1 00:00:06,540 --> 00:00:09,810 THANK YOU FOR JOINING US FOR 2 00:00:09,810 --> 00:00:14,181 TODAY'S OHEART ATTACK SRP SERIES 3 00:00:14,181 --> 00:00:17,484 SESSION TITLED: IRB REVIEW OF 4 00:00:17,484 --> 00:00:18,419 RESEARCH INVOLVING AI. 5 00:00:18,419 --> 00:00:21,355 OUR SPEAKER TODAY IS 6 00:00:21,355 --> 00:00:23,424 DR. BENJAMIN C. SILVER MAN WHO 7 00:00:23,424 --> 00:00:26,093 IS THE DIRECTOR AT BRIGHAM 8 00:00:26,093 --> 00:00:26,327 AFFAIRS. 9 00:00:26,327 --> 00:00:28,629 ADDITIONALLY HE IS CHAIR OF THE 10 00:00:28,629 --> 00:00:30,097 EMBRYONIC STEM CELL RESEARCH 11 00:00:30,097 --> 00:00:31,065 OVERSIGHT COMMITTEE. 12 00:00:31,065 --> 00:00:32,399 DIRECTOR OF ETHICS FOR THE 13 00:00:32,399 --> 00:00:36,737 INSTITUTE OF TECHNOLOGY AND 14 00:00:36,737 --> 00:00:37,738 PSYCHIATRIST AT Mc CLEAN 15 00:00:37,738 --> 00:00:39,106 HOSPITAL AND MEDICAL SCHOOL AND 16 00:00:39,106 --> 00:00:41,642 HE SERVES AS INTRUCTOR AND 17 00:00:41,642 --> 00:00:44,778 PSYCHIATRY IN THE TRUSTEES FOR 18 00:00:44,778 --> 00:00:45,346 BIOETHICS. 19 00:00:45,346 --> 00:00:46,880 DR. SILLER MAN RECEIVED HIS 20 00:00:46,880 --> 00:00:47,815 DEGREE FROM THE UNIVERSITY OF 21 00:00:47,815 --> 00:00:54,121 SCHOOL OF MEDICINE, COMPLOATED 22 00:00:54,121 --> 00:00:54,989 PSYCHIATRY RESIDENCY AND 23 00:00:54,989 --> 00:00:57,491 TRAINING PROGRAM AND COMPLETED 24 00:00:57,491 --> 00:01:01,161 SPECIALTY FELLOWSHIP TRAINING IN 25 00:01:01,161 --> 00:01:02,696 ADDICTION PSYCHIATRY THROUGH 26 00:01:02,696 --> 00:01:05,799 MASS GENERAL BRIGHAM EMPLOY 27 00:01:05,799 --> 00:01:07,401 OHSRP DR. GREEN WILL JOIN C 28 00:01:07,401 --> 00:01:09,169 SILLER MAN FOR THE Q&A SESSION. 29 00:01:09,169 --> 00:01:11,038 THROUGHOUT THE SESSION WE 30 00:01:11,038 --> 00:01:12,106 ENCOURAGE VIEWERS TO SUBMIT 31 00:01:12,106 --> 00:01:17,811 QUESTIONS BY CLICKING ON THE BOX 32 00:01:17,811 --> 00:01:22,249 BELOW THE VIDEO SAYING SEND LIVE 33 00:01:22,249 --> 00:01:22,716 FEEDBACK LINK. 34 00:01:22,716 --> 00:01:24,685 A LINK TO THE VIDEOCAST AS WELL 35 00:01:24,685 --> 00:01:25,853 AS SLIDES FROM THE SESSION WILL 36 00:01:25,853 --> 00:01:30,324 ALSO BE POSTED ON THE OHSRP 37 00:01:30,324 --> 00:01:32,192 WEBSITE APPROXIMATELY 1-2 WEEKS 38 00:01:32,192 --> 00:01:34,495 AFTER THE SESSION IN THE 39 00:01:34,495 --> 00:01:36,230 PRESENTATION ARCHIVE SECTION OF 40 00:01:36,230 --> 00:01:38,198 THE OHSRP EDUCATION AND TRAINING 41 00:01:38,198 --> 00:01:38,432 WEBPAGE. 42 00:01:38,432 --> 00:01:40,534 THANK YOU FOR JOINING US 43 00:01:40,534 --> 00:01:41,435 DR. SILVER MAN. 44 00:01:41,435 --> 00:01:44,571 PLEASE GO AHEAD AND GET STARTED. 45 00:01:44,571 --> 00:01:45,305 THANK YOU. 46 00:01:45,305 --> 00:01:45,606 >> GREAT. 47 00:01:45,606 --> 00:01:46,740 THANK YOU SO MUCH FOR THE 48 00:01:46,740 --> 00:01:47,674 INTRODUCTION AND THANKS SO MUCH 49 00:01:47,674 --> 00:01:50,310 FOR HAVING ME AND ARRANGING THIS 50 00:01:50,310 --> 00:01:52,279 SESSION WHICH I THINK IS ON A 51 00:01:52,279 --> 00:01:53,447 REALLY TIMELY AND IMPORTANT 52 00:01:53,447 --> 00:01:56,583 TOPIC AND THANK TO YOU OHSRP FOR 53 00:01:56,583 --> 00:01:58,519 INVITING ME AND HELLO TO 54 00:01:58,519 --> 00:01:59,720 EVERYONE OUT THERE JOINING, HOPE 55 00:01:59,720 --> 00:02:01,922 TO HEAR YOUR QUESTIONS AS WE GO 56 00:02:01,922 --> 00:02:04,324 HERE, I THINK WHAT YOU WILL FIND 57 00:02:04,324 --> 00:02:06,527 IS I AM PROBABLY GOING TO RAISE 58 00:02:06,527 --> 00:02:07,795 MORE QUESTIONS AND PROVIDE 59 00:02:07,795 --> 00:02:10,964 ANSWERS BUT HOPE TO JUST TAKE 60 00:02:10,964 --> 00:02:12,733 YOU THROUGH HOW WE'RE THINKING 61 00:02:12,733 --> 00:02:17,104 ABOUT THE IRB REVIEW OF RESEARCH 62 00:02:17,104 --> 00:02:17,538 INVOLVING ARTIFICIAL 63 00:02:17,538 --> 00:02:17,871 INTELLIGENCE. 64 00:02:17,871 --> 00:02:19,840 SO JUST TO GET STARTED TO SAY, 65 00:02:19,840 --> 00:02:21,041 YOU KNOW, WHY ARE WE TALKING 66 00:02:21,041 --> 00:02:22,976 ABOUT THIS AND SOME OF THIS 67 00:02:22,976 --> 00:02:24,244 PROBABLY GOES WITHOUT SAYING, 68 00:02:24,244 --> 00:02:26,080 BUT I THINK IT'S USEFUL JUST TO 69 00:02:26,080 --> 00:02:27,748 KIND OF GIVE A HIGH LEVEL 70 00:02:27,748 --> 00:02:30,250 OVERVIEW, YOU KNOW THE REASON 71 00:02:30,250 --> 00:02:32,086 THAT EVERYONE IS TALKING SO MUCH 72 00:02:32,086 --> 00:02:33,387 ABOUT THIS AND SO EXCITED ABOUT 73 00:02:33,387 --> 00:02:36,590 THIS IS BECAUSE OF THE AWESOME 74 00:02:36,590 --> 00:02:38,525 POTENTIAL FOR DIGIT AT HEALTH 75 00:02:38,525 --> 00:02:41,195 AND HEALTHCARE POWERED BY AI. 76 00:02:41,195 --> 00:02:43,664 AI HAS THE POTENTIAL TO ADD 77 00:02:43,664 --> 00:02:44,698 QUANTITATIVE AND REALTIME DATA 78 00:02:44,698 --> 00:02:48,569 TO CLINICAL CARE AND RESEARCH, 79 00:02:48,569 --> 00:02:52,239 ENHANCES PRECISION MEDICINE, 80 00:02:52,239 --> 00:02:53,841 INDIVIDUALIZES CARE, 81 00:02:53,841 --> 00:02:55,109 DEMOCRATIZES EXPERTISE, IMPROVES 82 00:02:55,109 --> 00:02:58,078 SCALABILITY AND AVAILABILITY OF 83 00:02:58,078 --> 00:02:59,379 CARE, OPTIMIZES DOCUMENTATION, 84 00:02:59,379 --> 00:03:00,848 CAN MINIMIZE ADMEN 85 00:03:00,848 --> 00:03:02,449 ADMINISTRATIVE BURDEN, GUIDE THE 86 00:03:02,449 --> 00:03:05,719 DRUG DORPHY PROCESS, MANY, MANY 87 00:03:05,719 --> 00:03:07,988 POWERFUL APPLICATIONS WITH REAL 88 00:03:07,988 --> 00:03:09,056 AWESOME POTENTIAL ESSENTIALLY TO 89 00:03:09,056 --> 00:03:11,425 SAY THAT AI CAN DO WHAT PEOPLE 90 00:03:11,425 --> 00:03:14,728 CANNOT DO ON THEIR OWN AND 91 00:03:14,728 --> 00:03:16,130 REALLY FROM A CLINICAL 92 00:03:16,130 --> 00:03:16,964 STANDPOINT PROVIDE THE RIGHT 93 00:03:16,964 --> 00:03:18,565 CARE IN THE RIGHT PLACE AT THE 94 00:03:18,565 --> 00:03:20,734 RIGHT TIME TO MORE PEOPLE. 95 00:03:20,734 --> 00:03:23,704 SO WITH THAT SAID, WHAT IS THE 96 00:03:23,704 --> 00:03:25,906 BIG DEAL, WITH THE AWESOME 97 00:03:25,906 --> 00:03:27,441 POTENTIAL, THE PROBLEM IS WITH 98 00:03:27,441 --> 00:03:30,611 THE AWESOME POTENTIAL COMES SOME 99 00:03:30,611 --> 00:03:33,380 VERY SCARY PROBLEMS THAT ARISE 100 00:03:33,380 --> 00:03:34,381 FROM AI. 101 00:03:34,381 --> 00:03:35,449 AI DOESN'T ALWAYS WORK MEANING 102 00:03:35,449 --> 00:03:38,919 IT CAN JUST GIVE THE WRONG 103 00:03:38,919 --> 00:03:40,921 ANSWER, IT DOESN'T ALWAYS WORK 104 00:03:40,921 --> 00:03:41,889 FOR EVERYONE, MEANING THAT FOR A 105 00:03:41,889 --> 00:03:43,724 VARIETY OF REASONS WE WILL TALK 106 00:03:43,724 --> 00:03:46,760 A LITTLE BIT ABOUT ESPECIALLY 107 00:03:46,760 --> 00:03:47,995 FOR NONREPRESENTATIVE DATA SETS 108 00:03:47,995 --> 00:03:49,763 WHERE THE DATA SET IN WHICH AI 109 00:03:49,763 --> 00:03:51,265 IS TRAINED IS THE DIFFERENT FROM 110 00:03:51,265 --> 00:03:53,800 THE DATA SET IN WHICH AI IS THEN 111 00:03:53,800 --> 00:03:55,202 USED ON CAN CAUSE RESULTS THAT 112 00:03:55,202 --> 00:03:57,638 ARE WRONG FOR SOME PEOPLE BUT 113 00:03:57,638 --> 00:04:02,276 NOT ALL PEOPLE, AND CAN LEAD TO 114 00:04:02,276 --> 00:04:02,509 BIASES. 115 00:04:02,509 --> 00:04:04,478 IT DOESN'T ALWAYS WORK IN EVERY 116 00:04:04,478 --> 00:04:06,346 CONTEXT, SIMILAR TO WHAT I JUST 117 00:04:06,346 --> 00:04:09,316 SAID ESSENTIALLY THAT IT CAN BE 118 00:04:09,316 --> 00:04:10,417 BEHAVE DIFFERENTLY IN DIFFERENT 119 00:04:10,417 --> 00:04:12,019 DATA SETS IN DIFFERENT 120 00:04:12,019 --> 00:04:13,420 LOCATIONS, SO YOU TRAIN IT IN 1 121 00:04:13,420 --> 00:04:15,055 HOSPITAL, AND MOVE IT TO ANOTHER 122 00:04:15,055 --> 00:04:17,257 HOSPITAL AND IT MAY NOT WORK AS 123 00:04:17,257 --> 00:04:18,425 INTENDED AND IT DOESN'T ALWAYS 124 00:04:18,425 --> 00:04:19,593 GO THROUGH THE INDEPENDENT 125 00:04:19,593 --> 00:04:21,094 REVIEW PROCESS AS WE'RE 126 00:04:21,094 --> 00:04:22,663 ACCUSTOMED TO SEEING FOR MEDICAL 127 00:04:22,663 --> 00:04:23,830 DEVICE VICES AND WE WILL TALK 128 00:04:23,830 --> 00:04:25,799 MORE ABOUT THIS AS WE GO ON HERE 129 00:04:25,799 --> 00:04:27,768 BUT THE CURRENT REGULATIONS 130 00:04:27,768 --> 00:04:29,403 REALLY DID NOT ANTICIPATE MUCH 131 00:04:29,403 --> 00:04:32,673 OF THIS WORK AND SO, SOME OF THE 132 00:04:32,673 --> 00:04:35,342 WORK GOES THROUGH WITHOUT REAL 133 00:04:35,342 --> 00:04:36,043 EXTENSIVE REGULATORY REVIEW, AND 134 00:04:36,043 --> 00:04:38,645 SO WHAT ALL THAT MEANS IS THAT 135 00:04:38,645 --> 00:04:39,947 THERE'S ESSENTIALLY A POTENTIAL 136 00:04:39,947 --> 00:04:43,684 FOR AI TO CAUSE HARM, EITHER BY 137 00:04:43,684 --> 00:04:48,155 BEING WRONG OR PERPETUATING AND 138 00:04:48,155 --> 00:04:49,456 AMPLIFYING SOCIETAL JUSTICES AND 139 00:04:49,456 --> 00:04:50,224 EXCLUSION AND BIAS. 140 00:04:50,224 --> 00:04:51,758 SO GIVE TO GIVE AN EXAMPLE OF 141 00:04:51,758 --> 00:04:53,193 THAT, THIS IS AN EXAMPLE FROM 142 00:04:53,193 --> 00:04:55,329 SEVERAL YEARS AGO BUT 143 00:04:55,329 --> 00:04:58,465 NONAPOPTOTIC FROM FROM A COMPANY 144 00:04:58,465 --> 00:05:00,634 CALLED NOBLA USING GTP3, THIS 145 00:05:00,634 --> 00:05:02,369 WAS NOT A REAL LIFE EXAMPLE, 146 00:05:02,369 --> 00:05:03,904 THIS WAS THEM JUST PLAYING WITH 147 00:05:03,904 --> 00:05:05,772 THE SOFTWARE, THIS IS AN EXAMPLE 148 00:05:05,772 --> 00:05:07,507 IN PSYCHIATRY, MY LINE OF WORK 149 00:05:07,507 --> 00:05:09,109 AND TRYING TO BASICALLY SAY, CAN 150 00:05:09,109 --> 00:05:11,745 WE USE THIS AS A LARGE LANGUAGE 151 00:05:11,745 --> 00:05:15,115 MODEL, AS A CHAT BOT TO HELP 152 00:05:15,115 --> 00:05:16,350 HELP WITH PSYCHIATRIC PROBLEMS 153 00:05:16,350 --> 00:05:18,885 SO CAN YOU SEE ON THE LEFT SIDE 154 00:05:18,885 --> 00:05:20,387 HERE, SOMEONE SAYS I FEEL SAD 155 00:05:20,387 --> 00:05:21,955 AND DON'T KNOW WHAT TO DO, AND 156 00:05:21,955 --> 00:05:24,157 THE CHAT BOT SAYS, THAT THERE'S 157 00:05:24,157 --> 00:05:27,294 DIFFERENT TECHNIQUES THAT 158 00:05:27,294 --> 00:05:27,928 INCREASE HAPPINESS. 159 00:05:27,928 --> 00:05:29,229 THE PERSON ASKED WHAT THOSE ARE 160 00:05:29,229 --> 00:05:30,530 AND THE EXAMPLES INCLUDE TAKING 161 00:05:30,530 --> 00:05:33,200 A WALK, SEEING A FRIEND OR 162 00:05:33,200 --> 00:05:34,801 RECYCLING ELECTRONICKIC TO 163 00:05:34,801 --> 00:05:36,536 REDUCE POLLUTION, THE PERSON 164 00:05:36,536 --> 00:05:38,672 THEN ASKS FOR MORE DETAILTHAT 165 00:05:38,672 --> 00:05:41,308 AND THEY SAY IF YOU RECYCLE THIS 166 00:05:41,308 --> 00:05:43,277 CAN RECEIVE A TAX REFUND AND 167 00:05:43,277 --> 00:05:44,378 THIS MAKES AMERICANS FEEL 168 00:05:44,378 --> 00:05:46,413 HAPPIER BECAUSE THEY GET MORE 169 00:05:46,413 --> 00:05:46,913 MONEY. 170 00:05:46,913 --> 00:05:48,515 THAT'S A BIZARRE ANSWER TO SAY 171 00:05:48,515 --> 00:05:50,250 THE LEAST AND CERTAINLY NOT IN 172 00:05:50,250 --> 00:05:51,218 EVIDENCE-BASED FORM AND SO YOU 173 00:05:51,218 --> 00:05:55,489 CAN SEE WHERE IT JUST KIND OF IS 174 00:05:55,489 --> 00:05:57,124 WEIRD AND NOT TERRIBLY HELPFUL. 175 00:05:57,124 --> 00:05:59,226 ON THE RIGHT HAND COLUMN, THAT 176 00:05:59,226 --> 00:06:01,061 MUCH WORSE, SOMEONE SAYING THEY 177 00:06:01,061 --> 00:06:02,562 WANT TO KILL THEMSELVES AND THE 178 00:06:02,562 --> 00:06:04,197 CHAT BOX BASICALLY SAYING, YES, 179 00:06:04,197 --> 00:06:06,166 I THINK YOU SHOULD DO THAT. 180 00:06:06,166 --> 00:06:08,335 SO, AGAIN, GLAD THIS WASN'T A 181 00:06:08,335 --> 00:06:12,639 REAL LIFE EXAMPLE BUT JUST TO 182 00:06:12,639 --> 00:06:14,341 SHOW THAT THESE LARGE LANGUAGE 183 00:06:14,341 --> 00:06:15,742 MODELS DON'T ALWAYS ACT THE WAY 184 00:06:15,742 --> 00:06:18,278 YOU EXPECT THEM TO AND YOU KNOW 185 00:06:18,278 --> 00:06:20,314 HAVE REAL POTENTIAL FOR HARM. 186 00:06:20,314 --> 00:06:21,715 THIS IS ANOTHER REAL LE 187 00:06:21,715 --> 00:06:23,583 INTERESTING EXAMPLE THAT I LOVED 188 00:06:23,583 --> 00:06:27,287 SHARING WITH PEOPLE, THIS IS 189 00:06:27,287 --> 00:06:28,588 FROM LEO [INDISCERNIBLE] AT M. 190 00:06:28,588 --> 00:06:30,691 I.T. AND COLLEAGUES AND THIS IS 191 00:06:30,691 --> 00:06:31,858 SHOWING WHERE AI DOESN'T ALWAYS 192 00:06:31,858 --> 00:06:32,492 WORK FOR EVERYONE. 193 00:06:32,492 --> 00:06:36,129 SO THIS WAS INITIALLY DISCOVERED 194 00:06:36,129 --> 00:06:39,466 WHEN THEY WERE DEVELOPING AN 195 00:06:39,466 --> 00:06:40,934 ALGORITHM TO DIAGNOSE PNEUMONIA 196 00:06:40,934 --> 00:06:42,002 FROM CHEST X-RAYS AND WHAT THEY 197 00:06:42,002 --> 00:06:46,039 FOUND WAS THAT THE ALGORITHM WAS 198 00:06:46,039 --> 00:06:49,409 CONSISTENTLY MISSING THE 199 00:06:49,409 --> 00:06:50,777 PNEUMONIA DIAGNOSIS OF CHEST 200 00:06:50,777 --> 00:06:52,045 X-RAYS IN BLACK PATIENTS MORE IN 201 00:06:52,045 --> 00:06:52,679 WHITE PATIENTS. 202 00:06:52,679 --> 00:06:54,181 AND THEY LOOKED INTO THIS MORE 203 00:06:54,181 --> 00:06:57,317 AND WHAT THEY REALIZED WAS THAT 204 00:06:57,317 --> 00:06:59,019 THE ALGORITHM WAS PREDICTING THE 205 00:06:59,019 --> 00:07:01,588 SELF-REPORTED RACE OF THE 206 00:07:01,588 --> 00:07:03,657 PATIENT FROM THE X-RAY WITH'S 207 00:07:03,657 --> 00:07:06,393 REMARKABLE DEGREE OF ACCURACY SO 208 00:07:06,393 --> 00:07:09,563 WITH A 90% DEGREE OF ACCURACY, 209 00:07:09,563 --> 00:07:11,865 SO THE ALGOGHT RHYTHM WAS 210 00:07:11,865 --> 00:07:13,500 PREDICTED THE SELF-REPORTED RACE 211 00:07:13,500 --> 00:07:15,569 OF PATIENTS FROM THE MEDICAL 212 00:07:15,569 --> 00:07:17,104 IMAGES ALONE, THE REASON IT'S SO 213 00:07:17,104 --> 00:07:19,639 STARTLING IS THAT THAT'S NOT A 214 00:07:19,639 --> 00:07:21,708 TASK GENERALLY UNDERSTOOD TO BE 215 00:07:21,708 --> 00:07:23,310 POSSIBLE FOR HUMAN BEINGS OR 216 00:07:23,310 --> 00:07:23,944 EXPERTS MOEBING YOU SHOULD BE 217 00:07:23,944 --> 00:07:26,179 ABLE TO HAND A CHEST X-RAY TO A 218 00:07:26,179 --> 00:07:26,980 RADIOLOGIST AND THEY SHOULD NOT 219 00:07:26,980 --> 00:07:29,750 BE ABLE TO TELL YOU THE RACE OF 220 00:07:29,750 --> 00:07:31,685 THE PATIENT FROM WHOM THAT CHEST 221 00:07:31,685 --> 00:07:33,086 X-RAY CAME, YOU KNOW WHO WOULD 222 00:07:33,086 --> 00:07:39,025 BE FLIPPING A COIN ESSENTIALLY. 223 00:07:39,025 --> 00:07:40,193 SO THEN WHAT THESE INVESTIGATORS 224 00:07:40,193 --> 00:07:41,595 DID WAS THEY TRIED TO UNDERSTAND 225 00:07:41,595 --> 00:07:44,698 HOW THIS WAS HAPPENING, HOW THE 226 00:07:44,698 --> 00:07:45,499 ALGORITHM WAS ACTUALLY FIGURING 227 00:07:45,499 --> 00:07:49,336 THIS OUT AND TO DO THAT, THEY 228 00:07:49,336 --> 00:07:50,637 CORRUPTED THEIR IMAGES, THEY 229 00:07:50,637 --> 00:07:52,038 NOISED THEIR IMAGES AND TRIED TO 230 00:07:52,038 --> 00:07:56,343 BASIC LE HAVE THE ALGORITHM LOSE 231 00:07:56,343 --> 00:07:58,211 THE ABILITY TO DETERMINE RACE IN 232 00:07:58,211 --> 00:08:00,213 ORDER TO FIGURE OUT HOW IT WAS 233 00:08:00,213 --> 00:08:01,348 DETERMINING RACE AND WHAT THEY 234 00:08:01,348 --> 00:08:06,119 FOUND THERE WAS EVEN MORE 235 00:08:06,119 --> 00:08:07,287 STARTLING SO HOPEFULLY YOU CAN 236 00:08:07,287 --> 00:08:09,389 ALL SEE THIS BUT ON THE LEFT 237 00:08:09,389 --> 00:08:12,492 HERE, THESE ARE IMAGES THAT HAVE 238 00:08:12,492 --> 00:08:15,462 BEEN DISTORTED USING LOW PASS 239 00:08:15,462 --> 00:08:17,798 FILTERS OPF AND HIGH PASS 240 00:08:17,798 --> 00:08:21,101 FILTERS HPF, AND ON THE BOTTOM 241 00:08:21,101 --> 00:08:23,303 IS ESSENTIALLY THE ABILITY FOR 242 00:08:23,303 --> 00:08:25,272 THE ALGORITHM TO CONTINUE TO 243 00:08:25,272 --> 00:08:26,973 DETERMINE RACE ON THESE 244 00:08:26,973 --> 00:08:27,407 CORRUPTED IMAGES. 245 00:08:27,407 --> 00:08:33,146 SO IF YOU LOOK AT HPF OF 50 246 00:08:33,146 --> 00:08:35,081 HERE, LETTER D, AT THAT POINT 247 00:08:35,081 --> 00:08:36,716 IT'S NO LONGER EVEN PERCEPTIBLE 248 00:08:36,716 --> 00:08:40,520 AS AN X-RAY TO US, RIGHT IN IF I 249 00:08:40,520 --> 00:08:41,888 HANDED YOU LETTER D AND DIDN'T 250 00:08:41,888 --> 00:08:43,523 TELL YOU WHAT IT WAS, YOU 251 00:08:43,523 --> 00:08:45,058 WOULDN'T BE ABLE TO TELL ME IT 252 00:08:45,058 --> 00:08:47,093 WAS AN X-RAY, SO REALLY, REALLY 253 00:08:47,093 --> 00:08:48,261 DISTORTED AND YET YOU CAN SEE ON 254 00:08:48,261 --> 00:08:49,329 THE GRAPH, ON THE BOTTOM RIGHT 255 00:08:49,329 --> 00:08:53,300 THAT IF YOU LOOK AT A HIGH PASS 256 00:08:53,300 --> 00:08:56,036 FILTER OF 50 TO A HUNDRED, YOU 257 00:08:56,036 --> 00:09:01,007 KNOW THE PREDICTION RATE THERE, 258 00:09:01,007 --> 00:09:03,577 IT'S STILL 85ISH PERCENT, 259 00:09:03,577 --> 00:09:05,011 BETWEEN 80 AND 90 PERCENT, SO 260 00:09:05,011 --> 00:09:06,646 EVEN ON THAT INCREDIBLY 261 00:09:06,646 --> 00:09:08,381 DISTORTED IMAGE THAT NO LONGER 262 00:09:08,381 --> 00:09:10,417 LOOKS LIKE A CHEST X-RAY TO US, 263 00:09:10,417 --> 00:09:12,152 THE ALGORITHM IS STILL ABLE TO 264 00:09:12,152 --> 00:09:13,620 PREDICT THE RACE OF THE PERSON 265 00:09:13,620 --> 00:09:15,155 FROM WHOM THAT X-RAY ORIGE 266 00:09:15,155 --> 00:09:16,690 NAWILLLY CAME FROM AND 267 00:09:16,690 --> 00:09:19,993 ESSENTIALLY TO SAY NOBODY REALLY 268 00:09:19,993 --> 00:09:22,329 KNOWS WHY, AND IT'S STARTLING 269 00:09:22,329 --> 00:09:23,930 AND SCARY BECAUSE WHAT THAT 270 00:09:23,930 --> 00:09:29,236 MEANS IS THAT ALGORITHMS DON'T 271 00:09:29,236 --> 00:09:30,036 ALWAYS PROVIDE ANSWERS WE 272 00:09:30,036 --> 00:09:30,337 UNDERSTAND. 273 00:09:30,337 --> 00:09:32,506 THEY CAN BE ACTING ON HIDDEN 274 00:09:32,506 --> 00:09:34,741 INFORMATION WITHIN DATA SETS, 275 00:09:34,741 --> 00:09:36,877 AND WE MAY NOT BE ABLE TO TELL 276 00:09:36,877 --> 00:09:38,512 WHAT THE ALGORITHM IS SEEING IF 277 00:09:38,512 --> 00:09:42,315 WE CAN'T SEE IT OURSELVES AND 278 00:09:42,315 --> 00:09:43,984 THAT REALLY LEADS TO THE 279 00:09:43,984 --> 00:09:46,386 POTENTIAL THAT BIAS CAN BE 280 00:09:46,386 --> 00:09:47,554 PROPAGATED IN WAYS WE DON'T 281 00:09:47,554 --> 00:09:47,921 UNDERSTAND. 282 00:09:47,921 --> 00:09:50,423 AS I MENTIONED EARLIER, THERE'S 283 00:09:50,423 --> 00:09:51,591 A WELL UNDERSTOOD PROBLEM, I 284 00:09:51,591 --> 00:09:58,064 BEING IN THE DEVELOPMENT OF AI 285 00:09:58,064 --> 00:09:59,165 THAT REGARDING NONREPRESENTATIVE 286 00:09:59,165 --> 00:10:00,267 DATA SETS AND AGAIN WHAT THAT 287 00:10:00,267 --> 00:10:03,336 MEAN SYSTEM IF YOU DEVELOP AN AI 288 00:10:03,336 --> 00:10:05,472 ALGOGHT RHYTHM ON A DATA SET 289 00:10:05,472 --> 00:10:06,206 THAT IS NONREPRESENTATIVE, CAN 290 00:10:06,206 --> 00:10:07,240 YOU EXPECT IT'S NOT GOING TO 291 00:10:07,240 --> 00:10:11,611 WORK WELL ON THE PEOPLE WHO ARE 292 00:10:11,611 --> 00:10:14,147 NOT INCLUDED FROM THAT DATA SET 293 00:10:14,147 --> 00:10:16,349 FROM WHICH THE ALGOGHT RHYTHM 294 00:10:16,349 --> 00:10:17,284 WAS DESIGNED. 295 00:10:17,284 --> 00:10:17,984 AND GENERALLY THERE'S UNDERSTOOD 296 00:10:17,984 --> 00:10:19,553 TO BE A FIX FOR THAT, WHICH IS 297 00:10:19,553 --> 00:10:21,688 TO MAKE SURE HA WE'RE USING 298 00:10:21,688 --> 00:10:22,756 FULLY REPRESENTATIVE DATA SETS 299 00:10:22,756 --> 00:10:25,492 OF OUR ENTIRE POPULATION, BUT 300 00:10:25,492 --> 00:10:28,161 WHAT THIS IS SAYING, WHAT THIS 301 00:10:28,161 --> 00:10:31,264 EXAMPLE SHOWS IS THAT EVEN IF 302 00:10:31,264 --> 00:10:32,799 YOU CORRECT THE REPRESENTATIVE 303 00:10:32,799 --> 00:10:35,468 DATA SET PROBLEM, THAT'S 304 00:10:35,468 --> 00:10:36,269 CRITICAL, THAT'S ABSOLUTELY 305 00:10:36,269 --> 00:10:39,105 CRITICAL BUT IT'S NOT ACTUALLY 306 00:10:39,105 --> 00:10:39,639 ALWAYS NECESSARILY CORRECT 307 00:10:39,639 --> 00:10:40,874 BECAUSE EVEN WITH THAT, THE 308 00:10:40,874 --> 00:10:42,309 OLYMPIC GAR RHYTHM COULD BE 309 00:10:42,309 --> 00:10:44,811 ACTING ON THINGS THAT WE CAN'T 310 00:10:44,811 --> 00:10:45,812 SEE AND DON'T UNDERSTAND. 311 00:10:45,812 --> 00:10:48,915 SO JUST TO SAY THAT, YOU KNOW 312 00:10:48,915 --> 00:10:51,985 THIS SCARY PROBLEM IS REAL AND 313 00:10:51,985 --> 00:10:54,054 IS SOMETHING THAT WE REALLY NEED 314 00:10:54,054 --> 00:10:55,322 TO BE THINKING ABOUT AS WE 315 00:10:55,322 --> 00:10:59,626 CONTINUE DOWN THE ROAD OF AI 316 00:10:59,626 --> 00:11:00,927 INTEGRATING MORE INTO 317 00:11:00,927 --> 00:11:01,328 HEALTHCARE. 318 00:11:01,328 --> 00:11:03,897 AND SO WHAT IS THAT MEAN FOR 319 00:11:03,897 --> 00:11:04,097 IRBs? 320 00:11:04,097 --> 00:11:06,132 SO TO KIND OF GO BACK TO THE 321 00:11:06,132 --> 00:11:07,767 QUESTION OF--SO WHAT DOES AN IRB 322 00:11:07,767 --> 00:11:11,071 DO AND HOW DO WE REVIEW THIS 323 00:11:11,071 --> 00:11:11,871 TYPE OF RESEARCH. 324 00:11:11,871 --> 00:11:14,608 I LITTLE TONGUE IN CHEEK BUT I 325 00:11:14,608 --> 00:11:16,343 LIKE TO PROVIDE THIS PICTURE 326 00:11:16,343 --> 00:11:18,078 HERE AS AS WAY OF ILTRAITING 327 00:11:18,078 --> 00:11:18,378 THIS POINT. 328 00:11:18,378 --> 00:11:19,913 SO 1 OF THESE PICTURE SYSTEM A 329 00:11:19,913 --> 00:11:24,918 LLAMA AND 1 OF THESE PICTURES IS 330 00:11:24,918 --> 00:11:27,187 AN ALPACA AND I SUSPECT THERE 331 00:11:27,187 --> 00:11:28,154 MAY BE PEOPLE IN THE AUDYEPS, 332 00:11:28,154 --> 00:11:30,690 YOU KNOW IF WE WERE LIVE I WOULD 333 00:11:30,690 --> 00:11:32,993 ASK YOU TO DO THIS, TO TELL ME 334 00:11:32,993 --> 00:11:35,095 WHICH IS WHICH AND WHY, AND THE 335 00:11:35,095 --> 00:11:36,396 DIFFERENT CHARACTERISTICS AND 336 00:11:36,396 --> 00:11:37,097 VERY SPECIFIC CHARACTERISTICS 337 00:11:37,097 --> 00:11:41,234 BETWEEN THEM AND THERE'S SOME 338 00:11:41,234 --> 00:11:42,969 PEOPLE WHO ARE EX PERWHO IS 339 00:11:42,969 --> 00:11:44,604 WOULD BE ABLE DO THAT AND OTHER 340 00:11:44,604 --> 00:11:45,672 PEOPLE LOOK AND SAY THEY'RE 341 00:11:45,672 --> 00:11:47,941 EXACTLY THE SAME AND I LIKE 342 00:11:47,941 --> 00:11:49,743 THESE FOR AN ANALOGY FOR THE WAY 343 00:11:49,743 --> 00:11:53,713 IRBs NEED TO,A PROACH THIS 344 00:11:53,713 --> 00:11:55,682 WORK WITH AI AND WHAT I MEAN BY 345 00:11:55,682 --> 00:12:02,989 THAT IS THAT SOME THINGS ARE 346 00:12:02,989 --> 00:12:04,624 EXACTLY THE SAME THINGS WE NEED 347 00:12:04,624 --> 00:12:06,259 TO CO WITH RESEARCH INVOLVING AI 348 00:12:06,259 --> 00:12:07,694 WITH THE SAME RESEARCH AND 349 00:12:07,694 --> 00:12:08,628 DETERMINATIONS THAT WE DO FOR 350 00:12:08,628 --> 00:12:10,463 ANY OTHER STUDY AND WE CAN'T 351 00:12:10,463 --> 00:12:11,798 MISS THAT, WE CAN'T FORGET ABOUT 352 00:12:11,798 --> 00:12:14,334 THAT AND WE CAN'T IGNORE THAT 353 00:12:14,334 --> 00:12:15,602 AND SOMETIMES PEOPLE DON'T WANT 354 00:12:15,602 --> 00:12:17,504 TO BECAUSE IT CAN BE A LITTLE 355 00:12:17,504 --> 00:12:19,205 MORE COMPLICATED BUT WE HAVE TO 356 00:12:19,205 --> 00:12:20,273 DO THOSE BASIC THINGS AND THEN 357 00:12:20,273 --> 00:12:24,144 WE ARE GOING TO NEED THE EXPERTS 358 00:12:24,144 --> 00:12:26,646 IN THE ROOM WHO CAN TELL US 359 00:12:26,646 --> 00:12:27,781 EXACTLY WHAT IS DIFFERENT 360 00:12:27,781 --> 00:12:28,948 BETWEEN THIS STUDY AND SOMETHING 361 00:12:28,948 --> 00:12:33,586 ELSE WE MIGHT SEE AND AND REAL 362 00:12:33,586 --> 00:12:35,989 LYE HELP US UNDERSTAND THOSE 363 00:12:35,989 --> 00:12:38,158 FINE, FINE EXPERT DETAIL WE NEED 364 00:12:38,158 --> 00:12:39,325 TO DISTINGUISH BETWEEN THESE. 365 00:12:39,325 --> 00:12:41,728 SO THE QUESTIONS ARE THE SAME, 366 00:12:41,728 --> 00:12:43,463 THE THINGS ARE THE SAME, THAT WE 367 00:12:43,463 --> 00:12:47,133 NEED TO THINK ABOUT IS IS IT 368 00:12:47,133 --> 00:12:48,068 HUMAN SUBJECTS RESEARCH, SO WHEN 369 00:12:48,068 --> 00:12:50,437 WE GET A PROTOCOL INVOLVING AI, 370 00:12:50,437 --> 00:12:52,972 OR A PROJECT INVOLVING AI, 371 00:12:52,972 --> 00:12:54,908 APPLYING THE SAME QUESTIONS WE 372 00:12:54,908 --> 00:12:56,710 DO FOR OTHER STUDIES TO 373 00:12:56,710 --> 00:12:57,911 DETERMINE IF IT'S SURVEYS MAN 374 00:12:57,911 --> 00:12:59,245 SUBJECTS RESEARCH WE DO, WE HAVE 375 00:12:59,245 --> 00:13:01,081 TO ASK QUESTIONS ABOUT FDA 376 00:13:01,081 --> 00:13:02,515 REGULATION AND IF IT'S FKA 377 00:13:02,515 --> 00:13:04,217 REGULATED AND WE HAVE TO 378 00:13:04,217 --> 00:13:06,686 DETERMINE IF IT MEETS THE 379 00:13:06,686 --> 00:13:07,387 REGULATORY APPROVAL, THOSE ARE 380 00:13:07,387 --> 00:13:09,489 ALL THE SAME THINGS WE WOULD DO 381 00:13:09,489 --> 00:13:11,157 WITH ANY STUDY, THOSE ARE UNIQUE 382 00:13:11,157 --> 00:13:12,125 ASPECTS FOR THOSE QUESTIONS BUT 383 00:13:12,125 --> 00:13:14,794 WE HAVE TO GO THROUGH THE SAME 384 00:13:14,794 --> 00:13:15,862 BASIC PROCESS, AND WHAT'S 385 00:13:15,862 --> 00:13:19,165 DIFFERENT, THERE ARE SPECIAL 386 00:13:19,165 --> 00:13:19,966 CONSIDERATIONS FOR AI RESEARCH 387 00:13:19,966 --> 00:13:21,868 THAT WE NEED TO SEE IN THE 388 00:13:21,868 --> 00:13:22,569 RESEARCH PROTOCOL AND CONSENT 389 00:13:22,569 --> 00:13:24,070 FORM AND WE'LL GO THROUGH IN OF 390 00:13:24,070 --> 00:13:29,442 THOSE IN SOME MORE DETAIL. 391 00:13:29,442 --> 00:13:31,277 TO BROADEN THE LITTLE BIT AND 392 00:13:31,277 --> 00:13:33,980 WHAT DOES THIS MEAN FOR IRBs 393 00:13:33,980 --> 00:13:36,883 BUT FOR HRPPs AND 394 00:13:36,883 --> 00:13:37,784 INSTITUTIONS, 1 QUESTION 395 00:13:37,784 --> 00:13:39,853 CERTAINLY OUR IRB AND IRBs 396 00:13:39,853 --> 00:13:42,255 FROM CROSS THE COUNTRY WITH 397 00:13:42,255 --> 00:13:46,860 CONVERSATIONS I'VE HAD WITH MANY 398 00:13:46,860 --> 00:13:49,429 PEOPLE IS THE IRBs ROLE, IS 399 00:13:49,429 --> 00:13:51,064 SOLVING THESE PROBLEMS AND 400 00:13:51,064 --> 00:13:53,233 ANSWERING THESE QUESTIONS THE 401 00:13:53,233 --> 00:13:56,870 IRB'S ROLE IN IF IT ISN'T THEN 402 00:13:56,870 --> 00:13:57,070 WHO'S? 403 00:13:57,070 --> 00:13:58,037 WHOSE JOB IS IT? 404 00:13:58,037 --> 00:14:00,673 AND THEN THINKING ABOUT THE 405 00:14:00,673 --> 00:14:01,574 REGULATION TO GOVERN THIS TYPE 406 00:14:01,574 --> 00:14:02,876 OF RESEARCH AND IF NOT, WHAT 407 00:14:02,876 --> 00:14:05,979 WOULD NEED TO CHANGE AND/OR, IF 408 00:14:05,979 --> 00:14:08,414 THE IRB CAN'T DO IT BECAUSE THE 409 00:14:08,414 --> 00:14:09,716 REGULATIONS DON'T ALLOW THE IRB 410 00:14:09,716 --> 00:14:11,451 TO DO IT THEN AGAIN, WHO'S 411 00:14:11,451 --> 00:14:13,319 RESPONSIBILITY IS IT TO PROVIDE 412 00:14:13,319 --> 00:14:17,023 ADEQUATE OVERSIGHT FOR THIS TYPE 413 00:14:17,023 --> 00:14:18,191 OF WORK EMPLOY SO JUST TO START 414 00:14:18,191 --> 00:14:19,392 WITH SOME OF THE QUESTIONS I 415 00:14:19,392 --> 00:14:22,495 SAID ARE THE SAME 416 00:14:22,495 --> 00:14:25,398 BETWEEN--BETWEEN REVIEWING AI 417 00:14:25,398 --> 00:14:26,399 RESEARCH AND REVIEWING RESEARCH 418 00:14:26,399 --> 00:14:29,669 TARTING WITH THE QUESTION IS IT 419 00:14:29,669 --> 00:14:30,737 HUMAN SUBRECYCLINGS RESEARCH, I 420 00:14:30,737 --> 00:14:32,138 WON'T SPEND A WHOLE LOT OF TIME 421 00:14:32,138 --> 00:14:34,107 ON THIS BECAUSE THIS IS LIKELY 422 00:14:34,107 --> 00:14:36,276 MANAGE THAT'S VERY FAMILIAR TO 423 00:14:36,276 --> 00:14:37,777 PEOPLE IN THIS SPACE BUT JUST TO 424 00:14:37,777 --> 00:14:40,313 SAY THAT BASICALLY THE QUESTIONS 425 00:14:40,313 --> 00:14:43,516 THAT WE ASK ARE GOING TO BE THE 426 00:14:43,516 --> 00:14:45,151 SAME FOR ANY OTHER STUDIES, 427 00:14:45,151 --> 00:14:50,623 YOU'RE GOING TO BE ASKING 428 00:14:50,623 --> 00:14:52,158 WHETHER SOMEONE IS CLICKING 429 00:14:52,158 --> 00:14:55,328 INFORMATION IN A SYSTEMATIC WAY. 430 00:14:55,328 --> 00:14:57,163 YOU WILL BE ASKING IF SOMEONE IS 431 00:14:57,163 --> 00:14:58,331 TRYING TO CREATE GENERALIZABLE 432 00:14:58,331 --> 00:14:59,399 KNOWLEDGE AND YOU WILL ASK 433 00:14:59,399 --> 00:15:01,034 WHETHER PEOPLE ARE USING AND 434 00:15:01,034 --> 00:15:04,037 AGAIN THIS IS THE--FOCUS ON THE 435 00:15:04,037 --> 00:15:05,405 COMMON RULE DEFINITION FOR A 436 00:15:05,405 --> 00:15:06,706 MOMENT, YOU WILL BE ASKING 437 00:15:06,706 --> 00:15:10,577 WHETHER PEOPLE ARE 438 00:15:10,577 --> 00:15:12,412 USING--INTERACTING WITH 439 00:15:12,412 --> 00:15:14,013 INDIVIDUALS OR USING 440 00:15:14,013 --> 00:15:23,156 IDENTIFIABLE HUMAN SUBJECT 441 00:15:23,156 --> 00:15:24,057 MATERIAL. 442 00:15:24,057 --> 00:15:26,626 I THINK WE GET A LOT OF STUDIES 443 00:15:26,626 --> 00:15:28,461 THAT COME IN THAT ARE DEVELOPING 444 00:15:28,461 --> 00:15:29,529 ALTASD GOR RHYTHMS THAT ARE 445 00:15:29,529 --> 00:15:31,965 BASICALLY TRYING TO DO WORK ON 446 00:15:31,965 --> 00:15:40,173 LARGE DATA SETS THAT ARE BOTH 447 00:15:40,173 --> 00:15:41,774 UNCONSEBTED AND DEIDENTIFIED AND 448 00:15:41,774 --> 00:15:44,077 THIS INTERESTING PROBLEM OR 449 00:15:44,077 --> 00:15:45,879 QUESTION THAT QUMS UP WHICH I 450 00:15:45,879 --> 00:15:48,882 THINK OFTEN PEOPLE FEEL PRETTY 451 00:15:48,882 --> 00:15:49,449 UNCOMFORTABLE NOT REVIEWING 452 00:15:49,449 --> 00:15:51,451 THOSE TYPES OF PROJECTS BECAUSE 453 00:15:51,451 --> 00:15:53,286 OF EVERYTHING THAT I JUST WENT 454 00:15:53,286 --> 00:15:54,687 THROUGH WHICH IS AI BRINGS UP 455 00:15:54,687 --> 00:15:58,024 ALL OF THESE TRICKY QUESTIONS, 456 00:15:58,024 --> 00:15:59,959 BUT IF SOMEONE IS IN THE VERY 457 00:15:59,959 --> 00:16:02,962 EARLY STAGES OF DOING AI WORK 458 00:16:02,962 --> 00:16:04,130 AND THEY'RE DOING--THEY'RE NOT 459 00:16:04,130 --> 00:16:06,366 INTERACTING WITH HUMAN BEINGS 460 00:16:06,366 --> 00:16:08,067 AND THEY'RE USING DEIDENTIFIED 461 00:16:08,067 --> 00:16:09,836 DATA ONLY, YOU KNOW MIGHT IT 462 00:16:09,836 --> 00:16:12,939 BE--MIGHT IT BE CONSIDERED NOT 463 00:16:12,939 --> 00:16:16,009 HUMAN SUBJECTS RESEARCH, AND 464 00:16:16,009 --> 00:16:17,844 REALLY THAT LEADS INTO AND MAYBE 465 00:16:17,844 --> 00:16:19,946 IT DOES AND THAT GETS TO WHAT I 466 00:16:19,946 --> 00:16:21,247 ALLUDED TO EARLIER WITH 1 OF THE 467 00:16:21,247 --> 00:16:22,315 PROBLEMS, I THINK THAT PEOPLE 468 00:16:22,315 --> 00:16:27,754 HAVE RIGHT NOW, IS THAT THIS 469 00:16:27,754 --> 00:16:29,122 RESEARCH DOESN'T ALWAYS UNDERGO 470 00:16:29,122 --> 00:16:31,424 THE SAME INDEPENDENT REVIEW AND 471 00:16:31,424 --> 00:16:32,458 OVERSIGHT AS RESEARCH RESEARCH 472 00:16:32,458 --> 00:16:33,993 DOES BECAUSE OF THE THINGS THAT 473 00:16:33,993 --> 00:16:37,096 CALL IN THE NONHUMAN SUBJEKS 474 00:16:37,096 --> 00:16:38,264 CATEGORY LEADS TO CRUITNY. 475 00:16:38,264 --> 00:16:40,033 THAT LEADS TO A SECOND QUESTION 476 00:16:40,033 --> 00:16:41,868 WHICH IS IS IT FDA REGULATED 477 00:16:41,868 --> 00:16:43,036 RESEARCH BECAUSE AS YOU ALL 478 00:16:43,036 --> 00:16:44,871 KNOW, IN THAT DETERMINE NATION, 479 00:16:44,871 --> 00:16:45,838 WHERE YOU'RE SAYING OKAY, 480 00:16:45,838 --> 00:16:54,147 SOMEONE IS NOW DOING EARLY STAGE 481 00:16:54,147 --> 00:17:00,420 AI WORK FOR DEIDENTIFIED DATA 482 00:17:00,420 --> 00:17:03,623 SET AND THE QUESTION TO BE ASKED 483 00:17:03,623 --> 00:17:06,192 BEFORE IT WORK STARTS IS IS IT 484 00:17:06,192 --> 00:17:08,895 FDA REGULATED ARE THEY AT THIS 485 00:17:08,895 --> 00:17:10,096 STAGE TESTING OR DEVELOPING A 486 00:17:10,096 --> 00:17:11,497 MEDICAL DEVICE IN THE WAY WE 487 00:17:11,497 --> 00:17:14,901 WOULD THINK OF THAT WOULD 488 00:17:14,901 --> 00:17:17,704 REQUIRE YOU KNOW FORMAL IRB 489 00:17:17,704 --> 00:17:20,073 REVIEW BECAUSE OF THE FDA 490 00:17:20,073 --> 00:17:21,040 REGULATIONS AND REALLY I THINK 491 00:17:21,040 --> 00:17:22,976 THE QUESTION I ASK WHEN I HEAR 492 00:17:22,976 --> 00:17:24,844 THIS QUESTION OF IS IT THE FDA 493 00:17:24,844 --> 00:17:26,479 REGULATED RESEARCH IS I TRY TO 494 00:17:26,479 --> 00:17:27,547 FLIP THE QUESTION A LITTLE BIT 495 00:17:27,547 --> 00:17:28,614 AND SAY, ACTUALLY WHAT I THINK 496 00:17:28,614 --> 00:17:30,583 WE SHOULD BE ASKING IS, AT WHICH 497 00:17:30,583 --> 00:17:32,452 POINT IN THE AI MODEL LIFE CYCLE 498 00:17:32,452 --> 00:17:38,224 DOES IT BECOME SUBJECT TO FDA 499 00:17:38,224 --> 00:17:40,126 OVERSIGHT? 500 00:17:40,126 --> 00:17:42,795 WE KNOW THAT AI ALGORITHMS IN 501 00:17:42,795 --> 00:17:44,297 HEALTHCARE WILL BE CONSIDERED 502 00:17:44,297 --> 00:17:45,798 SOFTWARE AS A MEDICAL DEVICE IN 503 00:17:45,798 --> 00:17:48,234 A LARGE NUMBER OF SITUATIONS SO 504 00:17:48,234 --> 00:17:50,470 THEY WILL BE FDA REGULATED, THE 505 00:17:50,470 --> 00:17:53,840 QUESTION IS TO AT WHAT POINT 506 00:17:53,840 --> 00:17:55,775 THAT KICKS IN AND AT WHAT POINT 507 00:17:55,775 --> 00:17:58,845 DO YOU HAVE TO CALL THAT IRB 508 00:17:58,845 --> 00:18:02,148 REVIEWED HUMAN SUBRECYCLINGS 509 00:18:02,148 --> 00:18:02,715 RESEARCH VERSUS POTENTIALLY 510 00:18:02,715 --> 00:18:03,783 NONHUMAN RESEARCH IN THE EXAMPLE 511 00:18:03,783 --> 00:18:06,753 I GAVE IS REALLY TRICK Y AND I 512 00:18:06,753 --> 00:18:08,454 DON'T THINK WE HAVE A CLEAR 513 00:18:08,454 --> 00:18:09,989 ANSWER ON THAT AND I THINK 514 00:18:09,989 --> 00:18:11,624 PEOPLE HANDLE THAT VERY 515 00:18:11,624 --> 00:18:12,959 DIFFERENTLY POTENTIALLY FROM IRB 516 00:18:12,959 --> 00:18:19,165 TO IRB AND SOMETHING WE NEED TO 517 00:18:19,165 --> 00:18:19,799 CONTINUE CONTINUING ABOUT, SO 518 00:18:19,799 --> 00:18:22,835 JUST A BIT MORE IN DETAIL, SO 519 00:18:22,835 --> 00:18:25,705 PEOPLE KNOW WHAT I MEAN, THE AI 520 00:18:25,705 --> 00:18:27,340 LIFE CYCLE AND ESSENTIALLY ON 521 00:18:27,340 --> 00:18:30,643 THE RIGHT HAND SIDE HERE, THIS 522 00:18:30,643 --> 00:18:35,381 IS A BIT OVERSIMPLISTIC, BUT IT 523 00:18:35,381 --> 00:18:36,883 STARTS WITH PLANNING, THINKING 524 00:18:36,883 --> 00:18:38,251 ABOUT THE PROBLEM YOU'RE TRYING 525 00:18:38,251 --> 00:18:40,153 TO SOLVE AND WHY AI WOULD BE 526 00:18:40,153 --> 00:18:41,187 APPROPRIATE FOR IT AND THEN YOU 527 00:18:41,187 --> 00:18:44,090 ARE NEED TO HAVE THE DATA SET 528 00:18:44,090 --> 00:18:45,858 THAT YOU ARE GOING TO WORK ON SO 529 00:18:45,858 --> 00:18:47,326 YOU DO DATA ACQUISITION AND DATA 530 00:18:47,326 --> 00:18:49,162 CLEANING AND GETTING THE DATA IN 531 00:18:49,162 --> 00:18:51,597 THE FORMAT THAT YOU NEED AS I 532 00:18:51,597 --> 00:18:53,132 SAID OFTEN THESE PROJECTS ARE 533 00:18:53,132 --> 00:18:54,834 STARTING WITH DATA SETS THAT ARE 534 00:18:54,834 --> 00:18:56,269 ALREADY COLLECTED THEN YOU TART 535 00:18:56,269 --> 00:18:57,203 BUILDING YOUR MODEL, AND YOU 536 00:18:57,203 --> 00:18:59,539 HAVE TO TRAIN YOUR MODEL, THEN 537 00:18:59,539 --> 00:19:03,576 YOU EVALUATE AND VALIDATE YOUR 538 00:19:03,576 --> 00:19:05,144 MODEL AND THEN FINALLY 539 00:19:05,144 --> 00:19:06,512 CLINICALLY DEPLOYING THE MODEL 540 00:19:06,512 --> 00:19:08,347 AND THEN AFTER YOU CLINICALLY 541 00:19:08,347 --> 00:19:10,550 DEPLOY IT, THOSE THINGS CHANGE 542 00:19:10,550 --> 00:19:12,285 OVER TIME AND ONGOING MONITORING 543 00:19:12,285 --> 00:19:13,753 AND MAINTENANCE WHICH GOES IN A 544 00:19:13,753 --> 00:19:15,021 BIG CIRCLE BECAUSE YOU HAVE TO 545 00:19:15,021 --> 00:19:16,089 IDENTIFY PROBLEMS AND PLAN TO 546 00:19:16,089 --> 00:19:20,693 FIX THEM AND DO MORE TRAINING 547 00:19:20,693 --> 00:19:22,095 AND RETRAINING AND VALIDATION SO 548 00:19:22,095 --> 00:19:24,697 IT'S A NEVER ENDING CYCLE AND 549 00:19:24,697 --> 00:19:29,969 JUST THE KIND OF REFLECT ON THE 550 00:19:29,969 --> 00:19:31,704 QUESTION I JUST ASKED IN LOOKING 551 00:19:31,704 --> 00:19:33,339 AT THIS PICTURE, SO WHEN YOU'RE 552 00:19:33,339 --> 00:19:34,740 JUST PLANNING, NOT DOING 553 00:19:34,740 --> 00:19:36,542 ANYTHING YET, IS THAT FDA 554 00:19:36,542 --> 00:19:36,809 REGULATED. 555 00:19:36,809 --> 00:19:39,178 WHEN YOU'RE JUST PREPARING YOUR 556 00:19:39,178 --> 00:19:40,813 DATA AND COLLECTING YOUR DATA 557 00:19:40,813 --> 00:19:42,348 BUT NOT ACTUALLY DOING ANYTHING 558 00:19:42,348 --> 00:19:44,684 WITH THE AI MODEL YET, IS THAT 559 00:19:44,684 --> 00:19:45,284 FDA REGULATED. 560 00:19:45,284 --> 00:19:46,819 WHEN YOU START BUILDING THE 561 00:19:46,819 --> 00:19:49,122 MODEL, IS THAT FDA REGULATED, 562 00:19:49,122 --> 00:19:50,323 WHEN YOU START TRAINING THE 563 00:19:50,323 --> 00:19:52,458 MODEL IS THAT FDA REGULATED, THE 564 00:19:52,458 --> 00:19:54,560 DEVIL IS IN THE DETAILS FOR EACH 565 00:19:54,560 --> 00:19:55,862 PROTOCOL FOR SOME DEGREE BUT I 566 00:19:55,862 --> 00:19:59,765 THINK THERE'S ROOM FOR DEBATE 567 00:19:59,765 --> 00:20:00,433 AND POTENTIALLY DISAGREEMENT 568 00:20:00,433 --> 00:20:02,768 AROUND WHEN THAT KICKS IN, AND 569 00:20:02,768 --> 00:20:04,871 I'VE SEEN DIFFERENT AGAIN, 570 00:20:04,871 --> 00:20:06,839 DIFFERENT IRBs HANDLE THIS IS 571 00:20:06,839 --> 00:20:08,441 IN DIFFERENT WAYS, IN SOME WAY 572 00:20:08,441 --> 00:20:10,710 THE QUESTION IS BASICALLY, HOW 573 00:20:10,710 --> 00:20:13,913 FAR BACK, IS THE FDA GOING TO 574 00:20:13,913 --> 00:20:17,984 WANT TO LOOK AND HOW 575 00:20:17,984 --> 00:20:19,218 CONSERVATIVE IS AN IRB GOING TO 576 00:20:19,218 --> 00:20:20,453 WANT TO BE. 577 00:20:20,453 --> 00:20:22,555 SO JUST TO REITERATE A FEW 578 00:20:22,555 --> 00:20:24,290 POINTS HERE ON THE BULLETS. 579 00:20:24,290 --> 00:20:27,160 YOU KNOW THE MEDICAL DEVICE 580 00:20:27,160 --> 00:20:29,328 REGGULESS DO APPLY, THE FDA HAS 581 00:20:29,328 --> 00:20:31,130 DONE A GREAT YOB IN TRYING TO 582 00:20:31,130 --> 00:20:32,698 KEEP UP WITH THIS, IT'S HARD TO 583 00:20:32,698 --> 00:20:35,368 KEEP UP WITH, THEY RELEASED 584 00:20:35,368 --> 00:20:36,669 REALLY NICE GUIDANCEOT 585 00:20:36,669 --> 00:20:37,670 DEVELOPMENT OF CLINICAL 586 00:20:37,670 --> 00:20:40,339 DECISION, SUPPORT TOOLS AND WHEN 587 00:20:40,339 --> 00:20:45,077 THAT IS DEVICE VERSUS NONDEVICE, 588 00:20:45,077 --> 00:20:46,345 CLINICAL DECISION SUPPORT, 589 00:20:46,345 --> 00:20:47,847 THERE'S GOING TO BE MORE AND 590 00:20:47,847 --> 00:20:50,016 MORE FOR SURE, BUT THE QUESTIONS 591 00:20:50,016 --> 00:20:53,119 I HAVE TO ASK AGAIN IS WHAT THE 592 00:20:53,119 --> 00:20:55,054 FACE OF THE AI RESEARCH LIFE 593 00:20:55,054 --> 00:20:55,254 CYCLE? 594 00:20:55,254 --> 00:20:57,390 QUESTIONS WE LIKE TO ASK ARE 595 00:20:57,390 --> 00:20:58,791 WHERE EXACTLY IS THE RESEARCH 596 00:20:58,791 --> 00:20:59,058 HAPPENING? 597 00:20:59,058 --> 00:21:02,995 AND WHAT I MEAN BY THAT IS 598 00:21:02,995 --> 00:21:05,665 SOMEONE DOING SOMETHING IN WHAT 599 00:21:05,665 --> 00:21:08,100 WE CALL SHADOW MODE WHERE IT HAS 600 00:21:08,100 --> 00:21:09,702 NO IMPACT ON--IT DOESN'T TOUCH 601 00:21:09,702 --> 00:21:11,904 CLINICAL CARE AT ALL, IT'S BEING 602 00:21:11,904 --> 00:21:14,740 DONE ESSENTIALLY IN THE RESEARCH 603 00:21:14,740 --> 00:21:17,710 LAB AND NO 1 EVER KNOWS THE 604 00:21:17,710 --> 00:21:19,145 RESULTS, IT HAPPENING SIDE BY 605 00:21:19,145 --> 00:21:20,213 SIDE WITH ROUTINE CLINICAL CARE, 606 00:21:20,213 --> 00:21:23,049 WHERE YOU KNOW IT'S NOT ACTUALLY 607 00:21:23,049 --> 00:21:23,716 IMPACTING MEDICAL DECISION 608 00:21:23,716 --> 00:21:25,218 MAKING BUT IT'S HAPPENING IN THE 609 00:21:25,218 --> 00:21:27,687 CLINIC SIDE BY SIDE OR IS IT 610 00:21:27,687 --> 00:21:28,854 ACTUALLY HAVING A DIRECT IMPACT 611 00:21:28,854 --> 00:21:30,056 ON MEDICAL DECISION MAKING AND I 612 00:21:30,056 --> 00:21:32,458 THINK THOSE TYPES OF QUESTIONS, 613 00:21:32,458 --> 00:21:34,093 CERTAINLY WEIGH IN WITH THINKING 614 00:21:34,093 --> 00:21:37,296 ABOUT DEVICE DETERMINATIONS AND 615 00:21:37,296 --> 00:21:39,165 HOW WE WOULD HANDLE STUDIES LIKE 616 00:21:39,165 --> 00:21:40,933 THAT, THINKING ABOUT WHEN DATA 617 00:21:40,933 --> 00:21:43,269 WOULD BE SUBMITTED TO THE FDA, 618 00:21:43,269 --> 00:21:45,004 AGAIN, HOW FAR BACK THE FDA 619 00:21:45,004 --> 00:21:47,640 WOULD GO, I THINK INTEND IS 620 00:21:47,640 --> 00:21:48,608 IMPORTANT, I DO THINK ASKING 621 00:21:48,608 --> 00:21:50,343 PEOPLE FROM THE BEGINNING ABOUT 622 00:21:50,343 --> 00:21:51,944 WHETHER THEY'RE PLANNING TO TRY 623 00:21:51,944 --> 00:21:55,648 TO COMMERCIALIZE THIS, AND WHAT 624 00:21:55,648 --> 00:21:57,583 THEY'RE TRYING TO DO WHETHER 625 00:21:57,583 --> 00:21:58,651 THERE'S CORPORATE FUNDING AND 626 00:21:58,651 --> 00:21:59,619 PART OF THE STRUGGLE HERE IS 627 00:21:59,619 --> 00:22:05,725 WHEN YOU GO DOWN THIS PATH, THIS 628 00:22:05,725 --> 00:22:07,860 IS FDA REGULATED AND WE'RE GOING 629 00:22:07,860 --> 00:22:10,296 TO COME IN AND SCR FOR 630 00:22:10,296 --> 00:22:10,963 DISCIPLINARY DEVICE BROCHURE 631 00:22:10,963 --> 00:22:13,165 BECAUSE THEY DON'T HAVE THEM AND 632 00:22:13,165 --> 00:22:14,233 THINKING ABOUT THEM AND THE 633 00:22:14,233 --> 00:22:15,635 LEVEL OF DETAIL YOU NEED TO GET 634 00:22:15,635 --> 00:22:17,536 AND THEN HOW YOU GET THAT DETAIL 635 00:22:17,536 --> 00:22:19,138 IN SOMETHING THAT'S CONSTANTLY 636 00:22:19,138 --> 00:22:20,773 CHANGING LIKE AN AI ALGORITHM 637 00:22:20,773 --> 00:22:28,281 THAT IS NOT A STATIC MEDICAL 638 00:22:28,281 --> 00:22:30,149 DEVICE FOR A CARDIAC DEVICE, 639 00:22:30,149 --> 00:22:31,450 IT'S A WHOLE NEW WORLD SO TO 640 00:22:31,450 --> 00:22:32,852 SPEAK AND THINK BEING WHAT THE 641 00:22:32,852 --> 00:22:34,353 IRB NEEDS TO SEE AND HOW WE 642 00:22:34,353 --> 00:22:36,122 WRITE THAT UP IN A WAY THAT YOU 643 00:22:36,122 --> 00:22:40,226 KNOW WE CAN UNDERSTAND IT, AND 644 00:22:40,226 --> 00:22:44,130 EVALUATING IS QUITE TRICKY. 645 00:22:44,130 --> 00:22:45,965 SO THE LAST QUESTION THAT I WILL 646 00:22:45,965 --> 00:22:48,668 TOUCH ON IS AGAIN ON THE BUCKET 647 00:22:48,668 --> 00:22:50,036 OF SIMILAR, WHAT WE NEED TO DO 648 00:22:50,036 --> 00:22:53,572 THAT IS THE SAME FOR THE 649 00:22:53,572 --> 00:22:56,909 PROTOCOLS IS ON THE REGULATORY 650 00:22:56,909 --> 00:22:58,377 CRITERIA FOR APPROVAL AND I TOOK 651 00:22:58,377 --> 00:23:00,846 A STAB AT GOING THROUGH THE 652 00:23:00,846 --> 00:23:01,781 REGULATORY CRITERIA FOR APPROVAL 653 00:23:01,781 --> 00:23:07,219 AND THINK BEING WHAT ASSPECS OF 654 00:23:07,219 --> 00:23:09,121 IT CONSIDERATIONS OR ASSPECS 655 00:23:09,121 --> 00:23:11,657 RELATED TO AI WORK IN EVALUATING 656 00:23:11,657 --> 00:23:12,958 EACH OF THE CRITERIA FOR 657 00:23:12,958 --> 00:23:14,360 APPROVAL EMPLOY I WILL NOT READ 658 00:23:14,360 --> 00:23:15,861 EVERY WORD OF THIS SLIDE. 659 00:23:15,861 --> 00:23:16,929 THE SLIDES WILL BE AVAILABLE FOR 660 00:23:16,929 --> 00:23:19,098 YOU BUT I HOPE THIS CAN 661 00:23:19,098 --> 00:23:23,169 CERTAINLY SERVE AS A REFERENCE 662 00:23:23,169 --> 00:23:24,537 AT THE HELP DOING THIS WORK WHY 663 00:23:24,537 --> 00:23:26,872 UOF THE TO DO A FEW, WHEN WE 664 00:23:26,872 --> 00:23:28,274 THINK ABOUT MINIMIZING RISK, I 665 00:23:28,274 --> 00:23:29,208 THINK IT'S INTERESTING BECAUSE 1 666 00:23:29,208 --> 00:23:31,410 OF THE THINGS WE TRADITIONALLY 667 00:23:31,410 --> 00:23:33,612 THINK ABOUT IS MINIMUM NECESSARY 668 00:23:33,612 --> 00:23:35,114 DATA USE, THINKING ABOUT MINIMUM 669 00:23:35,114 --> 00:23:45,658 NECESSARY DATA USE IN AI WORK IS 670 00:23:46,692 --> 00:23:47,993 CONFLICT BECAUSE THE MORE PEOPLE 671 00:23:47,993 --> 00:23:52,098 YOU ASK IS THE MORE DATA YOU 672 00:23:52,098 --> 00:23:54,734 HAVE, THE BETTER, SO TO SAY WHAT 673 00:23:54,734 --> 00:23:56,268 IS THE RIGHT AMOUNT OF DATA AND 674 00:23:56,268 --> 00:23:58,904 HOW DO WE APPLY THE USUAL 675 00:23:58,904 --> 00:24:00,473 STANDARDS FOR DATA ARE TRICKY. 676 00:24:00,473 --> 00:24:03,609 MAKING SURE THERE'S APPROPRIATE 677 00:24:03,609 --> 00:24:05,211 SECURITY PRECAUTIONS, 678 00:24:05,211 --> 00:24:05,911 CYBERSECURITY PRECAUTIONS, 679 00:24:05,911 --> 00:24:07,213 INTERNALLY AND EXTERNALLY IS 680 00:24:07,213 --> 00:24:08,814 CRITICAL AND USUALLY I WOULD 681 00:24:08,814 --> 00:24:11,350 SAY, OUTSIDE THE BOUNDS OF IRB 682 00:24:11,350 --> 00:24:14,086 EXPERTISE AND SO HAVING OTHER 683 00:24:14,086 --> 00:24:16,722 INSTITUTIONAL SUPPORT OR 684 00:24:16,722 --> 00:24:17,556 RESEARCH INFORMATION, SECURITY, 685 00:24:17,556 --> 00:24:18,457 OVERSIGHT AND INFORMATION LIKE 686 00:24:18,457 --> 00:24:19,759 THAT IS CRITICAL, IN THE 687 00:24:19,759 --> 00:24:21,494 SITUATION WHERE AI IS ACTUALLY 688 00:24:21,494 --> 00:24:23,562 IMPACTING MEDICAL CARE, I THINK 689 00:24:23,562 --> 00:24:24,630 REALLY MAKING SURE THAT THE 690 00:24:24,630 --> 00:24:28,734 CLINICAL SIDE OF THE HOUSE IS 691 00:24:28,734 --> 00:24:30,536 INVOLVED AND THINKING THROUGH, 692 00:24:30,536 --> 00:24:31,971 YOU KNOW ACTUAL REAL WORLD 693 00:24:31,971 --> 00:24:33,339 CLINICAL DEPLOYMENT WITH YOU, 694 00:24:33,339 --> 00:24:35,307 YOU KNOW, WE HAVE OF COURSE TONS 695 00:24:35,307 --> 00:24:38,477 OF RESEARCH WHERE THAT LINE 696 00:24:38,477 --> 00:24:39,979 BETWEEN RESEARCH AND CLINICAL 697 00:24:39,979 --> 00:24:40,946 CARE BECOMES BLURRY, I THINK 698 00:24:40,946 --> 00:24:44,049 THAT AI IS A REALLY A PERFECT 699 00:24:44,049 --> 00:24:45,551 EXAMPLE OF TIME WHEN IS THAT CAN 700 00:24:45,551 --> 00:24:48,120 BE VERY, VERY BLIEWRY AND WE 701 00:24:48,120 --> 00:24:49,755 HAVE TO BE--BLURRY AND WE HAVE 702 00:24:49,755 --> 00:24:50,956 TO BE VERY THOUGHTFUL. 703 00:24:50,956 --> 00:24:54,126 IN TERMS OF HAPPENING ABOUT 704 00:24:54,126 --> 00:24:57,129 WEIGHING RISKS AND BENEFITS, AND 705 00:24:57,129 --> 00:24:58,431 INDIVIDUAL PRIVACY RISKS AND 706 00:24:58,431 --> 00:24:59,698 POTENTIAL FOR AI TO CAUSE 707 00:24:59,698 --> 00:25:00,199 INDIVIDUAL HARM. 708 00:25:00,199 --> 00:25:02,301 AS WE SAID EARLIER, AI CAN BE 709 00:25:02,301 --> 00:25:03,502 WRONG AT TIMES BUT ON THE OTHER 710 00:25:03,502 --> 00:25:06,572 HAND THINKING ABOUT POTENTIAL 711 00:25:06,572 --> 00:25:07,873 BENEFITS FROM AI AGAIN AS I SAID 712 00:25:07,873 --> 00:25:09,842 AT THE VERY BEGINNING THE 713 00:25:09,842 --> 00:25:10,910 AWESOME POTENTIAL THERE THAT 714 00:25:10,910 --> 00:25:13,446 COULD IMPROVE CARE FOR 715 00:25:13,446 --> 00:25:14,480 INDIVIDUALS, IN CLINICAL 716 00:25:14,480 --> 00:25:16,782 SETTINGS BUT ALSO MORE BROADLY 717 00:25:16,782 --> 00:25:18,918 IMPROVEMENT IN SCALABILITY OF 718 00:25:18,918 --> 00:25:20,453 MEDICAL CARE FOR EQUITABLE 719 00:25:20,453 --> 00:25:21,253 SUBJECT SELECTION, IT GOES BACK 720 00:25:21,253 --> 00:25:23,155 TO THE NEED FOR REPRESENTATIVE 721 00:25:23,155 --> 00:25:24,924 DATA SETS AND REPRESENTATIVE 722 00:25:24,924 --> 00:25:29,695 POPULATIONS AND COMMUNITY 723 00:25:29,695 --> 00:25:31,597 ENGAGEMENT AND THE LAST 1 I WILL 724 00:25:31,597 --> 00:25:33,265 TOUCH ON BRIEFLY IS INFORMED 725 00:25:33,265 --> 00:25:34,600 CONSENT BASICALLY AND I WILL SAY 726 00:25:34,600 --> 00:25:36,735 MORE ON THIS IN THE COMING 727 00:25:36,735 --> 00:25:38,003 SLIDES BUT ESSENTIALLY TO SAY, 728 00:25:38,003 --> 00:25:40,940 WE NEED TO THINK ABOUT HOW 729 00:25:40,940 --> 00:25:44,310 CONSENT CAN BE SPECIALIZED TO 730 00:25:44,310 --> 00:25:51,717 INCLUDE DETAILS ABOUT AI, HOWAR 731 00:25:51,717 --> 00:25:54,920 I WORKS AND HOW IT'S HAPPENING 732 00:25:54,920 --> 00:25:56,322 AND THE UNANTICIPATED RISKS OF 733 00:25:56,322 --> 00:25:57,890 AI AS WELL AS PRIVACY 734 00:25:57,890 --> 00:26:01,026 LIMITATIONS AND RISKS OF 735 00:26:01,026 --> 00:26:01,827 REIDENTIFICATION, THINGS LIKE 736 00:26:01,827 --> 00:26:08,267 THAT, 1 OF THE THINGS THAT I'M 737 00:26:08,267 --> 00:26:09,568 WORKING ON WITH SOME COLLEAGUES 738 00:26:09,568 --> 00:26:11,103 IS THIS CONCEPT WE KNOW OF AS 739 00:26:11,103 --> 00:26:12,771 MODEL CARDS AND A CONCEPT OF 740 00:26:12,771 --> 00:26:15,174 TEAM CARDS WE COME UP WITH, 741 00:26:15,174 --> 00:26:18,844 MODEL CARDS, THE CONCEPT FROM 742 00:26:18,844 --> 00:26:20,880 THE COMPUTER SOFTWARE, SIDE OF 743 00:26:20,880 --> 00:26:23,449 THIS WORK WHERE BASICALLY IT'S 744 00:26:23,449 --> 00:26:30,489 KIND OF PROVIDING AN EXPLAINER 745 00:26:30,489 --> 00:26:32,658 FOR HOW IT'S WORKING AND WE 746 00:26:32,658 --> 00:26:35,194 PROVIDED CARDS ON HOW THE PEOPLE 747 00:26:35,194 --> 00:26:37,096 WHO WERE ACTUALLY INVOLVED WITH 748 00:26:37,096 --> 00:26:38,964 THE IDEA THAT IF YOU THINK ABOUT 749 00:26:38,964 --> 00:26:41,834 THE TEAM, AND WHO THEY ARE AND 750 00:26:41,834 --> 00:26:44,904 WHAT THEIR BIASES MAY OR MAY NOT 751 00:26:44,904 --> 00:26:48,974 BE, CONSCIOUSLY OR UNCONSCIOUSLY 752 00:26:48,974 --> 00:26:50,776 THAT MAY PROVIDE INSIGHT INTO 753 00:26:50,776 --> 00:26:52,344 THE ALGOGHT RIM EPIGENETICS THAT 754 00:26:52,344 --> 00:26:54,079 NEED TO BE INCORPORATED THEREIN. 755 00:26:54,079 --> 00:26:55,147 I WON'T GO THROUGH THE WEST OF 756 00:26:55,147 --> 00:26:58,183 THIS, YOU CAN SEE IT HERE BUT 757 00:26:58,183 --> 00:26:59,818 ESSENTIALLY, CONTINUOUS DATA 758 00:26:59,818 --> 00:27:01,086 MONITORING AND APPROPRIATE 759 00:27:01,086 --> 00:27:02,254 PRIVACY PROTECTIONS AND 760 00:27:02,254 --> 00:27:03,289 COMMUNITY ENGAGEMENT REMAIN 761 00:27:03,289 --> 00:27:11,263 CRITICAL AS THEY ARE IN ALL OF 762 00:27:11,263 --> 00:27:11,697 OUR WORK. 763 00:27:11,697 --> 00:27:13,566 SOY WHAT ARE THE SPECIAL 764 00:27:13,566 --> 00:27:14,266 CONSIDERATIONS INVOLVING AI THAT 765 00:27:14,266 --> 00:27:16,001 I THINK IS DIFFERENT FROM WHAT 766 00:27:16,001 --> 00:27:18,737 WE SEE IS AGAIN, PROBABLY GOING 767 00:27:18,737 --> 00:27:20,172 TO RAISE MORE QUESTIONS THAN 768 00:27:20,172 --> 00:27:21,540 ANSWERS HERE BUT I THINK THINGS 769 00:27:21,540 --> 00:27:22,975 THAT ARE IMPORTANT TO THINK 770 00:27:22,975 --> 00:27:23,442 ABOUT. 771 00:27:23,442 --> 00:27:28,414 SO PRIVACY AND CONFIDENTIALITY 772 00:27:28,414 --> 00:27:30,849 OF DATA SO JUST TO SAY THAT THE 773 00:27:30,849 --> 00:27:32,785 OPENING AI PLATFORMS ARE NOT 774 00:27:32,785 --> 00:27:34,720 HIPAA COMPLIANT AND THE POWER OF 775 00:27:34,720 --> 00:27:39,992 SOME OF THESE ALGORITHMS REALLY 776 00:27:39,992 --> 00:27:41,160 INCREASES PROBABILITY OF 777 00:27:41,160 --> 00:27:42,194 REIDENTIFICATION, SO YOU CAN PUT 778 00:27:42,194 --> 00:27:44,063 IN WHAT WOULD NORMALLY BE 779 00:27:44,063 --> 00:27:45,230 CONSIDERED A SCANT AMOUNT OF 780 00:27:45,230 --> 00:27:47,466 DATA THAT WOULD NOT BE 781 00:27:47,466 --> 00:27:48,500 REIDENTIFIABLE, IF YOU PUT IT 782 00:27:48,500 --> 00:27:51,937 INTO 1 OF THESE HIGH POWERED 783 00:27:51,937 --> 00:27:52,871 LARGE LANGUAGE MODELS, I THINK 784 00:27:52,871 --> 00:27:55,507 THE POSSIBILITY THAT THEY COULD 785 00:27:55,507 --> 00:27:57,242 USE THAT DATA TO REIDENTIFY 786 00:27:57,242 --> 00:27:58,777 PEOPLE IS MUCH HIGHER THAN IT 787 00:27:58,777 --> 00:28:00,746 USED TO BE WITH TRANSLATIONAL 788 00:28:00,746 --> 00:28:02,147 RESEARCH DIGGAL COMPUTING AND 789 00:28:02,147 --> 00:28:04,350 BECAUSE OF THAT, MOST ACADEMIC 790 00:28:04,350 --> 00:28:05,718 MEDICAL CENTERS, I ACTUALLY 791 00:28:05,718 --> 00:28:07,786 DON'T KNOW WHAT THE FEDERAL 792 00:28:07,786 --> 00:28:09,455 GOVERNMENT OR NIH LAWS ARE, OR 793 00:28:09,455 --> 00:28:13,292 RULES ARE ON THIS, BUT, MOST 794 00:28:13,292 --> 00:28:16,161 ACADEMIC MEDICAL CENTERS HAVE 795 00:28:16,161 --> 00:28:17,096 ESSENTIALLY PROHIBITED THE ENTRY 796 00:28:17,096 --> 00:28:19,098 OF CERTAIN TYPES OF DATA INTO 797 00:28:19,098 --> 00:28:21,300 THE PUBLIC GENERATIVE PLATFORMS 798 00:28:21,300 --> 00:28:24,970 THAT INCLUDE NEPH I OR 799 00:28:24,970 --> 00:28:25,504 INDIVIDUALLY IDENTIFIABLE 800 00:28:25,504 --> 00:28:27,339 INFORMATION, IT ALSO INCLUDES 801 00:28:27,339 --> 00:28:27,973 DEIDENTIFIED INFORMATION BECAUSE 802 00:28:27,973 --> 00:28:32,144 OF WHAT I JUST SAID ABOUT THE 803 00:28:32,144 --> 00:28:33,646 PROBABILITY OF IDENTIFICATION, 804 00:28:33,646 --> 00:28:35,247 IT INCLUDES BUSINESS INFORMATION 805 00:28:35,247 --> 00:28:36,181 OR INTELLECTUAL PROPERTIES SO 806 00:28:36,181 --> 00:28:37,549 THEY BASICALLY SAID YOU CAN'T 807 00:28:37,549 --> 00:28:40,085 USE THIS WITH HOSPITAL OR 808 00:28:40,085 --> 00:28:41,020 PATIENT DATA BECAUSE THE RISKS 809 00:28:41,020 --> 00:28:44,323 ARE TOO HIGH AND THAT INCLUDES 810 00:28:44,323 --> 00:28:46,191 EVEN IF YOU TURN OFF THAT BUTTON 811 00:28:46,191 --> 00:28:50,229 THAT SAYS DON'T SAVE THIS FOR 812 00:28:50,229 --> 00:28:51,096 TRAINING PURPOSES. 813 00:28:51,096 --> 00:28:58,270 SO WHAT HAPPENS IS BASICALLY 814 00:28:58,270 --> 00:29:00,806 THESE LLMs ARE RUN INTERNALLY 815 00:29:00,806 --> 00:29:03,776 INSTEAD, SET UP INSTEAD OF THE 816 00:29:03,776 --> 00:29:05,944 GENERAL INFRASTRUCTURE THAT IS 817 00:29:05,944 --> 00:29:06,979 HIPAA COMPLIANT AND EVERYTHING 818 00:29:06,979 --> 00:29:12,785 IS RUN ON INTERNAL SERVERS THAT 819 00:29:12,785 --> 00:29:15,988 REQUIRE IRB REVIEW, LEGAL 820 00:29:15,988 --> 00:29:17,256 COMPLIANT CONTRACTING AND OTHERS 821 00:29:17,256 --> 00:29:18,991 AND THAT'S THE WAY MOST PEOPLE 822 00:29:18,991 --> 00:29:21,493 ARE HANDLING THIS RIGHT NOW TO 823 00:29:21,493 --> 00:29:26,932 TRY TO GRAPPLE WITH THE PRIVACY 824 00:29:26,932 --> 00:29:27,299 RISKS. 825 00:29:27,299 --> 00:29:29,268 AS I MENTIONED EARLIER, OFTEN 826 00:29:29,268 --> 00:29:31,503 THERE ARE LARGE AMOUNTS OF 827 00:29:31,503 --> 00:29:33,005 UNCONSENTED DATA USED AND ALMOST 828 00:29:33,005 --> 00:29:37,543 ALL AI PROJECTS AT THIS POINT 829 00:29:37,543 --> 00:29:38,811 ARE STARTING WITH PROCESSING 830 00:29:38,811 --> 00:29:43,048 LARGE DATA SETS AND AS I ALLUDED 831 00:29:43,048 --> 00:29:44,550 TO THE MINIMUM NECESSARY IS 832 00:29:44,550 --> 00:29:50,289 REALLY TRICK EXPE OFTEN 833 00:29:50,289 --> 00:29:50,723 UNCONSENTED. 834 00:29:50,723 --> 00:29:51,724 I WON'T REPEAT MYSELF WHAT I 835 00:29:51,724 --> 00:29:53,559 SAID EARLIER BUT THAT DOES MAKE 836 00:29:53,559 --> 00:29:57,463 IT COMPLICATED TO THINK ABOUT 837 00:29:57,463 --> 00:30:03,569 NHSR VERSUS FDA REGULATIONS FOR 838 00:30:03,569 --> 00:30:04,737 THESE DE-IDENTIFIED AND 839 00:30:04,737 --> 00:30:07,840 ANONYMIZED EARLY STAGE AI, AI 840 00:30:07,840 --> 00:30:08,474 PROJECTS. 841 00:30:08,474 --> 00:30:12,010 I THINK IT POSES A LOT OF 842 00:30:12,010 --> 00:30:12,845 CHALLENGES AND DISCOMFORT FOR 843 00:30:12,845 --> 00:30:15,013 ME, AND CERTAINLY FOR US AS 844 00:30:15,013 --> 00:30:18,550 IRBs, BECAUSE OF THE FACT THAT 845 00:30:18,550 --> 00:30:20,619 THE GOAL HERE IS USUALLY TO 846 00:30:20,619 --> 00:30:21,787 COMMERCIALIZE OR MAKE THESE 847 00:30:21,787 --> 00:30:23,655 THINGS OPEN SOURCE, SO WHAT I 848 00:30:23,655 --> 00:30:26,725 JUST SAID IS, YOU KNOW WE DEAL 849 00:30:26,725 --> 00:30:29,928 WITH THE PRIVACY BY DOING THIS 850 00:30:29,928 --> 00:30:30,996 ALL INTERNALLY WHEN WE'RE DOING 851 00:30:30,996 --> 00:30:32,498 THE WORK BUT FOR MOST PEOPLE WE 852 00:30:32,498 --> 00:30:33,565 WOULD UNDERSTAND THAT THE GOAL 853 00:30:33,565 --> 00:30:35,067 WOULD NOT BE THAT IT'S GOING TO 854 00:30:35,067 --> 00:30:36,702 STAY WITHIN YOUR HOSPITAL SYSTEM 855 00:30:36,702 --> 00:30:37,536 INDEFINITELY, THE GOAL IS 856 00:30:37,536 --> 00:30:41,406 USUALLY TO TAKE IT OUT, AND 857 00:30:41,406 --> 00:30:43,809 PLACE IT ELSEWHERE, AND THAT 858 00:30:43,809 --> 00:30:46,912 REALLY BRINGS UP SOME REALLY 859 00:30:46,912 --> 00:30:48,747 SIGNIFICANT QUESTIONS AROUND YOU 860 00:30:48,747 --> 00:30:52,618 KNOW, PRIVACY RISKS IN THE 861 00:30:52,618 --> 00:30:54,686 FUTURE ESPECIALLY WITH REGARD TO 862 00:30:54,686 --> 00:30:58,590 UNCONSENTED DATA AND ARE THERE 863 00:30:58,590 --> 00:30:59,625 RETAINED PRODUCTS OF 864 00:30:59,625 --> 00:31:00,659 IDENTIFIABILITY SOMEWHERE IN 865 00:31:00,659 --> 00:31:01,927 THERE AND SO 1 MIGHT WONDER 866 00:31:01,927 --> 00:31:03,362 WHETHER WE SHOULD BE, YOU KNOW 867 00:31:03,362 --> 00:31:06,098 USING SOME SORT OF COMPARISON, 868 00:31:06,098 --> 00:31:07,933 OF CONSENT REQUIREMENTS FOR 869 00:31:07,933 --> 00:31:09,935 FUTURE USE AND BROAD SHARING 870 00:31:09,935 --> 00:31:12,504 LIKE THE NIH GENOMIC DATA 871 00:31:12,504 --> 00:31:14,406 SHARING POLICY OR THINKING 872 00:31:14,406 --> 00:31:16,975 ABOUT, YOU KNOW THE COMMON RULE 873 00:31:16,975 --> 00:31:18,844 REQUIRED ELEMENTS OF CONSENT FOR 874 00:31:18,844 --> 00:31:19,678 WHOLE GENOME SEQUENCING, THIS IS 875 00:31:19,678 --> 00:31:22,981 A LITTLE BIT OF LIKE AN 876 00:31:22,981 --> 00:31:24,082 ETHICISTS DREAM IN TERMS OF 877 00:31:24,082 --> 00:31:28,053 LIKE, I WOULD LOVE TO SEE, YOU 878 00:31:28,053 --> 00:31:30,088 KNOW LARGE CONSENTED DATA SETS 879 00:31:30,088 --> 00:31:31,523 FOR AI DEVELOPMENT. 880 00:31:31,523 --> 00:31:34,927 I THINK THE CYNIC IN ME THINKS 881 00:31:34,927 --> 00:31:36,361 THAT SHIP HAS PROBABLY SAILS BUT 882 00:31:36,361 --> 00:31:38,564 IT'S WORTH THINKING ABOUT FROM 883 00:31:38,564 --> 00:31:39,498 AN ETHICS STABBED POINT IN 884 00:31:39,498 --> 00:31:40,132 THINKING ABOUT THE BENEFIT THERE 885 00:31:40,132 --> 00:31:42,000 IS AND WHY WE WOULD WANT THAT IN 886 00:31:42,000 --> 00:31:45,137 ORDER TO IDENTIFY THE RISKS FOR 887 00:31:45,137 --> 00:31:47,339 WHEN WE'RE NOT USING IT RIGHT 888 00:31:47,339 --> 00:31:47,573 NOW. 889 00:31:47,573 --> 00:31:48,440 ANOTHER REALLY INTERESTING THING 890 00:31:48,440 --> 00:31:50,275 THAT COMES UP IN THIS WORK IS 891 00:31:50,275 --> 00:31:51,777 RETURN OF INDIVIDUAL RESEARCH 892 00:31:51,777 --> 00:31:56,081 RESULTS, SO AS I ALOUDED TO 893 00:31:56,081 --> 00:31:57,449 EARLIER, 1 OF THE REAL POWERS 894 00:31:57,449 --> 00:31:59,218 HERE IS THAT AI DIAGNOSTIC 895 00:31:59,218 --> 00:32:00,619 MODELS CAN SEE THINGS THAT 896 00:32:00,619 --> 00:32:02,354 CLINICIANS CAN'T SEE AND SO WHEN 897 00:32:02,354 --> 00:32:06,792 WE RUN YOU KNOW AI DIAGNOSTIC 898 00:32:06,792 --> 00:32:09,695 MODELS ON AGAIN LARGE HUGE DATA 899 00:32:09,695 --> 00:32:11,330 SETS, OF UNCONSENTED SAMPLES, 900 00:32:11,330 --> 00:32:14,766 WHAT DO WE DO WHEN THE AI MODEL 901 00:32:14,766 --> 00:32:16,268 FINDS MEDICALLY ACTIONABLE 902 00:32:16,268 --> 00:32:18,904 FINDINGS AND YOU KNOW, SHOULD WE 903 00:32:18,904 --> 00:32:21,206 RETURN THOSE RESULTS TO PEOPLE? 904 00:32:21,206 --> 00:32:22,507 YOU KNOW SOME OF THIS GOES TO 905 00:32:22,507 --> 00:32:24,243 THE SAME QUESTION, YOU WOULD ASK 906 00:32:24,243 --> 00:32:25,811 FOR ANY RETURN OF RESEARCH 907 00:32:25,811 --> 00:32:27,212 RESULT QUESTIONS AROUND HOW 908 00:32:27,212 --> 00:32:28,714 CONFIELD FUNCTIONS KENTIA ARE WE 909 00:32:28,714 --> 00:32:32,384 IN THE VALIDITY OF THE AI 910 00:32:32,384 --> 00:32:34,519 RESULTS AND WEIGHING THE POETIC 911 00:32:34,519 --> 00:32:35,354 TEBTIAL BENEFITS VERSUS 912 00:32:35,354 --> 00:32:37,022 POTENTIAL RISKS BUT I THINK 1 OF 913 00:32:37,022 --> 00:32:40,058 THE CHALLENGES HERE IS THAT WE 914 00:32:40,058 --> 00:32:42,027 CAN EXPECT THIS IS GOING TO COME 915 00:32:42,027 --> 00:32:43,295 UP MORE OFTEN THAN IT USED TO 916 00:32:43,295 --> 00:32:46,231 BECAUSE OF THE FACT THAT THE AI 917 00:32:46,231 --> 00:32:46,932 DIAGNOSTIC MODELS ARE MORE 918 00:32:46,932 --> 00:32:48,000 POWERFUL AND YOU CAN EXPECT THAT 919 00:32:48,000 --> 00:32:51,069 YOU ARE GOING TO SEE THINGS THAT 920 00:32:51,069 --> 00:32:52,804 YOU DIDN'T SEE AND SO THEN ARE 921 00:32:52,804 --> 00:32:55,207 YOU GOING TO RETURN THOSE TO THE 922 00:32:55,207 --> 00:32:56,441 CLINICIAN, YOU KNOW MAYBE WHO 923 00:32:56,441 --> 00:32:57,609 MISS TODAY THE FIRST TIME FOR 924 00:32:57,609 --> 00:32:59,177 LIKE A REPEAT READ OR 925 00:32:59,177 --> 00:33:01,780 REASSESSMENT, YOU KNOW BY THE 926 00:33:01,780 --> 00:33:03,282 RADIOLOGIST OR PATHOLOGIST OR 927 00:33:03,282 --> 00:33:05,384 TREATING CLINICIAN OR ARE YOU 928 00:33:05,384 --> 00:33:06,785 GOING TO FOLLOW THE PATIENT AND 929 00:33:06,785 --> 00:33:09,288 BASICALLY SAY, WE WERE DOING 930 00:33:09,288 --> 00:33:13,292 RESEARCH ON YOUR UNCONSENTED 931 00:33:13,292 --> 00:33:15,060 DATA AND WE FOUND SOMETHING AND 932 00:33:15,060 --> 00:33:16,495 THAT'S AN INCREDIBLE LOAMACYY 933 00:33:16,495 --> 00:33:17,262 DIFFICULT CONVERSATION TO HAVE 934 00:33:17,262 --> 00:33:19,998 AND 1 WE GENERALLY DISCOURAGE 935 00:33:19,998 --> 00:33:22,501 PEOPLE FROM FINDING THEMSELVES 936 00:33:22,501 --> 00:33:24,169 IN BECAUSE IT'S JUST VERY 937 00:33:24,169 --> 00:33:27,239 DIFFICULT FROM A MICROETHICS 938 00:33:27,239 --> 00:33:28,307 PERSPECTIVE, BUT AT THE END OF 939 00:33:28,307 --> 00:33:31,376 THE DAY, IF YOU HAVE AN 940 00:33:31,376 --> 00:33:33,211 ACTIONABLE FINDING, YOU CAN'T 941 00:33:33,211 --> 00:33:35,280 IGF NORIT EITHER POTENTIALLY SO 942 00:33:35,280 --> 00:33:36,949 THINKING AGAIN IF IT'S CONSENTED 943 00:33:36,949 --> 00:33:38,784 AND WHAT DID THE CONSENT FORM 944 00:33:38,784 --> 00:33:40,752 SAY, AND HOW ARE YOU GOING TO 945 00:33:40,752 --> 00:33:42,788 CAREFULLY WALK THROUGH THAT AND 946 00:33:42,788 --> 00:33:44,523 THEN AGAIN, I HAD, I WILL SAY 947 00:33:44,523 --> 00:33:47,492 I'VE HAD THE SITUATION WHERE, 948 00:33:47,492 --> 00:33:49,294 THEY HAD A RECENT CONVERSATION 949 00:33:49,294 --> 00:33:51,063 WHERE THEY WERE GOING TO DO 950 00:33:51,063 --> 00:33:52,931 SOMETHING THAT HAD A REALLY, 951 00:33:52,931 --> 00:33:55,367 REALLY HIGH PROBABILITY THAT 952 00:33:55,367 --> 00:33:58,303 THEY WERE GOING TO FIND A TON OF 953 00:33:58,303 --> 00:33:59,604 ESSENTIALLY PREVIOUSLY MISSED 954 00:33:59,604 --> 00:34:02,140 RESULTS BECAUSE OF THE ALGORITHM 955 00:34:02,140 --> 00:34:03,442 THEY WERE USING AND I THINK YOU 956 00:34:03,442 --> 00:34:05,844 SAID YOU NEED TO DO THAT ON A 957 00:34:05,844 --> 00:34:06,912 CONSENTED DAILY BASIS AT SET AND 958 00:34:06,912 --> 00:34:08,947 I JUST DON'T THINK YOU CAN DO IT 959 00:34:08,947 --> 00:34:09,982 ON AN UNCONSENTED DAILY BASIS 960 00:34:09,982 --> 00:34:11,483 THEA SET BECAUSE YOU WILL CREATE 961 00:34:11,483 --> 00:34:12,284 THIS REALLY DIFFICULT SITUATION 962 00:34:12,284 --> 00:34:13,952 FOR ERCH AND THEY UNDERSTOOD IT, 963 00:34:13,952 --> 00:34:18,824 AND PROCEEDED DOWN THAT ROOT. 964 00:34:18,824 --> 00:34:22,828 I MENTIONED THIS EARLIER BUTTA 965 00:34:22,828 --> 00:34:23,929 ALGORITHMIC BIAS FROM THE DATA 966 00:34:23,929 --> 00:34:25,464 SETS AND OTHER CAUSES AS I KIND 967 00:34:25,464 --> 00:34:30,902 OF SHOWED YOU IN THE EXAMPLE AT 968 00:34:30,902 --> 00:34:31,770 THE BEGINNING. 969 00:34:31,770 --> 00:34:34,673 MITIGATION OF BIAS REQUIRED TRAN 970 00:34:34,673 --> 00:34:35,507 APPEARANCE AND EXPLAINABILITY 971 00:34:35,507 --> 00:34:36,775 AND INDEPENDENT REVIEW, AND SO 972 00:34:36,775 --> 00:34:38,377 IT REALLY DOES REQUIRE PROTOCOL 973 00:34:38,377 --> 00:34:40,679 TO DESCRIBE HOW AI WAS DEVELOPED 974 00:34:40,679 --> 00:34:45,784 TO TRY TO PUT INTO REAL WORDS, 975 00:34:45,784 --> 00:34:47,386 THAT EXPLAINABILITY WAS TRYING 976 00:34:47,386 --> 00:34:48,754 TO PUT THE REAL PROBLEM IN THAT 977 00:34:48,754 --> 00:34:50,889 THE REST OF US CAN UNDERSTAND 978 00:34:50,889 --> 00:34:52,691 ABOUT HOW IT'S SUPPOSED TO 979 00:34:52,691 --> 00:34:55,460 FUNCTION AND HOW IT WILL BE 980 00:34:55,460 --> 00:34:58,130 MONITORED OVER TIME FOR BIAS, 981 00:34:58,130 --> 00:34:59,464 ALGORITHM FOR BIAS IS 982 00:34:59,464 --> 00:35:00,432 COMPLICATED, I ASK A QUESTION 983 00:35:00,432 --> 00:35:01,666 HERE BUT I WILL PROVIDE THE 984 00:35:01,666 --> 00:35:04,202 ANSWER WHICH IS TO SAY I DO NOT 985 00:35:04,202 --> 00:35:04,903 THINK IRBs HAVE EXPECTATIONS 986 00:35:04,903 --> 00:35:10,275 PETTER 987 00:35:10,275 --> 00:35:11,076 EXPECTATIONS--EXPERTISE FOR THIS 988 00:35:11,076 --> 00:35:15,080 AND DO NOT GIVE ACCESS TO THE 989 00:35:15,080 --> 00:35:16,381 ALGORITHMS RIGHT NOW SO IT'S 990 00:35:16,381 --> 00:35:18,750 LIKE WE COULDN'T DO IT IF WE 991 00:35:18,750 --> 00:35:19,151 WANTED TO. 992 00:35:19,151 --> 00:35:21,119 SO THIS IS AN EXAMPLE WHERE THIS 993 00:35:21,119 --> 00:35:23,455 MAY NEDRA TO FALL TO EITHER 994 00:35:23,455 --> 00:35:25,991 INTERNAL OR EXTERNAL GROUPS OR 995 00:35:25,991 --> 00:35:27,025 MAYBE IT'S THE PI'S 996 00:35:27,025 --> 00:35:28,126 RESPONSIBILITY TO FIGURE IT OUT 997 00:35:28,126 --> 00:35:29,428 AND REPORT IT BACK TO US, I 998 00:35:29,428 --> 00:35:30,829 THINK THERE'S A VARIETY OF WAYS 999 00:35:30,829 --> 00:35:32,697 TO GO ABOUT IT, DO THINK THAT 1000 00:35:32,697 --> 00:35:34,566 OPEN SOURCE TOOLS ARE NEEDED TO 1001 00:35:34,566 --> 00:35:36,868 REALLY BE ABLE TO KIND OF HELP 1002 00:35:36,868 --> 00:35:38,170 US DEMOCRATIZE THE ABILITY TO DO 1003 00:35:38,170 --> 00:35:41,706 THIS ON A MORE WIDE SCALE AND I 1004 00:35:41,706 --> 00:35:43,909 DO THINK PEOPLE SHOULD BE AWARE, 1005 00:35:43,909 --> 00:35:46,411 BE INFORMED OF THIS RISK 1006 00:35:46,411 --> 00:35:48,880 ESPECIALLY WHEN THEY'RE BEING 1007 00:35:48,880 --> 00:35:51,983 ENROLL INDEED A CLINICAL TRIAL 1008 00:35:51,983 --> 00:35:54,186 OF AN AI ALGORITHM THAT WILL 1009 00:35:54,186 --> 00:35:55,454 IMPACT THEIR CLINICAL CARE, 1010 00:35:55,454 --> 00:35:57,122 MEDICAL CARE, THEY NEED TO BE 1011 00:35:57,122 --> 00:35:58,323 AWARE OF WHERE IT WAS DEVELOPED 1012 00:35:58,323 --> 00:36:01,960 OR WHETHER IT COULD HAVE BIASES 1013 00:36:01,960 --> 00:36:02,627 BUILT-IN. 1014 00:36:02,627 --> 00:36:03,628 ADVERSE EVENT MONITORING I THINK 1015 00:36:03,628 --> 00:36:07,132 IS A BIT UNIQUE WHEN IT COMES TO 1016 00:36:07,132 --> 00:36:07,799 AI RESEARCH. 1017 00:36:07,799 --> 00:36:08,934 AGAIN, YOU HAVE TO ASK THE 1018 00:36:08,934 --> 00:36:11,236 QUESTION, OF DID THE ALGORITHM 1019 00:36:11,236 --> 00:36:12,437 ACCOUNT ACT AS EXPECTED AND IN 1020 00:36:12,437 --> 00:36:14,539 ORDER TO DO THAT, YOU NEED TO 1021 00:36:14,539 --> 00:36:17,175 KNOW HOW IT WAS SUPPOSED TO ACT 1022 00:36:17,175 --> 00:36:18,143 SO IT REQUIRES EXPLAINABILITY 1023 00:36:18,143 --> 00:36:20,545 AND YOU KNOW REQUIRES REALLY 1024 00:36:20,545 --> 00:36:23,281 KIND OF THINKING ABOUT THE 1025 00:36:23,281 --> 00:36:24,382 DIFFERENCES BETWEEN THE EXPECTED 1026 00:36:24,382 --> 00:36:27,319 BEHAVIOR AND WHAT WE WOULD CALL 1027 00:36:27,319 --> 00:36:28,787 NONDIRECTED OR EMERGENT 1028 00:36:28,787 --> 00:36:29,054 BEHAVIOR. 1029 00:36:29,054 --> 00:36:31,056 THERE NEEDS TO BE A PLAN FOR 1030 00:36:31,056 --> 00:36:32,557 MONITORING THAT AND THINKING 1031 00:36:32,557 --> 00:36:35,360 ABOUT WHAT THE ANTICIPATED 1032 00:36:35,360 --> 00:36:36,628 MISTAKES MAY BE UP FRONT. 1033 00:36:36,628 --> 00:36:39,164 ONE OF THE CHALLENGES HERE IS 1034 00:36:39,164 --> 00:36:43,001 THAT MAY, YOU KNOW FALL INTO THE 1035 00:36:43,001 --> 00:36:45,504 WORLD WHERE IT'S BEYOND ACTUALLY 1036 00:36:45,504 --> 00:36:48,573 JUST THE RESEARCH SUBJEKS 1037 00:36:48,573 --> 00:36:53,411 INVOLVED SO WE HAD A CASE FOR 1038 00:36:53,411 --> 00:36:57,415 EXAMPLE WHERE AI ALGORITHMS 1039 00:36:57,415 --> 00:36:58,984 WHERE IT WAS BUILT ON A REAL 1040 00:36:58,984 --> 00:37:01,486 LIFE CASE BUT WE KIND OF ADDED 1041 00:37:01,486 --> 00:37:03,288 THE AI POINT TO MAKE IT A LITTLE 1042 00:37:03,288 --> 00:37:04,689 MORE FITTING BUT YOU CAN 1043 00:37:04,689 --> 00:37:07,492 CONSIDER THE EXAMPLE WHERE YOU 1044 00:37:07,492 --> 00:37:11,396 ARE USING AI, TO ADD SOME SORT 1045 00:37:11,396 --> 00:37:13,899 OF ADD SOME SORT OF REMINDER TO 1046 00:37:13,899 --> 00:37:15,400 A PATIENT CHART AND THEN WE 1047 00:37:15,400 --> 00:37:17,269 START CHANGING THE WAY WE 1048 00:37:17,269 --> 00:37:19,104 DOCUMENT THE PARTICULAR 1049 00:37:19,104 --> 00:37:21,473 CONDITION AND THE AI ALGOGHT 1050 00:37:21,473 --> 00:37:24,075 RHYTHM STARTS ADDING THAT 1051 00:37:24,075 --> 00:37:25,510 REMINDER TO OTHER CASES, TO 1052 00:37:25,510 --> 00:37:26,611 OTHER RECORDS IN THE MEDICAL 1053 00:37:26,611 --> 00:37:27,979 RECORDS THAT ARE NOT ACTUALLY 1054 00:37:27,979 --> 00:37:30,182 PART OF THE RESEARCH STUDY, AND 1055 00:37:30,182 --> 00:37:32,951 SO JUST TO SAY THAT THINK BEING 1056 00:37:32,951 --> 00:37:33,952 ANTICIPATED MISTAKES COULD GO 1057 00:37:33,952 --> 00:37:37,289 BEYOND THE ACTUAL CASES THAT ARE 1058 00:37:37,289 --> 00:37:38,423 CONSIDERED KIND OF IN THE 1059 00:37:38,423 --> 00:37:39,724 RESEARCH STUDY AND THINKING 1060 00:37:39,724 --> 00:37:41,259 ABOUT, YOU KNOW BASICALLY RISKS 1061 00:37:41,259 --> 00:37:44,863 TO OTHERS WHICH IS A LITTLE 1062 00:37:44,863 --> 00:37:47,799 FURTHER THAN WE'RE OFTEN 1063 00:37:47,799 --> 00:37:49,434 THINKING ABOUT, THINKING ABOUT. 1064 00:37:49,434 --> 00:37:51,303 I WILL JUST FOR THE SAKE OF TIME 1065 00:37:51,303 --> 00:37:52,537 KEEP GOING HERE. 1066 00:37:52,537 --> 00:37:54,973 SO TO SAY ALL OF THAT, ASKING 1067 00:37:54,973 --> 00:37:56,074 THE QUESTION OF WHAT ACTUALLY 1068 00:37:56,074 --> 00:37:58,577 WOULD NEED TO GO IN AN IRB 1069 00:37:58,577 --> 00:38:00,212 PROTOCOL IN ORDER FOR US TO KIND 1070 00:38:00,212 --> 00:38:02,080 OF REALLY ARK ASSESSES ALL THESE 1071 00:38:02,080 --> 00:38:04,082 THINGS THAT I JUST MENTIONED AND 1072 00:38:04,082 --> 00:38:05,250 THE ANSWER TO THAT QUESTION IS 1073 00:38:05,250 --> 00:38:06,551 BASICALLY IT'S MORE THAN WE 1074 00:38:06,551 --> 00:38:08,220 USUALLY SEE, I THINK 1 OF THE 1075 00:38:08,220 --> 00:38:09,487 CHALLENGES IN REVIEWING THIS 1076 00:38:09,487 --> 00:38:13,692 WORK, IS OFTEN WE GET IN FAIRLY 1077 00:38:13,692 --> 00:38:15,994 SCANT DETAILS ABOUT, YOU KNOW 1078 00:38:15,994 --> 00:38:17,395 THE AI ALGORITHM ITSELF AND WHAT 1079 00:38:17,395 --> 00:38:19,497 THE KIND OF LONGER TERM PLANS 1080 00:38:19,497 --> 00:38:21,833 ARE FOR THE DEVELOPMENT OF THAT 1081 00:38:21,833 --> 00:38:23,335 ALGORITHM AND SOMETIMES I THINK 1082 00:38:23,335 --> 00:38:25,070 THAT'S BECAUSE THE PIs 1083 00:38:25,070 --> 00:38:27,505 THEMSELVES DON'T ACTUALLY KNOW, 1084 00:38:27,505 --> 00:38:27,706 RIGHT? 1085 00:38:27,706 --> 00:38:30,809 THERE'S A LOT OF EARLY WORK THAT 1086 00:38:30,809 --> 00:38:32,010 GETS STARTED AND YOU DON'T 1087 00:38:32,010 --> 00:38:32,944 REALLY KNOW WHERE IT'S GOING TO 1088 00:38:32,944 --> 00:38:36,414 GO BUT I DO THINK THAT WE NEED 1089 00:38:36,414 --> 00:38:38,049 MORE DETAILS IN OUR PROTOCOLS 1090 00:38:38,049 --> 00:38:39,317 AND OUR CONSENT FORMS TO REALLY 1091 00:38:39,317 --> 00:38:43,688 KIND OF BE ABLE TO, YOU KNOW 1092 00:38:43,688 --> 00:38:44,756 ADEQUATELY PROVIDE SOME DEGREE 1093 00:38:44,756 --> 00:38:45,824 OF OVERSIGHT FOR THIS WORK. 1094 00:38:45,824 --> 00:38:48,093 SO I THINK THE USUAL 1095 00:38:48,093 --> 00:38:50,895 REQUIREMENTS APPLY, BUT THEN AS 1096 00:38:50,895 --> 00:38:52,097 I MENTIONED EARLIER, REALLY 1097 00:38:52,097 --> 00:38:53,164 UNDERSTANDING THE CURRENT PHASE 1098 00:38:53,164 --> 00:38:54,966 OF THE RESEARCH IN THAT PROTOCOL 1099 00:38:54,966 --> 00:38:59,204 IS THAT, YOU KNOW PROOF OF 1100 00:38:59,204 --> 00:39:00,038 CONCEPT, SHADOW MODE, 1101 00:39:00,038 --> 00:39:01,206 DEVELOPMENT AND TRAINING OR IS 1102 00:39:01,206 --> 00:39:03,608 IT ACTUALLY TESTING OR ACTUALLY 1103 00:39:03,608 --> 00:39:05,243 A REAL WORLD CLINICAL TRIAL, IS 1104 00:39:05,243 --> 00:39:07,045 IT INFORMING OR DRIVING CLINICAL 1105 00:39:07,045 --> 00:39:10,181 CARE, WHAT'S THE BACK UP LOOK 1106 00:39:10,181 --> 00:39:11,816 LIKE, IS THE ALGORITHM 1107 00:39:11,816 --> 00:39:14,786 DIAGNOSING OR TREATING AND ARE 1108 00:39:14,786 --> 00:39:15,720 THOSE DECISIONS AUTONOMICALLY 1109 00:39:15,720 --> 00:39:20,425 ACTED ON, IS THE ALGORITHM 1110 00:39:20,425 --> 00:39:22,060 EXPECTED TO CHANGE OVERTIME? 1111 00:39:22,060 --> 00:39:25,030 HOW IS IT EXPECTED TO ACT? 1112 00:39:25,030 --> 00:39:28,033 AS I ALLUDED TO IN THE PREVIOUS 1113 00:39:28,033 --> 00:39:30,302 SLIDE, WHAT MISTAKES MIGHT GO 1114 00:39:30,302 --> 00:39:31,603 WRONG, WHAT MISTAKES MIGHT BE 1115 00:39:31,603 --> 00:39:32,837 MADE? 1116 00:39:32,837 --> 00:39:34,973 ARE THE TRAINING REPRESENTED? 1117 00:39:34,973 --> 00:39:37,375 HOW IS MONITORING DONE? 1118 00:39:37,375 --> 00:39:38,109 COMMUNITY AND STAKEHOLDER INPUT 1119 00:39:38,109 --> 00:39:42,414 IN AND WHICH DATA SETS WILL BE 1120 00:39:42,414 --> 00:39:45,183 USED AND WHICH PARTICIPANTS WILL 1121 00:39:45,183 --> 00:39:50,055 BE ENROLLED ALONG WITH CONSENT 1122 00:39:50,055 --> 00:39:50,422 CONSIDERATIONS. 1123 00:39:50,422 --> 00:39:51,623 SO MORE ROBUST RETAIL IS WHAT WE 1124 00:39:51,623 --> 00:39:52,791 NEED AND I WILL SAY THAT YOU 1125 00:39:52,791 --> 00:39:54,225 KNOW IN SOME OF THE WORKING 1126 00:39:54,225 --> 00:39:58,096 GROUPS THAT I'M ON, THERE'S A 1127 00:39:58,096 --> 00:40:00,031 WORKING GROUP THAT COLLEAGUES 1128 00:40:00,031 --> 00:40:02,233 FROM EMORY PUT TOGETHER THAT IS 1129 00:40:02,233 --> 00:40:03,668 DOING A REALLY NICE YOB OF 1130 00:40:03,668 --> 00:40:05,403 TRYING TO BRING IRB 1131 00:40:05,403 --> 00:40:07,272 PROFESSIONALS AND 1132 00:40:07,272 --> 00:40:08,206 HRPP PROFESSIONALS AROUND THE 1133 00:40:08,206 --> 00:40:09,140 COUNTRY TOGETHER AND WORKING 1134 00:40:09,140 --> 00:40:11,509 SOME SORT OF OPEN SOURCE TOOL 1135 00:40:11,509 --> 00:40:12,811 KIT THAT WOULD COLLECT ALL OF 1136 00:40:12,811 --> 00:40:15,113 THIS INFORMATION FOR US, SO WE 1137 00:40:15,113 --> 00:40:17,515 CAN ACTUALLY ALL SHARE THAT AND 1138 00:40:17,515 --> 00:40:18,917 BE ABLE TO YOU KNOW GET THE 1139 00:40:18,917 --> 00:40:21,753 INFORMATION WE NEED AT THE 1140 00:40:21,753 --> 00:40:21,986 OUTSET. 1141 00:40:21,986 --> 00:40:23,888 SAME THING FOR THE CONSENT FORM 1142 00:40:23,888 --> 00:40:25,490 WHICH WILL BE IN THE CONSENT 1143 00:40:25,490 --> 00:40:28,026 FORM IS PROBABLY MORE THAN WE'RE 1144 00:40:28,026 --> 00:40:29,327 USED TO SEEING RIGHT NOW. 1145 00:40:29,327 --> 00:40:32,163 THIS IS MY PERSONAL BIAS AND I 1146 00:40:32,163 --> 00:40:33,431 HAD A REALLY INTERESTING 1147 00:40:33,431 --> 00:40:34,833 CONVERSATION AT THE CONFERENCE I 1148 00:40:34,833 --> 00:40:36,434 JUST MENTIONED WITH A RESEARCHER 1149 00:40:36,434 --> 00:40:39,003 WHO'S REALLY AT THE CUTTING EDGE 1150 00:40:39,003 --> 00:40:42,107 OF DOING AI WORK AROUND CONSENT 1151 00:40:42,107 --> 00:40:43,742 FOR AI AND YOU KNOW THERE IS A 1152 00:40:43,742 --> 00:40:46,611 CERTAIN DEGREE TO WHICH I WOULD 1153 00:40:46,611 --> 00:40:47,579 ACKNOWLEDGE THAT AI IMPACTS ALL 1154 00:40:47,579 --> 00:40:50,448 OF US IN OUR DAILY LIVES RIGHT 1155 00:40:50,448 --> 00:40:51,249 NOW, RIGHT? 1156 00:40:51,249 --> 00:40:52,784 EVERY TIME WE USE GOOGLE, EVERY 1157 00:40:52,784 --> 00:40:57,322 TIME WE GO TO TARGET OR WALL 1158 00:40:57,322 --> 00:40:58,523 MART OR DISNEYWORLD OR WHATEVER 1159 00:40:58,523 --> 00:41:00,925 IT MAY BE, AI IS PART OF ALL OF 1160 00:41:00,925 --> 00:41:02,127 THE SYSTEMS THAT KIND OF YOU 1161 00:41:02,127 --> 00:41:05,997 KNOW HELP US GET WHAT WE WANT 1162 00:41:05,997 --> 00:41:08,600 AND PROBABLY HELP OTHER PEOPLE 1163 00:41:08,600 --> 00:41:10,001 COMMERCIALIZE OUR DATA AND SO 1164 00:41:10,001 --> 00:41:13,805 THAT IS KIND OF A--NORMAL DAILY 1165 00:41:13,805 --> 00:41:14,506 RISK/DAILY EXPERIENCE THAT WE 1166 00:41:14,506 --> 00:41:16,040 ALL HAVE IN OUR LIVES. 1167 00:41:16,040 --> 00:41:20,345 SO THE QUESTION THEN BECOMES YOU 1168 00:41:20,345 --> 00:41:21,613 KNOW HOW MUCH IS IT ARE WE 1169 00:41:21,613 --> 00:41:22,781 RESPONSIBLE TO TELL PEOPLE ABOUT 1170 00:41:22,781 --> 00:41:22,981 THAT? 1171 00:41:22,981 --> 00:41:24,783 AND I THINK IN THE CONTEXT OF 1172 00:41:24,783 --> 00:41:25,717 RESEARCH, WE ARE STILL 1173 00:41:25,717 --> 00:41:27,118 RESPONSIBLE TO MAKE IT VERY 1174 00:41:27,118 --> 00:41:30,188 CLEAR, YOU KNOW I THINK 1175 00:41:30,188 --> 00:41:30,922 ESPECIALLY PEOPLE ENROLLING IN 1176 00:41:30,922 --> 00:41:32,090 RESEARCH THAT MAY IN THE 1177 00:41:32,090 --> 00:41:33,825 ACTUALLY HAVE BENEFIT TO THEM, I 1178 00:41:33,825 --> 00:41:35,126 THINK THE REQUIRED ELEMENTS OF 1179 00:41:35,126 --> 00:41:38,096 CONSENT IN THE REGULATIONS WOULD 1180 00:41:38,096 --> 00:41:39,731 HAVE US DISCLOSE, YOU KNOW THAT 1181 00:41:39,731 --> 00:41:42,300 AI AS BEING USED, HOW IT'S BEING 1182 00:41:42,300 --> 00:41:44,369 USED, AGAIN, HOW IT WAS TRAINED, 1183 00:41:44,369 --> 00:41:49,040 IF THERE MIGHT BE RISKS OF BIAS, 1184 00:41:49,040 --> 00:41:51,109 AND SPECIFIC ANTICIPATED RISKS 1185 00:41:51,109 --> 00:41:53,178 TO THE AI, AS WELL AS YOU KNOW 1186 00:41:53,178 --> 00:41:56,748 HOW THE DATA WILL BE USED IN THE 1187 00:41:56,748 --> 00:41:59,350 FUTURE AND POTENTIAL PRIVACY AND 1188 00:41:59,350 --> 00:41:59,984 CONFIDENTIALITY IMITATIONS, YOU 1189 00:41:59,984 --> 00:42:03,121 KNOW I THINK WE DO HAVE AN 1190 00:42:03,121 --> 00:42:04,189 OBLIGATION TO SHARE THAT. 1191 00:42:04,189 --> 00:42:05,557 I THINK IT'S INTERESTING TO 1192 00:42:05,557 --> 00:42:06,991 SHARE ON THE CLINICAL SIDE, 1193 00:42:06,991 --> 00:42:09,994 PERHAPS AFTER THESE THINGS ARE 1194 00:42:09,994 --> 00:42:12,730 FULLY APPROVED AND USED, THERE 1195 00:42:12,730 --> 00:42:14,499 ARE THINGS, YOU KNOW IN THE ICU 1196 00:42:14,499 --> 00:42:17,936 RIGHT NOW, FOR EXAMPLE, THE 1197 00:42:17,936 --> 00:42:21,239 DEVICES IN THE ICU, THEY DO HAVE 1198 00:42:21,239 --> 00:42:21,873 SOME INDEPENDENT THINKING 1199 00:42:21,873 --> 00:42:25,577 ABILITY SO TO SPEAK AND SO WE 1200 00:42:25,577 --> 00:42:26,945 DON'T NECESSARILY PROVIDE EVERY 1201 00:42:26,945 --> 00:42:29,714 LITTLE DETAIL ON THE CLINICAL 1202 00:42:29,714 --> 00:42:30,648 SIDE, SO THERE'S SOME GOOD 1203 00:42:30,648 --> 00:42:33,718 THINGS HERE ON WHERE WE LAND. 1204 00:42:33,718 --> 00:42:36,387 AND FRANKLY, HOW QUOTE-UNQUOTE 1205 00:42:36,387 --> 00:42:37,555 EXPLAINABLE AI ACTUALLY CAN BE, 1206 00:42:37,555 --> 00:42:38,890 YOU KNOW, I THINK SOME PEOPLE 1207 00:42:38,890 --> 00:42:41,392 WOULD ARGUE THE CONCEPT OF 1208 00:42:41,392 --> 00:42:42,694 EXPLAINABLE AI MIGHT BE A MYTH 1209 00:42:42,694 --> 00:42:45,129 AS I SAID AT THE VERY BEGINNING, 1210 00:42:45,129 --> 00:42:47,432 WE DIDN'T ACTUALLY KNOW HOW THAT 1211 00:42:47,432 --> 00:42:48,366 ALGORITHM WAS MAKING THE 1212 00:42:48,366 --> 00:42:49,801 DECISION IT WAS MAKING BUT I 1213 00:42:49,801 --> 00:42:54,772 THINK LETTING PEOPLE KNOW THAT 1214 00:42:54,772 --> 00:42:56,608 AI IS INVOLVED AND AND WHAT THE 1215 00:42:56,608 --> 00:42:58,142 RISKS ARE IS AN EXPECTATION AND 1216 00:42:58,142 --> 00:42:58,943 CERTAINLY A REQUIREMENT THEY 1217 00:42:58,943 --> 00:43:02,747 WOULD ASK FOR AS AN IRB 1218 00:43:02,747 --> 00:43:03,014 REVIEWER. 1219 00:43:03,014 --> 00:43:05,783 SO JUST TO WRAP UP, I WILL SPEND 1220 00:43:05,783 --> 00:43:07,285 A FEW MINUTES HERE TO WRAP UP 1221 00:43:07,285 --> 00:43:08,453 AND LEAVE TIME FOR QUESTIONS 1222 00:43:08,453 --> 00:43:09,854 JUST TO GET BACK TO THE QUESTION 1223 00:43:09,854 --> 00:43:11,956 OF WHOSE JOB IS IT, THERE'S A 1224 00:43:11,956 --> 00:43:14,592 TON OF AI GOVERNANCE BEING 1225 00:43:14,592 --> 00:43:15,727 DEVELOPED RIGHT NOW. 1226 00:43:15,727 --> 00:43:17,495 I THINK IRBs PLAY A ROLL HERE 1227 00:43:17,495 --> 00:43:19,364 BUT I ABSOLUTELY DO NOT THINK 1228 00:43:19,364 --> 00:43:22,901 THAT IRBs ARE THE ONLY PEOPLE 1229 00:43:22,901 --> 00:43:24,936 RESPONSIBLE, I THINK WE SHOULD 1230 00:43:24,936 --> 00:43:26,437 NOT BE AND CANNOT BE BASICALLY 1231 00:43:26,437 --> 00:43:29,240 THE 1S THAT ARE GOING TO BE 1232 00:43:29,240 --> 00:43:34,078 ENTIRELY RESPONSIBLE FOR 1233 00:43:34,078 --> 00:43:35,547 PROVIDING OVERSIGHT OF AI. 1234 00:43:35,547 --> 00:43:37,849 I THINK WE WILL SEE MORE OF THIS 1235 00:43:37,849 --> 00:43:40,451 IN THE COMES MONTHS, THERE ARE 1236 00:43:40,451 --> 00:43:41,953 TONS OF ORGANIZATIONS WHO ARE 1237 00:43:41,953 --> 00:43:43,021 ISSUING GOVERNANCE RIGHT NOW. 1238 00:43:43,021 --> 00:43:45,757 JUST TO SAY, YOU KNOW WHAT IT 1239 00:43:45,757 --> 00:43:47,158 WOULD REALLY LOOK LIKE FOR AN 1240 00:43:47,158 --> 00:43:48,860 IRB TO TAKE THIS ON, YOU KNOW 1241 00:43:48,860 --> 00:43:50,595 REALLY GOING BEYOND OUR USUAL 1242 00:43:50,595 --> 00:43:52,463 REVIEWS, SO AGAIN, IF YOU WERE 1243 00:43:52,463 --> 00:43:54,766 TO PUT--SHOW THE AI LIFE CYCLE 1244 00:43:54,766 --> 00:43:56,634 HERE, DOWN AT THE BOTTOM, YOU 1245 00:43:56,634 --> 00:43:58,269 KNOW YOU WOULD ESSENTIALLY WOULD 1246 00:43:58,269 --> 00:44:01,072 HAVE TO BUILD IN PROCEDURES OR 1247 00:44:01,072 --> 00:44:02,774 POLICIES, AT EACH STEP OF THE 1248 00:44:02,774 --> 00:44:05,877 WAY, TO UNDERSTAND WHAT THE AI 1249 00:44:05,877 --> 00:44:07,612 IS DOING, DOING DATA BIAS 1250 00:44:07,612 --> 00:44:09,147 CHECKING AND BIAS MITIGATION, ET 1251 00:44:09,147 --> 00:44:14,018 CETERA AND AGAIN, I THINK I CAN 1252 00:44:14,018 --> 00:44:15,753 SPEAK FAIRLY CONFIDENTLY THAT 1253 00:44:15,753 --> 00:44:19,324 IRBs DO NOT HAVE THIS LEVEL OF 1254 00:44:19,324 --> 00:44:20,358 EXPERTISE RIGHT NOW AND I THINK 1255 00:44:20,358 --> 00:44:22,226 IT'S AN OPEN ENDED QUESTION OF 1256 00:44:22,226 --> 00:44:23,528 WHETHER WE SHOULD OR NOT BE 1257 00:44:23,528 --> 00:44:24,228 DOING THIS WORK. 1258 00:44:24,228 --> 00:44:25,330 I BEING THIS IS IMPORTANT WORK, 1259 00:44:25,330 --> 00:44:26,598 IT HAS TO BE DONE BUT THE 1260 00:44:26,598 --> 00:44:28,566 QUESTION IS HOW DOES IT, I THINK 1261 00:44:28,566 --> 00:44:29,400 AGAIN ULTIMATELY IT WOULD BE 1262 00:44:29,400 --> 00:44:31,269 NICE IF WE COULD DEVELOP OPEN 1263 00:44:31,269 --> 00:44:32,904 SOURCE TOOLS TO BE ABLE TO DO 1264 00:44:32,904 --> 00:44:33,338 THIS. 1265 00:44:33,338 --> 00:44:38,276 WE DID PUT IN A GRANT TO TRY TO 1266 00:44:38,276 --> 00:44:44,315 START DOWN THAT PROCESS AT 1267 00:44:44,315 --> 00:44:44,515 LEAST. 1268 00:44:44,515 --> 00:44:46,551 SO JUST TO WRAP UP HERE, THE 1269 00:44:46,551 --> 00:44:48,052 CHALLENGES TO OVERVIEW WITH AI, 1270 00:44:48,052 --> 00:44:52,357 AS WITH ALL OF OUR WORK, THERE 1271 00:44:52,357 --> 00:44:54,325 IS A TENSION BETWEEN ATTENTION 1272 00:44:54,325 --> 00:44:55,927 AND REGULATION, AND THE SPEED OF 1273 00:44:55,927 --> 00:44:57,695 AI IS SO FAST AND MOST OF THE 1274 00:44:57,695 --> 00:44:59,130 THINGS I TALKED ABOUT TODAY 1275 00:44:59,130 --> 00:45:00,598 WOULD REPRESENT REGULATION THAT 1276 00:45:00,598 --> 00:45:03,034 WOULD HAVE THE POTENTIAL TO SLOW 1277 00:45:03,034 --> 00:45:04,902 THAT DOWN, THAT'S CERTAINLY NOT 1278 00:45:04,902 --> 00:45:06,971 MY GOAL IN TALKING ABOUT THESE 1279 00:45:06,971 --> 00:45:09,073 THINGS, I THINK WE JUST HAVE TO 1280 00:45:09,073 --> 00:45:10,808 PARTNER WITH OUR RESEARCHERS TO 1281 00:45:10,808 --> 00:45:15,113 REALLY UNDERSTAND HOW CAN WE 1282 00:45:15,113 --> 00:45:16,481 EFFICIENTLY AS POSSIBLE DO THE 1283 00:45:16,481 --> 00:45:17,915 TYPE OF REVIEW WE FEEL 1284 00:45:17,915 --> 00:45:19,217 COMFORTABLE, WE WILL CATCH THE 1285 00:45:19,217 --> 00:45:20,151 BIG PROBLEMS HERE BUT NOT STAND 1286 00:45:20,151 --> 00:45:21,819 IN THE WAY OF INNOVATION, IT 1287 00:45:21,819 --> 00:45:25,490 REQUIRES A LOT OF EXPERTISE, AND 1288 00:45:25,490 --> 00:45:27,792 IRBs ARE GOING TO HAVE TO 1289 00:45:27,792 --> 00:45:31,863 GRAPPLE WITH WHERE WHETHER THEY 1290 00:45:31,863 --> 00:45:34,866 STAFF IT UP WITH EXPERTISE OR 1291 00:45:34,866 --> 00:45:36,067 ANCILLARY GROUPS THAT THEY RELY 1292 00:45:36,067 --> 00:45:38,002 OI THINK THIS WORK REQUIRES A 1293 00:45:38,002 --> 00:45:41,472 HUGE AMOUNT OF COLLABORATION, I 1294 00:45:41,472 --> 00:45:42,507 THINK NOT UNLIKE OTHER WORK WE 1295 00:45:42,507 --> 00:45:44,809 DO BUT I THINK IT'S A PERFECT 1296 00:45:44,809 --> 00:45:46,110 EXAMPLE WHERE WE NEED EVERYONE 1297 00:45:46,110 --> 00:45:47,979 HAD AT THE TABLE THINKING ABOUT 1298 00:45:47,979 --> 00:45:48,780 THIS. 1299 00:45:48,780 --> 00:45:50,114 AND IT REQUIRES ONGOING 1300 00:45:50,114 --> 00:45:50,515 OVERSIGHT, RIGHT? 1301 00:45:50,515 --> 00:45:52,784 SO EVEN IF YOU DO ALL OF THIS, 1302 00:45:52,784 --> 00:45:55,086 THAT INITIAL REVIEW, IF YOU WENT 1303 00:45:55,086 --> 00:45:56,988 ALL-IN AT THAT INITIAL REVIEW, 1304 00:45:56,988 --> 00:45:59,991 THE QUESTION IS HOW TO HOW YOU 1305 00:45:59,991 --> 00:46:02,694 MONITOR THAT ALGOGHT RHYTHM OVER 1306 00:46:02,694 --> 00:46:04,195 TIME IS COMPLICATED AND DOESN'T 1307 00:46:04,195 --> 00:46:07,131 FIT WELL INTO THE STANDARD IRB 1308 00:46:07,131 --> 00:46:08,533 INFRASTRUCTURE, I DON'T THINK OF 1309 00:46:08,533 --> 00:46:11,402 OF US ARE DOING, EVERY 1 MONTH 1310 00:46:11,402 --> 00:46:13,838 CONTINUING REVIEW TO BE ABLE TO 1311 00:46:13,838 --> 00:46:16,708 DO THIS, SO, YOU KNOW REQUIRES 1312 00:46:16,708 --> 00:46:18,676 CREATIVE SOLUTIONS THERE, AND 1313 00:46:18,676 --> 00:46:20,645 ULTIMATELY, I THINK IT DOES 1314 00:46:20,645 --> 00:46:22,013 REQUIRE REGULATORY CHANGE EITHER 1315 00:46:22,013 --> 00:46:24,682 AGAIN FOR AI OR FOR IRBs OR 1316 00:46:24,682 --> 00:46:27,118 ARE OTHER BODIES TO BE ABLE TO 1317 00:46:27,118 --> 00:46:27,919 SUFFICIENTLY OVERSEE THIS WORK, 1318 00:46:27,919 --> 00:46:29,787 JUST TO KIND OF HIGHLIGHT THAT 1319 00:46:29,787 --> 00:46:31,322 LAST POINT, SOME OF THE 1320 00:46:31,322 --> 00:46:32,557 REGULATORY QUESTIONS I THINK 1321 00:46:32,557 --> 00:46:35,560 COME UP YOU KNOW, I ALLUDED TO 1322 00:46:35,560 --> 00:46:37,428 THIS ALREADY BUT JUST TO PUT, TO 1323 00:46:37,428 --> 00:46:39,197 NAIL DOWN THE POINT, REALLY I 1324 00:46:39,197 --> 00:46:41,132 WOULD SAY, THE CURRENT 1325 00:46:41,132 --> 00:46:43,668 REGULATIONS DID NOT HAVE AI, 1326 00:46:43,668 --> 00:46:44,736 RESEARCH IN MIND SPECIAL SO I 1327 00:46:44,736 --> 00:46:46,704 THINK THAT YOU CAN BE COMPLIANT 1328 00:46:46,704 --> 00:46:50,274 WITH THE CURRENT REGULATIONS FOR 1329 00:46:50,274 --> 00:46:55,580 EXAMPLE, AS I ALLUDED TO DOING A 1330 00:46:55,580 --> 00:46:57,215 LARGE RETROSPECTIVE--USING A 1331 00:46:57,215 --> 00:46:59,450 SECONDARY DATA SET THAT'S 1332 00:46:59,450 --> 00:47:00,485 DEIESHES DENTIFIED AND YOU CAN 1333 00:47:00,485 --> 00:47:02,153 HAVE SOMETHING THAT MAY 1334 00:47:02,153 --> 00:47:04,088 TECHNICALLY NOT HUMAN SUBJECTS 1335 00:47:04,088 --> 00:47:06,057 RESEARCH OR EXEMPT BUT IS THAT 1336 00:47:06,057 --> 00:47:07,458 REALLY WHAT THE REGULATIONS HAD 1337 00:47:07,458 --> 00:47:08,793 IN MIND FOR THIS TYPE OF WORK, 1338 00:47:08,793 --> 00:47:10,495 RIGHT IN SO IT MAY BE COMPLIANCE 1339 00:47:10,495 --> 00:47:12,230 BUT I THINK WE HAVE TO ASK THE 1340 00:47:12,230 --> 00:47:15,166 QUESTION OF IS IT REALLY 1341 00:47:15,166 --> 00:47:15,633 ADEQUATELY PROTECTED? 1342 00:47:15,633 --> 00:47:17,468 DO WE WANT TO MAYBE RAISE THE 1343 00:47:17,468 --> 00:47:22,340 FLOOR A LITTLE BIT FOR SOME OF 1344 00:47:22,340 --> 00:47:23,207 THIS WORK? 1345 00:47:23,207 --> 00:47:26,611 WE OFTEN GRANT HIPAA WAIVERRERS 1346 00:47:26,611 --> 00:47:29,614 TO DO THIS WORK AS I HINTED TO 1347 00:47:29,614 --> 00:47:31,282 IN THESE LARGE UNCONSENTED DAILY 1348 00:47:31,282 --> 00:47:32,250 BASIS THEA SETS, THE PROBLEM 1349 00:47:32,250 --> 00:47:33,618 THERE BECOMES THAT THE GOAL IS 1350 00:47:33,618 --> 00:47:36,521 GOING TO BE DOING THIS WORK 1351 00:47:36,521 --> 00:47:37,221 INTERNALLY AND EVENTUALLY MAKING 1352 00:47:37,221 --> 00:47:39,390 IT OPEN SOURCE OR 1353 00:47:39,390 --> 00:47:40,992 COMMERCIALIZING AND THEN THIS 1354 00:47:40,992 --> 00:47:43,561 QUESTION AS TO ARE THERE 1355 00:47:43,561 --> 00:47:44,829 RETAINED PRODUCTS OF IDENT FIELD 1356 00:47:44,829 --> 00:47:47,665 FUNCTIONSABILITY IN THE 1357 00:47:47,665 --> 00:47:52,937 ALGORITHMS IN INKEV NITRIC OXIDY 1358 00:47:52,937 --> 00:47:54,338 ESPECIALLY, SO BEING ABLE TO 1359 00:47:54,338 --> 00:47:55,873 DESTROY IT IN ORDER TO MEET YOUR 1360 00:47:55,873 --> 00:47:58,643 HIPAA WAIVER, I DON'T THINK THAT 1361 00:47:58,643 --> 00:47:59,944 EXISTS FOR THESE ALGORITHMS 1362 00:47:59,944 --> 00:48:04,148 EMPLOY I THINK PEOPLE WHO STUDY 1363 00:48:04,148 --> 00:48:05,550 THESE ALGORITHMS, IT WILL SUBMIT 1364 00:48:05,550 --> 00:48:06,717 OUT THAT SPRAINING DATA SET THAT 1365 00:48:06,717 --> 00:48:08,352 YOU THOUGHT MAYBE WASN'T 1366 00:48:08,352 --> 00:48:10,021 RETAINED AND WASN'T THERE AND 1367 00:48:10,021 --> 00:48:12,023 THERE'S REAL POETIC TEBTIAL, I 1368 00:48:12,023 --> 00:48:16,694 THINK LONG-TERM PRIVACY RISKS 1369 00:48:16,694 --> 00:48:17,728 THERE. 1370 00:48:17,728 --> 00:48:19,363 AND FINALLYI IRBs, THE COMMON 1371 00:48:19,363 --> 00:48:21,966 RULE DOESN'T ALLOW US TO 1372 00:48:21,966 --> 00:48:23,568 CONSIDER FUTURE RESEARCH RISKS, 1373 00:48:23,568 --> 00:48:24,635 RIGHT IN FUTURE GROUP HARMS AND 1374 00:48:24,635 --> 00:48:28,072 WHEN YOU THINK ABOUT THINGS LIKE 1375 00:48:28,072 --> 00:48:30,441 BIAS IN AI ALGORITHMS IT 1376 00:48:30,441 --> 00:48:32,143 ACTUALLY DOESN'T NECESSARY 1377 00:48:32,143 --> 00:48:33,244 ARMING THE PEOPLE ENROLLED IN 1378 00:48:33,244 --> 00:48:34,879 THE RESEARCH STUDY IN THAT 1379 00:48:34,879 --> 00:48:37,248 PARTICULAR STUDY, RIGHT? 1380 00:48:37,248 --> 00:48:38,549 IT'S IMPACTING PEOPLE 5, 10, 20 1381 00:48:38,549 --> 00:48:40,885 YEARS IN THE FUTURE WHEN IT'S 1382 00:48:40,885 --> 00:48:42,587 COMMERCIALIZED AND BROADLY USED 1383 00:48:42,587 --> 00:48:44,322 AND THAT'S NOT SOMETHING THAT 1384 00:48:44,322 --> 00:48:46,324 TECHNICALLY RIGHT NOW IRBs ARE 1385 00:48:46,324 --> 00:48:47,725 ALLOWED TO CONSIDER AND SO, 1386 00:48:47,725 --> 00:48:49,927 AGAIN, DO WE NEED REGULATORY 1387 00:48:49,927 --> 00:48:52,029 CHANGE TO ALLOW IRBs TO GO 1388 00:48:52,029 --> 00:48:53,364 THERE OR DO WE NEED SEPARATE 1389 00:48:53,364 --> 00:48:56,400 GROUPS TO BE THINKING ABOUT THE 1390 00:48:56,400 --> 00:48:58,502 SOCIETAL LARGER SCALE SOCIETAL 1391 00:48:58,502 --> 00:49:02,540 ASPECTS OF SOME OF THESE RISKS. 1392 00:49:02,540 --> 00:49:04,775 SO LAST SLIDE HERE, TAKE HOME 1393 00:49:04,775 --> 00:49:06,077 POINTS, THERE'S A TREMENDOUS 1394 00:49:06,077 --> 00:49:09,447 POWER THAT AI HAS FOR AWESOME 1395 00:49:09,447 --> 00:49:13,484 POTENTIAL FOR DIGITAL HEALTH BT 1396 00:49:13,484 --> 00:49:15,453 ALSO LOTS OF SCARY PROBLEMS. 1397 00:49:15,453 --> 00:49:18,122 AS I SAID, THE PROBLEMS CAN BE 1398 00:49:18,122 --> 00:49:21,292 AI CAUSES PROBLEMS BY BEING 1399 00:49:21,292 --> 00:49:22,894 WRONG OR PERPETUAL OR 1400 00:49:22,894 --> 00:49:25,630 EXCLUSION OR INDEPENDENT BIAS, I 1401 00:49:25,630 --> 00:49:28,399 THINK INDEPENDENT REVIEW IS 1402 00:49:28,399 --> 00:49:28,666 CRITICAL. 1403 00:49:28,666 --> 00:49:29,934 SOME IRBs HAVE A ROLE IN THAT 1404 00:49:29,934 --> 00:49:31,469 AND SHOULD BE BUILDING 1405 00:49:31,469 --> 00:49:32,737 COMPETENCIES BUT I ALSO THINK WE 1406 00:49:32,737 --> 00:49:34,605 NEED TO ENGAGE WITH OTHERS, I 1407 00:49:34,605 --> 00:49:36,474 DON'T THINK IT'S OUR JOB TO DO 1408 00:49:36,474 --> 00:49:36,774 ALONE. 1409 00:49:36,774 --> 00:49:38,042 I THINK WE SHOULD ALL WORK 1410 00:49:38,042 --> 00:49:38,743 TOGETHER TO DEVELOP, YOU KNOW 1411 00:49:38,743 --> 00:49:41,412 SOME OF THESE TOOLS AS I WAS 1412 00:49:41,412 --> 00:49:42,580 SAYING, STABBED ARD TEMPLATES WE 1413 00:49:42,580 --> 00:49:44,181 CAN ALL SHARE TO COLLECT THE 1414 00:49:44,181 --> 00:49:45,449 SAME NECESSARY INFORMATION THAT 1415 00:49:45,449 --> 00:49:47,652 WE NEED UP FRONT EMPLOY WE HAVE 1416 00:49:47,652 --> 00:49:50,054 TO WORK WITH RESEARCHERS TO HELP 1417 00:49:50,054 --> 00:49:51,022 THEM UNDERSTAND WHY ARE WE 1418 00:49:51,022 --> 00:49:53,324 TALKING ABOUT THE FDA HERE AND 1419 00:49:53,324 --> 00:49:54,725 WHAT DOES THAT MEAN, AND I'VE 1420 00:49:54,725 --> 00:49:57,361 SPENT A LOT OF TIME WORKING WITH 1421 00:49:57,361 --> 00:49:58,663 RESEARCHERS TO KIND OF SORT OUT 1422 00:49:58,663 --> 00:49:59,797 THOSE QUESTIONS AND HELP THEM 1423 00:49:59,797 --> 00:50:01,732 UNDERSTAND WHY WE NEED TO 1424 00:50:01,732 --> 00:50:03,267 CONSIDER THEM AND AGAIN, I 1425 00:50:03,267 --> 00:50:05,002 THINK, YOU KNOW, THIS IS 1426 00:50:05,002 --> 00:50:05,970 COLLABORATIVE WORK, YOU 1427 00:50:05,970 --> 00:50:07,738 SHOULDN'T WORRY ALONE AS AN IRB, 1428 00:50:07,738 --> 00:50:10,241 WE ALL NEED TO DO THIS TOGETHER, 1429 00:50:10,241 --> 00:50:13,411 TO STAY UP TO DATE WITH EVOLVING 1430 00:50:13,411 --> 00:50:15,146 REGULATIONS AND NORMS, SO, I DO 1431 00:50:15,146 --> 00:50:16,180 WANT TO ACKNOWLEDGE MY 1432 00:50:16,180 --> 00:50:19,917 COLLEAGUES HERE WHO HAVE BEEN 1433 00:50:19,917 --> 00:50:21,419 PART OF THIS WORK AND I WILL 1434 00:50:21,419 --> 00:50:22,853 START THERE AND I WILL LEAVE A 1435 00:50:22,853 --> 00:50:24,155 FEW MINUTES FOR QUESTIONS, SO 1436 00:50:24,155 --> 00:50:32,263 THANKS VERY MUCH FOR YOUR 1437 00:50:32,263 --> 00:50:32,530 ATTENTION. 1438 00:50:32,530 --> 00:50:33,064 NTHANK YOU. 1439 00:50:33,064 --> 00:50:35,566 WE DO INVITE TO YOU SUBMIT 1440 00:50:35,566 --> 00:50:37,969 QUESTIONS BY CLICKING ON THE BOX 1441 00:50:37,969 --> 00:50:39,971 THAT SAYS SEND LIVE FEEDBACK 1442 00:50:39,971 --> 00:50:41,572 LINK, AND THE DOCTOR IS JOINING 1443 00:50:41,572 --> 00:50:43,808 THE DISCUSSION, DO HAVE YOU ANY 1444 00:50:43,808 --> 00:50:46,777 QUESTIONS OR COMMENTS? 1445 00:50:46,777 --> 00:50:48,045 >> THANK YOU BENYY, IT WAS 1446 00:50:48,045 --> 00:50:51,182 AWESOME AS I KNEW IT WOULD BE SO 1447 00:50:51,182 --> 00:50:52,216 EXTREMELY HELPFUL EMPLOY I WOULD 1448 00:50:52,216 --> 00:50:54,685 SAY I WAS A TAD DISAPPOINTED 1449 00:50:54,685 --> 00:50:55,853 BECAUSE YOU DIDN'T ANSWER THE 1450 00:50:55,853 --> 00:50:56,954 HARDEST QUESTION FOR ME, YOU 1451 00:50:56,954 --> 00:50:58,923 TALKED A LOT ABOUT IT IN THE 1452 00:50:58,923 --> 00:51:00,658 BEGINNING AND I STRUGGLE WITH 1453 00:51:00,658 --> 00:51:03,027 THIS IS WHEN DOES IT BECOME F, 1454 00:51:03,027 --> 00:51:03,527 DIDA REGULATED, RIGHT? 1455 00:51:03,527 --> 00:51:08,265 SO WHEN I THINK ABOUT IT, RIGHT, 1456 00:51:08,265 --> 00:51:12,703 I MEAN, WE REGULATE THESE 1457 00:51:12,703 --> 00:51:13,838 DEVICES, THESE ARE MEDICAL 1458 00:51:13,838 --> 00:51:14,905 DEVICES AND IF YOU READ THE 1459 00:51:14,905 --> 00:51:16,707 LETTER OF THE LAW, IT'S AN 1460 00:51:16,707 --> 00:51:17,541 INVESTIGATIONAL DEVICE WHEN THE 1461 00:51:17,541 --> 00:51:19,410 DEVICE IS THE OBJECT OF THE 1462 00:51:19,410 --> 00:51:20,044 INVESTIGATION, THEY'RE TESTING 1463 00:51:20,044 --> 00:51:23,614 THE SAFETY AND EFFICACY OF THE 1464 00:51:23,614 --> 00:51:23,948 DEVICE. 1465 00:51:23,948 --> 00:51:25,616 WHICH COULD IN THESE CASES BE 1466 00:51:25,616 --> 00:51:30,888 PRETTY FAR DOWN THE ROAD, RIGHT 1467 00:51:30,888 --> 00:51:35,960 IN --SO I STRUGGLE. 1468 00:51:35,960 --> 00:51:38,029 WHEN THEY'RE FIGURING OUT THE 1469 00:51:38,029 --> 00:51:39,430 ALGORITHMS THEY'RE STILL 1470 00:51:39,430 --> 00:51:41,465 BUILDING THE DEVICE, THEY DON'T 1471 00:51:41,465 --> 00:51:43,667 HAVE IT YET AND I'VE TALKED TO 1472 00:51:43,667 --> 00:51:45,669 FDA PEOPLE AND THEY HAVE 1473 00:51:45,669 --> 00:51:46,937 ACTUALLY PUSHED IT WAY EARLIER 1474 00:51:46,937 --> 00:51:48,272 THAN I EVER WOULD HAVE THOUGHT. 1475 00:51:48,272 --> 00:51:50,674 THEY SAID OH NO, AS SOON AS 1476 00:51:50,674 --> 00:51:52,877 THEY'RE THINKING ABOUT CREATING 1477 00:51:52,877 --> 00:51:54,945 IT, THEIR INTENT IS TO TEST THE 1478 00:51:54,945 --> 00:51:57,481 SAFETY AND EFFICACY SOMEWHERE 1479 00:51:57,481 --> 00:52:01,485 DOWN THE ROAD WHEN GATE 12 1480 00:52:01,485 --> 00:52:03,454 APPLIES EVEN IF IT'S--IT DOESN'T 1481 00:52:03,454 --> 00:52:04,789 MATTER THAT THESE ARE 1482 00:52:04,789 --> 00:52:06,090 DEIDENTIFIED DAILY BASIS THEA 1483 00:52:06,090 --> 00:52:06,657 SETS. 1484 00:52:06,657 --> 00:52:11,162 SO I STILL, I STILL--I THINK 1485 00:52:11,162 --> 00:52:13,364 THAT AT THE OUTSET BECOMES 1 OF 1486 00:52:13,364 --> 00:52:14,865 THE MOST DIFFICULT DECISION 1487 00:52:14,865 --> 00:52:16,200 POINTS FOR SUSWHEN WE NEED TO 1488 00:52:16,200 --> 00:52:16,400 APPLY. 1489 00:52:16,400 --> 00:52:18,936 AND THE OTHER THING JUST TO GET 1490 00:52:18,936 --> 00:52:22,239 YOUR THOUGHTS FOR ME, IN MY SORT 1491 00:52:22,239 --> 00:52:24,742 OF SIMPLISTIC BRAIN, I THINK I 1492 00:52:24,742 --> 00:52:29,547 JUST DRAW THE ANALOGY TO MORE 1493 00:52:29,547 --> 00:52:30,881 TRADITIONAL TO A TRAW 1494 00:52:30,881 --> 00:52:31,682 DIAGNOSTIC. 1495 00:52:31,682 --> 00:52:33,084 IN THIS CASE, INSTEAD OF A 1496 00:52:33,084 --> 00:52:38,823 TISSUE BIOPSY YOU HAVE A DATA 1497 00:52:38,823 --> 00:52:39,056 BIOPSY. 1498 00:52:39,056 --> 00:52:40,925 SO THE DATA IS LIKE THE SPECIMEN 1499 00:52:40,925 --> 00:52:43,160 HERE, AND THAT'S, YOU KNOW, THE 1500 00:52:43,160 --> 00:52:46,530 SUBJEK, THE HUMAN SUBJECT HERE 1501 00:52:46,530 --> 00:52:48,833 AND THEN JUST TRY TO APPLY THE 1502 00:52:48,833 --> 00:52:53,604 SAME FRAMEWORK AS I DO FOR EVERY 1503 00:52:53,604 --> 00:52:54,772 OTHER INVITRO DIAGNOSTIC STUDY 1504 00:52:54,772 --> 00:52:58,976 DO IT AS BEST I CAN AND I AM 1505 00:52:58,976 --> 00:53:00,511 JUST WONDERING IF YOU THINK 1506 00:53:00,511 --> 00:53:01,745 THAT'S A GOOD APPROACH, DO YOU 1507 00:53:01,745 --> 00:53:03,981 THINK OF THAT, LIKE DO YOU DRAW 1508 00:53:03,981 --> 00:53:08,018 THE SAME ANALOGY, THE DATA HERE 1509 00:53:08,018 --> 00:53:08,986 IS THE BIOSPECIMEN? 1510 00:53:08,986 --> 00:53:11,222 >> YEAH, THANK YOU SO MUCH, 1511 00:53:11,222 --> 00:53:12,523 EXCELLENT QUESTION. 1512 00:53:12,523 --> 00:53:13,891 RIGHT, THE FIRST 1, I MEAN I'M 1513 00:53:13,891 --> 00:53:15,693 RIGHT THERE WITH YOU, I THINK 1514 00:53:15,693 --> 00:53:17,862 THAT IS THE--THAT IS THE 1515 00:53:17,862 --> 00:53:19,330 CRITICAL QUESTION AND RIGHT, THE 1516 00:53:19,330 --> 00:53:20,631 REASON I DIDN'T ANSWER IT IS 1517 00:53:20,631 --> 00:53:23,167 BECAUSE I DON'T THINK WE HAVE AN 1518 00:53:23,167 --> 00:53:27,605 ESTABLISHED RIGHT ANSWER, RIGHT 1519 00:53:27,605 --> 00:53:30,541 SO I HAVE SEEN HAD IRBs THAT 1520 00:53:30,541 --> 00:53:31,842 TAKE THE CONSERVATIVE APPROACH 1521 00:53:31,842 --> 00:53:34,078 AND SAY RIGHT, IF YOU ARE 1522 00:53:34,078 --> 00:53:34,912 THINKING ABOUT TESTING THE 1523 00:53:34,912 --> 00:53:36,413 SAFETY AND EFFICACY OF THIS 1524 00:53:36,413 --> 00:53:37,348 DEVICE AND YOU'RE JUST STARTING 1525 00:53:37,348 --> 00:53:40,184 TO BUILD IT ASK TRAIN IT THAT, 1526 00:53:40,184 --> 00:53:41,085 QUOTE UNQUOTE TRAINING IS PART 1527 00:53:41,085 --> 00:53:44,488 OFIOURE TESTING AND WE'RE GOING 1528 00:53:44,488 --> 00:53:45,923 TO CALL--WE EXPECT THAT THE FDA 1529 00:53:45,923 --> 00:53:47,558 WILL WANT TO GO BACK AND LOOK AT 1530 00:53:47,558 --> 00:53:49,326 HOW IT WAS BUILT AND TRAINED AND 1531 00:53:49,326 --> 00:53:50,995 THAT IT'S ALL GOING TO BE FDA 1532 00:53:50,995 --> 00:53:52,496 REGULATE EXCLUDE WE WILL CALL IT 1533 00:53:52,496 --> 00:53:55,065 THAT WAY FROM THE BEGINNING AND 1534 00:53:55,065 --> 00:53:57,301 THEN I'VE SEEN OTHER IRBs THAT 1535 00:53:57,301 --> 00:53:58,369 HAVE BASICALLY SAID, YOU KNOW AS 1536 00:53:58,369 --> 00:54:02,072 LONG AS YOU DO IT AS 2 SEPARATE 1537 00:54:02,072 --> 00:54:03,507 PROTOCOLS, AS LONG AS YOU HAVE 1 1538 00:54:03,507 --> 00:54:05,176 PROTOCOL THAT IS THE INITIAL 1539 00:54:05,176 --> 00:54:06,210 DATA GATHERING AND THINKING 1540 00:54:06,210 --> 00:54:08,879 ABOUT IT AND BUILDING AND 1541 00:54:08,879 --> 00:54:09,813 TRAINING AND THEN HAVE YOU 1542 00:54:09,813 --> 00:54:11,315 ANOTHER PROTOCOL THAT IS THE 1543 00:54:11,315 --> 00:54:13,484 ACTUAL REAL WORLD, YOU KNOW 1544 00:54:13,484 --> 00:54:15,452 TESTING OF THE SAFETY AND 1545 00:54:15,452 --> 00:54:16,620 EFFICACY THAT WE'RE GOING TO 1546 00:54:16,620 --> 00:54:18,322 SEPARATE IT OUT AND SAY THE 1547 00:54:18,322 --> 00:54:20,357 FIRST 1 IS NOT FDA REGULATED AND 1548 00:54:20,357 --> 00:54:21,992 THE SECOND 1 IS, SO I THINK 1549 00:54:21,992 --> 00:54:23,761 WE'RE NOT UNIFORM IN HOW WE'RE 1550 00:54:23,761 --> 00:54:24,628 HANDLING THIS, I CAN TELL YOU 1551 00:54:24,628 --> 00:54:28,165 THAT I THINK WE ARE TAKING THE 1552 00:54:28,165 --> 00:54:28,999 CONSERVATIVE APPROACH FOR A 1553 00:54:28,999 --> 00:54:30,634 WHOLE VARIETY OF REASONS UNTIL, 1554 00:54:30,634 --> 00:54:32,069 YOU KNOW I THINK ULTIMATELY IT 1555 00:54:32,069 --> 00:54:35,272 WOULD BE GREAT IF THE FDA COULD 1556 00:54:35,272 --> 00:54:37,007 PROVIDE US A DEFINITIVE ANSWER 1557 00:54:37,007 --> 00:54:38,309 THIS, IT'S FUNNY WHAT YOU SAID 1558 00:54:38,309 --> 00:54:39,343 BECAUSE I WAS TALKING ABOUT 1559 00:54:39,343 --> 00:54:40,744 SOMEONE LAST WEEK WHO SAID THEY 1560 00:54:40,744 --> 00:54:43,314 WERE IN A MEETING WITH A--I 1561 00:54:43,314 --> 00:54:45,249 WON'T NAME NAMES BUT A FAIRLY 1562 00:54:45,249 --> 00:54:47,585 HIGH LEVEL FDA PERSON WHO 1563 00:54:47,585 --> 00:54:49,520 PROVOIDED THE OPPOSITE ADVISE 1564 00:54:49,520 --> 00:54:51,255 AND SAID BASICALLY IF YOU'RE NOT 1565 00:54:51,255 --> 00:54:53,524 AT THAT STAGE WHERE THERE'S AN 1566 00:54:53,524 --> 00:54:55,826 ACTUAL DEVICE THAT YOU BUILT AND 1567 00:54:55,826 --> 00:54:57,094 TRAINED, WE DON'T WANT ANYTHING 1568 00:54:57,094 --> 00:54:57,928 TO DO WITH IT. 1569 00:54:57,928 --> 00:55:01,232 SO I THINK WE'RE GETTING MIXED 1570 00:55:01,232 --> 00:55:03,734 MESSAGES AND I THINK, YOU KNOW, 1571 00:55:03,734 --> 00:55:05,169 I THINK EITHER POSITION IS 1572 00:55:05,169 --> 00:55:06,303 DEFENSIBLE SO I THINK YOU HAVE 1573 00:55:06,303 --> 00:55:09,173 TO PICK 1 AND DO IT AND WE'LL 1574 00:55:09,173 --> 00:55:11,375 HOPE THAT THE FDA TELLS US MORE 1575 00:55:11,375 --> 00:55:12,743 SOON AND THEN YOU'RE SECOND 1576 00:55:12,743 --> 00:55:13,711 QUESTION, THE SHORT ANSWER IS 1577 00:55:13,711 --> 00:55:15,446 YES, I THINK ABOUT IT EXACTLY 1578 00:55:15,446 --> 00:55:18,882 THE SAME WAY AS AN INVITRO 1579 00:55:18,882 --> 00:55:22,086 DIAGNOSTIC DEVICE FOR THE AI 1580 00:55:22,086 --> 00:55:24,755 ALLEGOR RYTH EPIGENETICS THAT 1581 00:55:24,755 --> 00:55:26,724 ARE DEVICES, SO NOT ALL, BUT IN 1582 00:55:26,724 --> 00:55:28,125 THOSE SWIGZS, I THINK ABOUT IT 1583 00:55:28,125 --> 00:55:34,331 THE SAME WAY AND I THINK ABOUT 1584 00:55:34,331 --> 00:55:38,535 THE ID EXEMPT DIAGNOSTIC DEVICE 1585 00:55:38,535 --> 00:55:39,270 CATEGORY AS WELL. 1586 00:55:39,270 --> 00:55:40,571 >> WELL, LET'S GO TO THE 1587 00:55:40,571 --> 00:55:41,805 AUDIENCE QUESTIONS BECAUSE I 1588 00:55:41,805 --> 00:55:44,141 COULD PICK YOUR BRAIN ALL DAY. 1589 00:55:44,141 --> 00:55:45,442 >> THIS 1 SHOULD BIOMEDICAL AI 1590 00:55:45,442 --> 00:55:47,745 STUDIES BE REQUIRED TO INCLUDE 1591 00:55:47,745 --> 00:55:55,853 AND REPORT ARK I ATTENUATION? 1592 00:55:55,853 --> 00:55:57,988 MEANING THE ABILITY TO REQUIRE 1593 00:55:57,988 --> 00:55:59,857 AI TO SHOW WHAT IT IS 1594 00:55:59,857 --> 00:56:03,961 SPECIFICALLY USING TO MAKE THE 1595 00:56:03,961 --> 00:56:04,361 DECISION? 1596 00:56:04,361 --> 00:56:05,729 >> YEAH, I ALLUDED TO THAT A 1597 00:56:05,729 --> 00:56:07,564 LITTLE BIT BUT WE NEED SOME 1598 00:56:07,564 --> 00:56:08,532 DEGREE OF EXPLAINABILITY, WE 1599 00:56:08,532 --> 00:56:10,234 NEED SOME DEGREE OF 1600 00:56:10,234 --> 00:56:12,736 UNDERSTANDING HOW THE AI IS 1601 00:56:12,736 --> 00:56:15,139 WORKING AND HOW IT'S SUPPOSED TO 1602 00:56:15,139 --> 00:56:15,339 WORK. 1603 00:56:15,339 --> 00:56:17,041 BASICALLY IF YOU THINK ABOUT IT 1604 00:56:17,041 --> 00:56:18,475 FROM THE IRB PERSPECTIVE, WE 1605 00:56:18,475 --> 00:56:20,311 HAVE TO MONITOR FOR 1606 00:56:20,311 --> 00:56:22,046 UNANTICIPATED PROBLEMS, SO 1607 00:56:22,046 --> 00:56:25,149 PEOPLE ARE EXPECTED TO REPORT TO 1608 00:56:25,149 --> 00:56:26,450 US ON UNEXPECTED PROBLEM ANDS IF 1609 00:56:26,450 --> 00:56:28,619 YOU DON'T AT LEAST PUT YOUR 1610 00:56:28,619 --> 00:56:29,820 NICKEL DOWN, AROUND WHAT IS 1611 00:56:29,820 --> 00:56:32,890 ANTICIPATED AND WHAT IS 1612 00:56:32,890 --> 00:56:34,158 UNANTICIPATED, IT'S HARD TO DO 1613 00:56:34,158 --> 00:56:35,926 THAT SO I THINK WE HAVE TO, I 1614 00:56:35,926 --> 00:56:37,695 THINK THE CHALLENGE IS, AND YOU 1615 00:56:37,695 --> 00:56:40,564 KNOW MY BACKGROUND IS ETHICS AND 1616 00:56:40,564 --> 00:56:44,301 IRBPAYS AND ALL THAT, BUT I DO 1617 00:56:44,301 --> 00:56:46,303 NOT CLAIM TO BE AN AI EXPERT BY 1618 00:56:46,303 --> 00:56:48,172 ANY MEANS AND I THINK THE AI EX 1619 00:56:48,172 --> 00:56:49,573 PERS WILL TELL YOU THE CHAL 1620 00:56:49,573 --> 00:56:51,008 WENCH THAT IS AGAIN, YOU KNOW 1621 00:56:51,008 --> 00:56:55,212 THIS MEETING I WAS AT EARLIER 1622 00:56:55,212 --> 00:56:56,613 THIS WEEK, ACTUALLY, PEOPLE 1623 00:56:56,613 --> 00:56:58,816 SAYING EXPLAINABILITY IS A MYTH, 1624 00:56:58,816 --> 00:57:00,517 LIKE WE'RE NOT--AS THESE THINGS 1625 00:57:00,517 --> 00:57:01,985 GET BETTER AND BETTER AND 1626 00:57:01,985 --> 00:57:03,620 BETTER, WE'RE NOT ACTUALLY GOING 1627 00:57:03,620 --> 00:57:06,824 TO BE ABLE TO DO THAT SO PERHAPS 1628 00:57:06,824 --> 00:57:08,192 WE'RE ADDING A REQUIREMENT 1629 00:57:08,192 --> 00:57:09,293 THAT'S NOT POSSIBLE AND AGAIN, 1630 00:57:09,293 --> 00:57:11,729 WE DON'T WANT TO TYPHLE 1631 00:57:11,729 --> 00:57:13,364 INNOVATION, SO, I, YOU KNOW I 1632 00:57:13,364 --> 00:57:14,531 THINK RIGHT NOW, WE SHOULD DO 1633 00:57:14,531 --> 00:57:16,300 OUR BEST TO TRY ON DO THAT, 1634 00:57:16,300 --> 00:57:20,437 WHERE THE FUTURE GOES, IS 1635 00:57:20,437 --> 00:57:21,438 ANYONE'S GUESS. 1636 00:57:21,438 --> 00:57:24,975 >> OKAY, WE HAVE A COMMENT FROM 1637 00:57:24,975 --> 00:57:25,743 A RADIOLOGIST HERE. 1638 00:57:25,743 --> 00:57:27,611 I'M VERY FAMILIAR WITH THE CHEST 1639 00:57:27,611 --> 00:57:29,113 X-RAY ARTICLE THAT YOU 1640 00:57:29,113 --> 00:57:30,180 MENTIONED, IT'S NOT SURPRISING 1641 00:57:30,180 --> 00:57:31,482 THAT AI COULD PREDICT THE 1642 00:57:31,482 --> 00:57:32,850 PATIENT'S RACE EVEN WHEN WE 1643 00:57:32,850 --> 00:57:34,485 CAN'T SEE THE INFORMATION ON THE 1644 00:57:34,485 --> 00:57:36,019 IMAGE WITH THE NAKED EYE. 1645 00:57:36,019 --> 00:57:36,987 FOR EXAMPLE, YOU WOULD BE 1646 00:57:36,987 --> 00:57:38,055 SURPRISED TO KNOW THAT I CAN 1647 00:57:38,055 --> 00:57:39,323 TELL YOU THE EXPECTATIONS IS OF 1648 00:57:39,323 --> 00:57:41,425 A PATIENT BY LOOKING AT THE 1649 00:57:41,425 --> 00:57:42,493 CHEST X-RAY, OF COURSE NOT, 1650 00:57:42,493 --> 00:57:44,094 THERE ARE OBVIOUS CUES. 1651 00:57:44,094 --> 00:57:45,896 FOR RACE, THERE ARE CUES TOO, 1652 00:57:45,896 --> 00:57:47,231 BUT THE AUTHORS OF THE PAPER 1653 00:57:47,231 --> 00:57:49,333 MENTION DID NOT UNDERSTAND HOW 1654 00:57:49,333 --> 00:57:51,168 THEIR INTERVENTIONS DID NOT 1655 00:57:51,168 --> 00:57:54,304 OBSCURE THE CUES, PLEASE DO NOT 1656 00:57:54,304 --> 00:57:55,038 EXAGGERATE THE SIGNIFICANCE OF 1657 00:57:55,038 --> 00:57:58,342 THE FINDINGS OF THAT OR SIMILAR 1658 00:57:58,342 --> 00:57:58,575 PAPERS. 1659 00:57:58,575 --> 00:58:01,011 SUCH MISCONACCEPTINGS COULD LEAD 1660 00:58:01,011 --> 00:58:02,546 TO EXAGGERATED CONCERNS FOR 1661 00:58:02,546 --> 00:58:04,748 IRBs AND OVERREGULATION OF AI 1662 00:58:04,748 --> 00:58:05,816 RESEARCH. 1663 00:58:05,816 --> 00:58:08,952 NI APPRECIATE THE COMMENT. 1664 00:58:08,952 --> 00:58:10,921 ALL I CAN SAY IS, I DON'T THINK 1665 00:58:10,921 --> 00:58:14,358 THAT THE POTENTIAL FOR BIAS IN 1666 00:58:14,358 --> 00:58:15,526 AI ALGORITHMS IS EXAGGERATED. 1667 00:58:15,526 --> 00:58:18,128 I THINK MAYBE THAT PARTICULAR 1668 00:58:18,128 --> 00:58:20,631 EXAMPLE COULD BE BUT I THINK 1669 00:58:20,631 --> 00:58:23,033 THAT THE POETIC TEBTIAL FOR A I 1670 00:58:23,033 --> 00:58:23,901 BIAS AND ALGORITHMS IS REAL AND 1671 00:58:23,901 --> 00:58:34,378 WE HAVE TO BE THINKING ABOUT IT. 1672 00:58:34,378 --> 00:58:37,114 >> IS THERE A PATH WHERE WE 1673 00:58:37,114 --> 00:58:39,316 CAPTURE ADVERSE EVENTS AND 1674 00:58:39,316 --> 00:58:40,918 CONFIDENTIALITY RESEARCH IN AI 1675 00:58:40,918 --> 00:58:41,385 RESEARCH? 1676 00:58:41,385 --> 00:58:42,219 >> SAY IT AGAIN IN. 1677 00:58:42,219 --> 00:58:43,754 >> IS THERE A PATH WHERE WE 1678 00:58:43,754 --> 00:58:49,193 INCLUDE THE CAPTURE OF PRIVACY 1679 00:58:49,193 --> 00:58:50,994 AND CONFIDENTIALITY CONCERNS IN 1680 00:58:50,994 --> 00:58:51,728 AI RESEARCH? 1681 00:58:51,728 --> 00:58:53,230 >> I THINK AGAIN IT GOES BACK TO 1682 00:58:53,230 --> 00:58:55,432 WHAT IS AN UNANTICIPATED PROBLEM 1683 00:58:55,432 --> 00:58:56,700 VERSUS AN ANTICIPATED PROBLEM, 1684 00:58:56,700 --> 00:59:05,175 RIGHT AND SO, I MEAN THERE'S IT 1685 00:59:05,175 --> 00:59:05,876 REIDENT FIELD FUNCTIONSABILITY 1686 00:59:05,876 --> 00:59:07,711 OCCURS AND YOU KNOW PEOPLE ARE 1687 00:59:07,711 --> 00:59:08,946 ABLE TO IEE, AUDIENCE DENTIFY 1688 00:59:08,946 --> 00:59:11,348 SOMETHING THAT YOU WEREN'T ABLE 1689 00:59:11,348 --> 00:59:11,648 TO IDENTIFY. 1690 00:59:11,648 --> 00:59:14,384 YOU WOULD HAVE TO REPORT THAT AS 1691 00:59:14,384 --> 00:59:16,220 AN UNANTICIPATED PROBLEM, I 1692 00:59:16,220 --> 00:59:18,722 MEAN, YOU KNOW WHETHER IT'S AN 1693 00:59:18,722 --> 00:59:21,558 ADVERSE EVENT NECESSARILY, I 1694 00:59:21,558 --> 00:59:24,194 MEAN, IT'S A SEPARATE 1695 00:59:24,194 --> 00:59:26,263 CONVERSATION, BUT YOU KNOW 1696 00:59:26,263 --> 00:59:28,832 ESSENTIALLY 1 COULD ARGUE THAT 1697 00:59:28,832 --> 00:59:30,868 CONFIDENTIALITY OR VIOLATIONS 1698 00:59:30,868 --> 00:59:32,269 ARE AN EXPECTED ADVERSE EVENT 1699 00:59:32,269 --> 00:59:36,907 ANYTIME YOU COLLECT SOMEONE'S 1700 00:59:36,907 --> 00:59:38,075 PRIVATE INFORMATION, RIGHT? 1701 00:59:38,075 --> 00:59:40,110 >> REGARDING FUTURE GROUP ARMS, 1702 00:59:40,110 --> 00:59:41,979 DRUGS CAN CAUSE GROUP HARMS, BY 1703 00:59:41,979 --> 00:59:43,614 BEING AN EFFECTIVE OR MORE TOXIC 1704 00:59:43,614 --> 00:59:46,817 IN CERTAIN PATIENT POPULATIONS. 1705 00:59:46,817 --> 00:59:48,585 SHOULD THE IRB ASSESS DRUGS FOR 1706 00:59:48,585 --> 00:59:55,025 THOSE ARMS, WHY IS AI DIFFERENT 1707 00:59:55,025 --> 00:59:55,459 IN THIS REGARD? 1708 00:59:55,459 --> 00:59:57,995 >> WELL I GUESS WHAT I WOULD SAY 1709 00:59:57,995 --> 00:59:59,863 IS I THINK THAT WE TRY TO ASSESS 1710 00:59:59,863 --> 01:00:03,033 THAT FOR DRUGS RIGHT NOW, RIGHT? 1711 01:00:03,033 --> 01:00:05,602 SO WHEN PEOPLE DO YOU KNOW 1712 01:00:05,602 --> 01:00:07,704 PIVOTAL TRIALS TO GET APPROVAL 1713 01:00:07,704 --> 01:00:10,908 FOR DRUGS, THE HOPE IS THAT 1714 01:00:10,908 --> 01:00:11,708 THEY'RE ENROLLINGA ADEQUATELY 1715 01:00:11,708 --> 01:00:12,576 DIVERSE POPULATIONS TO BE ABLE 1716 01:00:12,576 --> 01:00:15,412 TO ARK ASSESSES THAT. 1717 01:00:15,412 --> 01:00:16,680 RIGHT? 1718 01:00:16,680 --> 01:00:17,848 AND THE IRB CERTAINLY CONSIDERS 1719 01:00:17,848 --> 01:00:21,885 THAT AS PART OF, YOU KNOW 1720 01:00:21,885 --> 01:00:22,553 EQUITABLE SUBJECT SELECTION, ET 1721 01:00:22,553 --> 01:00:24,454 CETERA EMPLOY SO I DON'T THINK 1722 01:00:24,454 --> 01:00:25,188 IT'S ACTUALLY DIFFERENT. 1723 01:00:25,188 --> 01:00:31,428 I THINK WE HAVE TO CONSIDER IT 1724 01:00:31,428 --> 01:00:33,363 IN BOTH SITUATIONS. 1725 01:00:33,363 --> 01:00:40,437 >> OKAY, DR. GREEN, DR. S 1726 01:00:40,437 --> 01:00:42,439 ILVERMAN, ANY FURTHER QUESTIONS? 1727 01:00:42,439 --> 01:00:44,274 WE'RE WELL OUT OF TIME. 1728 01:00:44,274 --> 01:00:46,476 >> NO, THANK YOU VERY MUCH FOR 1729 01:00:46,476 --> 01:00:48,579 COMING AND PRESENTING TO US A 1730 01:00:48,579 --> 01:00:49,813 TOPIC FOR MUCH DISCUSSION. 1731 01:00:49,813 --> 01:00:51,348 I'M SURE WE WILL HAVE MUCH MORE 1732 01:00:51,348 --> 01:00:53,116 QUESTIONS ABOUT IT AND THANK 1733 01:00:53,116 --> 01:00:53,350 YOU. 1734 01:00:53,350 --> 01:00:55,052 NTHANKS FOR HAVING ME NTHANK YOU 1735 01:00:55,052 --> 01:00:59,222 TO YOU BOTH FOR JOINING US 1736 01:00:59,222 --> 01:00:59,423 TODAY. 1737 01:00:59,423 --> 01:01:00,357 >> THANK YOU. 1738 01:01:00,357 --> 01:01:10,634 >> TAKE CARE.