I WANT TO WELCOME YOU TO THIS WORKSHOP ON THE USE OF FHIR FOR RESEARCH. I'M THE DEPUTY DIRECTOR OF OFFICE OF DATA SCIENCE STRATEGY AT THE NIH. THIS OFFICE CO-SPONSORS TODAY'S WORKSHOP, WITH THE NATIONAL LIBRARY OF MEDICINE AT NIH. IN THIS COLLABORATION I HAVE THE PLEASURE OF WORKING WITH DR. THERESAESCOBAN. TODAY I HOPE YOU, AS I DO, ARE LOOKING FORWARD TO HEARING THE PERSPECTIVES AND EXPERIENCES OF THOSE WHO HAVE IMPLEMENTED FHIR FOR THEIR RESEARCH, AS WELL AS HEARING OPPORTUNITIES TO INCORPORATE DATA FROM WEARABLES IN MOBILE HEALTH. AND WITHOUT FURTHER ADO I WOULD LIKE TO INTRODUCE DR. SUSAN GREGURICK. SUSAN IS MY BOSS AND ALSO THE DIRECTOR OF THE DATA SCIENCE STRATEGY AT THE NIH. IN THAT CAPACITY CARRIES A DUAL TITLE, THE CARD-CARRYING MEMBER OF THE DATA SCIENCE COMMUNITY. SHE WAS THE DIVISION DIRECTOR FOR BIOPHYSICALLICS, BIOMEDICAL TECHNOLOGY AT THE NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES. AND PRIOR TO THAT SHE WAS A PROGRAM DIRECTOR IN THE OFFICE OF BIOLOGICAL AND ENVIRONMENTAL RESEARCH AT THE DEPARTMENT OF ENERGY. AND WITH THAT, I'M GOING TO TURN THE MIC TO SUSAN. >> THANK YOU. DATA SCIENCE IS A TEAM EXPERT, IT'S A PLEASURE TO WORK ON TEACH SUCH AS YOUR SELF AND THERESA AND OTHERS. I WANT TO THANK YOU FOR JOINING US TODAY FOR WHAT IS GOING TO BE A WONDERFUL WORKSHOP TO DISCUSS THE OPPORTUNITIES AND CHALLENGES AND RESOURCES OF FHIR. WITH WITH OUR FEDERAL COLLEAGUES, EXPECTATIONS FOR FHIR, WE'RE EXCITED TO LEARN WAYS OUR COLLEAGUES ARE USING FHIR TO EXCHANGE ELECTRONIC HEALTH CARE RECORDS. THAT WORKSHOP AND THIS ONE TODAY WILL HELP US AT NIH SHAPE AND UNDERSTAND THE ADVANCES OF FHIR FOR RESEARCH USES. AND SO IT'S A PLEASURE TO BE JOINED BY EXPERTS WITH KNOWLEDGE AND EXPERIENCE USING FHIR IN RESEARCH TO INFORM OUR APPROACHES AND THE ADVANTAGE OF DATA EXCHANGE, ACCESSIBILITY, INTEROPERABILITY AND HARMONIZATION. THERE ARE MANY COMPONENTS AND WAY TO EXCHANGE INFORMATION SUCH AS FHIR. THE FIRST PANEL WILL BE ON LEVERAGING FIRE TO UTILIZE PATIENT-GENERATED DATA FROM WEARABLED AND DEVICES IN RESEARCH. SECOND ON FHIR AND POPULATION-BASED STUDIES. FINALLY DR. PAUL HARRIS OF VANDERBILT UNIVERSITY WILL MODERATE A DISCUSSION WITH OUR PANELISTS AND ATTENDEES FUTURE USES OF FHIR FOR RESEARCH, REALLY IMPORTANT TO GET YOUR INPUT. BUT TO KICK US OFF IT'S MY GREAT PLEASURE TO INTRODUCE DR. JOSH DENNY, CEO OF NIH'S "ALL OF US" RESEARCH PROGRAM, WHO WILL DELIVER OUR KEYNOTE PRESENTATION. JOSH HAS BEEN INVOLVED IN "ALL OF US" SINCE ITS INCEPTION, FIRST AS A MEMBER OF THE ADVISORY COMMITTEE TO THE NIH DIRECT'S PRECISION MEDICINE WORKING GROUP DEVELOPING THE BLUEPRINTED, LED THE PROGRAM'S PROTOTYPING PROJECT AND SERVED AS PRINCIPAL INVESTIGATOR FOR "ALL OF US" DATA AND RESOURCE CENTER. AS A PHYSICIAN-SCIENTIST, JOSH IS DEEPLY COMMITTED TO IMPROVING PATIENT CARE, THROUGH THE ADVANCED PLACEMENT OF PRECISION MEDICINE. BEFORE JOINING NIH JOSH WAS A WAS AT VANDERBILT, IN HIS ROLES HE WAS BOTH A PRACTICING INTERNIST AND RESEARCHER. HIS RESEARCH INTERESTS INCLUDED USE OF ELECTRONIC HEALTH CARE RECORDS AND GENOMICS TO BETTER UNDERSTAND DISEASE AND RESPONSES, HE'S LED EFFORTS IN PRECISION MEDICINE TO IMPROVE PATIENT OUTCOMES. JOSH WAS A LEADER IN DEVELOPING THE PHENOME-WIDE ASSOCIATION STUDIES FOR PHENOTYPIC RISK SCORES, P.I. FOR VANDERBILT SITES IN THE EMERGE NETWORK, PHARMACOGENETIC RESEARCH NETWORK, IMPLEMENTING GENOMICS INTO PRACTICING, IGNITE NETWORK, A LOT OF GOOD WORK, ELECTED MEMBER OF THE NATIONAL ACADEMIES OF MEDICINE, AMERICAN SOCIETY FOR CLINICAL INVESTIGATORS, AMERICAN COLLEGE OF MEDICAL INFORMATICS. IT'S A PLEASURE AND AN AWE-INSPIRING TALK WE'LL HEAR FROM JOSH. THANK YOU FOR KICKING US OFF TODAY. >> IT'S A PLEASURE TO BE WITH YOU TODAY. AND TALK ON THIS IMPORTANT TOPIC, AND I'M GOING TO SHARE MY SCREEN HERE AND KICK OFF THE PRESENTATION. AND I'LL JUST HAVE TO -- I'M ASSUMING EVERYTHING IS BEING SHARED CORRECTLY NOW. IF IT ISN'T, SOMEONE BREAK IN AND YELL. SO, TODAY I GET TO SPEAK WITH ALL OF YOU, MANY OF WHOM I KNOW AND HAVE DONE PIONEERING WORK IN THIS SPACE ABOUT THE "ALL OF US" RESEARCH PROGRAM, A HUGE PART OF WHICH IS ELECTRONIC HEALTH RECORDS, TO USE AS A WAY TO LOOK AT INFORMATION AROUND PHENOTYPES, AND LONGITUDINAL EXPOSURE TO HEALTH CARE, AND FHIR IS PART OF THAT. ON THE MISSION TOWARDS IMPROVING HEALTH THROUGH PRECISION MEDICINE. OUR MISSION IS TO ACCELERATE HEALTH RESEARCH AND MEDICAL BREAKTHROUGHS ENABLING INDIVIDUALIZED PREVENTION AND CARE FOR ALL OF US, AND IT'S THREE DIFFERENT COMPONENTS. THE FIRST IS NURTURING RELATIONSHIPPING WITH ONE MILLION OR MORE PARTNERS FROM ALL WALKS OF LIFE FOR DECADES, CURRENTLY RESTRICTED TO ADULTS 18 OR OVER BUT EXPANDING TO PEDIATRICS IN THE NEAR FUTURE. ANOTHER COMPONENT IS DELIVERING A LARGE RICH BIOMEDICAL DATASET, WHERE FHIR BECOMES IMPORTANT IN THE FUTURE AND WE WANT TO HAVE A ROBUST ECOSYSTEM WITH RESEARCHERS AND FUNDERS THAT ENABLE RESOURCE TO GROW RICHER OVER TIME. I DON'T OFTEN TALK IN EXTERNAL AUDIENCES ABOUT OUR CORE VALUES BUT I THOUGHT IT WAS REALLY RELEVANT TO THIS TALK. THE FULL CORE VALUES ARE LISTED LISTED PARTICIPATION IS OPEN, WE REALLY FOCUS AND WANT TO REFLECT RICH DIVERSITY OF THE UNITED STATES. WE BELIEVE PARTICIPANTS ARE PARTNERS IN OUR PROGRAM, WHICH IS PART OF WHERE FHIR COMES INTO PLAY, AND WE BELIEVE THE TRUST IS EARNED THROUGH TRANSPARENCY, PARTICIPANTS WILL HAVE ACCESS TO THEIR INFORMATION, WE WANT DATA TO BE BROADLY ACCESSIBLE FOR RESEARCH, SECURING PRIVACY IS IMPORTANT, AND CATALYZE POSITIVE CHANGE IN RESEARCH, BOTH IN RESEARCH AND HOW RESEARCH IS DONE, AS WELL AS THE WAYS WE CAN INTERACT WITH OUR PARTICIPANTS. AND SO I'M GOING TO TALK ABOUT THE KIND OF DATA WE COLLECT. THE FIRST IS COMMON CONSENT PROCESS WHICH INCLUDES AUTHORIZATION FOR ELECTRONIC HEALTH RECORD COLLECTION, ONLINE VIDEO CONSENT PROCESS. CURRENTLY PARTICIPANTS THAT WE ENROLL ARE 18 ARE OVER, WE'LL EVENTUALLY EXPAND TO PEDIATRICS IN THE NEAR FUTURE. AND THIS INCLUDES AUTHORIZATION TO SHARE ELECTRONIC HEALTH RECORDS FROM OUR SITES THAT CAN PROVIDE THOSE. WE HAVE A SET OF SURVEYS THAT PARTICIPANTS FILL OUT, COVERS DEMOGRAPHIC AND LIFESTYLE INFORMATION, PERSONAL AND FAMILY MEDICAL HISTORY, HEALTH CARE ACCESS, DURING COVID LAUNCHED REPEATED SURVEY AROUND COVID EXPERIENCES, SO THAT GOES BEYOND WHETHER OR NOT YOU HAVE COVID. IT HAS TO DO WITH A PARTICIPANT EXPERIENCE IN TERMS OF THEIR OPINIONS, THEIR DISCRIMINATION, MENTAL HEALTH ISSUES, ACTIVITY, SOCIAL DISTANCING AFFECTED THEM. YOU CAN SEE THE SCREEN SHOT ON THE RIGHT IS JUST AN EXAMPLE OF GIVING THE CARD, WE GIVE BACK WITH BASIC CHARACTERISTICS, THAT'S ALSO AVAILABLE THROUGH OUR WEB AND ONLINE SMARTPHONE INTERFACES. WE COLLECT BIOSAMPLES, A KEY PART OF THAT. BUT AS A KEY PART OF THAT DNA, RNA, SERUM AND PLASMA, IF WE CAN'T COLLECT BLOOD, THAT INCLUDES GEOGRAPHIC REASONS OR DURING COVID, YOU MAY NOT WANT TO COME IN, WE CAN SEND SALIVA KIT AND DEVELOPED THAT DURING COVID, TO ANYWHERE IN THE COUNTRY, AND WE COLLECT URINE. WE HAVE MOBILE TECHNOLOGY, THROUGH BRING-YOUR-OWN DEVICE CURRENTLY, LINK IN FITBIT AND APPLE DATA AND ABILITY TO SEND DEVICES TO PARTICIPANTS, WE HAVE A PILOT RIGHT NOW WHERE WE'RE SENDING OUT A THOUSAND FITBIT DEVICES TO PARTICIPANTS STARTING WITH CERTAIN SELECT AREA OF THE COUNTRY, CERTAIN PLATFORMS, WE'LL TEND TO EXPAND THAT. WE SEE THIS AS BEING PART OF WHAT WILL CONTINUE TO GROW OVER TIME WITH AT-BASE COLLECTIONS AND PROGRAM-BASED DEVICES THAT MAY BE BEYOND COMMERCIAL DEVICES BEYOND COMMERCIAL FITBITs. RETURN OF INFORMATION IS AN IMPORTANT PART OF WHAT WE DO. GENETIC INFORMATION IS AN IMPORTANT PART OF CREATING A RESEARCH ENTERPRISE AS WELL. IT'S REALLY ONE OF THE DEFINING CHARACTERISTICS AS WE COLLECT BIOSPECIMENS. WE GENERATE TWO KINDS OF GENETIC DATASETS NOW, AND DERIVED SEPARATE KINDS OF RETURN. GENETIC ANCESTRY AND TRAITS ARE INFORMATION THAT WE'RE THROUGH GENOTYPING ARRAYS, PARTICIPANTS WHEN THEIR DATA ARE READY CAN VIEW GENETIC ANCESTRY AND NON-HEALTH RELATED TREE INFORMATION. WE LAUNCHED THOSE IN DECEMBER OF 2020. WHOLE GENOME SEQUENCING ON ALL ONE MILLION PARTICIPANTS WE'RE RECRUITING, WE'LL RETURN HEALTH-RELATED GENETIC TRAITS, STILL WORKING ON THIS, THIS ALSO HAS FDA OVERSIGHT. THOSE DATA WILL SUPPORT THE SO-CALLED ACMG 59, INHERITED CANCER SYNDROMES AND CARDIOVASCULAR ARRHYTHMIAS AND RELATED TRAITS FOR WHICH THERE ARE ACTIONABLE THINGS THAT CAN BE DONE IF YOU HAVE ONE OF THOSE RARE VARIANTS AND PHARMACOGENOMICS WILL BE RETURNED ON THE WELLTHE DEFINED WHICH WE CAN CALL GENETIC VARIANTS FROM WHOLE GENOME SEQUENCING INFORMATION. WE'RE WORKING ON THIS, WE EXPECT TO LAUNCH THAT IN EARLY 2022. THIS GIVES YOU A SENSE OF THE STATUS OF THE PROGRAM RIGHT NOW. WE LAUNCHED NATIONALLY IN MAY OF 2018. WE DEVELOPED AN ENROLLMENT FACILITIES AT ABOUT 350 IN-PERSON SITES CAPABLE OF ENROLLING AROUND 3,000 PARTICIPANTS PER WEEK THAT COMPLETED ALL THE BASIC STEPS INCLUDING DONATION OF BIOSPECIMENS, UNTIL COVID STRUCK. YOU CAN SEE THAT THE ENROLLMENT ACTIVITIES, ALL THE IN-PERSON ACTIVITIES HAD TO BE CAUSED DURING COVID UNTIL REALLY LATE IN THE FALL, WINTERTIME, IN WHICH WE'VE BEEN SLOWLY REBUILDING THAT CAPABILITY BACK, REALLY TRYING TO BUILD THAT CAPABILITY BACK AS FAST AS WE CAN, WE'RE PROBABLY A THIRD OF OUR EXPECTED CAPACITY. WE HOPE TO BE BACK TOWARDS PRE-COVID PACE TOWARDS THE END OF 2021. OVERALL WE'VE ENROLLED 390,000 PARTICIPANTS. CONSENT FOR SHARING OF ELECTRONIC HEALTH RECORDS IS A KEY COMPONENT OF WHAT WE DO, WE'VE COLLECTED COLLECTED EHRs ON 246,000 SAMPLES. I MENTIONED WE REALLY HAVE A GOAL OF REFLECTING RICH DIVERSITY OF THE UNITED STATES, AND YOU SEE THAT WE REPRESENT ALL 50 STATES AND TERRITORIES, MAJORITY FROM STATES WE'VE PARTNERED WITH ACADEMIC OR OTHER MEDICAL CENTERS INCLUDING FEDERALLY QUALIFIED HEALTH CENTERS AND THE V.A. OVERALL 80% OF THE "ALL OF US" PARTICIPANTS ARE UNDERREPRESENTED IN BIOMEDICAL RESEARCH, RACE/ETHNICITY, SOCIOECONOMIC STATUS, EDUCATIONAL ATTAINMENT, SEXUAL AND GENDER MINORITIES, WILL ININCLUDE DISABILITY AND OTHER STATUSES AS WELL. YOU CAN SEE OVER HALF ARE NON-WHITE, PERSONAL IDENTIFICATION, AND YOU CAN SEE AGE DISTRIBUTION AS WELL. AND WE LOOK AT OLDER INDIVIDUALS AS BEING UNDERREPRESENTED IN BIOMEDICAL RESEARCH ALSO. AS WE DEVELOP THIS, WE BELIEVE THAT IT REALLY WOULD FACILITATE RESEARCH AS WELL AS IMPROVE SECURITY AND OUR TRANSPARENCY WITH OUR PARTICIPANTS TO PURSUE A CLOUD-CENTRIC APPROACH. THIS WAS FROM THE OUTSET WHAT WE SOUGHT TO DO AND THOUGHT NOT ONLY COULD WE FACILITATE COLLABORATION AND FACILITATE FAIR PRINCIPLES AND REPRODUCIBILITY, ABILITY TO LOOK AT THE DATA, INTERROGATE AND GETTING COLLABORATEDDED ACROSS INSTITUTIONS, DEMOCRATIZING RESEARCHER ACCESS, CAPABILITY OF THIS THIS ESPECIALLY WHEN YOU THINK ABOUT SCALE OF GENOMIC DATA, THE SCALE OF ELECTRONIC HEALTH RECORD DATA AND OTHER KINDS OF DATA THAT WE'LL BRING INTO THE DATASET OVER TIME. AND SO THIS GIVES YOU MORE DETAIL ABOUT KIND OF WHAT WE SEE HAPPENING, NOT ALL THESE THINGS ARE HAPPENING YET. THIS IS KIND OF CURRENT AND ENVISIONED. RIGHT NOW FROM OUR HEALTH CARE PROVIDER ORGANIZATIONS, THOSE MEDICAL CENTERS ARE CONTRIBUTING EHR DATA FROM MOSTLY STRUCTURED INFORMATION VISITS, BILLING CODES, LAB DATA, WE SEEK TO MOVE TOWARDS NARRATIVE KINDS OF DATA AND OVER TIME MAY APPROACH IMAGING DATA AS WELL. AND THEN FROM PARTICIPANTS, WE DO HAVE WAYS OF PARTICIPANTS PROVIDING DATA, OF COURSE THEY ARE PROVIDING SURVEYS WHICH ACTUALLY COME IN FHIR FORMAT, BUT THEN THEY CAN ALSO LINK IN ELECTRONIC HEALTH RECORD DATA WHICH I'LL GO INTO DETAIL, PROVIDING LINKAGES TO THEIR PATIENT PORTALS, SENDING THOSE IN FHIR FORMAT, AND WE ADD STATUS CENTRALLY. WE HAVEN'T DONE A LOT OF THAT. WE'RE INITIALLY PUTTING IN DATA FROM THE CENSUS DATA THAT WE CAN LINK IN BUT WE WILL SEEK TO ADD MORE TYPES OF DATA CENTRALLY, BASED ON PARTICIPANTS OR OTHER CHARACTERISTICS THAT WE CAN LINK IN. THE DATA COME INTO THE INTO THE REPOSITORY, CURATE AND REMOVE OBVIOUS IDENTIFIERS, GIVING YOU A SENSE OF GROWTH OF EHR DATA. AS COVID HIT, WE STOPPED HAVING IN-PERSON ENROLLMENT, WE REACHED A PLATEAU PARTICIPANTS, CONTINUING TO INCREASE OVER TIME. WE HAVE EHR DATA FROM 50 SITES NOW. THOSE DIFFERENT PROVIDERS THAT ARE PROVIDING DATA MAP THEIR DATA TO THE DATA MODEL AND UPLOAD INTO GOOGLE BUCKETS. WHEN THEY UPLOAD INTO THE INDIVIDUAL GOOGLE BUCKET, REPORTS ARE PRODUCED AS WE PULL DATA TOGETHER AT THE DATA AND RESEARCH CENTER. THERE ARE MULTIPLE LEVELS OF DATA HARMONIZATION, QUALITY CHECKING, BACK AND FORTH WITH THE SITES TO MAKE THE DATA BETTER. THIS GIVES A SENSE OF THE DATA PROVIDERS WE HAVE. AND WHAT THE DATA QUALITY LOOK LIKE. SO ON THE LEFT YOU CAN SEE EPIC IS THE MAJORITY VENDOR, OVERALL 60 VENDORS, MANY DIFFERENT VERSIONS AS WE LOOK AT DIFFERENT SITES. SOME SITES THEMSELVES AGGREGATE MULTIPLE VENDORS BEFORE UPLOADING THOSE DATA TO US. ON THE RIGHT YOU SEE BY TIME IN EACH COLUMN, THE IMPROVEMENT OF THE QUALITY OF DATA OVER TIME. AND SO GREENER REPRESENTS HIGHER QUALITY DATA OVER TIME. SO YOU CAN SEE THAT ESSENTIALLY THE NUMBERS ARE A BIT ARBITRARY BUT WE'RE 100% -- 100% WOULD BE PERFECT IN THEIR CATEGORIES. YOU CAN SEE WE'RE GETTING MORE STANDARDIZATION GENERALLY OVER TIME. SOMETIMES THINGS GO DOWN BECAUSE YOU GET NEW DATASETS IN, AND WITH THOSE NEW DATASETS THE QUALITY NEEDS TO BE BETTER. SO, AS A RESEARCHER, USING ELECTRONIC HEALTH RECORD DATA FOR MUCH OF MY RESEARCH CAREER, I THOUGHT IT WOULD BE USEFUL TO SUMMARIZE A LITTLE BIT OF SOME OF THE DRIVING USE CASES FOR THIS AND HOW PEOPLE USE ELECTRONIC HEALTH RECORD DATA. AS WE THINK ABOUT BUILDING PHENOTYPES FROM EHR DATA, I THINK IT'S IN THE FOUR BUCKETS, YOU COULD DIVIDE INTO MORE BUT START WITH STRUCTURED DATA, PEOPLE USE BILLING CODE DATA, I'VE USED IT, MANY OTHERS TO DRIVE RESEARCH. LATER ON THINGS LIKE MEDICATION DATA, CLINICAL NOTE DATA, BY WHICH YOU CAN THINK OF PROCEDURE REPORTS, DISCHARGE SUMMARIES, SOME TYPES OF LAB AND TEST RESULTS THAT ARE NARRATIVE FORMATS, AND OTHER LAB AND TEST RESULTS, PUTTING THESE DATA TOGETHER IN DIFFERENT WAYS HELPS YOU GET TO YOUR TRUE MORE ACCURATE CASES AND RICHER PHENOTYPES, USING LOGIC MODELS, LOGIC OR OTHER KINDS OF REGRESSION SCORING ALGORITHMS TO DEEP LEARNING MODELS OR OTHER KINDS OF ARTIFICIAL INTELLIGENCE MACHINE LEARNING APPROACHES, MANY WAYS TO MOVE AT THESE KINDS OF DATA. IF YOU LOOK AT ONE SITE THAT AGGREGATES PHENOTYPE ALGORITHMS FROM A COUPLE NETWORKS LIKE THE EMERGE NETWORK AND IGNITE AND OTHER RESOURCES OUT THERE, CKB, THIS IS OUTDATED BUT I SUSPECT DATA IS SIMILAR ACROSS 154 ALGORITHM, BILLING CODE DATA USED THE MOST, 73%. MEDICATION 53, CPT CODES 444 AND THEN 42%, TEXT DOCUMENTS. VITAL SIGNS BEING AT THE BOTTOM, AT 12%. YOU THINK ABOUT "ALL OF US" WE HAVE SURVEYS, COMBINED WITH THOSE KINDS OF DATA, DIGITAL HEALTH TECHNOLOGY DATA, I I MENTIONED FITBIT AND LINKAGING. WE'RE SEEING RESEARCHERS GOING ACROSS DATASETS OR BEING WITHIN DIFFERENT LANES IN DIFFERENT WAYS. I THINK THIS INFORM US, NEEDS THE FULL ACCESS TO EHR, THE RICH DATA YOU CAN GET THERE. I MENTIONED WE HAVE THIS BRING-YOUR-OWN DEVICE PROGRAM. TO GIVE YOU STATS, 12,000 PEOPLE SHARED FIT FITBIT DATA. 4,000 LINKING THAT, A SEPARATE APPLE HEALTH RECORD, 2500 PEOPLE LINKED IN, ON YOUR iPHONE OR iOS DEVICE YOU HAVE LINKED YOUR APPLE, GONE THROUGH THE HEALTH RECORD INTERFACE WITH APPLE TO LINK TO ONE OR MORE PROVIDERS, AND THEN YOU LINK YOUR "ALL OF US" APP TO YOUR APPLE DATA. OVERALL IT'S 15,000 THAT HAVE SHARED SOME SORT OF DATA. WE HAVEN'T ADVERTISED THIS IN ANY WAY. IT'S KIND OF SOMETHING SOMEONE HAS TO FIND AN INTERFACE, MORE COMMON OVER THE APP. YOU CAN LINK FITBIT DATA THROUGH THE WEBSITE AS WELL. BUT THE APPLE DATA YOU HAVE TO LINK THROUGH THE -- WE HAVE ANOTHER PLATFORM BASED ON PLATFORM CALLED PAIR EVOLUTION, AREAS THAT AREN'T WITH HEALTH CARE PROVIDER ORGANIZATIONS. THROUGH THIS YOU CAN LINK TO FITBIT DATA AND APPLE HEALTH KIT DATA, LINK ELECTRONIC HEALTH RECORD DATA AND EVOLUTION SUPPORTS 900 PROVIDER NETWORKS, EACH WOULD LINK IN A FHIR WAY. NOT ALL OF THEM ARE PRESENTING FHIR BUT OF COURSE THAT'S WHERE EVERYBODY IS MOVING. THAT REPRESENTS 65% OF HEALTH CARE DELIVERED IN THE U.S. TODAY. PART OF THE CARE EVOLUTION PLATFORM IS VISUAL INTERFACE THAT PARTICIPANTS CAN LOOK AT THEIR DATA WITH SOME GRAPHS AS YOU CAN SEE HERE, AND IT ACTUALLY AGGREGATES ACROSS MULTIPLE DIFFERENT PROVIDERS AS WELL, IF YOU LINK IN MULTIPLE PROVIDERS. AND THIS GIVES A SENSE OF THE KIND OF DATA, ON THIS PLATFORM, A SMALL PERCENTAGE OF OUR POPULATION, WE HAVE 2,000 PEOPLE THAT ARE PROVIDING EHR DATA THAT REPRESENTS ABOUT 40% OF THE PEOPLE ON THIS PLATFORM, IN THIS MORE PILOT WAY, WE HOPE TO EXPAND THIS OVER TIME. YOU CAN SEE THAT MOST PEOPLE ARE USING CARE EVOLUTION NATIVE AS OPPOSED TO APPLE HEALTH RECORD FEATURE, YOU CAN LOOK AT THAT, THE PIE GRAPH, 89% ARE USING THE DIRECT FEATURES IN CARE EVOLUTION EFFECT OPPOSED TO APPLE. YOU'RE GETTING FROM A LOT OF THESE DATA PROVIDERS EVEN THOUGH IT'S NOT REALLY A REQUIREMENT IS THAT LAST ROW THERE, REPORTS. SO REPORTS ARE NARRATIVE DATA THAT A LOT OF THESE DATA PROVIDERS ARE ACTUALLY PROVIDING THROUGH THE CAREEVOLUTION PLATFORM AND YOU'RE BRINGING THAT IN. WE SEE A LOT OF DATA SITES PROVIDE DATA BEYOND WHAT IS REQUIRED. THIS SLIDE WALKS US THROUGH WHERE WE ARE CURRENTLY WITH REGULATIONS AROUND 21ST CENTURY CURES MEANINGFUL USE, THOSE KINDS OF REGULATIONS WHICH MAJOR VENDORS COMPLY WITH TODAY. WE'RE MOVING TOWARDS WITH USCDI, GIVING EXPANDED SET OF ENVIRONMENTS. ON THE LEFT WE HAVE MOSTLY CODED DATA, PROBLEM LISTS, MEDICATIONS, LABS, VITAL SIGNS, PROCEDURES, IMMUNIZATION, ON THE RIGHT CLINICAL CONTENT WHICH A LOT OF PEOPLE ALREADY COMPLYING WITH AND ALREADY MOVING TOWARDS. EXPANDS REQUIREMENTS AROUND OTHER THINGS. MANY OF YOU IN THE AUDIENCE KNOW THIS BETTER THAN I DO. SIGNIFICANTLY BETTER, PROBABLY. AS WE GO TO "ALL OF US," BASIC ARCHITECTURE, RAW DATA MOVING TO CURATEDDATED REWITH HARMONIZATION, DIVIDED INTO TIERS. BOTTOM TIER IS PUBLIC TIER, YOU CAN GET IT RIGHT NOW, NO LOG-IN REQUIRED. IT GIVES YOU SOME VERY SIMPLE CROSS-TABS PRIVACY PRESERVES, THAT'S THROUGH OUR DATA BROWSER. WE HAVE TWO MIDDLE TIERS THAT REGISTER AND CONTROL TIER, WHICH GIVES YOU THAT INDIVIDUAL ROW LEVEL ACCESS TO DATA THAT WILL LET YOU DO RESEARCH THERE. AND RIGHT NOW IT'S JUST THE REGISTERED TIER THAT'S LAUNCHED. WE'RE WORKING ON THE CONTROL TIER IN THE FUTURE THAT WILL HAVE MORE DATA, MORE GRANULAR DATA, HIGHER BAR TO HOW YOU ACCESS DATA AND NOTABLY WILL INCLUDE GENOMICS. IT'S ALSO WHERE WE'LL THINK ABOUT HOW WE DELIVER NARRATIVE DATA WHICH WE DON'T HAVE IN ANY VOLUME NOW, JUST DONATED DATA THAT PARTICIPANTS ARE PROVIDING. WE'LL SEEK TO ADD DATA OVER TIME. OVER TIME WE HAVE ANCILLARY STUDIES THAT GET INTO INDIVIDUAL BIOSPECIMEN AND PARTICIPANT DATA THAT WILL HAVE REACCESS, DEFINITELY A FUTURE COMPONENT. A YEAR AGO WE'LL LAUNCH THE RESEARCHER WORK BENCH, HOW RESEARCHERS COME IN, IN A CLOUD ENVIRONMENT TO DO RESEARCH STUDIES, GET ACCESS TO INDIVIDUAL ROW LEVEL DATA, A CLOUD-BASED RESOURCE, EMPLOYS A PASSPORT ACCESS MODEL WHICH IS ONE OF OUR KEY INNOVATIONS. YOU AS A PERSON ARE APPROVED ACCESS TO RESOURCE AND YOU CAN DO ANY RESEARCH STUDY AND CREATE DE NOVO WORKSPACES AND DEFINE WHAT YOUR PROJECT IS WITHOUT SEEKING NEW APPROVAL TO DO THAT PROJECT. WE HAVE GUIDELINES ABOUT WHAT KINDS OF STUDIES, EDUCATION AROUND RESEARCH PROCESS AS WELL. BUT FOR THE MOST PART ANY DISEASE, MEDICATION RESPONSE, THOSE KINDS OF THINGS CAN BE DONE AND STARTED AD HOC AND YOU CAN BASICALLY BE GOING IN MINUTES OF HAVING A NEW IDEA. SINCE WE LAUNCHED A YEAR AGO AS OF JUNE WE HAVE 290 DATA USE AND REGISTRATION AGREEMENTS SIGNED, MOST OF THOSE ARE MASTER INSTITUTIONAL AGREEMENTS MEANING ANY RESEARCHER FROM AN INSTITUTION CAN COME ON, APPROACHING 900 RESEARCHERS, 600 WORKSPACES CREATED. THIS GIVES A SENSE OF CURRENT CURRENTS, 350,000 PEOPLE HAVE SURVEY DATA, THAT'S COVID PARTICIPANTS SURVEY, 63,000 UNIQUE PARTICIPANTS. PHYSICAL MEASUREMENT DATA ON 260,000, ELECTRONIC HEALTH RECORD DATA, CURRENTLY AVAILABLE SET OF DATA 204,000, AND 80,000 PEOPLE WITH FITBIT DATA. THIS IS THE LONGITUDINALLALITYOF THE DATA. AS A RESEARCHER, I WAS EXCITED WITH LONGITUDINALITY, IN SILICO STUDIES LOOKING IN TIME. HAVE YOU SURVIVOR BIAS, MAJORITY AFTER 2018, BUT OTHERWISE OF COURSE THIS ISN'T A RETROSPECTIVE LOOK, YOU DID THE DATA EXPERIENCE AS IT'S ENTERED IN THE RECORD AND YOU CAN SEE OUR RECORDS GO BACK INTO THE 1980s FOR MANY PEOPLE. OF NOTE ON THE RIGHT, CONDITIONS WE HAVE THAT ARE PROVIDED. AND THIS IS JUST REPRESENTING WHAT'S BEING UPLOADED BY SITES ON BEHALF OF PARTICIPANTS, BASED ON THEIR CONSENT AND HIPAA AUTHORIZATION. WE ALSO HAVE A NUMBER OF IN SILICO PEDIATRIC PATIENTS IN HERE, SO THE NUMBER THERE IS I THINK AROUND 18,000 PARTICIPANTS THAT ACTUALLY HAVE PEDIATRIC DATA BEFORE THEY ENROLLED. AND JUST A COUPLE EXAMPLES OF HOW THESE DATA HAVE BEEN USED IF PUBLICATION, SO THIS WAS ONE OF THE FIRST PUBLICATIONS THAT WAS MADE, THE DATA. THIS STARTS WITH RESEARCH THAT WAS DONE IN A SINGLE SITE BY SALLY BAXTER, AN OPHTHALMOLOGIST. SHE DEVELOPED AN ALGORITHM USING HER ELECTRONIC HEALTH RECORDS TO PREDICT WHO WOULD NEED SURGERY FOR GLAUCOMA, AND THEN SHE TOOK THAT ALGORITHM AND APPLIED IT, AND WHEN SHE TOOK THE ALGORITHM INITIALLY DEVELOPED AT HER SITE, HER PERFORMANCE MEASURED BY THE CHARACTERISTIC WAS AROUND .5, SO WHEN SHE TOOK FROM A SINGLE SITE TO APPLICATION ACROSS 50 SITES, HER ALGORITHM DID NOT WORK VERY WELL. IT WAS PRETTY SIMILAR TO RANDOM CHANCE. WHEN SHE THEN TRAINED ALGORITHMS OF A VARIETY OF FORMATS, USING THE "ALL OF US" DATA, YOU CAN SEE THE PERFORMANCE IMPROVED DRAMATICALLY WITH SOME ALGORITHMS ACHIEVING AUCs OF GREATER THAN .8. IT'S JUST A MENTION OF THE IMPORTANCE OF USING MULTI-SITE DATA WHEN TRAINING A MACHINE LEARNING MODEL. HERE'S ANOTHER EXAMPLE FROM A FORMER Ph.D. STUDENT OF MINE. I WAS ON HIS COMMITTEE, NOT HIS CHIEF MENTOR. IN MARCH OF 2021, HE DEFENDED HIS Ph.D. DISSERTATION, WHICH INVOLVED A NUMBER OF CHARACTERISTICS. ONE OF HIS MAJOR PROJECTS WAS REPURPOSING DRUGS USE BE GENE EXPRESSION DATA, STARTING WITH PUBLICLY AVAILABLE GENE EXPRESSION DATA AND HE DID A COUPLE ENDPOINTS, WE'LL DIVE INTO DRUGS THAT MIGHT LOWER CHOLESTEROL. USING THIS PUBLICLY AVAILABLE GENE EXPRESSION DATA, ABOUT 69 DRUG CANDIDATES, AND LOOK AT THOSE AND EHRs AT VANDERBILT, DEVELOPED COMPONENTS, TO EVALUATE EFFECT OF THESE MEDICATIONS AND SEE ON THE RIGHT THAT SOME OF THE KNOWN STATINS ARE VERY EFFECTIVE LOWERING BLOOD CHOLESTEROL DID VERY WELL AT THE ELECTRONIC LEVEL, AND YOU COULD SEE THOSE EFFECTS. HE LOOKED AT OTHER DRUGS HE IDENTIFIED, SOME MIGHT ACHIEVE. AS HE PRESENTED THIS, THE QUESTION CAME UP AFTER THIS PROJECT WHICH IN THE AUDIENCE, AND IT WASN'T ME, HE DID THIS AT ONE SITE, WHAT ABOUT REPLICATION? AND CAN YOU FIND THIS AND EXTEND THESE DATA TO SHOW THIS EFFECT WENT SOMEWHERE ELSE? THIS PROJECT TOOK HIM THREE YEARS TO DEVELOP, A LOT OF STUFF IN THEIR METHOD DEVELOPMENT. BUT THE PROCESS OF APPLYING AND ALGORITHM IN ANOTHER SITE USUALLY TAKES A LONG TIME, YOU HAVE TO TALK TO PEOPLE, GET APPROVALS, FIND SOMEONE TO EXECUTE THE ALGORITHM AND ADOPT YOUR CODE AND YOUR DATA MODELS TO THE PROCESS. AND SO, YOU KNOW, AFTER HIS DEFENSE HERE, ABOUT A WEEK LATER HE E-MAILS THIS FIGURE. HE HAD NEVER USED "ALL OF US" BEFORE, HADN'T EVEN APPLIED TO ACCESS "ALL OF US." HE STARTED THE WHOLE PROCESS FROM START TO FINISH AND RUN HIS CODE IN "ALL OF US" ACROSS OUR DATASET TO REPLICATE THIS EFFECT, THESE ARE THE RESULTS FROM "ALL OF US." WHAT YOU SEE ON THE RIGHT ARE KNOWN STATINS, STATINS DO HAVE SIGNIFICANT EFFECTS, SIMILAR IN EFFECT SIZE, LOWER THAN WHAT HE FOUND AT VANDERBILT BUT CERTAINLY ON THE SAME ORDER OF MAGNITUDE, SEPARATION BY STATINS WHICH FOLLOWS KNOWN POTENCY REALLY OF THE STATINS THEMSELVES AND WAS ABLE TO LOOK AT OTHER DRUGS IN THERE AS WELL. IMPORTANTLY, THIS TOOK FROM START TO FINISH APPLYING TO THE RESOURCE FOR THE FIRST TIME, A WEEK. AND WHEN HE TOOK HIS CODE AND CUT AND PASTED, IT'S A LOT OF CODE BUT ESSENTIALLY THE ONLY CHANGES REQUIRED WERE CHANGING THE NAMES OF THE TABLES FROM OMAP TO THEIR STANDARD FORM AT VANDERBILT, SOME OF THE NAMES HAD BEEN ALTERED TO A DIFFERENT NAME. SO VANDERBILT IS A NON-STANDARD FORM HERE. AND THAT WAS ONE OF THE REASONS WHY HE COULD GET THESE RESULTS SO QUICKLY. SO, TO END, I WANT TO TALK ABOUT WHERE WE ARE ON THE DATA ROADMAP, AND WHAT'S COMING IN THE FUTURE. I MENTIONED WE HAD OUR PUBLIC LAUNCH OF OUR RESEARCHER WORKBENCH IN MAY OF 2020, RELEASED ANOTHER DATASET, RELEASE A DATASET TWICE A YEAR AT THE CURRENT PACE. LAST DATASET COMING IN DECEMBER OF 2020, THAT'S ALSO THE SAME TIME WE STARTED RETURNING ANCESTRY AND TRAIT RESULTS BASED ON GENOTYPING ARRAYS TO PARTICIPANTS. WE JUST LAUNCHED A RETURN THAT STARTED LAST WEEK. OUR COVID-19 SEROLOGY RESULTS TO PEOPLE WHO HAD BEEN TESTED DURING EARLY 2020 FROM JANUARY THROUGH MARCH AND WE IDENTIFIED SOME EARLIER CASES OF COVID-19 WHICH SUGGESTS WIDER EXPOSURE IN CASE BURDEN IN THIS COUNTRY WHICH IS KNOWN FROM A COUPLE OTHER STUDIES AS WELL THAT SUGGESTS THIS. AND LATE 2021 OR EARLY 2022 WE EXPECT TO HAVE OUR EARLY GENOMICS TO RELEASE TIER RESEARCHERS AND MORE COVID-19 DATA AND TOWARDS THE FUTURE PROBABLY WE'RE LOOKING OUT BEYOND 2022 AT THIS POINT. WE WILL CONTINUE TO EXPAND OUR DATA WITH LINKAGES, CLINICAL DATA, THINGS LIKE THAT. EARLY IN 2022 WE HOPE TO START RETURNING TO PARTICIPANTS HEALTH-RELATED GENETIC RESULTS. I'LL CONCLUDE WITH A FEW MINUTES FOR QUESTIONS. THANK YOU SO MUCH FOR YOUR ATTENTION HEREAND YOUR TIME. >> SOMETIMES IT'S EASIER IF FOLKS WANT TO USE THE CHAT BOX TO PUT IN Q&A. >> THE FIRST QUESTION I SEE IS FROM DR. CHUTE. THANK YOU FOR YOUR QUESTION. IS SYNCHRO SCIENCE STILL A DEVELOPMENT BY "ALL OF US" AND WILL SOFTWARE BE AVAILABLE FOR SIMILAR COHORT EFFORTS? IT'S SOMETHING WE PILOTED. WE HAVE SEEN TECHNOLOGICAL SUCCESS. THERE'S A WEBSITE FOR IT, THERE ARE A NUMBER OF LIBRARIES DEVELOPED IN THAT SPACE. I THINK WE'LL BE MOVING PROBABLY TOWARDS -- YOU KNOW, I GUESS IT'S A QUESTION. IS IT SING FOR SCIENCE OR DID THE WORLD MOVE TO ADOPT AND REUSE THE SAME PRINCIPLES FOR SYNC FOR SCIENCE AND AUTHORIZATION PORTALS, PORTAL AUTHORIZATION? SYNC FOR SCIENCE IS ONE OF THE MOVEMENTS THAT PUSHED US THERE. WHETHER WE USE THAT NOMENCLATURE OR NOT, THOSE LIBRARIES ARE GOING TO BE PUBLICLY AVAILABLE, SOME ALREADY ARE, AND THEY WILL CONTINUE TO BE. JOSH MANDELL PUT IN THE LINK, AS THE AUTHOR IS A GREAT RESOURCE FOR THAT. YOU MENTIONED OMAP QUERIES. RIGHT NOW ALL OF OUR DATA PRESENTED IN OMAP, IN FACT WE'RE EXPANDING OMAP WITH THINGS LIKE OUR SURVEY QUESTIONS TO INTERDIG INTER-- INTERDIGITATE WITH OMAP. WE DO THE SAME WITH FHIR DATA AND PUT IT IN OMAP. WE HAVEN'T DONE IT YET BUT THAT'S THE PLAN. NEXT QUESTION. WONDERING IF WE COULD COLLABORATE ON A PUBLIC HEALTH ANGLE TO "ALL OF US" ADDING REPORTABLE CONDITIONS, LOGIC THAT MAY BE A TANGIBLE ADDITION. I WONDER IF YOU MIGHT WANT TO -- IF YOU CAN, COME ONLINE AND JUST EXPOUND A LITTLE BIT MORE ON WHAT YOU MEAN. >> YES, GOOD MORNING. THIS OZZIE IN CDC. HI, JOSH. LONG TIME. IT'S THE EHR DATA COMING IN, WONDERING IF WE COULD ADD NOT JUST THE CONDITIONS AND ICD CODES BUT PUTTING IN WHETHER THOSE INDIVIDUALS HAD A REPORTABLE CONDITION, NOT JUST COVID BUT ANY OTHER AND THAT WOULD BE A GREAT ADDITION TO THE OVERALL LOGIC AND WOULD HELP US THINK THROUGH MORE, NOT JUST THE CHRONIC AND THE OTHERS BUT COMMUNICABLE CONDITIONS TOO. OVER. >> THANK YOU. THAT'S AN INTERESTING PROPOSAL. WE CERTAINLY HAVE AND WILL HAVE THOSE KINDS OF DATA. I HAVE TO THINK THROUGH WHAT THAT MEANS IN TERMS OF CASES AND HAPPY TO THINK THROUGH YOU OR OTHERS WHAT THOSE USE CASES WOULD BE. WE AREN'T GETTING DATA NECESSARILY ON A REALTIME BASIS FROM OUR SITES, SO IT WOULDN'T BE AS USEFUL FOR THAT COMPONENT AND DON'T INTEND TO BE A REPRESENTATIVE SAMPLE IN THE UNITED STATES. HOWEVER, IT'S CERTAINLY INTERESTING AND I THINK THE SEROLOGY STUDY WE DID ON COVID-19 IS A POINT TO HOW WE CAN ADD VALUE TO THESE COMPONENTS. WE WANT TO MAKE -- BE CAREFUL WITH OUR -- HOW WE THINK ABOUT AND PROTECT PARTICIPANTS PRIVACY IN THIS COMPONENT. DAVID, HELLO. YOU ASKED ABOUT BENEFITS OF CARE EVOLUTION, GOING TO THE HEALTH SYSTEM DIRECTLY, SO IN THIS CASE I WOULD -- CARE EVOLUTION IS A SMALL PERCENTAGE OF OUR POPULATION, THE VAST MAJORITY ARE ON A PLATFORM CREATED BY VIBRANT, AND -- BUT THE CARE EVOLUTION HAS LET US TEST A FEW NEW THINGS, ONE OF WHICH IS WHAT THEY CALL A HEALTH AND WELLNESS DASH BOARD, THAT IS PARTICIPANT-FRIENDLY RETURN. CARE EVOLUTION DEVELOPED SOME PROTOCOLS TO ALLOW US TO CONNECT TO A BROADER RANGE OF ENDPOINTS THAN RIGHT NOW IS SUPPORTED BY APPLE HEALTH RECORD, AND SO THAT LETS US TEST A LITTLE MORE OF EXPOSURE TO THE U.S. THOSE BENEFITS, SOME DOES GUY TO THE PARTICIPANT, ABLE TO PULL AND AGGREGATE DATA AND LOOK AT IT. I DON'T KNOW, YOU KNOW, IF PEOPLE HAVE DONE STUDIES OF THE VALUE OF PARTICIPANTS HAVING THAT EHR INFORMATION, WE HAVE ANECDOTAL EXPERIENCE IN AGGREGATED APP, BUT I THINK THAT'S SOMETHING WE LOOK TO EXPAND THE CAPABILITY OF, SO WE'RE LOOKING RIGHT NOW HOW TO TAKE THE LEARNINGS FROM A PARTIAL INSTALL BASE TO GENERALIZE ACROSS OUR ENTIRE INSTALL BASE AND WANT TO EXPAND THAT CAPABILITY AND ABILITY TO VISUALIZE. INCIDENTALLY, ONE MORE INTERESTING COMPONENT I THINK ON THIS WAS WE STARTED BY ASKING PARTICIPANTS WHAT THEY WANT. WE DID SURVEYS. WE DID WHAT WE CALL FOCUS GROUPS ACROSS THE COUNTRY, AND ACCESS TO EHR INFORMATION WAS MIDDLE OF THE ROAD OF WHAT PEOPLE WANTED. THE BIGGER DRIVERS FOR THEM WERE THINGS LIKE PHARMACO GENETICS. GIVEN THESE FOLKS WANTED TO HAVE ACCESS TO EHR INFORMATION ALSO HAD PATIENT PORTALS, BUT I DO THINK IT IS A BENEFIT, PEOPLE WANTED THE INFORMATION, THEY JUST DIDN'T RANK IT QUITE AS HIGHLY. LET'S SEE. I SEE A LOT OF OTHER QUESTIONS COMING IN. HOW ARE WE DOING ON TIME? >> I THINK WE'RE GOOD. WE HAVE UNTIL 11:50. >> OH, GREAT. OKAY, GOOD. SO, PAUL HARRIS, FROM A SCALABILITY STANDPOINT HOW IMPORTANT IS THE NOTION OF REDUCING OVERHEAD FOR LARGE COHORT PROGRAMS LIKE "ALL OF US"? DO YOU THINK REDUCING THE OVERHEAD WILL ALLOW SMALLER INSTITUTIONS TO PARTICIPATE? I THINK IT'S REALLY IMPORTANT WE FIGURE OUT HOW TO DO THIS IN BETTER WAYS. ONE OF THE THINGS WE WANT IS TO HAVE OUR ENROLLMENT TO BE AVAILABLE ACROSS THE U.S. RIGHT NOW WE HAVE, YOU KNOW, 50 OR SO LARGE MEDICAL CENTERS THAT DEVELOP THE CAPABILITY, SOME WERE FEDERALLY QUALIFIED HEALTH CENTERS, AND WE FOUND SOME HAD A SIGNIFICANT CHALLENGE TO GOING FROM THEIR RESOURCES TO A CODIFIED OMAP DATASET THEY COULD UPLOAD TO US. FHIR IS ONE TECHNOLOGY THAT COULD FACILITATE THIS, BOTH EITHER FROM PARTICIPANTS SHARING THEIR OTHER THAN DATA TO THE SITE ITSELF SHARING DATA ON THE PARTICIPANTS' BEHALF. ONE THING I'LL NOTE THAT IS A CONCERN IS AS WE TALK ABOUT PARTICIPANT-DRIVEN EHR SHARING YOU'LL NOTICE IF YOU PAID ATTENTION TO THE NUMBER, A MUCH SMALLER FRACTION OF OUR POPULATION, IT REQUIRES ANOTHER LEVEL OF A HIGHER LEVEL, MAYBE TECHNOLOGICAL SOPHISTICATION, AND IT IS BIASING TOWARDS MORE REPRESENTED POPULATIONS OF BIOMEDICAL RESEARCH SO I THINK IT'S REALLY IMPORTANT THAT WE CONTINUE TO FIND WAYS THAT WE CAN ACT ON THE PARTICIPANTS' BEHALF AND MAKE THINGS AS EASY AS POSSIBLE. I THINK ALSO COMING IN THE YOUR BIC WITIZATION WILL BE IMPORTANT HOW WE CAN GET SITES TO SHARE DATA AND STANDARDIZATION OF FHIR INTO DEEPER AREAS, DECREASE GAPS BETWEEN OMAP AND FHIR. THERE'S A QUESTION ABOUT OMAP DATA MODEL FOR GENE OMICS. WE'RE NOT USING IT. THERE ARE COMPONENTS AROUND DATA, HOW YOU CAN REPRESENT GENOMIC DATA IN OMAP BUT GENERALLY THE SIZE OF THE DATA YOU'RE TALKING ABOUT, THAT SORT OF THING, IS BETTER WHEN YOU'RE TALKING OUTSIDE OF LIKE MAYBE CLINICALLY ACTIONABLE VARIABILITIANTS, PROBABLY BETTER HANDLED THROUGH STANDARD GENOMIC TECHNOLOGY DEVELOPMENT AND WE'RE WORKING WITH GA 4 GA AND OTHER GROUPS YOU'RE FAMILIAR WITH. IDA, I'D LOVE TO HEAR YOUR THOUGHTS ON OMAP FOR DIGITAL HEALTH. DIGITAL HEALTH DIGITAL HEALTH. WE DON'T HAVE THE DIG DIGITAL HEALTH DATA WITH OMAP EITHER. HAS THE SEEM CONSIDERED CREATING SYNTHETIC DATASETS BASED ON EHR DATA? WE HAVE A SYNTHETIC DATASET. AT THIS POINT WE'RE WORKING ON IT, I DON'T THINK -- IT'S NOT REALLY OUT THERE YET BUT WE'VE INTERNALLY WORKED ON IT, BASED ON AN OMAP. OUR OMAP IS OUR EXPOSED DATASET, INTERESTING TO THINK ABOUT FHIR IN THAT COMPONENT. AND FORTUNATELY PAUL IS ON THIS CALL, AND SEVERAL OTHER PEOPLE FROM THE DATA AND RESEARCH CENTER. OMAP, RACHEL ASKS DO WE HAVE OMAP DATA MODEL FOR PATIENT-REPORTED DATA AND ACTUALLY WE DO. SO WE'RE INTEGRATING OUR SURVEY DATA INTO OMAP, AND I BELIEVE IF YOU GO TO ATHENA, THERE ARE WAYS TO FIND THAT QUICKLY ALTHOUGH I DON'T REMEMBER WHAT THEY ARE. SOMEONE MORE KNOWLEDGEABLE ON THIS CALL COULD THROW THAT IN THE CHAT. BUT WE'RE DEFINITELY ONE OF THE DIVISIONS HERE AND THOSE DATA WHICH, YOU KNOW, AS YOU'LL RECALL PERHAPS THE SURVEY DATA ACTUALLY IS TRANSPORTED VIA FHIR AND THEN INTO OMAP, AND SO JUST AN EXAMPLE BOTH TECHNOLOGIES, BY INSERTING INTO OMAP LINKING THE SURVEY WAS WELL AS FIRST MEASURED DATA, WITH COMMON DATA MODEL, THAT PROVIDES MORE HIERARCHICAL AND CODIFIED REPRESENTATIVE STRUCTURE FOR THOSE DATA. AND THEN BOB FREEMAN, BRING RESEARCHERS TO THE DATA ARCHITECTURE CURRENTLY IN USE STILL RELIES ON CENTRALIZED MODEL. VERY TRUE. WILL "ALL OF US" EXPLORE DECENTRALIZED MODELS FOR GENOMICS DATA FOR EXAMPLE? AS "ALL OF US" EXISTS, AS A CORE PROGRAM IN WHICH WE ARE ENROLLING PARTICIPANTS IN THIS COMMON PROJECT, I THINK WE'LL PROBABLY CONTINUE TO BE IN FOCUS ON A CENTRALIZED MODEL. FOR OUR PROGRAM. THERE ARE WAYS THOUGH THAT WE'RE TALKING CERTAINLY ACROSS THE GOVERNMENT, ACROSS THE NIH I SHOULD SAY, AND SUSAN IS REALLY AT THE POINT IN A LOT OF THESE EFFORTS, HOW "ALL OF US" CAN PARTICIPANTS AS, YOU KNOW, ONE OF A FEDERATED SET OF PARTNERS IN EFFORTS, LOCALIZED CENTRALIZED EFFORTS. SO WE'RE DEFINITELY NOT IMMUNE AND REALLY WANT TO FACILITATE THE POWER OF COMMON DATA ARCHITECTURES TO ALLOW FOR RESEARCH TO BE DONE, EXCELLENT QUESTION, AS THE OTHERS, THAT'S ONE OF THE POWERS WE HAVE. WE HAVE AN ADVANTAGE IN OUR MODEL, IN OUR SIZE, WE CAN CENTRALIZE THINGS. RIGHT NOW THAT FACILITATES THE BEST AND FASTEST WAYS ON OUR DATASET. >> THANK YOU SO MUCH, JOSH. ALSO THE FOLKS ACROSS NIH FOR INTEROPERABILITY. YOU'VE DONE AMAZING WORK TO BRING RESEARCHERS TO THE DATA FOR RESEARCH PARTICIPANTS. I WANT TO THANK YOU FOR GIVING THE KEYNOTE. I BELIEVE I'M HANDING THIS OFF TO YOU NOW, ALLISON, FOR OUR NEXT SESSION. AGAIN, THANK YOU. THIS HAS BEEN A GREAT SESSION. BACK TO YOU, BELINDA. >> YES, THANK YOU VERY MUCH, SUSAN. THANK YOU, DR. DENNY. I COULD NOT THINK OF A BETTER KEYNOTE TALK BY YOU ON THE "ALL OF US" PROGRAM. IT REALLY SETS THE DIRECTION FOR THIS WORKSHOP AGENDA IN TERMS OF SHEDDING LIGHT ON WEARABLES, ON POPULATION DATA ISSUES, THANK YOU VERY MUCH. I HAVE THE PLEASURE OF INTRODUCING DR. ALLISON HEATH, WHO WILL MODERATED THE FIRST SESSION ON LEVERAGING FHIR TO UTILIZE PATIENT-GENERATED DATA FROM WEARABLES OF MOBILE DEVICES IN RESEARCH. DR. HEATH IS DIRECTOR OF DATA TECHNOLOGY AND INNOVATION, CENTER FOR DATA DRIVEN DISCOVERY IN BIOMEDICINE AT CHILDREN'S HOSPITAL OF PHILADELPHIA. SINCE JOINING THE CHILDREN'S HOSPITAL, DR. HEATH AND TEAM HAVE BEEN WORKING ON SOLVING BIG DATA CHALLENGES IN THE UNIQUE CONTEXT OF PEDIATRIC DISEASES AND MOST NOTABLY IS HER LEADERSHIP IN THE NIH-FUNDED KIDS FIRST INITIATIVE, AND I AM GOING TO TURN THE MIC OVER TO DR. HEATH. THANK YOU. >> THANK YOU SO MUCH, BELINDA. IT'S GREAT TO FOLLOW SUCH A GREAT KEYNOTE THERE. TODAY I'M REALLY JUST MODERATING THE SESSION ON WEARABLES AND MOBILE DEVICES. YOU MENTIONED WE'VE BEEN DOING A LOT OF WORK IN THE RESOURCE CENTER WHERE WE BUILT OUT A LOT OF FHIR, INTEROPERABILITY AND PLATFORM WORK. I'M EXCITED ABOUT THE SESSION MAINLY BECAUSE I MYSELF DON'T WORK THROUGH THE MOBILE AND WE'RABLE DEVICES BUT THINK THERE'S A GREAT OPPORTUNITY AS YOU SEE THAT AND YOU'LL HEAR FROM SPEAKERS. A QUICK INTRODUCTION TO SET THE STAGE AND HAND OVER TO THE TWO FOLKS PRESENTING. THINKING ABOUT THE KEYNOTE AND I'M IN THE CENTER FOR DATA DRIVEN DISCOVERY, WHAT DOES DATA DRIVEN RESEARCH MEAN? THINKING ABOUT WORK FLOWS, BRINGING IN RAW DATA, FIGURING OUT DATA, CONTEXT, INFORMATION, KNOWLEDGE, IMPACT, AND REALLY ME AND MY TEAM SPEND TIME THINKING ABOUT PLATFORMS AND IT'S GREAT TO SEE SOME OF THAT EMERGING. THE STEPS ALWAYS NEED TO HAPPEN, DO YOU DO WE BUILD STEPS TO MAKE IT HAPPEN IN THAT TIME FRAME. THERE'S STANDARDS, BUILDING ON STANDARDS SUCH AS FHIR, WE'LL HEAR MORE ABOUT THE MOBILE STANDARDS AS WELL TODAY. THINK ABOUT PLATFORM SPACES. WE THINK ABOUT THE ANALOG TO DIGITAL, HOW DO PATIENTS, CAREGIVERS, EVERYONE PARTICIPATING, HOW DO YOU TRANSLATE INTO ANALOG, INDIVIDUALS ENEMPOWERED THROUGH THE WORK FLOW SUCH THAT YOU HAVE IMPACT AND PEOPLE THAT CAN BE EMPOWERED BY THIS. SOME OF THE QUESTIONS, DECENTRALIZED PLATFORMS ACROSS THE NIH SPACE, THINKING ABOUT THESE PLATFORMS, IT MAKES SENSE FOR PEOPLE HAVE TO HAVE PLATFORMS TO COME TO THE DAY OR DISTRIBUTE THE DATA. I PERSONALLY DO WORK IN THE WEARABLE MOBILE SPACE BUT IT WAS THE PERSONAL MOMENT FOR ME PERSONALLY SO WORKING IN THE SPACE YOU THINK ABOUT ALL THE REASONS HEALTH RECORDS ARE BEING DIGITIZED, FLEXIBLE STANDARDIZATION, I'VE BEEN HEARING A LOT. ABOUT THREE YEARS AGO, I HAD ACTUALLY MOVED TO CHOP RECENTLY, I LIVE IN SOUTH JERSEY. I WENT TO ATLANTIC CARE, THEY OFFER THAT, I COULD CONNECT MY APPLE HEALTH TO MY MEDICAL RECORDS. LOOKS COOL BUT I DON'T KNOW IF I WANT TO DO THAT. I THOUGHT ABOUT IT. AND THEN TALKING TO APPLE HEALTH PEOPLE I GOT CONVINCED TO LINK MY OWN HEALTH RECORDS THERE. THIS IS AROUND THE TIME WE WERE THINKING ABOUT HOW DO WE MANAGE THE CLINICAL DATA, IT'S COMPLEX, TOUGH, NOT A LOT OF STANDARDS, IN THIS THREE YEARS AGO. I LOGGED IN AND SAW I COULD GET MY FHIR SOURCE DATA, ALL I HAD WAS A FLU VACCINE. IT WAS COOL. HOW DOES THIS WORK? THEY HAD BEEN BUGGING ME TO GET MY BLOOD DRAWN, I HADN'T HAD IT DONE IN FOREVER. I WENT AND GOT MY LABS DRAWN THAT MORNING, BY EVENING I HAD THE VIEW ON MY PHONE. I WAS ABLE TO LOOK THROUGH MY LABS, IF YOU WERE AROUND AT THIS TIME EVERY CONFERENCE I WAS SHOWING PEOPLE THIS. IT WAS EYE OPENING AND SHOWS THE POWER OF HAVING AN APP, HAVING SOMETHING AS PERSONAL AS YOUR OWN PHONE THAT YOU CAN REALLY UNDERSTAND THAT DATA, CAN HAVE DIFFERENT WAYS WE CAN CONNECT TO PLATFORMS, TO PROVIDE AND GET DATA BACK. THINKING ABOUT, WELL, IT'S BEING USED FOR CLINICAL CARE, CAN WE USE IT TO RESEARCH DATA? AND THINKING ABOUT CONNECTIONS, WE HAVE A LOT OF PLATFORMSSYSTEMS SET UP, OPPORTUNITIES FOR LEVERAGING WITH THE RIGHT TECHNOLOGY STANDARDS APPLICATIONS. I'LL HAND OVER TO THE REAL EXPERTS HERE THAT WILL BE TALKING ABOUT THIS STARTING WITH DR. SIM, UNIVERSITY OF CALIFORNIA SAN FRANCISCO, STANDARDS FOR CARE RESEARCH, FOLLOWED WITH DR. KRISTEN MILLER TALKING ABOUT PAIN MANAGEMENT APPLICATIONS. WE'LL DO THE SPEAKERS BACK TO BACK AND HOPEFULLY HAVE TIME FOR QUESTIONS. FEEL FREE TO ASK QUESTIONS IN THE CHAT. I'LL HAND IT OVER TO DR. SIM. >> THANK YOU FOR THAT GREAT OVERVIEW. AND CAN I SHARE MY SCREEN? YES, THERE WE GO. ARE YOU SEEING MY SCREEN? >> YES. >> GREAT, OKAY. THANK YOU. SO, THANK YOU FOR INVITING ME TO THIS VERY IMPORTANT SESSION ON SUCH IMPORTANT WORK. I'M GOING TO TALK ABOUT DIGITAL BIOMARKERS, STANDARDS FOR CARE AND RESEARCH. WE'LL START WITH WHAT DIGITAL BIOMARKERS ARE. SO DIGITAL BIOMARKERS ARE PHYSIOLOGIC AND BEHAVIORAL MEASURES COLLECTED BY MEANS OF DIGITAL DEVICES SUCH AS PORTABLES, WEARABLES, PLANTABLES OR DIGESTIBLES CHARACTERIZING OR PREDICT HEALTH-RELATED OUTCOMES. WE THINK ABOUT THE SEX AND SO FORTH BUT THINKING MORE BROADLY, ALL KINDS OF SENSORS THAT ARE GOING TO BE COMING INTO USE. THESE SENSORS COLLECT DATA THAT ARE PROSESSED MAYBE ON YOUR PHONE, MAYBE IN THE CLOUD. THAT DATA IS COMBINED WITH OTHER DATA, INTERNET OF THINGS DATA, COMES BACK MAYBE TO YOUR PHONE FOR DIGITAL SUPPORT TO USE AS A PERSON OR MAYBE TO, YOU KNOW, DESKTOP COMPUTER FOR YOUR CLINICIAN, FOR EXAMPLE. THERE'S A COMPLICATED DATA FLOW OF DATA THAT GOES BACK AND FORTH. DIGITAL BIOMARKERS, THERE'S BASIC ASSUMPTION THAT ARE RISING ABOUT THESE. SO THERE ARE GOING TO BE MANY NEW DIGITAL BIOMARKERS TO FIND, WE'RE JUST AT THE BEGINNING OF DIGITAL HEALTH. THESE WILL COME FROM NEW SENSORS WE'VE NEVER HEARD OF BEFORE. NEW PATIENT-REPORTED OUTCOMES. I THINK PATIENT-REPORTED OUTCOMES AND SENSOR DATA IS DIFFERENT. BLOOD PRESSURE CAN BE SOMETHING YOU USE A MANUAL CUFF AND REPORT IT, IT'S GOING TO BE FLUID, WHAT IS SENSOR, AND WHAT IS PATIENT REPORTED. AMAZON HILO IS SENSING THAT, DATA IS ACQUIRED FROM THE PATIENT, CONTINUALLY CHANGING HARDWARE AND SOFTWARE, DIGITAL BIOMARKERS OF COMBINED OUTPUT FROM MULTIPLE SENSORS, THE MOST IMPORTANT THING IS THAT DATA WILL FLOW FAR AND WIDE TO MULTIPLE ACTORS FOR MULTIPLE PURPOSES. HOW DO WE BUILD AN ECOSYSTEM THAT'S FUTURE PROOF AND ABLE TO SUPPORT DATA FLOW TO MAINTAIN INTEGRITY? WE NEED TO KNOW WHERE THE DATA CAME FROM, WHAT ARE THE CONDITIONS UPON WHICH IT WAS COLLECTED, WHAT IS THE CONTEXT, AND A LOT OF THE FACTORS THAT ALLOW US TO UNDERSTAND SOMETHING ABOUT ERRORS, RIGHT? SO THOSE ARE ALL REALLY, REALLY IMPORTANT THINGS, WE THINK ABOUT DATA FLOWING FAR AND WIDE. STANDARDIZING THAT DATA WILL MAKE THAT DATA EXCHANGE PREDICTABLE INTO THE SYSTEM, INCREDIBLY IMPORTANT, IT WILL MAKE IT EASIER TO AGGREGATE DATA, FACILITATE DEVELOPMENT AND VALIDATION OF UP AND COMING DIGITAL BIOMARKERS, REDUCE COST OF USING, CARE AND RESEARCH, THINKING ABOUT THAT TOGETHER, WE NEED TO BUILDED SAME SYSTEM FOR CARE AND RESEARCH, LEARNING HEALTH CARE SYSTEMS BUT REALLY TWO SIDES OF THE SAME COIN. I'M A CO-FOUNDCO, FOUNDED TEN YEARS AGO, OPEN HEALTH, WORKING TO DEFINE OPEN SOURCE DATA STANDARDS FOR THE MOBILE HEALTH DATA. YOU CAN SEE WE'VE GOT A NUMBER OF GRANTS, LARGE NIH CENTERS THAT WE'VE WORKED WITH, MORE RECENTLY WE HAVE WORKED AT THE IEEE TO BECOME A GLOBAL STANDARD. TWO WEEKS AGO WE WERE APPROVED, IEEE 1752, WORKING WITH OMC FOR STANDARDS. WHY NOT JUST USE FHIR FOR mHEALTH? IT'S A REALLY GOOD QUESTION. THIS IS THE WAY I THINK ABOUT IT. mHEALTH AND HEALTH-I.T. ARE TWO BIG AND DIFFERENT USE CASES. MAYBE YOU'RE FAMILIAR WITH THE ONE ON THE RIGHTHEALTH I.T. WHERE FHIR IS DOMINANT. IT'S STABLE, COMPARATIVELY. WELL UNDERSTOOD. THE DATA CONTROL IS MORE CENTRALIZED AND EHR COMPANIES, ORGANIZATIONS, VERY MUCH WORKING IN THE HEALTH I.T. SPACE. YOU KNOW, HIGHLY REGULATED VERY HEALTH FOCUSED. IN CONTRAST MOBILE HEALTH USE CASE, TARGET USERS ARE PEOPLE, NOT EVEN PATIENTS, PEOPLE LIVING THEIR LIFE 24/7 EVERYWHERE, VARIABLE, NOISY, POORLY VALIDATED, MANY DIFFERENT COMPANIES AND CONSUMER HEALTH SPACE NEVER HEARD OF FHIR AND DON'T KNOW ABOUT HEALTH I.T. AND DATA BEING SHARED ISN'T A WHOLE RECORD, IT'S FOR DATA ANALYTICS. THERE ARE A LOT OF CONSTRAINTS ABOUT YOUR PHONE, POWER, DATA USAGE, AND PEOPLE WORKING IN THIS SPACE WITH REGULAR DEVELOPERS, START-UP COMPANY, VERY MUCH LESS REGULATED, VERY MUCH EVOLVING, CERTAINLY REGULATORY LANDSCAPE IS EVOLVING. IT'S NOT THAT ONE IS MORE RIGHT, THEY ARE JUST DIFFERENT. SO WHAT WE THOUGHT ABOUT REALLY IS THAT WE'RE TRYING TO MEET DEVELOPERS WHERE THEY ARE, OPEN mHEALTH AND FHIR SERVE DIFFERENT USE CASES BUT BOTH CAN BE MAPPED TO EACH OTHER. WE'RE MOVING TO THE WORLD WHERE WE DON'T HAVE MANY, MANY, MANY STANDARDS BUT A A FEW THAT CAN TALK TO EACH OTHER, FIT FOR PURPOSE FOR USERS IN THAT PARTICULAR SPACE. SO, I THINK WE CAN HAVE THE BEST OF BOTH WORLDS USES OPEN mHEALTH AND FHIR AND MAP IMPLEMENTATIONS WHICH I'LL TALK ABOUT IN A LITTLE BIT. WE SHOULD THROW IN OMAP AS WELL, A GOOD DISCUSSION I WOULD BE EXCITED TO HAVE, TALKING, LISTENING TO THE OMAP COMMUNITY FOR A WHILE, IT'S TIME TO THINK ABOUT HOW THESE CAN COME TOGETHER, CERTAINLY A LOT OF OPPORTUNITIES THERE. SO JUST A BIT ABOUT THE OPEN mHEALTH APPROACH TO DATA SHARING, WE DEFINE COMMON SCHEMAS, LIKE TEMPLATES, AND WE HAVE OPEN SOURCE TOOLS TO VALIDATE, PULL IT IN AND STORE IT AND SHARE IT SECURELY. I WANT TO NOTE A LOT OF FUNDING WE'VE HAD FROM NIH AND ALSO NSF FOR THIS WORK. SO A LITTLE BIT DEEPER INTO THE COMMON SCHEMAS, THIS IS JUST JSON, THERE'S A HEADER, A BODY, WE ANNOTATE TO STANDARDIZED VOCABULARIES, SNOMED AND LOINC, TRYING TO TAKE THAT WORK OF ANNOTATION AWAY FROM FROM A START-UP DEVELOPER AND STILL HAVE THE INTEGRITY. I'LL GIVE YOU WHO SECONDS TO THINK ABOUT WHAT THIS MEANS. HAVE THAT IN YOUR MIND. AVERAGE DATA POINT, AVERAGE FASTING GLUCOSE OVER THREE MONTHS, AVERAGE OVER THE PERIOD JANUARY TO MARCH 2021. AS A CLINICIAN, THIS IS WHAT I NEED. I DON'T KNOW -- JUST GIVE IT TO ME. WE NEED THIS FOR RESEARCH, FOR CLINICAL CARE WE NEED THIS. THERE'S A LOT MORE THAT WE NEED. THINK ABOUT A SLEEP DIGITAL BIOMARKER, WE REALLY WANT TO KNOW WHEN YOU TELL ME SLEEP, I DON'T KNOW WHAT YOU'RE TALKING ABOUT. SLEEP DURATION, SLEEP QUALITY, ARE YOU REFRESHED AFTER YOU WAKE UP? LET'S TAKE SLEEP DURATION, TIME IN BED, TIME IN BED ASLEEP, DO YOU COUNT MICROAWAKINGS? HOW VALID COMPARED TO GOLD STANDARD, ERROR RANGE, VARIABILITY WITHIN AND AMONG INDIVIDUALS I KNOW WHAT TO DO WITH THE ERROR. WHAT IS PROBABLY THE PERSON'S SLEEP, SENSING ERRORS THAT MAY BE SYSTEMATIC, WHOSE SLEEP? MEASURING THE BED? WHOSE SLEEP? IS IT MEASURING SOMETHING THAT YOU'RE SLEEPING AFTER JET LAG, FOR EXAMPLE. LOOKING AT LONGITUDINAL DATA FOR RECERTAINLY, HOW DO YOU MAKE SENSE OF THAT? CERTAIN CATEGORIES OF METADATA, REALLY BOTTOM LINE IS THAT THERE'S NO END TO WHAT WE WANT TO KNOW ABOUT DIGITAL BIOMARKERS. MAYBE MORE SO THAN EHR DATA BECAUSE THIS IS 24/7 IN OUR LIFE DATA. AND THERE IS GOING TO BE SOME RESEARCHER THAT WANTS TO KNOW SOME OBSCURE ASPECT OF METADATA WHICH IS CRITICAL FOR THE RESEARCH QUESTION. WE CAN'T POSSIBLY COLLECT ALL METADATA, YET WE CANNOT IGNORE THE PROBLEM AND COLLECT NO METADATA. IT'S A CHALLENGING PROBLEM. MANY OF US WILL GO, LET'S JUST DO THE 80/20 RULE, GRAB BASIC MINIMAL METADATA AND GET STARTED. THAT'S WHAT WE'RE DOING WITH THE WORK WITH THE IEEE WORKING GROUP. METADATA IS A COMPONENT OF OUR STANDARD, IT'S JUST AN INITIAL STAB AT IT BUT I THINK WORKING ESPECIALLY WITH RESEARCH GROUPS LIKE "ALL OF US" AND THE REST OF NIH RESEARCHERS REALLY DEFINES WHAT KIND OF METADATA DO WE NEED, HOW DO WE CAPTURE THAT METADATA, HOW DO WE SHARE IT IN A WAY THAT'S SCALABLE AND FEASIBLE? I THINK THAT'S ONE OF THE BIGGEST QUESTIONS I SEE IN DATA STANDARDS FOR MOBILE HEALTH. ONES IN BLACK WERE JUST APPROVED, ONES IN GRAY WE'RE ABOUT TO BE WORKING ON. IF YOU'RE INTERESTED, PLEASE DO JOIN US AT OUR IEEE WORKING GROUP. THE WORK WE'RE DOING IS GAINING TRACTION WITHIN RESEARCH, WE JUST STARTED DISCUSSIONS TO INCORPORATE OPEN mHEALTH INTO THE "ALL OF US" PROJECT. I DID NOTE RECENT CALL FOR PROPOSALS, THE POST-ACUTE SEQUELAE OF SARS CALLED OUT RECOMMENDING APPLICANTS TO USE OPEN mHEALTH. THERE'S A LOT OF WORK TO BE DONE BUT I THINK A GREAT OPPORTUNITY THERE. I DID WANT TO TOUCH ON FHIR AND HOW OPEN mHEALTH RELATES TO FIRE, DO YOU DO WE GET THE BEST OF BOTH WORLDS? JUST TO REVIEW THE FHIR LINGO, SOMETIMES IT'S CONFUSING, RIGHT? FHIR, YOU KNOW, BASIC BUILDING BLOCK IS RESOURCES, LIKE SCHEMAS, THE IDEA IS OF A JSON IS A TEMPLATE, DEFINE HOW DATA ARE STRUCTURED AND EXCHANGED. IN CONTRAST TO TO mHEALTH, THAT SINGLE RESOURCE IS USED FOR MANY DIFFERENT KINDS OF QUANTITATIVE OBSERVATIONS, BLOOD PRESSURE OR WEIGHT, AT OPEN mHEALTH ONE FOR BLOOD PRESSURE, A DIFFERENT SCHEMA FOR WEIGHT BUT YOU CAN STILL MAP BETWEEN THE TWO. IN A FHIR OBSERVATION RESOURCE THERE'S A PROFILE THAT RESOURCES ARE RESTRICTED TO CERTAIN CONSTRAINTS, TECHNOLOGY IS A REQUIRED FIELD, TO IMPLEMENT A SPECIFIC, YOU KNOW, USE CASE, BLOOD PRESSURE FOR U.S. CORE DATA INTEROPERABILITY, IF THAT SOUNDS COMPLICATED IT IS. GRAPHICALLY THERE'S THE GENERIC RESOURCE DEFINITION AND PROFILE, OBSERVATION OF PROFILE FOR BLOOD PRESSURE AND THEN THE ERRORS ARE THE IMPLEMENTATION GUIDES FROM GENERIC TO PROFILE. THAT'S WHAT WE'VE USED, THE SAME APPROACH. WE HAVE THE OPEN mHEALTH STEP COUNT SCHEMAS ON JSON, AND WE MAP IT TO THE OBSERVATION RESOURCE PROFILE FOR STEP COUNT AND THEN IMPLEMENTATION GUIDE IS THE WAY I THINK ABOUT IT. WE HAVE OPEN mHEALTH ON FHIR IMPLEMENTATION GUIDES FOR THESE DATA TYPES YOU SEE, THERE'S THE OBVIOUS ONES TO START WITH. AND SO THAT IS NOW AVAILABLE ON OUR GITHUB PAGE AS WELL. SO I THINK THAT'S A SUMMARY. THAT'S CRITICAL. THE PIECE WILL PROVENANCE I THINK IS REALLY CRITICAL AND METADATA. WE ARE CERTIFIED AS A GLOBAL IEEE STANDARD, IMPORTANT BECAUSE WE'RE GETTING TRACTION IN THE INDUSTRY SPACE, AND FOR GROUPS OUTSIDE OF HEALTH CARE THAT ARE DEVELOPING THESE SENSORS, AND I THINK BRIDGING THE HEALTH AND NON-HEALTH WORLD IS VERY IMPORTANT, I THINK THERE'S NO SUCH THING AS HEALTH AND NON-HEALTH DATA. EVERYTHING IS RELATED TO HEALTH. I THINK WE NEED TO BUILD THOSE BRIDGES BEYOND JUST THE HEALTH I.T. ECOSYSTEM. WE DO FHIR IMPLEMENTATION GUIDE SUPPORTS MAPPING TO FHIR FOR INTEGRATATION INTO CLINICAL FOR CLINICAL W ORK. AS WE MENTIONED BEFORE, TALKING ABOUT OMAP AS WELL. SO I WILL STOP FOR THE NEXT SPEAKER. >> THANK YOU. FEEL FREE TO PUT QUESTIONS IN THE CHAT AS WE GO AND WE'LL ANSWER THEM TO AFTER DR. MILLER'S TALK WHO I'LL HAND IT OVER FOR SCREEN SHARE. >> THANK YOU. THIS IS AN EXCITING DAY OF PRESENTATIONS. THANK YOU FOR INVITING ME TO SHARE OUR WORK AS WELL. I'M THE SCIENTIFIC DIRECTOR, NATIONAL CENTER FOR HUMAN FACTORS AT HEALTH CARE, MEDSTAR HELD, FACULTY APPOINTMENT AT GEORGETOWN. THE NATIONAL CENTER FOR HUMAN FACTORS AND HEALTH CARE WE'RE DOING A LOT OF WORK IN HEALTH I.T., PATIENT REPORTED OUTCOMES, mHEALTH, PATIENT PORTALS, BUILDING ON WHAT WAS PRESENTED IN A SPECIFIC USE CASE FUNDED BY AGENCY FOR HEALTH CARE RESEARCH AND QUALITY, HIGHLIGHTING SUCCESSES AND CHALLENGES THAT WE'VE HAD IN USING FHIR FOR MOBILE HEALTH APPLICATIONS. I'LL BE SHARING TODAY AN APP WE'VE LAUNCHEDDED A MEDSTAR HEALTH, TAPR-CPM FOR CHRONIC PAIN MANAGEMENT APP. SO THIS IS FUNDED BY AHRQ, TO DESIGN, DEVELOP, DEPLOY, EVALUATE AN APP WHICH IS QUITE CHALLENGING TO TAKE SOMETHING FROM DESIGN TO INCEPTION TO THE DEPLOYMENT AND EVALUATION SO WE'RE VERY GRATEFUL FOR THE OPPORTUNITY TO DO THAT. MEDSTAR HEALTH HAS PARTNERED WITH A HANDFUL OF COLLABORATORS, TECHNICAL DEVELOPERS. GEORGE DOWN AND THEIR -- GEORGE TOWN AND IMPACT WHO IS LEADING OUR EVALUATION. THIS WAS DESIGNED TO CREATE TWO APPS, THAT'S ONE OF THE THINGS I'LL HIGHLIGHT IS THAT BIDIRECTIONAL COMMUNICATION, EXCITING TO SEE INFORMATION FROM THE EHR BEING PUSHED TO THE PATIENTS AND PATIENT-GENERATED DATA OR PATIENT-CAPTURED OUTCOMES PUSHED BACK INTO THE EHR. WE'RE IN THE DEPLOYMENT PHASE. WE'RE WORKING WITH BOTH PRIMARY CARE PRACTICES AND PAIN SPECIALISTS FOR DEPLOYMENT, ULTIMATELY LOOKING FOR 60 PROVIDERS, 150 PATIENTS. GENERALLY IN THE CHRONIC PAIN MANAGEMENT SPACE GIVEN THE OPIOID EPIDEMIC AND LOTS OF OTHER CHALLENGES ON THE CLINICAL SIDE, A NUMBER OF DIRECTIONS WE COULD HAVE GONE, WHERE WE DECIDED TO FOCUS WAS ON OPIOID TAPERING, OPTIMIZING PAIN THERAPY. WE HAD DONE SCIENTIFIC DISCOVERY EARLY ON AND HEARD LOTS OF IMPORTANT THINGS FROM BOTH PROVIDERS AND PATIENTS. NAMELY FROM PROVIDERS THAT TAPERING IS CHALLENGING AND IF THERE'S CLINICIANS ON THIS CALL I'M SURE THEY MIGHT HAVE EXPERIENCED THE SAME THING. GUIDELINES ARE DIFFICULT TO FIND AND PERSONALIZE. THEY ARE GIVEN ON A HIGH LEVEL, SO, TRANSLATING CAN BE CHALLENGING. IT'S A DIFFICULT AWKWARD CONVERSATION TO INTRODUCE A PATIENT TO AN OPIOID TAPER. THERE IS REALLY NO ONGOING FOLLOW-UP WHEN WE TALK TO PATIENTS THAT HAVE BEEN SUCCESSFULLY OR UNSUCCESSFULLY GONE THROUGH A TAPER FELT LIKE PROVIDERS SAID HERE IS YOUR NEW PRESCRIPTION, SEE YOU IN A MONTH, GOOD LUCK. THIS IS REALLY IMPORTANT ON THE PATIENT ENGAGEMENT STANDPOINT TO HAVE THAT ONGOING RELATIONSHIP WHEN THE PATIENT LEAVES THE PRIMARY CARE SETTING OR LEAVES THE HOSPITAL, WE'RE ABLE TO CAPTURE INFORMATION TO REALLY MAKE THAT NEXT VISIT THAT MUCH MORE RELEVANT. I'LL QUICKLY WALK YOU THROUGH THE APPS SO YOU GET A SENSE OF WHAT WE'VE DESIGNED AND WHAT'S BEING DEPLOYED. OBVIOUSLY AS A HUMAN FACTOR, ENGINEERS ARE EXCITED ABOUT THE DESIGN STANDPOINT. I'LL WALK YOU THROUGH TECHNICAL SPECIFICATIONS BUT EARLY ON A LOT OF TIME SPENT THINKING THROUGH THE DESIGN COMPONENTS AND SOME OF THE CONSIDERATIONS. SO, AGAIN, WHAT'S THE USE CASE, IS IT MORE BROADLY CHRONIC PAIN MANAGEMENT, IS IT A SPECIFIC MOMENT IN TIME FOR OPIOID TAPER AND THE FOLLOW-UP THAT COULD LAST THREE MONTHS, SIX MONTHS, WHO IS THE USERS, KNOWING THAT THESE INTERFACES NEED TO LOOK AND FUNCTION VERY DIFFERENTLY. EVEN CONSIDERING THE WORKFLOW, THIS IS BEING PRESENTED TO CLINICIANS BUT PRIMARY CARE AND PAIN MEDICINE HAVE DIFFERENT RELATIONSHIPS WITH PATIENTS, REQUIRE DIFFERENT INFORMATION FOR DECISION MAKING. ONE OF THE CHALLENGING BUT MOST EXCITING PARTS IS THE TECHNICAL SPECIFICATION ACROSS EHR VENDORS, CERTAINLY WE'RE LEARNING , THE CERNER SITE WORKING WITH ALL SCRIPTS AND VENDORS TO SEE WHAT IT LOOKS LIKE WHEN DEPLOYED AT OTHER HELD CARE SYSTEMS, ARE WE ABLE TO CREATE THIS IN AN INTEROPERABLE WAY? SOME INTERESTING THINGS I'M NOT SURE WE UNDERSTOOD BUT UNDERSTOOD REQUIREMENT TO OTHER SIDES, DO THEY HAVE SERVERS, ARE THEY USING CLOUD STORAGE, WHAT ARE THE FIRE WALLS AND I.T. COMPONENTS? AND NOT SURPRISINGLY SOME OF THE MORE SOCIOTECHNICAL COMPONENTS, MANY LEVELS OF APPROVAL, TECHNICALLY AND CLINICAL PRACTICE WE NEED TO DEPLOY AN APP LIKE THIS. WE APPLIED LOTS OF METHODS, EARLY ON, CREATING LOTS OF RESEARCH WORK GROUPS THAT REPRESENTED MANY STAKEHOLDERS, CONDUCTING STAKEHOLDER INTERVIEWS WITH CLINICIANS BOTH PRIMARY CARE AND PAIN SPECIALISTS WITH PATIENTS, WITH FAMILY AND CARE GIVERS, PATIENTS WITH CHRONIC PAIN AND ALSO HEALTH I.T. APP DEVELOPERS ON CLINICIAN AND PATIENT-FACING SIDE, CONDUCTED WORKFLOW ANALYSIS TO UNDERSTAND WHAT POINT IN TIME SOMEONE MIGHT USE THIS, HOW IT MIGHT BE INTRODUCING, TESTING FOR WIRE FRAMES, PROTOTYPES, ULTIMATE EVALUATION OF APP AND TECHNICAL SPECIFICATIONS WHICH I'LL DIVE INTO SHORTLY. SO I WANTED TO GO THROUGH THE APP QUITE QUICKLY BUT SHOW SOME OF THE HIGHLIGHTS OF WHAT WE'VE DONE. WHEN WE THINK ABOUT THE WORKFLOW HERE, THERE'S THREE THREE TIME POINTS. THERE'S A FOLLOW-UP VISIT, THEY ARE ABLE TO REVIEW DATA AND MAYBE MAKE ANY UPDATES TO THE MEDICATION PLAN IF THE TAPER IS GOING WELL, AND PAIN IS MANAGEMENT, TO CONTINUE AS IS BUT PERHAPS THE PAIN WASN'T MANAGED AND SO WE NEED TO DIAL BACK THE TAPER. THERE'S THE HOME EXPERIENCE THAT'S HAPPENING IN BETWEEN SO THE MOMENT THE PATIENT LEAVES, BEING ABLE TO TRACK AND MANAGE PAIN AND DAILY FUNCTION, THIS IDEA OF SUPPORTED PATIENT ENGAGEMENT. ON THE PROVIDER SIDE I'LL SHOW YOU SCREEN SHOTS OF WHAT WE'VE CREATED. FIRST IS THE PATIENT CONTEXT, IT'S A SPECIFIC PATIENT THAT QUALIFIES FOR A TAPER, PHYSICIANS KNOW THEM WELL, BASED ON CHARACTERISTICS AND DESIRE TO TAPER, BUT WE WANTED TO PULL EVERYTHING IN ONE PLACE. INSTEAD OF HAVING CLINICIANS HUNT AND GATHER IN THE EHR TO FIND THIS INFORMATION, WE'VE PUT IT TOGETHER IN ONE PLACE. WE'RE ALSO ABLE TO CONNECT TO THE PDMP, THE DRUG MONITORING PROGRAM, A HUGE SUCCESS TO CONNECT TO A HEALTH INFORMATION EXCHANGE. THIS IS AGAIN ADDRESSING ONE OF THE MOST CHALLENGING PARTS WHICH IS PERSONALIZING THAT TAPER TO THE PATIENT. SO AGAIN THE BACK OF THE NAPKIN CALCULATION, 5% FLOW, TO 10% STANDARD, GIVING CLINICIAN AN OPPORTUNITY TO PICK OR CUSTOMIZE AS THEY WOULD LIKE TO CREATE THE MEDICATION PLAN FOR THE PATIENT. THEY ARE ABLE TO PICK A START DATE, MAYBE PATIENT'S MEDICATION IS TO BE REFILLED IN THREE WEEKS SO THAT'S THE APPROPRIATE START DATE. DETERMINING WHETHER THEY ARE GOING TO START WITH LONG ACTING OR SHORT ACTING MEDICATIONS, GO THROUGH A SERIES OF PROMPTS TO MAKE SURE RIGHT MEDICATIONS ARE SELECTED. SAY YOU PICKED 5% TAPER ON A MEDICATION, AND THAT PILL DOESN'T EXIST IN THAT MILLIGRAM FORM, SO REALLY UNDERSTANDING WHAT'S AVAILABLE FROM THE PHARMACY IN TERMS IN THE TAB AND DOSE AND SAFETY CHECKS TO MAKE SURE THAT WE'RE NOT INTRODUCING HARM. THE NEXT SCREEN IS THE ONE I'M MOST EXCITED ABOUT, THINKING ABOUT PATIENT ABOUT PATIENT, WITH THE BIDIRECTAL COMMUNICATION IS IMPORTANT, HAVE YOU THOUGHT ABOUT YOGA, DEEP BREATHING, ANYTHING IS PUSHED THEN TO THE PATIENT APP AND mHEALTH SIDE THE PATIENTS ARE ABLE TO TRACK SOME OF THESE ACTIVITIES. THE PROVIDER MIGHT ALSO WANT TO PRESCRIBE DIFFERENT MEDICATIONS FOR PAIN OR WITHDRAWAL, AND THINKING MORE PROACTIVELY WHAT THAT PATIENT MIGHT NEED. THERE'S A SUMMARY THAT THE PROVIDER CAN DROP INTO NOTES OR DISCHARGE INSTRUCTIONS WHERE THEY FEEL IS MOST APPROPRIATE AND THEY ARE ABLE TO INVITE THE PATIENT TO USE THE APP AND ENROLL THEM ON THE PATIENT SIDE. THINKING ABOUT THE FOLLOW-UP I'LL SHOW YOU THE HIGHLIGHT, PATIENT-FACING SIDE, INFORMATION WE'RE ABLE TO CAPTURE. WHAT WOULD THAT LOOK LIKE IN A FOLLOW-UP VISIT? HERE ARE SOME SAMPLES OF WHAT THAT COULD LOOK LIKE IN PROVIDER DASHBOARD, PROVIDERS ARE ABLE TO SEE DIFFERENT PROMIS MEASURES, PAIN INTENSITY AND INTERFERENCE, ABLE TO LOOK AT THAT IN CORRELATION WITH THE TOTAL MMEs, AND BOTTOM RIGHT YOU CAN SEE THOSE ACTIVITIES THAT ARE DONE SO THIS PATIENT LOGS PHYSICAL THERAPY TWICE, THAT PATIENT ENGAGEMENT UNDERSTANDING WHAT THE PATIENT'S DOING ONCE THEY LEAVE THE HEALTH CARE SETTING. THE PROMIS MEASURES, THINKING ABOUT HOW WE'RE TRANSLATING INFORMATION BACK TO THE CLINICIANS MAKING SURE WE'RE PROVIDING RELEVANT INFORMATION, RECOGNIZING THEY MIGHT HAVE JUST 15 MINUTES WITH THE PATIENT SO HOW CAN THEY GET A SENSE OF WHAT'S GOING ON AND USE THAT TIME WISELY SO YOU CAN SEE THE PATIENT REPORTED OUTCOME MEASURES, HOW THEY HAVE CHANGED OVER TIME, ABLE TO INDICATE IF THERE'S SIGNIFICANT INCREASE IN PAIN, FOR EXAMPLE, AND BE ABLE TO TREND THAT INFORMATION. SO SHARING PATIENT-FACING APP, THAT'S ONE PART, PROVIDER SIDE, SETTING THE TAPER. FOR THE PATIENTS WHAT WE HEARD IS THEY REALLY WANT THAT ONGOING ENGAGEMENT, TO FEEL LIKE THEY ARE CONNECTED TO THE CLINICIAN, SO BEING ABLE TO SHARE WEEKLY PAIN SCORES, MONITORING PAIN AND PROGRESS, TRACKING ACTIVITIES, LOTS OF EDUCATIONAL RESOURCES. YOU'LL SEE HERE WHAT THE INVITATION LOOKS LIKE. I CAN TALK ABOUT THE SECURITY BUT WE'RE USING THE PATIENT PORTAL AS THAT SECURITY CHECK TO ENSURE THIS IS IN FACT THE RIGHT PATIENT. THE APP IS AVAILABLE IN THE GOOGLE PLAY AND APP STORES, BUT ALSO CAN BE ACCESSED FROM A WEB BROWSER. SO THE MAIN PART HERE USING DIFFERENT PROMIS MEASURES, PATIENTS ARE ASKED TO RECORD SCORES WEEKLY WHICH IS PUSHED INTO THE EHR AS YOU SAW. SO THAT BUILDS THAT INFORMATION, CAN BE REVIEWED AT A FOLLOW-UP VISIT. WE'RE ALSO ABLE TO KEEP A DAILY PAIN JOURNAL. IF I THINK ABOUT SOME OF THE PATIENT-REPORTED OUTCOMES WORK WE'RE DOING, MAYBE ON A TABLET IN THE WAITING ROOM OR ANY SORT OF SURVEYS THAT PATIENTS ARE CAPTURING, THE DIFFERENCE WITH THIS mHEALTH APPLICATION AND BEING ABLE TO USE AN APP TO TRACK INFORMATION IS THAT AS MUCH AS THE PATIENT WANTS TO ENGAGE, THEY ARE ABLE TO. THEY CAN ENTER THE MORE TRADITIONAL 0 TO 10 PAIN SCORE, THERE'S A JOURNAL FUNCTION IF THEY WANT TO ENTER NARRATIVE INFORMATION, THEY CAN MARK PAIN ON THE BODY, YOU SEE THE THIRD SCREEN OVER, LOOKING WHERE THE PAIN MIGHT BE RADIATING FROM. THERE'S AN EMOJI SCALE IF THEY WANT TO TRANSLATE ACTIVITIES THEY ARE DOING. THIS IS UP TO THE PATIENT AS MUCH AS THEY WANT TO BE ENGAGED, A LOT OF THIS DOESN'T GET PUSHED BACK TO THE CLINICIAN, SO THE HEAT MAP AND EMOJIS ARE FOR THE PATIENTS TO LEARN FROM THEIR OWN ACTIVITIES. SO, FOR EXAMPLE, IF YOU'RE DOING PHYSICAL THERAPY YOU MIGHT NOT BE FEELING THE BENEFITS BUT TWO DAYS LATER YOU'RE SEEING THAT, OH, MY PAIN HAS DECREASED SO THEY ARE LEARNING FROM HOW THOSE ACTIVITIES CAN IMPROVE THEIR PAIN MANAGEMENT. AND, AGAIN, THIS IS THE BIDIRECTIONAL COMMUNICATION, YOU SAW ON PROVIDER SCREEN WHAT ACTIVITIES ARE YOU DOING, THAT'S BEEN PUSHED TO THE PATIENT APP. PUSHED BACK INTO THE EHR. AND THEN LASTLY EDUCATIONAL RESOURCES, AND SO THIS IS NOT MATERIAL THAT WE CAME UP WITH BUT SOURCING FROM EXPERTS IN THE FIELD, PAIN ESPECIALLY WEB SITES, CONNECTING FOLKS TO DIFFERENT SOCIAL RESOURCES, NETWORKING GROUPS, AND SO REALLY GIVING THAT SOCIAL SUPPORT FOR THE PATIENTS AS THEY GO THROUGH THE OPIOID TAPER. FROM A DATA ARCHITECTURE STANDPOINT A LOT A LESSONS, WRITER FHIR BACK IN, OUR ABSOLUTE IS THE DATA HUB WHICH ALLOWED THE BIDIRECTIONAL COMMUNICATION, WE'RE USING NET SCALER FOR BALANCE LOADING, AND THEN YOU CAN SEE EVERYTHING IS IT ISING BEHIND THE CERNER FIRE WALL, APIs TO CAPTURE PATIENT-REPORTED OUTCOMES TO PUT BACK INTO THE EHR. IN TERMS OF FHIR RESOURCES FOR THE CERNER DEPLOYMENT WE'RE ABLE TO USE FIRE RESOUSE, R SCRIPTS, YOU SEE THEM LISTED HERE, SMART STANDARDS FOR DATA SECURITY, AND PROMIS MEASURES HAVE BEEN AN INTERESTING LESSON LEARNED AS WELL BEING ABLE TO EXECUTE USE OF THE EXTERNAL ASSESSMENT CENTER TO BE ABLE TO USE THE PROMIS MEASURES TO THEIR FULL CAPACITY SO THINGS LIKE THE COMPUTER ADAPTIVE TEST WHICH ALLOWS THE PATIENTS TO ENTER THE LEAST AMOUNT OF INFORMATION TO GET THE MOST VALID SCORE. ONE OF THE THINGS WE'VE SPENT A LOT OF TIME ON IS MAPPING THE FHIR RESOURCES THAT RECOGNIZE YOU WILL NOT BE ABLE TO READ THIS, SO I'LL SHOW YOU ANOTHER EXAMPLE ZOOMED IN. THINGS LIKE ALCOHOL OR TOBACCO USE OR HERE SUBSTANCE USE, REALLY UNDERSTANDING WHAT THESE LINKS ARE. AND SO LOOKING AT THE DATA THAT IS IN OUR EHRs, THE DATA THAT PATIENTS MIGHT BE ENTERING, HOW DOES THAT TRANSLATE ON A TECHNICAL LEVEL AND RECOGNIZING THIS ACTUALLY NEEDS TO BE DONE FOR THE MOST PART AT A LOCAL LEVEL WITH EACH SITE, RIGHT? SO MEDSTAR MIGHT BE ASKING THE FREQUENCY OF SUBSTANCE USE AS ONE OR TWO TIMES PER YEAR, ONE OR TWO TIMES PER MONTH, BUT WE'VE SEEN THIS ISN'T STANDARDIZED. SOMEONE ELSE MIGHT ASK ONE TO FIVE TIMES PER YEAR OR THREE TIMES PER WEEK AND HOW DO WE MAP THAT IN AN ACCURATE WAY? HUB TECHNOLOGY AND BIDIRECTIONAL COMMUNICATION, ALSO INTEGRATION WITH PDMP AND INTEGRATION WITH PROMIS MEASURES, WORKING WITH THE PROMIS MEASURE GROUP REALLY UNDERSTANDING WHERE THEY ARE SPENDING THEIR ENERGY IS WORKING WITH THE EHR VENDORS TO HAVE THE PROMIS MEASURES INTEGRATED THROUGH THE VENDORS AS OPPOSED TO DEVELOPERS PAYING FOR LICENSING FEES. I THINK THAT'S SHIFTING THE LANDSCAPE AND WILL MAKE IT WE THINK EASIER FOR FOLKS TO LEVERAGE THESE VALIDATED TOOLS TO CAPTURE THE RIGHT INFORMATION. SOME OF THE CHALLENGES THAT WE HAD EXPERIENCED LIKE ANY OTHER APP WORKING WITH OUR LEGAL AND RISK MANAGEMENT GROUP IS UNDERSTANDING SOME OF THE LEGAL LIABILITY. IF WE'RE CAPTURING INFORMATION ON A DAILY BASIS FROM PATIENTS, MAKING SURE THAT PATIENTS UNDERSTAND THERE'S NOT SOMEONE ON THE OTHER SIDE OF THE APP LOOKING AT THAT INFORMATION IN REAL TIME. AND SEE IF THERE IS A SIGNIFICANT CHANGE IN A PROMIS MEASURE SCORE, FOR EXAMPLE, HOW DO WE EXPLAIN THAT TO PATIENTS WITHOUT ADDING EXTRA LEGAL RISK TO OUR OWN CLINICIANS? SOME OF THE THINGS THAT WE HEARD EARLY ON IS OPIOID TAPERING IS OFTEN TIED TO DEPRESSION DEPRESSION OR MENTAL HEALTH, GIVEN THE LIABILITY WE'RE PUTTING CLINICIANS AT RISK HAVING TO REVIEW IN REAL TIME THAT CHANGES THE WAY CLINICIANS CURRENTLY HAVE THEIR WORKFLOW. THINKING ABOUT THE PATIENTS, PROMIS MEASURES ARE CHALLENGING FOR US TO EXPLAIN TO CLINICIANS AND PATIENTS. WHAT DOES THAT INFORMATION MEAN? SO VESSEL PARTNERS, LEAVING WORK FROM COGNITIVE PSYCHOLOGY, BEHAVIORAL, ECONOMIC STANDPOINT OF HOW DO PEOPLE INTERPRET INFORMATION AND HOW DO WE MAKE SURE WE'RE GIVING IT IN A CERTAIN CONTEXT? WE HAVE CHALLENGES MAINTAINING SCOPE, FOLKS ASKING IF THEY CAN USE THIS APP FOR GENERAL CHRONIC PAIN MANAGEMENT FOR THIS DEPRESSION, PATIENTS WERE ASKING IF THEY COULD SHARE DATA WITH FAMILY OR CAREGIVERS, SO MAKING SURE WE WERE KEEPING TO WHAT WE ORIGINALLY DESIGNED FOR THIS APP. AND THEN THINKING ABOUT FUTURE STATE, INTEGRATE WEARABLES OR STREAMING DATA, WRITING FHIR INTO THE EHR, WHAT ARE WE CAPTURING, HOW MUCH INFORMATION IS RELEVANT FOR CLINICIANS AND WHAT IS TOO MUCH. THINKING ABOUT WHAT THIS LOOKS LIKE MOVING FORWARD, I THINK MY IDEAS COMPLETELY ALIGN WITH THE WORK COMING OUT OF THE ONC, IN THE FINAL RULE, FACILITATING A DISCUSSION WITH I.T. HELD STAKE HOLDERS, MAKING SURE APP DEVELOPERS ARE FOLK USING ON INTEROPERABILITY, DETAIL, ACCURACY, TIMELINESS, THINGS WE HAD TO DEAL WITH FOR OUR APP AS WELL. HOW DO WE COMBINE DATA FROM CONSUMERS, EHR AND CLAIMS DATA, WE'RE ABLE IN THIS EXAMPLE TO CAPTURE THAT CONSUMER DATA, INTEGRATE WITH EHR, HAVE NOT GOTTEN TO THE LEVEL OF ADMINISTRATIVE OR CLAIMS DATA. LASTLY, A GENERAL VALID CONCERN FROM PATIENTS ABOUT WHAT HAPPENS TO THEIR DATA WHEN THEY ARE ENTERING THIS INTO THE APP, FOR US SPECIFICALLY THINKING ABOUT OPIOID TAPERING IT'S A SENSITIVE TOPIC, FOLKS ARE WORRIED ABOUT WHAT IF THEIR EMPLOYERS GOT HOLD OF THIS DATA OR WHAT IF IT BECAME PUBLIC, HOW DO WE ENSURE THERE'S PRIVACY AND SECURITY, WITHOUT NEGATIVELY IMPACTING WORK FLOW. SO FOR US TO USE THE PATIENT PORTAL, SOME OF OUR PATIENTS NEED TO SIGN UP FOR THE PORTAL OR RESET PASSWORD, BUT WE DON'T WANT TO MAKE IT TOO MUCH OF A WORK-AROUND FOR THEM TO BE ABLE TO USE THE APP. SO I'LL STOP THERE AND TURN IT BACK OVER TO DR. HEATH FOR SOME DISCUSSION. >> THANK YOU FOR THE GREAT TALK, CONNECTING MOBILE HEALTH SPACE AND A SPECIFIC APP. WE HAVE A COUPLE QUESTIONS IN THE CHAT. DR. SIM, THIS IS FOR YOU, IN TERMS OF WHAT CAN A HEALTH SYSTEM DO TO START GETTING -- START USING OPEN mHEALTH, HOW DO PEOPLE GET STARTED? >> FOR HEALTH SYSTEM TO USE IT, RIGHT NOW IT'S NOT QUITE READY FOR THAT. WE'RE DEVELOPING SOME TOOLS THAT IS IN PARTNERSHIP WITH THE COMMONS PROJECT, PEOPLE WHO BUILT COMMON HEALTH, IT'S THE DROID THE -- IT'S THE ANDROID EQUIVALENT OF APPLE HEALTH. AROUND COMMON HEALTH WE'RE BUILDING A WHOLE DATA ECOSYSTEM THAT PULLS IN DIGITAL HEALTH DATA, EHR, LAB DATA, LAB, QUEST, SO THAT ROLLS OUT AND WILL BE THE BEST WAY FOR HEALTH SYSTEMS TO ENGAGE IN OPEN HEALTH. NOT QUITE THERE YET BUT KEEP YOUR EYE OUT FOR IT. CONTACT ME OFFLINE IF YOU'RE INTERESTED IN WHAT WE'RE DOING AND WANT TO HELP. >> I THINK THE NEXT QUESTION IS DOES OPEN mHEALTH SCHEMAS RELATED TO MEDICATION AT ADHERENCE? >> WE CONVENED EXPERTS IN PHARMACY AND CLINICAL PRESCRIPTIONS AND ALSO WITH DEVICES, STARTER COMPANIES, MEDICAL ADHERENCE DEVICES, A COMPLETE SCHEMA AND THERE WASN'T HASN'T BEEN AS MUCH TRACTION BUT, YES, IT IS THERE AND AGAIN IF YOU'RE INTERESTED IN THAT JUST CONTACT ME. >> AND THEN A QUESTION FROM EARLIER IS COULD YOU SPEAK ABOUT POTENTIAL BRIDGING FROM MOBILE HEALTH TO OMAP, FORCING MOBILE AND DIGITAL HEALTH DATA INTO SOMETHING LIKE OMAP? >> THANKS FOR THAT QUESTION, A GREAT QUESTION. I'LL SAY FIRST THERE'S A DIFFERENCE BETWEEN DIGITAL BIOMARKERS, LIKE YOUR SEX, FOR EXAMPLE, AND RAW DATA, YOUR ACCELEROMETRY, XYZ DATA. IT'S NOT APPROPRIATE FOR RAW DATA, THAT'S A DIFFERENT USE CASES, FOR GENERATING NEW BIOMARKERS, TESTING NEW DIGITAL BIOMARKERS, BUT I THINK MOST PEOPLE, WE'RE TALKING ABOUT DERIVED BIOMARKERS, AND THOSE CAN BE LOW FREQUENCY, CHECK YOUR BLOOD PRESSURE, WIRELESS EVERY COUPLE DAYS, OR HIGH TEMPORO FREQUENCY. AND SO I THINK THERE'S PROBABLY THAT SORT OF, YOU KNOW, DENSITY OF DATA BUT I THINK IN TERMS OF -- I DON'T THINK THAT'S AN ISSUE. FHIR WANTS TO BE ABLE TO REPRESENT ALL SORTS OF THINGS, LOTS OF THINGS, OPEN mHEALTH PHILOSOPHICALLY HAS BEEN MORE LIKELY. WE CAPTURE JUST THE MOST IMPORTANT STUFF, MOST CLINICALLY RELEVANT METADATA, SO THE ISSUE MORE IS JUST REPRESENTATION, HOW DO WE REPRESENT THE SORT OF CONTEXT THAT'S IMPORTANT TO A PIECE, DIGITAL BIOMARKER, AND THEN THE METADATA AND PROBLEMS, BECAUSE IT IS SO EARLY IF YOU PUT IN A DATA, A PIECE OF DATA LIKE HOW LONG YOU SLEPT, THAT'S NOT USEFUL DATA IF YOU DON'T KNOW WHAT THE SENSOR WAS AND WHAT THE ALGORITHM WAS THAT GENERATED THAT PIECES OF DATA. I THINK IT'S THOSE REPRESENTATIONAL ISSUES, VERY INTERESTED TO HAVE THAT DISCUSSION. >> MAYBE DR. MILLER, IN TERMS OF YOU TALKED ABOUT THE INDIVIDUAL APP, BUT HAVE YOU THOUGHT ABOUT THE AGGREGATION OF THIS DATA OR IS THAT PART OF WHAT THE DATA HUB DOES, HOW DO YOU THINK ABOUT LOOKING AT KIND OF ACROSS THE DIFFERENT INFORMATION THAT YOU'RE GETTING FROM THE APPLICATIONS? >> YEAH, CERTAINLY THAT'S SOMETHING THAT WE'RE EXPLORING AND ALSO FROM IMPLEMENTATION STANDPOINT, WILL WE SEE THAT CONTINUED ENGAGEMENT IF IT'S A LONGER TIME, ONE OF MY CONCERNS, AND SHARED WITH OTHERS, IS IF WE'RE CAPTURING THIS INFORMATION AND WE NEED TO AGGREGATE IN A MEANINGFUL WAY AND SHARE IN A MEANINGFUL WAY, WHAT DOES THAT ACTUALLY MEAN AND WHAT ARE CLINICIANS REALLY ASKING FOR AND WHAT'S BONUS FOR PATIENTS TO HAVE FOR THEMSELVES, OR AS I MENTIONED EARLIER I DON'T THINK MY FAMILY GETS IT, I CAN SHARE WITH THEM AS WELL, AND WHAT DOES THAT LOOK LIKE. SO I THINK, YEAH, STILL A LOT TO LEARN ON THE DATA SIDE. >> AND THEN A QUESTION FROM THE CHAT, DR. MILLER, YOU MENTIONED NO REAL TIME REVIEWING PATIENT RESPONSES BUT IS THERE ANY METHOD WITHIN THE APP TO ESCALATE TO NURSE FOR REVIEW OR TO GENERAL AUTOWORDS, FOR EXAMPLE, FOR CLINTONCLINICIANS, TOO HIGH OR TOO LOW? >> GOOD QUESTION. WE'RE STRUGGLING FOR A COUPLE REASONS. FIRST WITH PATIENT-REPORTED OUTCOME MEASURES WHAT IS A SIGNIFICANT CHANGE? FOR MANY OF THEM THERE'S NO VALIDATED WAY TO KNOW, THREE POINTS OFF STANDARD DEVIATION, OR FOUR, WHEN IS THE RIGHT TIME THAT WE SHOULD BE WORRIED AND PUSH THAT INFORMATION TO THE CLINICIAN. THINKING ABOUT CLINICAL WORKFLOW, I WORRY NOT UNFOUNDED. WE'VE HEARD FROM CLINICIANS ON THIS PROJECT AND OTHER PROJECTS WHERE YOU TALK ABOUT CLINICAL DECISION SUPPORT, FOR EXAMPLE, OR ALERTING AND RESPONSES DO NOT PUSH ME INFORMATION, I'M TOO BUSY, TOO MUCH GOING ON. ESPECIALLY IN THE PRIMARY CARE SETTING, KNOWING CLINICIANS WHO HAVE TWO OR THREE HUNDRED PATIENTS IN THEIR PANEL IS NOT REALISTIC FOR THEM TO GET THESE NOTIFICATIONS. RECOGNIZING THAT MIGHT NOT EVEN BE THE RIGHT PERSON. SO I SEE IAN SAID SOMETHING ABOUT A NURSE FOR TIMELY REVIEW, THAT'S PART OF THE NEXT STEPS, IF WE DO COME UP WITH THE RIGHT WAY TO ALERT AND RECOGNIZE WHEN ALERTING IS IMPORTANT, WHO WILL THAT ALERT GO TO? AND IS THERE SOME BETTER RESOURCE THAT WE CAN PROVIDE FOR FOLKS TO GET WHATEVER SUPPORT THAT THEY NEED, WHETHER IT'S PAIN MANAGEMENT OR DEPRESSION OR MENTAL HEALTH OR SOMETHING ELSE TIED TO THAT. AGAIN, WE'RE COGNIZANT OF THE LEGAL LIABILITY AND RISK HERE, AND SO IN SOME WAYS I THINK THIS IS A LITTLE BIT PROOF-OF-CONCEPT IN A SENSITIVE AREA LIKE THIS, WHAT'S THE APPROPRIATE WAY TO ESCALATE CARE WHEN NEEDED. >> GREAT. AND THEN A QUESTION FROM VIVIAN, A LARGE BLOCK OF BRINGING STREAMING DEVICES, HOW TO AGGREGATE, ARE YOU SEEING STANDARDS OF BEST PRACTICES FORKING A -- FOR AGGREGATION OF TIME SERIES DATA? >> I THINK TIME SERIES DATA, THERE'S BOTH TIME SERIES DATA AND HIGH FREQUENCY RAW DATA, THOSE ARE VERY, VERY DIFFERENT. IF WE'RE TALKING ABOUT SORT OF TIME SERIES OF, YOU KNOW, RAW SENSOR DATA THAT'S VERY HIGH FREQUENCY, VERY HIGH VOLUME, REALLY I'M NOT SURE THAT FHIR IS THE RIGHT REPRESENTATION. WE'VE BEEN LOOKING AT USING JSON AS A WAY TO STORE THAT DATA AND I THINK USE CASE THERE IS VERY DIFFERENT. WHO IS LOOKING FOR THAT RAW SENSOR DATA AND WHAT ARE THEY DOING WITH IT, RIGHT? THOSE ANALYTICS ARE VERY, VERY DIFFERENT THAN WHAT YOU WOULD WANT TO DO FOR A CLINICIAN. SO VERY UPSTREAMOF THE DIGITAL BIOMARKER. LIKE WEIGHT PER DAY, RIGHT? THEN I THINK THE AGGREGATION ISSUES ARE REALLY MORE AROUND REPRESENTATIONAL ISSUES, WHEN WAS IT CAPTURED, WHAT IS CAPTURE TIME, DIFFERENT AGGREGATION CHALLENGES. >> COMMENTING ABOUT BRINGING RAW DATA AND HOW YOU GET THE RIGHT PEOPLE UP INTO LIKE FHIR APPLICATION EXCHANGE. ON THAT, I THINK WE'RE OUT OF TIME IN THIS SESSION. IT'S BEEN WONDERFUL. I'LL GIVE THE SPEAKERS AN SPEAKERS AND EMOJI. >> WE'RE GOING TO TAKE A BREAK. IT'S 12:12 EASTERN. WE'LL RETURN AT 1:00. SO 20-MINUTE BREAK. FEEL FREE TO STAY LOGGED IN, WE'LL BE ON MUTE AND SEE EVERYONE BACK HERE IN 20 MINUTES FOR OUR NEXT SESSION. >> WELCOME BACK FROM A SHORT BREAK. THE NEXT SESSION WILL DISCUSS THE USE OF FHIR IN POPULATION LEVEL STUDIES, AND THIS SESSION WILL BE MODERATED BY AMY CRAMER, THE DIRECTOR OF GLOBAL PRODUCT DEVELOPMENT STRATEGIC PARTNERSHIPS AT PFIZER. SHE'S A VERY ACTIVE MEMBER OF THE LEADERSHIP -- OF SEVERAL ACTIVITIES, CO-CHAIR OF VULCAN ACCELERATOR, CO-CHAIR IN THE CLINICAL INTEROPERABILITY GROUP, DRAWS HER EXPERIENCE AS CARDIAC CRITICAL CARE NURSE AND SHE'S IDEALLY SUITED FOR LEADING SOME OF THE HL7 ACTIVITIES. WITH THAT INTRODUCTION, I'M GOING TO TURN THIS OVER TO AMY. >> THANK YOU VERY MUCH. THANK YOU, EVERYONE, FOR ALLOWING ME TO BE PART OF TODAY'S CONVERSATION. I WANTED TO START JUST WITH A LITTLE BIT ABOUT TALKING ABOUT VULCAN, A FEW SLIDES, AS LONG AS EVERY CAN SEE THESE SLIDES. CAN YOU SEE THE SLIDES ON VULCAN? >> YES. >> WONDERFUL. THANK YOU. SO VULCAN IS AN HL7 FHIR ACCELERATOR, DEDICATED TO RESEARCH, AN EXCITING GROUP THAT'S BEEN BROUGHT TOGETHER. WE'RE JUST ABOUT OUR ONE-YEAR ANNIVERSARY OF BEING AN ACCELERATOR DEDICATED TO THESE TRANSLATIONAL AND CLINICAL RESEARCH AND OUR MEMBERSHIP CONTINUES TO GROW. WE DO HAVE ADDITIONAL INDIVIDUALS AND ORGANIZATIONS THAT HAVE JOINED SINCE THIS SLIDE HAS BEEN MADE LAST WEEK. APOLOGIES TO THEM NOT BEING ON HERE BUT THE WIDE ARRAY OF COMMUNITIES IN VULCAN LOOKING AT VULNERABILITY OF THE PERSPECTIVES OF RESEARCH INCLUDED. WE FELT WE NEEDED TO INTEGRATE RESEARCH INTO DELIVERY OF HEALTH CARE, BY STREAMLINING DATA COLLECTION AND EXCHANGE INTO SINGULAR PROCESS, IN SHORT INTEROPERABILITY. SO WHAT WE'RE DOING TO REACH THAT GOAL IS COLLABORATING WITH INTERNATIONAL RESEARCH COMMUNITY TO ALIGN ON THE WAY TO DO THIS, THE WAIT TO DO INTEROPERABILITY. AND VERY SPECIFICALLY, DEVELOPING OUT THE HL7 FHIR STANDARD TO SUPPORT THIS BIDIRECTIONAL FLOW OF DATA. FOUR GUIDING PRINCIPLES ARE TO BRIDGE EXISTING GAPS THAT EXIST BETWEEN CLINICAL CARE OR DATA AVAILABLE IN THE EHR, TRANSLATIONAL RESEARCH AND WHAT WE WOULD USE. THE SECOND IS TO STRATEGICALLY CONNECT AND COLLABORATE. WE AREN'T LOOKING TO EVER REPLACE ANYONE'S WORK, WE'RE WE'RE HERE TO SUPPORT DEVELOPMENT OF FHIR RESOURCE AND STANDARDS TO ENABLE WORK THAT NEEDS TO BE DONE. AND BY HAVING THESE STRATEGIC CONNECTIONS AND COLLABORATIONS, WE CAN MAXIMIZE OUR COLLECTIVE RESOURCES, WHEN VULCAN FIRST STARTED ONE OF THE MOST INTERESTING PIECES OF IT WAS THERE WAS A LOT OF FANTASTIC WORK GOING ON, OFTEN THE RESEARCH ALMOST THE SAME OR NEARLY THE SAME. THEY ALL WANTED TO COLLABORATE. THEY SIMPLY DIDN'T KNOW ABOUT EACH OTHER'S WORK. SO, VULCAN ALLOWS US TO BRING TOGETHER AND HAVE A SOURCE OF TRUTH OF WHAT WORK IS GOING ON TO BRING VISIBILITY OR LOOK FOR WAYS TO COLLABORATE. THE LAST PIECE OF THE GUIDING PRINCIPLE, WE NEED TO DELIVER INTEGRATED SOLUTIONS AND TOOLS TO DEVELOP THEM IN THE HOPES THEY WILL THEN BECOME THINGS THAT WILL BE USED IN THE RESEARCH COMMUNITY. SO, TODAY OUR SESSION IS AROUND FHIR AND POPULATION-BASED STUDIES, AND SO WE'RE GOING TO TALK TO SOME RESEARCHERS WHO HAVE BEEN USING FHIR IN RESEARCH, AND TALKING SPECIFICALLY ABOUT BOTH SUCCESSES AND OUR OPPORTUNITIES FOR IMPROVEMENT, THE FHIR SPECIFICATION, FHIR-ENABLED TOOLS AND AREAS THEY MAY SEE. I THOUGHT I WOULD SHARE LESSONS IN PFIZER, FOR VULCAN, I REPRESENT TRANCELERAT BIOPHARMA, WE HAVE BEEN ABLE TO EXCHANGE BACK IN 2019 DATA INTO OUR EDC SYSTEM USING FHIR. AND SO WE'VE DONE THIS NOT ONLY IN THE U.S. BUT WE'VE BEEN DOING THIS IN BOTH CHINA AND JAPAN. FORTUNATE TO LEARN LESSONS AS WE SCALE TO ADDITIONAL SITES. SOME AREAS THAT HAVE BEEN CHALLENGING ARE THE FHIR STANDARDS MAY NOT INCLUDE ALL OF THE DATA THAT WE'RE LOOKING FOR, BUT FEEL THERE'S GOING TO BE SOME PROGRESSION THERE. ALSO, NOTIFICATION OF WHEN DATA MAY CHANGE, AND I THINK THE SUBSCRIPTION RESOURCE ABOUT BE A BIG HELP IN THAT AREA. AND THEN AREAS THAT AREN'T TECHNICAL AT ALL, BUT AREAS SUCH AS SCALING. WHEN WE FIRST STARTED IN THIS AREA, MY EXPERIENCE WAS A LOT OF PEOPLE DIDN'T UNDERSTAND WHAT FHIR COULD DO FOR RESEARCH, AND I THINK THAT'S BEEN VERY SUCCESSFULLY SHIFTED, AND NOW MANY PEOPLE UNDERSTAND, OR ARE INTERESTED IN USING FHIR FOR RESEARCH. AND SO NOW WE HAVE SO MANY OPPORTUNITIES IN DIFFERENT WAYS TO DO THIS, IT'S ALMOST CREATED A NEW AREA WE NEED TO FOCUS ON WHICH IS HOW DO WE ALIGN ON THE PROCESSES TO DO THIS SO THAT IT DOESN'T BECOME SO BURDENSOME THAT WE CAN'T ACTUALLY IMPLEMENT, BUT ALSO ALLOWS FOR FREE COMPETITION. SO, WITH THAT, I JUST WANT TO SAY I ENCOURAGE EVERYONE TO JOIN VULCAN. I'M PLEASED AND PROUD WITH VULCAN THAT COMMITTEES RECOGNIZED THE DEFINITION OF VALUE TO BE NOT ONLY A FINANCIAL CONTRIBUTION, WHICH FOR-PROFIT ORGANIZATIONS TAKE, PFIZER INCLUDED, BUT THERE'S GREAT VALUE IN THOUGHT LEADERSHIP. SO OUR NOT-FOR-PROFIT, FOR INSTANCE ACADEMIC MEDICAL SITES, GOVERNMENT AGENCIES, MEET VALUE REQUIREMENT BY PROVIDING EQUAL THOUGHT LEADERSHIP. AND THIS HAS BEEN VERY EXCITING AND ALLOWED US TO BRING TOGETHER SOME FANTASTIC MINDS FROM ALL OVER THE WORLD TO COLLABORATE. SO, WITH THAT, WE HAVE AN EXCELLENT PANEL WHICH I'M VERY EXCITED ABOUT TODAY TO LEARN FROM MYSELF. AND SO I WOULD LIKE TO PASS IT OVER TO DR. MANDL WHO IS GOING TO BE KICKING US OFF. >> THANK YOU, AMY. THAT'S GREAT. VERY INSPIRING KICKOFF. HELLO TO MANY FAMILIAR FACES ON THE ZOOM AND SOME NEW ONES. I'M GOING TO START TO TALK ABOUT BRINGING FHIR INTO RESEARCH THAT'S PUBLIC HEALTH ORIENTED AS A FOCUS AND ALSO AS I TEND TO DO, LOOKING FOR NOT ONLY WHAT'S HAPPENING NOW BUT FOR WHAT SOME OF THE NEAR-TERM FUTURE OPPORTUNITIES ARE, AS WE PREPARE IN THAT DIRECTION. SO, AT THE BEGINNING OF THE PANDEMIC, SIDDHARTHA MUKHERJEE HAD A WELL-INFORMED QUOTE IN THE NEW YORKER, THINK OF EHR AS KIND OF INTRANET, FLEESIBLE, PROGRAMMABLE, EASY TO USE. RIGHT NOW ITS TOE PENSION AS A RESOURCE IS BLOCKED NOT LEAST BY OWNERS OF THE PROPRIETARY SOFTWARE WHO MAINTAIN IT AS CLOSED SYSTEM IT SHOULD BE A SIMPLE TASK TO ENCRYPT OR MOVE A PATIENT'S IDENTIFYING DETAILS LISTING HIS OR HER MEDICAL INFORMATION FOR THE COMMON GOOD. A LOT OF WHAT WE'VE BEEN SEEING IN THE INSPIRING PRESENTATIONS TODAY, THE KEYNOTES AND FIRST PANEL, ARE REALLY ABOUT GETTING DATA TO MOVE IN SERVICE OF RESEARCH, KNOWLEDGE, DISCOVERY. I'LL REMIND FOLKS WHAT WAS ACHIEVED, IT'S WORTH REMINDING OURSELVES WHAT HE ACHIEVED AND HOW, FREQUENTLY, HE NEEDED TO SHARE PRE-PRINTS OF ARTICLES FROM THE PHYSICS LITERATURE AND INVENTED A MARKUP LANGUAGE SO THEY COULD LOOK NICE WITH TITLES AND COLUMNS AND FIGURES, AND HE INVENTED A WAY TO MOVE THOSE AROUND, HTTP, RENDER THEM IN A WEB BROWSER, SERVE THEM UP FOR THE WEB SERVER. HE WENT ONE STEP FURTHER AND ACTUALLY STANDARDIZED THESE COMPONENTS THROUGH THE WORLDWIDE WEB CONSORTIUM. THIS ENABLED TREMENDOUS INNOVATION ON TOP OF A VERY PARSIMONIOUS SET OF STANDARDS. AND I WANT TO TAKE A LOOK AT HOW WE GOT TO WHERE WE ARE BRIEFLY AND WHAT'S COMING NEXT THAT ENABLES THE KINDS OF VISIONS THAT VULCAN, THAT "ALL OF US," AND THAT PATIENT-GENERATED DATA INITIATIVE CAN LOOK FORWARD TO. SO, I DON'T DO VERY MUCH LOBBYING BUT I GOT ONE SENTENCE, 21ST CENTURY CURES ACT, THAT WAS PUT IN THERE, BIPARTISAN EFFORTS BY DR. BILL CASSIDY AND SHELDON WHITEHOUSE, AND IT REQUIRES THAT THERE BE APPLICATION PROGRAMMING INTERFACES TO ALLOW HEALTH INFORMATION TO BE EXCHANGED WITHOUT SPECIAL EFFORT PROVIDING ACCESS TO ALL DATA ELEMENTS OF A PATIENT'S ELECTRONIC HEALTH RECORD. THIS HAS BEEN -- THIS CAPABILITY HAS BEEN REFERRED TO A NUMBER OF TIMES IN THESE TALKS TODAY BUT I WANT TO REFINED FOLKS WE'RE NOT GOING TO HAVE THIS FULL CAPABILITY AT SCALE IN THE TIME FRAME UNTIL DECEMBER OF 2022. SO, AS MUCH INTERESTING -- AS MUCH INTERESTING ACTIVITIES ARE HAPPENING ALREADY, WHAT WE CAN LOOK FORWARD TO COULD BE MANY FOLD GREATER. THERE ARE TWO REGULATED APIs IN THE ONC RULE THAT IMPLEMENT THE INTEROPERABILITY PROVISIONS OF THE 21ST CENTURY CURES ACT, SPECIFICALLY I'M VERY PROUD MY TEAM HELPED DEVELOP THESE TWO TECHNOLOGIES. THE FIRST IS SMART FHIR THAT ENABLED THE APPLE HEALTH APP JOSH DENNY WAS TALKING ABOUT IN THE "ALL OF US" PROGRAM TO CONNECT TO NOW OVER 600 HEALTH CARE SYSTEMS ACROSS A UNIVERSAL STANDARD API, AND IT WAS VERY FORWARD LOOKING, AND ICONOCLASTIC OF APPLE, AT LEAST WITHIN ITS OWN APPLE CONTEXT, TO USE AN OPEN STANDARD TO CONNECT TO THE HEALTH SYSTEMS, APPLE HAS GENERALLY ADHERED TO PROPRIETARY TECHNOLOGIES, AND OBVIOUSLY VERY SUCCESSFULLY. AND HERE WE HAVE HL7, AND THE SMART PROJECT UP ON THE APPLE STAGE AT THE WORLDWIDE DEVELOPERS CONFERENCE. AND THEY HAVE STUCK TO IT. IN FACT, THE MOST RECENT WORLDWIDE DEVELOPERS CONFERENCE ALSO USES SMART ON FHIR TO GET DATA ON THE PATIENT'S PHONE AND BACK IN TO CERNER AND OTHER PRODUCTS, THE FULL ROUND TRIP. THE SECOND API IS CALLED BULK FHIR API, LETS US GET AT DATA IN COMPLETELY STANDARDIZED FORMAT ON POPULATION. AGAIN, THOSE TWO ARE REQUIRED FOR DECEMBER OF NEXT YEAR, SO EVEN THOUGH WE'RE SEEING EARLY BENEFITS OF THIS LAW AND REGULATION, WE ARE ANTICIPATING A MUCH LARGER ECOSYSTEM. AND SO THINKING ABOUT POPULATION STUDIES, AT THE BEGINNING OF THE PANDEMIC I HAD THE OPPORTUNITY TO REFLECT BACK ON WORK THAT I DID BEFORE SEPTEMBER 11, THAT BECAME VERY POPULAR DURING SEPTEMBER 11th, AFTERMATH, AND THAT WAS TO DESIGN SYSTEMS THAT USE DATA FROM HEALTH CARE SYSTEMS TO PROVIDE POPULATION LEVEL INSIGHT FOR PUBLIC HEALTH. AND THE SYSTEMS THAT WE DEVELOPED EARLY ON WERE CALLED SYNDROMIC SURVEILLANCE SYSTEMS, AND THEY GAVE US AN OPPORTUNITY TO LOOK AT HOW MANY PATIENTS ARE COMING IN TO EMERGENCY DEPARTMENTS ALL OVER THE COUNTRY, WITH PARTICULAR SYNDROMES THAT COULD BE CONSISTENT WITH BIOLOGICAL EVENT. WE WERE INITIALLY FOCUSED ON BIOTERRORISM ACTUALLY BUT TURNS OUT TO BE IMPORTANT FOR SYNDROMES NOT BIOLOGICAL, INCLUDING THINGS LIKE SEVERE UPPER RESPIRATORY ILLNESS THAT COULD COME FROM A PANDEMIC. INTERESTINGLY, THESE SYSTEMS WHICH WE DEVELOPED MORE THAN 20 YEARS AGO AND MANY OF WHICH ARE STILL ACTUALLY IN PLACE, FOR EXAMPLE, CENTERS FOR DISEASE CONTROL, USEFULLY PROVIDING PUBLIC HEALTH INSIGHT IN REAL TIME OR NEAR REALTIME BASIS BASED ON CHIEF COMPLAINTS AS YOU'LL SEE IN THE UPPER RIGHT-HAND CORNER, SMALL STRINGS OF TEXT ENTERED BY TRIAGE NURSES, WHEN A PATIENT SHOWS UP IN THE EMERGENCY DEPARTMENT. AND THEY TURN OUT TO ACTUALLY BE VERY USEFUL DESPITE AS YOU'LL SEE ALL THESE MISSPELLINGS UP THERE. NOW BECAUSE WE ANTICIPATE THE FULL EHR BEING AVAILABLE ACROSS THESE APIs, FROM ONE PATIENT AT A TIME, SMART ON FHIR API, OR FOR THE WHOLE LARGE POPULATION DATA EXTRACT, WHAT WE CAN ANTICIPATE IS THAT THE U.S. CORE WILL BE AVAILABLE INCLUDING ICD CODES, MEDICATIONS, ORDERS, LAB RESULTS, PROCEDURE CODES, RACE AND ETHNICITY A BIG TOPIC, A BIG MISSING VARIABLE IN MANY OF THE PANDEMIC ANALYSES THAT RECEIVED MUCH ATTENTION FOR NOT BEING THERE. AND ALSO BACK OF THE ENVELOPE CALCULATION, I'M PLEASED IF ANYONE WANTS TO CORRECT ME ON THIS NUMBER, BECAUSE IT'S BASED ON BACK OF THE ENVELOPE BUT TWO BILLION NOTES COMING OUT OF ELECTRONIC HEALTH RECORDS. WE GO FROM THAT DATASET, TWO BILLION NODES, TO BE ABLE TO DO BIOSURVEILLANCE FROM THESE LITTLE FOUR OR FIVE-WORD CHIEF COMPLAINTS, AND THAT OPPORTUNITY I THINK CANNOT BE OVERSTATED. IF YOU LOOK AT HOW WE GOT TO WHERE WE ARE, WE'LL BE UPDATING THIS FOR 2021 SOON, WE STARTED THINKING ABOUT APIs, ZAK AND I ROW A PIECE IN THE NEW ENGLAND JOURNAL, IN 2019, AN EFFORT THAT TOOK A VILLAGE INCLUDING HL7 OF COURSE, APPLE, ELECTRONIC HEALTH RECORD VENDORS, ARGONAUT PROJECT AND MANY OTHERS, WE GOT TO ACTUALLY FULL REGULATION OF API TECHNOLOGIES THAT WE CAN LOOK FORWARD TO, BUT IT TOOK ONE DECADE. SO, WE'RE LOOKING AT THE OPPORTUNITY TO HAVE MUCH RICHER STANDARDIZED ELECTRONIC HEALTH RECORD DATA, THAT PUBLIC HEALTH CAN NOW BEGIN TO LEVERAGE THIS FEDERALLY REQUIRED HEALTH I.T. STANDARD, AS FOR PUBLIC HEALTH RESEARCH AND FOR PUBLIC HEALTH SURVEILLANCE. AND THE EHR INFRASTRUCTURE BOTH SILOED BY INSTITUTIONS CAN ALSO BE THOUGHT OF IN THE FEDERATED NETWORK ACROSS MANY SITES OF CARE WITHOUT NECESSARILY MOVING ALL THE DATA CENTRALLY. I THINK THESE OPPORTUNITIES BOTH FHIR API TOGETHER GIVE US THE OPPORTUNITY TO UNDERPIN BIDIRECTIONAL COMMUNICATION BETWEEN PUBLIC HEALTH AND CLINICAL CARE. AND SO THE ORIGINAL NEW ENGLAND JOURNAL ARTICLE LOOKED AT THIS AND LOOKED AT THE OPPORTUNITY FOR AN APPS MODEL, AND NOW APPS INCLUDE APPS THAT BE PATIENT FACING, PROVIDER FACING, RESEARCH FACING, PUBLIC HEALTH FACING. THIS, I WANT TO THANK THE OFFICE OF NATIONAL COORDINATOR FOR FUNDING US ON THE INITIAL SMART PROJECT. AGAIN BACK IN 2010, WHERE THEY GAVE US FOUR YEARS TO DEVELOP AND TRANSLATE THESE API TECHNOLOGIES THAT ALLOW APPS TO CONNECT TO ELECTRONIC MEDICAL RECORDS IN A COMPLETELY STANDARDIZED AND ABSTRACTED WAY. I WANTED TO SHOW YOU BRIEFLY OUR PATHWAY THERE. WE HAD TO DEVELOP OUR FIRST APP, JOSH MANDELL HELPED OUR FIRST CANDIDATE SMART API, WE NEEDED TO DEVELOP AN APP THAT WORKED AGAINST IT. WE WERE INSPIRED BY THIS "WIRED" MAGAZINE IMAGINED LABORATORY INFORMATION OF THE FUTURE, IMAGINED BY DAVE MCCANNDLESS, WE WERE ABLE TO REPLICATE THIS WATERCOLOR PAINTING IN "WIRED" INTO AN ACTUAL SMART APP PULLING DATA ACROSS THE API, AND HAD IT RUNNING IN THREE DIFFERENT ELECTRONIC HEALTH RECORD SYSTEMS THAT WERE OPEN SOURCED THAT WE HAD CONTROL OVER, SHOWING THAT THE APP IS NOT OWN SUBSTITUTABLE BUT WE CAN ADD OR DELETE FROM THE ELECTRONIC HEALTH RECORD ACROSS AN API, IT'S ALSO REUSABLE ACROSS MULTIPLE SYSTEMS, THE S AND THE R IN SMART. WE HAD ANOTHER VERY NICE DEMONSTRATION, AN ORGANIZATION CALLED POLYGLOT HAD MEDICATION INSTRUCTIONS, IT TOOK THEM 48 HOURS TO TURN THEIR INCREDIBLE RESOURCE, THOUSANDS OF MEDICATION SHEETS IN MULTIPLE LANGUAGES INTO A SMART APP PULLING MEDICATIONS LISTS ACROSS THE API AND THEY BECAME A VERY -- A COMMERCIALLY SUCCESSFUL VENTURE, ACQUIRED BY FIRST DATA BANK, AND NOW AVAILABLE IN THE EHR APP STORES, PATIENT AND PHYSICIAN-FACING VERSIONS. WE'RE ABLE TO LINK GENOMIC DATA WITH ELECTRONIC HEALTH RECORD DATA. THIS IS A MASHUP OF 23ANDME DATA WITH ELECTRONIC HEALTH RECORD DATA AND RISK MAX, THIS BRINGS RESEARCH WORLD AND THE CLINICAL WORLD TOGETHER IN A CLINICAL ENCOUNTER. WE HAVE THE SMART APP GALLERY WHICH IS ACTUALLY JUST RELEASED IN A NEW IMPLEMENTATION THAT IS A UNIVERSAL DIRECTORY ALSO FUNDED BY OFFICE OF NATIONAL COORDINATOR, INTERESTING SMART APPS. POWER OF REGULATION IS VERY CLEAR. THIS IS WHAT WE'RE ABLE TO ENJOY AS WE LOOK AT RESEARCH GOING FORWARD IN THIS CONTEXT. BACK IN MEANINGFUL USE STAGE 3, IT WAS REQUIRED THAT PATIENTS BE ABLE TO GET DATA THROUGH AN API, ONTO THEIR DEVICES, WHATEVER THOSE DEVICES MIGHT BE. THERE WAS NO STANDARD SPECIFIED IN THIS REGULATION. SO, ARGONAUT WAS CONVENED. HL7, MICKEY TREPAFI WAS THE LEADER, THE SMART TEAM WAS APART AS WERE SEVERAL ELECTRONIC HEALTH RECORD VENDORS. IT EXPANDED SUBSEQUENTLY BUT IN THE FIRST YEAR IT BUILT THE SMART ON FIRE API INTO ALL THE ELECTRONIC HEALTH RECORDS, THAT'S WHY YOU SEE PROGRESS NOW, EVEN THOUGH IT WILL BECOME UNIVERSAL AT THE END OF NEXT YEAR AND WE'LL SEE MUCH MORE. AGAIN, THE APPLE HEALTH APP IS A GREAT EXAMPLE, BUT THERE'S ALSO NOW THE COMMON HEALTH APP, AND I KNOW IDA SIM HAS BEEN WORKING ON DEPLOYMENT OF THE ANDROID VERSION AT UCSF, AND WE'RE LOOK AT A 21ST CENTURY HEALTH I.T. SYSTEM, REAL WORLD INFORMATION ECONOMY THAT CAN UNDERPIN RESEARCH, PUBLIC HEALTH, CLINICAL CARE. THE SMART HL7 FHIR BULK DATA ACCESS API, WHICH DAN GOTTLIEB AND JOSH MANDELL WERE LEAD ARCHITECTS OF IN A COOPERATIVE AGREEMENT WITH HL7 AND OHC, THAT I WAS -- THAT I LED OUT OF BOSTON CHILDREN'S HOSPITAL IS NOW SOMETHING THAT I THINK WE WANT TO BEGIN TO ANTICIPATE. CMS DID MORE THAN ANTICIPATE, WHEN IT WAS STILL AN IMMATURE STANDARD. CNS BEGAN TO USE IT TO PROVISION POPULATION-LEVEL DATA TO PATIENTS, TO PROVIDER ORGANIZATIONS WITH ROSTERS OF PATIENTS, OR FOR THEIR AT-RISK POPULATIONS. BUT HERE IN THE DATA AT POINT OF CARE AND BENEFICIARY CLAIMS DATA, WHERE WE HAVE ELECTRONIC HEALTH RECORD DATA NOW. THESE APIs I THINK OF AS BUILDING BLOCKS THAT ARE -- I DON'T MEAN TO INTEND, AS IMPACTFUL AS TIM'S WEB, THEY ARE USING THE SAME IDEA THAT YOU HAVE PARSIMONIOUS STANDARDS, JUST A FEW, THAT GET YOU VERY FAR AND YOU CAN BUILD THEM INTO DIFFERENT TYPES OF SYSTEMS. A 21ST CENTURY CURES INFORMATION ECONOMY. AND I WANT TO ENCOURAGE US TO KEEP A COUPLE OF THINGS IN MIND. ONE IS THAT WITH MORE DATA FLOWING THERE WILL BE MORE RISK TO PATIENT PRIVACY, PATIENT AUTONOMY, SECURITY, AND BREACHES. AND WE HAVE THE OPPORTUNITY TO TAKE VERY PATIENT-PROTECTIVE APPROACHES TO DESIGNING THE POLICIES UNDER WHICH THESE APIs ARE USED. AND THE OPPORTUNITY TO BE GOOD DATA CITIZENS AS ORGANIZATIONS, AS RESEARCHERS, AS HEALTH CARE INSTITUTIONS, AS COMPANIES, TECH COMPANIES, THERE'S AN OPPORTUNITY TO DO THIS RIGHT. I ALSO WANT TO POINT OUT THAT THERE'S AN OPPORTUNITY TO POTENTIALLY SCUTTLE THE INTEROPERABILITY PLAY IF WE OVERPROTECT THE APIs AND DON'T LEAVE THEM AS OPEN AS POSSIBLE TO AS MANY PLAYERS IN THE SYSTEM AS POSSIBLE. SOME OF THE FEATURES OF THE -- OF IMPLEMENTING THE 21ST CENTURY CURES CURES ACT RULES RELATE TO HOW MUCH WILL IT COST TO USE THESE APIS, SO IF JOSH DENNY WANTS TO CONNECT EITHER A PATIENT-FACING APP TO THESE APIs, THAT WILL BE FREE. BUT IF HE WANTS TO CONNECT THE BULK -- AN APP TO THE BULK FHIR APIs, THAT'S GOING TO COST MONEY. WHO IS GOING TO PAY THAT MONEY AND WHAT DOES THE MONEY -- HOW MUCH MONEY IS IT GOING TO BE FOR HEALTH SYSTEMS TO GIVE UP THE DATA THAT THEY ENTERED INTO THE EHRS THEY PURCHASED, AND I ENCOURAGE US TO KEEP OUR EYE ON THAT BALL AS WELL AS WE GO FORWARD. A FORWARD POINT TO WORK THAT'S ONGOING, WE'VE BEEN ENGAGED WITH CDC, SINCE EARLY IN THE PANDEMIC, LOOKING AT, FOR EXAMPLE, THE USE OF SOME OF OUR ONC-FUNDED TECHNOLOGY FOR CONNECTING TO BULK FHIR APIs IN ORDER TO SERVE PUBLIC HEALTH NEEDS, AND THINKING ABOUT WAYS THAT WE CAN PREPARE FOR 2022, WHEN THE APIs WILL BE REQUIRED UNDER THE RULES. I WILL LEAVE IT RIGHT THERE. >> THANK YOU SO MUCH. THAT WAS EX- EXCELLENT. THERE'S SO MUCH GREAT INFORMATION, LEAVING TIME FOR QUESTIONS, I'D LIKE TO MOVE ON TO BOB FREIMUTH. >> THANK YOU VERY MUCH, A PLEASURE TO SPEAK TODAY, I LOOK FORWARD TO BUILDING ON THE TALKS WE'VE HEARD THIS MORNING. I WOULD LIKE TO START BY GIVING AN EXTENSION, GETTING INTO THE WEEDS OF SOME OF THE TOPICS AND PRINCIPLES WE'VE HEARD ALREADY THIS MORNING. WE'RE HEARD A LOT OF INSPIRING TALKS ABOUT THE APPLICATIONS AND USAGE OF EHR AND OTHER CLINICAL AND PATIENT-PROVIDED DATA. WE'VE TALKED ABOUT INFRASTRUCTURE AND TECHNOLOGY THAT CAN BE USED TO GET THAT DATA FLOWING BETWEEN PRODUCERS AND CONSUMERS. AND WHAT I'D LIKE TO DO IS DRILL DOWN JUST A LITTLE BIT INTO TALKING ABOUT SOME OF THE REPRESENTATION OF THE DATA ITSELF. SO WE NEED TO BE ABLE TO MOVE -- WE NEED TO DO MORE THAN JUST BE ABLE TO MOVE DATA AND TO MOVE IT QUICKLY AND EFFICIENTLY. WE ALSO NEED TO BE ABLE TO REPRESENT THAT DATA IN A WAY THAT ALLOWS INTERPRETATION TO BE USED ACCURATELY FOR RESEARCH AND CLINICAL CARE. AND SO I'M GOING TO TALK A LITTLE BIT ABOUT THE EXPERIENCES OF THE EMERGE RESEARCH NETWORK. THIS IS A DOMAIN, GENOMIC MEDICINE IS A DOMAIN WHERE THE USE CASES AND DEMAND FOR DATA ACTUALLY EXCEED AND OUTPACE OUR ABILITY TO REPRESENT THESE DATA IN A ROBUST FASHION. I'M GOING TO START BY GIVING JUST A BRIEF SLIDE OR TWO ON THE EMERGE NETWORK, FOR THOSE THAT MIGHT NOT BE FAMILIAR, FUNDED BY NHGRI, CURRENTLY IN ITS FOURTH PHASE OF ACTIVITY. YOU CAN SEE THE AIMS IN THE UPPER RIGHT. I WON'T GO THROUGH AND VERBALIZE FOR THE SAKE OF TIME BUT I WILL JUST POINT OUT SOME OF THE TAKEHOME POINTS FROM THIS. THE EMERGE NETWORK, BECAUSE OF THE AIMS, WHAT IT HOPES TO ACCOMPLISH, REQUIRE A NUMBER OF THINGS TO BE ENABLED. WE FIRST OF ALL NEED THE ROBUST COMPUTATIONAL REPRESENTATION OF GENOMIC DATA, AND RESULTS THAT ARE OBTAINED FROM CLINICAL SEQUENCING. WE NEED TO BE ABLE TO INTEGRATE THOSE DATA WITH CLINICAL DATA, THAT CORRESPONDS TO THE PATIENTS AND PARTICIPANTS IN THE STUDIES THAT THEY REPRESENT. WE NEED TO BE ABLE TO MERGE THOSE DATASETS ACROSS MANY STUDY SITES AND BE ABLE TO LINK, AND THIS IS AN UNDERSTATED BUT VERY IMPORTANT POINT, WE NEED TO BE ABLE TO LINK PATIENT-SPECIFIC GENOMIC RESULTED TO EVIDENCE CASING ING A -- CAS AGNOSTIC DATABASES. 11 STUDY SITES, WENT THROUGH A TYPICAL STUDY DESIGN, THERE WAS A ROUND OF RECRUITING, SOME CONSEQUENCING THAT OCCURRED CENTRALLY AMONG TWO SEQUENCING CENTERS. THERE WAS HARMONIZATION BETWEEN THE TWO CENTERS IN TERMS OF HOW THE VARIANTS WERE CALLED. AND REPORTS THAT WERE THEN DISTRIBUTED BACK TO THE STUDY SITES. THOSE STUDY SITES THEN WERE RESPONSIBLE FOR INTEGRATING THOSE DATA AND THOSE REPORTS INTO THEIR EHRs, IMPLEMENTING CDS, TO GO ALONG WITH THAT TO HELP PROVIDERS UTILIZE THAT. NOW, IN ADDITION TO THIS CORE IMPLEMENTATION EFFORT, THE NETWORK ALSO DEVELOPED AND PILOT TESTED FHIR AS A WAY TO RETURN STANDARDS-BASED DISCRETE GENOMIC RESULTS. AND THIS OCCURRED IN PARALLEL WITH THE MAIN EFFORT. THE GOALS OF THIS WERE TO CREATE STRUCTURED REPRESENTATIONS, SO CLINICAL GENOMIC RESULTS, BASED ON THE FHIR GENOMICS REPORTING IMPLEMENTATION GUIDE THAT WAS AVAILABLE AT THE TIME. TO DO THIS USING THE STRUCTURES THAT WERE AVAILABLE BUT ALSO TO EVALUATE THOSE STRUCTURES, TO SEE WHAT WE COULD DO TO CONTRIBUTE TO THEIR FURTHER DEVELOPMENT AND MATURATION. WE WANTED TO BE ABLE TO CONTRIBUTE BACK TO THE STANDARDS DEVELOPMENT COMMUNITY AS OPPOSED TO SIMPLY CREATING A NEW FIT FOR PURPOSE STANDARD THAT HAD LIMITED GENERALIZABILITY. SO, SOME OF THE DESIGN PRINCIPLES THAT WERE FOLLOWED HERE, AND I'M NOT GOING THROUGH THIS ENTIRE SLIDE, YOU CAN READ IT FASTER THAN I CAN NARRATE IT, BUT THE DESIGN PRINCIPLES ARE SHOWN HERE. WE WANTED TO STRUCTURE THE CONTENT, THIS HAD TO GO BEYOND SIMPLY THE STRUCTURE THAT WAS PROVIDED BY PDF REPORTS, WE NEEDED TO ALIGN THE REPRESENTATION OF THE DATA ELEMENTS WITH STRUCTURES THAT WERE NATIVE TO FHIR, WE NEEDED THE DATA VALUES THEMSELVES TO BE COMPUTATIONALLY UNAMBIGUOUS, SOMETHING THAT COULD BE COMPUTED UPON, AND THERE'S AN UNLIMITED NUMBER OF SHARP EDGES THAT TEND TO CATCH PEOPLE UP WHEN WE START EXCHANGING LOCALIZED RENDERINGS OF GENOMIC DATA. BECAUSE OF THAT WE WANTED TO CODIFY AS MANY CONCEPTS AS POSSIBLE. THAT OF COURSE REQUIRES ADDITIONAL WORK IN TERMINOLOGY SPACE, IN VALUE SETS, AND OTHER AIRS THAT -- AREAS WE WON'T GO INTO TODAY. OVERALL DESIGN OF THE EMERGE STUDY ON THE LEFT-HAND SIDE YOU SEE THE CLINICAL SEQUENCING, RESULTED IN REPORTS THAT ARE SHOWN HERE IN THE CENTER OF THE SLIDE, THERE WERE EFFORTS TO IDENTIFY CORE DATA ELEMENTS OUT OF REPORTS, TO ANALYZE, COMPARE THEM AGAINST FHIR GENOMICS REPORTING IMPLEMENTATION GUIDE, IG, DEVELOP EMERGE IG THAT WOULD BE ABLE TO SUPPORT THE DATA STRUCTURES THAT WERE USED BY THE NETWORK. ON THE RIGHT-HAND SIDE IN THAT VERTICAL COLUMN YOU'LL SEE HOW THAT IMPLEMENTATION GUIDE WAS THEN USED AS PART OF A PILOT PROJECT, FUNDED IN PART BY THE ONC SYNC FOR GENES PROGRAM, WHO OF THE CLINICAL SITES WERE ABLE TO TEST THAT OUT AND PROVIDE FEEDBACK FOR UTILIZATION OF THOSE DATA STRUCTURES WITHIN REAL USE CASES. I'M NOT GOING THROUGH THOUGHTS BUT IT'S IMPORTANT TO UNDERSTAND COMPLEXITY INVOLVED IN DOING SOMETHING LIKE THIS. STRUCTURING IT OUT TO BE USED FOR CLINICAL AND TRANSLATIONAL RESEARCH, FIRST STEP TO ANALYZE RECORDS PRODUCED. YOU SEE A PARTIAL SNAPSHOT OF TWO PDF REPORTS PRODUCED BY EACH OF THE CLINICAL SEQUENCING CENTERS. ON THE LEFT WE HAVE BAYLOR, ON THE RIGHT WE HAVE BROAD. YOU CAN SEE JUST FROM THE COLORS HERE EACH OF WHICH REPRESENTED DIFFERENT TYPE OF INFORMATION, THAT THE TWO REPORTS HAVE SIMILAR TYPES OF STRUCTURES BUT THEY ARE CERTAINLY NOT HARMONIZED TO ANY DEGREE. AFTER THAT ANALYSIS THERE WAS MAPPING BACK INTO THE FHIR STRUCTURES LOOKING AT RESOURCES, ALSO THROUGH OTHER RESOURCES AND PROFILES THAT WERE AVAILABLE THROUGH FHIR AND WE FHIR-IZED ELEMENTS TO CREATE THE REPORT STRUCTURE YOU SEE ON THE RIGHT-HAND SIDE OF THE SLIDE. THIS WAS A TREMENDOUS AMOUNT OF WORK, I CAN CLAIM CREDIT FOR ALMOST NONE OF IT. BUT IT WAS A VERY LARGE EFFORT DOCUMENTED AT A WEBSITE THAT YOU CAN GO TO AND TAKE A LOOK AT FOR MORE INFORMATION. THE URL IS SHOWN ON THE RIGHT-HAND SIDE. TAKE A LOOK AT THAT. IT'S A WONDERFUL WEBSITE THAT WAS PUT TOGETHER BY THE PRIMARY WORKERS ON THIS PROJECT, AND IT DOCUMENTS A TREMENDOUS AMOUNT OF EFFORT THAT WENT INTO THIS. WHAT I WOULD LIKE TO CALL ATTENTION TO HERE IS A SECTION. DOCUMENTATION, ISSUES AND RESOLUTIONS. THIS ENUMERATES A NUMBER OF THE BIGGEST ISSUES THAT WERE ENCOUNTERED TRYING TO USE FHIR FOR GENOMICS RESEARCH FOR THE USE CASE WE HAVE HERE, PROVIDED BY THE EMERGE RESEARCH NETWORK. AND THERE ARE A COUPLE DOZEN OF THESE THAT ARE EXPLAINED IN DEPTH AND HYPERLINKED TO OTHER INFORMATION, YOU CAN SEE THE RESOLUTION OF HOW THE NETWORK ITSELF WORKED WITH THE HL7 WORK GROUPS THAT OWN THESE RESOURCES AND PROFILES TO WORK THROUGH EACH OF THESE ISSUES. THIS TABLE SHOWS A SUMMARY OF THE ISSUES THAT WERE REPORTED, AS PART OF THIS EFFORT. YOU'LL NOTICE IN THE RIGHT-HAND SIDE THERE WERE ONLY TWO OF THEM THAT WE WERE NOT ABLE TO RESOLVE THROUGH EITHER CHANGE TO THE IMPLEMENTATION GUIDE OR A LOCAL WORK-AROUND THAT ALLOWED US TO GET THE JOB DONE. IN FACT THESE TWO ITEMS WERE DEFERRED FROM THE SPACE OF THE PROJECT, IN FACT THESE TWO ARE BOTH THINGS THAT ARE CRITICALLY IMPORTANT TO SUPPORT RESEARCH. FHIR IS A CLINICALLY ORDERED STANDARD, AND RIGHT OUT OF THE GATE WE'RE FINDING SIGNIFICANT LIMITATIONS IN ITS ABILITY TO SUPPORT WE SEARCH, AND WE'RE AT TIMES AT A LOSS HOW TO PATRIOT. NOW SOME ISSUES THAT FALL INTO THE TWO CATEGORIES ARE ENUMERATED ON THIS SLIDE. I'LL SUMMARIZE THEM ON THE NEXT, WITHOUT GOING INTO TOO MUCH DETAIL, I HOPE. THE FIRST HAS TO DO WITH VARIANT DATA TYPE. GENOMIC DATA AND PARTICULARLY THE WAY THAT WE REPRESENT GENOMIC VARIANTS ARE OFTEN REPRESENTED AND EXCHANGED AMONG PARTNERS THROUGH COMMUNITY STANDARDS, OFTENTIMES VERY DEEPLY EMBEDDED WITHIN WORKFLOWS AND WITHIN CULTURE. HOWEVER, THESE CONVENTIONS ARE OFTEN HIGHLY DISPARATE, OFTEN LOCALIZED TO PARTICULAR USE CASES AND PARTNERS. THEY HAVE IN SOME CASES METHODS FOR EXTENSIBILITY. AS A RESULT OF FUZZINESS AROUND THESE IN COMBINATION WITH HETEROGENEITY, THEY ARE FOR THE MOST PART HUMAN READABLE PURPOSES GO SERVE THE PURPOSE BUT WHEN IT COMES TO DOING RESEARCH AT SCALE THROUGH COMPUTATIONAL MEANS THEY FUNCTIONALLY BECOME NON-INTEROPERABLE. SECONDLY, WE HAVE THE NEED FOR A COMPUTATIONAL UNAMBIGUOUS WAY OF SPECIFYING A DEFINITIONAL VARIANT, WITHOUT GOING INTO TOO MUCH DETAIL WE'RE WORKING IN PARTNERSHIP BETWEEN THE HL7 CLINICAL GENOMICS WORK GROUP AND GLOBAL ALIANCE WORKING ON THE VARIATION REPRESENTATION SPECIFICATION, TO BE ABLE TO EXCHANGE VARIANT INFORMATION MORE ROBUSTLY THAN WE CAN TODAY. WE NEED TO REPRESENT NOT ONLY THE PRIMARY GENOMIC DATA THAT WERE ASSAYED AS PART OF THE ORIGINAL SEQUENCING AND REPORT BUT ALSO THE ASSERTIONS AND INTERPRETATIONS THAT LAYER ON THAT PRIMARY DATA WHICH ARE CRITICALLY IMPORTANT FOR NOT ONLY THE CLINICAL UTILIZATION OF THAT BUT ALSO IMPORTANT IN A RESEARCH SETTING WHEN LOOKING FOR ASSOCIATIONS AND CAUSALITY. THESE INTERPRETATIONS OF COURSE DEPEND ON THE EVOLUTION OF KNOWLEDGE, AS WE LEARN MORE OUR INTERPRETATIONS CAN CHANGE, AND SO THESE INTERPRETATIONS ARE UNLIKE SOME CLINICAL DATA, SOME CLINICAL OBSERVATIONS THAT ARE REPORTED TO THE EHR AS TEST RESULTS, ARE VERSIONED. THESE ARE THINGS THAT CAN LIVE ON THROUGHOUT A PATIENT'S LIFETIME AND MUST BE REASSESSED PERIODICALLY. LASTLY ON THIS PARTICULAR POINT WE NEED TO MAINTAIN A CLEAR DISTINCTION BETWEEN CASE INDEPENDENT KNOWLEDGE, THAT IS SOMETHING YOU WOULD FIND IN THE GENERALIZED KNOWLEDGE BASE, SOMETHING LIKE ClinGen, AND PATIENT-SPECIFIC DATA AND IMPLICATIONS THEREOF WHICH WOULD BE MORE TRADITIONALLY REPRESENTED IN CURRENT FHIR DATA STRUCTURES. WE NEED TO BE ABLE TO REPRESENT GENETIC VARIANTS, THAT CAN BE REFERENCED IN EITHER A CASE INDEPENDENT OR PATIENT SPECIFIC CONTEXT. AND THEN FINALLY THE SECOND POINT HERE THAT WAS MARKED AS DEFERRED, PART OF THIS PROJECT, WAS CAPTURING ENOUGH INFORMATION ABOUT THE DATA THAT'S BEING REPORTED TO ALLOW A CONSUMER OF THAT DATA TO UNDERSTAND WAS THIS RESULT SOMETHING THAT WAS PRODUCED IN A RESEARCH SETTING OR WAS IT PRODUCED IN A CLINICAL SETTING, WAS IT GENERATED BY A CLIA TEST, SIGNED OUT BY A LABORATORY, WAS IT SUBJECTED TO CONFIRMATORY SEQUENCING, OR WAS IT DONE THROUGH OTHER METHODS BECAUSE THAT OF COURSE CAN COLOR THE WAY THAT THAT DATA IS THEN UTILIZED FOR SECONDARY PURPOSES DOWNSTREAM. SO SUMMARIZING THE POINTS THAT CAME OUT OF THAT EMERGE PROJECT TO KICK THE TIRES ON FHIR, IF YOU WILL, THROUGH THE PHASE 3 OF THE EMERGE RESEARCH NETWORK, THERE WERE A NUMBER OF NEEDS THAT CAME OUT OF THIS. FIRST OF ALL, WE NEED TO BE ABLE TO COMPUTATIONALLY AN UNAMBIGUOUSLY DEFINE GENETIC VARIANT, REFERENCE THAT VARIATION OUTSIDE OF THE CONTEXT OF PATIENT OBSERVATIONS WHICH MEANS WE NEED DIFFERENT TYPES OF DATA STRUCTURES THAT ALLOW US TO REPRESENT DATA IN KNOWLEDGE BASES THAT SUPPORT THE INTERPRETATION AND REINTERPRETATION OF GENOMIC RESULTS, SUPPORT STATEMENTS ABOUT DISEASE ASSOCIATION AND UNDERLYING GENETIC CAUSES, IN PHARMACOGENOMICS, POTENTIAL FOR INTERACTION AND ADVERSE EVENTS, COMING TOGETHER AS WE THINK ABOUT POPULATION STUDIES AND EPIDEMIOLOGY. WE ALSO NEED TO THEN ALLOW FOR THE USE OF THESE DATA STRUCTURES TO BE REPRESENTED AND USED WITHIN THINGS LIKE INCLUSION AND EXCLUSION CRITERIA FOR RESEARCH STUDIES, SO THAT THEY CAN BE USED TO FACILITATE PATIENT MATCHING AND COHORT IDENTIFICATION. NOW, THE HL7 CLINICAL GENOMICS WORK GROUPS THAT TAKEN THIS FEEDBACK TO HEART, WORKING HARD TRYING TO IDENTIFY NEW TYPES OF STRUCTURES THAT ALLOW US TO SUPPORT USE CASES BETTER. HL7 IS FOCUSED ON CLINICAL REPORTING, AS WE JUST HEARDED THROUGH PROJECTS LIKE VULCAN AND OTHERS, THERE'S A SIGNIFICANT AND INCREASING INTEREST IN SUPPORTING RESEARCH AS WELL. AND IN ORDER TO DO THIS WE'VE TAKEN FEEDBACK FROM PROJECTS LIKE EMERGE AND STARTED THINKING ABOUT WHAT WE WOULD NEED TO DO IN THE FUTURE TO BE ABLE TO SUPPORT THESE THINGS A LITTLE BIT BETTER. THIS HAS LED US TO THINK ABOUT DEVELOPMENT OF NEW FHIR RESOURCES TO SUPPORT MOLECULAR SEQUENCES, AND MOLECULAR VARIATION, RESPECTIVELY. I WON'T GO INTO DETAILS ON THIS BUT I DID WANT TO SUMMARIZE SOME OF THE BENEFITS OF WHY THESE NEW TYPES OF RESOURCES MIGHT BE USUAL SPECIALIZED FOR GENOMICS RESOURCES, ALLOW YOU TOES SUPPORT CONTEXT-AGNOSTIC REFERENCES INCLUDING THOSE WE SEE FOR RESEARCH. IT ALLOWS DATA TO MORE NATURALLY FIT THE RENDERINGS IN WHICH WE TRY TO REPRESENT THEM RESULTING IN MORE INTUITIVE RENDERINGS FOR DOMAIN EXPERTS, EXPRESS SEMANTICS MORE PRECISELY, AND HELPS THE GENERATOR OF THOSE DATA AND THOSE MESSAGES TO USE DISCRETE DATA ELEMENTS ROBUSTLY, ALLOWS YOU TOES GET TO THAT POINT WHERE WE'RE ENABLING COME -- COMPUTATIONAL DATA, ACHIEVING SIMPLITY AND PARITY. IN CONCLUSION, I WANTED TO SHOW A QUICK ROADMAP OF WHERE WE'RE GOING IN THE FUTURE, CURRENT STATE OF FHIR GENOMICS ON THE LEFT-HAND SIDE OF THE SLIDE, PRIMARILY WORKING WITH IMPLEMENTATION GUIDE, THAT LEVERAGES EXISTING PROFILES OF REPORTS AND OBSERVATIONS, WE HAVE A MOLECULAR SEQUENCE RESOURCE BUT IT'S NOT UTILIZED WITHIN THAT IMPLEMENTATION GUIDE, OR UTILIZED MINIMALLY. ON THE RIGHT-HAND SIDE WHERE WE COULD GO IN THE FUTURE, WE'VE SIMPLIFIED OBSERVATION PROFILES AND CREATED NEW TYPES OF DATA STRUCTURES THAT REPRESENT THE GENETICS DOMAIN. I'D LIKE TO ACKNOWLEDGE THOSE THAT DID THE HARD WORK ON THIS, NAMELY LARRY AND MULAI WHO DID THE LION'S SHARE ON THE EMERGE PROJECT THAT I MENTIONED PREVIOUSLY, AND COMPARING TO THE FHIR IMPLEMENTATION GUIDE, AND OF COURSE ACKNOWLEDGE THE RESEARCH FUNDED HERE THROUGH THE RESEARCH NETWORK SUPPLEMENTED THROUGH THE ONC SYNC FOR GENES PROGRAM. THE DATA IS AVAILABLE THROUGH PUBLICATION THIS YEAR, I WELCOME YOU TO TAKE A LOOK. WITH THAT I WILL CLOSE. THANK YOU FOR YOUR ATTENTION AND PASS IT BACK TO AMY AND ROBERT FOR THE NEXT TALK. >> THANK YOU, BOB. YOU'VE GOT EVERYONE EXCITED. I SEE QUESTIONS COMING ALREADY. I ENCOURAGE THE GROUP TO PLEASE START PUTTING YOUR QUESTIONS IN THE COMMENT BOX AND WE WILL GET TO THEM IN JUST A MOMENT. WITH THAT I'D LIKE TO HAND IT OVER TO ROBERT. >> THANK YOU. I HAVE A DIFFERENT TALK. DR. DENNY EARLIER TOLD US ABOUT "ALL OF US," WHAT'S GOING ON. I'LL SHARE ABOUT THAT. MOSTLY I'LL TALK ABOUT NIH CLOUD PLATFORM INTEROPERABILITY WORKING GROUP AND WORK WE'VE BEEN DOING THERE. I DO INVITE EVERYONE TO PARTICIPATING INTO THE WORK WE'RE DOING. AS A COMMUNITY TOGETHER WE'LL BE ABLE TO DO A LOT MORE. THESE PROJECTS, WE'RE IN A GREAT PLACE. WITH "ALL OF US," WE HAVE A FEW USE CASES INTERNALLY THAT WE'RE USING FHIR AND USING QUESTIONNAIRES AND QUESTIONNAIRE RESPONSES TO CAPTURE SURVEYS. SENT TO THE RAW DATA REPOSITORY JOSH MENTIONED EARLIER. WE'RE CAPTURING SEVERAL RESPONSES THAT WAY. THE DRC COLLECTS PHYSICAL MEASUREMENTS AT ENROLLMENT, STAFF WILL ENTER DATA THERE, THAT INFORMATION IS BEING SENT OVER USING COMPOSITIONS WITH OBSERVATIONS. HEIGHT, WEIGHT, SIMILAR DATA CAPTURED FROM THE PROGRAM SIDE, CONTRIBUTED USING FHIR AS WELL. WE ALSO HAVE THESE USE CASES, EXTERNAL FHIR USE CASES THAT CAME UP EARLIER. THERE WAS A PILOT DONE WITH SYNC FOR SCIENCE, APPLE HEALTH RECORDS MENTIONED BEFORE AND DIRECT COLLECTION IN APPS. NOT EVERYTHING IS USING THE ANDROID/APPLE HEALTH RECORDS BUT ANDROID APPS ARE STILL ABLE TO MAKE FHIR CONNECTIONS AS WELL, GET THAT AND PROVIDE INFORMATION BACK THROUGH THE PORTAL AND BACK TO DATA AND RESEARCH CENTER AS WELL. THAT'S THE EXTERNAL WAY REACHING OUT TO FHIR INTERFACES RECEIVING DATA RIGHT NOW. THAT'S NICE. THAT'S PRETTY SOLID AND CONSISTENT. AS TALKED ABOUT, THOSE ARE IMPORTANT PILLARS FOR CAPTURING DATA, GETTING EHR DATA FLOWING, POPULATION HEALTH SETTING. WE'RE ALSO LOOKING AT TRYING TO UNDERSTAND IN "ALL OF US" HOW TO INTEGRATE THAT FIRE EHR DATA WITH OMOP DATA. WE'RE MAKING OMOP DATA AVAILABLE TO RESEARCHERS TO UNDERSTAND HOW TO INTEGRATE IN WITH THE OMOP DATA FROM THE FHIR HEALTH CARE ORGANIZATIONS, ALSO LOOKING AT -- I'M INTRIGUED ABOUT STANDARDIZATION OF WEARABLE DATAS IF IT'S READABLE, WHAT WE SHOULD INCLUDE, FHIR, OPEN mHEALTH, WE HAVE A VARIETY OF MECHANISMS COLLECTING WEARABLES DATA INCLUDING FITBIT AND APPLE HEALTH. OUTSTANDING CHALLENGES AND OPPORTUNITIES, I THINK THERE'S A FEW HERE. I'LL START WITH THE MIDDLE ONE. HOW DO WE COMMUNICATE QUALITY AND THOSE DIFFERENCES THAT MET DATA THAT COME UP ABOUT THE HR DATA FROM AN OMOP SCENARIO. DEPENDING ON THE NEXT 18 MONTHS UNTIL THE USCDI MANDATES AND ENFORCES, WHAT DO WE CAPTURE AND SHOW AND PROVIDE THAT TO RESEARCH USERS TO MAKE SURE EVERYONE UNDERSTANDS WHERE THE DATA CAME FROM, WHAT SOME OF THE IDIOSYNCRACIES MAY BE. WE'RE ALSO -- WITH A LOT OF QUESTIONS, FEEL FREE TO REACH OUT TO ME, IF YOU HAVE IDEAS OR THOUGHTS ON THIS, LET ME KNOW. WHAT ARE COST AND BENEFITS TO PROVIDING FHIR API TO RESEARCHERS? WE COULD REPRESENT DATA, IS THAT SOMETHING VALUE, INSTEAD OF PROVIDING QUESTION AND ANSWER DATA WOULD IT BE HELPFUL TO PROVIDE QUESTIONNAIRE RESPONSES TO RESEARCHERS SO NOT THAT IT'S NOT FAIR BUT IS THERE SOMETHING INHERENT TO THAT FHIR STRUCTURE THAT MIGHT PROVIDE UTILITY. I'M INTERESTED IF YOU HAVE OPINIONS. I'LL BE READING THE CHAT OR REACH OUT LATER. WE HAVE A CLEAR SET OF A GREAT VISION CAST EARLIER, WE HAVE A GREAT DIRECTION FOR "ALL OF US" AND FHIR. NIH CLOUD PLATFORM INTEROPERABILITY FHIR WORKING GROUP, IT'S A COLLABORATION AMONG A NUMBER OF NIH-SPONSORED CLOUD PLATFORMS, INCLUDING DBGaP, YOU SEE ANVIL, BIODATA CATALYST, KIDS FIRST RESOURCE CENTER, KIDS FIRST PROGRAM. THESE ORGANIZATIONS ARE COLLABORATING, MANY ENTITIES ARE BUILDING CLOUD-BASED PLATFORMS TO MAKE DATA SHARING AVAILABLE. I WON'T GO THROUGH A TON OF DETAIL BUT INTEROPERABILITY IS CRITICAL, A NUMBER OF US HAVE BEEN LOOKING INTO HOW CAN WE MAKE FHIR ALSO WORK BETTER IN THE RESEARCH CONTEXT. A NUMBER OF GROUPS ARE MAPPING AND LOADING IN THE PLATFORMS IN FHIR, SPONSORED ROBUST RESEARCH STUDIES, DATA IS CAPTURED AND AVAILABLE IN PLACES LIKE DBGaP, HOW DO WE SUPPORT NEW STUDIES IN THE FUTURE? THAT'S BEEN THE WORK WE'RE DOING. WE'RE INTERESTED IN REPRESENTING STUDY LEVEL DATA, PARTICIPANT LEVEL DATA, IMPLEMENTATION GUIDE, GIT DIFF HUB AVAILABLE, AND WANT TO LINK OUT WHEN APPROPRIATE TO EXTERNAL DATA SOURCES. IT CAME UP IN THE CHAT, I THINK DR. SIM WAS MENTIONING, YOU DON'T NECESSARILY WANT CENSORED DATA IN FHIR, GENOMICS DATA, RAW FILE READS, YOU WON'T PUT THOSE IN FHIR RESOURCES. THE DATA REPOSITORY SERVICE, CAN WE USE STANDARD LINKS TO SAY IF YOU WANT TO GET THIS WHOLE GENOME DATA, FULL SEQUENCE DATA, GET IT HERE. THIS IS HOW YOU ACCESS IT. WE'RE ALSO LOOKING TO -- DATA WE CAN PUT INTO FHIR, MAKE IT DIRECTLY AVAILABLE TO LING OUT. EARLY GROUPS HAVE SERVICES AVAILABLE INCLUDING KIDS FIRST, ANVIL, DBGaP. I THINK A LOT OF US ARE WORKING TOWARDS PRODUCTION SERVICES FOR OPEN ACCESS DATA. WE MENTIONED LIMITATIONS. IT WASN'T INTENDED TO PROVIDE THE STUDY BASE. YOU HAVE IN EHR CONTEXT, A PATIENT, A PROVIDER I MAY HAVE ACCESS TO ALL DATA, WE'RE WORKING ON HOW DO WE WORK IN THIS CONTEXT OF FHIR, THESE SERVICES, TO MAKE SURE RESEARCHERS CAN GET ACCESS TO DATA. THIS IS FROM DBGaP, DATA IS DEPOSITED HERE, THIS IS EMERGE DATA THAT WAS DEPOSITED. I'VE GOT A LOT OF THINGS, INFORMATION ABOUT THE STUDIES, LIKE THE DESCRIPTIONS. YOU SEE AUTHORIZED ACCESS BLOCKS, THERE'S A BUNCH OF INFORMATION. HOW WERE THESE CONSENTED? WHAT CAN WE USE DATA FOR? DO YOU NEED IRB APPROVAL? THAT'S A LOT OF COMPLEX INFORMATION. YOU LOOK ON THE RIGHT, HERE IS AN EXAMPLE OF A PHENOTYPIC VARIABLE DISTRIBUTION, WE'VE GOT DIABETES, STRUCTURED CONCEPTS ABOUT WHETHER THEY HAVE DIABETES OR NOT. THIS INFORMATION IS REALLY CRITICAL AND HELPFUL, DOCUMENTATION IS PROVIDED IN DBGaP, A NUMBER OF TOOLS, BUT ONE CAN IMAGINE BUILDING THIS INTO A FHIR SETTING, MODERN APIs USED FOR INTEROPERABILITY CAN MAKE THIS DATA MORE AVAILABLE. HERE IS ANOTHER EXAMPLE. I APOLOGIZE, IT'S AWFUL. THERE'S A LOT OF PRE-COMPUTED METRICS ABOUT INFORMATION THAT'S AVAILABLE THAT CAN BE SHARED. SO A LOT OF WORK IS GOING INTO BUILDING THAT OUT. SOME OF OUR NEXT STEPS IS TRANSFORMING AND LOADING EXISTING DATA AND REFINING MODEL, WE'VE BEEN STEEPING IN FHIR FOR A YEAR OR TWO, UNDERSTANDING WHAT RESOURCES ARE INTENDED FOR, HOW CAN WE REPRESENT AND MAKE IT AVAILABLE. THIS IDEA WE'LL CONTINUE TO ITERATE FROM THESE DATA TO MAKE THAT DATA AVAILABLE ROBUSTLY IN FHIR. A LOT OF TIMES THERE'S STRUCTURED CONCEPTS, NOT STRUCTURED INFORMATION, HOW DO YOU CLEARLY COMMUNICATE AND MAKE IT AVAILABLE? WE WANT TO CONTINUE TO COLLABORATE ON REPRESENTATIONS FOR STUDY LEVEL AND SUMMARY LEVEL DATA. RESEARCH STUDY RESOURCE DOES HAVE A NUMBER OF GOOD ATTRIBUTES AND CAN HELP A LOT. HOWEVER, THERE'S A LOT OF OTHER DATA, QUESTIONS ABOUT IF I WANT TO DO THAT SUMMARY I SHOWED BEFORE HOW MANY -- I CAN'T LOOK AT THE DATASET, CAN YOU TELL ME HOW MANY PEOPLE HAVE THIS VALUE, WHAT'S THE DISTRIBUTION OF VALUES, BEST WAY TO CAPTURE AND REPRESENTATIVE THAT INFORMATION, DBGaP PARLANCE AS WELL, TO REPRESENT DATA DICTIONARIES, RESEARCH STUDY INFORMATION, RECRUITMENT AND ENROLLMENT CRITERIA. AND WORK WITH NEW SUBMITTERS TO DEVELOP THAT NEXT GENERATION PROCESS FOR DATA COLLECTION AND DATA SUBMISSION INTO THESE SERVICES AND CLOUD PLATFORMS. I THINK THE ONE GOOD THING, TO GET H.R. DATA IN THAT WAY, TO USE FHIR TO ATTRACT DATA, WE TALKED ABOUT "ALL OF US" OTHER WAYS TO MAKE SURVEYS CAN BE EXTENT IN, STRUCTURE OTHER INFORMATION SO WHATEVER WE'RE CAPTURING, WHATEVER TOOLS WE'RE USING, PEOPLE CAN SAY, YEAH, FHIR IS GREAT, I'M ABLE TO SUBMIT MY DATA AS A RESEARCHER INTO FHIR, OR PULL IT OUT AND USE IT. WE'RE EXCITED FOR THAT. WE'VE GOT A FEW CHALLENGES HERE, I'M REALLY INTERESTED TO HEAR OPINIONS FROM YOU ALL HERE. HOW DO WE MAKE THAT FHIR ROBUST FOR THE DATA THAT ALREADY EXISTS, ESPECIALLY IN CASES ALL WE HAVE IS STRING TEXT ABOUT THE DESCRIPTION OF A VARIABLE, WE DON'T HAVE A STRUCTURED CONCEPT TO TALK ABOUT. HOW CAN A RESEARCHER -- IF I WANT TO PULL OUT ALL BMIs, I'M COMMUNICATING ABOUT DATA, TIMES OF TESTS, POPULATION OF INTEREST WITH RELEVANT MEASUREMENTS, DBGaP CAN BE A CHALLENGE, HOW DO I CAPTURE THAT INFORMATION, "ALL OF US," THAT'S ONE DATASET, WHAT DOES THAT LOOK LIKE AT A SCALE WHERE WE HAVE FIVE PLATFORMS THAT WANT TO MAKE DATA AVAILABLE? I MENTIONED THIS ALREADY, ONCE WE GET A TABLE OF BMI, ALL INDIVIDUALS, GENOMIC DATA, INTEGRATE ACROSS GENOMICS TO FIND OUT WHO HAS THE RIGHT DATA AND GET CERTAIN VALUES OUT FOR A SET OF INDIVIDUALS I HAVE ACCESS TO AS A RESEARCHER. THOSE ARE BIG CHALLENGES THAT WE'RE CURRENTLY LOOKING TOWARDS. ALSO, YEAH, THANKS FOR LISTENING. I APPRECIATE YOUR ENGAGEMENT AND APPRECIATE NIH SUPPORT FROM THE ANVIL. I'M GOING TO CLOSE WITH AN EXAMPLE, WHAT MAKES ME EXCITED TO DO THIS WORK. I'M NOT AN API EXPERT, THIS IS MY FIRST EXPERIENCE, BUT WITHIN A FEW DAYS WAS ABLE TO PULL TOGETHER FHIR TOOLING, SO THERE'S A SHINY APP HERE THAT WE WORKED ON, WE'RE ABLE TO QUICKLY PULL TOGETHER RESEARCH STUDY BROWSER, AN INTERESTED PARTY, AND THIS IS MY EXAMPLE, WAS ABLE TO CONNECT TO THE FHIR SERVICES, LOOK TO SEE WHAT RESEARCH STUDIES WERE AVAILABLE, ABLE TO COMPUTE METRICS ABOUT THAT STUDY, TO UNDERSTAND RACE/ETHNICITY INFORMATION. WAS ABLE TO GO THROUGH VERY QUICKLY AND SAY, HEY, HELL ME ABOUT THESE PARTICIPANTS, HOW MANY DISEASES AND PHENOTYPES DO THEY HAVE, WHAT INFORMATION CAN WE GET OUT OF THAT, TO LOOK AND SAY, HEY, I WANT TO GET GENOMICS DATA FOR THIS INDIVIDUAL, WE CAN LOOK AND SAY, HEY, HERE ARE JSON RESULTS, AND I CAN ASK, TELL ME ABOUT WHERE I CAN GET THIS FILE OR WHAT I NEED TO GET THIS FILE. WITH THE GENOMICS DATA, VCS DATA FROM THIS INDIVIDUAL, WE CAN REACH OUT TO OTHER APIs. WE CAN SAY, HEY, BASED ON THIS SOURCE DATA I HAVE RECORDED, WHETHER THAT'S COMING FROM EHR OR A STUDY, TELL ME WHAT YOU THINK, IF THERE'S ANY DISEASES I SHOULD BE CONSIDERING, ANY GENES I SHOULD CONSIDER. WE'RE AT A PLACE WE'RE ABLE TO BE ABLE TO DO THIS. I THINK IT'S SUPER EXCITING. SO, YEAH, IF YOU'RE INTERESTED, LET ME KNOW. YEAH, WE'RE LOOKING TO ENGAGE WITH PARTNERS, ESPECIALLY RESEARCH PARTNERS, HOW TO BUILD TOOLS THAT WORK AND HAPPY TO HELP CONNECT AND SUPPORT PEOPLE. THANK YOU. >> THANK YOU, ROBERT. THERE'S A LOT OF PASSION AND SO MUCH INFORMATION THAT WE CAN SHARE AROUND THIS THAT IT'S HARD TO CRAM IT INTO OUR TIME. I DID GET APPROVAL TO GO A LITTLE BIT OVER SO THERE CAN BE TIME FOR QUESTIONS, BUT FIRST QUESTION THAT CAME IN WAS FROM VIRGINIA, ASKING WHETHER THE CHALLENGES WERE FOR ALL SECONDARY USES OR FOR RESEARCH. IT'S RESEARCH USE CASES BECAUSE THERE'S DIFFERENT WAYS THAT WE'RE USING DATA IN RESEARCH BUT INTERESTED TO HEAR FROM THE PANEL. KEN, YOU'VE GOT THOUGHTS TO SHARE ON THAT IT LOOKS LIKE. >> WELL, I THINK WE'RE AT A POINT WHERE THERE'S BOTH A TREMENDOUS OPPORTUNITY FOR ECONOMIES OF SCALE, BECAUSE WE CAN HAVE DATA FROM THE U.S. CORE, THAT SERVES MANY USE CASES. AND WHEN DON RUCKER IN HIS ROLE AS NATIONAL COORDINATOR ASKED US TO DEVELOP THE BULK FIRE API, THE INSIGHT THAT HE HAD THAT WAS VERY IMPORTANT IS THAT BECAUSE IT WOULD BE USED FOR PAYMENT DATA AND ELECTRONIC HEALTH RECORD DATA, BOTH, IT WILL THEREFORE BE POTENTIALLY OF INTEREST TO THE CARE PROVIDERS, CARE PROVIDER ORGANIZATIONS, WHO ARE GENERATING THOSE DATA. SO, IF BY LINKING THOSE DATA TO PAYMENT, WE ACTUALLY CAN HELP ENGAGE THE HOSPITALS AND PRACTICES IN PRODUCING AND EXPORTING HIGH-QUALITY DATA, THEN WE NOW HAVE A DATA SOURCE FOR MULTIPLE USE CASES. THAT'S ONE SIDE OF THE SPECTRUM, GLASS HALF FULL. GLASS HALF EMPTY, THE U.S. CORE IS NOT THAT BIG YET. ALSO IT HAS WHET OUR APPETITES FOR GETTING ENORMOUS AMOUNTS OF DATA OUT. THERE'S GOING TO BE -- HAVE TO BE A BALANCED APPROACH TO EXTENSIONS THAT ARE USED THAT PARTICULAR PROJECTS, AND THEN WHETHER THOSE GET STANDARDIZED BACK INTO THE CORE OR INTO OTHER STRUCTURES, AND THE OPPORTUNITY TO REALLY FIGURE OUT HOW TO EXTEND THE STANDARD, HOW TO EXTEND THE U.S. CORE, HOW TO BE CONSTANTLY TESTING IN REAL WORLD SETTINGS IS WHERE SOME OF THE CHALLENGE BUT ALSO OF THE OPPORTUNITY LIES. >> THANKS, KEN. BOB OR ROBERT, DO YOU HAVE ANYTHING YOU WANT TO ADD TO THAT? >> I REPLIED WITHIN THE CHAT. IN THE INTEREST OF TIME I'LL LET THAT STAND ALONE. OTHER THAN TO SIMPLY SAY THAT BECAUSE OUR KNOWLEDGE OF GENOMICS IS EVOLVING SO QUICKLY IT'S DIFFICULT TO PREDICT WHAT DATA IS IMPORTANT FOR FUTURE USE CASES, DATA MIGHT BE INCOMPLETE IN -- FROM FUTURE STATE POINT OF VIEW AND DIFFICULT TO HAVE DATA STRUCTURE TO ACCOMMODATE FUTURE USE CASES. >> SO, I HAVE ONE QUESTION, AND I'M SEEING ONE MORE JUST CAME UP, A COMMENT INTO THE CHAT. WHEN I LOOK AT THIS AND CHALLENGES I'VE SEEN FOLKS HAVE AND I'VE HAD MYSELF USING FHIR FOR RESEARCH, ONE OF THE CHALLENGES THAT SEEMS HARDEST IS THE NON-TECHNICAL PIECES THAT COMBINE WITH THE TECHNICAL PIECES. IF YOU WERE TO SAY IN THE NEXT 18 MONTHS, WHO DO YOU NEED AT THE TABLE, RIGHT? AND THIS IS SELF-SERVING TRYING TO PULL PEOPLE TO THE TABLE, WHO DO YOU NEED TO GET TO US WHERE WE NEED TO BE IN ORDER TO BE ABLE TO DO THIS? WHO NEEDS TO BE AT THE TABLE, GUYS? >> WHICH TABLE. >> SO TO BRING THE GROUP TOGETHER, RIGHT? IF WE LOOK WHERE WE'RE AT FOR THIS 18 MONTHS JUST PASSED, SUCCESS WE'VE HAD, IF WE WANT TO MOVE FORWARD IN THE NEXT 18 MONTHS WHO ELSE NEEDS TO BE AT THE TABLE THAT'S NOT AT THE TABLE NOW, WHAT DO YOU NEED TO TAKE THAT SUCCESS AND MAKE IT GO EVEN FURTHER? >> I WOULD SAY YOU WANT PEOPLE AT THE TABLE WHO ARE ACTUALLY TRYING THINGS ON THE GROUND, TO BRING BACK REAL WORLD EXPERIENCES, SO WE CAN SEE WHAT WORKS. IT'S AN OPPORTUNITY TO BE THE INNOVATION FIRST PART OF THIS, AND THEN BECAUSE THIS IS HAPPENING, AUSPICE OF HL7, OPPORTUNITY TO BE SELECTIVE IN NEXT STEPS DRIVING THE STANDARD FORWARD. WE DON'T KNOW THE RIGHT THING TO STANDARDIZE, WE MAY NOT CAPTURE THOSE DRIVER MUTATIONS IN THE FIRST DATA MODEL, THAT MIGHT BE WHAT WE WANT TO DELIVER BACK. WE CAN'T FIGURE OUT HOW TO CAPTURE DATA OFF SENSORS IN PEOPLE'S CONNECTIVE DEVICES AND A NEW SENSOR IS DEVELOPED THAT DOESN'T FIT. IT'S GOING TO BE THAT INTERFACE BETWEEN THE INNOVATORS AND STANDARDS BODY TO MOVE THAT FORWARD AND FOLKS TO ADVOCATE FOR EXTENDING THE U.S. CORE IN A PRINCIPLED AND AGGRESSIVE WAY. >> THANK YOU, EVERYONE. >> TWO-MINUTE WARNING FROM THE MODERATOR. >> PEOPLE WHO ARE WILLING TO GET IN THERE AND COMPLAIN ABOUT THE PAIN POINTS USING THE DATA WE'VE COLLECTED, WHY CAN'T I DO THIS, HOW AM I SUPPOSED TO GET THIS OUT, ALL THAT STUFF. RIGHT NOW DOING RESEARCH, A LOT OF US HAVE DONE RESEARCH IN THESE AREAS, BUT WHAT TOOLS ARE NEEDED, WHERE ARE GAPS IS GOING TO BE ONE OF THE BIGGEST CHALLENGES. PEOPLE WHO AREN'T HERE YET BECAUSE THEY ARE NOT FUNDED YET TO BANG THEIR HEAD AGAINST THE STUFF UNTIL IT WORKS. >> THOSE OF US WHO BANG OUR HEADS ARE WILLING TO TALK LOUDLY, MYSELF INCLUDED. THANK YOU FOR YOUR TIME AND SHARING. IT'S BEEN EXCELLENT. WE'RE GOING TO PASS IT BACK OVER FOR OUR BREAK SO THANK YOU AGAIN. >> THANK YOU, AMY. THANK YOU FOR A WONDERFUL SECOND SESSION. WE'RE GOING TO TAKE A BREAK UNTIL 2:15. LET'S TAKE ABOUT EIGHT MINUTES, AND WHEN WE RETURN WE'LL HAVE OUR FINAL DISCUSSION ON THE FUTURE OF FHIR IN RESEARCH. THANKS AGAIN FOR JOINING TODAY. WE'VE HAD A GREAT DISCUSSION AND A GREAT SET OF PRESENTATIONS. IT IS MY DISTINCT PLEASURE FOR THE NEXT SESSION TO INTRODUCE DR. PAUL HARRIS, WHO WILL BE MODERATING A DISCUSSION ON THE FUTURE ON THE USE OF FHIR IN RESEARCH. DR. HARRIS IS PROFESSOR OF BIOMEDICAL INFORMATICS, VANDERBILT, CLINICAL AND TRANSLATIONAL RESEARCH INFORMATICS, DIRECTOR OF THE VANDERBILT CENTER FOR INFORMATICS, CREATED REDCap THAT HAS SEEN WIDESPREAD ADOPTION, AND AS YOU'VE HEARD EARLIER TODAY HE'S PRINCIPAL INVESTIGATOR FOR THE "ALL OF US" RESEARCH PROGRAM, DATA AND RESEARCH CENTER, DR. HARRIS RECEIVED MASTER'S AND Ph.D. IN IN BIOMEDICAL ENGINEERING, AND I WILL TURN IT OVER. >> THANK YOU FOR THE INVITATION TO BE HERE AND ALL THE GREAT PRESENTATIONS WE'VE SEEN SO FAR. I'M GOING TO DROP ONE QUESTION INTO THE CHAT WINDOW TO ASK THE PANELISTS TO COMMENT ON. IN THE TIME IT TAKES PEOPLE TO RESPOND TO THAT ONE, IF YOU HAVE ADDITIONAL QUESTIONS FROM THE LARGER AUDIENCE PLEASE FEEL FREE TO DROP THEM IN THE CHAT WINDOW AND WE'LL TAKE THEM IN ORDER THAT THEY COME IN. IF WE RUN OUT, I'VE GOT SEVERAL THAT I'VE GENERATED THROUGH THE DAY. IN THE LAST SESSION, KEN MENTIONED THE VALUE OF INNOVATORS MOVING THE FIELD FORWARD. EARLIER IN THE DAY KRISTEN SPOKE ABOUT CHALLENGES ASSOCIATED REAL WORLD LAUNCH AND SUPPORT FOR FHIR-BASED APPLICATIONS. THIS ONE IS NEAR AND DEAR TO MY HEART, THINKING ABOUT REAL WORLD LESSONS LEARNED FOR DISSEMINATION OF THESE APPLICATIONS LOCALLY AND ACROSS EVEN OTHER INSTITUTIONS, I GUESS I WOULD ASK FOR A LITTLE BIT OF ELUCIDATION ON THE CHALLENGES ASSOCIATED WITH WORKING WITH VARIOUS STAKEHOLDERS AND IS FHIR MAKING THIS EASIER OR HARDER THESE DAYS FOR YOU? AND WHAT LESSONS AND ADVICE WOULD YOU HAVE -- COULD YOU PROVIDE FOR OTHERS BASED ON YOUR EXPERIENCES? >> I'LL JUMP IN, PAUL. FIRST OF ALL, YOU'RE CANONICAL EXAMPLE, YOU'RE AN INNOVATOR, FIRE-ENABLED REDCap, I CAN'T THINK OF A BETTER EXAMPLE FOR AN INNOVATION THAT IS TRYING TO USE STANDARD, GET AHEAD AND FIGURE OUT HOW TO -- WHERE EXTENSIONS MIGHT HAPPEN. IF I HAD TO THINK OF A BETTER EXAMPLE, FROM WHAT WE HEARD FROM EMERGE AND "ALL OF US," ALSO GREAT EXAMPLES OF THIS AS WELL. THE KEY I THINK IS TO FOCUS FIRST ON GETTING SOMETHING DONE MAKING IT WORK, AND THEN MOVING TO A STANDARDS PROCESS. EVERY NOW AND THEN, THIS ENDS UP HAPPENING VERY QUICKLY. SOMEHOW WITH FHIR API WE HAD SOME IMPLEMENTATIONS, A RULE COMING UP, CHOPRA WAS A MANIAC KEEPING US FOCUSED ON GETTING THIS INTO THE RULES. WE DID EVERYTHING TO GET IT IN THERE, AND IT GOT IN. IT WAS REALLY EARLY. I THINK IT'S A GREAT SUCCESS, I DON'T THINK IT'S EXACTLY THE MODEL THAT WE SHOULD BE USING. THERE IS A GREAT MODEL OUT THERE RIGHT NOW, AND THAT THIS LATEST CREDENTIALING, LATEST CREDENTIAL, THE VACCINATION CREDENTIAL, SMART CARDS INITIATIVE, WHICH IS ENTIRELY ATTRIBUTABLE, THE SUCCESS IS ENTIRELY ATTRIBUTABLE TO JOSH MANDELL'S LEADERSHIP. HE GOT THIS THING GOING. JUST STARTED TRYING IT OUT. USED AS STANDARDIZED A PROCESS AS HE COULD, STARTED IMPLEMENTING, GOT A GROUP TOGETHER TO KICK THE TIRES AND NOW BECAUSE THIS IS SUCH EXTRAORDINARY NATIONAL IMPORTANCE, YOU THINK OF VACCINE PASSPORT PROGRAMS, WHATEVER YOU THINK, THE IDEA YOU COULD ISSUE A CREDENTIAL FROM SOMEONE FROM THE HEALTH CARE SYSTEM IS FUNDAMENTALLY IMPORTANT AND SEPARABLE, BUT IS BEING USED INCLUDING ACROSS THE STATE OF CALIFORNIA. THE OPPORTUNITY THERE, AND NOW, JOSH IS WORKING WITH SMART TEAM WITH HL7 AROUND STANDARDIZING. SUCH URGENCY IN NATIONAL INTEREST IN THAT, THAT PROCESS IS ALSO ACCELERATING. I THINK MANY PROCESSES WILL NOT BE AS ACCELERATED, THAT'S APPROPRIATE I THINK. WE NEED TO COME TO SOME EQUILIBRIUM AS TO WHAT'S THE RIGHT CASE FOR THAT. BUT PEOPLE SHOULD NOT PULL BACK AT INNOVATING WITH THE STANDARDS AND SECONDLY ONE DECIDEDLY OPPOSITE POINT, THAT ALSO IT'S REALLY WORTH LOOKING AT WHAT IS THERE NOW, AND FIGURING OUT HOW FAR WE CAN GET WITH WHAT'S THERE NOW, WITHOUT -- THIS IS THE GLASS HALF FULL, WITHOUT WORRYING ABOUT WHAT WE DON'T HAVE, WITH THE ORIGINAL SMART PROJECT, WE'RE CONSTANTLY CRITIQUED AND NOT WITHOUT BASIS BUT FOR BEING A READ-ONLY ALL WE CAN DO IS DATA VISUALIZATION, READ ONLY, BUT LOOK AT THINGS LIKE IT'S STILL READ ONLY MOSTLY, LOOK WHAT JOSH DENNY IS ABLE TO DO IN THE "ALL OF US" PROGRAM WITH THE HEALTH APP. AS RESEARCHERS WE FIGURE OUT WHAT PROJECT MATCHINGS TO THE DATA WE HAVE, MATCHES TO THE PERSONNEL, MATCHES TO THE MONEY WE HAVE. AND SO THERE'S A LOT THERE I THINK THAT WE CAN DO WITH WHAT WE HAVE NOW. SORRY FOR THE LONG-WINDED ANSWER. >> KRISTEN, I INVOKED YOUR NAME. DO YOU HAVE ANY COMMENTS? >> TWO THINGS I STRUGGLE WITH, OTHERS DO AS WELL, IS SUSTAINABILITY AND SCALE. I THINK YOU ASKED IS THIS HELPING OR HURTING, RIGHT? I THINK FOR SCALE, FHIR HAS BEEN INCREDIBLE IN TERMS OF SHARING TOOLS THAT CAN BE PUBLICLY DISSEMINATED, RIGHT? SO PLATFORMS LIKE CDS CONNECT, EVEN GITHUB, BECAUSE WE'RE USING FHIR I MEAN NOTHING IS REALLY PLUG AND PLAY BUT IT DOES ALLOW OTHER INSTITUTIONS TO BE ABLE TO NOT HAVE TO REINVENT THE WHEEL. EITHER USE THE ENTIRE TOOL OR PARTS OF IT AT AN OPERATIONAL LEVEL. THE CHALLENGE I'LL FINDING, I CAN SPEAK FOR MY OWN EXPERIENCE, SUSTAINABILITY, HEALTHCARE SYSTEMS WE WORK IN AND EXPERIENCE WE HAVE IN MORE OPERATIONS SO I THINK THE EXPERTS IN SOME OF THESE TECHNOLOGY STANDARDS SIT ON THE RESEARCH SITE OF THE INSTITUTION AND NOT OPERATIONS. SO OUR I.T., I S FOLKS, EXPERTS IN CERNER COMMAND LANGUAGE, EVERYDAY COMPONENTS TO OPERATE, WHEN WE BRING THEM A FHIR APP I DON'T THINK EVERYONE REALLY KNOW HOUSE TO INTEGRATE THAT, HOW TO MAINTAIN IT, SO THERE'S BEEN ONGOING CHALLENGES WHEN A FUNDED PROJECT ENDS WHO NOW TAKES RESPONSIBILITY ACCOUNTS OFTENTIMES THEY ARE RECODING TOOLS TO MAKE THEM FIT INTO THE EHR, USING ADVANCED FRAMEWORKS THAT REACT, FOR EXAMPLE, THAT'S NOT SOMETHING THAT OUR TRADITIONAL I.T. FOLKS ARE TRAINED IN. IT FEELS LIKE WE'RE TAKING A STEP BACKWARDS REBUILDING TOOLS, SOMETIMES REMOVING FHIR OUT OF THEM. I DON'T KNOW IF OTHERS EXPERIENCE THE SAME THING BUT IN SOME WAYS IT'S ENCOURAGING, IN SOME WAYS IT'S DISCOURAGING WHEN WE NEED TO PASS A TOOL OFF FOR LONG-TERM SUSTAINABILITY. >> THANKS. BOB? >> THANK YOU. I THINK THE QUESTION IS A VERY GOOD ONE. I THINK THERE ARE CERTAINLY WAYS THAT FHIR MAKES THIS EASIER. THE OBVIOUS IS IN HELPING THE DATA FLOW. I THINK THERE ARE, HOWEVER, WAYS IN WHICH WE CAN ACTUALLY BE MAKING A SITUATION MORE DIFFICULT FOR OURSELVES, SOMETIMES NOT REALIZE IT. I WANT TO CALL THEM OUT HERE. AND THAT IS WHEN IT IS SO EASY TO EXCHANGE INFORMATION, IT'S SOMETIMES TEMPTING TO DO SO WITHOUT TAKING THE TIME TO REALLY VALIDATE THAT THE DATA THAT YOU ARE PUTTING INTO THESE STRUCTURES MATCHES THE INTENT OF THE STRUCTURES. AND WHAT THIS MEANS IS THAT THERE CAN OFTEN BE OCCASIONS WHERE DIFFERENCES IN SEMANTICS CAN BE OVERLOOKED WHICH CAN DOWNSTREAM CONFOUND ANALYSIS AND RESULTS OF RESEARCH, POTENTIALLY DUE IN SOME CASES AT LEAST TO THE FLEXIBILITY THAT'S BUILT INTO THE FHIR SPECS WHERE THE SAME FIELD CAN BE USED TO REPRESENT DATA IN SLIGHTLY DIFFERENT WAYS, AS A CONSUMER, RECIPIENT OF THE DATA, SOMETIMES IT CAN BE VERY TEMPTING TO RAPIDLY GO OUT AND PULL IN DIFFERENT DATA OR PULL IN DATA FROM DIFFERENT DATA SOURCES AND THROW IT ALL TOGETHER INTO A NICE TABLEAU DASHBOARD OR SOMETHING WITHOUT ACTUALLY TAKING THE TIME TO DRILL INTO IT AND MAKE THE SEMANTICS AND DATA STRUCTURES ALIGN. >> THANK YOU. I WANT TO GO TO A QUESTION VIVIAN PUT INTO THE CHAT WINDOW. BEFORE I DO, IF ALLISON IS HEATH IS ON THE LINE STILL, I KNOW IN HER ROLE AT CHOP SHE DOES A LOT OF IMPLEMENTATION WORK. WOULD YOU LIKE TO COMMENT ON THAT THAT QUESTION, ALLISON? I'M THINKING NOT. LET'S GO TO VIVIAN. HOW DO WE INCENTIVIZE THE RESEARCH COMMUNITY, FOR EXAMPLE TO INTEGRATE INSTEAD OF STOPPING AT PUBLICATION OR CONFUSION OR INCENTIVIZE POINT-OF-CARE SOFTWARES LIKE EHRs ABOUT FUNCTIONALITY TO ACCEPT THAT DATA. ANYONE WANT TO TAKE THAT ONE? >> I'LL JUST POINT OUT THAT THE CDS HOOK STANDARD WHICH ADDRESSES PART OF THAT, HOW TO -- HOW A THIRD-PARTY DECISION SERVICE CAN BE TRIGGERED BY CERTAIN ACTIONS WITHIN ELECTRONIC HEALTH RECORDS, THOSE ACTIONS WILL VARY IN THEIR STRUCTURE COMPLETELY FROM ONE ELECTRONIC HEALTH RECORD TO ANOTHER BUT COULD BE IMPLEMENTED IN A STANDARDIZED WAY, THAT DID MAKE IT THROUGH THE ARGONAUT PROCESS SO ARGONAUT PARTICIPANTS KNOW HOW TO IMPLEMENT IT, AND IT WAS EVEN MENTIONED, I WAS VERY PLEASED TO SEE IN THE FIRST VERSION OF THE ONC RULE BUT MY TECH SERVE IN THE SECOND VERSION DIDN'T FIND IT. IS THERE IS A STANDARD THAT FOLKS CAN USE THAT I THINK WE SHOULD PUSH FOR. IT'S VERY SIMPLE STANDARD FOR THIRD-PARTY DECISION SUPPORT THAT LETS ONE OUTPUT IN A VERY LIGHTWEIGHT WAY OR A DEEPER WAY BY LAUNCHING AN APP WITHIN THE ELECTRONIC HEALTH RECORD. SO I THINK THIS IS A VERY IMPORTANT QUESTION THAT WE'RE SEEING BECAUSE ACTION IN ADDITION TO JUST KNOWLEDGE IS GOING TO BE SOMETHING HOPEFULLY WE CAN GET TO SOON. >> GREAT. THANK YOU. I'M GOING TO START WITH BOB ON THE NEXT QUESTION. SORRY, I WANT TO MAKE SURE WE'RE COVERING THE THINGS IN THE CHAT. VIRGINIA MAKES A GREAT POINT THAT -- HOW FHIR APIs ARE DOCUMENTED MATTERS AND THERE ISN'T A STANDARD FOR DOING THAT NOW. AND THEN ROBERT CARROLL EXPRESSES APPRECIATION FOR SOME OF BOB'S WORK. I'M GOING TO BOB NEXT, AND THEN, ROBERT, I'M GOING TO YOU SECOND WITH THIS QUESTION. BOB MENTIONED IN HIS EARLIER COMMENTS THAT THERE WERE A NUMBER OF GAPS IN FHIR SPECIFICATIONS FOR GENOMIC RESEARCH, AND EMERGENCE IS OBVIOUSLY INVESTING HEAVILY, A KEY INFORMANT. I'M CURIOUS, IN EMERGE AND ROBERT, WITH "ALL OF US," ALL OF THE PROJECTS THAT I KNOW YOU'VE BEEN CARRYING ON OVER THE LAST SEVERAL YEARS, ARE THERE LESSONS LEARNED AND SUGGESTIONS FOR OTHERS IN COMMUNICATING AND WORKING WITHIN THE LARGER FHIR COMMUNITY TO NARROW THESE GAPS? >> IT'S AN OUTSTANDING QUESTION. IT'S ONE THAT I CAN COMMENT ON HERE, BUT HAVE AN IMMEDIATE DISCLAIMER THAT I'M SURE IF I SAT AND THOUGHT FOR ANOTHER HOUR I WOULD EASILY DOUBLE WHAT I HAVE TO SAY. THERE'S A LOT OF POTENTIAL ANSWERS TO THIS. THERE ARE A FEW THINGS THAT COME TO MIND IMMEDIATELY. ONE OF THEM IS I WOULD ENCOURAGE ANYONE THAT IS TANGENTIALLY RELATED TO THE SPACE TO ENGAGE. THE MOST IMPORTANT THING HERE IS THEY GET INVOLVED WITH HL7, DIVE INTO THE DEEP END FEET FIRST. IT'S VERY DIFFICULT TO UNDERSTAND WHAT CAPABILITIES ARE AVAILABLE AND WHERE GAPS MIGHT EXIST. IF DOING IT AT AN ARM'S LENGTH. SECOND, ONCE YOU DIVEN EXPECT -- DIVE IN, EXPECT A LEARNING CURVE. GOVERNANCE AND OPERATIONAL PROCEDURES OF HL7 ARE AN EXPERIENCE. LAYERED ON TOP IS THE FIRE PHILOSOPHY HOW THINGS WORK AND ARE DESIGNED, ALL OF THIS REQUIRES A CERTAIN LEARNING OPPORTUNITY. NEXT THING I WOULD SAY IS GO AHEAD AND DIVE INTO THE DETAILS. WE CANNOT OVERLOOK THE ISSUES RELATED TO THE SPECIFIC DATA ITSELF OR USE CASES THAT THOSE DATA MIGHT BE USED FOR. THIS IS SOMETHING WE KEEP UNCOVERING IN THE GENOMICS DOMAIN. I'LL LEAVE IT AT THAT. PENULTIMATELY, TIMELINES, THERE IS A SIGNIFICANT AT TIMES MISMATCH BETWEEN THE, I'LL SAY, FUNDING OPPORTUNITY THAT'S SPONSORING INVESTMENT IN ENGAGEMENT AND HL7 TIMELINE. UNDERSTANDING IT CAN TAKE A YEAR OR TWO TO GET ANYTHING DONE IN HL7 FROM A STANDARDS APPROVAL PROCESS PERSPECTIVE MAY NOT ALIGN WITH A FUNDER'S TIME LINE. AND THEN I THINK LASTLY, JUST I THINK THERE IS WORK TO BE DONE FROM CULTURAL PERSPECTIVE TO UNDERSTAND HOW WE CAN TRANSFORM THE FHIR COMMUNITY, ESPECIALLY WHEN IT HAS TO DO WITH RESEARCH, TO BE ONE THAT WHERE THESE CONVERSATIONS TAKE PLACE IN A PRE-COMPETITIVE SPACE. STAKEHOLDERS ARE OFTEN OUTSIDE OF THE STABLE, COMPETITORS WITH EACH OTHER, ACADEMICALLY OR THROUGH INDUSTRY. WE NEED TO FIND A WAY OF BEING ABLE TO WORK TOGETHER IN SUCH A WAY THAT WE CAN MAKE PROGRESS TOGETHER ON THIS STANDARD IN A PRE-COMPETITIVE FASHION WITHOUT LETTING OTHER FACTORS GET IN THE WAY. I'LL STOP THERE. >> CAN I ADD TO WHAT WAS SAID? I ABSOLUTELY AGREE, HL7 MANY YEARS BACK, IT WAS DIFFICULT TO NAVIGATE. IF I DIDN'T HAVE COLLEAGUES WHO HELPED ME, I WOULD STILL PROBABLY BE LOST. THERE'S DAYS WHEN I STILL FEEL EVEN BEING CO-CHAIR OF AN ACCELERATOR IT'S DIFFICULT. ONE THING VULCAN IS WORKING ON HL7 IS DEVELOPING A TRACK OF INFORMATION AND TRAININGS. TRAININGS THAT START BEFORE INTRO TO FHIR BECAUSE FOR SOME PEOPLE INTRO TO FHIR IS STILL TOO DEEP OF AN INTRO. ALSO MAKING IT VERY SPECIFIC TO RESEARCH BECAUSE THERE ARE NUANCES AND THERE ARE GREAT DIFFERENCES, I'LL USE THE EXAMPLE OF ADVERSE EVENTS, WHAT THAT CAN MEAN BETWEEN CLINICAL CARE AND CLINICAL RESEARCH. AND THAT IS WHY WE PUT TOGETHER VULCAN, THE EXACT PURPOSE OF HAVING THAT BECAUSE WE DON'T WORK TOGETHER, WE'RE GOING TO START GOING OUR OWN DIRECTIONS, WHICH WE ARE DOING A LITTLE BIT RIGHT NOW. AND IT'S GOING TO MAKE IT EVEN HARDER TO GET TO THAT ENDPOINT OF WHAT YOU'RE SAYING WITH THE TWO-YEAR TURN-AROUND GETTING SOMETHING TO BE PUBLISHED STANDARD IN HL7. SO IF WE COME TOGETHER AND WORK THROUGH THINGS, THEN WE CAN GET THAT PUSH TO MOVE THINGS FORWARD FASTER. JUST SHARE THAT. >> THANK YOU. >> JUST WANTED TO SHARE THAT. >> GREAT, THANK YOU. ROBERT CARROLL? >> I FEEL LIKE I HAVE A FRIEND HL7 PERSON, THAT WAS MY EXPERIENCE, RIGHT? THERE'S A MILLION THINGS, WHERE DO YOU WANT TO GO TO THIS? WE WALK IN A MEETING AND FRANKLY IT'S REALLY IMPORTANT THAT'S BEING DONE, IT'S LIKE I DON'T KNOW WHAT'S GOING ON. LIKE I GET WHAT'S HAPPENING BUT, WELL, I DON'T NEED TO TALK ABOUT THIS STUFF. I NEED TO UNDERSTAND WHAT THIS -- HOW DO I GET INVOLVED IS MY CONCERN, GET THESE THINGS ADDRESSED. THE WORK WE'VE BEEN DOING HAS BEEN OUR OWN UNIT OFF TO THE SIDE. IT'S FUNNY, BOB EARLIER DESCRIBED GETTING FHIR BUILT AND IMPLEMENTATION PIECES, HOPING, WELL, TWO THINGS. IF YOU'RE INTERESTED, GET INVOLVED AND ENGAGED, GET IN TOUCH WITH ME. WE'RE WORKING ON TRAINING OPPORTUNITIES. I'VE ALMOST COME FULL CIRCLE, SO MANY THINGS WILDLY COMPLICATED, WE TRIED TO WAY OVERENGINEER TO COME BACK AND SAY REALISTICALLY, LET'S NOT USE FHIR AS A MODELING LANGUAGE TO PURPOSELY DESCRIBE EXACTLY THE THING WE HAVE, THE WAY WE HAD IT, BUT TO COME BACK AND SAY, WHAT'S THE USE OF THE RESOURCE THAT MAKES SENSE AND IF WE NEED TO MAKE QUALITY -- I WAS THINKING EARLIER, IF WE NEED TO MAKE QUALITY GUARANTEES, IF YOU DO YOUR DATA THIS WAY, CAN YOU USE THE SPECIAL PROFILE, NOT TRY AND OVERENGINEER, THAT'S BEEN REALLY IMPORTANT. TOOLS IN PLACE WILL HELP PEOPLE, I THINK A LOT -- IT WORKS REALLY WELL. YOU HAVE ACCESS TO RESOURCES, THERE'S A FEW METHODS. ONCE YOU GET THE RIGHT TRAINING, THE TARGETED TRAINING, HEY, I NEED TO USE THESE TOOLS, HOW DO I GET THIS DATA AT, THAT CAN WORK REALLY WELL. I'M STILL FIGURING OUT THE RIGHT WAYS TO INVOLVE ON GETTING INVOLVED ON HL7 COMMUNITY. AND GET CONNECTED. HAVING IT THERE, TOOLS AND TRAINING, LIKE WE'RE GETTING THERE. >> GREAT. THANK YOU. TWO QUESTIONS COMING TO THE CHAT. ONE IS ABOUT INCENTIVIZING THE RESEARCH COMMUNITY. KRISTEN MILLER AGREED TO SPEAK TO THAT. MAYBE YOU CAN RESTATE THE QUESTION AS YOU GO FORWARD AND WE'LL CALL DAVID DOERR TO THE MICROPHONE TO ASK HIS QUESTION. >> SURE. VIVIAN ASKED HOW DO WE INVENT RISE THE THE RE-- HOW DO WE INCENTIVIZE, THIS IS AN INTERESTING SPACES, THERE ARE OTHERS ON THE CALL MORE QUALIFIED TO DISCUSS THIS, NAMED AS PARTICIPANTS AS WELL. I HAVE SEEN A SHIFT OVER THE LAST TEN YEARS OR SO TO FOLKS WANTING TO MAKE TOOLS PUBLICLY AVAILABLE AS OPPOSED TO PROPRIETARY. EITHER YOU PUT YOUR BLOOD SWEAT AND TEARS IN AND DON'T WANT TO GIVE IT AWAY OR SOME POINT OUT LEGAL COMPONENTS, IS THERE SOME LEGAL LIABILITY IF YOU MAKE YOUR TOOL PUBLICLY AVAILABLE AND IT'S MISUSED OR THERE'S A MALFUNCTION, ARE YOU RESPONSIBLE. THINKING ABOUT CDS CONNECT, TOOLS TO MAKE TOOLS PUBLICLY SHAREABLE, I THINK THE CONVERSATION CHANGED AND FOLKS ARE RECOGNIZING THERE IS DEVELOP, REPUTATION OR GOOD NATURE, THAT'S PART OF THE INCENTIVE, THERE'S A BIGGER CONVERSATION TO HAVE HOW DO WE KEEP PUSHING THAT AND WHAT IS THE VALUE OF HAVING SOMEONE CREATE THAT TOOL THAT CAN BE USED FOR OTHERS, NOT JUST THEIR HEALTH CARE SYSTEM. VIVIAN SAID IS THAT A REQUIREMENT, THAT'S AN INTERESTING THOUGHT FROM THE FUNDING AGENCIES THAT THEY ARE MAKING THIS PART OF OUTPUT OF WHAT YOU'RE DELIVERING. BUT CERTAINLY I'M SEEING PEOPLE MORE WILLING TO SHARE, THERE'S OBVIOUSLY SOME CHALLENGES THERE MAKING SURE THE GUIDELINES ARE UP TO DATE, FOR EXAMPLE, IF YOU PUBLICLY SHARE THAT NOW WHO IS RESPONSIBLE BUT PEOPLE SEEM TO BE MORE WILLING TO SHARE AT LEAST. >> GREAT. THANK YOU, KRISTEN. VIVIAN, THANKS FOR THE GREAT QUESTIONS. I THINK YOU'RE ON A REALLY INTERESTING PATH THERE. ESPECIALLY PRIORITIZING DISSEMINATION OF THE RESEARCH. DAVID DOERR HAS DONE SOME INTERESTING WORK ON THE WEST COAST. DO YOU WANT TO UNMIC AND ASK YOUR QUESTION OR STATE YOUR QUESTION? >> SURE. THANKS, PAUL. YOU KNOW, I'M IN OREGON HEALTH AND SCIENCE UNIVERSITY. WE'VE TRIED TO TAKE ON IMPLEMENTING FOR RESEARCHERS THE NUMBER OF FHIR APPLICATIONS AND WHAT WE'VE RUN INTO IS ISSUES AROUND RESEARCH COMPLIANCE, PRIVACY AND SECURITY. WE HAVE THE ATTENTION OF THE C-SUITE BUT THEY ARE CONCERNED, HOW WILL THEY MANAGE THIS, AND THE HEALTH WORKFORCE INTERNALLY, HOW DO WE GET THEM UP TO SPEED, WHAT'S THE RIGHT LEVEL OF TRAINING FOR THAT, IN ESSENCE HOW CAN WE GET FRAMEWORKS AND MODELS TO HELP ACADEMIC HEALTH SYSTEMS MOVE THESE ISSUES ALONG? >> GREAT. ANYBODY WANT TO COMMENT ON THAT? >> I'M GO BACK TO A COMMENT I MADE BEFORE WHICH IS WITH DON RUCKER'S EXTREME PRACTICAL OBSERVATION, C-SUITES CARE ABOUT MONEY, AND THAT THESE DATA MAY BE USEFUL IN PAYMENT JUSTIFICATION FOR CONTRACT PRICING AROUND VALUE-BASED CARE, DEMONSTRATION OF QUALITY METRICS, AND IT'S LIKELY THAT THIS IS A VIABLE PATHWAY TO BEGINNING THAT CONVERSATION, AND THEN EVEN THOUGH WE MIGHT THINK ABOUT THE RESOURCE USES AS PRIMARY, IN A HIGH-FUNCTIONING ACADEMIC HEALTH SYSTEM, WE DON'T HAVE TO CONVINCE THE C-SUITE IN EVERY CASE IF IT'S THE SAME DATA AS THEY SAY PRIMARY FOR PAYMENT AND OPERATIONS. SO I THINK THERE'S A POTENTIAL REALLY INTERESTING OVERLAP THERE THAT'S WORTH EXPLORING. >> VIRGINIA, SO FOR ALL OF THE SPEAKERS, I PUT ONE LAST QUESTION IN. IF WE HAVE TIME WE'LL COVER THAT LAST QUESTION. IF WE DON'T HAVE TIME, BECAUSE WE HAVE OTHER BETTER QUESTIONS, THAT WILL BE GREAT. TAKE A LOOK AT THAT ONE. NOW LET'S BRING UP VIRGINIA'S COMMENT. ISN'T THERE SOME MONEY THROUGH RESEARCH, ANYBODY WANT TO TAKE THAT ONE ON? >> IS THAT A RESPONSE TO MY COMMENT, THAT THE MONEY COMES IN THROUGH CARE, OR IS THAT A DIFFERENT -- >> YEAH, YEAH. >> YOU KNOW, YES, THERE IS. BUT IT'S NOT WHERE MOST C-SUITES ARE FOCUSED, IN FACT. EVEN THOUGH AT PLACES LIKE MINE, THE OVERHEAD RATES ARE QUITE STANDING BUT THERE'S SO MUCH INVESTMENT IN RESEARCH INFRASTRUCTURE IT'S NOT ALWAYS SEEN AS A PROFIT CENTER, AS IT WERE. >> WELL, SORRY, I'LL LET THE OTHER EXPERTS SPEAK TO THAT. BUT I WOULD AGREE, KEN. ALSO YOU HAVE THE SUSTAINABILITY COSTS AND, YOU KNOW, IT'S A DIFFICULT THING TO SORT OF BUILD AND IMPLEMENT IN THE RESEARCH SIDE OF THINGS. OTHER COMMENTS ON THAT? >> YES, A LOT OF VERY HARD TECHNICAL WORK FOR PRODUCTION LEVEL SERVICES TO CONTINUE TO UPDATE AND MAKE SURE EVERYTHING IS MAINTAINED PROPERLY AND APPROPRIATELY. IT CAN BE TOUGH IN THAT ACADEMIC RESEARCH, THE SAME CHALLENGE WHEN IT COMES TO, HEY, CAN YOU -- DOES THE CLINICAL DECISION HOOK WORK, IS IT GOING TO WORK, DO YOU HAVE TO PRODUCE AND BUILD THAT? THE GUARANTEES AND AGREEMENTS AND TYPE OF STUFF YOU WANT TO HAVE, YEAH, IT'S HARD TO GET ENOUGH INVESTMENT I THINK. >> IS THERE POTENTIAL OPPORTUNITY FOR PUBLIC/PRIVATE PARTNERSHIP, FINDING PARTNERS, FOR THE SUSTAINABILITY IMPLEMENTATION, THOSE KINDS OF PIECES, MAYBE EVEN TAKE ON -- I'M NOT SAYING THEY WILL BUT MAYBE EVEN TAKE ON SOME OF THE LEGAL RAMIFICATIONS AND RESPONSIBILITY COMPLIANCE. IS THERE AN OPPORTUNITY TO MAYBE LEVERAGE THE PARTNERS THAT ARE OUT THERE, SOME OF THE OPPORTUNITY TO MAYBE LEVERAGE PARTNERS THAT WOULD BE INTERESTED IN WORKING WITH YOU? >> ANYONE HAVE COMMENTS THERE? GOOD FOOD FOR THOUGHT. SORRY, AM I STILL ON? I'VE BEEN HAVING INTERMITTENT INTERNET CONNECTION ISSUES. >> YOU'RE ON. >> OKAY, GREAT. ANY OTHER QUESTIONS FROM THE GROUP? I'VE TOYED BETWEEN THE QUESTION I POSED AND ANOTHER ONE BUT GIVEN I'VE ALREADY POSED A QUESTION, WHAT ARE THE MOST DIFFICULT CHALLENGES, OR THE POSITIVE, WHAT'S THE MOST IMPORTANT OPPORTUNITY THAT YOU'VE SEEN IN TERMS OF SUPPORTING -- BUILDING OR -- BUILDING SYSTEMS OR LEVERAGING BACK OFFICE DATA FOR RESEARCH, WHERE FHIR HAS BEEN AN ENABLING SOLUTION? FOR ME, I'LL SAY THAT FOR ME ON THIS ONE, IT IS BEING ABLE TO SUPPORT, AS KEN MENTIONED EARLIER, BEING ABLE TO TAKE DATA FROM THE EHR INTO RESEARCH DATA SYSTEMS, FOR REGISTRIES OR FOR PROSPECTIVE TRIALS IN A WAY THAT OTHER PEOPLE CAN ALSO ADOPT THOSE METHODS RAPIDLY. IT'S BEEN MAGIC. SO, IT'S BEEN A WONDERFUL TECHNOLOGY FOR US AND THE WORK THAT WE'VE DONE, BOTH AT VANDERBILT AND THEN DISSEMINATING THAT OUT. OTHERS, WOULD YOU LIKE TO COMMENT, EITHER ON THE CHALLENGE OR THE OPPORTUNITY SIDE? >> I'LL THROW IN ONE CHALLENGE, AND THAT IS AS I MENTIONED, THE REQUIREMENTS FOR ROBUST SUPPORT OF THE APIs DON'T MATURE UNTIL NEXT YEAR. AND SO GETTING AHEAD OF THE CURVE IS A BIT CHALLENGING, WHEN THE DATA ARE NOT THERE IN FHIR FORMAT YET. SO EVERY PROJECT HAS TO HAVE A -- WILL CONVERT THE DATA TO FHIR SOMEHOW, IN ORDER TO TEST THESE FUTURE SOLUTIONS. AND THAT'S A PROBLEM THAT I THINK EHR VENDORS CAN HELP US WITH MORE, IN THE LEAD UP TO DECEMBER 2022. >> GREAT. >> I THINK THE BIGGEST CHALLENGE OPPORTUNITY IS TOOLS TO SUPPORT MANAGING COMPLEXITY FOR RESEARCHERS USED TO USING THEIR DSBs TO DO ANALYSIS. I NEED A DATA TABLE, HOW DO I GET WHAT I WANT OUT OF THIS COMPLEX FHIR JSON. >> BOB, KRISTEN, ANY THOUGHTS? >> I GUESS JUST ONE QUICK THOUGHT HERE. I'LL GO BACK TO MY SEMANTICS COMMENT PREVIOUSLY. I THINK ONE OF THE THINGS THAT WE'VE LEARNED AND KEEP LEARNING IN THE GENOMICS SPACE IS THAT FHIR IS FORCING US TO ADDRESS CHALLENGES WITH RESPECT TO DATA NORMALIZATION THAT WE DIDN'T NECESSARILY HAVE TO ADDRESS AS DEEPLY PREVIOUSLY. OPENING UP THESE APIs WITHOUT NECESSARILY KNOWING HOW THE DATA IS GOING TO BE USED HAS MADE US THINK VERY, VERY CAREFULLY ABOUT HOW TO DATA THAT USED TO BE REPRESENTED IN A COMMENT FIELD OR AS ATTACHED TO SOME UNSTRUCTURED TEXT, AND MAKING THAT COMPUTABLE HAS TURNED INTO A MUCH BIGGER CHALLENGE THAN I THINK I EXPECTED. >> I'LL END WITH AN IMPORTANT OPPORTUNITY THAT'S WRAPPED IN LEGAL, TECHNICAL HUMAN FACTORS, CHALLENGES, BUT I THINK THAT PATIENT ENGAGEMENT AND ONGOING COLLECTION OF PATIENT DATA IS SUCH A HUGE OPPORTUNITY, THINKING ABOUT FHIR MAKING THAT MORE ACCURATE AND VALID AND TECHNICALLY MORE FEASIBLE TO PUSH BACK INTO THE EHR, BUT SOMEONE MENTIONED EARLIER WE'RE GENERATING MILLIONS OF DATA POINTS A DAY, SOME COULD BE CRITICAL FOR CLINICIANS TO THINK ABOUT CHRONIC DISEASE MANAGEMENT OR EVEN ACUTE PHYSIOLOGIC DETERIORATION, WAYS TO CAPTURE THIS WITH WEARABLES AND WITH mHEALTH AND THEN IN A MEANINGFUL WAY BACK TO THE CLINICIANS TO SUPPORT DECISION MAKING, I THINK THERE'S HUGE OPPORTUNITY THERE. >> THANK YOU, KRISTEN. I WANT TO THANK EVERYONE FOR THE QUESTIONS, I WANT TO THANK THE SPEAKERS FOR THE DISCUSSION. AND, AGAIN, THANK YOU TO THE NIH FOR ORCHESTRATING THIS MEETING. IT'S BEEN GREAT. MY ONLY LAMENT IS THE FACT WE'RE STILL IN 2D INSTEAD OF 3D. SO HOPEFULLY SOON WE'LL ALL BE BACK TOGETHER AND WE CAN END THESE TYPES OF SESSIONS WITH ALL-WAY CONVERSATIONS BUT THANK YOU. THIS HAS BEEN A GREAT DAY. TERESA, I'M HANDING IT BACK TO YOU. >> THANK YOU, PAUL. THANKS TO ALL OF YOU FOR PARTICIPATING IN THE DISCUSSIONS. CERTAINLY A LOT OF GREAT INSIGHTS TODAY IN TERMS OF OUR NEEDS AROUND ADVANCING USE OF FHIR IN RESEARCH. SO, I HEARD LOTS OF DIFFERENT THINGS, WE TOOK GREAT NOTES, THE SESSION IS BEING RECORDED. BUT CERTAINLY THERE'S A MULTITUDE OF DATA SOURCES THAT WE LEVERAGE IN RESEARCH AS WELL AS HEALTH CARE, AND THERE'S NEEDS TO FIGURE OUT HOW TO INTEGRATE, MERGE THOSE DATA, AS WELL AS LINK TO OTHER INFORMATION, PARTICULARLY IN CONTEXT OF CLINICAL CARE. IN TERMS OF CONSIDERATIONS THERE'S CONSIDERATIONS AROUND DATA THEMSELVES, TIMES OF DATA COMPLETENESS AND ALSO ISSUES AROUND AMBIGUITY, METADATA FOR APPLICATION, WHETHER IT'S PARTICULAR RESEARCH USE CASES AS WELL AS CLINICAL APPLICATION DOWN THE LINE. AND A GREAT NEED FOR INFRASTRUCTURE AND TOOLS OR PLATFORMS TO FACILITATE THE USE OF FHIR. THERE WAS GREAT COMMENTS IN TERMS OF FIGURING OUT THE PACE. INNOVATION, AND SORT OF THIS TENSION BETWEEN GETTING AS FAR AS WE CAN WITH WHAT WE KNOW BUT THEN WITH WHAT'S AVAILABLE NOW BUT THEN ALSO LEAVING ROOM FOR ADDITIONAL INNOVATION, AND BUILDING ON THE STANDARD AS IT CURRENTLY EXISTS TO BE BETTER USED IN RESEARCH AND PAYING ATTENTION TO ISSUES OF SCALABILITY AND SUSTAINABILITY, BRINGING RESEARCH TO PRODUCTION. AND THEN CERTAINLY CONSIDERATIONS UNIQUE TO RESEARCH AROUND PREVIOUS EASY -- PRIVACY AND SECURITY, TRAINING, INFORMATICS, STAFF AT MANY INSTITUTIONS. AND SO WITH THAT I'D LIKE TO THANK EVERYONE AGAIN FOR JOINING US TODAY. I LOOK FORWARD TO ONGOING CONVERSATION, AS BELINDA ALLUDES TO THIS MORNING THIS IS AN ONGOING PROCESS AT NIH AND WE APPRECIATE YOUR INPUT AND FEEDBACK. WITH THAT, HAVE A GREAT REST OF YOUR DAY. >> THANK YOU VERY MUCH. THIS HAS BEEN WONDERFUL. IT WOULDN'T HAVE GOTTEN TO THIS POINT WITHOUT YOUR PARTICIPATION AND SPEAKERS. PAUL, I HOLD OUT FOR THE PROMISE THAT NEXT YEAR WE'LL HAVE A WORKSHOP IN PERSON. WITH THAT, THANK YOU. HAVE A WONDERFUL EVENING.