488 --> 02:49:34,322
>> I AGREE.

4341
02:49:34,322 --> 02:49:36,291
I THINK THE CHALLENGE CREATING

4342
02:49:36,291 --> 02:49:38,593
BUCKETS THE YELLOW AND RED CAN

4343
02:49:38,593 --> 02:49:40,529
BLEND A LITTLE BIT.

4344
02:49:40,529 --> 02:49:40,762
>> SURE.

4345
02:49:40,762 --> 02:49:42,631
>> AND THERE'S SOME
HESITATION

4346
02:49:42,631 --> 02:49:44,833
WITH SAYING IT'S ONGOING,

4347
02:49:44,833 --> 02:49:46,368
WHETHER WE NEED TO BE CLEAR IT'S

4348
02:49:46,368 --> 02:49:48,003
ONGOING BUT WE MAY NOT BE WHERE

4349
02:49:48,003 --> 02:49:49,671
WE NEED TO BE AND NEED TO ALIGN

4350
02:49:49,671 --> 02:49:52,407
ON THE FACT THAT'S WHAT WE ALL

4351
02:49:52,407 --> 02:49:53,308
AGREE ON.

4352
02:49:53,308 --> 02:49:55,377
BECAUSE THAT'S MY CONCERN WITH

4353
02:49:55,377 --> 02:49:56,378
SAYING IT'S ONGOING.

4354
02:49:56,378 --> 02:49:57,145
IT'S PLANNED.

4355
02:49:57,145 --> 02:49:58,780
AND THEN WE'RE NOT REALLY

4356
02:49:58,780 --> 02:50:00,215
GETTING TO THAT POINT OF SOME OF

4357
02:50:00,215 --> 02:50:02,150
THE THINGS IN THE

4358
02:50:02,150 --> 02:50:02,717
RECOMMENDATION.

4359
02:50:02,717 --> 02:50:06,321
SUCH AS EFFECTIVENESS AND THEN

4360
02:50:06,321 --> 02:50:07,389
REPORT STUDIES ACROSS MULTIPLE

4361
02:50:07,389 --> 02:50:08,423
DRUGS USING THE SAME

4362
02:50:08,423 --> 02:50:08,790
INFRASTRUCTURE.

4363
02:50:08,790 --> 02:50:11,226
>> AND THAT'S A GREAT
EXAMPLE

4364
02:50:11,226 --> 02:50:12,260
THAT REQUIRES MORE DISCUSSION

4365
02:50:12,260 --> 02:50:16,598
FROM THIS GROUP AND SO THAT WILL

4366
02:50:16,598 --> 02:50:17,666
COME BACK INTO DISCUSSION.

4367
02:50:17,666 --> 02:50:21,002
LET ME JUST THROW ONE OUT THERE.

4368
02:50:21,002 --> 02:50:27,375
DOES ANYBODY BELIEVE THAT 12E IS

4369
02:50:27,375 --> 02:50:29,978
FAR ENOUGH ALONG THAT IT

4370
02:50:29,978 --> 02:50:30,845
REQUIRES NO SIGNIFICANT INITIAL

4371
02:50:30,845 --> 02:50:32,480
DISCUSSION IN TERMS OF WHAT IS

4372
02:50:32,480 --> 02:50:35,884
FULFILLED OR WHAT IS PLANNED?

4373
02:50:35,884 --> 02:50:41,022
 

4374
02:50:41,022 --> 02:50:42,557
>> FULFILLED AND PLANNED
AROUND

4375
02:50:42,557 --> 02:50:45,493
THE SAME THING, FROM MY SIDE.

4376
02:50:45,493 --> 02:50:47,028
I KEEP THINKING WE'LL HAVE

4377
02:50:47,028 --> 02:50:52,167
ANOTHER COLOR LIKE ORANGE THAT'S

4378
02:50:52,167 --> 02:50:53,068
BETWEEN STUFF.

4379
02:50:53,068 --> 02:50:54,603
YES, 12E IS BEING PLANNED.

4380
02:50:54,603 --> 02:50:57,606
IS IT FULFILLED?

4381
02:50:57,606 --> 02:50:57,772
NO.

4382
02:50:57,772 --> 02:50:59,841
>> CORRECT, BUT IS IT
ONGOING

4383
02:50:59,841 --> 02:51:05,280
AND PLANNED AND IS THERE ENOUGH

4384
02:51:05,280 --> 02:51:06,848
MOMENTUM THAT'S BEEN DESCRIBED

4385
02:51:06,848 --> 02:51:08,383
IN THAT TOPIC AREA THAT IT'S NOT

4386
02:51:08,383 --> 02:51:11,753
ANYTHING WE HAVE TO PROVIDE

4387
02:51:11,753 --> 02:51:16,424
ADDITIONAL DISCUSSION OR

4388
02:51:16,424 --> 02:51:16,925
RECOMMENDATIONS AROUND?

4389
02:51:16,925 --> 02:51:17,993
>> ARE YOU ASKING US TO
LOOK

4390
02:51:17,993 --> 02:51:21,062
AGAIN IN 12 MONTHS AND SEE WHAT

4391
02:51:21,062 --> 02:51:22,063
THEY HAVE ACCOMPLISHED?

4392
02:51:22,063 --> 02:51:23,031
>> WE'RE TRYING TO MAKE

4393
02:51:23,031 --> 02:51:24,099
ASSESSMENT WHERE WE ARE NOW.

4394
02:51:24,099 --> 02:51:26,267
>> WHEN I HEAR YOUR
LANGUAGE,

4395
02:51:26,267 --> 02:51:28,269
I'M TRYING TO UNDERSTAND DOES

4396
02:51:28,269 --> 02:51:31,673
THAT MEAN I'M HANDS UP NOW OR,

4397
02:51:31,673 --> 02:51:33,742
OKAY, I'M HAPPY, COME BACK IN 12

4398
02:51:33,742 --> 02:51:35,744
MONTHS AND SHOW ME THAT YOU'VE

4399
02:51:35,744 --> 02:51:36,811
GOT TO THOSE STEPS.

4400
02:51:36,811 --> 02:51:40,448
I GUESS I'M HAVING A HARD TIME

4401
02:51:40,448 --> 02:51:42,617
BEING AS SO CONCRETE AS, OKAY,

4402
02:51:42,617 --> 02:51:44,252
HANDS UP, I'M DONE, VERSUS NO,

4403
02:51:44,252 --> 02:51:51,726
YOU'RE ON THE PATH BUT I DON'T 

4404
02:51:51,726 --> 02:51:54,562
KNOW THAT YOU'RE DONE.

4405
02:51:54,562 --> 02:51:56,031
>> WE'RE NOT MAKING A

4406
02:51:56,031 --> 02:51:57,732
DETERMINATION EVERYTHING HAS TO

4407
02:51:57,732 --> 02:51:58,500
BE COMPLETED.

4408
02:51:58,500 --> 02:52:00,235
WHAT I'M TRYING TO GET AT IS

4409
02:52:00,235 --> 02:52:01,670
THERE ELEMENTS THAT CAN BE

4410
02:52:01,670 --> 02:52:04,272
TRIAGED, IS THERE ANY MEANINGFUL

4411
02:52:04,272 --> 02:52:05,707
CONVERSATION THAT NEEDS TO TAKE

4412
02:52:05,707 --> 02:52:08,109
PLACE ABOUT COMMON DATA

4413
02:52:08,109 --> 02:52:11,746
ELEMENTS, OR IS THERE ENOUGH

4414
02:52:11,746 --> 02:52:13,481
DIRECTION THAT'S CURRENTLY

4415
02:52:13,481 --> 02:52:15,750
ONGOING THAT ADDITIONAL

4416
02:52:15,750 --> 02:52:16,651
DELIBERATION OR CONVERSATION

4417
02:52:16,651 --> 02:52:21,823
FROM THIS COMMITTEE WOULDN'T BE

4418
02:52:21,823 --> 02:52:22,090
NECESSARY?

4419
02:52:22,090 --> 02:52:25,193
>> YEAH, I'LL ADD JUST
THINK

4420
02:52:25,193 --> 02:52:26,394
ABOUT IT DIFFERENTLY AS WELL,

4421
02:52:26,394 --> 02:52:30,665
ALL POLICY TAKES YEARS TO

4422
02:52:30,665 --> 02:52:30,932
IMPLEMENT.

4423
02:52:30,932 --> 02:52:33,401
ALL POLICY TAKES YEARS TO

4424
02:52:33,401 --> 02:52:35,136
IMPLEMENT, OKAY?

4425
02:52:35,136 --> 02:52:37,105
SO, THERE IS NO EXPECTATION I

4426
02:52:37,105 --> 02:52:38,106
THINK FROM ANYONE THAT WOULD

4427
02:52:38,106 --> 02:52:40,975
HAVE EXPECTED ALL OF THESE

4428
02:52:40,975 --> 02:52:41,843
RECOMMENDATIONS AND

4429
02:52:41,843 --> 02:52:42,377
SUBRECOMMENDATIONS TO BE

4430
02:52:42,377 --> 02:52:45,013
ACTIONED BY THE TIME WE MAKE THE

4431
02:52:45,013 --> 02:52:45,680
REPORT TO CONGRESS.

4432
02:52:45,680 --> 02:52:49,384
BECAUSE THERE ARE SO MANY THINGS

4433
02:52:49,384 --> 02:52:52,987
THAT GO INTO THE SUPPORT

4434
02:52:52,987 --> 02:52:54,456
PLANNING RESOURCING, BRINGING

4435
02:52:54,456 --> 02:52:56,291
TOGETHER STAKEHOLDERS, AND I

4436
02:52:56,291 --> 02:52:58,359
THINK WHAT WE NEED TO DO NEAR

4437
02:52:58,359 --> 02:53:01,796
THIS EXERCISE IS SOMETHING IS

4438
02:53:01,796 --> 02:53:04,499
TRULY DONE, IT'S DONE.

4439
02:53:04,499 --> 02:53:05,800
WHY 14 AND 15 WE'RE NOT GOING TO

4440
02:53:05,800 --> 02:53:06,568
EVER DISCUSS AGAIN BECAUSE THEY

4441
02:53:06,568 --> 02:53:07,435
ARE DONE.

4442
02:53:07,435 --> 02:53:09,838
THEY ARE SIMPLE AND THEY ARE

4443
02:53:09,838 --> 02:53:10,438
DONE.

4444
02:53:10,438 --> 02:53:11,339
MANY OTHER RECOMMENDATIONS ARE

4445
02:53:11,339 --> 02:53:13,141
VERY COMPLEX.

4446
02:53:13,141 --> 02:53:15,009
SO THE LIKELIHOOD IS MOST OF

4447
02:53:15,009 --> 02:53:19,047
THESE ARE EITHER GOING TO BE

4448
02:53:19,047 --> 02:53:21,783
ONGOING OR PLANNED, OR THEY

4449
02:53:21,783 --> 02:53:24,853
REQUIRE ADDITIONAL ATTENTION OR

4450
02:53:24,853 --> 02:53:25,453
RECONSIDERATION.

4451
02:53:25,453 --> 02:53:26,588
AND THAT'S NOT A PROBLEM FOR

4452
02:53:26,588 --> 02:53:29,657
THAT COULD BE THE CASE.

4453
02:53:29,657 --> 02:53:31,192
SO I WANTED TO THINK ABOUT THAT

4454
02:53:31,192 --> 02:53:34,095
IN YOUR MIND AS YOU'RE THINKING

4455
02:53:34,095 --> 02:53:34,496
ABOUT THIS.

4456
02:53:34,496 --> 02:53:36,030
FOR SOMETHING TO BE TRULY

4457
02:53:36,030 --> 02:53:38,099
FULFILLED IT MEANS ALL THE

4458
02:53:38,099 --> 02:53:39,868
ACTIONS GOING INTO SEEING IT

4459
02:53:39,868 --> 02:53:45,340
COME TO LIGHT ARE DONE.

4460
02:53:45,340 --> 02:53:47,175
>> THAT'S A GREAT WAY TO

4461
02:53:47,175 --> 02:53:50,078
DESCRIBE IT, THE FOUNDATION HAS

4462
02:53:50,078 --> 02:53:52,781
BEEN LAID ALREADY.

4463
02:53:52,781 --> 02:53:57,485
 

4464
02:53:57,485 --> 02:53:59,120
SO I'M NOT HEARING ENDORSEMENT

4465
02:53:59,120 --> 02:54:01,656
FOR ANY OF THESE WHICH MEANS I

4466
02:54:01,656 --> 02:54:11,065
THINK WE NEED TO NEED TO MORE OF

4467
02:54:11,065 --> 02:54:11,800
A MODERATED DISCUSSION AROUND

4468
02:54:11,800 --> 02:54:12,367
THEM.

4469
02:54:12,367 --> 02:54:17,539
DO YOU HAVE A CLARIFICATION

4470
02:54:17,539 --> 02:54:18,106
QUESTION OR PROPOSEAL

4471
02:54:18,106 --> 02:54:18,273
>> .

4472
02:54:18,273 --> 02:54:19,040
>> NEITHER.

4473
02:54:19,040 --> 02:54:20,675
WHERE I'M HAVING TROUBLE

4474
02:54:20,675 --> 02:54:21,276
ANSWERING YOUR QUESTIONS

4475
02:54:21,276 --> 02:54:25,747
DIRECTLY WE'RE THINKING ABOUT

4476
02:54:25,747 --> 02:54:28,917
ANSWERING DIRECTLY, WE'VE HEARD

4477
02:54:28,917 --> 02:54:30,652
FROM SOME CORE STAKEHOLDER

4478
02:54:30,652 --> 02:54:35,356
FEDERAL GROUPS, BUT I THINK WHAT

4479
02:54:35,356 --> 02:54:36,124
I'M HAVING TROUBLE TRANSLATING

4480
02:54:36,124 --> 02:54:39,327
HOW WE ARE IF FDA IS DEALING

4481
02:54:39,327 --> 02:54:41,930
WITH IT, FDA OF COURSE IS THE

4482
02:54:41,930 --> 02:54:43,231
CENTRAL STAKEHOLDERS AND

4483
02:54:43,231 --> 02:54:46,768
COMPONENT, AND NICHD IS DEALING

4484
02:54:46,768 --> 02:54:49,470
WITH IT, AND, YOU KNOW, THE

4485
02:54:49,470 --> 02:54:50,371
ORGANIZING CENTER, RIGHT?

4486
02:54:50,371 --> 02:54:52,540
BUT THERE ARE OTHER ENTITIES,

4487
02:54:52,540 --> 02:54:55,510
WHETHER PUBLIC/PRIVATE

4488
02:54:55,510 --> 02:54:58,012
PARTNERSHIP, WHETHER AHRQ, OTHER

4489
02:54:58,012 --> 02:54:59,614
ENTITIES NAMED IN THE DOCUMENT

4490
02:54:59,614 --> 02:55:02,417
SO IT'S HARD TO SAY HOW FAR ARE

4491
02:55:02,417 --> 02:55:07,622
WE IF WE  TALKING ABOUT A FEW

4492
02:55:07,622 --> 02:55:11,092
ENTITIES ANDS SOAR  -- AND

4493
02:55:11,092 --> 02:55:13,094
OTHERS WE HAVEN'T TOUCHED.

4494
02:55:13,094 --> 02:55:18,967
WE'VE HEARD FROM ONLY A FEW

4495
02:55:18,967 --> 02:55:19,701
FEDERAL STAKEHOLDERS TODAY.

4496
02:55:19,701 --> 02:55:26,941
>> YOU'RE RAISING A VERY

4497
02:55:26,941 --> 02:55:30,445
IMPORTANT QUESTION.

4498
02:55:30,445 --> 02:55:34,082
WE HAVE TO -- THE CRUX OF THE

4499
02:55:34,082 --> 02:55:38,686
REPORT, WE'VE INVITED SPEAKERS

4500
02:55:38,686 --> 02:55:39,888
FROM DIFFERENT AGENCIES ACROSS

4501
02:55:39,888 --> 02:55:41,289
THE GOVERNMENT, AND THEY ARE

4502
02:55:41,289 --> 02:55:42,924
PROVIDING US WITH INSIGHTS INTO

4503
02:55:42,924 --> 02:55:45,126
THE WORK THEY ARE DOING THERE.

4504
02:55:45,126 --> 02:55:46,761
THESE ARE EXAMPLES OF ACTIVITIES

4505
02:55:46,761 --> 02:55:47,962
THAT ARE ONGOING.

4506
02:55:47,962 --> 02:55:50,798
IT DOESN'T MEAN WE HAVE

4507
02:55:50,798 --> 02:55:52,333
ENCOMPASSED EVERYTHING BUT AGAIN

4508
02:55:52,333 --> 02:55:55,069
OVERLAY WHAT YOU HEARD TODAY

4509
02:55:55,069 --> 02:55:55,470
WITH THE SPECIFIC

4510
02:55:55,470 --> 02:55:56,504
RECOMMENDATIONS THAT ARE THERE.

4511
02:55:56,504 --> 02:55:59,674
AND I THINK THAT WE CAN ALSO IN

4512
02:55:59,674 --> 02:56:01,542
OUR REPORT THE WAY THE REPORT IS

4513
02:56:01,542 --> 02:56:03,778
PUT TOGETHER WE CAN MAKE SURE WE

4514
02:56:03,778 --> 02:56:05,713
TAILOR THE LANGUAGE TO SAY IN

4515
02:56:05,713 --> 02:56:07,749
THE AGENCIES THAT WE'RE ABLE TO

4516
02:56:07,749 --> 02:56:08,983
PRESENT TO US, HERE'S THE

4517
02:56:08,983 --> 02:56:13,788
PROGRESS WE'VE SEEN THAT'S BEEN

4518
02:56:13,788 --> 02:56:15,089
MADE.

4519
02:56:15,089 --> 02:56:16,758
OUR REPORT IS A REFLECTION OF

4520
02:56:16,758 --> 02:56:18,593
THE REQUISITE ACTIVITIES OR

4521
02:56:18,593 --> 02:56:20,461
ACTIONS TAKEN WITHIN THESE

4522
02:56:20,461 --> 02:56:22,697
AGENCIES. 

4523
02:56:22,697 --> 02:56:24,465
DOES THAT SEEM ACCEPTABLE?

4524
02:56:24,465 --> 02:56:26,267
>> THAT'S HELPFUL, YES,
THANK

4525
02:56:26,267 --> 02:56:26,434
YOU.

4526
02:56:26,434 --> 02:56:29,637
>> AND THAT TOUCHES ON
WHAT

4527
02:56:29,637 --> 02:56:31,072
WE'RE SEEING, A COMMENT BY

4528
02:56:31,072 --> 02:56:32,807
PROFESSOR CHARO AS WELL THAT

4529
02:56:32,807 --> 02:56:37,745
SAYS IT NEEDS TO BE SEPARATED

4530
02:56:37,745 --> 02:56:39,714
FOR PREGNANCY AND LACTATION.

4531
02:56:39,714 --> 02:56:40,815
WE CAN HAVE CAVEATS, THIS IS

4532
02:56:40,815 --> 02:56:42,984
WHAT WE HEARD AND INTERPRET IT

4533
02:56:42,984 --> 02:56:44,752
AS BEING AT THIS PARTICULAR

4534
02:56:44,752 --> 02:56:48,856
POINT IN TIME HERE FOR PREGNANCY

4535
02:56:48,856 --> 02:56:57,732
BUT NOT LACTATION, VICE VERSA. 

4536
02:56:57,732 --> 02:57:00,935
 

4537
02:57:00,935 --> 02:57:03,671
>> I'M GOING TO LEAVE MY
VIDEO

4538
02:57:03,671 --> 02:57:05,340
OFF, LAST TIME IT CRASHED MY

4539
02:57:05,340 --> 02:57:05,807
ZOOM.

4540
02:57:05,807 --> 02:57:08,843
I WAS GOING TO JUST OFFER, FOR

4541
02:57:08,843 --> 02:57:11,546
ME IN RESPONSE TO DR. CHARO'S

4542
02:57:11,546 --> 02:57:14,749
COMMENT, IF ELEMENT OR

4543
02:57:14,749 --> 02:57:16,918
SUPPLEMENT DOES NOT MEET

4544
02:57:16,918 --> 02:57:18,553
SUFFICIENT FEELINGS AROUND

4545
02:57:18,553 --> 02:57:20,955
EITHER PREGNANCY OR LACTATION,

4546
02:57:20,955 --> 02:57:23,691
THAT WOULD MEAN IT GOES DOWN IN

4547
02:57:23,691 --> 02:57:30,898
COLOR CODING TO USE THAT

4548
02:57:30,898 --> 02:57:33,868
FRAMEWORK, AND THEN WE COULD

4549
02:57:33,868 --> 02:57:34,836
COMMENT LACTATION SHOULD BE

4550
02:57:34,836 --> 02:57:36,604
FURTHER BOLSTERED IN THE REPORT.

4551
02:57:36,604 --> 02:57:38,673
I WAS GOING TO SAY IN TERMS OF

4552
02:57:38,673 --> 02:57:41,009
TRIAGING FOR ME PERSONALLY NONE

4553
02:57:41,009 --> 02:57:43,177
OF THESE ARE GREEN.

4554
02:57:43,177 --> 02:57:48,783
AND I HAD A COMMENT THAT LIKE I

4555
02:57:48,783 --> 02:57:51,519
CAN TELL YOU WHICH I HAD AS

4556
02:57:51,519 --> 02:57:53,588
YELLOW AND RED BUT TWO I HAD AS

4557
02:57:53,588 --> 02:57:53,921
WHITE.

4558
02:57:53,921 --> 02:57:55,723
I UNDERSTAND WE DON'T HAVE THE

4559
02:57:55,723 --> 02:57:58,192
OPPORTUNITY TO GET TO SCORCHED

4560
02:57:58,192 --> 02:58:00,161
EARTH BUT THERE'S A KEY ELEMENT

4561
02:58:00,161 --> 02:58:05,833
THAT WAS MISSING TO THIS 

4562
02:58:05,833 --> 02:58:06,834
PARTICULAR CONVERSATION ABOUT

4563
02:58:06,834 --> 02:58:07,502
REGISTRIES, THE ISSUE OF

4564
02:58:07,502 --> 02:58:11,739
ARTIFICIAL INTELLIGENCE WHEN WE

4565
02:58:11,739 --> 02:58:13,508
THINK ABOUT LARGE DATA

4566
02:58:13,508 --> 02:58:18,012
MANIPULATION OR MODELING, A LOT 

4567
02:58:18,012 --> 02:58:21,616
OF THESE COMMENTS HAVE TO DO,

4568
02:58:21,616 --> 02:58:25,753
THE REPORT FROM PRGLAC, NOVEL

4569
02:58:25,753 --> 02:58:28,623
DATA METHODS AND RESOURCES AND

4570
02:58:28,623 --> 02:58:31,459
LEVERAGING, I FEEL LIKE I'M AN

4571
02:58:31,459 --> 02:58:33,227
OB/GYN RESEARCHER WITH CLINICAL

4572
02:58:33,227 --> 02:58:35,296
EXPERTISE, NOT A COMPUTER

4573
02:58:35,296 --> 02:58:35,730
SCIENTIST.

4574
02:58:35,730 --> 02:58:38,132
I ALMOST WISH THAT -- MAYBE WE

4575
02:58:38,132 --> 02:58:39,434
DO HAVE A COMPUTER SCIENTIST IN

4576
02:58:39,434 --> 02:58:41,102
THE VIRTUAL ROOM AND I WOULD BE

4577
02:58:41,102 --> 02:58:45,606
GLAD TO HEAR FROM THAT PERSON TO

4578
02:58:45,606 --> 02:58:46,874
UNDERSTAND SOME OF THESE

4579
02:58:46,874 --> 02:58:55,216
COMMENTS IN RESPECT TO THE LIKE 

4580
02:58:55,216 --> 02:58:57,819
RAPIDLY ADVANCING COMPUTER

4581
02:58:57,819 --> 02:58:58,152
SCIENCE WORLD.

4582
02:58:58,152 --> 02:58:58,820
>> THAT'S HELPFUL.

4583
02:58:58,820 --> 02:59:00,555
SOUNDS LIKE THERE'S NOTHING WE

4584
02:59:00,555 --> 02:59:04,392
CAN TRIAGE AND WE PROBABLY NOW

4585
02:59:04,392 --> 02:59:05,626
OUGHT TO SYSTEMATICALLY GO

4586
02:59:05,626 --> 02:59:08,362
THROUGH THESE AND GET THE FEEL

4587
02:59:08,362 --> 02:59:09,897
OF THE COMMITTEE AS TO WHETHER

4588
02:59:09,897 --> 02:59:15,069
OR NOT WE'VE SEEN ENOUGH 

4589
02:59:15,069 --> 02:59:17,905
INFORMATION THAT WE HAVE A SENSE

4590
02:59:17,905 --> 02:59:19,240
OF WHETHER OR NOT IT'S BEEN

4591
02:59:19,240 --> 02:59:21,409
ADDRESSED OR ON TRACK OR WHETHER

4592
02:59:21,409 --> 02:59:22,610
WE NEED MORE INFORMATION TO

4593
02:59:22,610 --> 02:59:27,315
REVIEW.

4594
02:59:27,315 --> 02:59:30,284
CHRISTINA, DO YOU WANT TO GO

4595
02:59:30,284 --> 02:59:30,618
STRAIGHT DOWN?

4596
02:59:30,618 --> 02:59:32,787
>> I WOULD SUGGEST DOING
THAT

4597
02:59:32,787 --> 02:59:35,423
SEPARATELY THEN FOR PREGNANCY

4598
02:59:35,423 --> 02:59:36,691
AND LACTATION BECAUSE -- FOR

4599
02:59:36,691 --> 02:59:40,228
LACTATION I THINK IT WILL BE A

4600
02:59:40,228 --> 02:59:47,034
LOT MORE RED ORIENTED THAN IT 

4601
02:59:47,034 --> 02:59:48,836
WILL BE FOR PREGNANCY.

4602
02:59:48,836 --> 02:59:49,270
>> AGREED.

4603
02:59:49,270 --> 02:59:50,838
LET'S START WITH THE DESIGN TO

4604
02:59:50,838 --> 02:59:53,074
LINK MOTHER AND INFANT DATA.

4605
02:59:53,074 --> 02:59:56,577
TAKE A QUICK LOOK OR REFRESH

4606
02:59:56,577 --> 03:00:03,351
YOUR VIEW OF THE SUBCATEGORIES

4607
03:00:03,351 --> 03:00:04,652
ESTABLISH ONGOING WORKING GROUPS

4608
03:00:04,652 --> 03:00:07,522
WITH HHS AND DATA HEALTH RECORD

4609
03:00:07,522 --> 03:00:11,759
EXPERTISE, EXISTING RESOURCES

4610
03:00:11,759 --> 03:00:15,062
AND REGISTRIES.

4611
03:00:15,062 --> 03:00:21,936
DEVELOP VARIABLES FOR

4612
03:00:21,936 --> 03:00:22,570
MOTHER-INFANT RECORDS.

4613
03:00:22,570 --> 03:00:24,472
GENERAL SENSE OF THE GROUP, DO

4614
03:00:24,472 --> 03:00:30,578
YOU FEEL THERE'S BEEN SOME 

4615
03:00:30,578 --> 03:00:34,448
MOVEMENT IN THIS SPACE?

4616
03:00:34,448 --> 03:00:34,682
>> YES.

4617
03:00:34,682 --> 03:00:37,185
>> SOME NODDING HEADS.

4618
03:00:37,185 --> 03:00:39,554
WE'VE GOT SOME YELLOW, YES.

4619
03:00:39,554 --> 03:00:48,329
AND LET'S TALK A LITTLE BIT THEN

4620
03:00:48,329 --> 03:00:49,197
ABOUT ELEMENTS WE FEEL REQUIRE

4621
03:00:49,197 --> 03:00:50,932
OUR GROUP TO CALL OUT A SPECIFIC

4622
03:00:50,932 --> 03:00:52,466
PIECE OF INFORMATION THAT MIGHT

4623
03:00:52,466 --> 03:00:53,901
BE MISSING, SOMETHING THAT MAY

4624
03:00:53,901 --> 03:00:58,072
NOT HAVE BEEN ADDRESSED, SO WE

4625
03:00:58,072 --> 03:00:59,707
CAN ACKNOWLEDGE THAT 12A IS

4626
03:00:59,707 --> 03:01:01,142
SEARCH ONGOING OR PLANNED AND

4627
03:01:01,142 --> 03:01:04,412
THERE'S BEEN MOVEMENT IN THIS

4628
03:01:04,412 --> 03:01:04,612
SPACE.

4629
03:01:04,612 --> 03:01:06,480
AND THE QUESTION BECOMES WHAT

4630
03:01:06,480 --> 03:01:09,650
ARE THE CONCERNS WE HAVE ABOUT

4631
03:01:09,650 --> 03:01:11,118
THESE ELEMENTS MOVING FORWARD

4632
03:01:11,118 --> 03:01:15,423
ULTIMATELY TO THAT GREEN LEVEL

4633
03:01:15,423 --> 03:01:16,924
OF IMPLEMENTATION, A LONG WAY TO

4634
03:01:16,924 --> 03:01:19,727
GO LOOKING THROUGH THE COMMENTS

4635
03:01:19,727 --> 03:01:20,828
HERE, LACK OF PATIENT-REPORTED

4636
03:01:20,828 --> 03:01:25,032
OUTCOMES.

4637
03:01:25,032 --> 03:01:34,008
WE'VE GOT ONE COMMENT WE CAN

4638
03:01:34,008 --> 03:01:34,442
WATCH AND WAIT.

4639
03:01:34,442 --> 03:01:36,777
DOES ANYBODY WANT TO REGISTER

4640
03:01:36,777 --> 03:01:38,279
SPECIFIC ITEMS TO PULL OUT HERE

4641
03:01:38,279 --> 03:01:44,852
THAT WE WANT TO BE REPRESENTED

4642
03:01:44,852 --> 03:01:45,586
IN OUR REPORT?

4643
03:01:45,586 --> 03:01:47,888
>> MIGHT I MAKE A
SUGGESTION?

4644
03:01:47,888 --> 03:01:48,222
>> YES PLEASE.

4645
03:01:48,222 --> 03:01:49,757
>> THERE'S QUITE A HANDFUL
OF

4646
03:01:49,757 --> 03:01:50,858
OUR WORKING GROUP WHO BELIEVES

4647
03:01:50,858 --> 03:01:53,160
THERE'S A LONG WAY TO GO BUT

4648
03:01:53,160 --> 03:01:55,463
THERE'S WORK THAT HAS PROGRESSED

4649
03:01:55,463 --> 03:01:56,230
IN PREGNANCY.

4650
03:01:56,230 --> 03:01:59,233
IS THERE ANYONE WHO DISAGREES

4651
03:01:59,233 --> 03:01:59,734
WITH THAT?

4652
03:01:59,734 --> 03:02:03,237
IT WOULD BE USEFUL TO HAVE I

4653
03:02:03,237 --> 03:02:08,576
SHARE WHY YOU DISAGREE.

4654
03:02:08,576 --> 03:02:10,111
>> I'M TRYING TO TRACK
WHAT

4655
03:02:10,111 --> 03:02:11,312
WE'RE SEEING IN THE MEETING

4656
03:02:11,312 --> 03:02:11,879
CHAT.

4657
03:02:11,879 --> 03:02:18,219
IT LOOKS LIKE WE'VE GOT GENERAL

4658
03:02:18,219 --> 03:02:19,754
CONSENSUS.

4659
03:02:19,754 --> 03:02:21,389
>> YES.

4660
03:02:21,389 --> 03:02:21,656
PREGNANCY.

4661
03:02:21,656 --> 03:02:22,023
>> IN PREGNANCY.

4662
03:02:22,023 --> 03:02:23,457
>> I JUST WANT TO ADD I
AGREE

4663
03:02:23,457 --> 03:02:26,327
WITH THAT, AND I THINK THERE MAY

4664
03:02:26,327 --> 03:02:29,263
BE A COMMENT THAT ALLUDES TO 

4665
03:02:29,263 --> 03:02:29,697
THIS.

4666
03:02:29,697 --> 03:02:31,999
WHAT I WAS STRUCK WITH WAS SOME

4667
03:02:31,999 --> 03:02:35,303
OF THE PRESENTATIONS REGARDING

4668
03:02:35,303 --> 03:02:36,504
DATABASES AND LINKAGES.

4669
03:02:36,504 --> 03:02:41,309
THERE'S BEEN WORK DONE IN THE

4670
03:02:41,309 --> 03:02:42,076
PHARMACO EPIDEMIOLOGICAL WORLD

4671
03:02:42,076 --> 03:02:44,045
FOR SEVERAL DECADES THAT IT

4672
03:02:44,045 --> 03:02:46,447
SEEMS LIKE ONE HAND IS NOT

4673
03:02:46,447 --> 03:02:47,748
NECESSARILY TALKING TO THE OTHER

4674
03:02:47,748 --> 03:02:53,554
AND THEY COULD BENEFIT FROM

4675
03:02:53,554 --> 03:02:53,954
SHARING METHODS.

4676
03:02:53,954 --> 03:02:55,423
>> THAT'S A GREAT COMMENT
THAT

4677
03:02:55,423 --> 03:03:01,462
WILL GET CAPTURED IN THE REPORT.

4678
03:03:01,462 --> 03:03:03,297
ARE THERE ANY ADDITIONAL

4679
03:03:03,297 --> 03:03:06,167
COMMENTS THAT SHOULD BE CAPTURED

4680
03:03:06,167 --> 03:03:09,770
ABOUT THE ELEMENTS IN 12A?

4681
03:03:09,770 --> 03:03:11,072
 

4682
03:03:11,072 --> 03:03:14,575
>> THERE WILL NEED TO BE

4683
03:03:14,575 --> 03:03:15,543
DISCUSSION REGARDING LACTATION,

4684
03:03:15,543 --> 03:03:18,979
MOST LIKELY FOR ALL OF THESE.

4685
03:03:18,979 --> 03:03:19,213
>> YES.

4686
03:03:19,213 --> 03:03:22,016
>> SO I WOULD ACTUALLY
MAKE A

4687
03:03:22,016 --> 03:03:23,017
RECOMMENDATION THAT WE JUST --

4688
03:03:23,017 --> 03:03:25,252
WE OPERATE UNDER THE ASSUMPTION

4689
03:03:25,252 --> 03:03:27,688
THAT LACTATION WILL BE

4690
03:03:27,688 --> 03:03:28,789
IDENTIFIED AS DEFICIENT UNLESS

4691
03:03:28,789 --> 03:03:30,424
WE IDENTIFY IT OTHERWISE HERE

4692
03:03:30,424 --> 03:03:31,292
WITH THE GROUP.

4693
03:03:31,292 --> 03:03:34,495
ARE YOU FEELING DATA ARE

4694
03:03:34,495 --> 03:03:37,331
LIMITED, THERE MAY -- INTENT TO

4695
03:03:37,331 --> 03:03:40,267
COLLECT DATA -- DO WE HAVE ONE

4696
03:03:40,267 --> 03:03:44,205
MORE LINK WITH MOM OR SEVERAL

4697
03:03:44,205 --> 03:03:44,839
BIRTHS?

4698
03:03:44,839 --> 03:03:45,973
I LIKE WHAT IS HAPPENING HERE IN

4699
03:03:45,973 --> 03:03:48,909
THE CHAT WHICH IS WE'VE GOT

4700
03:03:48,909 --> 03:03:50,010
ADDITIONAL COMMENTS AND

4701
03:03:50,010 --> 03:03:50,978
CONSIDERATIONS BEING POPULATED.

4702
03:03:50,978 --> 03:03:53,948
SO THIS SEEMS TO BE A VERY

4703
03:03:53,948 --> 03:03:55,282
EFFECTIVE USE OF OUR TIME IS TO

4704
03:03:55,282 --> 03:03:58,018
MAYBE GO AHEAD AND USE THE CHAT

4705
03:03:58,018 --> 03:03:59,520
FEATURE TO POPULATE THOSE

4706
03:03:59,520 --> 03:04:00,955
ADDITIONAL ELEMENTS THAT SHOULD

4707
03:04:00,955 --> 03:04:03,691
BE ADDRESSED IN THE REPORT.

4708
03:04:03,691 --> 03:04:10,131
AND LET'S MOVE DOWN TO 12B.

4709
03:04:10,131 --> 03:04:16,504
LEVERAGING LARGE STUDIES AND

4710
03:04:16,504 --> 03:04:18,239
DATABASES, EMRs, REGISTRIES.

4711
03:04:18,239 --> 03:04:20,241
IS THERE A GENERAL FEELING FROM

4712
03:04:20,241 --> 03:04:24,612
THE GROUP THIS IS ALSO ONGOING?

4713
03:04:24,612 --> 03:04:29,383
YEP, ONE THUMBS UP.

4714
03:04:29,383 --> 03:04:33,220
A COUPLE NODDING HEADS, ANOTHER

4715
03:04:33,220 --> 03:04:33,888
THUMBS UP.

4716
03:04:33,888 --> 03:04:34,522
FANTASTIC.

4717
03:04:34,522 --> 03:04:35,823
ANY SPECIFIC CAVEATS THAT NEED

4718
03:04:35,823 --> 03:04:37,725
TO BE ACKNOWLEDGED BASED ON WHAT

4719
03:04:37,725 --> 03:04:40,428
WE'VE HEARD TODAY?

4720
03:04:40,428 --> 03:04:45,166
 

4721
03:04:45,166 --> 03:04:47,034
>> I THINK -- I DON'T KNOW
IF

4722
03:04:47,034 --> 03:04:51,539
THEY WANT TO SPEAK UP,

4723
03:04:51,539 --> 03:04:54,141
MR. HERTZ, YOUR POINT IS WELL

4724
03:04:54,141 --> 03:04:55,676
TAKEN, A PIECE WE PERHAPS NEED

4725
03:04:55,676 --> 03:04:58,546
TO PARKING LOT TO DISCUSS, YES?

4726
03:04:58,546 --> 03:05:00,614
>> AND WHERE IS THAT?

4727
03:05:00,614 --> 03:05:01,582
THIS IS MOVING FASTER.

4728
03:05:01,582 --> 03:05:05,085
I'M GOING TO TRUST YOU TO TAKE

4729
03:05:05,085 --> 03:05:06,120
THE CHAT --

4730
03:05:06,120 --> 03:05:07,288
>> BARRIERS BEING
FULFILLED AS A

4731
03:05:07,288 --> 03:05:11,392
WHOLE ON A FULL SCALE BY ALL

4732
03:05:11,392 --> 03:05:12,193
IMPLEMENTERS AND STAKEHOLDERS, I

4733
03:05:12,193 --> 03:05:13,828
THINK THAT'S A VERY IMPORTANT

4734
03:05:13,828 --> 03:05:16,096
PART OF WHAT WE IDENTIFIED, NEED

4735
03:05:16,096 --> 03:05:19,066
TO DISCUSS IF THERE ARE IN FACT

4736
03:05:19,066 --> 03:05:20,100
SOME SPECIFIC BARRIERS.

4737
03:05:20,100 --> 03:05:20,534
>> AGREED.

4738
03:05:20,534 --> 03:05:25,105
>> YEAH, THIS IS K J AT
MARCH OF

4739
03:05:25,105 --> 03:05:25,539
DIMES.

4740
03:05:25,539 --> 03:05:26,841
YOU JUST EXPLAINED MY COMMENT

4741
03:05:26,841 --> 03:05:29,910
BUT WHAT I GUESS I WAS GETTING

4742
03:05:29,910 --> 03:05:32,746
AT IS THAT IF THERE HAD BEEN

4743
03:05:32,746 --> 03:05:34,281
SOME PROGRESS MADE WE COULD

4744
03:05:34,281 --> 03:05:36,016
DOCUMENT THAT BUT I THINK WE

4745
03:05:36,016 --> 03:05:40,721
NEED TO BE VERY CLEAR CUT

4746
03:05:40,721 --> 03:05:45,459
SHOWING WHERE BARRIERS ARE FOR

4747
03:05:45,459 --> 03:05:49,697
MORE WHOLESALE HOLISTIC FULL

4748
03:05:49,697 --> 03:05:51,665
SCALE ADOPTION, IN THE SYSTEM,

4749
03:05:51,665 --> 03:05:55,736
AS FAR AS EHRs, YOU KNOW, BY

4750
03:05:55,736 --> 03:05:57,905
HOSPITAL SYSTEMS AND WHERE THE

4751
03:05:57,905 --> 03:05:58,205
DATA ARE.

4752
03:05:58,205 --> 03:05:59,540
>> ABSOLUTELY.

4753
03:05:59,540 --> 03:06:00,441
EVEN OUR COLLEAGUES AT FDA LAID

4754
03:06:00,441 --> 03:06:02,510
OUT SOME OF THAT NICELY FOR US

4755
03:06:02,510 --> 03:06:08,315
WHERE THE CHALLENGES ARE 

4756
03:06:08,315 --> 03:06:11,252
W ITHRESPECT TO WHO OWNS DATA,

4757
03:06:11,252 --> 03:06:13,454
WHO TAKES THE LEAD, THINGS WE

4758
03:06:13,454 --> 03:06:16,724
COULD IDENTIFY AS BARRIERS TO BE

4759
03:06:16,724 --> 03:06:18,392
COGNIZANT OF AND PERHAPS MAKE

4760
03:06:18,392 --> 03:06:21,028
RECOMMENDATIONS ABOUT PROMOTING 

4761
03:06:21,028 --> 03:06:22,296
ADDITIONAL DISCUSSION OR

4762
03:06:22,296 --> 03:06:23,330
SOMETHING ELSE TO HELP US

4763
03:06:23,330 --> 03:06:29,003
ACKNOWLEDGE THE BARRIERS AND GET

4764
03:06:29,003 --> 03:06:29,270
PAST THEM.

4765
03:06:29,270 --> 03:06:29,703
>> PROFESSOR CHARO?

4766
03:06:29,703 --> 03:06:33,474
>> IT WAS INTERESTING HOW 

4767
03:06:33,474 --> 03:06:34,174
DIFFERENT DATA SOURCES HAD

4768
03:06:34,174 --> 03:06:35,242
DIFFERENT AREAS OF BIAS.

4769
03:06:35,242 --> 03:06:36,777
THERE WAS A COMMENT IN CHAT

4770
03:06:36,777 --> 03:06:39,179
SOMEBODY MADE ABOUT RURAL VERSUS

4771
03:06:39,179 --> 03:06:40,814
URBAN CENTERS AND EFFECT OF

4772
03:06:40,814 --> 03:06:41,682
COLLECTING DATA.

4773
03:06:41,682 --> 03:06:45,753
THERE WAS A PRESENTATION THAT

4774
03:06:45,753 --> 03:06:47,721
FOCUSED ON MEDICAID DATA WHICH

4775
03:06:47,721 --> 03:06:48,255
PICKS UP UNDERPRIVILEGED

4776
03:06:48,255 --> 03:06:49,356
POPULATION BUT I DON'T KNOW THAT

4777
03:06:49,356 --> 03:06:52,860
I WAS ABLE TO CAPTURE SOMETHING

4778
03:06:52,860 --> 03:06:55,129
THAT TOLD ME OVERALL WHAT'S THE

4779
03:06:55,129 --> 03:06:56,363
MIX OF BIASES AND ARE WE AT THE

4780
03:06:56,363 --> 03:06:58,098
POINT WHICH THEY ARE CANCELING

4781
03:06:58,098 --> 03:07:01,402
EACH OTHER OUT OR IS THERE A

4782
03:07:01,402 --> 03:07:03,804
KIND OF OVERSAMPLING OR

4783
03:07:03,804 --> 03:07:04,905
UNDERSAMPLING OF SPECIFIC

4784
03:07:04,905 --> 03:07:06,006
POPULATIONS?

4785
03:07:06,006 --> 03:07:08,409
IT DID SEEM HERE ONE NUANCE IS

4786
03:07:08,409 --> 03:07:12,413
THAT THERE BE AN  EVALUATION OF

4787
03:07:12,413 --> 03:07:15,649
SOURCES OF DATA TO LOOK AT

4788
03:07:15,649 --> 03:07:25,292
WHETHER OR NOT IT'S GIVEN AS AC 

4789
03:07:25,292 --> 03:07:26,093
ACCURATE SNAPSHOT.

4790
03:07:26,093 --> 03:07:27,394
>> THERE REMAIN UNKNOWN
ELEMENTS

4791
03:07:27,394 --> 03:07:30,664
IN TERMS OF SCOPE OF THESE

4792
03:07:30,664 --> 03:07:32,533
RESOURCES SO I THINK THAT'S A

4793
03:07:32,533 --> 03:07:35,736
GREAT POINT TO CAVEAT THIS AS

4794
03:07:35,736 --> 03:07:41,075
WELL.

4795
03:07:41,075 --> 03:07:43,143
12B, DELINEATION, INCREDIBLY

4796
03:07:43,143 --> 03:07:44,912
IMPORTANT, I AGREE WE NEED TO

4797
03:07:44,912 --> 03:07:46,680
DELINEATE CHALLENGES AND COULD

4798
03:07:46,680 --> 03:07:48,415
CERTAINLY DO THAT BUT, AGAIN,

4799
03:07:48,415 --> 03:07:50,851
ARE WE -- SOUNDS AS IF WE'RE IN

4800
03:07:50,851 --> 03:07:52,920
GENERAL AGREEMENT THAT AT LEAST

4801
03:07:52,920 --> 03:07:54,221
THERE'S INITIATIVE THIS IS

4802
03:07:54,221 --> 03:07:56,090
ONGOING AND WE'VE NOW STARTED TO

4803
03:07:56,090 --> 03:07:59,059
CAPTURE SOME OF THE LIMITATIONS

4804
03:07:59,059 --> 03:08:01,362
AND CONCERNS.

4805
03:08:01,362 --> 03:08:05,065
>> THERE'S A QUESTION FOR

4806
03:08:05,065 --> 03:08:06,266
CLARIFICATION, WOULD THESE

4807
03:08:06,266 --> 03:08:08,802
RESOURCES BE LISTED ON THE DASH

4808
03:08:08,802 --> 03:08:09,536
WEBSITE?

4809
03:08:09,536 --> 03:08:12,072
I'M GOING ASK OUR COLLEAGUES IF

4810
03:08:12,072 --> 03:08:13,807
KATIE IS ON IF SHE COULD SPEAK

4811
03:08:13,807 --> 03:08:18,178
TO THAT.

4812
03:08:18,178 --> 03:08:18,746
>> OKAY.

4813
03:08:18,746 --> 03:08:21,048
SO THE QUESTION IS, IS THERE A

4814
03:08:21,048 --> 03:08:24,318
WEBSITE THAT PROVIDES US WITH A

4815
03:08:24,318 --> 03:08:26,420
LIST OF REGISTRIES AND ANY

4816
03:08:26,420 --> 03:08:27,488
OTHER -- WHAT OTHER RESOURCES,

4817
03:08:27,488 --> 03:08:33,160
I'M SORRY, I DID MISS THAT.

4818
03:08:33,160 --> 03:08:36,363
>> YEAH, ALLISON, DO YOU
WANT TO

4819
03:08:36,363 --> 03:08:37,898
CLARIFY WHICH RESOURCES YOU'RE

4820
03:08:37,898 --> 03:08:44,571
THINKING ABOUT BECAUSE DASH IS

4821
03:08:44,571 --> 03:08:45,339
REALLY THAT RESULTS DATA.

4822
03:08:45,339 --> 03:08:47,975
SO WHAT ARE YOU THINKING ABOUT

4823
03:08:47,975 --> 03:08:49,243
THERE WITH THAT QUESTION?

4824
03:08:49,243 --> 03:08:51,478
>> MY QUESTION, WHAT DOES
DASH

4825
03:08:51,478 --> 03:08:53,681
OFFER US AS FAR AS IMPACTING

4826
03:08:53,681 --> 03:08:55,015
THIS CONVERSATION.

4827
03:08:55,015 --> 03:08:56,950
SOMEONE ELSE HAD ASKED WHERE DO

4828
03:08:56,950 --> 03:08:58,619
WE FIND THESE RESOURCES, IS

4829
03:08:58,619 --> 03:09:00,688
THERE A DATABASE FOR MANUSCRIPT,

4830
03:09:00,688 --> 03:09:02,656
I RESPONDED WITH A QUESTION

4831
03:09:02,656 --> 03:09:04,024
WHICH WAS, DOES DASH HELP US

4832
03:09:04,024 --> 03:09:05,492
HONE IN ON SOME OF THAT

4833
03:09:05,492 --> 03:09:07,695
INFORMATION?

4834
03:09:07,695 --> 03:09:08,929
>> OKAY, GREAT QUESTION.

4835
03:09:08,929 --> 03:09:11,732
YEAH, SO AT THE MOMENT, DASH

4836
03:09:11,732 --> 03:09:13,367
WILL POINT -- WHAT DASH CAN

4837
03:09:13,367 --> 03:09:15,569
POINT YOU TO IS DATA STORED

4838
03:09:15,569 --> 03:09:19,273
WITHIN DASH, DATA THAT HAS BEEN

4839
03:09:19,273 --> 03:09:21,041
SUBMITTED, DE-IDENTIFIED DATA

4840
03:09:21,041 --> 03:09:23,744
SUBMITTED INTO THE DASH

4841
03:09:23,744 --> 03:09:24,445
REPOSITORY ITSELF.

4842
03:09:24,445 --> 03:09:27,314
I THINK THERE ARE -- THERE'S

4843
03:09:27,314 --> 03:09:29,149
SOME MOVEMENT TO MODERNIZE DASH

4844
03:09:29,149 --> 03:09:31,018
AND MAKE IT -- TO DEVELOP SOME

4845
03:09:31,018 --> 03:09:35,622
TOOLS THAT CAN HELP POINT

4846
03:09:35,622 --> 03:09:37,024
INVESTIGATORS TO OTHER DATA THAT

4847
03:09:37,024 --> 03:09:39,993
ARE OUT THERE PARTICULARLY IN A

4848
03:09:39,993 --> 03:09:42,062
REPRODUCTIVE HEALTH SPACE BUT

4849
03:09:42,062 --> 03:09:42,963
THOSE ARE STILL YOU UNDER

4850
03:09:42,963 --> 03:09:44,031
DISCUSSION AT THIS POINT.

4851
03:09:44,031 --> 03:09:46,100
THEY HAVEN'T BEEN DEVELOPED OR

4852
03:09:46,100 --> 03:09:47,000
IMPLEMENTED BUT THAT'S THE

4853
03:09:47,000 --> 03:09:52,139
DISCUSSION THAT THE DASH TEAM IS

4854
03:09:52,139 --> 03:09:54,975
HAVING.

4855
03:09:54,975 --> 03:09:56,844
HOW TO FACILITATE IDENTIFYING

4856
03:09:56,844 --> 03:09:58,979
DATA ACROSS REPOSITORIES, NOT

4857
03:09:58,979 --> 03:10:01,014
JUST WITHIN DASH.

4858
03:10:01,014 --> 03:10:05,252
I DO WANT TO MENTION THE IMPRINT

4859
03:10:05,252 --> 03:10:05,652
KNOWLEDGE PORTAL.

4860
03:10:05,652 --> 03:10:07,221
SO THAT WILL -- THAT IS

4861
03:10:07,221 --> 03:10:08,222
COLLECTING DATA PRIMARILY

4862
03:10:08,222 --> 03:10:11,625
RELATED TO PUBLICATIONS BUT ALSO

4863
03:10:11,625 --> 03:10:12,926
FROM OTHER DATA SOURCES.

4864
03:10:12,926 --> 03:10:17,631
AND IT WILL POINT INVESTIGATORS

4865
03:10:17,631 --> 03:10:21,068
TO THE LOCATION OF DATA, SO

4866
03:10:21,068 --> 03:10:23,670
WHETHER THAT IS A MODEL OR A

4867
03:10:23,670 --> 03:10:24,571
DATASET, I THINK EVENTUALLY THE

4868
03:10:24,571 --> 03:10:27,741
GOAL IS TO HAVE THAT KNOWLEDGE

4869
03:10:27,741 --> 03:10:28,942
PORTAL ABLE TO POINT

4870
03:10:28,942 --> 03:10:31,044
INVESTIGATORS TO WHERE THE DATA

4871
03:10:31,044 --> 03:10:32,012
ACTUALLY ARE.

4872
03:10:32,012 --> 03:10:33,313
BECAUSE THAT'S DEFINITELY A NEED

4873
03:10:33,313 --> 03:10:34,848
IN THIS SPACE, JUST FIGURING OUT

4874
03:10:34,848 --> 03:10:36,049
WHERE ARE THE DATA BECAUSE THERE

4875
03:10:36,049 --> 03:10:37,684
ARE SO MANY DIFFERENT PLACES

4876
03:10:37,684 --> 03:10:38,952
WHERE IT IS SHARED AND STORED.

4877
03:10:38,952 --> 03:10:46,627
THAT WAS A GREAT QUESTION.

4878
03:10:46,627 --> 03:10:52,232
>> SO, IT SOUNDS LIKE THE

4879
03:10:52,232 --> 03:10:52,866
CONVERSATION AROUND 12B RELATES

4880
03:10:52,866 --> 03:10:56,804
TO THE FACT THAT THIS IS

4881
03:10:56,804 --> 03:10:58,205
ONGOING, AGAIN IT'S VERY

4882
03:10:58,205 --> 03:11:03,043
SPECIFIC WHERE IT IS OCCURRING, 

4883
03:11:03,043 --> 03:11:04,778
WHERE IT'S TAKING PLACE.

4884
03:11:04,778 --> 03:11:07,748
THERE MAY BE SOME ACCESSIBILITY

4885
03:11:07,748 --> 03:11:10,150
ISSUES, ALTHOUGH THIS IS

4886
03:11:10,150 --> 03:11:12,586
REALLY -- THIS PARTICULAR

4887
03:11:12,586 --> 03:11:13,887
RECOMMENDATION IS FOCUSING MORE

4888
03:11:13,887 --> 03:11:16,723
ON THE EXPLORATION OF THIS.

4889
03:11:16,723 --> 03:11:17,925
SO, THERE'S CLEAR EVIDENCE

4890
03:11:17,925 --> 03:11:22,296
THAT'S TAKING PLACE BUT IT'S

4891
03:11:22,296 --> 03:11:23,931
HIGHLY SPECIFIC AND TRANSPARENCY

4892
03:11:23,931 --> 03:11:26,733
MAY BE AN ISSUE TO DISCUSS.

4893
03:11:26,733 --> 03:11:29,403
>> AND I WOULD SUGGEST
AGAIN,

4894
03:11:29,403 --> 03:11:34,675
JUST TO ADD BEFORE WE MOVE TO

4895
03:11:34,675 --> 03:11:36,410
12C, PUT YOUR COMMENTS IN THE

4896
03:11:36,410 --> 03:11:36,610
CHAT.

4897
03:11:36,610 --> 03:11:38,612
THE CHAT IS BEING COLLECTED AND

4898
03:11:38,612 --> 03:11:41,348
RECORDED SO THIS HELPS US TO

4899
03:11:41,348 --> 03:11:42,983
KEEP A REMINDER OF POINTS RAISED

4900
03:11:42,983 --> 03:11:44,751
SO PLEASE DO CONTINUE TO USE THE

4901
03:11:44,751 --> 03:11:48,121
CHAT FEATURE. 

4902
03:11:48,121 --> 03:11:48,722
>> AND, AGAIN, --

4903
03:11:48,722 --> 03:11:51,091
>> WE CAN'T SEE THEM LIVE
BUT

4904
03:11:51,091 --> 03:11:54,728
WITH KEEP THE INFORMATION IN THE

4905
03:11:54,728 --> 03:11:55,062
CHAT FEATURE.

4906
03:11:55,062 --> 03:11:55,629
>> THIS COMMITTEE WILL BE

4907
03:11:55,629 --> 03:11:57,431
REVIEWING THE REPORT AND MAKING

4908
03:11:57,431 --> 03:11:58,332
CHANGES SO WHAT WE'RE TRYING TO

4909
03:11:58,332 --> 03:12:00,934
DO RIGHT NOW IS CAPTURE A

4910
03:12:00,934 --> 03:12:03,036
FRAMEWORK AND WE CAN EXPAND OUT

4911
03:12:03,036 --> 03:12:05,205
ANY OF THESE COMMENTS, ONCE

4912
03:12:05,205 --> 03:12:06,306
WE'RE ACTUALLY AT THE WRITING

4913
03:12:06,306 --> 03:12:08,609
STAGE.

4914
03:12:08,609 --> 03:12:10,777
 

4915
03:12:10,777 --> 03:12:11,245
 

4916
03:12:11,245 --> 03:12:14,381
>>  12C, THE USE OF DATA,
NOVEL

4917
03:12:14,381 --> 03:12:17,017
DATA RESOURCES, THAT SUPPORT

4918
03:12:17,017 --> 03:12:18,018
LARGE POST-MARKETING

4919
03:12:18,018 --> 03:12:19,753
OBSERVATIONAL STUDIES, SUPPORTS

4920
03:12:19,753 --> 03:12:23,724
STUDIES ACROSS MULTIPLE DRUGS,

4921
03:12:23,724 --> 03:12:25,225
USING THE SAME INFRASTRUCTURE, I

4922
03:12:25,225 --> 03:12:27,861
THINK THERE'S CLEAR EVIDENCE

4923
03:12:27,861 --> 03:12:28,862
THAT'S TAKING PLACE.

4924
03:12:28,862 --> 03:12:31,365
I'D LIKE TO HEAR FROM FOLKS ON

4925
03:12:31,365 --> 03:12:34,434
THE WORKING GROUP AS TO WHERE

4926
03:12:34,434 --> 03:12:38,906
THEY THINK THIS IS IN PROCESS.

4927
03:12:38,906 --> 03:12:42,542
 

4928
03:12:42,542 --> 03:12:44,177
>> DO YOU WANT TO ADD
ANYTHING

4929
03:12:44,177 --> 03:12:47,881
TO WHAT YOU SAID PREVIOUSLY? 

4930
03:12:47,881 --> 03:12:51,952
>> YEAH, I MEAN, I THINK
THIS IS

4931
03:12:51,952 --> 03:12:52,185
ONGOING.

4932
03:12:52,185 --> 03:12:54,454
IT'S TRICKY BECAUSE I THINK WE

4933
03:12:54,454 --> 03:12:56,890
CAN KIND OF GO -- WE CAN MAKE A

4934
03:12:56,890 --> 03:12:58,592
CASE FOR YELLOW OR RED IN MANY

4935
03:12:58,592 --> 03:13:00,560
OF THESE BUT I THINK FROM WHAT

4936
03:13:00,560 --> 03:13:03,864
WE SAW TODAY, THIS IS ONGOING,

4937
03:13:03,864 --> 03:13:05,299
IN MY PERSPECTIVE.

4938
03:13:05,299 --> 03:13:07,334
MORE SO IN THE SAFETY SPACE OF

4939
03:13:07,334 --> 03:13:09,770
IT AND NOT IN THE LACTATION

4940
03:13:09,770 --> 03:13:13,941
SPACE, BUT DEALING WITH

4941
03:13:13,941 --> 03:13:14,641
PREGNANCY.

4942
03:13:14,641 --> 03:13:16,109
LEYLA OR TRISH, DO YOU HAVE

4943
03:13:16,109 --> 03:13:16,576
ANYTHING MORE TO ADD?

4944
03:13:16,576 --> 03:13:17,678
>> THIS IS TRISH.

4945
03:13:17,678 --> 03:13:18,111
NOTHING TO ADD.

4946
03:13:18,111 --> 03:13:20,180
>> I DON'T HAVE ANYTHING
TO ADD

4947
03:13:20,180 --> 03:13:23,150
EITHER, THANKS. 

4948
03:13:23,150 --> 03:13:29,189
>> AND IT COULD  RUMP TO
RED --

4949
03:13:29,189 --> 03:13:30,924
BUMP TO RED IF THERE WAS NO

4950
03:13:30,924 --> 03:13:31,725
MOVEMENT, NOTHING HAPPENING.

4951
03:13:31,725 --> 03:13:35,662
HEARING WHAT YOU SAID

4952
03:13:35,662 --> 03:13:36,997
REGISTERING COMMENTS I THINK

4953
03:13:36,997 --> 03:13:38,065
WE'RE AT ONGOING PLAN AND I

4954
03:13:38,065 --> 03:13:42,002
WOULD ASK FOLKS TO USE THE CHAT

4955
03:13:42,002 --> 03:13:45,205
TO POPULATE ELEMENTS OR POINTS

4956
03:13:45,205 --> 03:13:47,074
OF CONSIDERATION THAT NEED TO BE

4957
03:13:47,074 --> 03:13:49,710
ADDRESSED WITH RESPECT TO

4958
03:13:49,710 --> 03:13:54,381
LIMITATIONS OR BARRIERS.

4959
03:13:54,381 --> 03:13:55,983
>> GO AHEAD, CHRISTINA.

4960
03:13:55,983 --> 03:13:57,985
>> ONE CAVEAT REGARDING

4961
03:13:57,985 --> 03:13:58,318
EFFECTIVENESS.

4962
03:13:58,318 --> 03:13:58,552
>> YES.

4963
03:13:58,552 --> 03:13:59,953
>> BECAUSE THAT'S THE ONE

4964
03:13:59,953 --> 03:14:02,923
COMPONENT THAT WE DO NEED TO

4965
03:14:02,923 --> 03:14:05,092
HAVE PERHAPS SOME DISCUSSION

4966
03:14:05,092 --> 03:14:08,195
WITHIN THE REPORT ON THE ABILITY

4967
03:14:08,195 --> 03:14:10,330
TO DO SO, WITH THE CURRENT TOOLS

4968
03:14:10,330 --> 03:14:13,734
OR IF THERE IS GOING TO BE

4969
03:14:13,734 --> 03:14:14,468
FUTURE CONSIDERATION OF

4970
03:14:14,468 --> 03:14:20,874
UTILIZATION OF TOOLS FOR 

4971
03:14:20,874 --> 03:14:21,742
PURPOSES OF EFFECTIVENESS

4972
03:14:21,742 --> 03:14:21,975
ANALYSIS

4973
03:14:21,975 --> 03:14:26,913
>>  SAMPLE OF BUILDING OUT
AREAS

4974
03:14:26,913 --> 03:14:28,849
THAT NEED TO BE ADDRESSED.

4975
03:14:28,849 --> 03:14:31,685
THANK YOU VERY MUCH, CHRISTINA.

4976
03:14:31,685 --> 03:14:33,553
12D RELATES TO USE OF INNOVATIVE

4977
03:14:33,553 --> 03:14:34,821
METHODS OF DATA ANALYSIS.

4978
03:14:34,821 --> 03:14:36,823
SO THIS GETS BACK TO WHAT A

4979
03:14:36,823 --> 03:14:39,359
PREVIOUS SPEAKER HAD JUST

4980
03:14:39,359 --> 03:14:40,327
BROUGHT UP ABOUT ARTIFICIAL

4981
03:14:40,327 --> 03:14:42,629
INTELLIGENCE, BUT THE USE OF

4982
03:14:42,629 --> 03:14:44,831
METHODS AND DEANNELYTICS TO LINK

4983
03:14:44,831 --> 03:14:45,932
MULTIPLE DATA SOURCES TO

4984
03:14:45,932 --> 03:14:48,435
IDENTIFY METHODS OF DATA

4985
03:14:48,435 --> 03:14:49,369
ANALYTICS, CONSIDER ESTABLISHING

4986
03:14:49,369 --> 03:14:50,003
PUBLIC/PRIVATE PARTNERSHIPS TO

4987
03:14:50,003 --> 03:14:58,545
VERY MANY STRATEGIES FOR USING

4988
03:14:58,545 --> 03:15:01,381
INNOVATIVE METHODS, WE DEFEEL

4989
03:15:01,381 --> 03:15:04,051
THERE'S BEEN -- - DO WE FEEL

4990
03:15:04,051 --> 03:15:05,385
THERE'S MOVEMENT IN THIS AREA.

4991
03:15:05,385 --> 03:15:07,754
>> CAN YOU CLARIFY WHAT
YOU MEAN

4992
03:15:07,754 --> 03:15:11,925
BY YOUR WORD "METHODS"?

4993
03:15:11,925 --> 03:15:15,796
>> I WOULD DRAW YOUR
ATTENTION

4994
03:15:15,796 --> 03:15:16,930
TO THE IMPLEMENTATION PLAN IT

4995
03:15:16,930 --> 03:15:19,399
BREAKS IT DOWN A LITTLE BIT MORE

4996
03:15:19,399 --> 03:15:20,367
FOR YOU THERE.

4997
03:15:20,367 --> 03:15:26,373
SO IF YOU LOOK AT 12D SUBPART A,

4998
03:15:26,373 --> 03:15:28,575
PROBABILISTIC MATCH, UNIQUE

4999
03:15:28,575 --> 03:15:29,176
IDENTIFIERS, NATURAL LANGUAGE

5000
03:15:29,176 --> 03:15:31,111
PROCESSING, THAT TYPE OF THING.

5001
03:15:31,111 --> 03:15:31,411
>> THANKS.

5002
03:15:31,411 --> 03:15:32,612
SORRY ABOUT THAT, I DIDN'T HAVE

5003
03:15:32,612 --> 03:15:34,181
IT UP ON MY SCREEN.

5004
03:15:34,181 --> 03:15:35,248
>> NO PROBLEM.

5005
03:15:35,248 --> 03:15:35,782
PAMELA, THANK YOU.

5006
03:15:35,782 --> 03:15:38,518
YOU'RE SAYING YES THERE'S

5007
03:15:38,518 --> 03:15:40,487
MOVEMENT BUT WE AGREE BETTER

5008
03:15:40,487 --> 03:15:42,222
HEARING FROM SOMEONE WITH

5009
03:15:42,222 --> 03:15:42,489
EXPERTISE.

5010
03:15:42,489 --> 03:15:44,224
I THINK HOW I WOULD INTERPRET

5011
03:15:44,224 --> 03:15:45,759
THAT IS THAT THE CONVERSATION

5012
03:15:45,759 --> 03:15:47,928
RIGHT NOW THAT ACTIVITY RIGHT

5013
03:15:47,928 --> 03:15:49,129
NOW IS PROBABLY INCOMPLETE OR

5014
03:15:49,129 --> 03:15:53,300
PERHAPS OUR KNOWLEDGE IS

5015
03:15:53,300 --> 03:15:53,600
INCOMPLETE.

5016
03:15:53,600 --> 03:16:02,476
WITH RESPECT TO WHETHER OR NOT 

5017
03:16:02,476 --> 03:16:08,982
THERE ARE OTHER SECTORS.

5018
03:16:08,982 --> 03:16:14,621
>> I WOULD AGREE.

5019
03:16:14,621 --> 03:16:15,422
>> IT'S NOT NECESSARILY

5020
03:16:15,422 --> 03:16:16,823
ALIGNMENT WITH THE WORKING

5021
03:16:16,823 --> 03:16:20,460
GROUP. 

5022
03:16:20,460 --> 03:16:26,800
I'D LOVE TO HEAR FROM OTHERS.

5023
03:16:26,800 --> 03:16:28,668
>> I DON'T SEE HOW THE

5024
03:16:28,668 --> 03:16:30,103
PRESENTATION I HEARD FROM TODAY

5025
03:16:30,103 --> 03:16:32,272
AND I'M HAPPY TO BE CORRECTED ON

5026
03:16:32,272 --> 03:16:34,674
THIS, I FEEL LIKE I'M THE MEAN

5027
03:16:34,674 --> 03:16:37,344
ONE IN THIS MEETING, IS THAT

5028
03:16:37,344 --> 03:16:39,713
THEY SEEMED LIKE METHODS I HAVE

5029
03:16:39,713 --> 03:16:41,381
SEEN AND HEARD OF BEFORE, MANY

5030
03:16:41,381 --> 03:16:41,715
TIMES.

5031
03:16:41,715 --> 03:16:44,651
WHICH IS NOT TO SAY THAT'S BAD

5032
03:16:44,651 --> 03:16:46,286
BUT THAT'S GREAT.

5033
03:16:46,286 --> 03:16:48,622
I'M GLAD THEY ARE DOING THINGS

5034
03:16:48,622 --> 03:16:51,124
THAT WORK WELL IN THE PREGNANCY

5035
03:16:51,124 --> 03:16:52,993
AND LACTATION SPACE BUT THAT'S

5036
03:16:52,993 --> 03:16:55,795
NOT NOVEL TO ME.

5037
03:16:55,795 --> 03:16:59,432
SPECIFICALLY, THE OUTLINE OF THE

5038
03:16:59,432 --> 03:17:01,801
RECOMMENDATIONS POINTS TOWARDS

5039
03:17:01,801 --> 03:17:02,435
NOVEL COMPUTER SCIENCE-DRIVEN

5040
03:17:02,435 --> 03:17:03,937
METHODS SO I'M NOT AN EXPERT IN

5041
03:17:03,937 --> 03:17:05,038
THAT SPACE.

5042
03:17:05,038 --> 03:17:09,309
I'D BE GLAD TO HAVE AN EXPERT

5043
03:17:09,309 --> 03:17:10,610
TELL US IF PEOPLE THINK WE'RE

5044
03:17:10,610 --> 03:17:13,480
DOING A GOOD JOB OR THERE'S MORE

5045
03:17:13,480 --> 03:17:13,747
TO GO.

5046
03:17:13,747 --> 03:17:15,448
>> I AGREE.

5047
03:17:15,448 --> 03:17:17,317
I WAS THINKING THIS WAS -- I

5048
03:17:17,317 --> 03:17:20,153
WANT TO SAY JUST KINDERGARTEN AS

5049
03:17:20,153 --> 03:17:21,588
OPPOSED TO FIRST GRADE, SECOND

5050
03:17:21,588 --> 03:17:24,090
GRADE, EVEN HIGH SCHOOL.

5051
03:17:24,090 --> 03:17:25,725
IT JUST DIDN'T SOUND LIKE, OH,

5052
03:17:25,725 --> 03:17:29,229
THIS IS A JUMP IN AND IT'S

5053
03:17:29,229 --> 03:17:30,463
RUNNING, IT'S MORE, OH, WHY

5054
03:17:30,463 --> 03:17:32,199
DON'T WE TRY THIS.

5055
03:17:32,199 --> 03:17:32,399
SORRY.

5056
03:17:32,399 --> 03:17:33,967
>> NO, THAT'S HELPFUL.

5057
03:17:33,967 --> 03:17:35,368
I WOULD SAY LET'S, FOR EXAMPLE,

5058
03:17:35,368 --> 03:17:39,973
TAKE A LOOK AT 12D SUBPART B,

5059
03:17:39,973 --> 03:17:41,641
USING DATA ANALYTICS METHODS TO

5060
03:17:41,641 --> 03:17:43,710
LINK MULTIPLE DATA SOURCES.

5061
03:17:43,710 --> 03:17:46,880
AND SO I DO THINK THAT WE'VE GOT

5062
03:17:46,880 --> 03:17:48,415
SOME, AND WE'VE HEARD A LITTLE

5063
03:17:48,415 --> 03:17:50,050
EVIDENCE FOR THAT TODAY.

5064
03:17:50,050 --> 03:17:52,786
THERE'S CERTAINLY AT LEAST PILOT

5065
03:17:52,786 --> 03:17:55,722
DATA OUT THERE THAT DEMONSTRATES

5066
03:17:55,722 --> 03:17:56,957
THAT THERE'S SOME CAPABILITY.

5067
03:17:56,957 --> 03:17:59,492
BUT, AGAIN, I'M NOT TRYING TO

5068
03:17:59,492 --> 03:18:01,561
SWAY THE GROUP ONE WAY OR

5069
03:18:01,561 --> 03:18:01,795
ANOTHER.

5070
03:18:01,795 --> 03:18:03,964
I'M JUST SUGGESTING THERE ARE

5071
03:18:03,964 --> 03:18:06,366
SOME ELEMENTS OF THIS THAT WE'VE

5072
03:18:06,366 --> 03:18:11,204
HEARD AT LEAST IN PROCESS AND

5073
03:18:11,204 --> 03:18:11,738
ONGOING.

5074
03:18:11,738 --> 03:18:11,938
LYNN?

5075
03:18:11,938 --> 03:18:14,908
>> MY ATTENTION WAS DRAWN
ALSO

5076
03:18:14,908 --> 03:18:17,277
TO 12D, PART C.

5077
03:18:17,277 --> 03:18:19,512
ESTABLISHING PUBLIC/PRIVATE

5078
03:18:19,512 --> 03:18:20,513
PARTNERSHIPS TO DEVELOP METHODS,

5079
03:18:20,513 --> 03:18:22,482
STRATEGIES USING METHODS.

5080
03:18:22,482 --> 03:18:25,085
I FEEL THERE MIGHT BE

5081
03:18:25,085 --> 03:18:26,052
PUBLIC/PRIVATE PARTNERSHIPS FOR

5082
03:18:26,052 --> 03:18:27,721
COLLECTION DATA I DID NOT FEEL

5083
03:18:27,721 --> 03:18:29,022
WE'RE AT ALL CLOSE WITH REGARD

5084
03:18:29,022 --> 03:18:31,992
TO PARTNERSHIPS FOR THE PURPOSE

5085
03:18:31,992 --> 03:18:34,928
OF INNOVATIVE METHODS.

5086
03:18:34,928 --> 03:18:38,898
SO I THINK THAT ALONG

5087
03:18:38,898 --> 03:18:40,767
CONTRIBUTES TO THE FEELING MORE

5088
03:18:40,767 --> 03:18:43,703
THIS IS A RED.

5089
03:18:43,703 --> 03:18:44,938
>> KATIE?

5090
03:18:44,938 --> 03:18:45,872
>> HI.

5091
03:18:45,872 --> 03:18:47,440
I APPRECIATE THESE COMMENTS.

5092
03:18:47,440 --> 03:18:49,309
DEFINITELY SOMETHING WE AS AN

5093
03:18:49,309 --> 03:18:52,679
INSTITUTE NEED TO CONSIDER.

5094
03:18:52,679 --> 03:18:56,182
I DO WANT TO REMIND YOU OF THE

5095
03:18:56,182 --> 03:18:57,050
TRANSLATIONAL RESEARCH PAR,

5096
03:18:57,050 --> 03:18:59,786
USING NOVEL ANALYTICS SUCH AS

5097
03:18:59,786 --> 03:19:02,289
AI/ML AND NATURAL LANGUAGE

5098
03:19:02,289 --> 03:19:03,456
PROFESSING VERY IMPORTANT WHEN

5099
03:19:03,456 --> 03:19:05,692
WE REISSUED THE PAR.

5100
03:19:05,692 --> 03:19:08,561
WE DID TRY TO INCORPORATE SOME

5101
03:19:08,561 --> 03:19:10,297
RECOMMENDATIONS FROM THE TASK

5102
03:19:10,297 --> 03:19:13,900
FORCE WHEN WE UPDATED THAT PAR

5103
03:19:13,900 --> 03:19:16,102
AND WE'RE HOPING WE SEE MORE OF

5104
03:19:16,102 --> 03:19:19,039
A HIT WITH THE  RESEARCH

5105
03:19:19,039 --> 03:19:20,140
COMMUNITY AND GET MORE

5106
03:19:20,140 --> 03:19:21,441
APPLICATIONS IN THIS SPACE

5107
03:19:21,441 --> 03:19:22,976
BECAUSE WE RECOGNIZE IT AS BEING

5108
03:19:22,976 --> 03:19:24,511
VERY IMPORTANT AND WE'RE HOPING

5109
03:19:24,511 --> 03:19:27,347
TO DRIVE SOME INTEREST HERE

5110
03:19:27,347 --> 03:19:28,548
WITHIN THIS COMMUNITY.

5111
03:19:28,548 --> 03:19:29,449
>> THANK YOU, KATIE.

5112
03:19:29,449 --> 03:19:32,819
THE ONE THING I WOULD TAKE AWAY

5113
03:19:32,819 --> 03:19:34,487
FROM YOUR COMMENT THERE IS

5114
03:19:34,487 --> 03:19:37,757
YOU'VE GOT A PROCESS AND FUNDING

5115
03:19:37,757 --> 03:19:41,628
OPPORTUNITY THAT LAYS THE

5116
03:19:41,628 --> 03:19:43,129
FOUNDATION FOR REALIZING THIS

5117
03:19:43,129 --> 03:19:43,830
PARTICULAR RECOMMENDATION.

5118
03:19:43,830 --> 03:19:44,898
SO I THINK THAT'S ONE THING WE

5119
03:19:44,898 --> 03:19:46,666
WANT TO KEEP IN MIND AS WELL.

5120
03:19:46,666 --> 03:19:49,703
AGAIN AS CHRISTINA MENTIONED

5121
03:19:49,703 --> 03:19:54,641
THINGS MIGHT BE FIVE, TEN,

5122
03:19:54,641 --> 03:19:56,743
FIFTEEN YEARS OFF BUT IS THE

5123
03:19:56,743 --> 03:19:57,143
FOUNDATION THERE?

5124
03:19:57,143 --> 03:19:59,579
>> I HAPPENED TO SEE
SARAH'S

5125
03:19:59,579 --> 03:20:02,515
HEAD PEAK OVER THE TOP OF MY

5126
03:20:02,515 --> 03:20:03,717
IMAGES, AND SHE REMINDS ME I

5127
03:20:03,717 --> 03:20:06,453
THINK ONE OF THE THINGS WE WANT

5128
03:20:06,453 --> 03:20:11,691
TO DO IS DON'T LET OUR

5129
03:20:11,691 --> 03:20:13,893
ENTHUSIASM FOR THE CONVERSATION

5130
03:20:13,893 --> 03:20:15,628
THAT TAKES PLACE THE FACT THAT

5131
03:20:15,628 --> 03:20:17,497
A.I. CAN SOLVE THE WORLD'S ILLS

5132
03:20:17,497 --> 03:20:19,799
WITH THE ACTUAL PLACE WE ARE

5133
03:20:19,799 --> 03:20:21,434
RIGHT NOW, BEING ABLE TO APPLY

5134
03:20:21,434 --> 03:20:23,737
SOME OF THESE TOOLS IN THE WORK

5135
03:20:23,737 --> 03:20:24,738
THAT WE'RE DOING.

5136
03:20:24,738 --> 03:20:26,339
SO, MAYBE ONE OF THE THINGS WE

5137
03:20:26,339 --> 03:20:31,277
MIGHT WANT TO THINK ABOUT DOING

5138
03:20:31,277 --> 03:20:33,480
IS TRULY HAVING A COLLEAGUE WITH

5139
03:20:33,480 --> 03:20:34,881
EXPERTISE IN INNOVATIVE SPACES

5140
03:20:34,881 --> 03:20:38,284
TO WEIGH IN ON THE ABILITY TO

5141
03:20:38,284 --> 03:20:42,122
APPLY OR BASED ON WHERE THESE

5142
03:20:42,122 --> 03:20:43,556
INNOVATIVE TOOLS QUANTITATIVE

5143
03:20:43,556 --> 03:20:44,991
METHODS ARE CURRENTLY FOR

5144
03:20:44,991 --> 03:20:46,126
PURPOSES OF SCIENTIFIC RESEARCH.

5145
03:20:46,126 --> 03:20:48,061
SO I DO WANT TO KEEP A LITTLE

5146
03:20:48,061 --> 03:20:49,929
BIT OF THAT TEMPER IN MIND TOO

5147
03:20:49,929 --> 03:20:51,231
BECAUSE THERE'S SO MUCH

5148
03:20:51,231 --> 03:20:54,300
ENTHUSIASM FOR THESE TOPICS AND

5149
03:20:54,300 --> 03:20:56,770
ABILITY TO PRACTICALLY APPLY IS

5150
03:20:56,770 --> 03:20:58,671
NOT NECESSARILY ALWAYS AT THE

5151
03:20:58,671 --> 03:21:01,074
SAME PLACE AS ENTHUSIASM LEVEL.

5152
03:21:01,074 --> 03:21:01,441
>> GOOD POINT.

5153
03:21:01,441 --> 03:21:03,810
>> I WANT TO ECHO WHAT
CHRISTINA

5154
03:21:03,810 --> 03:21:04,577
SAID, ENTIRELY AGREE BECAUSE

5155
03:21:04,577 --> 03:21:06,012
IT'S LIKE WHAT SOMEBODY SAID

5156
03:21:06,012 --> 03:21:06,980
EARLIER TOO.

5157
03:21:06,980 --> 03:21:11,351
IT'S GARBAGE IN,  GARBAGE OUT.

5158
03:21:11,351 --> 03:21:13,019
WE DO NOT HAVE LINKAGE BETWEEN

5159
03:21:13,019 --> 03:21:15,955
MOMS AND BABIES AT THIS POINT IN

5160
03:21:15,955 --> 03:21:18,057
TIME SO HOW CAN YOU UNLEASH A.I.

5161
03:21:18,057 --> 03:21:23,496
IF YOU DON'T KNOW WHICH MOM HAD

5162
03:21:23,496 --> 03:21:26,132
WHICH BABY? 

5163
03:21:26,132 --> 03:21:27,133
YEAH, I HAVE CONCERNS.

5164
03:21:27,133 --> 03:21:29,969
>> SO THIS ONE IS PROBABLY
THE

5165
03:21:29,969 --> 03:21:32,071
LEAST FAR ALONG, IF I'M HEARING

5166
03:21:32,071 --> 03:21:32,772
THE GROUP CORRECTLY.

5167
03:21:32,772 --> 03:21:35,108
I THINK WE'VE GOT A MIX OF

5168
03:21:35,108 --> 03:21:36,443
OPINIONS ABOUT MAYBE THERE'S A

5169
03:21:36,443 --> 03:21:38,711
LITTLE BIT OF FOUNDATION THERE.

5170
03:21:38,711 --> 03:21:40,814
SO WE WILL KEEP THAT, THE

5171
03:21:40,814 --> 03:21:43,650
RECOMMENDATIONS AS EITHER A VERY

5172
03:21:43,650 --> 03:21:44,984
LIGHT YELLOW OR RED, AS I'M

5173
03:21:44,984 --> 03:21:48,588
SEEING IN THE CHAT, AND THEN

5174
03:21:48,588 --> 03:21:50,123
WE'LL CLARIFY THROUGH OUR

5175
03:21:50,123 --> 03:21:51,157
COMMUNICATIONS AND ADDITIONAL

5176
03:21:51,157 --> 03:21:52,959
NOTES THAT WE MAKE AS WE MOVE

5177
03:21:52,959 --> 03:21:53,526
FORWARD.

5178
03:21:53,526 --> 03:21:58,465
BEFORE I TURN OVER TO CHRISTINA

5179
03:21:58,465 --> 03:22:00,733
FOR 13, LET'S HIT 12E.

5180
03:22:00,733 --> 03:22:06,105
COMMON DATA ELEMENTS TO

5181
03:22:06,105 --> 03:22:07,841
FACILITATE COLLABORATION.

5182
03:22:07,841 --> 03:22:09,275
WHERE DO PEOPLE FEEL WE ARE

5183
03:22:09,275 --> 03:22:10,710
BASED ON CONVERSATIONS TODAY

5184
03:22:10,710 --> 03:22:10,977
FROM ONC?

5185
03:22:10,977 --> 03:22:12,479
>> I THINK THAT'S THE
GREENEST

5186
03:22:12,479 --> 03:22:13,880
OUT OF ALL OF THEM.

5187
03:22:13,880 --> 03:22:16,716
I DO THINK THAT THERE'S BEEN

5188
03:22:16,716 --> 03:22:18,218
SOME REAL PROGRESS THERE SO I

5189
03:22:18,218 --> 03:22:19,385
HOPE IT WILL GET IMPLEMENTED

5190
03:22:19,385 --> 03:22:22,188
EVERYWHERE SO THAT WE CAN REAP

5191
03:22:22,188 --> 03:22:25,124
THE BENEFITS OF THAT INVESTMENT.

5192
03:22:25,124 --> 03:22:28,995
BUT TO ME THAT IS DEFINITELY

5193
03:22:28,995 --> 03:22:32,031
KIND OF A YELLOWISH-GREEN.

5194
03:22:32,031 --> 03:22:32,899
>> OKAY.

5195
03:22:32,899 --> 03:22:33,099
SARAH?

5196
03:22:33,099 --> 03:22:36,503
>> I WOULD POINT OUT
THOUGH PART

5197
03:22:36,503 --> 03:22:41,774
C ON THAT, WHERE IT'S BEING

5198
03:22:41,774 --> 03:22:43,510
PUSHED TO OR INCENTIVIZED,

5199
03:22:43,510 --> 03:22:44,944
COMMON DATA ELEMENTS ACROSS

5200
03:22:44,944 --> 03:22:49,082
EHRs, I STILL THINK THAT HAS A

5201
03:22:49,082 --> 03:22:50,083
LONG WAY TO GO.

5202
03:22:50,083 --> 03:22:52,819
I WASN'T JUST THINKING ABOUT EHR

5203
03:22:52,819 --> 03:22:53,486
BUT OTHER RESEARCH EFFORTS, I

5204
03:22:53,486 --> 03:22:55,722
DON'T THINK WE HAVE COMMON DATA

5205
03:22:55,722 --> 03:22:56,422
ELEMENTS AND DATA DICTIONARIES

5206
03:22:56,422 --> 03:22:57,857
ACROSS VERY MANY OF OUR STUDIES

5207
03:22:57,857 --> 03:22:59,058
YET AND SO I THINK THERE'S A

5208
03:22:59,058 --> 03:23:01,494
LONG WAY TO GO TO GET PEOPLE IN

5209
03:23:01,494 --> 03:23:03,730
AGREEMENT IN WHICH COMMON DATA

5210
03:23:03,730 --> 03:23:04,931
ELEMENT WE SHOULD BE USING.

5211
03:23:04,931 --> 03:23:05,965
>> THANK YOU, SARAH.

5212
03:23:05,965 --> 03:23:10,003
THAT'S IMPORTANT TO POINT OUT.

5213
03:23:10,003 --> 03:23:12,205
I SEE TALKING ABOUT NOT

5214
03:23:12,205 --> 03:23:13,740
SATISFACTORILY ANSWERING THE

5215
03:23:13,740 --> 03:23:14,741
PATIENT-REPORTED OUTCOMES.

5216
03:23:14,741 --> 03:23:17,210
SO THIS LOOKS LIKE ANOTHER

5217
03:23:17,210 --> 03:23:18,645
YELLOW WHERE WE HAVE THE MOST

5218
03:23:18,645 --> 03:23:20,179
PROGRESS BUT THERE'S STILL SOME

5219
03:23:20,179 --> 03:23:22,482
ELEMENTS THAT WE NEED TO

5220
03:23:22,482 --> 03:23:25,418
CONSIDER AS NEEDING ATTENTION.

5221
03:23:25,418 --> 03:23:26,853
 

5222
03:23:26,853 --> 03:23:29,589
FOR THE SAKE OF TIME I'M GOING

5223
03:23:29,589 --> 03:23:31,024
TO TRANSITION TO CHRISTINA TO

5224
03:23:31,024 --> 03:23:37,463
HIT 13 AND WE'LL THINK THROUGH

5225
03:23:37,463 --> 03:23:37,931
TIMING AND COALESCING

5226
03:23:37,931 --> 03:23:39,866
EVERYTHING.

5227
03:23:39,866 --> 03:23:45,004
 

5228
03:23:45,004 --> 03:23:50,076
>> THE PHONE  RANG SO I

5229
03:23:50,076 --> 03:23:52,145
APOLOGIZE FOR NOISE IN THE

5230
03:23:52,145 --> 03:23:52,779
BACKGROUND.

5231
03:23:52,779 --> 03:23:54,747
I'M GOING TO SAY UP FRONT THE

5232
03:23:54,747 --> 03:23:56,616
PURPOSE OF THIS WORKING GROUP IS

5233
03:23:56,616 --> 03:23:59,886
NOT TO RUSH THROUGH TO MAKE A

5234
03:23:59,886 --> 03:24:00,219
REPORT.

5235
03:24:00,219 --> 03:24:02,855
SO, I HAVE NO LOFTY ASPIRATIONS

5236
03:24:02,855 --> 03:24:04,824
WE'RE GOING TO COMPLETE WHAT WE

5237
03:24:04,824 --> 03:24:06,359
NEED COMPLETE FOR RECOMMENDATION

5238
03:24:06,359 --> 03:24:06,693
13.

5239
03:24:06,693 --> 03:24:07,760
WE'LL GET STARTED.

5240
03:24:07,760 --> 03:24:10,396
AND WHAT WE DON'T COMPLETE

5241
03:24:10,396 --> 03:24:11,831
TODAY, WE WILL WORK OUT A

5242
03:24:11,831 --> 03:24:14,233
PROCESS TO BE ABLE TO FIND AT

5243
03:24:14,233 --> 03:24:16,970
LEAST A PLACE OF INITIAL

5244
03:24:16,970 --> 03:24:17,537
ALIGNMENT OFFLINE.

5245
03:24:17,537 --> 03:24:19,038
APOLOGIES IN ADVANCE WE DON'T

5246
03:24:19,038 --> 03:24:20,607
KNOW WHAT THAT'S GOING TO LOOK

5247
03:24:20,607 --> 03:24:21,808
LIKE YET BUT IT'S NOT GOING TO

5248
03:24:21,808 --> 03:24:23,109
BE POSSIBLE FOR US TO GET

5249
03:24:23,109 --> 03:24:26,813
THROUGH ALL OF THIS IN 15

5250
03:24:26,813 --> 03:24:27,046
MINUTES.

5251
03:24:27,046 --> 03:24:29,682
SO, WE'LL START WITH 13A.

5252
03:24:29,682 --> 03:24:31,951
WHICH WAS TO -- LET'S GO BACK TO

5253
03:24:31,951 --> 03:24:32,852
THE RECOMMENDATIONS.

5254
03:24:32,852 --> 03:24:34,921
THE RECOMMENDATION HAS A VERY

5255
03:24:34,921 --> 03:24:39,859
IMPORTANT WORD THAT IT STARTS 

5256
03:24:39,859 --> 03:24:45,431
OFF WITH, "OPTIMIZE."

5257
03:24:45,431 --> 03:24:46,399
OPTIMIZE REGISTRIES FOR

5258
03:24:46,399 --> 03:24:47,400
PREGNANCY AND LACTATION, KEEP

5259
03:24:47,400 --> 03:24:49,402
THAT IN YOUR MIND WORKING

5260
03:24:49,402 --> 03:24:51,104
THROUGH THE SUPPLEMENTS OF THE

5261
03:24:51,104 --> 03:24:51,471
RECOMMENDATION.

5262
03:24:51,471 --> 03:24:54,207
13A WAS CREATE A USER-FRIENDLY

5263
03:24:54,207 --> 03:24:55,541
WEBSITE FOR REGISTRY LISTINGS.

5264
03:24:55,541 --> 03:25:00,980
WE DID HEAR THERE ARE SOME

5265
03:25:00,980 --> 03:25:01,914
REGISTRY LISTINGS.

5266
03:25:01,914 --> 03:25:04,751
DO THEY MEET THE NEED OF THE

5267
03:25:04,751 --> 03:25:07,120
USER-FRIENDLY WEBSITE LISTING

5268
03:25:07,120 --> 03:25:12,158
FOR PURPOSES OF ALL OF OUR NEEDS

5269
03:25:12,158 --> 03:25:15,228
IN PREGNANCY AND LACTATION SO

5270
03:25:15,228 --> 03:25:18,364
I'LL OPEN IT UP TO YOU.

5271
03:25:18,364 --> 03:25:20,566
>> I APPRECIATE THAT THERE
ARE

5272
03:25:20,566 --> 03:25:22,001
MAYBE EFFORTS TO MOVE TOWARDS

5273
03:25:22,001 --> 03:25:26,372
THIS BUT I THINK SOME ISSUES

5274
03:25:26,372 --> 03:25:32,512
RAISED EARLIER I THINK BY KATIE

5275
03:25:32,512 --> 03:25:35,548
SCHUBERT, I THINK I'M LEANING

5276
03:25:35,548 --> 03:25:40,920
TOWARDS RED FOR MOST OF THESE. 

5277
03:25:40,920 --> 03:25:43,222
THERE HAVE BEEN BARRIERS AND

5278
03:25:43,222 --> 03:25:49,328
REALLY WOULD -- AND MAY NEED

5279
03:25:49,328 --> 03:25:50,430
ADDITIONAL ACTIONS TO REALLY

5280
03:25:50,430 --> 03:25:53,166
COME UP TO WHERE WE WOULD LIKE

5281
03:25:53,166 --> 03:25:55,468
TO SEE MOST OF THESE BUT I GUESS

5282
03:25:55,468 --> 03:25:59,272
STARTING WITH A, I WOULD SAY RED

5283
03:25:59,272 --> 03:26:01,140
FOR THIS ONE, NOT TO THOUGHT

5284
03:26:01,140 --> 03:26:04,343
RECOGNIZE EFFORTS THERE BUT I

5285
03:26:04,343 --> 03:26:07,980
THINK THAT THERE ARE SOME

5286
03:26:07,980 --> 03:26:09,382
BARRIERS TO REALLY FULFILLING

5287
03:26:09,382 --> 03:26:11,017
THIS ONE THAT MAY NEED SOME

5288
03:26:11,017 --> 03:26:11,784
ADDITIONAL WORK.

5289
03:26:11,784 --> 03:26:13,453
I DON'T SEE THE KEY UNDERNEATH

5290
03:26:13,453 --> 03:26:19,025
SO I'M SORRY IF I'M GETTING IT

5291
03:26:19,025 --> 03:26:19,225
WRONG.

5292
03:26:19,225 --> 03:26:19,592
>> NO WORRIES.

5293
03:26:19,592 --> 03:26:20,560
THANK YOU.

5294
03:26:20,560 --> 03:26:22,328
I APPRECIATE YOUR COMMENTS.

5295
03:26:22,328 --> 03:26:23,930
KATIE, DID YOU WANT TO WEIGH IN

5296
03:26:23,930 --> 03:26:25,364
SINCE RACHEL DID MENTION YOU AND

5297
03:26:25,364 --> 03:26:28,835
I SEE YOUR COMMENT IN THE CHAT?

5298
03:26:28,835 --> 03:26:30,136
>> YEAH, SURE.

5299
03:26:30,136 --> 03:26:31,671
I HAVE TRANSITIONED TO THE PART

5300
03:26:31,671 --> 03:26:36,075
OF MY DAY WHERE I --

5301
03:26:36,075 --> 03:26:37,510
(INDISCERNIBLE) I'M OFF CAMERA

5302
03:26:37,510 --> 03:26:42,115
BUT I WOULD TOTALLY AGREE.

5303
03:26:42,115 --> 03:26:46,686
I THINK THE KEY WORD IS

5304
03:26:46,686 --> 03:26:47,887
"OPTIMIZE."

5305
03:26:47,887 --> 03:26:49,088
THERE ARE ELEMENTS THAT EXIST

5306
03:26:49,088 --> 03:26:54,127
BUT IT'S NOT  OPTIMIZED, AND

5307
03:26:54,127 --> 03:26:55,228
BEING USER FRIENDLY, ACCESS, I

5308
03:26:55,228 --> 03:26:57,063
WOULD AGREE I THINK IT'S

5309
03:26:57,063 --> 03:26:57,830
PROBABLY RED.

5310
03:26:57,830 --> 03:27:00,700
AND NOT EVEN QUITE INTO THE LIKE

5311
03:27:00,700 --> 03:27:01,834
IT'S MOVING ALONG.

5312
03:27:01,834 --> 03:27:03,870
I THINK IT PROBABLY NEEDS A PUSH

5313
03:27:03,870 --> 03:27:05,271
AND MORE CONVERSATION HOW TO DO

5314
03:27:05,271 --> 03:27:07,940
THIS, TO BE ABLE TO OPTIMIZE IT.

5315
03:27:07,940 --> 03:27:10,543
>> THANK YOU VERY MUCH,
KATIE.

5316
03:27:10,543 --> 03:27:13,379
THANK YOU FOR DOUBLE TASKS

5317
03:27:13,379 --> 03:27:13,780
CURRENTLY.

5318
03:27:13,780 --> 03:27:15,681
AND I ALSO SEE THAT MOST OF THE

5319
03:27:15,681 --> 03:27:18,951
COMMENTS IN THE CHAT ARE IN

5320
03:27:18,951 --> 03:27:19,919
AGREEMENT.

5321
03:27:19,919 --> 03:27:23,022
I WANT TO GO TO 13A, SMALL

5322
03:27:23,022 --> 03:27:23,289
LETTER B.

5323
03:27:23,289 --> 03:27:25,458
THERE IS A PIECE THAT CALLS FOR

5324
03:27:25,458 --> 03:27:27,693
DEVELOPMENT OF THE

5325
03:27:27,693 --> 03:27:28,294
PUBLIC/PRIVATE PARTNERSHIP TO

5326
03:27:28,294 --> 03:27:30,763
HOST A PREGNANCY OR LACTATION

5327
03:27:30,763 --> 03:27:31,531
REGISTRY.

5328
03:27:31,531 --> 03:27:35,802
SO I DO THINK THERE IS A CLEAR

5329
03:27:35,802 --> 03:27:37,470
DIRECTION HERE THAT THERE IS

5330
03:27:37,470 --> 03:27:38,638
ADDITIONAL WORK THAT NEEDS TO BE

5331
03:27:38,638 --> 03:27:38,971
DONE.

5332
03:27:38,971 --> 03:27:42,041
THERE'S GOING TO BE

5333
03:27:42,041 --> 03:27:44,110
CONSIDERATION OF RESOURCE, WHOSE

5334
03:27:44,110 --> 03:27:46,212
RESPONSIBILITY IT WOULD BE TO BE

5335
03:27:46,212 --> 03:27:47,513
THE THIRD PARTY CONVENER FOR

5336
03:27:47,513 --> 03:27:49,148
THIS PUBLIC/PRIVATE PARTNERSHIP.

5337
03:27:49,148 --> 03:27:51,984
SO I THINK THAT UNLESS THERE'S

5338
03:27:51,984 --> 03:27:54,854
ANYONE WHO DISAGREES WITH THE

5339
03:27:54,854 --> 03:28:00,960
DISCUSSION, I SEE A HAND RAISED.

5340
03:28:00,960 --> 03:28:03,162
>> YES, SO THOSE THERE FOR
THE

5341
03:28:03,162 --> 03:28:05,031
ORIGINAL PRGLAC FOR A POINT OF

5342
03:28:05,031 --> 03:28:10,937
HISTORY OR CONTEXT, OFTEN TIMES

5343
03:28:10,937 --> 03:28:13,005
THE REGISTRY IS AN EXAMPLE OR

5344
03:28:13,005 --> 03:28:13,239
MODEL.

5345
03:28:13,239 --> 03:28:18,244
CURIOUS TO LEARN WHAT FACETS.

5346
03:28:18,244 --> 03:28:19,812
ERA-T REGISTRY MIGHT HAVE

5347
03:28:19,812 --> 03:28:20,446
PROMPTED THAT FEELING OR

5348
03:28:20,446 --> 03:28:21,647
DISCUSSION, IS IT THAT IT WAS

5349
03:28:21,647 --> 03:28:25,284
ONE OF THE FEW OR ONLY, WAS IT

5350
03:28:25,284 --> 03:28:26,586
SOME PARTICULAR ASPECT OF

5351
03:28:26,586 --> 03:28:29,322
ACCESSING THAT DATA THAT MIGHT

5352
03:28:29,322 --> 03:28:31,524
HELP ME THROUGH THROUGHOUT OUR

5353
03:28:31,524 --> 03:28:31,991
MANY MEETINGS.

5354
03:28:31,991 --> 03:28:34,126
>> YEAH, I'M NOT AN EXPERT
ON

5355
03:28:34,126 --> 03:28:35,528
THE ART REGISTRY AND KNOW

5356
03:28:35,528 --> 03:28:36,863
THERE'S SOMEONE ON THE CALL WHO

5357
03:28:36,863 --> 03:28:40,366
PROBABLY IS MUCH MORE SO THAN I.

5358
03:28:40,366 --> 03:28:42,435
SHE MAY SPEAK IF SHE'D LIKE.

5359
03:28:42,435 --> 03:28:44,971
HAVING BEEN IN THOSE

5360
03:28:44,971 --> 03:28:45,605
CONVERSATIONS, ART WAS DISCUSSED

5361
03:28:45,605 --> 03:28:49,442
AS A FORM OF A MODEL REGISTRY, A

5362
03:28:49,442 --> 03:28:51,644
MODEL, BECAUSE IT HAS SUCH A

5363
03:28:51,644 --> 03:28:55,681
DEPTH OF HISTORY, A WEALTH OF

5364
03:28:55,681 --> 03:28:55,982
INFORMATION.

5365
03:28:55,982 --> 03:28:57,683
BECAUSE THERE'S SUCH A GREAT

5366
03:28:57,683 --> 03:29:04,023
EMBRACE IN A MULTI-STAKEHOLDER

5367
03:29:04,023 --> 03:29:05,224
PERSPECTIVE, IT'S A MODEL.

5368
03:29:05,224 --> 03:29:06,759
IF ANYONE WANTS TO SPEAK TO WHY

5369
03:29:06,759 --> 03:29:10,663
AND HOW THAT WOULD BE WELCOME.

5370
03:29:10,663 --> 03:29:13,532
>> THERE'S MORE OF AN
EXPERT BUT

5371
03:29:13,532 --> 03:29:15,067
CORRECT ME IN I'M WRONG.

5372
03:29:15,067 --> 03:29:16,936
MY UNDERSTAND IT'S A

5373
03:29:16,936 --> 03:29:17,904
DISEASE-BASED REGISTRY, RIGHT?

5374
03:29:17,904 --> 03:29:21,507
SO WHERE A LOT OF REGISTRIES ON

5375
03:29:21,507 --> 03:29:30,182
OUR WEB PAGE ARE PMR FOR

5376
03:29:30,182 --> 03:29:31,717
SPECIFIC MEDICAL PRODUCTS.

5377
03:29:31,717 --> 03:29:34,220
THAT LISTS PMR BUT THINGS

5378
03:29:34,220 --> 03:29:35,121
MISSING ARE NOT ENCOMPASSED BY

5379
03:29:35,121 --> 03:29:37,823
RESOURCE FDA PROVIDES.

5380
03:29:37,823 --> 03:29:40,026
MY UNDERSTANDING FROM A.R.T.,

5381
03:29:40,026 --> 03:29:41,560
DISEASE, TO YOUR POINT,

5382
03:29:41,560 --> 03:29:43,396
CHRISTINA, ISN'T IT FUNDED BY

5383
03:29:43,396 --> 03:29:44,964
INDUSTRY FOR THOSE DRUGS THAT

5384
03:29:44,964 --> 03:29:47,233
ARE USED IN THAT?

5385
03:29:47,233 --> 03:29:51,070
MAYBE SOMEONE ELSE KNOWS THAT

5386
03:29:51,070 --> 03:29:51,337
SPECIFIC.

5387
03:29:51,337 --> 03:29:52,738
>> YES, TINA CHAMBERS HAS
A HAND

5388
03:29:52,738 --> 03:29:52,905
UP.

5389
03:29:52,905 --> 03:29:54,573
>> YEAH, IT IS.

5390
03:29:54,573 --> 03:29:57,743
I THINK THE VALUE, UNIQUE VALUE

5391
03:29:57,743 --> 03:30:01,380
IS THAT IT'S DISEASE BASED, AND

5392
03:30:01,380 --> 03:30:03,015
IT'S A PARTNERSHIP WHERE

5393
03:30:03,015 --> 03:30:03,883
MULTIPLE PHARMACEUTICAL

5394
03:30:03,883 --> 03:30:05,084
COMPANIES WHO MAKE MEDICATIONS

5395
03:30:05,084 --> 03:30:09,522
IN THIS SPACE CAN JOIN THIS AS

5396
03:30:09,522 --> 03:30:12,425
AN EXISTING STANDING, YOU KNOW,

5397
03:30:12,425 --> 03:30:15,594
STANDARD GOVERNANCE ALREADY IN

5398
03:30:15,594 --> 03:30:17,229
PLACE, AND THAT THE METHODS FOR

5399
03:30:17,229 --> 03:30:20,967
COLLECTING THE DATA ARE WELL

5400
03:30:20,967 --> 03:30:21,267
ESTABLISHED.

5401
03:30:21,267 --> 03:30:25,004
AND IT'S, YOU KNOW, ABLE TO

5402
03:30:25,004 --> 03:30:26,639
COMPARE EXPOSURES EARLY IN

5403
03:30:26,639 --> 03:30:28,274
PREGNANCY TO THOSE ONLY LATER IN

5404
03:30:28,274 --> 03:30:30,810
PREGNANCY SO IT'S BEEN A HIGHLY

5405
03:30:30,810 --> 03:30:32,545
SUCCESSFUL MODEL IN THAT REGARD,

5406
03:30:32,545 --> 03:30:33,646
BOTH IN TERMS OF COLLABORATION

5407
03:30:33,646 --> 03:30:38,985
BUT IN TERMS OF MAKING IT

5408
03:30:38,985 --> 03:30:39,685
RELATIVELY SIMPLE AND

5409
03:30:39,685 --> 03:30:40,619
STRAIGHTFORWARD FOR PREGNANT

5410
03:30:40,619 --> 03:30:44,924
PERSONS TO PARTICIPATE. 

5411
03:30:44,924 --> 03:30:45,858
>> I THINK --

5412
03:30:45,858 --> 03:30:48,194
>> I THINK IT'S IMPORTANT
THAT

5413
03:30:48,194 --> 03:30:50,496
EVERYONE IS INVESTED IN PUTTING

5414
03:30:50,496 --> 03:30:53,232
EVERY PIECE OF DATA INTO THE

5415
03:30:53,232 --> 03:30:55,601
REGISTRY AND NO WE DON'T GET

5416
03:30:55,601 --> 03:30:57,636
PAID AT PROVIDERS, I THINK IT'S

5417
03:30:57,636 --> 03:30:59,705
THAT STRONG FEELINGS THAT WE'RE

5418
03:30:59,705 --> 03:31:01,340
NOT CAPTURING WITH OTHER

5419
03:31:01,340 --> 03:31:03,743
REGISTRIES THAT WE'RE TALKING

5420
03:31:03,743 --> 03:31:04,844
ABOUT HERE.

5421
03:31:04,844 --> 03:31:05,945
EVERY MATERNAL PROVIDER, OH MY

5422
03:31:05,945 --> 03:31:08,014
GOD, I HAVE TO REPORT IT, I

5423
03:31:08,014 --> 03:31:10,516
DON'T SEE THAT KIND OF

5424
03:31:10,516 --> 03:31:12,184
INVESTMENT HAPPENING ACROSS

5425
03:31:12,184 --> 03:31:13,819
OTHER DISEASES OR OTHER FOCI

5426
03:31:13,819 --> 03:31:14,887
WE'VE BEEN TALKING ABOUT.

5427
03:31:14,887 --> 03:31:16,856
AND I THINK THAT'S THE BIGGEST

5428
03:31:16,856 --> 03:31:18,624
PROBLEM THAT I SEE, WE'RE

5429
03:31:18,624 --> 03:31:20,259
DEVELOPING REGISTRIES, TALKING

5430
03:31:20,259 --> 03:31:21,260
ABOUT REGISTRIES, BUT THERE'S NO

5431
03:31:21,260 --> 03:31:23,429
SKIN IN THE GAME FOR PEOPLE TO

5432
03:31:23,429 --> 03:31:26,799
SUBMIT DATA TO THOSE REGISTRIES.

5433
03:31:26,799 --> 03:31:27,600
>> YES, THANK YOU

5434
03:31:27,600 --> 03:31:30,102
I HAD A FEELING YOU'D BE ABLE TO

5435
03:31:30,102 --> 03:31:31,103
OFFER THAT VALUABLE

5436
03:31:31,103 --> 03:31:31,537
CONTRIBUTION.

5437
03:31:31,537 --> 03:31:34,273
I ALSO WANT TO CALL UP ERIN, DO

5438
03:31:34,273 --> 03:31:35,674
YOU WANT TO SPEAK MORE TO YOUR

5439
03:31:35,674 --> 03:31:38,577
COMMENT BECAUSE I THINK IT'S A

5440
03:31:38,577 --> 03:31:39,678
VERY RELEVANT COMMENT FOR THIS

5441
03:31:39,678 --> 03:31:43,749
DISCUSSION AS WELL.

5442
03:31:43,749 --> 03:31:45,251
 

5443
03:31:45,251 --> 03:31:50,356
>> YOU MEAN WILL THE
LactMed

5444
03:31:50,356 --> 03:31:50,623
DATABASE?

5445
03:31:50,623 --> 03:31:51,357
>> YES, THANKS, AARON.

5446
03:31:51,357 --> 03:31:53,225
>> YEAH, SURE.

5447
03:31:53,225 --> 03:31:54,660
A COUPLE YEARS AGO NATIONAL

5448
03:31:54,660 --> 03:31:55,394
LIBRARY OF MEDICINE, WHO

5449
03:31:55,394 --> 03:31:58,798
SUPPORTED A VARIETY OF THESE

5450
03:31:58,798 --> 03:32:00,566
TYPES OF KNOWLEDGE BASES, FOR

5451
03:32:00,566 --> 03:32:04,070
EXAMPLE LIVER TOX AND SOME OF

5452
03:32:04,070 --> 03:32:06,338
THOSE, THEY HAVE -- THEY ARE

5453
03:32:06,338 --> 03:32:07,673
SUPPORTING THE INFRASTRUCTURE

5454
03:32:07,673 --> 03:32:11,844
FOR THE WEBSITE FOR THE

5455
03:32:11,844 --> 03:32:13,779
DISSEMINATION, DATABASE, THEY

5456
03:32:13,779 --> 03:32:15,748
HAVE ASKED DIFFERENT GROUPS THAT

5457
03:32:15,748 --> 03:32:18,918
ARE MORE SUBJECT AREA EXPERTS TO

5458
03:32:18,918 --> 03:32:21,220
PICK UP CURATION, SO NICHD TWO

5459
03:32:21,220 --> 03:32:24,957
OR THREE YEARS AGO PICKED UP

5460
03:32:24,957 --> 03:32:26,258
CURATION OF LactMed,

5461
03:32:26,258 --> 03:32:28,961
ESSENTIALLY MAINTAINING THE SAME

5462
03:32:28,961 --> 03:32:29,495
OPERATING PROCEDURES THAT

5463
03:32:29,495 --> 03:32:30,863
NATIONAL LIBRARY OF MEDICINE DID

5464
03:32:30,863 --> 03:32:32,832
AND WE'RE IN DISCUSSIONS RIGHT

5465
03:32:32,832 --> 03:32:35,134
NOW ABOUT WHAT THE NEXT

5466
03:32:35,134 --> 03:32:36,235
ITERATION OF LactMed SHOULD

5467
03:32:36,235 --> 03:32:36,869
LOOK LIKE.

5468
03:32:36,869 --> 03:32:39,705
SO I THINK ANY THOUGHTS FROM

5469
03:32:39,705 --> 03:32:41,807
THIS WORKING GROUP THAT IN TERMS

5470
03:32:41,807 --> 03:32:43,209
OF RECOMMENDATIONS THAT GO TO

5471
03:32:43,209 --> 03:32:44,877
COUNCIL WOULD BE VERY WELCOME

5472
03:32:44,877 --> 03:32:45,177
RIGHT NOW.

5473
03:32:45,177 --> 03:32:47,279
>> THANK YOU, AARON.

5474
03:32:47,279 --> 03:32:48,814
AND THANK YOU TO THE COLLEAGUES

5475
03:32:48,814 --> 03:32:51,750
FOR THAT IMPORTANT AS WELL.

5476
03:32:51,750 --> 03:32:53,519
SO I THINK JUST PAYING ATTENTION

5477
03:32:53,519 --> 03:32:55,688
TO THE TIME, WE HAVE FIVE

5478
03:32:55,688 --> 03:32:56,222
MINUTES LEFT.

5479
03:32:56,222 --> 03:32:58,724
AND SO INSTEAD OF RUSHING

5480
03:32:58,724 --> 03:32:59,959
THROUGH AND NOT REALLY PAYING

5481
03:32:59,959 --> 03:33:05,965
DUE DIAL  -- DUE DILIGENCE TO

5482
03:33:05,965 --> 03:33:07,266
THE REMAINING SUBCOMPONENTS,

5483
03:33:07,266 --> 03:33:09,468
WE'LL FIND AN OFFLINE WAY TO GET

5484
03:33:09,468 --> 03:33:12,204
AT LEAST SOME INITIAL ALIGNMENT

5485
03:33:12,204 --> 03:33:15,808
ON WHERE WE STAND.

5486
03:33:15,808 --> 03:33:18,010
WATCH YOUR IN-BOXES AS RELATED

5487
03:33:18,010 --> 03:33:19,311
TO 13B THROUGH D.

5488
03:33:19,311 --> 03:33:24,049
EMMA, I'M  GOING TO HAVE YOU

5489
03:33:24,049 --> 03:33:25,784
COME UP, SUE AS WELL.

5490
03:33:25,784 --> 03:33:28,087
FOR THE REMAINDER OF OUR WORK I

5491
03:33:28,087 --> 03:33:29,288
SAW YOUR COMMENT, LEE, IN

5492
03:33:29,288 --> 03:33:33,559
REGARDS TO THE FLEXIBILITY OF

5493
03:33:33,559 --> 03:33:36,028
THE TIMELINE, AND SINCE I'M

5494
03:33:36,028 --> 03:33:37,296
MERELY THE CO-CHAIR I'D LIKE TO

5495
03:33:37,296 --> 03:33:40,099
HAVE EMMA ADDRESS THAT QUESTION

5496
03:33:40,099 --> 03:33:42,535
FOR YOU PLEASE.

5497
03:33:42,535 --> 03:33:43,302
>> YEAH, ABSOLUTELY.

5498
03:33:43,302 --> 03:33:44,937
I THINK I DON'T WANT TO SPEAK

5499
03:33:44,937 --> 03:33:47,907
OUT OF TURN ESPECIALLY IN THIS

5500
03:33:47,907 --> 03:33:51,010
MINUTE BUT I THINK IF THE

5501
03:33:51,010 --> 03:33:52,878
WORKING GROUP FEELS LIKE THERE'S

5502
03:33:52,878 --> 03:33:56,415
MORE NEED, WE COULD TALK ABOUT

5503
03:33:56,415 --> 03:33:57,249
THAT.

5504
03:33:57,249 --> 03:34:00,753
WE HAD SET OUT THIS PLAN, ONE,

5505
03:34:00,753 --> 03:34:02,388
WITH HOPES WE WOULD PRESENT TO

5506
03:34:02,388 --> 03:34:04,823
THE JUNE COUNCIL, SO BECAUSE WE

5507
03:34:04,823 --> 03:34:09,528
DO NEED TO PRESENT UP TO NICHD'S

5508
03:34:09,528 --> 03:34:12,331
COUNCIL WE ARE PULLED INTO THAT

5509
03:34:12,331 --> 03:34:13,766
TIMELINE SO WE CAN CHECK

5510
03:34:13,766 --> 03:34:14,533
CERTAINLY IF THAT'S SOMETHING

5511
03:34:14,533 --> 03:34:17,069
THE WORKING GROUP WOULD LIKE TO

5512
03:34:17,069 --> 03:34:18,904
ENTERTAIN, PRESENTING TO A

5513
03:34:18,904 --> 03:34:19,805
FUTURE COUNCIL INSTEAD.

5514
03:34:19,805 --> 03:34:23,209
THAT'S SOMETHING WE CAN TALK

5515
03:34:23,209 --> 03:34:23,409
ABOUT.

5516
03:34:23,409 --> 03:34:25,811
ALTHOUGH I DON'T WANT TO MAKE

5517
03:34:25,811 --> 03:34:27,446
PROMISES ABOUT THAT.

5518
03:34:27,446 --> 03:34:29,748
>> SO IT WILL BE
DISCUSSION FOR

5519
03:34:29,748 --> 03:34:31,283
US TO HAVE.

5520
03:34:31,283 --> 03:34:33,686
THIS IS OUR FIRST CALL.

5521
03:34:33,686 --> 03:34:35,754
IT'S FULLY VIRTUAL AS WE'VE ALL

5522
03:34:35,754 --> 03:34:37,356
JUST EXPERIENCED, TRYING TO GET

5523
03:34:37,356 --> 03:34:39,391
THROUGH A LOT OF INFORMATION.

5524
03:34:39,391 --> 03:34:42,228
AND HONESTLY I THINK FOR OUR

5525
03:34:42,228 --> 03:34:43,295
FIRST MEETING, JUST BEGINNING TO

5526
03:34:43,295 --> 03:34:45,297
WORK WITH EACH OTHER, SOME OF

5527
03:34:45,297 --> 03:34:47,032
YOU MAYBE WORKING FOR THE FIRST

5528
03:34:47,032 --> 03:34:49,134
TIME TOGETHER, THIS IS A LOT TO

5529
03:34:49,134 --> 03:34:51,971
TRY AND ACCOMPLISH IN A SHORT

5530
03:34:51,971 --> 03:34:52,738
PERIOD OF TIME.

5531
03:34:52,738 --> 03:34:57,243
WE'LL SEE HOW THIS PROGRESSES.

5532
03:34:57,243 --> 03:34:58,310
SPEAKING FOR MYSELF, HAVING NOT

5533
03:34:58,310 --> 03:35:00,512
DISCUSSED THIS WITH SUE OR EMMA,

5534
03:35:00,512 --> 03:35:02,281
THE REST OF THE WONDERFUL NICHD

5535
03:35:02,281 --> 03:35:05,985
STAFF WHO HAVE BEEN SUPPORTING

5536
03:35:05,985 --> 03:35:07,753
US, WE SAID HOW ARE WE GOING TO

5537
03:35:07,753 --> 03:35:09,154
GET THROUGH ALL OF THIS AND WE

5538
03:35:09,154 --> 03:35:11,023
CHOSE A WAY WE THOUGHT WOULD AT

5539
03:35:11,023 --> 03:35:12,992
LEAST HELP US GET STARTED.

5540
03:35:12,992 --> 03:35:15,594
IF ANY OF YOU FEEL THAT THIS HAS

5541
03:35:15,594 --> 03:35:16,595
NOT BEEN CONSTRUCTIVE AND THERE

5542
03:35:16,595 --> 03:35:18,797
MIGHT BE A BETTER WAY TO DO THIS

5543
03:35:18,797 --> 03:35:20,966
DON'T HESITATE TO REACH OUT

5544
03:35:20,966 --> 03:35:21,500
OFFLINE.

5545
03:35:21,500 --> 03:35:22,935
WE'RE WILLING TO ENTERTAIN YOUR

5546
03:35:22,935 --> 03:35:23,202
THOUGHTS.

5547
03:35:23,202 --> 03:35:26,338
OUR NEXT MEETING IS GOING TO BE

5548
03:35:26,338 --> 03:35:27,573
LOOKING TO GET THROUGH A LOT OF

5549
03:35:27,573 --> 03:35:28,007
GROUND.

5550
03:35:28,007 --> 03:35:30,743
THERE'S GOING TO BE A LOT TO

5551
03:35:30,743 --> 03:35:30,976
DISCUSS.

5552
03:35:30,976 --> 03:35:33,145
AT LEAST THIS GIVES YOU A FLAVOR

5553
03:35:33,145 --> 03:35:35,481
OF HOW WE'D LIKE TO WORK IN THE

5554
03:35:35,481 --> 03:35:36,782
PREP LEADING UP TO THE MEETING

5555
03:35:36,782 --> 03:35:38,717
THAT WILL BE HELPFUL TO YOU.

5556
03:35:38,717 --> 03:35:45,424
WE WILL TRY TO ALWAYS MAKE SURE 

5557
03:35:45,424 --> 03:35:47,593
PRE-READS ARE DIRECTING YOU TO

5558
03:35:47,593 --> 03:35:48,360
RECOMMENDATIONS TO PREP FOR,

5559
03:35:48,360 --> 03:35:50,562
BECAUSE IT IS A LOT AND WE KNOW

5560
03:35:50,562 --> 03:35:51,664
YOU'RE DOING THIS BECAUSE YOU'RE

5561
03:35:51,664 --> 03:35:53,532
PASSIONATE ABOUT IT.

5562
03:35:53,532 --> 03:35:54,833
WE DO APPRECIATE THAT.

5563
03:35:54,833 --> 03:35:56,368
BUT I DO ALSO WANT TO JUST

5564
03:35:56,368 --> 03:35:58,337
REMIND YOU THAT OUR NEXT WORKING

5565
03:35:58,337 --> 03:36:00,739
GROUP MEETING I THINK I HAD IT

5566
03:36:00,739 --> 03:36:02,841
IN THE SLIDES IS SCHEDULED FOR

5567
03:36:02,841 --> 03:36:03,676
JANUARY 19.

5568
03:36:03,676 --> 03:36:05,611
SO IT'S NOT TOO FAR INTO THE

5569
03:36:05,611 --> 03:36:06,078
FUTURE.

5570
03:36:06,078 --> 03:36:07,413
THERE'S A LOT OF HOLIDAYS IN THE

5571
03:36:07,413 --> 03:36:10,616
U.S. BETWEEN NOW AND THEN.

5572
03:36:10,616 --> 03:36:13,552
SO WE'LL MAKE SURE WE FIGURE OUT

5573
03:36:13,552 --> 03:36:16,855
HOW TO ADDRESS 13B THROUGH D, WE

5574
03:36:16,855 --> 03:36:18,390
THOUGHT OFFLINE IF THERE'S A

5575
03:36:18,390 --> 03:36:20,693
DIFFERENT WAY FOR US TO DO THIS

5576
03:36:20,693 --> 03:36:22,828
WORK, REVISIT THE PARKING LOT

5577
03:36:22,828 --> 03:36:27,333
WHERE WE PLACED ITEMS THAT MIGHT

5578
03:36:27,333 --> 03:36:29,068
NEED ADDITIONAL DISCUSSION AND I

5579
03:36:29,068 --> 03:36:30,469
WANT TO MAKE SURE, SUE, NICK YOU

5580
03:36:30,469 --> 03:36:32,037
FEEL YOU NEED TO ADD HERE AND

5581
03:36:32,037 --> 03:36:34,907
EMMA AND THE REST OF THE STAFF

5582
03:36:34,907 --> 03:36:35,140
PLEASE.

5583
03:36:35,140 --> 03:36:36,775
>> I FULLY ENDORSE WHAT

5584
03:36:36,775 --> 03:36:38,210
CHRISTINA IS SAYING.

5585
03:36:38,210 --> 03:36:39,378
WE'RE TRYING TO FIGURE OUT THE

5586
03:36:39,378 --> 03:36:40,746
BEST WAY THROUGH A PROCESS OF

5587
03:36:40,746 --> 03:36:42,448
GETTING A LOT OF INFORMATION

5588
03:36:42,448 --> 03:36:45,718
REVIEWED AND SO WE'RE OPEN TO

5589
03:36:45,718 --> 03:36:46,151
ANY RECOMMENDATIONS.

5590
03:36:46,151 --> 03:36:47,386
THERE'S ONE REQUEST THAT I WOULD

5591
03:36:47,386 --> 03:36:49,021
HAVE OF THIS COMMITTEE BEFORE

5592
03:36:49,021 --> 03:36:50,356
THE NEXT MEETING.

5593
03:36:50,356 --> 03:36:51,256
ACTUALLY PROBABLY WITHIN THE

5594
03:36:51,256 --> 03:36:55,060
NEXT FEW WEEKS IF YOU CAN TAKE A

5595
03:36:55,060 --> 03:36:56,028
LOOK AT RECOMMENDATIONS WE'RE

5596
03:36:56,028 --> 03:36:58,997
GOING TO BE DEALING WITH AND IF

5597
03:36:58,997 --> 03:37:01,066
YOU BELIEVE THERE MAY BE KEY

5598
03:37:01,066 --> 03:37:03,469
SPEAKERS, SPEAKERS THAT CAN

5599
03:37:03,469 --> 03:37:04,470
SPEAK TO SPECIFIC ELEMENTS, SEND

5600
03:37:04,470 --> 03:37:06,205
THAT LIST OUR WAY.

5601
03:37:06,205 --> 03:37:07,773
WE MAY HAVE THEM UNDER

5602
03:37:07,773 --> 03:37:08,107
CONSIDERATION.

5603
03:37:08,107 --> 03:37:08,974
WE MAY NOT.

5604
03:37:08,974 --> 03:37:11,477
WE'RE TRYING TO PLAN SPEAKERS

5605
03:37:11,477 --> 03:37:11,810
NOW.

5606
03:37:11,810 --> 03:37:13,345
BUT SOMEBODY MENTIONED THE A.I.

5607
03:37:13,345 --> 03:37:14,213
AS AN EXAMPLE.

5608
03:37:14,213 --> 03:37:15,514
IF YOU FEEL THERE'S SOMEBODY WE

5609
03:37:15,514 --> 03:37:17,282
NEED TO HEAR FROM PLEASE LET US

5610
03:37:17,282 --> 03:37:17,649
KNOW.

5611
03:37:17,649 --> 03:37:19,685
WE'LL DO WHAT WE CAN TO MAKE

5612
03:37:19,685 --> 03:37:22,721
SURE THEIR VOICE IS REPRESENTED.

5613
03:37:22,721 --> 03:37:25,057
>> AND EMMA?

5614
03:37:25,057 --> 03:37:26,058
ANY LAST SAGE WORDS?

5615
03:37:26,058 --> 03:37:27,793
>> NO, NOT AT ALL.

5616
03:37:27,793 --> 03:37:30,529
THANK YOU.

5617
03:37:30,529 --> 03:37:32,631
THANK YOU BOTH FOR YOUR

5618
03:37:32,631 --> 03:37:34,366
LEADERSHIP AND WORKING GROUP

5619
03:37:34,366 --> 03:37:35,234
MEMBERS, WE APPRECIATE YOUR

5620
03:37:35,234 --> 03:37:36,235
PARTICIPATION AND EFFORTS.

5621
03:37:36,235 --> 03:37:37,870
I'LL BE IN TOUCH WITH LOTS OF

5622
03:37:37,870 --> 03:37:38,737
YOU SOON.

5623
03:37:38,737 --> 03:37:39,505
THANK YOU ALL SO MUCH.

5624
03:37:39,505 --> 03:37:40,939
>> THANK YOU, EVERYONE.

5625
03:37:40,939 --> 03:37:43,575
HAVE A REALLY WONDERFUL AND

5626
03:37:43,575 --> 03:37:46,178
RESTFUL WEEKEND AND VERY HAPPY

5627
03:37:46,178 --> 03:37:46,512
THANKSGIVING.

5628
03:37:46,512 --> 03:37:47,513
>> THANK YOU VERY MUCH TO
THE

5629
03:37:47,513 --> 03:37:49,381
SPEAKERS AS WELL.

5630
03:37:49,381 --> 03:37:49,648
TAKE CARE.

5631
03:37:49,648 --> 03:37:59,648
>> BYE-BYE.