Data Standards for Electronic Health Records Data Standards in Clinical Trials: Maximizing Innova>on by Standardizing October 19, 2012

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1 Data for Electronic Health Records Data in Clinical Trials: Maximizing Innova>on by Standardizing October 19, 2012 Doug Fridsma, MD, PhD, FACP, FACMI Chief Science Officer & Director, Office of Science & Technology

2 Health IT: Establishing the Founda>on BeHer healthcare Improving pabents experience of care within the InsBtute of Medicine s 6 domains of quality: Safety, Effec,veness, Pa,ent- Centeredness, Timeliness, Efficiency, and Equity. BeHer health Keeping pabents well so they can do what they want to do. Increasing the overall health of populabons: address behavioral risk factors; focus on prevenbve care. Reduced costs $ Lowering the total cost of care while improving quality, resulbng in reduced monthly expenditures for Medicare, Medicaid, and CHIP beneficiaries. Health Informa.on Technology 2

3 HITECH Framework: Meaningful Use at its Core Regional Extension Centers Workforce Training Medicare and Medicaid Incen>ves and Penal>es ADOPTION MEANINGFUL USE Improved Individual & Popula>on Health Outcomes Increased Transparency & Efficiency Improved Ability to Study & Improve Care Delivery State Grants for Health Information Exchange & Certification Framework Privacy & Security Framework EXCHANGE Health IT Practice Research

4 Meaningful Use Takes Off 52% percent of office- based physicians intend to take advantage of EHR incenbves The percentage of primary care providers who have adopted EHRs in their pracbce has doubled from 20% to 40% between 2009 to 2011 ONC s Regional Extension Centers (RECs) have signed up more than 100,000 primary care providers This means that roughly one third of the nabon s primary care providers have commi\ed to meaningfully using EHRs by partnering with their local REC. Momentum is building! Hospital adopbon has more than doubled since 2009, increasing from 16% to 35% Most (85%) of hospitals intend to a\est to Meaningful Use by

5 Meaningful Use and Clinical Research Though clinical research is not a specific part of Meaningful Use Making pabent data electronic creates new opportunibes for clinical trials management Terminologies and standards that will be cribcal are being developed/harmonized in the S&I Framework MU3 will focus on developing a learning health care system clinical trials plays an important role 5

6 ONC s Guiding Principles Interoperability is a journey, not a desbnabon Leverage government as a placorm for innovabon to create condibons of interoperability Health informabon exchange is not one- size- fits- all Build in incremental steps don t let the perfect be the enemy of the good 6

7 Office of Science & Technology Enable stakeholders to come up with simple, shared solutions to common information exchange challenges Teams convened to solve problems ENABLE COLLABORATE Coordinate Federal Partners CURATE Solutions & Usability R&D INNOVATE Curate a portfolio of standards, services, and policies that accelerate information exchange Collaborate with federal agencies to coordinate federal health IT priorities as manager of Federal Health Architecture Support Innovation through SHARP program, Innovation/Challenge Grants, and interfacing with international community

8 What is the S&I Framework? The and Interoperability (S&I) Framework represents one investment and approach adopted by the Office of Science & Technology (OST) to fulfill its charge of prescribing health IT standards and specificabons to support nabonal health outcomes and healthcare prioribes. The S&I Framework is an example of government as a plakorm enabled by integrated funcbons, processes, and tools for the open community of implementers and experts to work together to develop and harmonize health informabon exchange standards. 8

9 Why the S&I Framework Approach? S&I Framework Approach: Creates a collaborabve, coordinated incremental standards process, Guided by ONC, with input from Federal Advisory Commi\ees, Enabled and led by the an open community of industry parbcipants who are interested in solving real world problems Value created through this approach: Solves real- world issues to enable health informabon exchange Harnesses the experbse and passion of the community to solve problems Empowers the community to create the best solubons for interoperability and standards adopbon 9

10 ONC s Stack Vocabulary & Code Sets How should well- defined values be coded so that they are universally understood? Content Structure How should the message be forma\ed so that it is computable? Transport How does the message move from A to B? Security How do we ensure that messages are secure and private? Services How do health informabon exchange parbcipants find each other? 10

11 Applicability Purpose Demographics Vocabulary & Code Sets OMB Race/Ethnicity ISO (constrained) Content Exchange / U>liza>on Transport Problems SNOMED CT + US ext CDS HL7 Infobu\on + IGs Smoking Status SNOMED CT + US ext Family Health History SNOMED CT + US ext HL7 Pedigree Pa>ent Ed Resources HL7 Infobu\on + IGs ToC receive, display, & incorporate SNOMED CT + US ext RxNorm CCD/C32 CCR Consolidated CDA Applicability Statement for Secure Health Transport AppState + XDR/XDM SOAP RTM + XDR/ XDM 11

12 Applicability (cont.) Purpose ToC Create & Transmit [Common MU Data Set] ICD- 10- CM CVX Consolidated CDA e- Rx RxNorm NCPDP SCRIPT 10.6 Incorporate Labs (ambulatory) Data Portability Vocabulary & Code Sets LOINC [Common MU Data Set] ICD- 10- CM CVX Content Exchange / U>liza>on HL7 S&I LRI Spec Consolidated CDA Transport Applicability Statement for Secure Health Transport AppState + XDR/XDM SOAP RTM + XDR/ XDM 12

13 Applicability (cont.) Purpose CQM Export CQM Import CQM e- Submit View, download, transmit to 3 rd party Clinical Summary [Common MU Data Set] [Common MU Data Set] Content Exchange / U>liza>on QRDA Category I QRDA Category I QRDA Category I & III Consolidated CDA WCAG Level A Consolidated CDA Immz Repor>ng CVX HL IGs Syndromic Surveillance ELR Cancer Registry Vocabulary & Code Sets SNOMED CT + US ext LOINC SNOMED CT + US ext LOINC HL IG (inpabent only) HL IG CDA R2 + IG Transport Applicability Statement for Secure Health Transport 13

14 S&I Ini>a>ve Poriolio Snapshot Direct Project (S&I Archetype) Pre- Discovery Use Case HarmonizaBon RI, Test & Pilot EvaluaBon Transi>ons of Care Lab Results Interface Query Health Provider Directories Data SegmentaBon for Privacy Public Health ReporBng esmd Longitudinal CoordinaBon of Care Laboratory Orders Interface Health edecisions Automate Blue Bu\on (ABBI) Community- Led ini,a,ve Pilots Underway 2 nd IG Ballot Publica,on (4/9/12) Plan to begin pilo,ng in April 2012 Looking at poten,al pilots and reference implementa,on Targe,ng comple,on of pilot(s) and ini,al evalua,on by September st (of 3) use cases consensus- approved; Targe,ng comple,on of pilot(s) and ini,al evalua,on by October 2012 S&I Community launched August 2012 Working on Extension of the ToC Use Case for LCC (reuse); Limited Support Ini,a,ve Use Case Reached Consensus In August 2012 Developing Two Use Cases: Ar,fact Sharing and Guidance Service

15 Current S&I Ini>a>ves: Opera>ng Metrics How long has it been? How much have we accomplished? Framework Launch Date First Ini>a>ves Launched Elapsed Time (as- of today) Jan 7, 2011 Jan 31, months # Use Case Ar>facts 33 # Harmonized Segments/Sec>ons 150 # RI/Test Ar>facts 64 How much effort have we put in? # Wiki Registrants 1648 # CommiHed Members 591 # CommiHed Organiza>ons 448 # Working Sessions Held 799 # Days Between Sessions* 0.5 # Pilots CommiHed or In Discovery 20+ # Pilot Vendors 25+ # Pilot Healthcare Organiza>ons (e.g. hospitals, HIEs) HL7 Ballots 35+ # Ballot Comments Received 1,854 # Ballot Comments Resolved 1,479 3 * Assumes 260 working days per year 15

16 Development before the S&I Framework Disparate en>>es with a lifecycle ranging from months Iden>fica>on of Need for Standard Development Organiza>ons Tes>ng & Pilo>ng Implementa>on Regulatory Body Content Transport Interested Stakeholders Government Agencies Industry Need Terminology Early Adopters NaBonwide Implementers Changes in Technology Web service Privacy Conformance Bodies

17 Development with the S&I Framework Coordinated en>>es with a lifecycle ranging from 9-18 months Iden>fica>on of Need for Standard Development Organiza>ons Tes>ng & Pilo>ng Implementa>on Common Problem Forum CoordinaBon of Resources Interested stakeholders Regulatory Body Industry Need Content Transport Terminology Government Agencies Early Adopters NaBonwide Implementers Changes in Technology Web service Privacy Conformance Bodies

18 Development with the S&I Framework and future planned improvements Con>nuous improvement lifecycle, i.e. agile, to enable market & regulatory relevancy Iden>fica>on of Need for Standard Development Organiza>ons Tes>ng & Pilo>ng Implementa>on Common Problem DefiniBon CoordinaBon of Resources Interested stakeholders Regulatory Body Industry Need Content Transport Terminology Government Agencies Early Adopters NaBonwide Implementers Changes in Technology Web service Privacy Conformance Bodies

19 Development with the S&I Framework and future planned improvements Con>nuous improvement lifecycle, i.e. agile, to enable market & regulatory relevancy: S&I Framework: Needs idenbficabon Standard development IG development Implementa>on: Vendors Government Agencies Early Adopters Process Flow Feedback Loop Tes>ng and Implementa>on Plaiorm: PrecerBficaBon TesBng PiloBng

20 Common Data Elements/ Electronic Case Report Form Ini>a>ve Background: Electronic health records (EHRs) have the potenbal to provide useful informabon for ComparaBve EffecBveness Research (CER). CER is the conducbon and synthesis of systemabc research comparing different intervenbons and strategies to prevent, diagnose, treat and monitor health condibons. Many current CER projects rely on data collected in site- or system- specific EHRs. The applicability and power of such studies would be increased by the use of structured data definibons common data elements (CDEs) that comply with the consensus- derived health data standards established for Meaningful Use of EHRs. In other words, if relevant pa>ent data (e.g., lab test results, marital status, pa>ent- reported depression) were defined and collected in a common way in different CER studies, it would be easier to compare the results of CER studies, and it would be easier to use EHR systems as a source of valid CER data. 20

21 Common Data Elements/ Electronic Case Report Form Ini>a>ve Goals: IdenBfy and eventually require the use of key CDEs and pabent assessment instruments in CER funded by HHS and PCORI, Define these CDEs and assessment instruments using standard terminologies and terminology value sets, and Develop the infrastructure needed so that CDEs and standardized ways of collecbng data for CER are available for use within EHR products. These efforts will make it easier to conduct CER in diverse community health care seqngs, by reducing the data collec>on burden on health care providers and pa>ents and the need to make site- specific modifica>ons to EHR system capabili>es in order to enable community par>cipa>on. They will also ensure that data from different CER research studies can be more easily compared and aggregated. 21

22 Ques>ons/Discussion Learn more at: ONC website: S&I Framework wiki: h\p://wiki.siframework.org

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