WELCOME BACK TO DAY TWO OF OUR PRECISION MEDICINE INITIATIVE WORKSHOP. I'M GOING TO KICK US OFF QUICKLY AND SORT OF GIVE YOU AN OVERVIEW OF OUR MORNING TOGETHER AND THEN TURN IT OVER TO DR. COLLINS TO INTRODUCE OUR SPECIAL GUESTS THIS MORNING. SO YESTERDAY, WE TALKED A LOT ABOUT THE RISK AND BENEFITS OF USING EXISTING RESOURCES IN ORDER TO TAP HEALTHCARE DELIVERY SYSTEMS AND EXISTING RESEARCH COHORTS AND BRINGING THOSE IN TO THE PRECISION MEDICINE COHORT. WE TALKED ABOUT CHALLENGES AND OPPORTUNITY FOR DATA SHARING ACROSS INSTITUTIONS AND HOW IMPORTANT THAT WILL BE TO THE SUCCESS OF THE COHORT, NOT ONLY DATA SHARING AMONGST RESEARCHERS BUT ALSO DATA SHARING WITH THE INDIVIDUAL PARTICIPANTS. AND THEN WE HAD, I THOUGHT, A VERY IMPORTANT AND PROVOCATIVE CONVERSATION ABOUT INCLUSION OF UNDERREPRESENTED MINORITIES AND UNDERSERVED POPULATIONS IN THE COHORT AND THE PARTICULAR OPITIES AND CHALLENGES THAT THAT PROVIDES IN TERMS OF HOW ARE WE GOING TO DO THAT, HOW ARE WE GOING TO MAKE THAT HAPPEN. YESTERDAY WE HAD ALMOST A THOUSAND TWEETS, WE HAD 28 # TWITTE288 TWITTER IMPRESSIONS, AND WE HAD A NUMBER OF PEOPLE WATCHING ON THE WEBCAST AND WE HAVE PEOPLE TUNING IN TODAY ON THE WEBCAST, AND THAT WILL BE ARCHIVED AT THE PRECISION MEDICINE INITIATIVE WEBPAGE AT THE NIH. SO FEEL FREE TO GO BACK AND REVIEW THESE REALLY IMPORTANT TALKS THAT YOU'LL HEAR AGAIN TODAY. SO TODAY, WE'RE GOING TO HAVE A SPECIAL GUEST REPRESENTATIVE MARSHA BLACKBURN TALK WITH, THEN WE'RE GOING TO TALK ABOUT CORE DATA ELEMENTS THAT WE NEED FOR THE COHORT AND WHERE THEY CURRENTLY LIVE. WE'RE GOING TO TALK AND CONTINUE REALLY THE CONVERSATION ABOUT POSSIBILITIES FOR GETTING INFORMATION DIRECTLY FROM PARTICIPANTS RATHER THAN GETTING PARTICIPANT DATA THROUGH SOME INTERMEDIARY, WHETHER IT BE A HEALTHCARE SYSTEM OR SOMETHING ELSE. THEN WE'RE GOING TO HAVE A CONVERSATION ABOUT THE ADVANTAGES AND CHALLENGES OF A CENTRALIZED VERSUS A FEDERATED DATA MODEL, AND THIS HAS BEEN ALSO A RECURRING QUESTION AND ONE THAT I THINK WILL PERSIST FOR SOME TIME UNTIL WE REALLY SETTLE ON WHAT WILL BE THE DATA ARCHITECTURE FOR THE COHORT AS WE MOVE FORWARD, AND THEN WE WERE WRAP UP AND AFTER THAT, WE WILL BE -- THE WORKING GROUP WILL HAVE A CLOSED WORKING GROUP MEETING IN WHICH WE WILL CONSIDER ALL OF THE GREAT INPUT THAT YOU ALL HAVE PROVIDED TO US OVER THE COURSE OF THE LAST DAY AND A HALF AND THEN START TO REALLY FASTEN IN TO SOME OF THE KEY DECISIONS WE NEED TO BE ABLE TO MAKE IN ORDER TO HAVE OUR REPORT TO THE ADVISORY COMMITTEE IN SEPTEMBER. SO WITH THAT, I WILL TURN THE PODIUM OVER TO DR. COLLINS TO INTRODUCE OUR SPECIAL GUEST. >> WELL, GOOD MORNING, EVERYONE. WELCOME BACK TO THE SECOND DAY OF WHAT IS A VERY IMPORTANT AND VERY INTENSE DISCUSSION AS PART OF THIS SERIES OF FOUR WORKSHOPS TO HELP US BY SEPTEMBER TO LAY OUT THE DESIGN OF THIS REMARKABLY BOLD INITIATIVE TO HAVE 1 MILLION OR MORE MAYBE AMERICANS ENROLLED IN AN ENTERPRISE WHERE THEY'RE FULL PARTICIPANTS AND WHERE WE AIM THROUGH INFORMATION ABOUT GENOMICS, ELECTRONIC HEALTH RECORDS, WEARABLE SENSORS AND EVERYTHING ELSE TO REALLY TRANSFORM THE LANDSCAPE OF OUR UNDERSTANDING OF HOW IT IS THAT PEOPLE ARE ABLE TO MAINTAIN HEALTH OR HOW WE CAN BEST MANAGE WELLNESS SO IF IT HAPPENS TO US, IF CHRONIC DISEASE HAPPENS, HOW WE CAN BEST MANAGE THAT AS WELL. THIS WILL PROVIDE A PLATFORM FOR ANSWERING QUESTIONS HA OTHERWISE WE WON'T BE ABLE TO ANSWER, SO IT'S OF GREAT SIGNIFICANCE AND GREAT EXCITEMENT THAT WE'VE ARRIVED AT THIS POINT. I WANT TO THANK AGAIN OUR HOST HERE AT VANDERBILT FOR MAKING IT POSSIBLE FOR US TO MEET HERE IN NASHVILLE. WE HAD A GREAT DAY YESTERDAY ACROSS THE WAY AND NOW WE'RE IN A DIFFERENT SPACE BUT I THINK ALSO NICE COSEY PLACE WHERE WE CAN HAVE SERIOUS INFORMAL CONVERSATIONS AND I HOPE JUST LIKE YESTERDAY, THAT WILL BE THE CASE TODAY WHERE THERE'S LOTS OF OPPORTUNITY FOR DISCUSSION AND PEOPLE ARE GETTING UP ON THEIR FEET TO THE MICROPHONES AND POSING QUESTIONS AND REALLY TRYING TO DRIVE THIS DISCUSSION INTO AN AREA THAT'S GOING TO HELP US WITH THE DESIGN OF THIS EFFORT IN THE BEST POSSIBLE WAY. I'VE ALSO ENYOID NASHVILLE FOR ANOTHER REASON, BECAUSE YES, I DID GET TO GO TO THE BLUEBIRD CAFE LAST NIGHT, AT THE 9:00 SHOW, WHERE THERE WERE FOUR WONDERFUL SINGER SONG WRITERS SITTING IN A CIRCLE WHILE THE REST OF US SAT AND LISTENED TO THEIR ORIGINAL MUSIC, WHICH WAS REALLY AMAZINGLY IMPRESSIVE. AND YES, IT WAS ALSO SOMEWHAT UNEXPECTED TO BE ASKED TO JOIN THAT CIRCLE AND PRODUCE A SONG MYSELF, WHICH I DID, AND I DON'T KNOW IF THAT WILL TURN UP ON YTUBE, I KIND OF HOPE IT DOESN'T BECAUSE I GOT A LITTLE TANGLED UP IN THE BRIDGE IT THERE IT THIS THIS SONG THAT I WROTE ABOUT DISEASE. GO TO THE BLUEBIRD AND SING ABOUT DISEASE, DOES THAT MAKE SENSE? ANYWAY, SENATOR ALEXANDER, WHO WAS MY HOST, SEEMED TO THINK IT WAS OKAY SO I GUESS I'M GOG BREATHE A SIGH OF RELIEF. BUT WHAT A GREAT TOWN THIS IS AND WHAT A WONDERUL EXPERIENCE WE ALL HAVE HAD BEING HERE, AND AGAIN THANKS TO OUR COLLEAGUES AT VANDERBILT WHO WERE SO STRONG IN THIS AREA AK DEM CANICALLY AND HAVE MADE IT POSSIBLE FOR US TO MEET HERE. ANOTHER NICE THING ABOUT COMING TO TENNESSEE IS WE GET A CHANCE OUTSIDE THE BELTWAY TO MEET WITH ELECTED REPRESENTATIVES WHO ARE IN IMPORTANT POSITIONS HERE IN TMS OF WHAT MAY HAPPEN IN TERMS OF CONGRESSIONAL SUPPORT FOR WHAT WE'RE HERE TO TALK ABOUT, THIS PRECISION MEDICINE INITIATIVE. YESTERDAY WE HAD THE PRIF LINK OF HAVING SENATOR LAMAR ALEXANDER WITH US AND HE HAD A VERY INTERESTING TIME AND WAS QUITE COMPLIM TRI TO ALL OF YOU YESTERDAY.HANCE TO CHAT WITH AND TODAY, WE ARE VERY FORTUNATE TO HAVE REPRESENTATIVE MARSHA BLACKBURN, WHO IS THE ELECTED REPRESENTATIVE FROM THE SEVENTH DISTRICT OF TENNESSEE, A DISTRICT WHICH I GATHER STRETCHES ALL THE WAY FROM NASHVILLE TO MEMPHIS, IF YOU CAN IMAGINE THAT. SO SHE MUST HAVE PUT A LOT OF MILES ON HER CAR IN ORDER TO BE ABLE TO HAVE A CHANCE TO MEET WITH AWFUL OF THESE CONSTITUENTS. SO SHE'S ELECTED TO THE HOUSE IN 2002 AND HAS BEEN CONTINUOUSLY SERVING THE NATION IN THAT ROLE SINCE THEN, SO THAT'S A LONG STRETCH OF DEDICATION. BEFORE THAT, SHE WAS IN THE TENNESSEE STATE SENATE. SHE CURRENTLY SERVES AS THE VICE CHAIRMAN OF THE ENERGY AND COMMERCE COMMITTEE IN THE HOUSE OF REPRESENTATIVES. A VERY IMPORTANT COMMITTEE BECAUSE THAT IS THE AUTHORIZING COMMITTEE FOR NIH. AND IT IS THE COMMITTEE IN WHICH THE 21ST CENTURY CURES INITIATIVE HAS BEEN GETTING FORMULATED UNDER THE LEADERSHIP OF HER AND FRED UPTON, WHO IS THE CHAIR, FRANK PALLONE, WHO IS THE RANKING MEMBER AND A LOT OF INTERESTING THINGS HAVE HAPPEN OVER THE COURSE OF THE LAST YEAR, PREPARING FOR A PIECE OF LEGISLATION THAT NOW PASSED OUT OF FULL COMMITTEE UNANIMOUSLY. CAN YOU IMAGINE THAT? MAYBE SHE'LL TELL US A LITTLE MORE ABOUT HOW THAT CAME TO BE, BECAUSE THAT'S NOT THE SORT OF THING THAT HAPPENS THESE DAYS. SHE ALSO HAS PLAYED AN IMPORTANT LEADERSHIP ROLE IN OTHER WAYS ENSURING THAT CHILDREN ARE ADEQUATELY REPRESENTED IN BIOMEDICAL RESEARCH, AP EFFORT THAT SHE SPONSORED ALONG WITH CO-SPONSOR LOIS KEPPS. SHE'S CO-FOUNDER OF THE PROFESSIONAL SONG WRITE ARES CAUCUS AND I MOW THEY APPRECIATED THAT WHEN I MET WITH SOME OF THOSE FOLKS LAST MIGHT BAW THEY'RE ALL WORRIED IF SONG RIGHTERS HAVE A FUTURE. IN TERMS OF 21ST CENTURY CURES, NIH HAS BEEN INVOLVED IN THIS BY GETTING MANY REQUESTS FOR INPUT AND TECHNICAL ADVICE AND WE'RE VERY PLEASED TO SEE THE WAY IN WHICH THIS HAS BEEN DEVELOPING AND LOTS OF FEATURES IN THERE THAT ARE RELEVANT TO WHAT WE'RE TALKING ABOUT HERE INCLUDING THE NIH DIRECTOR ADDITIONAL AUTHORITIES INSISTING ON DATA ACCESS, WHICH WE THINK IS GOING TO BE FUNDAMENTAL AND IMPORTANT TO ALL OF THIS SO WE REALLY DO WANT TO EXPRESS OUR THANKS TO REPRESENTATIVE BLACKBURN AND ALL OF THOSE WHO HAVE BEEN PUTTING THIS TOGETHER IN A THOUGHTFUL WAY AND SEEKING INPUT ALL ACROSS THE WAY, I PERSONALLY HAVE BEEN INVOLVED IN NO LESS THAN FOUR HEARINGS AND ROUND TAIBLGHTS INCLUDING A COUPLE OUTSIDE OF WASHINGTON AND NUMEROUS STAFF CONVERSATIONS AND THAT KIND OF APPROACH WHERE REALLY THE CONGRESS IS LOOKING FOR THAT KIND OF INPUT AND ACTING ON IT OVER A THOUGHTFUL DELIBERATIVE PROCESS HAS BEEN GREAT TO SEE. SO WITHOUT TAKING ANY MORE OF HER TIME, LET ME ASK YOU, PLEASE, TO GIVE A WARM WELCOME TO REPRESENTATIVE MARSHA BLACKBURN OF THE SEVENTH DISTRICT OF TENNESSEE. [APPLAUSE] >> THANK YOU SO MUCH. I AM ABSOLUTELY THRILLED TO BE ABLE TO STOP BY THIS MORNING AND TO WELCOME THE NIH HERE AND TO PUBLICLY THANK BOTH KATHY AND DR. FRANCIS FOR HOW THEY HAVE WORKED WITH US AND OUR TEAM AS WE HAVE PULLED TOGETHER 21ST CENTURY CURES, AND AS DR. COLLINS SAID, WE'VE PASS THIS HAD UNANIMOUSLY OUT OF THE HOUSE COMET THE EE. IT GOES TO THE HOUSE OF THE FLOOR IN JUNE. WE EXPECT IT IS GOING TO HAVE OVER 350 VOTES. OUT OF THE 435 WHEN IT GETS TO THE HOUSE. AND IT WILL THEN GO OVER TO THE SENATE UNDER SENATOR ALEXANDER'S CAPABLE LEADERSHIP. WE'RE EXCITED ABOUT IT, WE ANTICIPATE THAT IT IS GOING TO MOVE FORWARD RATHER QUICKLY, AND IT IS SOMETHING THAT WILL BE SIGNED INTO LAW. NOW, JUST ON THAT GROUND, AND KIND OF HOW WE ARRIVED AT THIS, ONE OF THE THINGS THAT CHAIRMAN UPTON AND I, IN LEADING THE ENERGY AND COMMERCE COMMITTEE, AS WE LOOKED AT WHAT WE WANTED TO DO, AND WHAT WE WANTED TO ACCOMPLISH, AND LOOKED AT THE COST OF HEALTHCARE DELIVERY, AND OF MEDICAID AND MEDICARE SERVICES, THEN WHAT YOU DO IS BEGIN TO LOOK AT WHERE ARE THE HIGH COST AREAS, WHERE ARE THE HOLES, WHAT ARE THE PROBLEMS THAT NEED TO BE SOLVED? NOW ONE OF THOSE WAS LOOKING AT ALZHEIMER'S. YOU SAY, OKAY, THIS IS SOMETHING THAT IS COSTING OUR ECONOMY OR OUR COUNTRY IN HEALTHCARE COSTS $215 BILLION A YEAR. AND YOU HAVE 10,000 INDIVIDUALS PER DAY TURNING 65. AND YOU BEGAN TO LOOK AT WHAT THIS IS GOING TO DO. PUTTING MONEY INTO ALZHEIMER'S RESEARCH. IS SOMETHING THAT NEEDED TO BE DONE. HOW DO YOU SOLVE THAT PROBLEM, HOW DO YOU ADDRESS THAT PROBLEM? WHAT ARE THE BARRIERS TO ENTRY FOR RESEARCH INTO SOLVING THIS PROBLEM. SO THAT IS KIND OF THE TYPE PROCESS THAT WE AS LEGISLATORS WERE FOLLOWING IN DECIDING WHERE WE WERE GOING TO PUT OUR TIME AND EFFORT AND ENERGY AND WE FEEL LIKE IT IS TIME FOR OUR NATION TO BEGIN TO EMBRACE A CURES STRATEGY. AND LOOKING AT WELLNESS, LOOKING AT DISEASE MANAGEMENT, LOOKING AT OUTCOMES, HIGHER QUALITY OF LIFE KIND OF FLIPPING THIS ON ITS HEAD. AND MAKING CERTAIN THAT WE WERE FOCUSING ON SOLVING THESE HEALTHCARE AND THESE HEALTH ISSUE PROBLEMS. WE DECIDED TO LOOK MORE AT PRECISION MEDICINE, LOOK AT WHAT WAS TRACKING WITH PERSONALIZED MEDICINE AND I TELL YOU I'VE GOT TO GIVE YOU A TREMENDOUS AMOUNT OF CREDIT TO OUR HEALTH POLICY DIRECTOR WHO HAS SPENT TIME HERE AT VANDERBILT BEFORE COMING TO D.C. DOING AN NIH FELLOWSHIP AND THEN COMING IN TO OUR OFFICE AS THE HEALTH POLICY DIRECTOR, SHE HAS WORKED SO CLOSELY WITH DR. COLLINS' TEAM AND WITH SENATOR ALEXANDER'S TEAM AND OUR TEAM AT ENERGY AND COMMERCE COMMITTEE IN TALKING ABOUT WHAT WOULD WORK, AND WHAT WOULD HELP, TO BRING FORWARD NEW PRODUCTS AND THERAPIES AND INNOVATIONS THAT ARE GOING TO LEAD TO THE OUTCOME THAT WE WOULD ALL LIKE TO HAVE. SO WE THINK THAT WE HAVE SEEDED THIS, IF YOU WILL, IN THE RIGHT PLACE. CONGRESSMAN DIANA DEGETT OUT OF COLORADO LED THE TEAM FOR THE DEMOCRATS AND CHAIRMAN UPTON LED THE TEAM FOR THE REPUBLICANS AND WE HAVE ALL WORKED TOGETHER FOR A YEAR AND A HALF TO GET THIS TO THE POINT THAT THAT AS DR. INS SAID, IT WAS KIND OF ONE OF THOSE FREAKS OF NATURE IF YOU WILL, THAT YOU HAVE A BILL MOVE OUT OF COMMITTEE UNANIMOUS VOICE VOTE. SO THAT IS WHAT WE'VE DONE. I HAD THE OPPORTUNITY TO BRAG A LITTLE BIT THIS WEEK ON VANDERBILT AND WHAT YOU ARE DOING AND SOME OF THE RESEARCH WORK THAT IS TAKING CARE WHEN I WAS UP AT OAK RIDGE NATIONAL LABS AND TALKED SOME OF WHAT THEY'RE LOOKING TO DO MOVING INTO THEIR INTEREST IN PARTICIPATING WITH SOME PRECISION MEDICINE AND SOME INNOVATION, AND THEN ALSO TO TALK ABOUT THE OPPORTUNITIES THAT EXIST FOR US HERE IN TENNESSEE AS I YESTERDAY ADDRESSED THE TENNESSEE VALLEY CORRIDOR, AND THEIR ECONOMIC AND ENERGY SUMMIT. SO WE APPRECIATE WHAT YOU ALL ARE DOING AND WHAT IT MEANS NOT ONLY TO OUR COMMUNITY BUT TO OUR COUNTRY. AND GLOBALLY AS WE TRY TO SOLVE SOME OF THESE PROBLEMS. KATHY MENTIONED DATA, AND I WANT TO START THERE AND TALK JUST A LITTLE BIT. I KNOW YOU ALL ARE GOING TO LOOK AT -- YOU HAD SOME PRIVACY CONCERNS. THIS IS SOMETHING WE ALSO WERE ADDRESSING, AND CONGRESSMAN PETER WELCH OUT OF VERMONT AND I HAVE LED THE DATA PRIVACY AND DATA WORKING GROUP. THIS HAS BEEN A TWO YEAR PROJECT, YOU CAN GO TO THE ENERGY AND COULD MESS COMMITTEE WEBSITE OR TO CONGRESSMAN WELCH'S WEBSITE OR MINE AND GET A LITTLE BIT OF BACKGROUND ON WHAT WE HAVE DONE THERE. WE HAVE A DATA SECURITY BILL THAT WILL GO TO THE HOUSE FLOOR BEFORE LONG. IT IS GOING OH DEAL WITH BREACH NOTIFICATIONS, DATA CAN SECURITY STANDARD, PUT THE FTC IN CHARGE OF OVERSEEING DATA SECURI AND BREACH NOTIFICATION. IT WILL CARVE OUT HEALTH INFORMATION AND NOT EXERCISE PRE-EMPTION OVER THAT BUT LEAVE HEALTH INFORMATION WITH THE STATES FOR THE TIME BEING. EING ELSE WILL BE UNDER FEDERAL PRE-EMPTION BECAUSE WE'VE GOT DATA SECURITY LAWS, 47 DIFFERENT STATES HAVE 47 DIFFERENT BE VARIETIES F DATA SECURITY LAWS. WE ARE GOING TO COME BACK AND ADDRESS HEALTHCARE INFORMATION WHEN WE GET TO THE POINT OF OPENING UP HIPPA. SO UNTIL THAT POINT OF TIME, WE'RE GOING TO LEAVE THAT WITH THE STATES. SO THIS IS GOING TO BE SOMETHING LU SEE US TAKE UP DATA SCAWRT, PRIVACY, HEALTH COMPONENT, THEN YOU'LL SEE US MOVE INTO THE CYBEREND, WHERE WE'LL LOOK AT CONTROL SYSTEMS, THIS IS IMPORTANT TO THE ENERGY COMMUNITY AND THEN LOOK AT ENTERPRISE SYSTEMS. AND PUT SOME CYBERCOMPONENTS THAT ARE IN PLACE THERE. I KNOW THERE'S A LOT TO BE DECIDED. TRANSFER RIGHTS, THINGS OF THAT NAY TEU. SO PUTTING IN PLACE THE APPROPRIATE WORK, AS I SAID, WE WORKED ON THIS IN A BIPARTISAN WORKING GROUP FOR A TWO-YEAR PERIOD OF TIME BEFORE WE BROUGHT OUT A DISCUSSION DRAFT. BUT AT ENERGY AND COMMERCE, WE HAVE FELT LIKE THAT'S THE MOST EFFECTIVE WAY TO GET THE JOB DONE. AND MAKE CERTAIN THAT WE HAVE SOMETHING THAT IS GOING TO GET SIGNED INTO LAW AND THEN IF NECESSARY, WOULD STAND COURT CHALLENGES. SO DO STAY IN TOUCH WITH US ON THAT. 21ST CENTURY CURES. THERE ARE PROPOSALS INSIDE THIS BILL AND IT REALLY IS QUITE COMPREHENSIVE THAT ARE GOING TO HELP CMS, NIH, FDA, AND CDC. WE KNOW THAT IT WILL ENABLE THEM TO UTILIZE NEW TECHNOLOGIES AND WE ARE EXCITED ABOUT THAT. WE WANT TO ENCOURAGE NEW IDEAS, AND WE THINK IT'S IMPORTANT TO ALLOW INCORPORATION OF NEW DELIVERY SYSTEMS AS WE LOOK AT RESEARCH AND INNOVATION. SO THIS IS GOING TO INCENTIVIZE YOUNG INVESTIGATORS, SO THAT THEY'RE GOING TO GET OUT THERE AND HELP SOLVE SOME OF THESE PROBLEMS. I WILL SAY WE HAVE WORKED DILIGENTLY AND AGAIN WE APPRECIATE THE TIME THAT DR. COLLINS' TEAM HAS SPENT WITH US. WE'VE BEEN ABLE TO OFFSET THE COST ON THIS. AND OU ARE CONTINUING TO WORK WITH THE BUDGET COMMITTEE, I REPRESENT ENERGY AND COMMERCE AT THE BUDGET COMMITTEE TO OFFSET THE COST ON THIS SO THAT WE'RE GOING TO HAVE MAYBE $10 BILLION THAT ARE NEW DOLLARS THAT ARE GOING TO BE AVAILABLE TO HELP INCENTIVIZE THIS PROCESS, BUT WE'RE DOING THIS IN A REVENUE-NEUTRAL MANNER. WE THINK THAT'S IMPORTANT TO DO. AND IT MEANS SHIFTING OUR PRIORITIES BUT I THINK EVERY ONE OF YOU WOULD SAY IT'S TIME FOR THOSE PRIORITIES TO SHIFT. SO WE ARE DOING THAT WITHIN THIS LEGISLATION, LET ME TOUCH ON THREE PIECES THAT MY TEAM AND I HAVE REALLY TAKEN THE LEAD ON AND HAVE CRAFTED. FIRST OF ALL, THE SOFTWARE ACT IS EMBODIED IN HERE. CONGRESSMAN JANE GREEN HAS BEEN MY PARTNER IN THIS LEDGE SLAIG, AND BELIEVE IT OR NOT, WE'RE ON THE 18TH DRAFT BEFORE WE BROUGHT OUT THE BILL. BUT WHAT THIS WILL DO IS WORK WITH THE FDA AND INSTRUCT THEM ON HOW HEALTH I.T. SHOULD BE ADDRESSED BY THE FDA. AND THEIR REGULATORY FRAMEWORK THAT EXIST AT THE PDA RIGHT NOW WOULD APPROACH THIS AS A MEDICAL DEVICE. AND AS YOU ALL KNOW, IN THE 30s, WE DEFINED WHAT A DRUG IS. IN THE 70s, WE DEFINED A MEDICAL DEVICE. AND WE THINK THAT NOW IT IS APPROPRIATE THAT WE DEFINE WHAT IS A HEALTH TECHNOLOGY, A MEDICAL TECHNOLOGY, AND THAT A PROPER FRAMEWORK BE PUT IN PLACE. SO CONGRESSMAN GREEN AND I HAVE SPENT ABOUT THREE YEARS AS WE HAVE WORKED ON THESE PROVISIONS, AND WE KNOW THAT WE FORGOT TO HAVE SOME THINGS THAT ARE FLEXIBLE THAT ARE GOING TO BE WORKABLE AND USABLE, THINGS THAT ARE GOING TO HAVE A LIFE OR DEATH CONSEQUENCE, ABSOLUTELY. IMPLANTS, THINGS OF THAT NATURE, ALL OF THAT GOING TO NEED TO GO TO THE FDA. BUT MANY OF THE MHEALTH APPS THAT ARE FOR INFORMATION COLLECTING THAT ARE EMRs, THAT ARE INSTRUCTED AND THAT REQUIRED A LEARNED INTERMEDIARY, THOSE DO NOT NEED TO BE GOING TO THE FDA, THEY NEED TO GO TO THE MARKETPLACE. SO YOU WILL SEE THIS TIERED STRUCTURE AND THIS SEMI BODIE IS EMBODIED IN THE 21ST CENTURY CURES BILL. SO IN ORDER TO HELP YOU WITH RESEARCH AND WITH CLINICAL TRIALS, YOU'RE GOING TO BE ABLE TO UTILIZE THESE APPS. RECRUIT PEOPLE, FOLLOW RESEARCH PARTICIPANTS, AND THEN WE WILL ADDRESS THE OVERSIGHT OF IT ON A RISK-BASED STRATEGY. WE ALSO INCLUDED -- I HAD REWRITTEN THE AUTHORIZATION FOR THE REAGAN UDALL FOUNDATION, AND WE'VE PUT THAT INTO THIS BILL AND AS YOU ALL KNOW, THE FOUNDATION WORKS WITH THE FDA BY LOOKING AT NEW STUDY DESIGNS, NEW STATISTICAL METHODS AND OTHER METHODS TO REALLY EP THE FDA AND ENCOURAGE THEM TO KEEP CURRENT. WITH THE UTILIZATION. DR. COLLINS, IT'S SOMETHING THAT REPRESENTATIVE LOIS KEPPS WHO IS OUT OF CALIFORNIA WORKED CLOSELY WITH NIH, AND WHAT WE WANT TO DO IS TO QUANTIFY WOMEN OF CHILDREN WHO ARE PARTICIPATING IN NIH FUNDED STUDIES -- AND WE SHOULD KNOW HOW MANY INFANTS ARE IN STUDIES AS WELL AS HOW MANY SENIORS ARE IN STUDIES. SO YOU WILL SEE THE CHILDREN'S COUNTERACT INCLUDED IN THAT. WE ARE SO ENCOURAGED BY WHAT WE ARE HEARING FROM RESEARCHERS ON THIS LEGISLATION, WE THINK THIS KIND OF THE MOON SHOT, IF YOU WILL, FOR TODAY. THE 21ST CENTUR, THIS IS A WAY THAT WE CERTAINLY CAN GET AROUND AND ACHIEVE THE GOAL OF BETTER OUTCOME, BETTER QUALITY OF LIFE, SHORTER RECOVERY PERIODS, MORE INTENSE AND FOCUSED DISEASE MANAGEMENT WHICH WILL HELP US IN THIS ENTIRE PROCESS. SO THANK YOU ALL SO MUCH. I APPRECIATE BEING WITH YOU AND DR. COLLINS, I'M BACK TO YOU. >> THE 10 BILL YN DOLLARS, WHICH IS PART OF THE 21ST CENTURY -- WHICH IS A GREAT SOURCE OF ENCOURAGEMENT TO THE MEDICAL COMMUNITY, ESPECIALLY THE SORT OF 12 YEAR -- 2003 OF LOSING GROUND IN TERMS OF RESOURCES THAT WE'RE DOWN NOW ABOUT 23% BELOW WHERE WE WERE 2003, AND THIS $10 BILLION STRETCHED OUT OVER FIVE YEARS WOULD BE AN ENORMOUS BOONE TO GETTING US BACK TO A STABLE PATHWAY. I KNOW THAT HAS BEEN CHALLENGING TO COME UP WITH A WAY TO DO THAT WITHOUT ADDING TO THE DEFICIT, SO CAN YOU JUST GIVE US THE SENSE OF YOUR LEVEL OF OPTIMISM THAT THAT'S ACTUALLY GOING TO SURVIVE A LOT OF MORE STEPS IN THE PROCESS -- >> I THINK IT WILL SURVIVE. >> OH, GOOD. [LAUGHTER] I REALLY DO THINK IT WILL SURVIVE. WE HAVE WORKED -- AND CHAIRMAN UPTON AND REPRESENTATIVE PALLONE DESERVE A TREMENDOUS AMOUNT OF CREDIT ON WORKING THIS THROUGH. DIANA AND I BOTH DESERVE CREDIT -- WE DESERVE CREDIT TO. WHAT WE CAN DO IS TO FUND PLACES WHERE WE COULD REPOSITION MONEY. AND THEN REFOCUS MONEY, AND WOAR GOING TO CONTINUE TO WORK ON THIS. CHAIRMAN PRICE AT THE BUDGET COMMITTEE IS A FRESHMAN, SO WE'VE WORKED WITH HIM, HE UNDERSTANDS THE NEED OF RESEARCH, OF INNOVATION, AND SO FIGURING OUT HOW TO DO THIS SO THOUGH YOU'RE GOING TO COME OUT WITH A REVENUE-NEUTRAL POSITION WAS IMPORTANT TO DO. BUT I THINK IF I WENT AROUND THIS ROOM AND I SAID HOW MANY OF YOU THINK THE PROCESSES AND THE POLICIES, SOME OF THE RULES AT CMS ARE OUTDATED, EVERY HAND IN THIS ROOM WOULD PROBABLY GO UP. AS YOU REQUIRED THE USAGE AND THE INTEGRATION OF NEW TECHNOLOGIES, THERE ARE SAVINGS THAT CAN BE QUANTIFIED AND MONEY THAT CAN BE REPOSITIONED DURING HAD IT BUDGET WINDOW. WE'RE NOT THROUGH YET. WE THINK THAT THERE ARE SOME OTHER THINGS THAT WE'RE GOING TO PUT ON THE TABLE AND BE ABLE TO UTILIZE, I WAS MENTIONING TO DR. COLS THAT WE'RE GOING TO COME BACK, REVISIT, TAKE ANOTHER LOOK THE AT BECAUSE IT'S TIME TO DO THAT. WE CANNOT CONTINUE TO ACT LIKE IT'S 1965. SO IT'S TIME TO UPDATE THIS AND THE RESEARCH WORK MANY OF YOU WILL DO WILL BRING ABOUT BETTER OUTCOMES AND EFFICIENCIES AND THEREFORE SAVE SOME DOLLARS AND WE THINK THAT'S THE RIGHT TRACK. >> I'M INTRIGUED BY YOUR PLANS FOR LOOKING AT THE PRIVACY ISSUES. WE UNDERSTAND THAT YOU SAID FOR THE FIRST GO, THE STATES WILL STILL HANDLE HEALTH INFORMATION AS WE'RE TALKING ABOUT THE PRECISION MEDICINE INITIATIVE, THE DEFINITION OF HEALTH INFORMATION EXPANDS. SO I'M INTRIGUED AS TO HOW YOU FIND HEALTH INFORMATION AND ENSURES DATA BOTH AT FEDERAL LEVEL AS WELL AS PRIVATE INSURERS, I MEAN, IT'S NO LONGER JUST YOUR MEDICAL RECORD. >> EXACTLY. YOU KNOW, AND I WILL -- I CAN'T SAY THIS IS THE ONE, TWO, THREE, OF WHAT WE'RE GOING TO DO. WE'RE NOT THERE YET. WE'VE BEEN DIGGING INTO THIS FOR WOULD YEARS, AND IT'S LIKE IT GETS BIG E THE ISSUE GETS BIGGER BIGGER. HEALTHCARE.GOV OPEN THE UP ALL OF THAT. SOME OF THE QUESTIONS THAT WERE BEING ASKED YES, THAT DOES RELATE TO HEALTHCARE. NOW THE OTHER QUESTION THAT IS COMING INTO PLAY IN THIS ENTIRE DISCUSSION, I DON'T HAVE THE ANSWER FOR IT BUT IT'S AN ISSUE WE'RE GOING TO PUT ON THE TABLE. WHO OWNS YOUR HEALTH RECORDS? WHO OWNS THAT? THE DOCTOR, THE INSURANCE COMPANIES, YOUR EMPLOYERS, AND IS IS IT YOU. THAT'S EXACTLY RIGHT. AS WE HAVE HELD OUR HEARINGS AND WORKED THROUGH THE PRIVACY ISSUES, WHICH ARE ONE BUCKET, THE DATA SECURITY ISSUES, WHICH ARE ANOTHER BUCKET, I COINED A TERM FOR LACK OF A BETTER ONE, WHICH IS THE VIRTUAL YOU. AND WHO OPENS YOU IN YOUR PRESENCE ONLINE. THEN YOU GET INTO HOW THESE HEALTH RECORDS ARE HELD AND HOW THE INDIVIDUAL WANTS TO UTILIZE THAT, HOLD IT, SECURE IT, AND THEN HAVE A TOOLBOX OF OPTIONS WHERE THEY CAN ALLOW ACCESS TO THAT. THEN FOR RESEARCH PURPOSES, WE WERE DISCUSSING YESTERDAY AT TENNESSEE VALLEY CORRIDOR AND THE DAY BEFORE IT ORNL, THEN HOW DO YOU HAVE THE RIGHT ASSURANCES AND THE WRAPPER AROUND HAD INFORMATION SO THAT PEOPLE KNOW, YES, THIS IS ANONYMIZED, THEN HOW DO YOU ALLOW INDIVIDUALS THAT WANT TO CHOOSE TO OPT IN TO TRY THE RIGHT TRY LEGISLATION THAT HAS BEEN POPULAR HERE IN TENNESSEE AND I THINK QUITE FRANKLY WE WILL SEE THAT AT THE FEDERAL LEVEL. YOU KNOW, I WOULD ENCOURAGE YOU TO STAY IN TOUCH WITH US ON THIS, AND AS YOU WILL HEAR FROM KATHY AND DR. COLLINS, OUR TEAM NEEDS THIS KIND OF INPUT. AND WE WELCOME IT AND WE ACTUALLY -- AND I THINK THIS IS ONE OF THE REASONS 21ST CENTURY CURES IS SO WELL SEEDED AS IT LEAVES THE HOUSE AND MOVES TO SENATOR ALEXANDER IN THE SENATE. WE DON'T KNOW THE ANSWERS BUT WE'VE TALKED THIS ALL THROUGH TO TALK THIS THROUGH ON A CERTAIN BUCKET OF ISSUE, WE'LL COME BACK AND USE THE SAME PROCESS FOR THE NEXT BUCKET OF ISSUES. >> SINCERELY APPRECIATE YOU COMING OUT THIS MORNING. ONE QUESTION THAT I'M WONDERING ABOUT IS THE EXTENT TO WHICH THE FEDERAL TRADE CAN COMMISSION SHOULD BE IN CONTROL OF THE ENTIRE PROCESS VERSUS HHS. AND RIGHT NOW WE HAVE A SITUATION THAT IF YOU LEAVE THE CONTROL OF THE HEALTH INFORMATION AT THE STATE LEVEL, NOT ONLY DO WE HAVE FTC CONTROL OF MOST COMMERCE, HHS IN CONTROL OF HEALTH AND NOW YOU HAVE THE STATES ALL CONTROL -- >> RIGHT. >> AT THE LOCAL LEVEL. >> THE DATA SECURITY AND BREACH NOTIFICATION, ALL OF THAT HAS HISTORICALLY BEEN WITH THE FTC IN THE PHYSICAL WORLD, AND THEN HIPPA IS WHERE HEALTH INFORMATION S BASICALLY WHAT WE'RE SAYING IS, WE'RE GOING TO HANDLE THIS WITH FINANCIAL INFORMATION, THE FTC LEAVE THINGS AS THEY HAVE BEEN IN THE PHYSICAL WORLD TRANSFER THAT TO THE VIRTUAL SPACE. THAT BUCKET STAYS OVER THERE. THEN HPPA STAY WITH HEALTHCARE, IT STAYS AS IT IS. >> RIGHT. MY QUESTION IS WHY DO WE KEEP ALLOWING -- >> WE THINK THAT'S A BIGGER BUCKET. WE NEED TO COME BACK AND GIVE GREATER ATTENTION TO THAT SO THAT WE GET IT RIGHT. >> OKAY. >> THANKS VERY MUCH. VERY EXCITING ABOUT THE 21ST CENTURY CURES. I THINK THIS WORK IS ENTIRELY BRED KATEED UPON THE UNDERSTANDING THAT THERE'S THIS GREAT CONTINUUM IN HAD IT COUNTRY THAT GOES FROM INCREDIBLE PAC BASIC SCIENCE TO UNDERSTANDING THE FUNDAMENTAL CAUSES OF DISEASE AND THAT'S DEFINDS THE TEUPTS FOR CURES WE'RE TALKING ABOUT TODAY. IN THE PARTICULAR CASE OF ALZHEIMER'S DISEASE, MAJOR UNDERSTANDING THAT BETA AMYLOID AND THAT PATHWAY IS INTRINSICALLY ENVOFLED IN THE CAUSATION OF DISEASE RELIES ON THE PREVIOUS 50 YEARS OF BASIC SCIENCE THAT ENABLED THE DISCOVERY THAT PATIENTS WITH EARLY ONSET FORMS OF THIS DISEASE HAVE MUTATIONS THAT ARE CAUSING THE DISEASE IN THAT PATHWAY. THAT'S SETTING UP THE OPPORTUNITY FOR THIS BEST SHOT ON GOAL IF YOU WILL FOR THE FUTURE. WHICH GETS ME AROUND TO THE POINT WHEREAS WE THINK ABOUT CURE, WE'RE TOTALLY DEPENDENT ON UNDERSTANDING THE BASIC SCIENCE THAT IS UNDERLYING THE CAUSE OF DISEASE AND IT'S IMPORTANT THINKING ABOUT THE FUTURE OF NIH THAT WE NOT LEAVE THE FUNDAMENTAL BASIC SCIENCE BEHIND, THAT THE INVESTMENTS THAT WE'VE MADE OVER THE LAST TWO GENERATIONS IN BASIC SCIENCE HAVE LED US TO WHERE WE ARE TODAY AND YO WHAT WE'RE GOING TO LEAVE FOR THE SUBSEQUENT GENERATION. >> I AGREE WITH YOU, WHAND IS SO INTERESTING, I WAS AT EASTMAN YESTERDAY MORNING IN KINGSPORT, AND MET WITH THEIR LEADERSHIP TEAM, AND THEY HAD SOMETHING THERE IN JUST BASIC SCIENCE RESEARCH, CHEMICAL RESEARCH THAT THEY HAD DONE THAT THEY FELT LIKE MAY HAVE AN APPLICATION IN THE FIELD OF HEALTHCARE. AND WE'RE GOING TO REACH OUT AS TO HOW EXCITING FOR US HERE IN TENNESSEE, THE WORK YOU ALL ARE DOING HERE, WHEN I WAS IN THE STATE SENATE, I PUT FORWARD LEGISLATION AND WE ESTABLISHED THE BIOTECH COUNCIL HERE IN THE STATE. THAT WAS WHAT 15 YEARS AGO NOW? YOU LOOK AT THE RESEARCH AT ORNL, THE RESEARCH WORK THAT IS BEING DONE UP AT EAST TENNESSEE, WITH EASTMAN, YOU LOOK AT WHAT IS HAPPENING WITH MEMPHIS BIOS, THE LIFE SCIENCES CENTER WHERE VANDERBILT PARTICIPATES, SOMETHING I DID WHEN I WAS IN THE STATE SENATE AGAIN THERE IN COLD SPRINGS, AND WE HAVE A VERY NICE CLUSTER WORKING WITH HUDSON ALPHA DOWN IN HUNTSVILLE. YOU KNOW, WE JUST HAVE A VERY NICE CLUSTER HERE, A VERY DEDICATED FOCUS, SMART PEOPLE WHO ARE VERY COMMITTED TO SOLVING THESE PROBLEMS, AND I TELL PEOPLE ALL THE TIME, I SAID LOOK, WE'RE NOT GOING TO SOLVE THESE QUESTIONS, FIND THE ANSWERS TO THE QUESTIONS AND SOLVE THE PROBLEMS HERE IN D.C. IT IS GOING TO HAPPEN IN PLACES LIKE NASHVILLE, TENNESSEE WHERE WE'RE GOING TO SEE THAT WORK TAKE PLACE. >> SO JUST IN THAT CONTEXT, THAT ONE OF THE REASONS WE'RE HERE TODAY IS THINKING ABOUT THE FUTURE AND THE PROJECT THAT WE'RE IN THE PROCESS OF DISCUSSING AND LAYING OUT IS THINKING NOT JUST ABOUT CURES BUT ABOUT IDENTIFYING FACTORS THAT WOULD PREDICT FUTURE DISEASE AND ALLOW US IN THE FUTURE TO ACTUALLY PREVENT DES FROM DEVELOPING IN THE FIRST PLACE, WHICH OBVIOUSLY WOULD HAVE PROFOUND IMPLICATIONS FOR THE COST AND IMPACT ON HEALTH. >> WE AGREE. THAT'S WHY AS I SAID, I HAVE THE STRATEGY ALL DEVELOPED. CONGRESSMAN BARTON, CONGRESSMAN BITS, CONGRESSMAN BURGESS WHO'S ALSO A PHYSICIAN, EVERYBODY HAS BEEN SO ENGAGED ON THIS. IT REALLY HAS BEEN A COLLABORATIVE EFFORT FROM BOTH SIDES OF THE AISLE TO PRODUCE A PRODUCT THAT SAYS LET'S DEAL WITH THE BIG QUESTIONS. >> I'M PAUL FROM OPTUM LAPSE, A SEER YL ENTREPRENEUR INVOLVED IN DEVELOPING MEDICAL SOFTWARE FOR THE LAST TWO DECADES. I WAS VERY INTERESTED IN YOUR COMMENTS ABOUT THE FDA, SPECIFICALLY THERE IS GREAT VALUE IN CREATING STRUCTURE AROUND WHAT IS REGULATED AND WHAT ISN'T REGULATED, I APPLAUD YOU FOR THAT. ON THE OTHER HAND, THE MEDICAL SOFTWARE INDUSTRY AND INNOVATION AROUND TECHNOLOGY THAT ISN'T DEVICES, HAS A VERY DIFFERNT PACE IN FUNDING AND STYLE, THE FDA'S APPROACH OF USER FEES AN FLOW REGULATION COULD BE EXTREMELY STIFLING FOR THE INDUSTRY, SO WHAT GUARDRAILS AND OTHER THINGS ARE YOU PUTTING INTO THE BILL SO -- >> THAT'S EXACTLY WHY THIS CAME TO BE. WE'LL POINT ALL THE FIPGERS AT HM. >> MY SOFTWARE -- >> THIS IS EXACTLY WHAT LED US TO DO THIS. TALKING TO ENTREPRENEURS AND I OWE VAI TORES WHO WERE SAYING, HEY, I'M CONFUSED ABOUT THIS. THREATION THIS THING OVER HERE AT THE FCC AND IT'S CALLED NET NEUTRALITY AND PARAGRAPH 84 SAYS IF I'M GOING TO INNOVATE SOMETHING THAT'S GOT TO BE ATTACHED TO THE WEB, I NEED TO GO FILE WITH THEM AND THEN I'M HEARING FROM THE FDA THAT THEY'RE GOING TO LOOK AT TECHNOLOGY ON A CASE-BY-CASE BASIS, ARE YOU KIDDING ME? CASE BY CASE? >> AFTERWARDS. >> RIGHT. THAT IS RIGHT. AND THERE ARE NOW 97,000 MHEALTH APPS IN THE MARKETPLACE. 97,000. HE'S A WALKING APP RIGHT THERE. AND YOU WOULD AGREE WITH THAT, WOULDN'T YOU, KATHY? THE DR. COLLINS APP, WE CAN DO THAT. 97,000, 15% OF THOSE ARE USED BY HEALTHCARE PROFESSIONALS. WHAT WE ARE DOING IS SAYING, LOOK, IF IT HAS A LIFE OR DEATH CONSEQUENCE, A HIGH RISK, FDA, THAT SHOULD BE SOMETHING THAT GOES TO YOU. OTHER THINGS SEND IT STRAIGHT TO THE MARKETPLACE. IF IT'S SOMETHING THAT ENDS UP IN A GRAY AREA -- BUT YOU DON'T WANT TO HAVE THIS PROCESS WHERE INNOVATORS CANNOT HAVE THE CERTAINTY TO GET THE VC AND THE BACKING, ET CETERA, THAT IS NEEDED TO MOVE SOMETHING TO THE MARKETPLACE. SO WHAT WE'RE TRYING TO DO IS CLEAR THAT UP AND SAY FDA, THIS IS YOUR POT, EVERYBODY ELSE, YOU GO STRAIGHT TO THE MARKETPLACE, HAVE AT IT, INNOVATE, BRING THINGS FORWARD. >> THANK YOU, THAT WAS A GREAT ANSWER. YOU HAVE MY VOTE. [LAUGHTER] >> WE MET EARLIER, MY NAME IS GEORGE HILL, YOU'RE MY REPRESENTATIVE, I LIVE IN HOR SHOE BAY IN BELLEVUE, I REALLY THANK YOU FOR COMING AND INTERACTING WITH US AND THE SUPPORT YOU'RE PROVIDING TO NIH. YOU HAD AN OPPORTUNITY TO ASK -- TO CHALLENGE US, IN OTHER WORDS, YOU WALK THE HALLS OF CONGRESS AND THIS IS A BUDGET NEUTRAL TIME. SO FOR THOSE WHO ARE INTERESTED IN SEEING OUR RESEARCH TO BE FUNDED OR OTHER INITIATIVES CONTINUE TO BE FUNDED, BUT STICKING WITH RESEARCH AND SCIENCE, WHAT WOULD YOU SAY TO US SO THAT THERE WOULD BE AN EASIER PATHWAY TO HAVING SOME OF THOSE SUCCESSES OCCUR? YOU HEAR A LOT,, WHAT ARE WE NOT DOING? >> I APPRECIATE THAT. >> AS YOU SUMMARIZE WHAT YOU HVE FORWARD, TALK ABOUT IT -- BETWEEN POLICY AND INNOVATION, BECAUSE THEY MOVE IT DIFFERENT PLACES, AND SEE WHAT WE'RE TRYING TO DO WITH 21ST CENTURY CURES IS JUST CREATE THE ENVIRONMENT IN WHICH INNOVATION CAN TAKE PLACE. BUT NOT BE RESTRICTIVE IN SAYING IT'S GOT TO BE HERE AND IT'S GOT TO BE DONE THIS WAY. WHAT WE NEED TO HEAR FROM YOU IS THIS, WE'VE GOT AN IDEA LIKE DR. LIFTON WAS SAYING YOU'RE LOOKING AT A BODY OF RESEARCH OVER DECADES. AND IT LEADS YOU TO SAY, YOU KNOW, THERE MIGHT BE SOMETHING MORE HERE THAT IF WE DO A LITTLE BIT MORE RESEARCH AND DI DIG A LITTLE DEEPER, WE CAN FIND AN ANSWER FOR THIS. AND THAT IS WHERE NIH AND SOME OF THESE GRANT MONEYS CAN COME INTO PLAY AND ONE OF THINGS WE IN CONGRESS WANT TO SEE IS HOW THIS RESEARCH HAS FOLLOW-ON. WHEN WE DO OVERSIGHT HEARINGS, WE WANT TO THAT THERE IS AN ABILITY TO FOLLOW -- IT'S DIFFICULT FOR US IF WE THINK THERE'S GOING TO BE A GRANT MADE FOR RESEARCH AND IT GETS PART OF THE WAY BUT NOT ALL THE WAY THERE AND THEN IT STOPS, BECAUSE THEN YOU SAY WHAT DID THAT YIELD YIELD? NOW WE ALSO NEED TO HEAR FROM YOU AND THIS IS SOMETHING NIH HAS BEEN GREAT TALKING WITH OUR TEAM ABOUT AND RESEARCHERS WHO LIVE AROUND US HAVE TALKED TO ME ABOUT THE ABILITY TO SHARE DATA. AND WHAT IS TAKING PLACE IN DIFFERENT PLACES. WELL, TRANSFER RIGHTS OF COURSE, WE'RE GOING TO HAVE TO DEAL WITH THAT, THE PRIVACY CONCER THAT IS SHARED, ALL OF THAT ARE QUESTIONS WE'RE GOING TO HAVE TO ANSWER, AND WE KNOW THERE'S A PLACE FOR US IN DOING THAT AND WE SHOULD, AS DR. O'ROURKE SAID WITH HER QUESTION. AND MY ANSWER BACK, WE'RE GOING TO PUT THOSE ON THE TABLE AND ADDRESS THEM BECAUSE THEY'RE ENABLERS TO YOU TO DO YOUR JOB. SO WHAT WE NEED TO KNOW IS WHERE THESE ROAD BLOCKS ARE, WHAT'S AN IMPEDIMENT, WHAT IS A BARRIER TO ENTRY AND THEN HOW DO WE HELP YOU CONTINUE WITH THAT AND BE A WISE STEWARD OF THE DOLLARS THAT ARE THERE FOR RESEARCH WORK TO GET TO THESE GOALS OF ELIMINATING DISEASE, ADDRESSING IT, FINDING A CURE, AND A BETTER QUALITY OF LIFE. I CAN'T STAND HERE AND SAY WE'VE GOT ALL THE ANSWERS, WE DO NOT. WE ARE LOOKING FOR YOU AS WE'VE CREATED WHAT WE THINK IS GOING TO BE A VERY FLEXIBLE MODEL FOR RESEARCH AND INNOVATION. WE'RE LOOKING TO HEAR FROM YOU AS TO HOW WE TWEAK THAT AS WE GO FORWARD. WE CONTINUE WORK THAT WE KIND OF KEEP IT BETWEEN THE RACK SO THAT INNOVATORS AND ENTREPRENEURS AREN'T COMING BACK US TO AND SAYING WAIT A MINUTE, IF THEY'RE OVER REACHING SOMEWHERE, WE NEED OH KNOW. WE DID THAT IN OVERSEA. THANK YOU, SIR. >> CONGRESSMAN MARSHA BLACKBURN, YOU'VE BEEN WONDERFUL TO COME AND SPEND TIME FOR US AND INSPIRED US IN THE WAY YOU'RE LEADING THIS EFFORT ALONG WITH YOUR COLLEAGUES IN 21ST CENTURY CURES. I THINK YOU'VE ALL HEARD THE DOOR CONTINUES OH BE OPEN FOR CONTINUED INPUT INTO THIS PROCESS. LET'S HOPE FOR ANOTHER FEW MONTHS, WE'LL GET HAD ACTIVATED ON THE OTHER HOUSE OF CONGRESS, WHICH WE HEARD ABOUT FROM SENATOR ALEXANDER YESTERDAY, AND WE MIGHT ACTUALLY BY TEND OF THIS YEAR, EARLY NEXT YEAR, AND THAT WOULD BE AN ENORMOUS ACHIEVEMENT. A SIGNAL MOMENT. A REALLY RY REMARKABLE BIPARTISAN EFFORT TO TRY TO DO SOMETHING TO CAUSE THE -- SO THANK YOU SO MUCH FOR BEING HERE. [APPLAUSE] LOOKING AT THIS WHOLE PROJECT, IT'S QUITE REMARKABL IT'S BREAKING GROUND IN A LOT OF AREA, NOT THAT THEY HAVEN'T BEEN THOUGHT OF BEFORE BUT REALLY WILL BE THE EMBODIMENT OF SEVERAL REVOLUTIONS HAPPENING SIMULTANEOUSLY, PARTICIPANT LED RESEARCH WHICH IS A REMARKABLE CHANGE IN THE WAY RESEARCH IS DONE WITH THE PARTICIPANT NOT JUST TO SAY RECIPIENT OF OUR BRILLIANT -- ACADEMICS OR GOVERNMENT PEOPLE. THIS BIG DATA EMR REVOLUTION THAT'S OCCURRING THAT WE'RE GOING TO TAKE ADVANTAGE AND THE MOLECULAR REVOLUTION THAT RICK JUST REFERRED TO BUT AT THE END OF THE DAY, SOMETHING THAT'S CALLED PREET SITION MEDICINE NICHE TIRVETION YOU HAVE TO HAVE DATA THAT IS REPRODUCIBLE WHEN ANALYZED BY MORE THAN ONE PERSON COUGHS UP SOMETHING SIMILAR TO THE SAME RESULT AND I THINK -- YOU TAKE ALL THIS DISPARATE STUFF AND YOU END UP WITH SOMETHING THAT YIELDS A MEANINGFUL RESULT. FOR ME IN THE LAST FIVE YEARS AS I DEALT WITH THE INTERFACE OF A LOT OF OF BIG DATA AND RESEARCH, I'VE SEEN A LOT OF MISFIRES WHERE THE AMOUNT OF DATA FAR EXCEEDS THE AMOUNT OF KNOWLEDGE THAT'S BEING DERIVED FROM, IT'S -- THIS PANEL TO COME UP WITH THE INSIGHT. WHAT WE'D LIKE TO DO IN THE HOUR THAT WE HAVE, I WANT TO GIVE EVERYBODY A CHANCE TO IT MAKE A COUPLE OF COMMENTS FIRST, THEN WE'RE GOING TO GO DOWN THE LIST OF QUESTIONS THAT WE HAD, THEN WE'LL LEAVE AMPLE TIME FOR DISCUSSION. IT'S NOT A CHANCE TO SHARE HOW SMART WE ARE, WE'RE ALL SMART, IT'S WHAT KIND OF THINGS -- INSIGHTS -- WOULD BE IMPORTANT. >> THOSE ARE PRETTY GENERAL QUESTIONS FOR ME TO RESPOND TO. THERE ARE A LOT OF SMART PEOPLE HERE THAT KNEW A LOT ABOUT MOLECULAR AND CELLULAR LEVEL RISK, AND WHEN YOU TALK ABOUT PRECISION MEDICINE, THINK PEOPLE AUTOMATICALLY JUMP TO GENOMIC LEVEL ISSUE, BUT I WANT TO BE SURE THAT AS WE TALK ABOUT THESE THINGS, TO REMEMBER WE HAVE TO CONTEXTIZE A LOT, WE HAVE TO KNOW A LOT MORE BEYOND THE QUOTE BIOLOGY OF THE PHENOTYPES THAT WE EXAMINE AND ARE CONCERNED ABOUT, SO I THINK IT'S IMPORTANT FOR US TO LOOK AT -- WE LEARN FROM THE -- SOME OF THE EXISTING COHORT STUDIES, THOSE THINGS THAT HELP US PUT BIOLOGY IN PERSPECTIVE, HELP US UNDERSTAND A LITTLE BIT ABOUT HOW THE PHENOTI PIB MANIFESTATIONS THAT ACTUALLY OCCUR AND VERY INFLUENCE BY THINGS IN THE SOCIAL PSYCHOLOGICAL REALM IF YOU WILL. IT'S IMPORTANT FOR US TO CONTEXTUALIZE THINGS LIKE FAMILY ENVIRONMENT, NEIGHBORHOOD ENVIRONMENT, CAN YOU DRAW FROM THE MEDICAL RECORD, THERE'S A RICHNESS, A NUANCE THERE THAT WITH WE DO OURSELVES A DISSERVICE IF WE DEPRIORITIZE OR MINIMIZE ITS IMPORTANCE. I ALSO THINK THAT IF YOU STICK, FOR INSTANCE, TO WHAT'S IN THE MEDICAL RECORD, WE WILL MISS IMPORTANT OPPORTUNITIES NOT ONLY TO SEE ADDITIONAL RISK BEYOND WHAT GETS TRADITIONALLY CARRIED THROUGH IN THAT DOCUMENTATION BUT ALSO THOSE THINGS THAT MAY BE -- THAT ACTUALLY SUPPORT RESILIENCE IN THE FACE OF RISK. THERE'S IN THE DISPARITIES LITERATURE, THERE'S OFTEN ONE GROUP VERSUS ANOTHER GROUP AND WE FORGET ABOUT THE IN GROUP HETEROGENEITY, AND A LOT OF THAT HETEROGENEITY MAY BE DETERMINED BY SOME OF THE THINGS THAT CAME OUT, ARE NOT TRADITIONALLY CAPTURED BY THE MEDICAL RECORD. >> SPECIFIC QUESTIONS? >> GENERAL COMMENT. SO THOSE HA DON'T KNOW, I'M BRAD MALIN, PROFESSOR OF -- COMPUTER SCIENCE AT VANDERBILT UNIVERSITY. I THINK THERE ARE SEVERAL THINGS THAT NEED TO BE TAKEN INTO ACCOUNT BY THE COMMIT THE EE AS WE'RE MOVING FORWARD. FIRST OFF I WANT TO MAKE SURE THAT WHAT THE AREA IS THAT WE'RE LOOKING AT, IF IT'S PRECISION MEDICINE OR IS IT PRECISION HEALTH? IF IT'S PRECISION MEDICINE, THE DISCUSSIONS WE'VE BEEN HEARING SO FAR ARE AROUND HOW YOU RE-USE ELECTRONIC MEDICAL RECORDS AND THE FOCUS ON MEDICAL RECORDS, DOMAIN, MAKE A LOT OF SENSE. IF IT'S GOING TO BE ABOUT HEALTH, THEN THERE'S GOING TO BE MANY OTHER FIRE HOSES TO DRINK FROM AND WE NEED TO IT BE AWARE OF THE FACT THAT THAT INFORMATION IS UNCURATED, IT IS NOT KNOWN TO THE EXTENT TO WHICH IT IS VIABLE FOR RESEARCH PURPOSES AND STARTING TO INQUIRE A LOT OF INVESTIGATION FROM INDIVIDUALS WHO ARE THE NOT NECESSARILY INDIVIDUALS THAT YOU WOULD HAVE AT THE TABLE WHEN DOING MEDICAL RESEARCH. THERE'S A LOT OF DATA SCIENTISTS OUT THERE WHO ARE JUST DOING THINGS THAT YOU'RE PROBABLY UNAWARE OF AND IT COULD HAVE A LOT OF USE IN YOUR ENVIRONMENT BUT IT MAY NOT. THE SECOND THING I WANT TO BE CLEAR ABOUT IS THAT WE ALSO HAVE TO FIGURE OUT THE LEVELS AT WHICH WE MAKE THIS INFORMATION AVAILABLE TO PEOPLE AND WHO WE'RE MAKING IT AVAILABLE TO. WE ARE INCREASINGLY PICKING UP MORE INFORMATION AND CREATING MORE ZONES WITH RESPECT TO WHERE THAT INFORMATION IS GOING TO BE USED. WE ARE MOVING BEYOND THE CLINICIAN SCIENTIST AND AGAIN MOVING BACK TOWARDS THE DATA SCIENTIST AND TOWARDS CITIZEN SIGN IT TISES WHO REALLY BELIEVE THEY HAVE THE ABILITY TO DO INVESTIGATIONS WITH THE INFORMATION, THERE WILL BE THINGS SUCH AS PUBLIC DATASETS THAT WE'RE GOING TO NEED TO FIGURE OUT WHAT NEEDS TO BE IN THOSE DATASETS, SO WHEN WE TALK ABOUT CORE ELEMENTS, WE'LL BE TALKING ABOUT CORE ELEMENTS IN EACH OF THESE ZONES. THE FINAL THING I WANTED TO MAKE KNOWN, AND JUST AT LEAST HAVE THE COMMITTEE BE AWARE OF AS THEY MOVE FORWARD, IS THAT THERE ARE -- THAT NEEDS TO BE A DECISION UP FRONT ABOUT IF YOU GO CENTRALIZATION VERSUS FEDERATION. BECAUSE STANDARDS -- STANDARDS CAN HELP YOU KNOW IF THE DATA IS IN THE RIGHT FORM. STANDARDS DO NOT TELL YOU SEMANTICS OF THE DATA. PEOPLE USE THE SAME TERM VERY DIFFERENTLY AT DIFFERENT PLACES AND CAN YOU NOT JUST COMBINE THE DATA AND EXPECT THAT THE STATISTICAL SIGNIFICANCE IS GOING TO GO UP. IN FACT, IT MAY ACTUALLY GO IN THE WRONG DIRECTION. SO JUST BE AWARE OF THIS AS YOU START MAKING INCENTIVES FOR HOW TO START SPENDING THIS MONEY. >> YESTERDAY I ALMOST JUMPED OUT OF MY SEAT WHEN THERE WAS THESE DISCUSSIONS OF DAVE TA MOVING BACK AND FORTH GRACEFULLY BETWEEN SYSTEMS USING STANDARDS BUT IT'S LIKE YOU'RE TALKING CHINESE AND ENGLISH AND YOU DON'T KNOW WHICH IS WHICH. IT'S VERY GOOD FOR INDIVIDUAL PATIENT CARE BUT NOT NECESSARILY FOR RESEARCH AND I APPRECIATE THAT. THOMAS. >> SO HERE'S A FULL MOON REMARK INTENDED TO STIR THE POT A BIT. I'M AN EPIDEMIOLOGIST, TOM GLASS FROM JOHNS HOPKINS, AND I'VE BEEN STRUGGLING OVER THE LAST DAY OR SO WITH THE QUESTION OF WHAT KIND OF STUDY IS THIS THAT WE'RE TALKING ABOUT. AND PEOPLE KEEP USING THE WORD COHORT, BUT THEN WHEN I PRESS PEOPLE ON QUESTION -- YOU KNOW, THE STANDARD QUESTIONS I WOULD ASK ABOUT WHETHER IT'S A COHORT STUDY, THEN PEOPLE KEEP SAYING, WELL, I MEAN COHORT, AND THEY KEEP DOING THIS. [LAUGHTER] WHERE THEY SAY WHAT WE'RE DOING IS A HYBRID. TO EU USE A POTENTIALLY PROBLEMATIC METAPHOR, IF YOUR PARTNER SAYS, HONEY, DO YOU LOVE ME, AND YOUR ANSWER IS, WELL, I -- LOVE YOU, OR -- OR -- IT'S MORE LIKE A HYBRID, REALLY. [LAUGHTER] I THINK WE CAN ALL SEE THE PROBLEMS THAT ARISE. SO MY BEST UNDERSTANDING IS THAT ACTUALLY WHAT -- NOT ONLY ARE YOU NOT PLANNING A COHORT STUDY, BUT IF THE GOAL IS TO ADVANCE THE PMI INITIATIVE, THEN ACTUALLY TRYING TO DO A COHORT STUDY IS PROBABLY THE MOST INEFFICIENT AND COUNTERPRODUCTIVE THING COW POSSIBLY DO. MY FIRST SUGGESTION WOULD BE NO NOT CALL THE COHORT STUDY. WHAT DO YOU CALL IT INSTEAD? WELL, I CAME UP WITH A DATA WATERING HOLE OR A DATA COMBINITARIUM. WE NEED A NEW LABEL. THIS WILL HAVE A NUMBER OF IMPACTS AND IT'S ONE WAY TO AVOID THE PROBLEMS OF THE NATIONAL CHILDHOOD STUDY, IS OH CLEAR UP THE CONFUSION ABOUT WHETHER THIS IS A COHORT STUDY, BECAUSE TENSION AROUND THAT QUESTION WAS AT THE HEART OF SOME OF THE THINGS THAT WERE VERY DIFFICULT ABOUT THAT STUDY. IT WILL ALSO TAKE THE EMPHASIS OFF THE 1 MILLION NUMBER, BECAUSE THE SAMPLE SIZE CALCULATION PROBLEM IS AN ESSENTIAL FEATURE OF A COHORT STUDY, BUT IF WE'RE TRYING TO DO SOMETHING ELSE, THEN THE IMPORTANCE OF THAT NUMBER IS REDUCED. SO THAT WOULD BE MY FIRST COMMENT, IS THAT WE NEED TO FIND A NEW NAME FOR IT. >> RORY, YOU HAVE THE GREAT POSITION OF CLEANING UP THE GAL COMMENTS AND ANSWERING THE FIRST QUESTION, WHAT CATEGORIES OF CORE DATA IN ADDITION TO BASIC DEMOGRAPHICS SHOULD BE COLLECTED ON ALL PARTICIPANTS AND WHAT CRITERIA SHOULD BE USED TO DEFINE THE CORE DATASET. BUT YOUR GENERAL COMMENTS ARE WELCOMED FIRST, SO YOU'VE BEEN RUNNING A FAIRLY -- TYPE OF STUDY IN THE U.K. >> MY COMMENTS WERE FROM THE PERSPECTIVE OF WHAT I'VE LEARNED OVER THE LAST 10 YEARS WITH U.K. BIOBANK, WHICH I TEND TO CALL RESOURCE. THAT REALLY -- IN COMING OH THAT, IN THINKING ABOUT U.K. BAY OWE BANK, HAS MADE ME UNDERSTAND WHY THIS IS A VERY DIFFERENT EXPERIMENT, I THINK MANY OF VUS BEEN INVOLVED IN, BECAUSE ACTUALLY WHAT YOU'RE DOING AND I THINK YOU'RE DOING HERE IS BUILDING A RESOURCE FOR OTHER PEOPLE TO USE, AND THAT'S QUITE A DIFFERENT CONCEPT. IF WE THINK OF FRAMINGHAM BUILT BY PEOPLE WHO WERE GOING TO USE IT, THAT HAVE SPECIFIC HYPOTHESES, THEY KNOW EXACTLY WHAT THEY WANTED IT TO DO WITH IT. BIOBANK, PUSHED VERY HARD IN THE FINAL PROPOSAL TO SAY WHAT WOULD WE DO WITH IT AND -- REFUSED. YOU WILL BE DOING SOMETHING COMPLETELY DIFFERENT AND THAT'S WHAT IS TURNING OUT TO BE THE CASE. I THINK YOU THINK OF IT AS A RESOURCE WHERE YOU GET A LOT OF INFORMATION ABOUT THE PEOPLE WHO ARE IN THE RESOURCE AND ABOUT HALF OUTCOMES THAT OCCUR IN TOSE PEOPLE. AND THAT -- I THINK WHERE SOME OF THE -- ARISE, BECAUSE ACTUALLY -- THE PEOPLE IS REALLY QUITE STRAIGHTFORWARD. ONE LINKS TO OTHER DATA AND IN PARTICULAR WITH RESPECT TO THIS ISSUE ABOUT CORE DATA, ONE EMBEDS IT IN HEALTH DELIVERY NETWORKS OR EXISTING COHORTS WHERE YOU GET INFORMATION ABOUT THE HEALTH IN THE PAST. THEN AS I SAY, YOU GET A LITTLE -- MEASUREMENTS, QUESTIONS AND SAMPLES. THE DIFFICULT BIT IS THE LINKING TO THE HEALTH IN THE FUTURE, AND PHENOTYPING THE HEALTH OUTCOMES. IT'S NOT ABOUT BEING PRECISE ABOUT WHICH PATIENT YOU TREAT. WE KNEW THAT ALREADY. THE QUESTION IS ABOUT THE DISEASE. SO THE PRECISION OF THE PHENOTYPING OF THE HEALTH OUTCOMES THAT IS THE MOST IMPORTANT THING IN THIS KIND OF STUDY, AND IS THE MOST DIFFICULT THING IN THIS KIND OF STUDY, BECAUSE THE PARTICIPANTS ARE IN FRONT OF YOU WHEN YOU ASSESS UNDUE MEASUREMENTS. SO YOU HAVE TO GET THAT TO THE PASSIVE MEASURES OR BY CON ACTING THEM, BUT WHAT YOU THEN GET IS A RECRUIT MEASURE OF HEALTH. HOW DO YOU AT SCALE PHENOTYPE THOSE HEALTH OUTCOMES, AND THAT'S WHERE IT COMES BACK TO THIS ISSUE ABOUT A RESOURCE BEING BUILT FOR OTHER PEOPLE. WHAT ARE THE QUESTION, THE MEASUREMENTS AND THE SAMPLES. THAT ALSO OTHER PEOPLE WILL WANT, HOW DO YOU PHENOTYPE THE HEALTH OUTCOMES SO THAT ALL KINDS OF OTHER RESEARCHES AN OTHER DISCIPLINES CAN GET HEALTHIER TYPE HEALTH OUTCOMES TO DO THEIR RESEARCH. AND IT'S BUILDING A RESOURCE THAT IS ACCESSIBLE, AND ACCESSIBILITY WITH REGARD TO THE CORE DATA COMING TO THAT SPECIFIC POINT. I THINK THE QUESTIONS ONE WOULD ASK, YOU COULD START WITH THE U.K. BIOBANK ONES, LOTS OF CONSULTATION ABOUT QUESTIONS IN A WHOLE RANGE OF EA PEOPLE COULD COME UP WITH BETTER QUESTIONS AND THINGS LIKE THAT, ONE COULD GET MORE QUESTIONS THROUGH REMOTE APPROACHES TO PARTICIPANTS, THINK PARTICULARLY USING QUESTIONNAIRES HALD GIVE YOTHAT WOULDGIVE YOU MORE DETAILED INFORMATION ABOUT EXPOSURES. ONE COULD LOOK TO ANY COHORT OR ANY OTHER KIND OF U.S. DI LIKE THIS AND LOOK AT THE MEASURES THAT YOU MIGHT DO, THE OBVIOUS MEASURES, THE LESS OBVIOUS MEASURES AROUND IMAGING AND AROUND REMOTE MONITORING OF ENVIRONMENTAL EXPOSURES OF BLOOD PRESSURE, OF CARDIAC RHYTHM, AND THEN YOU COME TO THE SAMPLES. AND THE ISSUE WITH THE SAMPLES I THINK IS TWOFOLD. ONE IS SAMPLES ARE NOT REALLY ACCESSIBLE IF IT'S A RESOURCE. WHAT YOU NEED TO DO IS IS CHANGE THE SAMPLES INTO DATA. DATA ARE ACCESSIBLE, ARE SHAREABLE, IT DEMOCRATIZING THE RESOURCE, IT KNOWS IT'S AVAILABLE FOR THE USE BY ALL KINDS OF RESEARCH AS RICH OR POOR. CARDIOVASCULAR DISEASE AND CAN SE BUT OTHER KINDS OF DISEASES THAT DON'T HAVE A LOT OF FUNDING, ONCE IT'S DATA, IT'S FREE. YOU CAN GIVE THE DATA AWAY, BUT THE SAMPLES -- NOT BECAUSE WE DON'T WANT THEM USED, BUT BECAUSE THEY AREN'T DEPLETABLE. THAT'S THE SECOND ISSUE WITH THE SAMPLES. YOU CAN NEVER GET -- WITH OF COURSE THE EXCEPTION OF THE DNA, WHICH IS NOT DEPLETABLE, REALLY. THE OTHER BIOLOGICAL SAMPLES THAT I THINK IS REALLY PROBLEMATIC, HOW CAN YOU GET ENOUGH TV THAT THERE WILL STILL BE SOME OF IT LEFT IN 10 OR FOARN 20 YEARS. TO DO THE ASSAYS THAT YOU REALLY WANT TO DO THEN. THEN IT COMES TO THE QUESTION ABOUT WHAT SAMPLES. SO THERE'S HOW MUCH SAMPLE AND HOW MANY DIFFERENT TYPES OF SAMPLE CAN YOU COLLECT AROUND NOT JUST -- TYPING BUT AROUND -- ASSAYS IN BLOOD BUT ALSO OF COURSE THE MICROBIOME. SO I THINK THAT ALTHOUGH ONE CAN EMBED THIS RESOURCE, WITHIN EXISTING COHORT STUDIES OR HEALTH RECORD SYSTEMS TO GET THE PREVIOUS HEALTH DATA, I THINK THERE WILL NEED TO BE ADDITIONAL INFORMATION OBTAINED ON ALL THE PARTICIPANTS OR VERY LARGE SUBSETS AROUND QUESTION, MEASUREMENTS, AND SAMPLES THAT CAN BE USED BY EVERYBODY, BY SENDING ALL OF THAT DATA, WHETHER IT'S SAMPLE DATA, IMAGING DATA, QUESTIONNAIRES, MEASUREMENTS, INTO INFORMATION, SO AROUND REMOTE MONITORING, WHEN WE DO ACCELOMETRY, TO ANALYZE THEM IN THE WAY HA YOU WOULD ASSAY A SAMPLE AND TURN IT INTO INFORMATION THAT THEN I AS AN EPIDEMIOLOGIST CAN USE, SO AND THE SAME THING WITH THE HEALTH OUT COME, TO TURN THOSE INTO INFORMATION ABOUT WELL PHENOTYPED HEALTH OUTCOMES. >> YOU FIES HAVE DONE A GREAT JOB, ABOUT 3 MINUTES A PIECE ON THE GENERA,RIGHT ON TARGET. DO YOU THINK THERE SHOULD BE A CURATED CORE DATASET AS OPPOSED TO A LARGE DATA RESOURCE WHERE PEOPLE WOULD TURN THAT INTO A CURATED DATASET? SHOULD THERE BE A CORE DATASET ON THE WHOLE POPULATION OF THE STUDIES? >> AGAIN, I THINK I THINK THERE SHOULD BE A MINIMUM -- THERE ARE -- THERE'S A LOT OF WISDOM THAT HAS ALREADY GONE INTO PUTTING TOGETHER ESSENTIAL QUESTIONS THAT SHOULD BE ASKED IN SOME OF THE COHOARD STUDIES THAT ARE ALREADY OUT THERE AND RUNNING, AND I THINK WE COULD BENEFIT FROM SURVEYING THOSE QUESTIONS THAT AGAIN FOCUS RIGHT NOW ALONG THE CONTEXTUAL DATA SURROUNDING STRICTLY BIOLOGICAL. LOOKING AT THOSE QUESTIONS AND DISTILLING OUT SOME OF THE KEY QUESTIONS THAT GET AT SOME OF THE THINGS SUCH AS GREATER RISK IN THE CONTEXT GIVEN A CERTAIN BIOLOGICAL PROFILE, AND OTHERS SHOW UNIQUE RESILIENCE, HAVE PARADOXICALLY GOOD HEALTH GIVEN THE SAME SORT OF -- SO IF WE COULD SURROUND THAT INFORMATION WITH THAT SET OF CORE QUESTIONS THAT BEGIN, AT LEAST, TO GET US POINTED IN THE RIGHT DIRECTION. >> QUICK ANSWERS HERE. >> QUICK ANSWER. OKAY. THE QUICK ANSWER, I'M GOING TO PHRASE EVERYTHING FOR THE COMMITTEE AS POLICY RECOMMENDATIONS. I'M GOING TO ASK FOR POLICY. IF YOU'RE GOING TO HAVE A LARGE SET OF DATA, PLEASE HAVE A QUALITY CONTROL PIPELINE SET UP FOR THE MANAGEMENT OF THIS DATA. YES, THERE SHOULD BE A CORE DATASET BUT THERE SHOULD ALSO BE SOME CURATION TO THIS AND IT SHOULD BE PERFORMED OVER TIME. ANYBODY THAT TAKES DATA OUT, YOU SHOULD BE ASKING THEM TO BRING DATA BACK TO YOU. WHAT THEY DO WITH IT, IT SHOULD BE VALIDATABLE, IT SHOULD BE REP LICKABLE. IT DOESN'T MEAN THAT THEY HAVE TO GIVE YOU EVERY PIECE OF INFORMATION THAT THEY HAVE OR EVERYTHING THAT THEY'VE DONE, BUT ANYTHING THAT THEY'RE MAKING CLAIMS ABOUT IF IT'S GOING TO BE USEFUL FOR OTHER PEOPLE TO DO EITHER VALIDATION OR FURTHER DISCOVERY OFF OF IT, THERE SHOULD BE A WAY TO BRING IT BACK IN AND HAVE PROVIDENCE ASSOCIATED WITH IT AND IT SHOULD BE QCED. >> THE NEXT QUESTION, HOW DO WE GUARD AGAINST COHORT BECOMING ALL THINGS TO ALL PEOPLE. THE DEPICTION THAT I HAVE, AND I THINK YOU ALL HAVE REINFORCED IT, THERE'S GOING TO BE THIS MASSIVE AMOUNT OF DATA THAT WILL COME FROM EMRs AND ACCELEROMETERS AND WEARABLE DEVICES AND EVERYTHING. BUT WITHIN THAT, AT LEAST I BELIEVE THERE SHOULD BE A COMMON CORE DATASET WHICH IS MUCH MORE LIMITED BUT HIGHLY CURATED AS YOU SAID BECAUSE TO CURATE THE ENTIRE MASS OF DATA AS AN ENTERPRISE WON'T WORK, ABOUT YOU IT IF YOU DON'T CURATE EVERYTHING, YOU END UP WITH A MESS. SO YOUR DISCRETION OF A QUALITY PIPELINE AND METHOD OF DOING THAT I HINGE IS A GREAT WAY TO SAY IT. SO THOMAS, HOW DO WE KEEP THIS FROM BEING THE CHRISTMAS TREE WITH EVERYBODY' EVERYBODY'S ORNAMENTS ON I T THAT NO ONE WANTS TO TAKE OFF? >> FIRST SHOULD THERE BE A CORE DAY A SET, MY ANSWER IS YES. BUT IT SHOULD BE THE SMALLEST POSSIBLE AND WE SHOULD HAVE A VERY HIGH CEILING TO IT ADD THINGS TO IT. NOW, SO THE QUESTION I WAS ASKED, YOU KNOW, HOW DO WE GUARD AGAINST THE COHORT BECOMING ALL THINGS, I'VE STARTED ANSWERING THAT ALREADY WITH MY EARLIER COMMENT ABOUT CALLING A COHORT. I THINK ACTUALLY THAT WILL HELP. LET ME GIVE YOU THREE OTHER QUICK THOUGHTS AND IDEAS ABOUT HOW TO DO THAT. THE FIRST IS LIMB THE CHOICE OF DATA ELEMENTS BY FOLLOWING THIS RATHER CONTROVERSIAL RULE, WHICH IS DON'T ASK RESEARCH PARTICIPANTS OR HEALTHCARE PROVIDERS, DON'T PORE ASKING THEM QUESTIONS THAT THEY DON'T KNOW THE ANSWER TO. SIMPLE ENOUGH IDEA BUT WHAT IT MEANS IS, DON'T ASK PEOPLE WHAT THEIR PHYSICAL ACTIVITY IS, DON'T ASK THEM WHAT THEIR DIET IS, DON'T ASK THEM WHAT THEIR SOCIAL NETWORKS ARE. IF YOU WANT THAT INFORMATION, PUT A SENSOR ON THEM OR GET THEIR CELL PHONES. FOR A LONG TIME, WE'VE SORT OF OPERATED UNDER THE FICTION THAT WHEN WE DO SELF-REPORTED PHYSICAL ACTIVITY OR DIET, THEN IT TURNS OUT 60% OF AMERICANS FOLLOW PHYSICAL ACTIVITY GUIDELINES, ACCELEROMETERS SAY IT'S -- DON'T ASK QUESTIONS THAT YOU'RE GOING TO GET THAT PEOPLE DON'T KNOW THE ANSWER TO, AND THAT GOES FOR PATIENTS AND PARTICIPANTS AS WELL AS THEIR HEALTHCARE PROVIDERS. SECONDLY, WE NEED CRY EAR YA FOR FIGURING OUT WHAT ELEMENTS BELONG THAT ARE GOING TO BE ROBUST AND WILL HELP TO KEEP THE SCOPE RELATIVELY NARROW. AND TWO POSSIBLE CRITERIA FOR WHAT SHOULD BE INCLUDED AS A DATA ELEMENT THAT WILL HELP KEEM THINGS LEAN AND MEAN WOULD BE THE FOLLOWING. FIRST DATA PERISHABILITY. DATA ELEMENTS SHOULD BE INCLUDED TO THE EXTENT THAT IT IF THEY'RE NOT COLLECTED, AT THE TIME OF ENROLLMENT OR ET CETERA, THAT THERE'S NO WAY TO RECONSTRUCT, RECAPTURE OR LINK THEM. AN EXAMPLE WOULD BE CORD BLOOD, OBVIOUS EXAMPLE. ANOTHER EXAMPLE WOULD BE, SAY, EP JE NE DICK PROFILES, DURING CRITICAL PERIOD DEVELOPMENTAL WINDOWS. EXAMPLES OF VARIABLES THAT ARE -- NEED TO BE COLLECTED AND INCLUDED BECAUSE NOT DOING SO WILL MEAN THAT THEY ARE NO LONGER BE CAPTURED. A SECOND CRITERIA, YOU KNOW, IN MY WORLD OF EPIDEMIOLOGY WEE MOVING AWAY FROM SORT OF IDENTIFYING CAUSAL RELATIONSHIPS IN THE ABSTRACT, AND SHIFTING TOWARDS TRYING TO FIGURE OUT IMPACT OF TREATMENTS. AND ONE IMPORTANT IMPLICATION OF THIS FROM THE CAUSAL INFERECE WORLD IS THAT WE OUGHT TO PRIORITIZE, INCLUDING DATA ELEMENTS, THAT CAN BE IMAGINED OR CAN BE IN PRACTICE -- INTERVENTIONS AS TREATMENTS. THOSE TWO CRITERION WILL HELP TOO CLARIFY AND EMPHASIZE THE COLLECTION OF VARIABLES THAT ARE LIKELY TO BE MOST USEFUL. MY THIRD IDEA IS THAT, YOU KNOW, AS YOU POINT OUT IN FRAMINGHAM, MANY OF THE SUCCESSFUL COHORTS HAD EITHER CONCEPTUAL FRAMEWORK OR SPECIFIC SORT OF SCIENTIFIC MISSION BEHIND THEM. OBVIOUSLY HAVING ONE RESEARCH QUESTION GUIDE THIS EFFORT IS NOT POSSIBLE GIVEN WHAT YOU'RE ENVISIONING. HOWEVER, WHAT MINA SAID YESTERDAY I THINK IS EXACTLY CORRECT, WE'D BETTER THINK ABOUT SOME SHORT TERM DELIVERABLE GOALS THAT WILL DEMONSTRATE THAT THIS THING WORKS AND SHOULD BE INVESTED IN. SO TO AVOID THIS BEING ALL THINGS TO ALL PEOPLE, WHAT I WOULD SUGGEST IS CROWD SOURCING AND HAVING A CONTEST WHERE PEOPLE SUBMIT RESEARCH QUESTIONS AND IT COULD BE PEOPLE -- THE LAY PEOPLE, SCIENTISTS, IT COULD BE POLICY MAKERS, IT COULD BE DEVICE MAKERS. SUBMIT A SET OF RESEARCH QUESTION, IDENTIFY THE TOP 10 BEST RESEARCH QUESTIONS, THE ONES THAT CAN BE ANSWERABLE IN THE NEAR AND IMMEDIATE TERM, AND USE THAT AS A FRAMEWORK. RIGHT THOSE 10 RESEARCH QUESTIONS ON THE STONE TABLETS AND USE THEM AS A GUIDEPOST FOR FIGURING OUT WHAT YOU'RE GOING TO DO FIRST. IF YOU COULD ANSWER 10 RESEARCH QUESTIONS, THAT HAVE SURVIVED THE PROCESS OF VETTING AND ADJUDICATION BY REALLY SMART PEOPLE AND THAT YOU MAKE THIS AN INCLUSIVE OPPORTUNITY FOR PEOPLE TO PARTICIPATE BROADLY, THEN IF YOU COULD GIVE -- IF YOU COULD IDENTIFY THAT SET OF 10 PRIMARY SORT OF GUIDING RESEARCH QUESTIONS, THAT WILL BE YOUR BEST SET OF GUIDELINES, THAT WILL PROVIDE A GUIDING FRAMEWORK TO PREVENT THIS FROM MUSHROOMING INTO A STUDY THAT TRIES TO DO EVERYTHING AND CAN DO NOTHING. I'LL STOP THERE. >> THOSE ARE GREAT AND INTERESTING IDEAS. YOU KNOW, ONE OF THE SEMINAL MOMENTS IN MY CAREER IS FOLLOWING BEHIND RORY AND COLLEAGUES, THEY HAD JUST DONE THE ISIS TRIALS, THE FRONT OF ONE SHEET OF PAPER AS THE ENTIRE DATA COLLECTION INSTRUMENT. SO WE CAME ALONG AND TRIPLED IT TO THREE SHEETS OF PAPER. BUT WE CALCULATED EVERY DAY IN A 40,000 PERSON TRIAL WAS ABOUT 300,000 BUCKS, IF YOU ACTUALLY ADD UP THE COST OF LABOR TO COLLECT THE DATA. AND SO WE SAID THREE BAIDGES PAGES, YOU HAD TO FIGHT TO KEEP ANY QUESTION ON THE FORM. RORY, ANY INSIGHTS OF KEEPING THINGS UNDER CONTROL? >> YOU SHOULD ASK YOURSELF 10 QUESTIONS ABOUT EVERY QUESTION YOU PUT IN A QUESTIO QUESTIONNAIRE. I WANT TO CONNECT TO BRAD'S COMMENT ABOUT DATA COMING BACK HEAR, BECAUSE THAT'S AN APPROACH WE'VE TAKEN IN THE UK BIOBANK. LINK TO THE ISSUE OF CORE DATA AND ENHANCED DATA. WE HAVE A CORE DATASET, THEN YOU'VE GOT THIS OTHER STUFF THAT TURNS INTO INFORMATION RATHER THAN DATA, BECAUSE DATA IS ALL THIS KIND OF STUFF WHEREAS THE INFORMATION IS THIS ANALYZED STUFF THAT IS ACCESSIBLE, THAT MIGHT BE TURNING INFORMATION INTO ASSAYS, THAT MIGHT BE BY TAKING IMAGING DATA FOR AK SELL ROM TRI DATA AROUND ACTIVITY AND TURNING THAT INTO MEASURING THAT PEOPLE CAN USE. SO WE HAVE GOT A CORSET OF DATA AND THEN WE'VE GOT THIS OTHER STUFF THAT PEOPLE COME ALONG AND THEY -- PARTICULAR EXPERTS IN PARTICULAR AREAS COME ALONG AND USE, AND THEN THE REQUIREMENT IS THAT WHEN THEY USE IT AND IT TURN IT INTO ACCESSIBLE INFORMATION, THAT INFORMATION COMES BACK IN, AS BRAD HAS SAID, SO THAT OTHER PEOPLE CAN USE IT. NOW, IN THE MAIN, WE ARE DOING THAT FOR THE RESOURCE WITH RESPECT TO ASSAYING THE SAMPLES -- ASSAYS OF THE SAMPLES, BUT WITH RESPECT TO OTHER DATA, OTHER PEOPLE ARE DOING IT. SO FOR EXAMPLE, WE DID IMAGING OF THE EYE, IN ABOUT 100,000 PARTICIPANTS, TOMOGRAPHY, AND THERE IS NOW A GRADING CONSORTIUM OF EYE DOCTORS WHO ASKED US TO PUT IT IN, SO WE DID, AND NOW THE CROWD SOURCING, WITHIN PARTICULAR AREAS OF THE EYE. TURNING THAT STUFF INTO INFORMATION, THEY RELEASED RESEARCH, THEN BACK INTO THE RESOURCE, PEOPLE HA DON'T KNOW ANYTHING ABOUT THE EYE FOR INFORMATION ABOUT OTHER KINDS OF ANALYSES. WITH THE AK SELL ROM TRI DATA, THERE ARE CONSORTIUM TAKING THAT, TURNING IT INTO ACCESSIBLE INFORMATION SO I THINK YOU HAVE A CORSET, THEN YOU'VE GOT THIS OTHER STUFF TURNED INTO ACCESSIBLE INFORMATION BY EXPERTS OUT THERE IN DOING THEIR RESEARCH, THEY FEED IT BACK IN AND ENHANCE THE CORE DATASET WITH WELL CHARACTERIZED WELL THOUGHT THROUGH VALIDATED INFORMATION. >> SO ALMOST SORT OF ETHICAL PRINCIPLE IS IF YOU CHECK OUT SOMETHING FROM THE STORE, YOU CLEAN IT UP, YOU PUT IT BACK IN IN BETTER SHAPE THAT IT WAS LEFT AND IT'S ACCESSIBLE TO EVERYBODY ELSE, IT COMES AFTER, I THINK THAT'S A GREAT WAY TO THINK ABOUT IT. YOU HAVE INVESTED IN THE RESOURCE, YOU MIGHT HAVE DONE SO BY GETTING YOU A GRANT OR IT MIGHT AB COMPANY THAT COMES ALONG AND DOES ASSAYS IN THE SAMPLES BECAUSE IT'S USEFUL FOR YOUR RESEARCH AND THEN THOSE ASSAY DATA GO INTO THE RESOURCE. YOU BECOME A FUNDER. IT TAKES ALL THIS IMAGING DATA AND WORKS AT THE HOW IT'S SCALED TO TURN THAT INTO ACCESSIBLE INFORMATION. >> I WANT TO MAKE SURE WE HAVE TIME FOR Q & A AT THE END, TO ME THEY'RE SORT OF BOOK END QUESTIONS THAT WE WERE GIVEN, TO IT HERMAN, MUCH TO BE CORRECTED DIRECTLY FROM THE PARTICIPANTS AND TO BRAD, WHAT IS IT THAT EMR CANNOT GIVE US? >> I THINK AGAIN, IF YOU HAVE THE PARTICIPANTS' PERMISSION TO GET THEIR MEDICAL RECORDS, IT'S SORT OF LIKE AT LEAST IT APPEARS TO ME LIKE FLIPPING A SWITCH AND YOU GET A CERTAIN BODY OF INFORMATION THE PARTS PABT NO LONGER HAS A LOT OF CONTROL AS OH WHAT DETAILS AVAILABLE OR NOT THAT, IS WITHIN THAT MEDICAL RECORD. BUT ALL OF THAT AGAIN IS SET IN A CONTEXT AND IT'S THERE WHERE YOU HAVE THE OPPORTUNITY TO REALLY GET SOMETHING THAT'S MORE IN DEPTH EACH PARTICIPANT. SO I WOULD THINK THAT GETTING THOSE AGAIN CONTEXTUAL DATA THAT HELP US UNDERSTAND BETTER WHAT IS GOING ON WITH EACH INDIVIDUAL IS IMPORTANT. SO THE TYPES OF THINGS THAT WE GET THROUGH QUESTIONNAIRES, THROUGH THE -- ABOUT, AGAIN -- NEIGHBORHOOD, OTHER THINGS, ANSWERS TO QUESTION ABOUT THEIR INDIVIDUAL LEVEL EXPERIENCES. ARE THEY EXPERIENCING STRESS, HOW DOES STRESS RELATE TO ALL THE OTHER DATA THAT WE HAVE EVEN TWAITING PHENOTYPES THAT ARE OF CONCERN. OTHER PSYCHOLOGICAL PSYCHOSOCIAL VARIABLES THAT CAN BE OBTAINED ONLY THROUGH TALKING OR ACCESSING DIRECTLY THAT PARTICIPANT. OTHER THINGS I GUESS COULD BE VARIABLE THROUGH REMOTE MONITORING. THINGS LIKE YOU CAN ASK THEM ABOUT SLEEP, AND YOU'LL GET A PRETTY POOR ASSESSMENT OF THEIR SLEEP OR IDEA OF THE QUALITY THEREOF, BUT -- A LOT OF DETAIL THAT WILL BE VERY RELEVANT TO THAT PERSON'S HEALTH OVERALL. SO YOU GET A GREAT SET OF DATA OUT OF THE MEDICAL RECORD, BUT TALKING DIRECTLY TO THE PARTICIPANT ABOUT ALL OF THOSE THINGS OUTSIDE OF THE STRICTLY BIOLOGICAL, I THINK THOSE THINGS HAVE TO DID DIRECTLY TO THE PERSON. >> WHAT ARE THE LIMITATIONS OF THE EMR AND WHAT DO WE DO TO WORK AROUND IT? >> >> NUMBER UN, I'M NOT A KRI CLINICIAN. SO HOW MANY OF YOU HAD SALTY FOODS THIS MORNING? GREAT. DID YOU TELL YOUR DOCTOR? WILL YOU TELL YOUR DOCTOR? ALL RIGHT. WE DON'T GET TO OBSERVE THEM ALL, WE DON'T GET TO SEE THEM. I'LL GIVE YOU AN EXAMPLE. WE HAVE PLENTY OF BLOOD PRESSURE READINGS THAT PATIENTS ARE SENDING BACK TO VANDERBILT, SENDING BACK TO US SO WE CAN ANALYZE IT. WE HAVE NO IDEA WHAT THEY WERE DOING BEFOREHAND. WE DON'T KNOW WHERE THEY WERE, WE DON'T KNOW IT IF THEY WERE STANDING, SITTING, IF THEY HAD SALTY FOODS IN THE MORNING SO WE HAVE ABSOLUTELY NO IDEA HOW RELIABLE AN INDIVIDUAL'S BLOOD PRESSURE READING IS WHEN WE COMPARE IT TO SOMEBODY ELSE'S. SO AGAIN, I'M GOING TO COME BACK TO CONTEXT. CONTEXT BECOMES BIG. THE MORE CONTEXT YOU HAVE, THE MORE YOU CAN DO WITH THE DATA. THAT SED, THE MORE CONTEXT YOU HAVE, THE MORE VARIABLES YOU HAVE. AND THAT MAKES IT EVEN HARDER TO DO ANY ANALYSIS ON THE DATA. SO WHAT DO YOU HAVE -- WHAT IS NOT IN THE EMR? BASE CL ANYTHING THAT DOES NOT HAPPEN IN A CLINICAL SETTING AND THE PATIENT DOES NOT TELL A DAR OR NURSE DOESN'T STAND UP THERE, SO ABOUT 95 AND 99% OF YOUR AK TV TIFTS DON'T END UP IN THE EMR: I DO WANT TO BRING UP ONE OTHER ASPECT, THOUGH, BECAUSE I THINK IT HAS A MAJOR IMPLICATION FOR LOOKING AT PRECISION OR PERSONALIZATION, PARTICULARLY WE'RE TALKING ABOUT THE PATIENT AS IF THE PATIENT HAS THE ABILITY TO TELL US EVERYTHING THAT'S HAPPENED TO THEM, WHETHER IT BE THEIR BIOLOGY, WHETHER IT BE THEIR ENVIRONMENTAL EXPOSURE, WHETHER IT BE IF THEY SLEPT LAST NIGHT, BUT THAT'S NOT ALWAYS THE CASE. A LOT OF WHAT HAPPENS TO A PATIENT AND THE EXTENT TO WHICH THEY RESPOND TO TREATMENT IS ALSO WHO THEY'RE INTERACTING WITH IN THE CLINICAL SETTING. SO -- OR THEY'RE WORKING WITH A NURSE WHO HAS EXPERIENCE FOR 10 TO 15 YEARS OR ARE THEY WORKING WITH SOMEBODY WHO'S JUST OUT OF SCHOOL. ARE THEY WORKING WITH A CARE TEAM THAT TALKS WITH EACH OTHER ON A DAILY BASIS OR WITH A CARE TEAM THAT WAS BROUGHT TOGETHER ON AN AD HOC BASIS AND HAS NEVER WORKED WITH EACH OTHER BEFORE. THIS PERSON, WERE THEY GIVEN THEIR MEDICATION AT THE RIGHT REGIMENT, THE RIGHT RATE. SO IF YOU'RE GOING TO LOOK AT MEDICINE, IF YOU'RE GOING TO LOOK AT THE PRACTICE OF MEDICINE AND YOU'RE GOING TO TRY AND REFINE IT AND MAKE PEOPLE'S HEALTHCARE BETTER, YOU HAVE TO LOOK AT WHO'S ACTUALLY TREATING THE PATIENT. THIS REALLY OPENS UP THE SYSTEM WHEN YOU THINK ABOUT IT, BECAUSE WE'RE TALKING ABOUT THE PATIENT AS THE EGO BUT IN REALITY YOU WANT TO SAY HOW WERE THEY INGRESSED INTO THE SYSTEM, HOW ARE THEY PUSHED ALONG TO THE SYSTEM THROUGH THE SYSTEM, WHAT HAPPENED WHEN THEY LEFT THE HOSPITAL, WHO CALLED THEM TO CHECK AND SEE IF THEY WERE OKAY TO REMIND THEM THEY HAD TO TAKE THEIR MEDICATION AND THEN BRING THEM BACK IN THROUGH SOME TYPE OF A SCHEDULE, DID THEY MISS THAT MEETING, WHY DID THEY MISS THAT MEETING THIS IS THE TYPE OF INFORMATION THAT IF YOU'RE GOING TO TRY AND SPECIALIZE HEALTHCARE, YOU WANT TO HAVE THIS INFORMATION. BUT YOU DON'T NECESSARILY HAVE THE ABILITY TO COLLECT IT. SO IF YOU ASK A PATIENT, CAN WE HAVE THIS INFORMATION, DOES THAT MEAN THEY HAVE TO GO TO THEIR DOCTOR AND ASK THEIR PERMISSION TO REPORT THAT INFORMATION TO YOU. I DON'T SEE IT NE ANY OTHER HEALTHCARE SYSTEM BUT I THINK THAT WOULD BE USEFUL. >> WE'VE GOT 8 MINUTES LEFT, YOU'LL GET ANOTHER SHOT WHEN WE GET TO DEFIED FIX AND HOW IT MIGHT BE USEFUL. I WONDER IF YOU CAN TAKE THE LEAD IN THIS NON-COHORT DATA -- THAT WE'RE ABOUT TO ENGAGE IN. SHOULD THERE BE SOME SORT OF STANDARDIZED FOLLOW-UP OR SHOULD WE JUST COLLECT THE PASSIVE FOLLOW-UP FROM EMRs AND OTHER SOURCES. >> I THINK THE QUESTION OF FOLLOW-UP IS AN EXTREMELY CHALLENGING ONE, AND I THINK WHAT WE HAVE TO DO IS BALANCE THE CRITICAL NEED TO FOLLOW UP WITH COMPLETENESS BUT FOLLOWING UP WITH THE FREQUENCY AND INTENSITY WE WOULD LAKE. SO WHEN YOU FOLLOW UP AND YOU LOSE TWO THIRDS OF YOUR PEOPLE AND YOU LOSE UNDERREPRESENTED POPULATIONS AND YOU LOSE SICK PEOPLE, THEN YOU INDUCE SELECTION BIAS PROBLEMS THAT ARE EXTREMELY DAMAGING TO THE INFERENCES YOU CARE ABOUT. SO ONE OF THE COMMON MISTAKES PEOPLE MAKE IN STUDIES IS THAT THEY HAVE AN OVERLY AMBITIOUS FOLLOW-UP STRATEGY WITH INADEQUATE ATTENTION TO THE RESORES NEEDED TO ACTUALLY TRACK AND MAINTAIN A HIGH LEVEL OF CONTINUED PARTICIPANT ENGAGEMENT. SO I GUESS IF THERE WAS A KIND OF GOAL, IT WOULD BE -- A WAY THAT IS POSSIBLE MINIMIZES THE NEED FOR ACTUAL DIRECT CONTACT WITH PEOPLE YOU'RE FOLLOWING. SO THAT YOU LOWER THE ENGAGEMENT IN THE STUDY AND BEND OVER BACKWARDS TO MINIMIZE LOSS TO FOLLOW-UP, BECAUSE THAT IS SCIENTIFICALLY INCREDIBLY DAMAGING. SO THAT'S MY ANSWER. >> ANYONE ELSE HAVE ANYTHING PROFOUND TO SAY ABOUT THAT? I THINK BASICALLY PERSONALLY AGREE COMPLETELY WHAT YOU SAID AND I THINK PEOPLE WHO HAVEN'T DONE A LOT OF RESEARCH OFTEN COMPLETELY UNDERESTIMATE WHAT HAPPENS WHEN THERE'S A DIFFERENTIAL LOSS TO FOLLOW-UP OR INFORMATIVE SENSORRING AS IT'S CALLED. RORY? >> I AGREE, I THINK THAT AS A BASELINE, ONE NEEDS TO HAVE A COMPREHENSIVE PASSIVE FOLLOW-UP SYSTEM USING HEALTH OUT COME DATA -- A SET OF DATA IN THE SAME WAY THAT WE WOULD HAVE A SET OF CORE BASE LAN BASELINE DATA, THE CODED DATA THAT COMES AT REGULAR INTERVALS FROM HEALTHCARE RECORD SYSTEMS, CUT IT IN DIFFERENT WAYS, DIFFERENT PLACES, BUT YOU DON'T WANT JUST A BIG DOWNLOAD. THE ISSUE, THOUGH, IS THAT THAT WILL GET THE HEALTH OUTCOMES -- YESTERDAY THAT YOU CAN GET FROM HEALTH RECORD SYSTEMS. BUT NOT THE HEALTH OUTCOMES THAT YOU CAN'T GET FROM THOSE SYSTEMS. SO I THINK IT'S AN EXPERIMENT, BUT WHETHER THERE ARE OTHER WAYS NOW OF GETTING INFORMATION FROM PARTICIPANTS THAT THEY DON'T KNOW THEMSELVES, IN A WAY, BY WHICH I MEAN TAKE THE EXAMPLE OF COGNITION. ONE OF THE THINGS WE'RE LOOKING AT IS WHETHER WE CAN FOLLOW UP PARTICIPANTS, UNDERSTANDING THERE ARE PROBLEM WITH FOLLOW UP THROUGH REMOTE SYSTEMS TO OUTCOMES -- EDIE KLEIN. HOW YOU DECLINE ENOUGH MAY NOT BE FOLLOWED THROUGH INTERNET SYSTEMS. THAT DIAS IS NOT SUBSTANTIAL. SO YOU COULD USE ACCELEROMETER -- VARIOUS MONITORS OF PEOPLE'S ACTIVITY TO DETERMINE WHETHER THERE ARE CHANGES RELATED TO COGNITION, DO THEY STOP IT LEAVING THEIR HOME HAS BEEN ONE OF THE SUGGESTIONS THAT'S BEING MADE, MIGHT BE A MEASURE OF CHANGES. SO HEALTH SYSTEMS ARE CRITICAL THAT THEY GIVE YOU STAGE ONE OF WHAT PEOPLE PROBABLY HAVE IN TERMS OF DISEASE -- OUTCOMES, HEALTH OUTCOMES, AND YOU MIGHT GO TO A SECOND STAGE, GO TO MORE DETAILED RECORD SYSTEMS FOR PARTICULAR CONDITIONS FOR PARTICULAR INFORMATION TO GET TO BETTER PHENOTYPED HEALTH OUT COME. BUT THAT YOU MIGHT ALSO LOOK AT SOME OF THESE REMOTE SYSTEMS AND REMOTE MONITORING >> I DO WANT TO PUT IN ONE PLUG FOR THE ULTIMATE OUT COME -- IT'S PROBABLY NOT AN ISSUE IN THE U.K. BUT IN THE U.S., THE ACHILLES HEEL A LARGE PART OF THE PUBLISHED LITERATURE BASED ON ERM RESEARCH, YOU DON'T KNOW IF THE PERSON IS DEAD OR NOT BSE IT'S NOT RECORDED IN MOST ELECTRONIC HEALTH RECORDS AS A DATA ITEM, AND PEOPLE JUST AREN'T BACK AT CLINIC BUT YOU DON'T KNOW WHY. IN OUR AREA OF HEART ATTACK, IF YOU WANT TO SEE A NON-BIASED -- LOOK AT -- PEOPLE WHO HAVE SURVIVED AN EVENT WHERE HALF THE PEOPLE DIED. ISO HARD TO ACTUALLY GET THE DEATH OUTCOMES RIGHT NOW TO MAKE SURE THAT'S THERE, AT LEAST TERRIBLY BIASED STUDIES. >> I'M NOT GOING TO HIJACK THIS PANEL ON A LONG DISCUSSION ON THIS BECAUSE IT'S A HOT BUTTON. WHAT I'M GOING TO SAY IS THAT THE NOTION OF DEIDENTIFICATION IS THAT IT IS NOT -- THIS CONCEPT IS NOT MEANT TO BE DMONIZED. THERE ARE LOTS OF ARGUMENTS WHICH SAY THAT OR PUBLICATIONS THAT SHOW YOU CAN REIDENTIFY SOMEONE GIVEN THEIR DNA, GIVEN CLINICAL INFORMATION, GIVEN DEMOGRAPHIC INFORMATION, GREAT. I'M GOING TO ASK YOU GUYS ONE MORE QUESTION. HOW MANY OF YOU HAVE EVER REIDENTIFIED SOMEBODY IN YOUR DATASETS THAT YOU'VE STUDIED? RIGHT. SO WHY NOT? SO THERE'S A LOT OF INCENTIVES AND DISINCENTIVES. THERE ARE INCENTIVES FOR MAKING INVESTIGATORS AND RESOURCES LOOK STUPID BY PEOPLE WHO WANT TO DO SO. THERE ARE ALSO INCENTIVES FOR MAINTAINING THE RESOURCE AND BEING A GOOD SAMARITAN WITHIN THE COMMUNITY THAT YOU WORK IN. A LOT OF THIS IS REALLY A RISK MANAGEMENT PROBLEM IN THAT YOU WANT TO SET UP THE RIGHT INCENTIVE STRUCTURES, THE RIGHT CREDENTIALING STRUCTURES FOR MANAGING THE DATA AND ENSURING THAT IT'S USED IN A WAY THAT YOU WANT IT TO BE, AND YOU ALSO WANT TO HAVE APPROPRIATE PENALIZATION STRUCTURES ON THE BACK END TO DISINCENTIVIZE SOMEBODY FROM ACTUALLY MA ANYBODY LATING THE SYSTEM AND COMMITTING SOME TYPE OF MALFEASANCE. YOU WANT TO USE THE BEST -- PRO TECHS. I'M NOT GOING TO GO THROUGH WHAT THEE PROTECTIONS ARE. THEY COULD BE ENCRYPTION, AUDITS, REMOVAL SOME TYPE OF EXPLICIT IDENTIFIERS, REALLY ALL THEY'RE DOING IS SERVING AS MISINCENTIVES FOR MISUSE AND MALFEASANCE. SO ALL I'M GOING TO RECOMMEND AT THE END OF THE DAY, DO NOT LOOK AT THIS BLACK AND WHITE EITHER THE DATA IS IDENTIFIED, IDENTIFIABLE OR NOT IDENTIFIABLE. IT'S REALLY SOMEWHERE IN THE MIDDLE IN THAT YOU CAN MEASURE HOW MUCH OF A CHANCE THERE IS THAT THE INFORMATION WILL BE EXPOSED GIVEN THE DIFFERENT LEVELS OF WHICH YOU GIVE PEOPLE ACCESS TO IT AND WHO YOU GIVE ACCESS TO IT, BUT JUST DEFINE WHAT THOSE ARE GOING TO BE AND DO SOME TYPE AVERAS BEING ANALYSIS BEFORE YOU ACTUALLY SEND THE DATA OUT INTO THAT DOMAIN. AT THE END OF THE DAY, MAKE SURE THAT YOU HAVE POLICIES WHETHER THEY HAD FEDERALLY MANDATED OR CONTRACTUALLY NEGOTIATED SUCH THAT IF SOMEBODY DOES SOMETHING IN THE SYSTEM, YOU HAVE THE ABILITY TO HOLD THEM ACCOUNTABLE. I DO WORRY IF WE DON'T USE ACCOUNTABILITY STRUCTURES THAT IT LEAVES THE SYSTEM SUCH THAT YOU TAKE THE DATA, YOU THROW IT OFF THE CLIFF AND HOPE THAT IT HITS THE GROUND. YOU CAN'T GUARANTEE THAT. YOU DO NEED TO KNOW THAT THERE'S SOME TYPE OF A CONTROL STRUCTURE AT THE END OF THE DAY. >> I WANT TO THANK YOU GUYS. IT IS BY THE WAY, KATHY, ANOTHER ALL MALE PANEL. I DIDN'T SELECT IT. BUT I DO WANT TO THANK YOU. WE DO WANT TO OPEN IT UP FOR THE GROUP. I THINK YOU'VE EACH CONTRIBUTED SOMETHING THAT I THINK THE COMMITTEE WOULD BE WISE TO LISTEN TO DESIGNS. MIKE? >> I HOPE WE'RE PERMITTED TO USE THE WORD COHORT IN ITS LAY SENSE OF THE WORD. WE CHOSE NOT TO CALL MVP A COHORT STUDY BECAUSE IT'S NOT A STUDY, ATE PROGRAM OR PLATFORM, COHORT SIMPLY MEANS IN ITS LAY TERMS A COLLECTION OF INDIVIDUALS. IT'S SUCH A USEFUL TERM. I'D HATE TO ABANDON IT. WE'VE ORGANIZED OUR DATA IN TOLEDO MAINTHREE DOMAINS. BIOSPECIMENS, DATA WE COLLECT ONLY FROM THE PARTICIPANT AND DATA WE GET FROM SOMEWHERE ELSE. THE FOUR Cs ARE COLLECT, CLEAN, CURATE, D. COLLECT, CATALOG, CLEAN AND CURATE. AND THERE'S A COST BENEFIT IN EACH OF THOSE AREAS AND SO WHAT -- WE'VE SPENT A YEAR AND A HALF FIGURING WHAT WE COLLECT TO THE PARTICIPANTS AND WE TRIED TO BALANCE WHAT'S IN THE RECORD AND WHAT'S NOT, AND THEN WE ARE -- THAT IS SIMPLY MAKING SURE WHAT'S ON THE DATASET. I'M ON THE QUESTIONNAIRE THAT MAKES IT INTO THE DATASET. WHEN THERE'S DERIVED VARIABLES, THAT HAPPENS LATER WHEN AN INVESTIGATOR REALLY WANTS TO INVEST SOME RESOURCES IN IT, THE GRAND SEA OF DATA WHERE WE CAN GET DATA PASSIVELY, ELECTRONIC HEALTH RECORD, NATIONAL DEATH INDEX, CMX, DOD, THE EXPOSOME, PARTICULATE MATTER, WHAT WE'RE SIMPLY DOING IS CATEGORIZING THE POTENTIAL IN CERTAIN AREAS, WE'RE STARTING TO CLEAN AT A TIER 1 LEVEL, MEANING RUDIMENTARY LEVEL, THEN EXTENSIVE CURE RANGE OATION, WE'RE WAITING UNTIL THERE'S AN INVESTIGATOR THAT REALLY WANTS TO USE IT FOR TWO REASONS. ONE IS IT'S LABOR INTENSIVE AND THE SECOND IS IF I WAS TO KAUR KAUR RATE IT TO MY LIKING, IT MAY NOT SATISFY THE NEEDS OF THE NECTS INVESTIGATOR. IT'S USEFUL TO DEVELOP SOME SORT OF STRATEGY, TAKING THOSE CAT CATALOGS, EVEN THE BIOSPECIMEN, YOU COLLECT THE SPECIMEN, YOU CATALOG WHAT YOU HAVE, WE CLEAN IT BY DOING SOME PROCESSING LIKE DNA EXTRACTION AND THEN CURATION COMES ON A COST BENEFIT BASIS >> YOU COULD WRITE THE TEXTBOOK OF DATA JANITORSHIP AND I WOULD LIKE TO ACTUALLY HELP GET THAT DONE BECAUSE I THINK IT'S CRITICAL. I THINK FOR MANY PEOPLE IN THE GROUP WHO HAVEN'T DONE THIS, CAN YOU GIVE THEM AN IDEA OF HOW MUCH OF IT IS PUSH A BUTTON MAGICALLY AND HAVING SOME INFORMATICS SCHEME DO IT VERSUS MANUAL, HUMAN LABOR? >> I THINK THAT A BACK NEEDS TO BE WRITTEN AND TOGETHER IN THIS ROOM WE'RE GOING TO BEGIN TO WRITE THAT BOOK. THINK WE DO NEED TO INDUSTRIALIZE THIS PROCESS. THOSE OF US FROM ISIS, GUSTO, WE'VE BEEN DOING THAT ON A SMALLER SCALE THROUGH DATA WE COLLECT THROUGH QUESTIONNAIRES. I REALLY THINK WE'RE INVETTING THIS FIELD IN TRYING TO FIGURE OUT HOW TO DO THAT ON A GRAND SCALE WITH THE PASSIVELY COLLECTED DATASETS WE'RE WORKING WITH. A LOT OF THAT EFFORT HAS TO BE INVESTED IN FIRST MANUALLY UNDERSTANDING THE PROCESS AND CREATING SOME VALIDATION ALGORITHMS, BUT THEN TRYING TO -- I THINK IT'S BEEN SAID OVER AND OVER AGAIN ENGAGED -- PEOPLE FROM THE FINANCIAL FIELD FROM VARIOUS SECTORS WHO HAVE DONE THIS IN OTHER FIELDS TO HELP US BRING THIS FIELD ALONG. >> I SEE ALL THE DATA JANITORS AT THE ROOM GRAB THE MICS THIS IS GREAT. RORY, YOU HAD A COMMENT, THIS IS GOING TO BE HARD, >> THE ONE THAT I'M THINKING WAS WAS -- DEFER AND THAT RELATES PARTICULARLY TO SOME OF THE WAYS I WHICH ONE DEALS WITH THE DATA, ONE ASSAYS THE SAMPLES. ITH CHEAPER THAT WAY. >> IT WILL BECOME CHEAPER TO DO THE ASSAYS. YOU CAN DO MORE ASSAYS, YOU CAN DO HIGH QUALITY IF YOU DO THEM IN MORE THAN ONE GO. THE SAME THING WITH THINGS LIKE MONITORS, AT THE LAST MINUTE. ONCE AGAIN I WANT TO THANK THE PANELISTS, I THINK IT COULD GO FOR HOURS. SO WE'LL ONLY MAKE IT GO FOR MINUTES. BUT AS I REFLECT ON DR. COLLINS' QUESTION YESTERDAY, OR CHALLENGE YESTERDAY, WHICH HAD TO DO WITH THIS RESILIENCE COHORT, THE GROUP OF PEOPLE WHO SHOULD BE BY ALL ACCOUNTS SUSCEPTIBLE TO A DISEASE AND IN FACT DON'T EXPERIENCE IT OR ITS SEQUELAE, THEN I THINK WE'VE BEEN TALKING ABOUT TODAY, THE DEPTH OF THE DATA, I'M REALLY STRUCK, REALLY CHALLENGED, BECAUSE OUR PATIENTS WILL HAVE THE LEAST AMOUNT OF DATA EASILY ACCESSIBLE BY ANY OF THE METHODS WE WOULD WANT, SO THOSE PATIENTS WHO WE ASPIRED TO MODEL AT LEAST FOR RESILIENCE, WE DON'T HAVE THE DATA WITHOUT SOME OF THE THINGS THAT YOU ALL HAVE DISCUSSED. I SORT OF THE PICTURE THE OLD MOVIE THE TRUMAN SHOW AS SAYING THAT WE ALMOST NEED TO COME UP WITH SOME METHOD BY WHICH WE CAN SEE EVERYTHING THEY'VE DONE, HAVE IT AS -- SIGNAL AND BE ABLE TO PROCESS IT. SHORT OF SOMETHING QUITE THAT DRACONIAN, DO YOU HAVE OTHER STRATEGIES WOULD YOU RECOMMEND TO US TO CAPTURE THE KIND OF DATA WE WOULD NEED TO SORT OF PROMOTE THE IDEA OF RESILIENCE ANALYSIS? >> SO WE ALL KNOW THAT IT'S A GOOD IDEA TO MEASURE DNA. BECAUSE DNA SETS THE ETIOLOGIC INERTIA THROUGHOUT THE LIFE COURSE. IF YOU DON'T UNDERSTAND RESILIENCY AT RISK, THE TWO SIDES OF THAT, I'M BASICALLY REITERATING SOMETHING THAT HERMAN SAID WITHOUT HIS GORGEOUS BARITONE, IS WE NEED TO ADD TO THAT AN APPRECIATION OF THE IP FLEUNS OF THE DNA. ZNA SIGN CODE AT BIRTH. THERE ARE VERY FEW HIGH -- GENES THAT HAVE THE EX-PLA TRI POWER TO PREDICT RESILIENCY AND RISK AS MUCH AS WHERE YOU WERE BORN. THE PROGRAMMING THAT OCCURS IN EARLY LIFE, IF DNA IS THE ASSEMBLY INSTRUCTIONS BIOLOGICALLY, ZNA IS THE ASSEMBLY INSTRUCTIONS FOR BEHAVIOR FOR PSYCHOLOGY FOR ALL OF THE PSYCHOSOCIAL STUFF THAT MATTERS A GREAT DEAL. INCLUDING RESILIENCY. SO I'D MAKE AN ARGUMENT FOR ADDING ZNA AS A CRITICAL DATA ELEMENT BOTH BECAUSE I THINK IT IS A POWERFUL WAY OF UING THE LIFETIME RISK PROFILE OF AN INDIVIDUAL BUT AS A WAY OF ESTABLISHING THE BASIS FOR UNDERSTANDING A LIFETIME OF RESILIENCE. >> MY ONLY TWO WORDS ABOUT THIS IS -- THREE WORDS -- DYNAMIC GEOSPATIAL REFERENCING, I THINK IS WHERE WE NEED TO GO, BUT THAT'S FOR ANOTHER TIME. LET'S GO OVER HERE. >> THREE COMMENTS. YOU CAN GET TO DEATH BY USING THE NATIONAL DEATH INDEX. YOU'RE TWO YEARS BEHIND, BUT IT'S VERY LINKABLE, VERY DOABLE. YOU GET YOUR CAUSE OF DEATH, NEVER PERFECT BECAUSE DEATH CERTIFICATES ARE NEVER PERFECT BUT IT'S HIGHLY PREDICTIVE AND IT WORKS. SECOND ONE IS, YOU KNOW, WHEN WE'VE TALKED ABOUT RETENTION AND RESPONSE, THOSE ARE KIND OF TWO DIFFERENT ISSUES. RETENTION OF YOUR COHORT MEANS YOU KNOW WHERE YOU'RE PEOPLE ARE AND THAT YOU'RE FOLLOWING THEM AND THAT YOU HAVE SOME ASEMI BLNASSEMBLANCE TO COLLECT THEIR OUTCOMES. IF YOU'RE REPEATEDLY TRYING TO ACCESS NEW DATA, RESPONSE RATES -- BOTH OF THOSE CAN AFFECT THE INTERNL VALIDITY IF THIS IS GOING TO BE A TRUE COHORT FOLLOWING THEM FORWARD IN TIME, HAVING GOOD RESPONSE RATES IS GOING TO BENEFIT JUST THE QUALITY OF YOUR UPDATING OF YOUR EXPOSURE INFORMATION, AS WELL AS UPDATING YOUR OUTCOMES -- AND YOU CAN'T LINK TO A REGISTRY. I WANT TO ADDRESS A POINT ABOUT COLLECTING THE INFORMATION ON DIET AND PIZ CAL ACTIVITY. I DISAGREE WITH YOU. I DO THINK WE HAVE LEARNED A LOT BY COLLECTING THAT AND SOME OF THAT'S BECAUSE YOU CAN -- WITH LARGE NUMBERS YOU CAN GO MILE WIDE AND INCH DEEP, AND, IN FACT FACT, REPEATED STUDIES OVER THE LAST YEAR OR TWO, OUR GROUP AS WELL AS MULTIPLE OTHER GROUPS HAVE SHOWN REPEATEDLY THAT FOLLOWING BOTH THE AMERICAN CANCER SOCIETY GUIDELINES FOR CANCER PREVENTION AS WELL AS THE BCRIICR GUIDELINES PREVENTION -- HAVE CONSISTENTLY HAVE CONSISTENTLY SHOWED IT REDUCES CANCER, CARDIOVASCULAR AND -- AS WELL AS FOLLOWING THE COLLECTIVE GUIDELINES. SO AGAIN THE MILE WIDE AND INCH DEEP CAN GET YOU SOME PRETTY GOOD INFORMATION THAT CAN BE OF GOOD BENEFIT TO POPULATIONS. >> SO WE'RE DONE. CAN WE TAKE 10 MINUTES FOR EVENT THREE PEOPLE? OKAY, GREAT. ONE QUICK COMMENT, I RELATED TO REPRESENTATIVE -- I HAVE GREAT HOPES THAT 21ST CENTURY CURES WILL FIX SOME OF THE PROBLEMS WE CURRENTLY HAVE WITH THE NATIONAL DEATH INDEX AND OTHER MEANS IT CAN? >> IT'S A JURISDICTIONAL ISSUE SO WE'RE WORKING WITH THE COMMIT EVE JURISDICTION TO FIX IT. >> SORELY NEEDED. >> DR. GLASS, YOUR COMMENTS WERE REFRESHING BECAUSE THEY'RE VERY PRAGMATIC AND PRACTICAL. SO I'D LIKE TO KNOW WHAT YOUR SUGGESTIONS ARE FOR MAKING SURE WE INCLUDE DIVERSITY. YOU'RE AN EPIDEMIOLOGIST, YOU KNOW HOW IMPORTANT THIS IS. CAN YOU SUGGEST TO THE GROUP HERE WHAT YOU SUGGEST? KEEP IN MIND THAT IN 1993, WE HAD THAT CONGRESSIONAL MANDATE AND WE'VE DONE TERRIBLY, RIGHT? IT'S OUR FAULT AS REVIEWERS. >> ONCE YOU GIVE UP THE IDEA OF A COHORT STUDY WHERE YOU HAVE TO HAVE A DEFINED SAMPLING FRAME AND A RIGOROUS SAMPLING STRATEGY, THEN YOU CAN USE O-- OPPORTUNISTIC WAYS OF IDENTIFYING HARDER TO REACH POP LAYINGS BY WHERE THEY ARE MORE LIKELY TO BE FOUND. I THINK THAT A STRATEGY OF OVERSCREENING IS BETTER THAN OVERSAMPLING. RECOGNIZING THAT WE NEED LARGER NUMB BRS OF POTENTIAL PAR PANTS, GIVEN WE KNOW MANY OF THE POP LAYINGS WE CARE ABOUT INCLUDING ARE GOING TO HAVE A LOWER PARTICIPATION RATE, AND I THINK ALSO TRYING VERY HARD TO COLLECT DATA ON PEOPLE WHO SAY NO TO BEING PART OF THE STUDY. SO THAT WE CAN ADDRESS AND ADJUST FOR SAMPLE SELECTION BY PROBLEMS ON THE INTEGRATIVE SELECTION BIAS ISSUE IS SOMETHING THAT'S EXTREMELY WORTH DOING. SO WITH -- I CAN GIVE A LONGER ANSWER BUT THAT'S MY FIRST SET OF THOUGHTS. >> THANKS. NOW TURNING TO IT MY STATISTICAL MENTOR, FRANK HARRELL. >> YOU CAN'T REALLY MAKE PROGRESS UNTIL YOU GET SPECIFIC AND YOU START MENTIONING SPECIFIC CLINICAL QUESTIONS THAT YOU WANT TO ANSWER. I WOULD ALSO ENCOURAGE THE GROUP TO THINK ABOUT SPECIFIC CLASSES OF RESEARCH THAT THIS SORT OF RESOURCE WOULD BE ABLE TO ADDRESS WHICH MAY HELP GUIDE THE CONSTRUCTION OF THE RESOURCE. TE ARE CLASSES SUCH AS DIAGNOSIS, PROGNOSIS, RESOURCE UTILIZATION ACCESS TO CARE, ASSOCIATION STUDIES, AND CHARACTERIZING POPULATIONS WILL THERAPEUTIC EFFECTIVENESS BEING PRETTY FAR DOWN THE LIST OF WHAT THIS RESOURCE IS PROBABLY ABLE TO DO. IN TERMS OF CHARACTERIZING POPULATIONS, I THINK WE WOULD DO WELL TO COORDINATE THAT WITH SOME OF THE OTHER AGENCIES -- THEY HAVE RESOURCES SUCH AS -- WHICH HAS BEEN EXTREMELY VALUABLE, IT WOULD BE SORT AFTER SHAME NOT TO LINK UP WITH SOME OF HE'S OTHER RESOURCES. >> SO I'LL BE QUICK. IF YOU LOOK AT COUNTRIES IN SCANDINAVIA THAT HAVE SOCIALIZED MEDICINE, COLLECTION OF DATA OF THIS KIND IS -- IT'S LIKE THE IRS, IT'S LIKE NO STONE UNTURNED. YOU CAN DROP OUT OF IT, SO THERE. SO I'M WONDERING WITH THE OBAMACARE, NO ONE HAS MENTIONED THAT EFFORT WHICH IS HERE, IS IT BUILD INTO OBAMACARE SOME SORT OF DATA COLLECTION THAT WE'RE AFTER, SO WE COLLECTIVELY SORT OF COLLECT SYSTEMATICALLY DATA ALL OVER THE STATE IN A REPRESENTATIVE WAY. >> I'M GLAD YOU DIDN'T ASK THAT QUESTION AT 8:15. >> IN OUR ACADEMIC LIFE, JUST THE REASON YOU GAVE, AMAZING DATA COLLECTION. I JUST THINK IN THE U.S., IT'S GOING TO BE VERY HARD TO LINK UP DIRECTLY, ALTHOUGH AS DATA RESOURCES ARE MADE AVAILABLE, WE'LL LINK UP WITH THAT. RORY? >> SOMETHING LIKE THAT ACTUALLY HAPPENED NOT IN THE U.K. BUT IN CHINA, WE RECRUITED HALF A MILLION PEOPLE IN 10 REGIONS IN CHINA, LINKING IT INTO TO THE CANCER REGISTRIES AND DEATH REGISTRIES. THEN THE HEALTHCARE SYSTEM COLLAPSED AND THEN THEY PUT IN PLACE HEALTH INSURANCE SCHEMES WHICH WAS SO POPULAR THAT THEY HAD VERY HIGH COVERAGE AND WE'VE THEN BEEN ABLE TO LINK THOSE HALF NI MILLION PEOPLE INTO THOSE HEALTH RECORD SYSTEMS WHICH ARE COMPUTERIZED, BUILT THE FROM SCRATCH NEW, AND BECAUSE THEY'RE ABOUT MONEY, WHICH I THINK WAS THE POINT THAT WAS BEING MADE, THEY'RE VERY ACCURATE, BECAUSE IT'S ALL ABOUT BILLING. SO ALL THE BILLING THAT OCCURS TELLS YOU EXACTLY WHAT HAS HAPPENED IN THE HOSPITAL AND THE HEALTH OUT COME. SO I THINK THE SUGGESTION TO KIND OF THINK OF WHETHER -- SOME OF THE BUILDING ELEMENT RIGHT BE RELEVANT TO FINDING OUT WHAT HAPPENS IN THE WAY IT WAS COMPLETELY UNPLANNED AND UNEXPECTED BUT IT HAS ENRICHED THAT RESOURCE IN CHINA ENORMOUSLY. >> -- OBEY MA CARE AS BEING SOMEWHAT SPOTTY IN WHAT WE CALL THE -- STATES IN TERMS OF ITS UP TAKE AND HOW IT WILL IMPACT THE HEALTH OF THE POOR IN PARTICULAR PARTICULAR, ALMOST AUTOMATICALLY MISS SUBSTANTIAL -- FOUND IMPORTANT INFORMATION ABOUT PRECISION HEL. >> YOU MIGHT HAVE HEARD THE QUESTION I ASKED EARLIER THIS MORNING, I THINK THAT THE SUGGESTION IS WONDERFUL. I THINK THAT AMERICA IS A VERY SECTORIZED SOCIETY THAT HAS A SPLIT BETWEEN PROFIT AND NOT FOR PROFIT ENVIRONMENTS. ONE OF THE REASONS WHY WHAT YOU'RE SUGGESTING IS SO CHALLENGING HERE IS THAT YOU DO HAVE A SITUATION WHERE PLACES THAT ARE OUTSIDE THE HEALTHCARE DOMAIN ARE REGULATED BY DIFFERENT AUTHORITIES THAN THE HEALTHCARE SECTORS OR THE HEALTHCARE SECTOR ITSELF, SO EVEN IN HEALTHCARE, WHILE WE'RE TRYING TO PUSH FOR SOMETHING LIKE A BLUE BUTTON WHERE YOU CAN GET YOUR EMR INFORMATION AT THE CLICK OF BUTTON, WE DON'T HAVE A GREEN BUTTON SO THAT YOU CAN WALK INTO YOUR GROCER AND ASK FOR ALL OF YOUR PURCHASING HISTORY OVER THE LAST COUPLE YEARS. YOU CAN'T DO THE SAME THING WITH ANYBODY, UNLESS THEY'RE AN OON LINE PROVIDER LIE AMAZON AND YOU'RE ABLE TO GET YOUR PURCHASE HISTORY. SO THE FACT NA THER THAT THERE ARE ZONES, BOUNDARYS THAT AREN'T NECESSARILY PHYSICALLY ENFORCED BUT -- IT MAKES IT EXTREMELY IMPORTANT TO DO SO. SO IF WE'RE GOING TO FOCUS WITH RESPECT TO THIS PMI I THINK WE HAVE KNOW WHERE THOSE BOUNDARIES ARE. >> THIS WAS A GREAT PANEL, I THINK YOU ALL GAVE INSIGHTS THAT THE COMMITTEE NEEDS TO THINK ABOUT CAREFULLY AS THE STUDY IS DESIGNED. FOR THOSE NOT ON THE COMMITTEE, I'M SURE WE'LL BE BACK TALKING WITH YOU ABOUT THE STUDIES. SO THANKS. ALSO THANKS FOR STAYING ON TIME, QUITE REMARKABLE GIVEN THE DEPTH OF DISCUSSION. [APPLAUSE] GOOD MORNING. I'M SHIRIKI KUMANYIKA, ONE OF THE AD HOC WORKING GROUP MEMBERS, AND I HA HAVE THE PLEASURE OF MODERATING THIS PANEL ON POSSIBILITIES FOR DIRECT FROM PARTICIPANT DATA AND THE PRIOR PANEL WHICH WAS REALLY EXCELLENT IS A PERFECT SETUP FOR THIS, BECAUSE WE'VE NOW HEARD A LOT ABOUT WHAT DATA PEOPLE SAY WOULD BE COLLECTED FROM PARTICIPANTS. I JUST NOTED DOWN THE POSSIBLE SCOPE, STRESS, PERCEPTIONS OF ENVIRONMENTS, OF SLEEP, DESCRIPTION PERHAPS OF THE HEALTHCARE EXPERIENCE, COGNITION, ENVIRONMENT -- AND BEHAVIORS, OF COURSE, ALL THE BEHAVIORS THAT WE ARE INTERESTED IN. SO THERE ARE POSSIBILITIES FOR BOTH THE ACTIVE COLLECTION THROUGH -- FOUR HOUR INTERVIEW SITTING IN FRONT OF A PERSON BUT THROUGH ELECTRONIC MEANS AND THEN THE PASSIVE DATA COLLECTION LIKE THE WRIST BANDS THAT PEOPLE WEAR FOR CHECKING THEIR PHYSICAL ACTIVITY, AND WE HAVE FOUR PANELISTS WHO ARE GOING TO GIVE US THEIR PERSPECTIVE ON ISSUES RELATED TO DIRECT FOR PARTICIPANT DATA. SO TALK BRIEFLY ABOUT WHAT YOU WHO YOU ARE, WHAT YOUR PERSPECTIVE IS ON THIS ISSUE AND THEN QUESTIONS AND DISCUSSION AT THE END. SO WE'LL GO IN ORDER. WE'LL START WITH KATHY. >> HELLO, I'M KATHY. I WANTED TO BE HERE TODAY PRIMARILY BECAUSE I VIEW THIS ENTIRE PROJECT TO BE FASCINATING FROM A PERSONAL PERSPECTIVE, BUT THEN ALSO FROM A PERSPECTIVE OF HOW WE WORK WITH THE PARTICIPANTS WITHIN ONCOLOGY. FROM THE PERSONAL SIDE, MYELOMA IS STILL CONSIDERED A FATAL DISEASE. I DO HAVE MULTIPLE MYELOMA, I'VE HAD IT FOR A NUMBER OF YEARS PROBABLY CONSIDERED AN OUT ITLIAR SINCE I'VE LIVED 20 YEARS WITH IT, BUT INTERESTINGLY TO ME, MY IDENTICAL TWIN SISTER HAS STAGE THREE BREAST CANCER, AND IT ALWAYS MAKES ME WONDER, IN A WORLD OF IDENTICAL TWINS, WHY IS ONE GETTING MYELOMA AND ONE GETTING BREAST. MY FATHER DIED OF KIDNEY CANCER, MY MOTHER HAS MELANOMA, MY GRANDFATHER HAD MIL MYELOMA. I WORRY FOR MY CHILDREN AND I THINK THAT'S WHY I'M FASCINATES BY ALL OF THIS AND HOW WE ACTUALLY WANT TO PUT ALL THE INFORMATION TOGETHER. I THINK FROM A FOUNDATION PERSPECTIVE, EVERY PATIENT GROUP IS DIFFERENT AND HOW WE STUDY AND WORK WITH OUR PATIENTS IS COMPLETELY DIFFERENT. WE ARE INTENSELY VERTICAL. WE COLLECT HIGH AMOUNTS OF VERTICAL INFORMATION, GENO TYPIC, PHENOTYPIC, EVERYTHING. IT DOESN'T MEAN WE HAVE HALF OF THE PATIENTS IN OUR DATABASE AND WE ALSO GO JUST AN INCH DEEP, BUT RE REALLY LOVE GOG SUPER DEEP AND MAKING SURE ALL OF THAT DATA IS SHARED. SO I THINK IT'S IMPORTANT THAT WE KNOW WITHIN PATIENT GROUPS, WE ALL LOOK DIFFERENT BUT ALL HAVE AMAZING AMOUNTS OF TRUST WITH OUR PATIENTS SO THERE ARE SOME THINGS WE MAY BE ABLE TO DO QUICKLY WITHIN THE PROJECT. >> GOOD MORNING, ADAM, CHIEF OPERATING OFFICER OF THE AMERICAN SLEEP AM KNEE A ASSOCIATION. THE DISEASE I SORT OF REPRESENT IN THIS WORLD SORT OF PARALLELS THE HEALTHCARE SYSTEM IN THAT FRAGMENTED -- [PLEASE STAND BY FOR CAPTIONS] AS A RESULT >> AND WHAT I WANT TO BRING TO ALL OF YOU IS WHAT I KNOW ABOUT S BEEN REFERENCED TODAY.VE, I I AM HAPPY TO SAY I HAVE HAD BLUE BUTTON ON MY LAP EL. THIS MISSION IN 2010 IS BASED ON GIVING EVERY AMERICAN A RIGHT TO ACQUIRE THE PERSONAL MEDICAL DATA FROM BOTH EHR /SKP*PLSZ FROM INSURERS AND WHAT MOST PEOPLE CONKNOW IS APPLICATIONS OUT THERE -- MY COMPANY BUILT ONE -- THAT ALLOWS PATIENTS TO ACTUALLY PULL IN THEIR CODED DATA. THIS MEANS THAT 38 MILLION AMERICANS WHO ARE ON MEDICARE CAN GET THEIR FULLY CODED MEDICAL DATA ON THEIR APP TODAY AND CONTRIBUTE IT TO SUCH AN INITIATIVE. THIS IS AN EXTRAORDINARY RESOURCE. THIS GOES WELL BEYOND GETTING PERMISSION TO AN /AEHR SYSTEM TO PROVIDE YOUR DATA PASSIVELY TO RESEARCH INITIATIVE. NO, CITIZENS CAN ACTUALLY GET THEIR OWN DATA, WITH THEIR OWN APPS AND CONTRIBUTE TO IT IF THE CONSENT PROBLEM IS HANDLED, IF THE INDICADATA USAGE IS DONE CORRECT CORRECTLY. THIS CAN BE ENORMOUS RIIMPORTANT RIIMPORTANT. WE NEED TO /RETHINK A LOT /-OF THESE MOBILE -- I'M SORRY, MOBILE. THEY'RE ON THE SMART PHONE OF OUR CO-CITIZENS 2300 MILLION VONG THAT NOW HAVE SMART PHONES. SO 2300 MILLION STRONG. WE NEED TO THINK ABOUT HOW /TO IN IN/KRORCORPORATE THIS DATA AND TO COME UP WITH SOME COMMENTS THAT BRIEFLY WERE MADE THIS MORNING. A SMART PHONE ESTABLISHES A LINK TIE PATIENT THAT CAN BE USED TO GENERATE LONGITUDINAL DATA AND DATA TYPING OF OUTCOMES OVER TIME. WHILE I'M HERE, I LOOK FORWARD TO THE DISCUSSION. >> AND I'D LIKE TO THANK THE DIRECTOR. I WORK NAN AREA CALLED DATA BINE BINARY NETWORK, WHERE MY JOB IS TO WORK ON THE GOVERNANCE ISSUES ISSUES, INCLUDING SENT AND ALL THE POLICIES AROUND IT. WE WORKED UNDER /THE IDEA OF HAVING ONE OR TWO PEOPLE IN THE LAB ANALYZING INDICATDATA IS A FUNDAMENTALLY BROKEN APPROACH. WHAT WE NEED IS TO LET (S) AN RISE THE INDICADATA IN THE SAME WAY THE COMMUNITIES DEVELOP SOFTWARE. WE SPONTANEITY LOT /OF TIME DEVELOPING TECHNOLOGY AND WE HOST THE ACCELERATING MEDICINE PARTNERSHIPS FOR ALZHEIMER'S DISEASE AND A NUMBER OF OTHER GROUPS. IT TURNS OUT THAT WHEN YOU COLLABORATE WITH OTHER PEOPLE THAT YOU DON'T WORK WITH, THINGS WORK FASTER. BUT IT BECAME PRETTY CLEAR TO FINE-TUNE ENGINES FOR COMMUNITIES TO WORK ON AND THOSE ENGINES ARE DATA FO-- THAT ALLOW PEOPLE TO WORK ON. AND THE EXISTING SYSTEMS MAKE IT REALLY HARD TO INTEGRATE THAT INTO THIS COMMUNITY. SO EARLIER THIS YEAR, WE LAUNCHED TWO STUDIES IN PARTNER PARTNERSHIP WITH APPLE AS PART OF THE RESEARCH KIT RAUNCH. ONE IS IN PARK /KWRO*EUPBZ AND RECOVERY AND BREAST CANCER. WE ALSO BUILT A TECHNICAL INFRA INFRASTRUCTURE AND CONSENT WORK WAS SET UP ALONG ALL FIVE OF THE STUDIES USED BOTH OUR BACK ENDS AND OUR CONSENT WORK. WE'VE USED 5,000 PEOPLE IN THOSE STUDIES WITH VERY LITTLE ADVERTISING SINCE THE INITIAL LAUNCH OF THIS. AND I CAN TALK ABOUT WHERE THE CONSENT USE OF THIS BUT ACTUALLY WHAT'S MORE INTERESTING TO ME IS FIRST WE CAN APPLY PROCESS METHODS FOR ENGAGEMENT. WHICH ARE SORT OF THE CLASSIC WAYS THAT WE HAVE DONE AND WE'VE TALKED ABOUT. AS PART OF THE ECONOMIC METHODS FOR ENGAGEMENT AND GAINS TO GET PEOPLE TO PARTICIPATE IN THESE THINGS. AND SOME OF THE THINGS THAT ARE VERY WELL-KNOWN IN HEALTHCARE BUT USER INTERFACE DESIGN. AND ALL OF THESE TOGETHER COLLECTIVELY FORM /HRAELATE TO DO ENGAGEMENT. NONE OF THEM ALONE WORKS VERY WELL. SO TURNS OUT TO BE /AA REALLY GOOD WAY TO INCREASE INFORMEDNESS IN THE CONSENT PROCESS, WHETHER ON PHONE OR IN PERSON. BUT UNTIL WE CAN ACTUALLY HAVE THE PEOPLE THAT ARE IN THE STUDIES DO THE STUDIES AND CLAY THE PROT /KO*LSZ IN REALTIME TO REFLECT THOSE COMMENTS, YOU'RE NOT ENGAGING THE PARTICIPANTS IN THE STUDY. WE'RE AVERAGING THREE TO TEN COMMENTS PER PERSON /SKWR-PLTS -- IN THE STUDIES. TO /ADD THINGS LIKE TRACK NEW CENTERS. AND MADE A PROMISE TO SHARE ALL THE IN/TPFO WITH THE PARTICIPANTS. THESES ARE ALL DIFFERENT PIZZAS OF HOW WE ENGAGE. IT'S TON TREAT PEOPLE LIKE A RESEARCH FROM WHICH I -- YOU EXTRACT DATA AND MOVE FORWARD. BUT CONSENT IS /THE BEGINNING OF THE WAY TO ENGAGE PEOPLE IN /AA STUDY THAT THEY ACTUALLY HAVE A SAY IN. AND WHEN YOU LOOK AT THE DATA FROM THE VARIOUS STUDIES AND THE SENCENSUS DATA AND THE WAY THAT PEOPLE RA-- ARE PARTICIPATING, THE FACT THAT THEY CAN ACTUALLY REQUEST CHANGES TO THE CLINICAL PROTOCOL, THE FACT THAT THEY CAN GIVE COMMENTS AND IF THEY SEE THOSE KINDS /OF THINGS BEING REFLECTED IN THE STUDY, WITHIN 9 90 CAYS OF THE STUDY LAUNCHING -- THAT'S HOW GET ENGAGEMENT. GOVERNANCE AND ENGAGEMENT ARE SORT OF MATCHED AT THE HIP. AND CONSENT, RESULTS RETURN AS A PIECE, DATA RETURN AS /AEA PIECE -- ALL OF THESE THINGS TOGETHER FORM ENGAGEMENT. BECAUSE AT A CERTAIN POINT EXCITEMENT, GETTING NOTIFICATION NOTIFICATION, CONSENT, PEER INTERACTIONS, ALL OF THIS FADES WAY IN THE DAY /TO*-TO-DAY LIFE AND THAT'S A FACT OF LIFE. HEALTH IS JUST A PART OF IT. SO WE NEED TO HAVE SOME COHESIVE A-- WHOHOLISTIC APPROACH TO THIS THAT WE CAN APPLY OVER A PERIOD OF TIME. THANKS AGAIN. >> THANK YOU ALL FOR YOUR COMMENTS. AND THIS IS REALLY AN EXCITING TOP /KWREUIC AND WE'VE TOUCHED ALREADY ON THE AREAS THAT WE ADDRESSED AT THE QUESTIONS. I WANT TO ASK EACH YOU HAVE TO COMMENT ON WHAT IDEAS DO YOU HAVE TO HELP US UNDERSTAND THE BEST WAYS TO GET GOOD, RICH INFORMATION FROM PEOPLE AND NOT OVERBURDEN THEM IN THE PROCESS? SO JUST START GOING DOWN THE ROW HERE. >> SO FIRST OF ALL, I'D SAY THAT THERE ARE MANY PATIENTS THAT YOU HAVE TO UNDERSTAND THAT THEY DO WANT /TO LEARN AND SOME OF THEM ARE NOT LIKELY TO DO THINGS. AND I THINK DISEASES AND MORE CHALLENGING DISEASES AND THEY'RE NOT -- WE'RE GOING TO UNDERSTAND WE NEED TO BE HELPFUL --FUL. AND THE MORE COMMON AND RARE DISEASE IS YOU UNDERSTAND WHY DATA SHARING BECOMES MORE CRITIC CRITICAL. IF YOU HAVE A COMMON DISEASE, THERE ISN'T -- AREN'T ENOUGH PATIENTS TO GENERATE SAY DATABASE TO UNDERSTAND WHAT'S GOING ON IN THE DISEASE. ONE OF THE CHANNELSS THAT WE HAVE IN A PROJECT LIKE THIS RIGHT NOW IS THAT BEER STILL TRYING TO -- IF WE HAVE PATIENTS SITTING IN /THIS ROOM FOR THE LAST TWO DAYS, THEY ACTUALLY DON'T UNDERSTAND THE MORE SIMPLE PIECE OF THIS, WHICH IS IF YOU DON'T AGGREGATE THE DATA AND AG AGGREGATE EVERYBODY'S DATA, THEN THERE IS NOTHING TO ROOK AT. THERE IS NOTHING TO EP-- LOOK AT TO UNDERSTAND THE BIOLOGY AND WHAT'S GOING ON IN ALL OF THESE DISEASES. THEY DON'T UNDERSTAND THAT WE DON'T HAVE AGGREGATION OF DATA GOING ON RIGHT NOW. AND THE OTHER PIECE IS THEY NEED TO UNDERSTAND, IF YOU AGGREGATE THE DATA, WE START TO LEARN MORE AND MORE ABOUT YOU. SO THE MORE YOU LEARN ABOUT YOU, THE MORE EVENTUALLY YOU CAN GO BACK /SAND LOOK AT THAT DATASET AND UNDERSTAND WHAT YOU SHOULD BE DOING WITH YOUR OWN DISEASE. YOUR REVERY SPECIFIC DISEASE. SO WHAT WE ENDED UP DOING AND WE DON'T WANT /TO TALK ABOUT OUR OWN ISSUES BUT THE ONES THAT ARE CLOSEST TO US BUT I CAN -- YOU CAN APPLY THEM TO ANY EXAMPLE -- WE WENT BACK IN /SAND SAID OKAY, WE KNOW TEN SUB/TAOEUPSZ. WE'RE GOING TO SIFT THEM FOR FOLLOW THEM LONGITUDINALLY FOR AT LEAST EIGHT YEARSS AND COLLECT THE DATA, PUT IT INTO A PUBLIC DO PLAIN, ALLOW EVERYONE TO SHARE IT, TO BE ABLE FIND NEW TARGETS AND ABLE TO THEN WORK WITH COMPANIES TODD NEW TRIALSS IN THAT AREA. SO NOW WORKING AND /AA WHOLE INTEREST IN DATE SETS TO GET TOGETHER. NOW THAT WE HAVE THIS, IT'S ALL ABOUT PATIENT, SO WE REALLY NEED TO START DOING SMALLER INFORMATION AND PUT IT IN RIGHT AND STUDY THINGS LIKE ARE YOU IN REMISSION? THEY CAN'T FIGURE OUT IF THEY ARE IN REMISSION OR COMPLETE RE REMISSION. ONCE YOU START GIVING TH THE QUESTIONS. DO YOU KNOW -- SO YOU HAVE TO GO BACK /SAND FIX THAT PART OF IT. EVENTUALLY YOU HAVE 10% OF PATIENTS THAT ANSWER EVERY ONE /OF THOSE QUESTIONS AND ACTUALLY YOU -- AT /TTHAT POINT WE'VE NOW -- ALL OF OUR PATIENTS ARE PUT INTO A POOL AND IT SAYS YOU ARE B-RAS-POSITIVE. POINT THAT HAVE UNDERSTANDING WHAT'S GOING ON IN THEIR SUBTYPE AND REPOST CLINICAL TRIALSS TO -- SO THAT THAT SUBTYPES, BECAUSE THAT'S HOW YOU PUT ACCEL ACCELERATION INTO THE J NOT ONLY ARE YOU USING A HUGE DATA BANK TO IDENTIFY A TARGET, NOW YOU ARE GETTING CLINICAL TRIALS TO UNDERSTAND THE RIGHT DRUGS FOR THAT TARGET. BUT YOU ARE ALSO TAKING THIS -- THOUSANDS AND THOUSANDS OF PATIENTS WE HAVE AND GETTING THEM TO RAIE THEIR HAND TO SAY I AM INTERESTED IF THAT TRIAL AND CREATING ACCELERATION. BUT I WILL TELL YOU IT'S A LOT OF WORK TO GET PATIENTS. THE FIRST TELLING THEM THAT THEY FIT INTO A BIG /SKPHRAOUPBT MY HE WILL OMA LOOKS LIKE THIS AND THIS IS WHERE YOU ARE. BUT TO ENTER THE NEXT QUESTION ONCE YOU'VE GOT THEM ENGAGED. SO IT IS A PROCESS, BUT WE ARE GOING TO INFORM THEM OF THE BIGGEST ISSUE, WHICH IS WHY DO YOU WANT US, TOO, -- TO HAVE YOUR DATA? WHY IS THAT IMPORTANT? THEY DON'T RELEASES IT'S A PROBLEM. >> THE PROVERBIAL TEXT AKRCRONYM GNAW SEE A /RROT EVERY DAY IS WHAT'S IN IT FOR ME, WI FM. THERE ARE A LOT /OF PATIENTS WHO -- THAT HAVE -- ARE WORKING THREE JOBS AND CAN CARELESS ABOUT RESEARCH BUT THEIR WORLD IS GOING TO AFFECT THEIR CHILD'S LIFE OR THAT OF THEIR FAMILIES OR THAT OF THE WORK FORCE. AS /AA PULMONOLOGIST, WE USED TO SAY WITHOUT INSPIRATION YOU ARE GOING TO WIND UP WITH EXPIRATION EXPIRATION, WHICH IN THE BREATHE BREATHING ROOM THAT MAKESRLOT OF SENSE IF YOU THINK ABOUT IT. SO THERE IS RECRUITING, WHICH IS WHAT THE SOCIAL NETWORKING -- TWITTER, FACEBOOK, WHAT HAVE YOU YOU. THERE IS RETENTION. FUR /TKPWIF YOU ARE GOING TO GIVE, YOU GOT TO GET BACK. SO IT CAN'T BE A ONE-DIRECTIONAL CONVERSATION. IT'S GOT TO BE BIDIRECTIONAL. AND THEN THERE IS SUSTAINABILITY SUSTAINABILITY, AND THE -- I AM HAPPY THAT THE CROWD SOURCING CONVERSATION CAME UP EARLIER IN THAT NOT ONLY SHOULD WE BE CROWD CROWD-SOURCE FOR WHAT THE RESEARCH QUESTIONS SHOULD BE, BUT ULTIMATELY, WE'RE GOING TO CROWD SOURCE HOW /TO FUND THIS RESEARCH. PATIENTS ARE NOT GOING TO WAIT FOR THE TRADITIONAL WORLD TO FUND WHAT THEY WANT TO DO. I'M SURE YOU ALL ARE FAMILIAR WITH THE NOVEMBER CAMPAIGN, THE CAMPAIGN THAT WAS A CROWD-SOURCE CROWD-SOURCING CAMPAIGN THAT GREW FACIAL HAIR IN THE MONTH OF NOVEMBER. IT'S BEEN UP /SAND RUNNING FOR FIVE YEARS. THESE GUYS RAISED $150 AND -- $ $150 MILLION AND FUNDED 80 STUDIES DIRECTLY FROM THE BRICK AND YOU ALL ARE GOING TO START COMING TO THEM AND START LOOKING FOR FUNDING. THAT'S A GAME CHANGER. PUBLIC AND THAT'S WHAT THIS DIRECT DATA IS GOING TO ALLOW US TO DO. THE PATIENTS HAVE CONTROL AND ACCESS TO IT, THEY'RE GOING TO DETERMINE WHO GETS TO UNDER -- USE IT. >> SO I'LL PICK /UP ON WHAT'S IN IT FOR ME? WE LIVE IN A COUNTRY WHERE WE HAVE A TREMENDOUS PROBLEM IN MEDICAL CARE WITH PATIENT SAFETY SAFETY. MIGHT BE 100,000 OR 400,000 PREVENTABLE DEATHS PER YEAR IF OUR HEALTHCARE SYSTEM. AS /AA FEDERAL GOVERNMENT, WE CAN ENGAGE OUR CITIZENRY BY GETTING TH KNOWLEDGE THAT THEY CAN ACCESS MEDICAL RECORDS FROM THE VA, FROM MILITARY TRICARE AND THROUGH MEDICARE. THIS WILL HELP THEM TAKE CARE OF THEIR FAMILIES. YOU CAN KNOW YOUR MOTHER OR MOTHER -- FATHER'S MEDICAL PROBLEMS BY ACCESSING THEIR MED MEDICARE DATA. SO WE HAVE RESOURCE S S IN OUR Y WHERE WE CAN ENGAGE OUR CITIZENS, BOTH TO GET THEM SAFER SAFER, BETTER HEALTHCARE BY ACCESS TO THEIR INFORMATION, WHICH IS KEY. BUT ALSO BY PUTTING THEM IN POSITION TO CONTRIBUTE THAT DATA TO A NATIONAL RESEARCH EFFORT LIKE THE PRECISION MEDICINE INITIATIVE. SO WE NEED TO -- THE WORK WE'VE ALREADY DONE TOGETHER, THE EXTRAORDINARY WORK. WHAT WAS JUST SAID ABOUT CHINA.^ A WHOLE STUDY WAS /TKPWGOING TO FART -- FALL APART AND THEY USED DATA TO PUT IT BACK TOGETHER. WE HAVE THE DATA. IT'S THERE SITTING IN THE RECORD RECORD. LET'S FIGURE OUT HOW /TO TELL AMERICANS THEY CAN GET THIS DATA WITH A -- AN /APP OF THEIR OWN CHOOSING SO THAT WE CAN MAKE OUR CITIZENS CAPABLE OF CONTRIBUTE /THRAG DATA. AGAIN, THEY CAN HAVE THE DATA ON THEIR OWN DEVICE. >> SO I AM GOING TO START BY CHANNELING A/PHAPMANDA -- A VERY DIFFERENT CONVERSATION, WHICH IS HOW DO YOU MAKE PEOPLE PAY FOR MUSIC? HOW DO WE LET PEOPLE PAY FOR MUSIC? AND HOW DO WE MAKE PEOPLE ENROLL IN CLINICAL STUDIES? AND ASK THEM. IT'S REMARKABLE HOW FEW PEOPLE ARE EVER ASKED TO JOIN A CLINICAL STUDY DIRECTLY. BY THE GOVERNMENT. AND SO I DON'T KNOW IF WE LOST TRACK OF HOW IMPORTANT IT IS TO ASK PEOPLE TONE ROLE BECAUSE THAT'S ONE OF THE EASIEST THINGS WE'RE NOT DOING. AND I THINK WE'VE LEARNED FROM THE EXPERIENCE PRELIMINARILY, WHICH IS THEY NEED TO FEEL PROUD TO BE IN A STUDY LIKE THEY ARE REALLY HELPING. THEY WERE IN IT BECAUSE THEY ARE SIMPLE. THEY ARE IN IT BECAUSE THEY ARE HOPEFUL AND WE HAVE TO MAKE THEM PROUD THAT THEY ARE IN IT AND PART OF IT IS MAKING IT EASIER TO PARTICIPATE, THINKING BENEFIT -- ABOUT THE MOTIVATIONS. THAT THE RIGHT-TO-BUY INSURANCE THAT POLITE OTHERWISE BE DISCRIMINATORY BE AVAILABLE TO PEOPLE ENROLLING IN THE DESTROYED.^ THERE ARE VARIOUS IN INCENTIVES THAT ARE AVAILABLE TO US TO GET PEOPLE TO DO THIS. WE NEED TO MAKE IT EASY AND PLAC PEOPLE PROUD AND GIVE THEM IN INCENTIVES. BUT I THINK THE BIGGEST THING WE KEEN TALKING ABOUT IS IT'S GOING TO BE REALLY HARD TO PROMISE THAT THE DATA IS GOING TO BE USED. AND THE BIGGEST THING THAT LEARNED ALONG THE /HRALAST FIVE YEARS OF THE JOURNEY IS /THE IDEA IS THAT THEIR DATA IS NOT MAKING SOMETHING MEANINGFUL HAPPEN. SO SHOWING SAY PATH TO DATA USE THAT'S TRANS/PAEURPPARENT AT THE BEGINNING IS VITALITY. AND THEN AT A REGULAR INTERVAL, SHOW THE RESULTS. EVEN IF THOSE RESULTS -- WE DON'T UNDERSTAND THE RESULTS YET YET. BUT THE MINUTE -- WE DID A LARGE ENOUGH COHORT WITH ENOUGH INFORMATION WITH A SIGNIFICANT NUMBER OF FIRST ORDER INSIGHTS ARE BEGIN TO DROP OUT. WE HEARD YESTERDAY WE CAN PRE- PRE-DIAGNOSE DIABETES INSIDE USING THE GLUC OOSE METERS. I'M PRETTY SURE -- /PWR-RBGT IN IN/EU[INDISCERNIBLE]. IN/EU[INDISCERNIBLE]. THE ABILITY TO SAY HERE IS A ROAD MAP TO GETTING THE INSIGHTS INSIGHTS. HERE IS THE PATH TO ANALYZE THE DATA. HERE'S THE TRANSPARENCY GOVERNANCE OF HOW THEY ARE GOING TO BE ANALYZED, INCLUDING WHEN WE DON'T KNOW THINGS. AND THAT'S OKAY AND THE BIGGEST WAY TO KEEP SOMEBODY WHO IS ALREADY INTERESTED NEN ROMANTIC BECAUSE THEY ARE SICK. THEY KEEP THEM STAYED IN-- EN ENROLLED. IS /THE KNOWLEDGE THAT THEY GET IS DRIVING INFORMATION INTO IN INSIGHT ON A REGULAR BASIS. THAT'S GOING TO BE THE THING THAT'S GOING TO MAKE THESE THINGS STICK, COMPARED TO TRYING TO GET FLY GAME OR WORRYING ABOUT -- THESE PEOPLE ARE IN /TH THIS TO MAKE KNOWLEDGE THEIR -- THAT DATA AND THAT'S GOING TO BE THE NUMBER ONE MOST ENGAGING THING THEY CAN DO. FIRE SIGNIFICANT CHUNK OF THE POPULATION. >> THANK YOU. I'M LOOKING AT THE TIME, AND WE STARTED A LITTLE BIT LATE. WE ACTUALLY HAVE ONLY ABOUT TEN MINUTES BEFORE WE HAVE QUESTIONS QUESTIONS. /SWAOEUPBT TO BE FOCUSED AND PERHAPS ASK QUESTIONS ON HOW ONE PERSON -- TO SPEAK UP /SAND THEN WE'LL TRY TO TOUCH ON OTHER ISSUES. SO IT'S REALLY ABOUT MITIGATION AND THINGS THAT RELATE TO /RE RECRUITMENT OF THE STUDY. I WANT TO KNOW DO ANY OF YOU YOU HAVE EXPERIENCE THAT WILL TELL US HOW GOOD PEOPLE ARE AT PROVIDING DATA? WHAT TYPES OF DATA WILL PEOPLE GIVE US AND HOW GOOD IT IS DOING THAT THROUGH DIFFERENT MEANS? ACTUALLY, GIVING US THE DATA A ASSUME IS IT IS A PARTICIPANT WHO DOESN'T HAVE A DISEASE IRE PATIENT THAT DOES HAVE A DISEASE DISEASE. WHAT CAN WE GET FROM ELECTRONIC MEDICAL RECORD OR FROM SOME OTHER PATIENT-INDEPENDENT -- >> INBIVEN. >> I AM GOING TO CAUTION THE LIMITED NATURE OF THE EXAMPLE. WE'RE COLLECTING SURVEY DATA AND WE'RE SCRAPING DATA OUT /-FOF THE HEALTH APP ON THE PHONE. SPOA QUANTIFIED SUBSET OF INFORMATION ABOUT THE PATIENTS. WHEN -- THE MORE DATA YOU COLLECT. SO IN OUR BREAST CANCER STUDIES, OVER TIME THAT GIVES YOU A SENSE OF COGNITION AND THE TYPE GRAPHIC ERROR RATE OVER TIME. IN THE PARKISON STUDY ONE OF THE THINGS DO YOU IS ASK YOU TO PUT YOUR PHONES INTO YOUR POCKET OR STONES AND TAKE 20 STEPS FORWARD AND 20 STEPS BACK /SAND THAT GIVES US YOUR DATE AND YOUR BRILLIANCE BRILLIANCE. THAT'S A MUCH MORE INVASIVE TEST BECAUSE YOU HAVE TO SORT OF STOP AND TAKE TO STEPS BACK AND FORTH FORTH. AND SO THE LESSON -- AND THE TASK IS UNDER -- THE MORE THE TASK IS UNDER/STKWRAORBGSD THE MORE DATA YOU COLLECT OUT /-OF IT. THE SURVEY IS DONE IN BULK AT THE BEGINNING. AFTER THAT YOU NEED TO GIVE SORT OF CLOSED STYLE STEPS. THAT WORKS PRETTY WELL. AND ANOTHER IS THAT -- THE PEOPLE THAT ARE COMING IN ARE HIGHLY ENGAGED BECAUSE THEY ARE /PWHRAERPBG THE PARK /SO*EUPBSZ COMMUNITY SO WE HAVE A MUCH HIGHER WILLINGNESS TO CONTRIBUTE INFORMATION ON A REGULAR BASIS THAN THOSE WHO CAME IN BECAUSE OF THE PRESS. AND THE CHALLENGE NOW IS HOW DO WE KEEP THE PEOPLE THAT ARE ENGAGED AND GENERATING A LOT OF DATA DOING THAT OVER TIME? WE DON'T HAVE LONGITUDINAL DATA ABOUT HOW TO DO THAT YET BUT THAT'S THE THING WE'RE SORT OF OBSESSED WITH RIGHT NOW. >> BRIEF ADDENDUM. TO GET MEDICARE CLAIMS DATA TAKES US APPROXIMATELY 45 SECONDS TO DOWNLOAD AN APP, MAYBE ANOTHER MINUTE TO PUT IN YOUR MEDICARE-ISSUED CREDENTIALS CREDENTIALS, AND YOU HAVE YOUR DATA. SO IT'S VERY SIMPLE. ANYONE CAN DO IT. >> ARE YOU TALKING ABOUT THE PARTICIPANT FROM THE RECORD -- AS OPPOSED TO /-THE PARTICIPANT -- I THINK THAT'S PROBABLY WHAT WE'RE TRYING GET AT HERE IS WHERE IT'S SIMPLE TO GET IT. >> KATHY WANTED TO SAY SOMETHING. >> ONE QUICK THING IS RAISE /KWRYOUR HAND BECAUSE THE INFORMATION WAS SO CRITICAL AND POWERFUL. SO SOMETIMES YOU USE DIFFERENT IMMEDIAMEDIA TO TRY TO GET TO THESE PATIENTS. AND THE OTHER PIECE IS EVERY TIME YOU GIT -- GET -- GET BACK ON WE HAVE TO REMIND THEM WE DON'T HAVE THIS KIND OF SPECIFIC INFORMATION, BUT -- >> THE CONTENT NAPEOPLE CREATE OUTSIDE OF US IS ENORMOUSLY INDICATIVE OF THEIR THE HEALTH. CAN GET AN ANALYSIS ON GMAIL AND LEARN AN ENORMOUS AMOUNT. IT'S CREEPY. IT'S EXTREMELY CREEPY, BUT THIS IS HOW WE GET SORT OF THE ADVERTISEMENTS FOR /KHRAOEUL WHEN RESEARCHING FOR BACK BAIN -- BACK PAIN. THEY'RE NOT CAPTURED IN THE ORG ORIGINAL HEALTH SYSTEMS. THAT'S ACTUALLY ONE OF THE -- >> ANOTHER TOPIC IS A LITTLE BIT OUT /-OF THE BOX IN TERMS OF INTERACTING, PARTICIPANTS AND PATIENTS INTERACTING THROUGH THE DATA SO WHAT THEY GET BACK, WHAT OTHER PEOPLE KNOW, THE CENTRAL NETWORK DATA. THAT'S THE AN THIS /S*ES OF WHAT WE USUALLY THINK ABOUT IN TERMS OF DATA IS THAT IT'S NOT D BY OTHER PEOPLE DURING THAT TIME REPORT.^ CAN YOU TALK ABOUT THE FACT THAT SOME OF THE DIGITAL DEVICES, THE CAPTURED DEVICES ARE DESIGNED FOR SOCIAL NETWORK LIKE THE EXERCISE IS MONITORS AND SOME OF THESE THINGS. HOW IS THIS GOING TO ENTER INTO THE NEW AGE OF DATA COLLECTION FOR PEOPLE? RAR >> SO IN THE SLEEP WORLD, THE GOLD STANDARDS THAT WERE PRIME PRIMARILY USING C PAP CONTINUOUS S -- PRESSURE, WE -- WHICH MONITORS YOUR SLEEP FROM THE TIME YOU TURN YOUR MACHINE ON, ONSET, HOW LONG IT TAKES US YOU AFALL SLEEP -- ASLEEP. HOW MANY EPISODES YOU HAVE THROUGHOUT YOUR ENTIRE NIGHT HOW MUCH WAKING YOU HAVE AND NORMALLY THE TRADITIONAL WORLD YOU WOULD GO AND SEE YOUR SLEEP DOCTOR OR PRIMARY CARE 90 DAYS LATER AND THEY WOULD LOOK AT YOUR DATA AND HELP AU JUST. . NOW WITH MODERN TECHNOLOGY AND WITH ALL THIS DATA GOING /TOWD FOR ALL THESE MACHINES, YOU SHOULD BE ABLE TO IN REALTIME -- IF PATIENTS WERE ALLOWED TO BY LAW, LOOK AT THEIR DATA, BE ABLE TO FIGURE OUT AND MAYBE THIS ISN'T THE RIGHT MASK /STKPAORPL INSTEAD OF HAVING 90 DAYS /OF INCREMENTAL DECLINE IN THE QUALITY OF THEIR THERAPY, THEY WOULD IN THAT FIRST 24 HOURS, FIGURE OUT THE SOLUTION, OH, THIS IS THE VARIABLE I NEED TO CHANGE AND THEN THE ADHERENCE RATES GO WAY UP. NOW BECAUSE OF THE WAY LAWS ARE WRITTEN, PATIENTS AREN'T THERETO THEORETICALLY ALLOWED TO DOWN DOWNLOAD THEIR OWN DATA AND READ IT. THEY ARE ONLY ALLOWED TO LOOK AT TOTAL USAGE AND LEAKAGE. THEY'RE NOT ALLOWED TO LOOK AND SEE WHAT KIND OF EPISODES THEY ARE HAVING THROUGHOUT THE NIGHT. SO THAT /TPWHREUPBGSZ ENVIRONMENTAL FACTORS AND DEPENDING ON WHAT PART OF THE COUNTRY YOU'RE IN, ALLERGY EXPOSURE. THERE IS A COMPANY THAT NOW IS MEASURING LIGHT SENSITIVITY, TEMPERATURE SENSITIVITY, AND IN IN/KRORCORPORATING ALL OF THAT INTO THE EQUATION, BECAUSE UNTIL YOU LEARN HOW /TO MANAGE YOUR DISEASE DISEASE, YOU CAN'T MANAGE EVERYTHING ELSE IN YOUR LIFE. SO -- >> THIS ISN'T ABOUT TAKING YOUR DATA AND GETTING IT TO COMPANIES COMPANIES. WE NEED TO ACKNOWLEDGE THAT AND IT'S PRIMARILY USED TO STRATIFY US IN WAYS TO SELL US PRODUCTS. AND THE MODEL IS THAT REALLY FRAT -- STRATIFY US FROM A HEALTH PERCESPECTIVE BUT THIS DOESN'T NAPE CULTURAL VACUUM. IT HAPPENS IN THE CONTEXT OF NAS NASA, IT HAPPENS IN THE CONTEXT OF GOOGLE AND AMAZON AND WE HAVE THIS DIFFERENT REGIME THAT A ALLOWS TO US REQUIRE INFORMED CONSENT, IT ALLOWS US TO REQUIRE ENGAGEMENT AND RETURN AND ALL THE THINGS THAT WE'VE LOST AS CONSUMERS. SO IT'S INCREDIBLE WHAT YOU CAN DO WITH THIS THING IN TERMS OF -- IT'S JUST INCREDIBLE. IF YOU DON'T GIVE UP THE ETHICS. YOU ENROLL PEOPLE AND ASK THEM. GOOGLE KNOWS WHERE YOU ARE IN THE BUILDING. I'M NOT KIDDING. THEY KNOW IF IF YOU'RE AT THE DRIVE THROUGH AT MCDONALD'S OR AT THE GYM. FACEBOOK KNOWS THAT BECAUSE FACEBOOK IS TRACKING YOUR LOCATION. THEY'RE A BUSINESS. SO THE CHALLENGE IS HOW DO WE BALANCE THE CAPACITY OF THE DEVICE WITH THE VERY ESSENTIAL AND IMPORTANT TRADITION OF ETH ETHICS AND SENT AND SO FORTH? THERE IS A STARTUP. I COULDN'T FIGURE OUT TO YOU -- HOW TO GET STARTED. OF COURSE MY DAUGHTER IS LINING ME UP /SAND WHEN YOU ARE USED TO IT NOW SO YOU MAINTAIN IT AND YOU KEEP MOVING WITH IT. SO BUT FOR THEM, YOU LOOK AT T AGE DIFFERENCE AND HOW WE'RE ALL GOING TO MANAGE, IT LOOKS LIKE NIGHT AND DAY. I SAY THE SAME THING ABOUT AN E EHER. EVERYBODY ACTS LIKE ALL THE PATIENTS ARE LIVING AND BREATHE BREATHING STANDING AT THEIR EHRS EHRS. EVERY PATIENT SEE GIVES ME THEIR IPAD AND SAYS KATHY, PLEASE TELL ME. THERE IS SO MUCH INFORMATION THERE. I HAVE NO IDEA WHAT TO DO WITH THIS. AND LET ME TELL YOU WHAT ARE TELLER. I LOVE THE BLUE BUTTON. I'M 100% WITH YOU, BUT WE CAN'T PATIENTS TO GO IN /SAND DO THE PASS /TWAORD GET TO THEIR PORTAL PORTAL. SO HOW AIM COMBATING /THAOUFL DATA SO YOU CAN LOOK AT /IT? YOU GET OVERWHELMED, AND I THINK THERE IS THE INNERTIA OF GETTING THINGS STARTED, WHETHER IT'S FIT BIT OR KNOWING YOUR EHR AND THEN IS /THE SIM /PHREUPLICITY OF MAINTAINING IT ONCE YOU'VE GOT PEOPLE ENGAGED AND I THINK THAT'S WHAT WE'RE FACEING THIS WHOLE PROJECT IS /THE INNEERTIA OF GETTING THIS WHOLE PROJECT LIKE WHERE DO YOU BEGIN, SOME AND WE FIND THE PEOPLE THAT REALLY WANT TO DO THAT AND PROBABLY -- YOU FIND WHO WANTS TO SHARE THEIR DATA. YOU START LOADING THEM AND THEN YOU START TO BUILD ON IT AND YOU GET THOSE SHORT TERM LENS AND I THINK WE HAVE TO START FIGURING OUT WHO IS GOING TO SAY I AM DISH REALLY WANT TO DO THIS? I REALLY WANT YOU TO HAVE MY DATA TAKEN. >> THAT'S A TREMENDOUS, IMPORTANT POINT YOU NEVER HAVE TECH COMPANIES HAVE A GATHERING LIKE THIS AND NOT A THIRD OF THE ROOM BE INTERFACE DESIGNERS. BUT WE IP-- IGNORE THE INTER INTER/AOBACTION. THE STUFF WITH CONSENT -- THE REASON IT'S BEEN SUCCESSFUL IS NOT BECAUSE WE'RE GENIUSES. IT'S BECAUSE THEY WERE SOME OF THE FIRST PEOPLE TO APPLY. SO THEY'RE SORT OF A ONE-EYED MAN. AND SO WE NEED TO HAVE INTERFACE INTERFACES THAT ARE SENSEIB TO DIFFERENT POPULATIONS AND DIFFERENT COMMUNITIES. WE NEED TO HAVE ETHNOG GRAPHERS AND /STKOEURPBSZ. THOSE ARE NOT WORDS THAT YOU HEAR VERY OFTEN IN THE HEALTH SYSTEM AND IT'S A STRATEGY -- TRAGEDY. >> SO A QUICK POINT TO /RE/ASSURE THE AUDIENCE. THIS IS A SOUPER COMPUTER IN YOUR HAND /STKPWRUFPLT WANT /TO MAKE IT HIGHLY EN/KREUCRYPTED AND COMPLETELY SECURE AND TOTALLY NON-POROUS, YOU CAN. SO THAT'S VERY IMPORTANT. IT'S SO IMPORTANT THAT -- IT'S SO EN/KREUCRYPTED THAT THERE ARE SOLUTIONSS WHERE YOUR DATA IS ON A LOCK BOX AND GOES NOWHERE. POINT NUMBER ONE. POINT NUMBER ONE -- TWO, THERE ARE DEVELOPERS THAT DO JUST THAT TO -- THAT CURES THE PROBLEM OF -- AND PUTS YOUR DATA TOGETHER NAN EASY WAY AND WE DIDN'T WANT TO TO TEACH OUR PATIENTS ABOUT WHAT'S WRONG THEM AND BY EXPOSE EXPOSING THEM TO THEIR DATA WE START TO DO THAT, THANK YOU. >> OKAY. SO LAST QUESTION AND QUICK ANSWER SO WE CAN GO FLOOD Q /S&A. INTO THE Q /S&A? IS THERE SUCH THING AS TOO MUCH INFORMATION? IS THERE ANY SUCH THING AS TOO THE EXAMPLE IS IN GENETICS K? WHERE YOU FIND MUTATIONS OF CERTAIN SIGNIFICANCE. SO THOSE ARE NOT TRUNCATED MUTE MUTATIONS. THEY MAY BE AN ENHANCER MUTATION OR SOMETHING. I DON'T KNOW AND NONE OF US KNOW WHAT TO DO WITH THOSE. SO YOU HAVE A CHANGE IN GENE X -- NOT A GOOD IDEA. NOW, IF ATS AN ACTIONABLE MUTE MUTATION, THAT'S A DIFFERENT SUBJECT. IF IT'S A MUTATION THAT CLEARLY IS PENETRANT AND WILL AFFECT THE PATIENT'S HEALTH, THEN WE NEED TO HAVE A CONVERSATION ABOUT THAT KIND OF DATA, BUT I THINK WE WOULD AGREE ON THAT. >> IF THERE IS A MUTATION WE CAN ACT ON, YOUR DOCTOR KNOWS THAT AND THEY GET NOTIFIED BY THAT. BUT WE DON'T SEND ALL THE INFORMATION TO THE PATIENTS RIGHT NOW JUST BECAUSE THERE IS NOT A LOT THAT WE CAN DO WITH THE DATA RIGHT NOW THAT HAS INCH IMPLICATIONSS. I WILL, A HOWEVER, THAT WHEN YOU LOOK AT THE DATA, THINGS -- THAT WE WOULDN'T -- WOULD HAVE GOTTEN WITH FARMCA COMPANIES. IN/EU[INDISCERNIBLE] HEAD TO HEAD COMPARISONS. BUT IT'S A CLINICAL ISSUE TO A PATIENT. IT'S REALLY EASY TO DO SO WE NEED TO TALK TO THE ONCOLOGIST AND THAT'S WHERE YOU GET THOSE SHORT TERM IN/PWREUFPB AND PUT IT /STKPHERPLZ YOU START TO MOVE WITH THAT AND EVENTUALLY THE DATE /SKWRA*S GOING TO GET MORE AND MORE TECHNICAL. BUT IF YOU DO ALL -- GIVE ALL THAT HAVE DATA TO THEM AT FIRST, YOU'RE IN/EU[INDISCERNIBLE] BECAUSE THEY'RE SO OVERWHELMED. IT HAS TO BE IN BITE-SIZED PIECE PIECES. >> WE'RE INTERNALLY USING BLUE, GREEN, BECAUSE THE IDEA IS WE SHOULDN'T DECIDE WHAT THE RIGHT AMOUNT IS. WE SHOULD LET THE PARTICIPANT DECIDE WHAT THE RIGHT AMOUNT IS. AND SO SOME PEOPLE DON'T WANT ANYTHING BACK AT ALL, INCLUDING INSIGHTS. SOME PEOPLE WANT AN ANNUAL REPORT. SOME PEOPLE WANT QUARTERLY REPORT AND ACCESS TO EVERYTHING, INCLUDING THE VARIATIONS OF UN UNCERTAIN SIGNIFICANCE. AND IT'S UP TO /THE PATIENT OR THE PARTICIPANT TO DECIDE HOW MUCH THEY WANT. WE PROVIDE THAT TO THEM AT A LEVEL -- IN /AA WAY THAT IS STRUCTURED INTO THE -- FROM EVERYTHING TO NOTHING AND /AA COUPLE /OF VARIATION S IS IN WEN. SO THAT PEOPLE CAN /KHAOFPLT AND DECIDE -- IF THEY DECIDE THEY WANT TO PUT THEIR VARIATION INTO A DIFFERENT STUDY, THEY HAVE THE RIGHT FROM THE VERY BEGINNING TO DO THAT. I CAN TELL YOU OPENING MY FILES WAS THE MOST DEPRESSING EXPERIENCE S S IN MY LIFE.^ A BUNCH OF LETTERS AND NUMBERS. LIKE WHAT DO I DO? SO I THINK THE DESIGN AND INTER INTERFACE AND SORT OF ETHNO ETHNOGRAPHY IS REALLY AND TOO MUCH OF WHAT WE'RE DOING RIGHT NOW IS SORT OF BACK IN THE ENVELOPE DESIGN. >> ADAM? >> I YOU JUST LIKE TO SAY THERE IS ALWAYS A LOT /OF TALK AND RESEARCH ABOUT TRAINING THE PATIENTS. IT PROBABLY FEEDS TO START HAPPENING AS A RESEARCH AND THAT'S TRAINING THE RESEARCHERS HOW /TO INTERACT WITH THE PATIENTS. I KNOW THAT HASN'T BEEN FORMED BUT THAT'S WHERE THE WORL IS GOING. AND IT MIGHT NOT BE A BAD IDEA FOR THIS COHORT TO REALLY CONSIDER THAT, AS BEING THE LEADER. BECAUSE YOU'VE GOT /PH-LSZ OF PEOPLE ON FACEBOOK, /TPWAOLG, TWITSER EVERY DAY AND THEY WANT QUESTIONS AND THEY -- IT NEEDS TO BE /AA TWO-WAY CONVERSATION AND IT'S STARTING TO HAPPEN, BUT NOT AT THE SPEED THAT SOCIETY'S GROWING AT. >> FOCUSES, IN/EU[INDISCERNIBLE]. PLEASE COME TO THE MICROPHONES WITH YOUR QUESTIONSS. IF YOU HAVE A MICROPHONE IN FRONT OF YOU. >> HARD TO HEAR. SO MY QUESTION TO YOU IS CHRIS, REGARDING USE OF BLUE BUTTON DATA AND ANYONE WHO HAS AN EXPERIENCE WITH IT, HOW MANY SYSTEMS DO YOU SEE THAT IS ACTUALLY PROVIDING COMPLETELY RECORDS AS OPPOSED TO JUST AN ENCOUNTER WITH THAT DATA? AND IN/EU[INDISCERNIBLE]? AND SO I'M CURIOUS ALSO HOW MUCH DATA YOU ARE GETTING OUTSIDE OF ETHICS IN/EU[INDISCERNIBLE] ET CETERA CETERA? >> SO IN/EU[INDISCERNIBLE]. WE DO HAVE IN/EU[INDISCERNIBLE] THAT SUPPORT THE STREAMS OF DATA USING -- CALLED DIRECT. IT ACTUALLY DOES WORK /SAND CAN WORK AND WILL WORK TO SECURELY GIVE INDIVIDUALS SUMMARY STRUCTURED DATA, CALLED CDA. I'VE HEARD COMPANIESS SAY NO, IT'S TOO SHORT. SO IN/EU[INDISCERNIBLE] PRETTY GOOD AND IT'S WHERE WE ARE TODAY. THIS IS A REALLY KEY POINT IN RESEARCH AND IN LIFE. WE NEED TO USE THE TOOLS WE HAVE TODAY TO MAKE PATIENT CARE -- AND TO GET THIS INITIATEIVE RESEARCH GOING. WE DON'T HAVE TO BE LIMITED TO THE VA DATA BUT IT HAS A CERTAIN BIAS. SO ETHICS RIGHT NOW TODAY. USES DIRECT AND RECORDS AND VE DEMONSTRATED THAT WITH OTHER EHR COMPANIES OF IN/OP INOPERABILITY. IT'S JUST STARTING. WE NEED TO PUSH IT. THANKFULLY THE DOCTOR IS PUSHING IT LIKE /SKPRAEZ THERE IS REALLY HOW WE'RE GOING TO MAKE PROGRESS. WE DON'T HAVE TO WAIT FOR FIRE. THAT'S TWO OR THREE YEARS DOWN THE ROAD. WE CAN DO A LOT NOW. >> I'D LIKE TO /EBEXTRAPOLATE A LITTLE BIT FROM SOME THINGS I'VE HEARD HERE AND IN THE CONFERENCE IN GENERAL IN TERMS OF PATIENT ENGAGEMENT, THE OWNERSHIP OF DATA BY THE PATIENT, ET CETERA AND ACTUALLY SOMETHING THAT'S HAPPENED ON -- OVER /THE /HRAFLAST FEW YEARS THAT I'VE HAD MANY PUBLIC AND PRIVATE DISCUSSIONSS WITH JAY ABOUT. MY CONCERN IS THAT IT'S HARD ENOUGH FOR PATIENTS TO INTERPRET THEIR OWN DATA, KATHY, AS YOU POINTED OUT, WHEN THEY GET ACCESS TO -- A CONCERN IS IF PATIENTS HAVE ACCESS TO /TTHAT DATA AND IT'S THEIR DATA AND CAN BRING CONTINUE OUT AND GET TOGETHER IN GROUPSS AND ANALYZE THE DATA WITHOUT RESEARCHERS S AND POTENTIALLY SOCIAL IMMEDIAMEDIA PUBLICIZE THE DATA AND DO STUDIES -- THAT COME TO CONCLUSIONS THAT ARE POTENTIALLY NOT WRONG BUT DANGEROUSLY IN INCORRECT. AND I'LL USE AN EXAMPLE. THERE IS A FAMOUS STUDY OF SOME WORK THAT WAS DONE AT THE BEGINNING OF STATINS WHICH SHOWED THAT PATIENTS WERE PUT ON STAT /KWREUPBSZ AND ACTUALLY DID /STHRAEUPBGS WORSE IN TERMS OF CARD /KWRO /SRAFIOVASCULAR OUTCOMES S AND UNTIL WE DID A MATCH AND IT COMPLETELY REVERSED ITSELF BECAUSE OBVIOUSLY THE SICKEST PATIENTS, THE PATIENTS WHO NEED THE STAT /KWREUPBSZ WERE STARTED TON. AND SO HOW DO WE STRIKE A BALANCE, AND IN WHICH WE EMPOWER PATIENTS AND GIVE THEM ACCESS TO DATA BUT PREVENT US BEING IN/UPB INUNDATEED WITH JUNK SCIENCE ESSENTIALLY? >> ONE /WAWAY IS LOOKING AT THE PATIENT GOODS WHERE WE CAN. FOR EXAMPLE, THERE ARE MANY, MANY PATIENTS ON FACEBOOK, AND THEY'RE ALL TALKING AND SOMETIMES I MAY EVEN GO OH, THAT'S NOT WHAT I PUT. EXPECT THEM TO BE DOING. I THINK SOME OF THE THINGS WE'RE PUTTING IN PLACE -- PLAY WITH -- RAA GATE WWAY WHERE PATIENTS GO MR. AND SIGN IN. WE GET A /ROERESEARCHER THAT IS A ASSIGNED TO /TTHAT GROUP AND IS A ASSIGNING THE DATA. THEY ARE UPDATEING THAT INFORMATION DIRECTLY AND THEN THE PATIENTS CAN CHIME IN. WE TRY TO MANAGE THAT AND WHAT I DO FIND IS FOR ALL THE PEOPLE ON FACEBOOK THAT ARE CHATTING, SOMETIMES THEY'LL COME BACK AND -- THIS IS THE RIGHT INFORMATION INFORMATION. SO WE ARE TRYING TO BUFFER THAT. BUT THAT PART IS SAY CHALLENGE BECAUSE YOU KNOW THEY'RE GOING TO GO DIRECTLY TO FACEBOOK AND YOU ARE TRYING TO MOVE THEM INTO THE RIGHT SPACES. >> IT'S CLAUDIA. HI. JOHN, I'D LOVE TO HAVE YOU VERY INTRIGUELY TALKED ABOUT THE ELEMENTS OF GOVERNANCE OR THE ELEMENTS OF DATA RETURN, ABILITY TO SHAKE THE PROTOCOL. AND WOULD JUST LIKE TO ASK YOU TO TELL A LITTLE BIT MORE OF WHAT YOU SEE THOSE PIECES BEING AND IF WE HAVE TIME, ABOUT WHETHER THEY'VE ALSO USED THE SAME PRINCIPLES IN THE WORK THEY'VE DONE. >> SO WE'RE A NON--PROFIT AND WE HAVE A VERY SPECIFIC SET /OF BIASES THAT INFUSE OUR GOVERNANCE AND EVERY FORCING -- ORGANIZATION IS GOING TO HAVE BIAS THAT INFUSE THEIR GOVERNANCE. WE TRY TO BE TRANS/PAEURPPARENT ABOUT THEM. OUR GOVERNMENT IS SET UP TO TRY TO CREATE AS MANY INSIGHTS AS POSSIBLE. SO WE HAVE A SET /OF GOVERNANCE TOOLS THAT GOVERN THE DATA USE COMMUNITY. THIS HAS -- PRIVACY POLICY FOR USERS AND WE HAVE A SET /OF TOOLS THAT WE USE TO /TRAOTRY TO INCREASE THE ODDS THE OF PEOPLE UNDERSTANDING THOSE. SO FOR EXAMPLE, WE WITH DON'T LET PEOPLE UPLOAD DATA TO OUR SYSTEM UNTIL THEY UNDERSTAND THE IMPLICATIONS OF UPLOADING HUMAN DATA TO THE CLOUD, THAT CUT OUR UPLOADERS FROM ABOUT THE 9,000 TO 700 WHEN WE IMPLEMENTED THAT. IT'S BEEN VERY EFFECTIVE. WE ARE LOOKING AT SOMETHING SIMILAR THAT WILL ALLOW PEOPLE TO ACCESS DATA COHORTS OUT /-OF OUR STUDIES TO IDENTIFY YOURSELF TO USE THE DATA. JUDE -- YOU'D HAVE TO TAKE AN OATH OR MAYBE EVEN A VIDEO OATH WHERE YOU AGREE TO BASICALLY NOT BE A /SKPWRERBG NOT HARM AND RE REIDENTIFY BECAUSE THOSE ARE TOOLS THAN A CREASE THE ODDS THAT THE DATA USE IS ETHICAL AND THAT THE USEERS COMPLY WITH THE IDEA OF DATA RETURN. AND NOT HAVE THE GOVERNANCE OVER DATA COLLECTION, WHICH IS TRYING TO MAKE /SHAOSURE THAT PEOPLE ARE AS INFORMED AS POSSIBLE. SO WE HAVE LEGAL DOCUMENTS WITH IKE /O*PBSZ, LEX -- TEXT LABELS AND A HIKERARCHY STRUCTURE THAT HAS BEEN PROVEN TO COMMUNICATE CONCEPTS. WE OPENED THESE THINGS SO THAT YOU CAN GRAB THEM. THEY'RE NOT METHODS OR PRODUCTS OR PLATFORMS. THEN WE HAVE TECHNICAL GOVERNANCE, WHICH IS API MONITORING AND USER MONITOR MONITORING AND LOCK THEIR ACCOUNT DOWN AND ASK THEM WHY, WHAT THEY'RE DOING? ON TOP OF THAT WE HAVE PROCESS- PROCESS-BASED GOVERNANCE TO MAKE SURE PEOPLE WITHIN THE ORGANIZATION DON'T HAVE THE RIGHTS TO ACCESS THE DATA SO I CAN'T SEE THE STUDY DATA BECAUSE MY IDS DON'T ALLOW ME BECAUSE I AM NOT PART OF THE ORGANIZATION THAT NEEDS TO ANALYZE THE DATA. SO TO US, THAT'S SORT OF THE MIX IS IN/TPORFORMING THE PARTICIPANTS, BECAUSE THE WORST PART IS TO PROVIDE DATA TO THE STUDY AND THEN RECEIVE INSIGHTS BACK. SO WE HAVE THE INTERFACE TOOLS. WE HAVE ASSESSMENT TEST. WE SEUSS THE SURVEYS AND THE APP APPS TO /TRAOTRY TO ASSESS. WE HAVE THIS MIXTURE OF PROCESS, TECHNOLOGY ON THE ACTUAL DATA USE SIDE AND WE SORT OF /TKPHAEUB REGULAR GROUP INSIDE THE DATA SCIENCE, CLINICAL SCIENCE, IT AND GOVERNANCE FORGOT TO MAKE /SHAOSURE THAT WHAT WE ARE DOING IS COHESIVE ENOUGH. AND ON TOP OF THAT WE MAKE SEWER THAT EVERY STUDY WE RUN HAS THE ABILITIES FOR FREE-TEXT COMING IN FROM THE PARTICIPANTS THEMSELVES. BECAUSE THEY TELL US THE PIECES A PRETTY REGULAR BASIS. MISSING >> THANK YOU. WHO IS OUR TIME CHECK? WE'RE ALMOST AT 11:00. WE HAVE THREE PEOPLE STANDING. CAN WE TAKE THOSE THREE QUESTIONS? THANK YOU. >> MY NAME JOHN BIRCH AND I'M AN -- I AM TRYING TO GET A GRASP OF THE PROBLEM, ADAM, THAT YOU JUST REFERRED TO THIS MORNING ABOUT THE DATA NOT BEING AVAILABLE, THE DATA FROM THE MACHINE THAT THE COMPANY COMPANIES THAT MAKE /THE DEVICES AND MUCH MORE OF THE APNEA OR THE C PEPS AND I KNOW THAT'S A RIGHTS PROBLEM AND I AM TRYING TO GET ACROSS HOW WIDESPREAD A PROBLEM THAT IS. I WAS ASTONISHED BLACK GREEN SAID THERE IS 97,000 TWIDEVICES AND APPS OUT THERE. THAT'S EVEN A LARGER NUMBER I KNEW, AND I'M SURE IN THE -- THIS WHOLE TOP /KWREUIC WILL GO ON. DOES HIPAA APPLY HERE? ISN'T HIPAA AT LEAST A PARTIAL SOLUTION TO SOME OF THESE? ARE THESE OR ARE THESE NOT COVERED ENTITIES? >> GREAT QUESTION. THE /TP*DC HAS TAKEN THIS ON IN A BIG WAY THAT I WOULD DIRECT YOU TO LOOK AT ON THIS ISSUE. IT DOES NOT COVER DATA PROS ONCE A PATIENT A/KWAOEURSZ THE DATA. SO IF I DOWN/HRAOLOOPED MY DATA AND HIPAA DOESN'T COVER THAT. I THINK YOUR QUESTION MIGHT BE SLIGHTLY DIFFERENT. THE OTHER DIRECTION. DATA GENERATE I HAD ABOUT A DEVICE. >> YES. >> SO IN THE APP WORLD THERE IS THE MANUFACTURER, THE DMA AND THE PATIENT. THE MANUFACTURER CAN'T SELL DIRECTLY TO THE PATIENT. WE WANT /TO /AFBADVOCATE FOR THAT BECAUSE SOMEBODY WITH 20 HOURS OF TRAINING AT A DME /TPHOESZ BEST WHAT THIS PATIENT /HREUFSZ WITH THIS DISEASE FOR AS /HROPLONG AS TIME GOES ON. WITHOUT THE GRID, I AM A DEAD MAN. THE FACT THAT -- COMING OUT WITH HOME BATTERIES IS /THE BEST NEWS BECAUSE MY BIGGEST FEAR IS NATURAL DISASTER STORM AND I CAN MANAGE MY LIFE. SO MANUFACTURERS ARE PATIUTTING A LOT OF DATA UP IN THE CLOUD, BUT IS IT THE MANUFACTURERS' DATA? OR IS IT OUR DATA? THAT HASN'T BEEN ANSWERED VERY CLEARLY. >> OKAY. I /TKPWGUESS THIS IS A COMPLEX QUESTION. BUT I WANTED TO THROW OUT THAT ALSO SAID THAT PART OF THE -- IN IN/EU[INDISCERNIBLE] THEY AREING ABOUT TO TRY TO MAKE MORE AND MORE DEVICES NON-FDA -- NOT REQUIRING FDA APPROVAL, WHICH WOULD MEAN PRESUME /A*ABLY THAT THEY ARE NOT GOING TO BE COVERED ENTITIES FOR SURE? I DON'T KNOW. I JUST WANT TO POINT OUT THAT I THINK THIS IS A VERY CRITICAL COMMON QUESTION THAT NEEDS TO BE CLARIFIED AND AS IT RELATES TO THE PROBLEM OF INNERTIA AND /AEA WHOLE HOST OF OTHER THINGS WHICH I THINK COULD IMPEDE PROGRESS. >> THE VAST MAJORITY OF THESE APPS -- DEVICES ARE SORT OF DIFFERENT FROM APPS FOR THE MOST PART BUT THE VAST MAJORITIES OF THEM FALL UNDER F /T-FPT /KR*E AND NOT UNDER HIPAA. IN/EU[INDISCERNIBLE]. AND THEN THE FDA-REGULATED DOESN'T NECESSARYSLY CREATE HIP HIPAA. HIPAA IS A TREATMENT SYSTEM AND A PAYMENT SYSTEM, NOT THE UNDER UNDERLYING NATURE OF THE DATA. SO THE GENERAL ANSWER THAT WE'VE COME ACROSS IS NO FOR THE MOST PART. THE DEVICES AND THE APPS CREATING DATA THAT IS OUTSIDE OF HIPAA AND THEREFORE OUTSIDE OF THE LEDGISLATIVE RIGHTS S WE HAVE TO ACCESS. AND -- >> AND WHEN THIS COMPANY GETS SOLD, DOES -- IS /THE DATA GOING TO BE ONE OF THE CORE ASSETS? I REALLY APPRECIATE THIS ENTIRE MEETING. IT'S OPENED UP A BUNCH OF QUESTIONS FOR NOT ONLY RESEARCHERS BUT THE PATIENTS. THE POINT I THINK WAS BROUGHT UP BY SADDAM -- ADAM OR KATHY WAS TRAINING THE PATIENTS AND RESEARCHERS. PERHAPS THIS SWEET SPOT IS /THE RESEARCHERS THAT BECOME PATIENTS PATIENTS, BECAUSE THEY BECOME VERY PROACTIVE AND WANT -- IN WHAT THEY ARE STOCKING AND THEY RELEASES IMMEDIATELY AS /I DID WITH MY SON, MY SON WAS DIAGNOSED WITH NEWUROBLAST /OEPOMA. I'M A CANCER GENETICIST AND MY HUSBAND AND I PERFORMED A PRECISION MEDICINE APPROACH TO HIS TREATMENT. WE DENIED STANDARD OF AIR AND BONE MARROW TRANSPLANT BECAUSE HE WAS NEGATIVE FOR THE MARKERS OF NEWUROBLAST /OEPOMA. DESPITE THE FACT THAT HIS PA THOLOGY SAID HE IS HIGH-RISK. TODAY TEN YEARS LATER HE IS A HEALTHY 11-YEAR-OLD BOY WITH NO LONG TERM SIDE EFFECTS. HOWEVER, I'VE NOTICED THE TREATMENTS WE'VE USED ON HIM. HE WAS SLATED FOR LIEU /KAOEEUKEMIA AND EVERYTHING ELSE DOWN THE ROAD IF HIS EARLY ADULTSHOOD. RESEARCHERS ALSO UNDERSTAND THE ESSENCE OF TIME. WE DON'T HAVE TEN YEARS. WE NEED TO SHARE DATA AND SAMPLES. SO I ASKED THAT THE COMMUNITY /RAEFPSZ OUTS TO RESEARCHERS TA TAWERE PATIENTS OR PARENTS OF PATIENTS TO HELP YOU GUIDE WHAT YOU ARE DOING TO MOVE FORWARD. BECAUSE WE UNDERSTAND ISSUES ON BOTH SIDES. ANOTHER THING I WANT TO MENTION IS THAT WE'RE TALKING ABOUT DEVICES. AND I HAVE A CELL PHONE THAT COST ME $200 A MONTH, AND HAVE DATA COMING IN /SKAND COMING OUT, AND WE HEARD YESTERDAY 250 PER PATIENT. THE DEVICES WE ARE TALKING ABOUT ARE EXTREMELY EXPENSIVE. SO HOW DO WE GET THOSE AREASS IN RURAL AREAS THAT DON'T HAVE ACCESS OR THOSE IN SOBEIOECONOMIC SOCIOECONOMIC-COLLAGEED AREAS TO BE ABLE TO HAVE ACCESS TO THESE DEVICES AND BE ABLE TO LEARN HOW TO USE THESE DEVICES? IN SAN DIEGO, WE HAVE MANY FAMILIES THAT DON'T HAVE COMPUTERS. THERE ARE NON-PROFITS THAT RE REFURBISHISH SCIENCE COMPUTERS AND GET THEM OUT TO FAMILIES AND TEACH THEM HOW TO USE IT. WE TALK ABOUT REACHING OUT TO RURAL AREAS AND SOBCIOECONOMIC AREAS, BUT WE ALSO TALK ABOUT VERY EXPENSIVE DECISION -- DEVICES AND HOW DO WE BRIDGE THAT GAP? >> SO WITH RESEARCH -- IS SURPRISINGLY WELL-DISTRIBUTED AMONG DIFFERENT SOBCIOECONOMIC CLASSES AND DIFFERENT BACKGROUNDS. IT'S REALLY QUITE SLOG. OLD WHITE GUYS CATCH OTHER -- YOUR POINT, THOUGH, IS WELL- WELL-TAKEN ABOUT THE DIGITAL DIV DIVIDE. I THINK MOBILE DEVICES ARE STARTING TO /TKHAOUR WHY YOU CAN GO TO BEST BUY FOR $00 AND GET THAT DEVICE. THAT'S LESS EXPENSIVE THAN WHAT WE ARE GIVING PATIENTS ON A PER- PER-MONTHLY BASIS. I THINK THAT -- MOBILE DEVICES AS THE WAY TO CON/SSER -- CONQUER THAT PROBLEM RATHER THAN BEING A PART OF THE PROBLEM. >> THE DEVICE ITSELF. COMMUNITIES HAVE DIFFERENT REACTIONS TO BEING SUR VEILED. I WORK WITH SOME PEOPLE IN BROOKLYN THAT DO ENVIRONMENTAL AND CLIMATE JUSTICE. YOU NEED TO BE EM/PWBED IN THE COMMUNITY THIS GETS BACK TO CULTURAL SENSITIVITY TO UNDERSTAND WHAT ARE THE MECH MECHANISMS FOR COLLECTION THAT ARE CULTURALLY APPROPRIATE FOR VARIOUS GROUPS BECAUSE WHAT THE PHONES WILL GIVE US AND PEOPLE ARE UN-- COMFORTABLE WITH STONES AND THAT'S BETTER THAN THE BIAS WE HAVE NOW, WHICH IS PEOPLE WHO KNOW ABOUT CLINICAL STUDIES. BUT THERE NEEDS TO BE /AA VERY MULTI/SRAR /KWRVARIATE ETHNOGRAPHIC A APPROACH TO THE WAY THAT WE TRY PUSH THIS OUT INTO DIFFERENT COMMUNITIES. >> OKAY, A QUICK COMMENT AND A QUESTION. >> ONE QUICK COMMENT. I THINK IN ORDER FOR PATIENTS TO UNDERSTAND PRECISION MEDICINE -- THE PRECISION MEDICINE AND THEN GET THOSE STORIES OUT THERE BECAUSE I THINK ANGELINA JOLIE PROBABLY EDUCATED MORE WOMEN ON PRECISION MEDICINE THAN ANYBODY AND PEOPLE THAT PEOPLE ARE GOING TO TRUST TO EXPLAIN WHAT WE'RE REALLY TRYING TO DO HERE. >> YEAH. RARE COMMENT AND THEN SORT OF A QUESTION. I THINK THIS PANEL IS GREAT. SOME OF THE THESE -- SOME OF THESE IDEAS WORK FROM A PATIENT PERCESPECTIVE AS WELL AS NEW TECHNOLOGY. THERE IS A -- THERE ARE REAL POSSIBILITIES HERE THAT I CAN'T EVEN BEGIN TO IMAGINE THAT YOU HAVE ALREADY BEEN WORKING WITH. I WANT TO KNOW SPECIFICALLY ABOUT SORT OF THE STUDY PROCESS CONFRONTING SORT OF THE DIYNAMIC NATURE AND RETURNING DATA AND THAT TYPE OF THING. JUST AS AN EXAMPLE, WE'VE BEEN DOING THIS IN A STUDY THAT I HAVE WHERE WE'VE BEEN FOLLOWING KIDS. THERE WERE -- THEY WERE SIX AND SEVEN YEARS OLD AND FOLLOWED LE BY -- FOR TEN YEARS NOW. THEY GOT A LITTLE BIT OLDER. SO THEY ACTUALLY LET THEM LOOK AT OUR QUESTIONNAIRES AND GIVE US FEEDBACK AND THEY SAID WHY DON'T YOU ASK THEM ABOUT ALCOHOL ALCOHOL. WE SAW KIDS LIKE 11 AND 12 YEARS OLD AND TELLING US WE SHOULD BE DOING THIS. SO WE ACTUALLY DID SOME OF THOSE THINGS. WE DIDN'T DO EVERYTHING THAT THEY SUGGESTED BUT IN OUR CYCLE, IT TAKES A LOT LONGER TO IMPLEMENT THESE CHANGES BECAUSE IRB, I WITH ONLY MEETS ONCE A MONTH, DOESN'T REQUIRE EVERYTHING. SO SOME OF THE QUESTIONS ABOUT POLICY CHANGES AND INTERPRETATION OF REGULATIONS ON AN INDIVIDUAL INSTITUTIONAL BASIS. AND THEN WE HAVE BEEN GIVEN INDIVIDUAL RESULTS OF BIOMARKER MEASUREMENTS. EVEN THOUGH WE DON'T KNOW WHAT TO DO WITH TA. SO I THINK IT GOES BACK TO THIS QUESTION DO WE GIVE BACK ONLY ACTIONABLE INFORMATION OR NOT? GETTING TO THE QUESTION, WHICH YOU DON'T HAVE TO ANSWER. AS RESEARCHERS AND FOOD AND NUTRITION, HOW CAN WE LEVERAGE THESE TECHNOLOGIES TO ACTUALLY CAPTURE WHAT PEOPLE ARE EATING BETTER? THERE HAS BEEN A LOT /OF PROGRESS IN THE PHYSICAL ACTIVITY SPACE, BUT I DON'T KNOW ABOUT THE FOOD AND NUTRITION SPACE. >> I AM ACTUALLY GOING TO JUMP IN HERE BECAUSE WE'RE RUNNING WAY OVER TIME NOW AND WE'RE GOING TO HAVE A WORKSHOP DEVOTED TO THESE TOPICS IN JULY. AND WE CAN WRAP UP. >> IT'S AMAZING HOW MUCH YOU CAN GET INTO AN HOUR AND HOW MANY NEW QUESTIONS YOU CAN GENERATE. I REALLY WANT /TO JOIN YOU IN THANKING OUR PANEL. [APPLAUSE] >> I HAVE THE PLEASURE OF INTRODUCING THE LAST PANEL STUDYING MODELS WHICH HAS BEEN CALLED A RELIGIOUS DISCUSSION, I THINK TWICE YESTERDAY. SO PERHAPS WE'LL HAVE A PASSIONATE DISCUSSION HERE. WE HAVE THREE DISCUSSIONS HERE. JEFF BROWN, MARK AND JOHN WELSH. I'LL LET EACH OF THEM INTRODUCE THEMSELVES AND SOME OF THE INITIAL VIEWS. EACH OF THEM HAS AS A PERCENT PERSPECTIVE DRIVEN BY THEIR OWN EXPERIENCES. JEFF? >> SO IT ACTUALLY SOUNDS LIKE -- DIDN'T HAPPEN. SO IT SOUNDS LIKE, JUST TO GET YOUR POINT, JOSH, WE STARTD TO SETTLE AROUND A PRETTY CLEAR -- WE'LL JUST CALL IT HYBRID A APPROACH -- BUT I DIDN'T HEAR THE BATTLES YESTERDAY AS MUCH AS I KIND OF EXPECTED. SO WE'LL SEE WHERE THIS GOES. I'LL INTRODUCE MYSELF. SO I POPULATION MEDICINE AT /HAFRPD CARE INSTITUTE, WHICH IS -- ASSOCIATE PROFESSOR OF MEDICAL SCHOOL. A TEAM OF 20 DISTRIBUTED NETWORKS OVER MY TIME OVER /THE LAST -- YEARS. ALL DISTRIBUTED ALL FOR DIFFERENT PURPOSES AND I AM GOING TO QUICKLY GO THROUGH A COUPLE AND PROVIDE SOME FRAMING OF HOW YOU HARD IT ISING ABOUT TO BE WHAT /YOU ARE DOING BUT NOW PERFECTLY POSSIBLE IT IS TO ACHIEVE THESE GOALS THAT ARE BEING LAID OUT. SO A COUPLE /OF NETWORKS. ONE, SENTINEL. THE ASSOCIATE DIRECTOR. WHAT I'M REALLY RESPONSIBLE FOR IS /THE DAY /TO*-TO-DAY OPERATIONS. SENTINEL IS FINDED BY FDA WITH A VERY CLEAR MISSION OF SAFETY QUESTIONS QUICKLY. WHEN SOMEONE AT /PA*D CALLS, WE HAVE TO BE ABLE TO ANSWER THEM IN DAYS, NOT MONTHS, NOT ANSWERS -- YEARS. SO IT IS A VERY CLEAR-FOCUSED MISSION FOR US AND WE HAD TO BUILD A SYSTEM THAT MET THOSE NEEDS. SOME OF THOSE NEEDS ARE -- IN IN/EU[INDISCERNIBLE]. YOU HAVE TO HAVE --. SO THAT DRIVES THE KINDS OF DATA YOU USE. SPEED WAS IMPORTANT, SO WE HAD TO BUILD A WAY OF ANSWERING QUESTIONS QUICKLY. THE NUMBER OF USERS WERE IMPORTANT. SO REALLY IN ONE SENSE THERE IS ONE USER, THE FDA. IN ANOTHER SENSE THERE ARE THOUSANDS OF USERS, WHICH RAALL THE PEOPLE AT FDA WHO COULD PICK UP THE PHONE AND ASK US A QUESTION. IN REALITY, WE CAN HAVE THOUSAND THOUSANDS OF PEOPLE ASKING QUESTIONS. THOSE QUESTIONS THAT HAVE A COORDINATING AND THAT IS THE ACTUAL GROUP THAT ANSWERS THE QUESTIONS. SO THAT'S HOW WE ORGANIZE THAT. THAT'S A TRACE BASED ON THE DESIGN REQUIREMENT. IT DIDN'T HAVE TO BE THAT WAY, BUT IT MADE SENSE TO DO THAT FOR FDA. WE HAD A VERY HIGH PRIORITY ON DATA QUALITY BEFORE WE USED THE DATA. YOU HAD -- IF YOU WERE GOING TO ANSWER QUESTIONS TOMORROW, YOU CAN'T START LEARNING ABOUT THE QUALITY OF THE DATA THAT DAY. YOU HAVE TO DO THAT WORK UPFRONT BECAUSE THAT'S A REQUIREMENT. I WILL QUICK RILOVE TO ANOTHER NETWORK ISSUE. WE ALSO HAD THE MASSACHUSETTS PUBLIC HEALTH NETWORK SET THE PROVIDERS OF MASSACHUSETTS. THAT NETWORK'S BASED ON EHR DATA DATA. THE IDEA IS REPORTING TO THE STATE. THEY UPDATED THE DATA EVERY NIGHT. IF SOMEONE HAS HEPATITIS, YES OR NO, IF YES, SEND TO STATE. THAT'S A REQUIREMENT. TOTALLY DIFFERENT DATA MODEL AND STRUCTURE. EVERYTHING IS DIFFERENT ABOUT THAT. IT'S STILL A CONTRIBUTED NETWORK. AND I AM NOW ALSO AT THE COORD COORDINATING CENTER FOR POCORM POCORMICK, WHERE WE HAVE -- OUR REQUIREMENTS ARE A LITTLE MORE DIVERSE, WHICH IS OBSERVATIONAL STUDENTS -- STUDIES -- THERE LABOR LOT /OF USERS AND TO SUPPORT PRACTICING /PHGMATIC CLINICAL TRIALS AND THOSE TWO AREN'T EASY TO A/SPRAOEUPB THAT'S ONE OF THE STRUGGLES BUT IT'S A DIFFERENT SET OF DATA REQUIREMENTS. AND WE ARE STARTING WITH EHRS AND ADDING CLAIMS FOR THE LONG LONGITUDE /TPHALT AND COMPLETE COMPLETENESS. TWO DIFFERENT USE CASES SO YOU WILL PROBABLY HEAR ME SAY A LITTLE BIT MORE ABOUT USE CASES AND DESIGN FOR PURPOSE. I WON'T TELL UT PUNCH LINE YET. >> SO I AM MARK. I'M A /ROERESEARCHER, GENERAL INTERNIST OF HEART, WHO FOUND IT /AA TOOL TO HELP WITH THAT.^ AND FOUR YEARS AGO MOVED TO INDUSTRY. SO BEEN AT SEMENS AND STILL LEARNING THAT SIDE AND PERCENT PERSPECTIVE OF THE BUSINESS.^ AND LIKE JEFF, HAVE TOUCHED A VARIETY OF NETWORKS AND TOOLS, INCLUDING THE HEALTH INFORMATION KAY -- EXCHANGE AND NETWORK FOR PATIENT CARE, WRITE WE'RE BE -- pWERE CENT RALLY HOSTED FED /RAEERATED MODELS AS WELL AS OTHERS. AND REALLY IT'S INTERESTING THE CONVERGENT -- I THINK WE COULD HAVE INTERCHANGED OUR NOTES AND DONE JUST FINE HERE. I THINK THE MAJOR THING THAT WE DO TO DO HERE IS THINKING -- THINK REALLY /PWHARTD USE CASE. AND THE USE CASE IT SEEMS TO ME FOR THIS P.MI GROUP OF PATIENTS IS RESOURCE THAT WAS USED IS A VERY CLEAR AND SPECIFIC ONE. I'VE GOT THE SAME ONE AS EVERYBODY ELSE. IN THAT USE CASE OF HIGHLY LEVERAGING A RESOURCE OF PATIENTS TO LEARN EVERYTHING WE CAN FROM THEIR DATA IS -- I AM GOING TO PUT SIMPLY -- WILL DRIVE THE ANSWER TO THE QUESTION OF HOW YOU WANT /TO APPROACH MANAGING THE DATA IN TERMS OF FEDERATION AND SIMPLE MANAGEMENT MANAGEMENT.BALANCE BETWEEN THOSE TWO AND I THINK IT'S A BALANCE. IT'S NEVER PURELY ONE OR THE OTHER. >> I'D LIKE TO THANK THE ORGANIZERS FOR /EUINVITING THE PATIENT PERCESPECTIVE CONSISTENT TROUT THE MEETING IN THESE WORK SHOPS AND THE BOLD VISION PROJECTED HERE. WE REALLY THINK IT'S AN -- IM IM/PPERATIVE TO DO. I COME WITH THIS FRAY DITCH PERCESPECTIVE IN THAT I WAS DIAGNOSED WITH A GENETIC CONDITION AND DEFICIENCY AND ACTUALLY DIAGNOSED AT THE NIH IN OUR COMMUNITY WAS AS A RESULT OF A STUDY TO MAP OUT THE NATURAL HISTORY OF /TREUTRYPSIN DEFICIENCY. SO OUR COMMUNITY MET AT STUDY SITES TROUT THE COUNTRY AND E EVOLVED FROM PARTICIPATION IN CLINICAL RESEARCH. SO I THINK THE EMPHASIS ON BUILDING A CULTURE OF RESPONSIBILITY TO PARTICIPATE IN CLINICAL RESEARCH /KP-T VALUE PROPOSITION THAT CAN BE CREATED FROM THAT TYPE OF PARTICIPATION /STKWHRARBGS TYPE OF COMMITMENT IS REALLY CRITICAL FOR US TO FOCUS ON MOVING FORWARD. AND I ALSO THINK THAT THE VALUE OF THE REGISTRY OR DATABASE OR P.MI, PATIENT RESEARCH NETWORK PA PACOR NET IS CRITICAL AND PEOPLE UNDERSTAND THAT VALUE. 890% OF INDIVIDUALS IN OUR -- 80 80% OF INDIVIDUALS AND WE'RE ADDING HEALTHCARE-PROVIDED DATA ON TO THAT DATASET. AND WE CAN RECRUIT FOR PHASE THREE STUDY OF THE CLINICAL TRIAL. SOMEWHERE BETWEEN SIX AND TEN WEEKS IN /AA CONDITION WE'VE IDENTIFIED ABOUT 10,000 INDIVIDUALS ACROSS THE COUNTRY AND WE NEED TO DO THE SAME THING IN COP P. TEN YEARS AGO WE STARTED THE COP P FOUNDATION AND WHAT WE'VE BEEN ABLE TO CREATE. WE CREATED A COP P -- COPD PATIENT REGISTRY. IT NEEDS TO BE BEYOND THAT. WE CREATE AID NON-RESEARCH REGISTRY THAT'S THE LARGEST ONE IN THE WORLD NOW. WE WORKED WITH THE COPD GENE PROJECT, THE LARGEST PROJECT EVER FUNDED BY THE NIH FOR PULL PULMON AARY RESEARCH AND BUILT A COHORT OF 10,000 STUDIES AND THE BENEFIT OF THAT AND WE'RE VERY PROUD TO BE PART OF THE PACORNET PACORNET, A P /P-FPPR N, AND THE VALUE OF BEING ABLE TO RECRUIT FOR, EN ENROLL IN THAT NETWORK IS CRITIC CRLY IMPORTANT TO US. THE FOCUS ON CO-MORBIDITIES WHERE 65 65% OF INDIVIDUALS HAVE SIX TO TEN CO-MORBIDITIES. WE FOCUS ON THE WHOLE PATIENT OR QUERRIES FROM ONE DATASET TO ONE -- ANOTHER, ONE DISEASE CONDITION TO ANOTHER IS VERY IMPORTANT. SO DISCUSSION ON THE CENTRALIZED VERSUS A FED /RAEERATED DATA PLATFORM PLATFORM, IS CRITICALLY IMPORTANT. THE IRB RIGHT NOW IS IN INSTITUTIONAL. /HRAOEURBLT IS NOT RESEARCH PROTECTION. INFORMED CONSENT IS NOT UNDERSTANDABLE AND THIS NEEDS TO BE ADDRESSED AND WE'RE DELIGHTED AS A PATIENT COMMUNITY TO SEE THIS NOW BEFORE LAUNCHING P.MI TO /TREUPSIES ISSUES AND WE'RE HARM HARMONIZED ON THE CLINICAL IMPORTANCE. IF WE RAND /O*OMIZE EHRS, BILLING SYSTEMS, THAT RESTRICTS BEING ABLE TO INTER/TKPWRAEGRATE OR MAKE THEM INTER/OPERABLE, LET'S FIX THAT. IT'S IN/EBEXCUSEABLE THAT WE CAN'T GO TO ONE INSTITUTION OR ONE FACILITY AND NOT BE ABLE TO HAVE ACCESS TO ONE MEDICAL INFORMATION. KATHY AND ADAM NICELY ARTICULATE ARTICULATEED AND WE NEED TO BE INVOLVED IN THE DECISION PROCESS PROCESS. WE HAVE THE CAPABILITY TO BE EDUCATED AND ENGAGED TO BE INVOLVED IN IDENTIFYING RESEARCH OBJECTIVES AND IT'S CRITICALLY IMPORTANT THAT WE HAVE FORMS LIKE THIS AND CARRY FORWARD IN THE COMMUNITY AND BUILD A VALUE PROPOSITION THAT'S MEANINGFUL TO THE INDIVIDUALS INFECTED, WHETHER YOU CALL IT PARTICIPANT, PATIENT ORIGIN PATIENT PATIENT. WE NEED TO BE AT THE TABLE AND WE NEED TO BE PARTICIPATING IN THE PROCESS. SO THANK YOU ALL FOR MAKING THAT HAPPEN AND FOR YOUR COMMITMENT TO /TTHAT. >> THANK YOU. , FOR THAT. SO I THINK I HEARD EVERYONE KIND OF TALK ABOUT A HYBRID APPROACH HERE AND I THINK THAT'S SOMETHING THAT'S COME THROUGH THE /HRALAST DAY AND A HALF. ESPECIALLY IF YOU THINK ABOUT COMBINING RESOURCES ACROSS DIFFERENT DO PLAINS AND INFORMATION THAT BY NECESSAITY WILL COME FROM DIFFERENT PLACES. I AM GOING TO PUSH ON THAT A LITTLE BIT MORE. THERE IS A COMPONENT FOR WHICH, IF WE THINK ABOUT HAVING CENTRALIZATION VERSUS FEDERATION FEDERATION, THAT ANY TIME AUR KRUG AT EACH OF THE SITES, VERSUS BRING THE SITES TOGETHER AND STORING IT OR MAYBE YOU ARE STORING SOME OF THE DATA, WHICH IS ALL OF THE DATA CENTRALLY AND AS WE THINK OF -- I THINK FOR OT RIGHT NOW WE MIGHT WANT /TO FOCUS TOO MUCH ON THE DIFFERENT DO /PHAEUPBSZ OF KNOWLEDGE BUT JUST TO ASSUME THAT WE HAVE SIMILAR DOMAINS OF INFORMATION OR DATA ARE COMING IN /SKAND WHAT THAT WOULD LOOK LIKE AND WHAT YOU GUYS SIT ON THE QUESTION OF EVERYTHING FED /RAEERATED MICK /SKPHR*EU ACTUALLY WANT /TO USE AND SOME CORE ELEMENT. >> WE CAN SHIFT. >> WE CAN SHIFT. >> I WILL START. I DESCRIBED MY LAST TEN YEARS -- WE DEVELOPED SOFTWARE TO MAKE DISTRIBUTIVE NETWORKS WORK. I THOUGHT IDEA IS DON'T DO IT. I WOULD SAY -- UNLESS YOU HAVE TO. EVERY TIME I TALK TO ANYONE WHO IS GOING TSTART A BIG STUDY AND THEY NEED TENS OF MILLIONS OF PEOPLE. MY ANSWER IS IF YOU DO IT AT ONE PLACE, DO IT AT /WUONE PLACE. IF YOU NEED MORE THAN ONE IN INSTITUTION, THEN IT'S MUCH MORE /KPRAEUBCOMPLICATED TO DO. I THINK I WOULD SUGGEST SOME CENTRAL CORE SET /OF DATA ELEMENTS THAT CAN ACTUALLY ANSWER LOTS OF QUESTIONS. THE QUESTION MIGHT BE HOW DEEP THAT CORE SET /OF ELEMENTS GO. READING SOME OF THE DETAILS THAT CAN BE STANDARD /AOEUIZED AS NEEDED. I THINK WE TALKED ABOUT THIS A LITTLE EARLIER. YOU DON'T WANT TO DO AN ASSAY ON EVERYONE FOR EVERYTHING. DO IT WHEN YOU NEED TO. DO IT ON THE HE SET /OF FOLKS YOU NEED OR GO GRAB THEIR RADIOLOGY RESULTS AND ACTUAL RADIOLOGY, THE DETAILS ONLY IF YOU NEED THEM. BUT YOU NEED TO KNOW WHAT HAPPENED AND YOU NEED TO KNOW IT'S THERE AND ONLY GO AND VIEW FOR THE PEOPLE YOU NEED, FOR EXAMPLE. HOW DEEP THAT GOES WILL BE AN INTERESTING DEBATE. I THINK THE MISSION HAS BUILT LOTS OF RESOURCES SO FAR. WE HAVE GOT CLAIMS DATA BUILT TO STANDARD /AOEUIZED -- STANDARDIZE AND THAT'S A THIN LAYER. AND /AA LOT /-OF OTHER INITIATEIVES AROUND /THE COUNTRY THAT CAN GO A LITTLE BIT DEEPER. BUT THE -- A CORE SET OF DATA ELEMENTS I THINK IS CRITICAL THAT CAN ANSWER QUESTIONSS. NOT JUST SOMEWHERE ELSE, AND THAT HAS TO BE FULLY CURATED. SHAOSURE THAT YOU CAN ACTUALLY USE THAT TO ANSWER QUESTIONS BUT NOT EVERY TIME TRY TO FIGURE OUT HOW /TO USE IT. >> THIS IS GOING TO BE A REALLY EASY PANEL, I THINK. I WOULD ECHO MOST OF WHAT /SWREF JUST SAID, AND JEFF. AND EVEN DURING THIS MEETING I KEPT TURNING THE DIAL FOR MYSELF MORE TOWARDS CENTRALIZED. SO MIGHT HAVE A COUPLE --. I AGREE COMPLETELY. I'D RATHER BE CURATING THE DATA BUT AT THE SAME TIME I THINK IT'S REALLY CRITICAL TO RETAIN THE CORE ORIGINAL DATA AND NOT TOO SOON ABSTRACT IT OUT AND SAY GREAT EXAMPLE IS /THE RECENT WORK LOOKING AT /EFPLGSC G FALSE WHERE YOU CAN EXTRACT DATA FROM THE SIGNAL THAT AN EXPERT CARD CARDIOLOGIST CANNOT SEE. TWO CARDIOLOGISTS LOOKING AT THE SAME TRACING SAYS SAME TRACING BUT WHEN YOU REALLY LOOK AT THE DETAILED TADATA TIME-BY-TIME THERE IS VARIATION THAT PUTS PATIENTS INTO DIFFERENT CATEGORIES SHOT.^ KNEW, RIGHT? I CERTAINLY DIDN'T IN MEDICAL SCHOOL. I THINK IT'S REALLY IMPORTANT THAT WE CAPTURE IN /AS SAW -- RAW A FORM AS AVAILABLE AND USE OF FILM SINCE IT SHOWS HOW OLD YOU ARE. LAUGHT[LAUGHTER] >> THE BIT MAPS, THE VISUAL IMAGES ARE GOING TO BE ANALYZED AND RE-ANALYZED BY BRIGHT PEOPLE IN 100 DIFFERENT WAYS THAT WE DON'T ANTICIPATE. SO WE SHOULDN'T EVER LOSE FID FIDELITY OF DATA. WE WANT /TO CUREATE AND MAKE IT USABLE. PEOPLE TALKED ABOUT EXTRACTING KNOWLEDGE FROM IT AND SO ON. YEAH, YOU WANT THE QRS MEASURE PULLED OUT /-OF THE E /KR-FPLC G TRACEING AND STORED AS A DATA VALUE SO THAT PEOPLE CAN USE IT. IF -- AND SO YOU WANT BOTH. AND ONE OF THE -- SO THAT'S SORT OF THE ANALYSIS AND RE-ANALYSIS BECAUSE THESE THINGS ARE GOING TO GET -- A DOZEN TIMES.^ A MAM MAMGRAPHY IS A GREAT EXAMPLE AT SEEM /*EPBSZ. WE DID LOTS OF WORK ON AUTOMATED IMAGINE ANALYSIS AND THE ALGA ALGORITHM FOR DETECTING AB ABNORMALITIES IN A MAM PROGRAM IS NOW AT 137IT / ITERATION. IT'S NOT STATIC. SEIEMENS. SO THAT RE-ANALYSIS IS -- THAT IS GOING TO HAPPEN REALLY DRIVES ME HEAVILY TOWARD AS MUCH AS WE CAN CENTRALIZEIZE, AS SOON AS WE CAN CENTRALIZE, GIVEN THIS PARTICULAR USE CASE. ANOTHER FACTOR ABOUT THAT THAT DRIVES THAT IS /THE DEMANDS ON THE RELATED SYSTEMS.^ AND SPEC SPECIMENS ARE FINITE, RIGHT? THERE IS ONLY SO MUCH BLOOD FROM 2003. WELL, THERE IS ALSO FINITE PARTICIPANT PATIENTS. I CAN ONLY ASK YOU SO MANY QUESTIONS AND YOU HEARD SOME OF THE EXAMPLES OF EVEN WITH THE RESEARCH KIT AND THINGS LIKE THAT. PEOPLE HAVE A LIMITED BANDWIDTH AND CAPACITY. EVEN IF THEY ARE MOTIVATEED AND INTERESTED. AND THEN THE OTHER -- THERE ARE OTHER THINGS LIKE ADDITIONAL DATA TAKE A LOT OF EFFORT. SO THESE ARE RESOURCES THAT THE MANAGEMENT OF THIS DATASET, THIS PATIENT RESOURCE ARE GOING OF OTHER TO CAREFULLY DUR -- CURAT. THEY'RE GOING TO BE -- TO HAVE TO BE THOUGHTFUL ABOUT WHEN DO I USE THAT ABILITY TO REACH BACK TO THE INSTITUTION WHERE THE PATIENT HAD -- AND GET DATA /THRAPTS AVAILABLE ELECTRONIC ELECTRONICALLY, FOR EXAMPLE? BECAUSE IT'S VERY PRECIOUS A RESOURCE. NOT ONLY IS IT NOT FREE, BUT SIMPLY THE ORGANIZATIONAL BAND BANDWIDTH AND CAPABILITY TO DO THAT ARE GOING TO BE LIMITED. SO I THINK THAT THAT'S THE FED RATE RATEED PART. THERE IS GOING TO BE RESOURCES -- THINGS THAT ARE FED /RAEERATED, THAT ARE GOING TO COME FROM OTHER PLACES -- BUT THEY'REING ABOUT TO BE -- TO HAVE TO BE IN INCREDIBLY CAREFULLY MANAGED AND ONE OF THE MANAGEMENT OF THAT IS GOING TO BE ONE OF THE MAJOR CHALLENGES HERE. WE HAD A PANEL EARLIER ABOUT THIS, BUT WHO CAN LOOK AT /THIS DATA? SO IN OUR INDIANA EXPERICE, IT WAS AMAZING TO ME THE DIFFICULTY WE HAD FIGURE OUT WHO WAS A QUALIFIED RESEARCHER. WHO IS GOING TO PROTECT THE PATIENTS' INTERESTS? WHO WAS GOING TO BE CREDIBLE IF THEIR METHODS? WHO WAS GOING TO -- AND IF IT'S JUST USING DATA, YOU CAN BE A LITTLE USE -- LOSE -- LOOSER. YOU NEED THE PATIENTS WHO ARE ENGAGED. YOU NEED THE FOCUS WHO UNDERSTAND THE /TPHARNATIONAL PRIORITIES FOR WHERE OUR HEALTHCARE POINTS ARE TO HELP PRIORITIZE HOW THOSE CONSUMER CONSUMERABLE RESOURCES GET USED. >> SO WE OBVIOUSLY RIGHT NOW HAVE TO LEAN TOWARDS A HYBRID MODEL. I THINK THERE IS NOBODY IN THE MILITARY HEALTH SECTOR THAT WOULD GIVE UP THEIR DATABASE INTO A CENTRAL PLATFORM. JUST TO /RECONSENTING PROCESS ITSELF WOULD BE A NIGHTMARE. . THERE ARE CO-MORBIDITIES RELATED OND HIGHEST CO-MORBIDITY IS TO COPD, FOR EXAMPLE AND THE DEPRESSION AND ANXIOUS /SPAO*EUT LOT /OF PEOPLE WOULD GIVE THEIR CT SCANS AND ALL OF THE CLINICAL DATA BUT DON'T WANT ANYBODY TO KNOW THAT THEY'RE ON AN ANTI- ANTIDEPRE-DEPRESSANT OR OTHER TYPES OF MEDICATIONS RELATED TO A HEALTH CONDITION THEY MIGHT HAVE HAVE. SO S. T. D. S, AND MENTAL HEALTH /SKPWRAEFPBLGT SO I THINK WE REALLY HAVE TO BE FLEXIBLE AS TO WHAT TYPES OF DATA PEOPLE /ARE GOING TO BE COMFORTABLE SHARING AND LISTEN TO THE INDIVIDUAL. IF WE DON'T TAKE ADVANTAGE OF WHAT IS ALREADY OUT THERE AND IN PECORI, WE ARE BAILING MEGA MEGA/PHOEPBGS -- POTENTIAL POR NOT ONLY THE RESEARCH COMMUNITY BUT TO IM/PROPROVE HEALTH OUTCUPS AND IT WOULD BE A SHAME IF WE DIDN'T TAKE ADVANTAGE OF THE RAIN FRINFRASTRUCTURE BEING CREATED WITH PRECORE /SKPWRAO*EU WHETHER THE CD RNS AND THE IMPORTANCE OF TAKING THAT INFORMATION AND UT UTILIZING THEM. AND /KAOEKISER PERMANENTE ALL COULD BUILD DATABASES OF WELL OVER A MILLION PEOPLE WITH LIMITED CHANNELS. THE RUNG CANCER SCREENING PROGRAM -- IT WOULD BE SHAMEFUL IF WE DON'T TAKE THAT IMAGE THAT IGHT MILLION AMERICANS BETWEEN THE CMS IS ALREADY PAYING FOR OF 55 AND 75 WITH 30-PACK YEARS OF EXPLOSION AND DON'T LOOK FOR COP COPD AND OTHER PLUNGE AND HEART CONDITION FORS THAT MATTER. SO LET'S TAKE THAT IMAGINE -- IMAGE AND MAKE /SHAOSURE THEY ARE READ THOROUGHLY AND TAKE THAT SHARE MY /SKEUSKIN CONCEPT THAT THE LUNG CANCER-/SWAOEUSD USING AND GO AND REQUEST A COPY OF YOUR SCAN AND GIVE IT TO /WHOUFR YOU WANT. THE COPD G STUDY HAS DEMONSTRATE DEMONSTRATED TO US THAT YOU CAN SUBFEPHENOTYPE COPD INTO 6 OR 7 SUBFEPHENOTYPES AND FOCUS DRUG DEVELOPMENT ON THOSE SPECIFIC AREAS WITH JUST /AA CT IMAGE. SO IS THAT ALMOST AS GOOD AS AN ELECTRONIC HEALTH RECORD? MAYBE. MAYBE IT GETS UNITED STATES PART OF THE WAY THERE. I THINK WE REALLY NEED TO BE FLEXIBLE AS WE LOOK TOWARDS WHAT ARE THE RESOURCES THAT HAVE >> BEEN MADEED -- CREATED? WHAT DO WE NEED? OBVIOUSLY, WE NEED A COMMON DATA SET TO BE ABLE TO COMPARE MULTI MULTIPLE CHRONIC CONDITIONS AND HEALTH STATUS. I THINK ON THE GENETIC SIDE, IT'S CRITICALLY IMPORTANT TO ENVISIONS. WE HAVE TO HAVE A COHORT THAT INCLUDES CHILDREN. IF WE DON'T -- 20 YEARS FROM NOW IF WE LOOKED BACK /SAND SAID WE DIDN'T BRING ANY CHILDREN INTO THIS BECAUSE IT WAS TOO SENSE SENSITIVE -- IT'S ABSOLUTELY CRITICAL. LET'S FOLLOW THOSE THAT HAVE A GENETIC /PHROEUFR THAT WE DON'T KNOW AND I THINK SOMEBODY SAID IT EARLIER THAT WE DON'T HAVE A CLUE WHAT IT REALLY MEANS. BUT LET'S POLL THAT ENVIRONMENTAL EXPOSURE AND HEALTH CONDITION AND CO-MORBID CELEBRITIES AND HOW THAT IMPACTS SOMEBODY WITH A GENETIC CONDITION THAT HAS IDENTIFIED. SO I JUST THINK RIGHT NOW WHERE WE ARE, WE ARE STUCK -- WELL, NOT STUCK BUT WE PROBABLY HAVE THE CHALLENGE OF BAILING /PHAOEURBD -- HYBRID MODEL. WOULDN'T IT BE NICE BECAUSE IT'S PARTICIPANT-CONTROLLED HOPEFULLY IT COULD BE A CENTRALIZED DATA PLATFORM BUT IT'S NOT GOING TO BE EVERYBODY -- EVERYTHING FOR EVERYBODY. >> GREAT. WHETHER YOU THINK ABOUT SOME OF THE POINTS THAT HAVE BEEN BROUGHT UP EARLIER, I WANT TO GO BACK TO MIKE AND LORI'S COMMENT. SO COLLECT, CATALOG, CLEAN, CURE CURAT AND DEFER. AND AS WE THINK ABOUT CENTRALIZATION AND FEDERATION, AND WE REALIZE THAT WE POTENTIALLY WON'T BE ABLE TO CENTRALIZE EVERYTHING FIRE VARIETY OF REASONSS, HOW DO YOU THINK ABOUT OF -- THOSE ELEMENTS IN THIS DATA VERSUS INFORMATION RETENTION? BECAUSE WE COULD GET ALL THE DATA WITHOUT CONVERTING IT ALL INTO WHAT WE CALL MEANINGFUL INFORMATION. AND IN THAT WHOLE COLLECT CLEAN CATALOG. ET CETERA. CS AND DS. >> A QUICK ANSWER TO THAT JIT /*. MY LEANING IS TOWARDS COLLECTING EVERYTHING THAT YOU CAN UPFRONT AND LATE-BINDING AND ONE OF THE THINGS THEY WERE TALKING ABOUT IS CLEAN, CURATED AND ALCOHOLATE THE THINGS THAT YOU CAN UPFRONT AND DO ALL THOSE THINGS UPFRONT THAT YOU CAN BUT DEFER THE THINGS YOU NEED TO PRIORITIZE THAT ARE LOWER PRIORITY BUT YOUR OPPORTUNITY TO COLLECT SOMETHING AGAIN IS ALWAYS GOING TO BE HARD HARDER. IT'S GOING TO GET FURTHER AWAY. AND MANY THINGS, FOR EXAMPLE, LAB RESULTS FROM A LABORATORY -- IT'S WHERE -- FIGURE OUT WHAT THEY ARE RATOR IF YOU NEED TO. THAN IT IS TO GO BACK LATER AND GET ANOTHER TEN FOR WHATEVER YOU REASON CHOSE TON GET. SO THIS COULD BE MY SUGGESTION FOR BALANCE. >> INAUDIB[INAUDIBLE] >> SO -- I LIKE THE FOUR CS. IT MAKES A LOT /OF SENSE AND I WOULD AGREE AND HE CECHO MARK'S POINT OF MAINTAINING THE WALL. AND I THINK THERE IS REALLY VERY LITTLE REASON TO MANIPULATE THE DATA THAT'S COMING OUT, IF IT'S REASONABLY WELL-STANDARD /AOEUFIZED ALREADY. ABOUT UNDERSTANDING IT VERSUS CHANGING IT. SO I'M PRETTY STRONGLY AGAINST LOTS OF MAPPING. MAPPING, YOU NEED TO MAP. YOU'VE ACTUALLY CHANGED THE MEANING WHEN YOU'VE MAPPED IT. SO WE KNOW HOW /TO HANDLE IC 9 CODE IN THE HOSPITAL SETTING. AND NOW REMEMBER THE ALGORITHMS WE BUILT OVER /THE /HRAFLAST 20 YEARS WORK. SO YOU NEED IT AT THE -- THERE WILL BE PLACES -- JUST BECAUSE THEY'RE SO MESSY OR IT'S LOCAL. INAUDIB[INAUDIBLE] STAR DASH STAR DOT MEANS. WE SEE ALL SORTS OF THINGS IN THERE. THAT WILL BE MEANINGLESS NO MATTER WHAT WE DO. SO YOU NEED IT AT A RAW FORM AND I THINK IN TIME -- EVEN FOR FENE PHENOTYPES. DON'T TRY IDENTIFYING DIABETES FOR SOMEONE. BUT I WANT TWO OF THESE AND ONE OF THOSE. LET THE RESEARCHERS DO IT AND BUILD TWO RULES TO MAKE IT FASTER TO DO THOSE THINGS, BUT LET'S NOT PRETEND THAT ANY OF THE DEFINITIONS WE'VE COME UP WITH OR THE PAST ONES. WE'VE SAY NO WHEN WE GIVE THEM /TPAOEUS, CLEAN DEFINITION /SOEUZ STOPPED DOING IT ACTUALLY ACTUALLY. -- SO I STOPPED DOING IT ACTUALLY. YOU CAN'T CENTRALIZE EVERYTHING. COULD YOU BE MORE EX/PHREPLICIT ABOUT WHAT CAN BE AND WHAT CAN'T? >> I WAS KIND OF /KWRUFRPG BACK TO JOHN'S POINT THAT SOME OF THESE REGISTRY INFORMATIONS, THEY MAY NOT WANT /TO POOL A DIFFERENT WAY. AND IN TERMS OF SITUATIONS WHERE GROUPS -- INAUDIB[INAUDIBLE] COULDN'T FOR SOME TECHNOLOGICAL REASON ACTUALLY SHARE THE DATA. AND I WANTED TO SHARE /THIS POINT WE COULDN'T SHARE DATA ELECTRONICALLY BUT MAYBE SOME POINT IN THE FUTURE WE COULD AND CERTAINLY COULD GO BACK /SAND LOOK AT CERTAIN TYPESS OF IMAGES. SO YOU CAN IMAGINE TECHNOLOGICAL AND PROCEDURAL CONSENT-BASED MECHANISMS WOULD PROHIBIT SHARING ALL THE INFORMATION FORWARD. >> THIS IS MY CHANCE TO ATTACK JEFF, WHICH I ALWAYS LOOK FORWARD TO DOING. LAUGHT[LAUGHTER] HAVING WORKED TOGETHER. TRY REC /SPAOEULG THE THING THAT YOU JUST SAID. CILING. I UNDERSTAND THAT MANY RESEARCH RESEARCHERS WANT RE/TK-FRG IN THE MOST FUNDAMENTAL TERMINATIONS BUT ON THE OTHER HAND IF YOU ARE CREATING A NATIONAL RESOURCE -- FOR EXAMPLE EXAMPLE, YOU'RE NOT REDEFINING EVERY TERM EVERY TIME DO YOU AN ANALYSIS, ARE YOU? CAN YOU DO IT IN TWO DAYS JUST BECAUSE YOU HAVE COMPLETE CONTROL OVER A SMALL GROUP OF PEOPLE DO -- TO DO THIS? NEVER DEFINE ANYTHING. YOU'LL END UP WITH THAT -- /TKHAOEPBT MATCH BECAUSE EVERYBODY'S MADE A SLIGHT CHANGE IN THE DEFINITION. LAUGHTER] >> SOMEONE AT FDA -- LAUGHTER IF I WERE SOMEONE AT FDA -- INAUDIB[INAUDIBLE] SO THAT'S A GOOD QUESTION. WE CREATE DEFINITIONS AT ALGA ALGORITHMS BUT NOT INSERT THEM IN THE DATA. STROKE IS A NICE EXAMPLE. STROKE IS AN OUTCOME WE ARE GOING TO REUSE. LET'S GET A DEFINITION WITH STROKE. AND -- THE OUTCOME IS STROKE. WOULD YOU LIKE TO USE THIS ONE? THIS IS THE ONE WE USED THE LAST THREE TIMES. >> /TPAU[INAUBIDLE]. >> YEAH, LET ME THROW A WRENCH INTO THAT FOR YOU. /STRAOEPBGS OUTCOME AND AN /EBGS EX/KHRAOEUBGS CRY /TAOITERIA WHICH /PHAOEUBTS DEFINED DIFFERENTLY. THAT'S WHY. WHICH MIGHT BE DEFINED DIFFERENTLY. >> JUST FROM YOUR EXPERIENCES. HOW YOU WANT /TO DEFINE DEPENDS ON YOUR DEFINITION OF THE DISEASE AS WELL AS SENSITIVITY AND THE VALUE OF THE DATA THAT YOU ARE RADIOING FOR. SO IF YOU ARE LOOKING AT IT AS AN OUTCOME, THE VALUES TYPICALLY CAN BE VERY HIGH. IF YOU ARE LOOKING AT IT AS AN EXCONCLUSION TERM, IT'S MORE SENSITIVITY. IF YOU CAN DEVELOP AN AGARITHM AND A PRECISION, YOU PROBABLY CAN HAVE ONE DEFINITION. THAT BEING SAID, IF YOU LOOK ACROSS -- THEY HAVE BEEN ADOPTED BY LOTS OF DIFFERENT GROUPS AND CERTAINLY DIABETES, ALGORITHM IS AN EXAMPLE AND TYPE TWO /STKAOEUBTS LITTLE MORE SPECIFIC SPECIFIC. IT'S BEEN ADOPTED A LOT AND CAN GET REUSED. SO I KNOW THAT THERE WERE OTHER DIABETES ALGORITHMS THROUGHOUT AND YOU CAN EVALUATE AND COMPARE THE EFFECT /KWREUIVENESS AND DIFFERENCE DIFFERENCES BETWEEN THEM. SO I THINK THERE -- THEY CAN -- THERE CAN BE REUSE AND I THINK WE HAVE SEEN EXAMPLES THAT HAVE. >> THIS WAS DAILY THAT WE GO THROUGH THIS STUFF WITH SENT EL?{}IF YOU CAN BUILD THE SYSTEM SO THAT YOU CAN ASK QUESTIONS QUICKLY OR IF ONE BATCH, WHAT WE DO -- INCLUDE A COUPLE /OF SLIGHTLY DIFFERENT DEFINITIONS TO MAKE /SHAOSURE THAT OUR DEFINITION DEFINITION'S NOT DRIVING THE ANSWERSS. SO ANALYSIS OF LET'S TRY THIS VERY PRICE DEFINITION A LITTLE BIT MORE BROADER AND SEE WHETHER THAT MATTERS AT ALL. AND IF YOU CAN BUILD A SYSTEM SO IS THAT THAT'S NOT A HUGE UNDER UNDERTAKING, THAT'S GREAT. SO IN SENTINEL IT'S REALLY THAT EASY. WE CAN DO THAT ALL THE TIME BUT WE BUILT IT THAT WAY SO WE CAN HANDLE THOSE. >> ARE WE TRYING TO BUILD SOMETHING THAT'S SORT OF A HIGH- HIGH-PRIEST OR A DEMOCRATIC RESEARCH PLATFORM AND INITIALLY WE BUILD THINGS FOR THE HIGH PRIEST AND THEY CAN ACCESS THE DATA --. WHAT I THINK WE'RE TRYING TO DO IS GATE /PHOFP -- MUCH MORE DEM DEMOCRATIC APPROACH, WHICH IS WHEN YOU MAKE A DEMOCRATIC YOU HAVE TO PUT CERTAIN CONSTRAINTS USE END UP WITH DIFFICULT-TO- DIFFICULT-TO-INTERPRET AND DIFFICULT-TO-RECONCILE ANSWERS AND THAT'S ONE OF THE BRILLIANCE BRILLIANCES. WE'RE TRYING TO GET TO A DEM DEMOCRATIC PLATFORM THAT AN ACADEMIC RESEARCHER OR WHATEVER CAN GO ASK A REASONABLE QUESTION AND MIGHT NOT BE PERFECT.^ AND THEN BE ABLE TO GO FURTHER. IN/EU[INDISCERNIBLE]. >> I KNOW EVERYBODY'S FOCUSED ON IMPROVING HEALTH OUTCOMES AND NEW THERAPIES AND WILL REALLY MAKE A DIFFERENCE IN PEOPLE /A'S LIVESS, BUT JUST AN IMAGE, THE COP G STUDY IDENTIFIED A VERY LARGE COHORT AND -- [STATIC] AND YET SPECIFIC EVIDENCE OF DETERIORATION OF TISSUE -- THE VISION THAT WE HAVE TO PROJECT TO THE PATIENT COMMUNITIES. OUT IT IS WITH BEING RELEASE TO DEVELOP A THERAPY THAT WOULD STOP IT DEAD IN ITS TRACKS BEFORE YOU KNEW YOU HAD IT, EXCEPT FOR BIOIMAGE. AND THE TECHNOLOGY IS BECOMING AVAILABLE TO BE ABLE TO ACCOMPLISH THAT. BUT I REALLY THINK, AS WE BUILD THIS PLATFORM, AS P.MI BECOMES A REALITY, THAT THAT REALITY HAS TO INCLUDE BEING ABLE TO DO THINGS JUST LIKE THAT -- STOP IT BEFORE YOU KNOW YOU HAVE IT. >> I THINK LET'S GO AHEAD AND START GETTING QUESTIONS THE FROM THE AUDIENCE. LET'S START HERE AND WE'LL ALTERNATE. >> OKAY, THANKS. >> SO THESE ARE ISSUES, AND I ACTUALLY WANT /TO PROPOSE AN ALTERNATIVE PARADIGM OF THINKING ABOUT THIS. BECAUSE I HEAR PEOPLE CONTINUE TO TALK ABOUT BE CORE DATE SETS. LET'S THINK ABOUT CORE COMP COMPETENCIES,'? AND SO IF THIS HYBRID-TYPE MODEL MODEL, WHICH IS THAT A CORE COMP COMPETENCY -- THE CENTRAL INDICADATASET WOULD BE ALONG THE CORE COMPETENCY OF GATHERING TOGETHER ELECTRONIC HEALTH RECORDS AND CLAIMS DATA AND THAT'S THE NATURAL PLACE TO BE THE HUB, IF YOU WILL. AND BUT THEN WHEN THERE IS A -- WHETHER IT'S BASED ON EXPERTISE, THE MANAGEMENT OF THE IMAGE DATA OR WHETHER IT'S BASED ON SPECIAL ATTENTION -- A COP G REGISTRY OR WHATEVER, SO THAT'S THE PLACE WHERE IT MAKES US SENSE BECAUSE A CORE COMPETENCY IN TALENT OR IN FOCUS IS OUTSIDE AND THAT WHAT YOU NEED TO CONNECT WITH THE -- ARE THE LINKS BETWEEN THOSE. AND THE -- [STATIC] THERE IS THAT FORENSIC ANALYSIS OF THE DATA AND IT HAS TO BE CURATED AND MAPPED. SO GENDER HAS TO BE MAPPED IF YOU ARE GETTING IT FROM 50 DIFFERENT PLACES OR IT'S -- IT'S NOT JUST STROKE.^ THE IT'S JUST ABOUT EVERYTHING. BUT THOSE PLACES KNOW -- GO AFTER THE /TPREFPBG ANALYSIS FORENSIC ANALYSIS OF EVERYTHING WHEREAS IF YOU CENTRALIZE EVERYTHING, YOU LOSE THE ABILITY TO DO THE FORENSIC DATA. YOU ARE GOING AFTER THE RAW AND ORIGINAL DATA. pCORE COMPETENCY FEDERATION WOULD CENTRALIZE -- WITH CENTRALIZATION AROUND THOSE POLICIES IS PROBABLY A GOOD MODEL. ANY RESPONSES? >> SO THE QUESTION WAS CURATED AND DOES IT MEAN THE SAME THING? I THINK IT DEPENDS ON THE KIND OF ANALYSIS THAT YOU ARE GETTING BECAUSE THERE IS AN ANALYSIS THAT FINDS DIFFERENT VARIABLE RANGES THAT HAPPENS AND YOU CAN ACTUALLY DOON ANALYSIS OF THE DATA WITH LOTS OF DATA AND THIS IS SORT OF THE /KPWAOLG GOOGLE A APPROACH AND DISCOVER INTERESTING THINGS. IN /AA LOT OF THE ANALYSES A LOT OF TIMES WE WIND UP AT /TTHAT DATA-READY STAGE IS ACTUALLY CURATED DATA. >> INAUDIB[INAUDIBLE] >> I THINK IT IS IMPORTANT TO RECOGNIZE THAT WE SHOULD LET THE PEOPLE KNOW BEST HOW TO DO THOSE AND DO THEM AND THEN THOSE LINK AGES ARE GOING TO BE THE IMPORTANT THINGS SO THAT MAKES THING THAT'S REALLY NSE AND IMPORTANT. NOT LOSING THE CONNECTION BACK TO THE ORIGINAL DATAHOLDER IF YOU WANT /TO CALL THEM. SO MAKING SURE THAT THOSE CONNECTIONS ARE MAINTAINED. >> MY FAVORITE EXAMPLE IS DEFINE GENDER RIGHT IN OTHER? >> GREAT. I WANT TO DRILL DOWN A LITTLE EEXPLICIT BIT FURTHER IN TERMS OF EX RECOMMENDATIONS. AT /SPHOEUPBT THESE MILLION INDIVIDUALS OR WHATEVER NUMBER IS AGREED UPON NEED TO BE SET OR DATA NEED TO BE CORRECTED, IT NEEDS TO BE -- I CAN'T REMEMBER WHAT THEY ARE. BUT SO SHOULD THE CENTRALIZED MODEL BE THERE FOR WHEN THE DATA IN /THIS POPULATION IS DEFINED AND SHOULD THE FEDERATED MODEL BE USED WHEN WE'RE TRYING TO DISCOVER WHO THESE INDIVIDUALS SHOULD BE? A COUPLE /OF CONFLICTS. >> WHEN DO WE USE ONE VERSUS THE OTHER? I REALLY LIKE YOUR QUESTION. LET ME MODIFY IT. SO SHOULD IT HAPPEN ONCE WE HAVE CURED THE DATA REGARDLESS OF WHETHER THE -- >> I'M SORRY, THE FEDERATION COULD BE ALL THE RAW DATA AND THE CORE COULD BE THE CURATED DATA. >> OKAY. I'LL TAKE A CRACK AT IT, AT MY PERIL. I THINK THE QUESTION OF HOW /TO RECRUT THESE PATIENTS IS A REALLY IMPORTANT ONE. AND I THINK THERE IS GOING TO BE A ROT MORE WATER TO GO UNDER /TIDGE. I CAN IMAGINE A VARIETY OF DIFFERENT APPROACHES TO /TTHAT BASED ON ISSUES ABOUT HOW IN TERMS OF WHAT QUESTIONS WE'RE TRYING TO ANSWER, HOW BROAD. THERE IS SOME CURIOSITY MADE THERE AND I THINK THAT WILL DEFINE HOW WE RECRUIT AND THAT MIGHT INVOLVE ALL KINDS OF DATA SOURCES OR MAYBE IT'S JUST /AA NATIONAL LOTTERY. THE DAY YOU COLLECT THE FIRST SET OF DATA, IT'S HEAVILY CENTRALIZED ON THE FIRST MEMBER OF THIS DATA RESOURCE. >> I WANT TO TALK SPECIFICALLY ABOUT THE /EUPINDIANA AND MASSACHUSETTS CLINICAL HEALTH INFORMATION EXCHANGE. A /RLOT OF DISCUSSION IS /SWAOEURPBLG WHETHER NOT THESE /S*RPLZ DESIGNED WITH ENORMOUS STIMULI ARE GOING TO BE USEFUL FOR MOTHAN JUST DIRECT PATIENT AIR AND SPECIFICALLY YOUR OWN EXPERIENCE IN WHERE THESE /PHAEPBLGTSZ IN HEALTH EXCHANGE HAVE WORKED.^ THEN THE LIMITATIONS WHAT YOU WOULD DO TO MAKE A DIFFERENCE. >> I CAN SPEAK TO MASSACHUSETTS SO THAT'S YES, SIR -- EASY. THE NETWORK I DESCRIBED EXISTED BEFORE THAT EXCHANGE, AND IS NOT RELATED TO IT. AND I AM NOT GOING TO GO ANYWHERE ELSE. I ACTUALLY DON'T KNOW HOW IT'S GOING. >> CLEARLY, INDIANA WORKS,. WE CHOSE A FED /RAEERATED MODEL THAT'S CENTRALLY MANAGED. THAT MEANS THAT EVERYBODY'S DATA IS /TPWHAUL ONE SINGLE DATA CENTER ON ONE CLUSTER OF MACHINES THAT'S SEPARATED ON THOSE MACHINES. SO WE CHEATED, RIGHT? WE HAD ALL THE BENEFITS OF CENTRALIZATION, WITH THE BENEFITS THAT ARE MORE POLITICAL POLITICAL, SOCIAL, WHATEVER, OF FEDERATION AND SEGREGATION. AND THAT'S WORKED RED LIGHT WELL WELL. AND -- WORKED REALLY WELL. AND THAT'S WORKED WELL FOR DOING WELL OVER 8,000 STUDIES HAVE BEEN RUNNING WITH A POPULATION OF AROUND 20 MILLION PEOPLE. THE STUDY OBVIOUSLY IS ON SUB SUBSETS OF THOSE SO I THINK THERE IS EVIDENCE IT WORKS. >> I DO WANT /TO -- SO WHAT YOU WON'T SEE IS NOT CARE. SO SOMETIMES I CALL IT -- WHEN YOU ARE DOING SOME TYPES OF HAS TO BE MEANINGFUL. OF CARE SO SO I AM REALLY HESITANT TO OVEREMPHASIZE THAT STREAM OR INSIDE OTHER SPECIFIC STREAM. >> I THINK YOU RAISED ANOTHER GOOD POINT. MY ARGUMENTS FOR CENTRALIZATION. THERE IS A LOT /OF DATA THAT IS NOT ROUTINE CLINICAL CARE DATA THAT WE'RE GOING TO WANT AND NEED FOR THIS PATIENT RESOURCE, WHETHER IT'S SO I CAN GIVE SHORT VERSION OF IT. ONE IS THE DATA NEEDS ARE NOT BAD. WE HAVE DATA AS MAYBE OTHER PEOPLE IN THE ROOM KNOW GOING BACK DECADES. THE TRICK IS EMRs CARRY A LOT OF BAGGAGE, SINGLE RESULT IS TENS OF K OF DATA. IT CAN TYPICALLY BE REDUCED DOWN TO ON THE ORDER OF TONS OF BITES OF DATA FOR THE PURPOSES OF MOST KINDS OF RESEARCH. THERE'S DETAILED OPERATIONAL RESEARCH THINGS AND SO ON WHERE YOU MIGHT WANT TO KNOW WHO IS THE TECHNICIAN WHO RAN THE MACHINE ON THURSDAY EVENING AND WHATEVER. ASSUMING YOU'RE A LITTLE HIGHER UP THAN THAT IN TERMS OF THE HIERARCHY, THE DATA STORAGE IS A TOTAL NON-ISSUE, AND, YOU KNOW, MY CTF GUYS CRINGE WHEN I SAY IT, STORAGE IS FREE. I KNOW IT'S NOT, BUT IT'S EFFECTIVELY FREE. AND THE COURSE OF MANAGING THE DATA IS SO MUCH GREATER THAN THE ACTUAL COST OF STORAGE. WE SHOULD NEVER ARCHIVE ANYTHING. THERE'S NO REASON TO. >> SO JUST A QUICK COMMENT BECAUSE WE'RE RUNNING OUT OF TIME. RACHEL FROM PCORI. WE HAVE A LOT OF EXPERIENCE OVER THE LAST 18 MONTHS ENGAGING WITH PATIENTS AND, JOHN, MAYBE YOU CAN ANSWER MY POINT HERE. TECHNICAL SOLUTION TO A WIDER PROBLEM, WE TALKED ABOUT WONDER EGG IF THE PANEL THINKS -- WONDERING IF THE PANEL THINKS WE ENGAGED THE COMMUNITY MORE BROADLY THE TECHNICAL TRADITIONS WOULD BE EASIER TO IMPLEMENT WITH GROUNDSWELL SUPPORT AND THINGS WE'RE DOING WRONG FRAMING THE CONVERSATION IN TERMS OF GROUNDSWELL SUPPORT, WE'RE WEARING OUR HATS AS PATIENTS, CAREGIVERS, PARENTS, WOULD BE ABLE TO WORK MORE EASILY WITH YOU IF WE UNDERSTOOD THE INCENTIVE FOR US TO PARTICIPATE IN THE CONVERSATION SO I GUESS MY QUESTION IS AROUND THE TECHNICAL SOLUTIONS BE EASIER IF WE FRAMED AROUND THE COMMUNITY. >> THAT'S A GOOD POINT, RACHEL. WE HAVE A SOCIAL PLATFORM WITH THOUSANDS OF PATIENTS ON IT EVERY DAY, THERE ARE QUESTIONS PEOPLE BRING UP, THEY ARE ANSWERED BY SEVERAL PEOPLE, DIFFERENT PERSPECTIVES, SOMEWHAT MONITORED BUT NOT CONTROLLED. AND I THINK BRINGING THIS, THE PMI, WE'LL BRING THIS PMI FOREFRONT IN THE DISCUSSION PROCESS ON THE SOCIAL MEDIA PLATFORM, BUT THAT NEEDS TO BE DONE ACROSS DISEASE STATES. THAT NEEDS TO BE DONE IN A MUCH MORE PUBLIC WAY. AND ENGAGED INDIVIDUALS IN WHAT THEY SAY, EVEN JUST THE USE OF THE WORD "COHORT," IT'S NOT THREE SYLLABLES, BUT COHORT, NOBODY KNOWS WHAT A COHORT IS IN THE REAL WORD, AND VERY FEW PEOPLE WOULD KNOW WHAT A COHORT WAS. SO I THINK WE NEED TO ENGAGE THE PUBLIC IN THAT DISCUSSION, AND HAVE THEM BE PART OF IT BECAUSE IF THEY DON'T FEEL OWNERSHIP, THEY ARE NOT GOING TO BE INVOLVED . IF WE DON'T BUILD A CULTURE AND THEY DON'T REALIZE THE BENEFIT OF WHAT WE'RE TRYING TO ACCOMPLISH AND ASK THEM WHAT THEY WANT US TO ACCOMPLISH, THEN IT WON'T BE EMBRACED, AND I THINK THAT'S THE TRUE MEANING OF ENGAGEMENT, INFORM, EMPOWER AND ENGAGE, WE NEED TO DO THAT BY HAVING A DISCUSSION, AND ASKING OPINIONS AND SHARING IDEAS. >> GREAT. WE'RE RUNNING OUT OF TIME, MIKE. YOU HAD A QUICK COMMENT. >> IT'S NOT ONLY THE DATA, BUT THE INSTITUTIONAL MEMORY THAT GOES WITH IT AND PEOPLE THAT USE THE DATA FOR YEARS, WE'VE DONE EXPERIMENTS, THERE ARE MANY MOVING PARTS, WE SORTED THROUGH WHAT THE PROBLEMS WERE, WE GOT MANY RESULTS, BUT IT'S NOT AS SIMPLE AS JUST TAKING DATA FROM MULTIPLE DIFFERENT ORGANIZATIONS AND DUMPING IT INTO ONE LITTLE -- >> GREAT POINT. I'LL LET YOU HAVE THE LAST COMMENT. >> SINCE WE'RE ON THE HARVARD GENOME PROJECT, PRECISION MEDICINE IS SOMETHING WE'RE PURSUING GLOBALLY, THE WHOLE WORLD IS PURSUING THIS, I'M WONDERING IF WHEN WE THINK ABOUT FEDERATION, IF WE CAN THINK ABOUT IT MORE GLOBALLY. THE GLOBAL ALLIANCE FOR GENOMICS AND HEALTH, MANY OF US ARE INVOLVED, IT'S MODELED AFTER THE W3C THAT MADE THE INTERNET A BIG SUCCESS. BUT I THINK IT'S SOMETHING THAT'S A TINY BIT UNDERAPPRECIATED, WHAT ELSE MADE THAT A SUCCESS, AN INTERESTING COMPETITION BETWEEN OPEN SOURCE IMPLEMENTATIONS OF THE STANDARDS OF THE W3C AND PROPRIETARY IMPLEMENTATION, THE COMPETITION WAS FRUITFUL. SO I WONDER, AS WE BUILD THIS COHORT AND WE THINK ABOUT FEDERATION, WE THINK ABOUT IT AT AN INTERNATIONAL SCALE, CAN WE THINK ABOUT FOSTERING THAT COMPETITION SO THAT THERE ARE COMPLETE, OPEN SOURCE IMPLEMENTATIONS OF THE CORE STANDARDS THAT CAN THEN COMPETE WITH PROPRIETARY IMPLEMENTATIONS? IT'S AN IDEA I THOUGHT ABOUT FROM, YOU KNOW, FOR MANY YEARS. I THINK IT WOULD BE FRUITFUL FOR US TO THINK ABOUT. >> IT'S A GREAT POINT. I THINK ONE OF THE -- I THINK MAYBE WE WON'T DIRECTLY ANSWER IT BECAUSE I THINK WE COULD SPEND A LOT OF TIME TALKING ABOUT IT, AND A BRIEF COMMENT TO SHARE? >> I THINK IT'S A GREAT POINT. WHAT CAN BE THE OPEN SOURCE? IT MIGHT BE THE MODEL OF THAT CORE, AND THEN THE SMARTEST PERSON THAT FIGURES OUT HOW TO USE THOSE DATA WELL, THEY WILL GET THE MOST USE OUT OF IT. YOU CAN THINK OF IT THAT WAY, AS YOU'RE BUILDING TOOLS ON TOP OF A MODEL, THAT'S HOW OTHER INDUSTRIES DO IT, THE AIRLINE INDUSTRY AND HEALTH INSURANCE TO SOME EXTENT AND SOME OTHERS, THEY HAVE A MODEL, AND THEN SOFTWARE VENDORS FIGHT TO MAKE IT WELL WORK FOR THEM, AND THAT CAN WORK HERE. >> GREAT. WELL, THANK YOU VERY MUCH. I'M GOING TO -- LET'S THANK OUR PANELISTS. [APPLAUSE] >> NOW TO CATHY TO CLOSE UP. >> I WANT TO MAKE A COUPLE LOGISTIC COMMENTS AND THEN TURN -- HAVE FRANCIS COLLINS HAVE THE LAST WORD. SO THE FIRST THING IS WE HAVE A REQUEST FOR INFORMATION THAT JUST GOT PUBLISHED, AND YOU CAN FIND IT ON THE PRECISION MEDICINE INITIATIVE WEBSITE AT NIH, IT HAS A LONG URL SO I WON'T READ IT OUT TO YOU, AND IT IS SPECIFICALLY ASKING FOR INPUT ON WAYS TO ENGAGE INDIVIDUALS AND COMMUNITIES, AND THAT WILL BE OPEN FOR COMMENT UNTIL JUNE 19th, SO PLEASE DO COMMENT ON THAT. WE WILL CAREFULLY REVIEW AND INCORPORATE YOUR INPUT INTO OUR DELIBERATIONS. THE SECOND THING IS THAT WE WILL GIVE SOME REAL THOUGHT TO YOU WHO WE CAN ENCOURAGE A RENAMING OF THE COHORT AND SOLICIT ALL YOUR IDEAS ON THE RENAMING OF THE COHORT AS WE'VE BEEN EXHORTED, AND CLEVER WAYS TO INPUT RESEARCH QUESTIONS AS IT GETS UP AND RUNNING. SO THIS MEETING HAS GIVEN GREAT INFORMATION TO CHEW ON BUT WE DON'T HAVE VERY MUCH TIME FACE TO FACE TO CHEW ON IT. AND SO WE'RE GOING TO END EARLY, AS SOON AS FRANCIS WRAPS US UP, AND THEN THIS ROOM IS GOING TO BE CONVERTED INTO THE ROOM FOR THE CLOSED WORKING GROUP MEETING, AND SO IF AFTER WE CONCLUDE EVERYBODY CAN MOVE RAPIDLY OUT, AND THE WORKING GROUP CAN MOVE RAPIDLY BACK IN, THAT WILL GIVE US MAXIMUM TIME TO BE ABLE TO THINK DEEP THOUGHTS ABOUT WHAT ALL YOU HAVE SHARED WITH US DURING THE COURSE OF THIS DAY AND A HALF. SO WITH THAT, I'LL TURN IT OVER TO FRANCIS TO WRAP US UP. >> WELL, IT HAS INDEED BEEN A VERY INTENSE AND INTERESTING DAY AND A HALF, CERTAINLY FOR MYSELF, I FEEL AS IF WE GOT A LOT OF REALLY IMPORTANT MATERIAL OUT ON THE TABLE, AND MOVED THE NEEDLE IN THE DIRECTION OF GREATER SPECIFICITY OF WHAT THIS ENTERPRISE FORMERLY KNOWN AS A COHORT MIGHT ACTUALLY LOOK LIKE. [ LAUGHTER ] I GUESS FOR THE MOMENT WE'LL CALL IT A RESOURCE, I GUESS I LIKE THAT AS AN ALTERNATIVE. BUT MAYBE WE NEED TO WORK A LITTLE HARDER ON THAT TOO. IT WOULD BE NICE TO HAVE A CATCHY NAME FOR THAT, EVERYBODY WOULD GO, OH, WOW, THAT'S SO COOL, AND I'M NOT SURE COHORT OR RESOURCE QUITE DOES IT. YEAH, WE'LL KEEP WORKING ON THAT, AND IDEAS ARE MOST WELCOME.. MOST WELCOME. I LIKE THE IDEA OF SOLICITING EARLY WINS ONCE WE BEGIN TO SEE THE SHAPE, WAYS WE CAN MAKE SURE WE DON'T MISS THE CHANCE TO ACTUALLY HAVE SOME SUCCESSES TO GAIN FURTHER MOMENTUM AND KEEP THE SUSTAINABILITY OF THIS UP FRONT. I THOUGHT THE CONVERSATIONS WE HAD THROUGHOUT THE COURSE OF THIS DAY AND A HALF ABOUT INCLUSIVENESS AND MAKING SURE THAT HOWEVER WE DESIGN THIS IS VERY SENSITIZED TO THOSE ISSUES, WE'RE EXTREMELY USEFUL AND WE'LL COME BACK TO THOSE IN EVEN GREATER INTENSITY ON JULY 1 AND 2 WITH THE NEXT WORKSHOP AT NIH FOCUSED ON PARTIC. AND I MUST SAY THE DISCUSSION THIS MORNING ABOUT CORE DATA ELEMENTS AND WHAT WE WANT TO BE SURE TO THINK ABOUT IN TERMS OF WHAT GETS COLLECT AND CURATED WAS EXTREMELY ILLUMINATING, WITH A LOT OF EXPERIENCE REPRESENTED ON THAT PANEL AND IN THIS ROOM, THAT I THINK CAN HELP US A LOT AS WE TRY TO PUT SOME MORE SPECIFICITY INTO THIS. SO I GUESS I WANT TO SAY HOW MUCH I APPRECIATE ALL THE THOUGHTS ON THIS, ALL THE SPEAKERS PUT INTO THIS, MANY OF YOU COMING QUITE A DISTANCE GIVING UP TIME FOR THIS EFFORT. WE HAVE TO BE APPRECIATIVE, AND WE ARE. TO THE WORKING GROUP, WHO HAVE BASICALLY SIGNED ON FOR THIS, SOME OF THEM PROBABLY WITHOUT COMPLETE WARNING ABOUT HOW LIFE-CONSUMING IT WAS GOING TO BE, SOME OF THEM HAVE GONE ABOVE AND BEYOND THE CALL OF DUTY. ONE OF THEM EVEN GAVE ME A TIE BECAUSE I FORGOT TO PACK ONE, SO, JOSH, THANK YOU. [ LAUGHTER ] I DIDN'T WANT TO GET CAUGHT IN FRONT OF MEMBERS OF CONGRESS WITH INAPPROPRIATE GARB SO YOU SAVED MY REPUTATION. [ LAUGHTER ] I KNEW I ASKED THE RIGHT GUY, YEAH, HE HAD AT LEAST ONE ANYWAY. HE OFFERED ME THE SPARE. HE OFFERED ME TWO ACTUALLY. ONE LOOKED LIKE IT ACTUALLY CAME FROM A COMEDY SHOW. >> FROM DAN'S CLOSET. >> OH, OKAY. JOSH ALSO EXPLAINED HE WAS COLOR BLIND, THAT'S HIS EXCUSE. WELL, THE WORKING GROUPS GOT THEIR WORK CUT OUT FOR THEM THIS AFTERNOON, AND AGAIN AS KATHY HAS JUST MENTIONED WE WANT TO GIVE THEM AS MUCH TIME AS POSSIBLE, SO ALL THAT I WANT TO NOW DO IS JUST TO SAY A WORD OF THANK YOU, PARTICULARLY TO THE STAFF THAT HAVE WORKED SO HARD TO PUT THIS TOGETHER, AND WHO PROBABLY HAVEN'T GOTTEN NEARLY THE CREDIT THEY DESERVE, AND THAT WOULD INCLUDE FROM NIH, ALLISON LEE, LAURA MILLNER AND GWEN JENKINS AND MELISSA AND MOLLY FROM VANDERBILT, AND A PARTICULAR ADVANTAGES TO KATHY HUDSON WHO HAS BEEN OVERSEEING PLANNING AND CONDUCT OF THIS PARTICULAR ENTERPRISE, AS AN ALL-CONSUMING PART OF HER LIFE EXPERIENCE, AND TO OUR CO-CHAIRS, BRAY AND RICK, THANK YOU ALSO FOR THE WAY IN WHICH YOU HELPED GET US TO THIS POINT AND THE WORK THAT REMAINS TO BE DONE. SO SHOULD WE GIVE ALL THOSE FOLKS A ROUND OF APPLAUSE, AND THEN WE'RE ADJOURNED. [APPLAUSE]