Structured Data Capture (SDC) Kick Off Document & Draft Charter

1. Structured Data Capture (SDC) Kick Off Document & Draft Charter January 23, 2013

2. Meeting Etiquette From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute  All Panelists • Remember: Please keep your phone on mute • Do not put your phone on hold. If you need to take a call, hang up and dial in again when finished with your other call • Hold = Elevator Music = frustrated speakers and participants • This meeting is being recorded • Another reason to keep your phone on mute when not speaking • Use the “Chat” feature for questions, comments and items you would like the moderator or other participants to know. • Send comments to All Panelists so they can be addressed publically in the chat, or discussed in the meeting (as appropriate). 2

3. Agenda • Opening Remarks – Doug Fridsma, MD, PhD Director, Office of Standards and Technology, ONC • The Standards & Interoperability Framework - Doug Fridsma • Patient-Centered Outcomes Research: Lisa Lang, MPP, Assistant Director, Health Services Research Information and Head, NICHSR, NLM, NIH • Patient Safety Event Reporting: Amy Helwig, MD, MS, Medical Officer, Center for Quality Improvement and Patient Safety, AHRQ • Initiative Introduction and Draft Charter – Evelyn Gallego-Haag, Initiative Coordinator, Structured Data Capture Initiative • Next Steps/Call for Participation – Jenny Brush, Project Manager, Structured Data Capture Initiative • Questions and Resources

4. Dr. Doug Fridsma, OSI, ONC Standards & Interoperability (S&I) Framework

5. Office of Science & Technology Enablestakeholdersto come up with simple, shared solutions to common information exchange challenges Curate a portfolioof standards, services, and policies that accelerate information exchange Teams convened to solve problems Solutions& Usability Coordinate Federal Partners R&D Support Innovationthrough SHARP program, Innovation/Challenge Grants, and interfacing with international Standards community Collaboratewith federal agencies to coordinate federal health IT priorities as manager of Federal Health Architecture

6. S&I Framework Overview Specific health interoperability initiatives guide the design and development of a fully integrated and connected health information system. An S&I Initiative focuses on a single challenge with a set of value-creating goals and outcomes, and the development of content, technical specifications and reusable tools and services. Call for Participation: The overall success of the S&I Framework is dependent upon volunteer experts from the healthcare industry and we welcome any interested party to get involved in S&I Framework Initiatives, participate in discussions and provide comments and feedback by joining the Wiki: http://wiki.siframework.org

7. S&I Framework Coordination FACAs • HIT Standards Committee • HIT Policy Committee • Tiger Team Community S&I Framework SDOs • Technology Vendors • System Integrators • Government Agencies • Industry Associations • Other Experts • HL7 • IHE • CDISC • NCPDP • ASC X12 • ASTM • WEDI • ISO/TC 215 • IHTSDO • NLM • NQF • Regenstrief • Other health IT standards related organizations ONC Programs & Grantees • State HIE Program & CoPs • SHARP Program • REC Program & CoPs • Beacon Program

8. The Big Picture… • Our Missions • Promote a sustainable ecosystem that drives increasing interoperability and standards adoption • Create a collaborative, coordinated, incremental standards process that is led by the industry in solving real world problems • Leverage “government as a platform” – provide tools, coordination, and harmonization that will support interested parties as they develop solutions to interoperability and standards adoption. S&I Framework S&I Pilots ATCBs and Testing Infrastructure NwHIN Exchange Operations NWHIN Implementation & Pre-Certification Testing S&I Framework Federal Responsibility eHealth Exchange Use Cases Standards Development Harmonization Joint Efforts Private Sector 8

9. S&I Framework Phases & Likely Structured Data Capture Activities You are here 9

10. Structured Data CaptureSuccess Metrics • Goal is to address this challenge in terms of the structured data requirements needed in: • Research • Patient-Safety Event Reporting SDC will focus on solving a specific interoperability challenge through the development of four new standards that will enable EHRs to capture and store structured data: • Standard for the CDEs that will be used to fill the specified forms or templates • Standard for the structure or design of the form or template (container) • Standard for how EHRs interact with the form or template • Standard to auto-populate form or template 10

11. Lisa Lang, NLM, NIH Patient-Centered Outcomes Research

12. Patient-Centered Outcomes Research The Assistant Secretary for Planning and Evaluation (ASPE) awarded National Library of Medicine (NLM) and ONC S&I Framework funds to establish infrastructure for the use of EHRs for PCOR • 2010 Patient Protection and Affordable Care Act: established funding for Comparative Clinical Effectiveness Research with focus on Patient-Centered Outcomes Research (PCOR) • Majority of this funding designated to establish a non-profit corporation, the Patient Centered Outcomes Research Institute (PCORI) • charged with assisting patients, clinicians, purchasers, and policy-makers in examining the "relative health outcomes, clinical effectiveness, and appropriateness" of different medical treatments by evaluating existing studies and supporting additional research • Remaining funds were designated to Federal Health programs to, a key purpose of which was to build data capacity for PCOR, including development of clinical registries and health outcomes research data networks, so that research data could be captured, aggregated and analyzed from multiple sources including EHRs 12

13. NLM and ONC Project to support PCOR Project Goal: Improve the efficiency, comparability, and utility of PCOR studies, the aggregation of PCOR data from EHRs, and the ease of translation of research results into practice by associating research- relevant CDEs with consensus-determined health data standards, standard terminology value sets and common interfaces. • Community-based S&I Initiative using S&I platform • New standard that will embed structured electronic forms with CDEs within the EHR to facilitate collection of research data • Collaborating with relevant NIH-wide committees and other stakeholders including other HHS agencies (AHRQ, FDA, CMS, CDC) and standard development organizations (CDISC) Web Portal page to existing HHS-supported CDEs and patient assessment instruments (PAIs) and definitions relevant to PCOR Technical design for storage of and access to CDEs and PAIs 13

14. NLM Common Data Element (CDE) Resource Portal • http://cde.nih.gov • Provides single point-of-entry for information about NIH-supported CDE initiatives and CDE tools & resources • Enables browsing of descriptive summaries of the CDE initiatives and of the subject areas to which they apply • Links out to repositories containing the data elements themselves. • Version 1.0 launched in January 2013 • Contains information on 16 NIH-supported initiatives • Future enhancements: additional NIH and HHS initiatives, improved navigation 14

15. Repository of CDEs and PAIs (under development) NLM, working with NIH and others, will develop a means of providing easy access and searching capability for standardized representations of CDEs and PAIs that have been specified using consensus data standards and terminologies Approach will capitalize on attributes, capabilities of existing distribution systems, such as FITBR, CaDSR, NLM Value Set Authority Center and others Resulting repository will serve as a resource for efforts to further standardize and harmonize CDEs and PAIs Initial development: 2013

16. Dr. Amy Helwig, AHRQ Patient-Safety Event Reporting

17. The Patient Safety andQuality Improvement Act of 2005 • Creates “Patient Safety Organizations” (PSOs) • Establishes “Network of Patient Safety Databases” (NPSD) • Authorizes establishment of “Common Formats” for reporting patient safety events • Requires reporting of findings annually in AHRQ’s National Health Quality/Disparities Reports

18. Common Formats • Common language for patient safety event reporting • Common language & definitions • Standardized rules for data collection • Standardize the patient safety event information collected

19. Unique Role of Common Formats Only patient safety reporting scheme designed to meet three goals: Provide information on harms from all causes Support local quality/safety improvement Allow the end user – to collect it once & supply it to whoever needs it Designed to serve IOM goals for national patient safety measurement

20. How do Common Formats work? • Comprehensive modules cover all types of events: • Incidents, near misses and unsafe conditions • Common events • Rare events (includes NQF Serious Reportable Events) • Modular design allows for expansion • Addition of new topics • Expansion to new settings

21. Value of the Common Formats Supports ongoing data-driven quality assessment, regardless of hospital complexity, organization or services provided • Focused on indicators related to improved health outcomes, processes of care, and the prevention and reduction of medical errors. • Applicable to high risk, high volume problems as well as less common events • Standardized reports allow for tracking and measuring improvements • Reports provide rich detail for areas hospitals select as priorities in patient safety

22. EHR Provider Environment Structured Data Capture Data Flow: Provider to NPSD to User User: AHRQ National Quality Reports Incident Reporting System User: Patient Safety Organization (PSO) Patient Safety Work Product Privacy Protection Center (PPC) Network of Patient Safety Databases (NPSD) Patient Safety Organization (PSO) User: Provider Other Qualified Sources User: Researchers and Policy Makers

23. Evelyn Gallego-Haag, ONC Structured Data Capture Initiative

24. Why Focus on Structured Data Capture? Aggregated and analyzed EHR data can be used to identify trends, predict outcomes and influence patient care, drug development and therapy choices. • Exponential growth in volume and detail of information captured by healthcare organizations • Strong public and private interest in leveraging clinical data captured in the health record during episodes of care (EOC) and using this data to supplement data collected for other purposes including: • Research • Patient-safety event reporting • Public Health Reporting • Eventually, such data could be used to enhance EHR data collected during EOC • Enhanced data would be valuable to health organizations for quality and performance improvement 24

25. Challenge & Opportunity of Using EHRs The utility of EHR data for supplemental purposes has been limited due to a lack of uniformity in the terminology and definitions of data elements across EHRs. This limitation is compounded by the fact that clinician workflow often records patient information in unstructured free-text data well after the episodes of care. EHRs are recognized as the data source with the highest potential to provide timely and relevant data in a form that is quickly usable for quality and safety improvement, population health, and research Linking EHR data with other data in a uniform and structured way could accelerate the utility of EHR data for supplemental purposes 25

26. The Value of SDC within EHRs Advances Stage 3 MU vision to design trusted infrastructure to enable patient information to flow securely from EHRs to other systems, such as research consortia, registries, and bio repositories Stage 3 MU Learning Health System Reduces Data Collection Burden Reduces burden on health care providers by enabling secure, single-point data entry that populates to multiple systems Improves Comparability of Data Aggregated patient data is more comparable and will better inform research, quality reporting and ultimately, influence patient care Reduces need for site-specific EHR enhancements Reduces the need to make site-specific modifications to EHR system capabilities in order to enable participation in important reporting and research activities 26

27. Structured Data Capture Initiative Some S&I Principles From here on, we are discussing the DRAFT charter – objectives, use cases, scope statements, and work groups – all will be up for the community to review and formulate on the wiki This is not a government initiative, or it is not a government-only initiative – this is an open, collaborative opportunity forpublic and private volunteers working towards shared objectives Leverage existing, widely used, and openly available standards and services. 27

28. Draft Charter for S&I Community Review on the Wiki Structured Data Capture CharterScope Statement • Define the necessary requirements which will drive the identification and harmonization of standards that will facilitate the collection of supplemental EHR derived data • Develop and validate a standards based data architecture so that a structured set of data can be accessed from EHRs and be stored for merger with comparable data for other relevant purposes to include: • The electronic Case Report Form (eCRF) used for clinical research including PCOR • The Incident Report used for patient safety reporting leveraging AHRQ ‘Common Formats’ • The Surveillance Case Report Form used for public health reporting of infectious diseases 28

29. Draft Charter for S&I Community Review on the Wiki Structured Data Capture CharterData Architecture • Standards will facilitate the collection of data so that any researcher, clinical trial sponsor, reporting and/or oversight entity can access and interpret the data in electronic format • Will leverage existing standards such as XML and CDISC Retrieve Form for Data Capture (RFD) Infrastructure will consist of four new standards that will enable EHRs to capture and store structured data: • Standard for the CDEs that will be used to fill the specified forms or templates • Standard for the structure or design of the form or template (container) • Standard for how EHRs interact with the form or template • Standard to auto-populate form or template 29

30. Structured Data Capture Conceptual Workflow CDE Library Finds form/template 2 Selects form/template 1 EHR System Converts, populates & displays form 3 Other domain AHRQ CDEs 4 Provider CDEs [Common Formats] Inputs data Specified Structured Displayed Form/Template Caches data Captured Data Form Library Form 5 xx Actor Key John Doe x 6 x Provider/ End User x Stores/ transmits data x x EHR System Other domain Clinical Research Patient Safety External Data Forms CDEs Forms Repository Extract, Transform, & Load Data by form/ template 7 End User

31. Structured Data Capture Standards Overlay 3. EHR Interaction Standard: Find, display, cache, store/transmit Finds form/template CDE Library 1. CDE Standard 2 Selects form/template 1 EHR System Converts, populates & displays form 3 Other domain AHRQ CDEs 4 Provider 4. Pre-populate Standard CDEs [Common Formats] Inputs data Specified Displayed Structured Form/Template Caches data Captured Data 2. Structure Standard Form 5 Form Library xx John Doe x 6 x x Stores/ transmits data Actor Key x x Provider/ End User Patient Safety Other domain Clinical Research External Data CDEs Forms Forms EHR System Repository Extract, Transform, & Load Data by form/ template 7 End User

32. Structured Data CaptureS&I Phases Roadmap Draft Charter for S&I Community Review on the Wiki Dec ‘12 Jan ‘13 Feb ‘13 Mar ‘13 Apr ‘13 May ‘13 Jun ‘13 Jul ‘13 Aug ‘13 Sept ‘13 Initiative Kick Off: 1/23/13 • Pre-Planning • Call for Participation • Conduct Environmental Scan • Success Criteria • Stakeholder Engagement • Pilots & Testing • Pilot site readiness • Implementation of solution • Test User Stories and Scenarios • Monitor Progress & Outcomes • Utilize Requirements Traceability Matrix • Use Case & Functional Requirements • Develop, review, and finalize the Use Case and Functional Requirements • Pre-Discovery • Launch initiative • Review and Finalize Charter • Review initial Candidate Standards • Standards & Harmonization • Finalize Candidate Standards • Standards Gap Analysis • Technical & Standards Design • Develop Requirements Traceability Matrix • Develop Implementation Guide • Evaluation • Evaluate outcomes against Success Metrics and Criteria Timelines for Consideration: MU Stage 3, SDO Ballot Cycles

33. Structured Data CaptureInitiative Work steams Draft Charter for S&I Community Review on the Wiki Sept ‘13 Dec ‘12 Jan ‘13 Feb ‘13 Mar ‘13 Apr ‘13 May ‘13 Jun ‘13 Jul ‘13 Aug ‘13 Initiative Kick Off: 1/23/13 Pre-Planning Use Case & Functional Requirements Pilots & Testing Evaluation Pre-Discovery Standards & Harmonization SDC All-Hands WG - TBD Lead Use Case WG: API Functionality Standards & Harmonization WG Pilots WG Content Work stream Common Formats SWG AHRQ Lead PCOR Content SWG NLM Lead Technical Work stream Technical SWG TBD Lead Timelines for Consideration: MU Stage 3, SDO Ballot Cycles

34. Structured Data Capture CharterExisting Efforts to Consider Draft Charter for S&I Community Review on the Wiki • NLM/NIH repository of PCOR-related projects: e.g. NCI, NINDS, Patient Reported Outcomes Measurement Information System (PROMIS), PhenX Toolkit • Other Projects using CDEs and standardized assessment tools: • AHRQ Common Formats for Patient Safety Event Reporting within USHIK • Other AHRQ funded projects: EDM Forum, DARTNet, DEcIDE Network • Other NIH funded projects: eMERGE, HMORN • NCI Biomedical Research Integrated Domain Group (BRIDG) • FDA mini-Sentinel • Patient Centered Outcomes Research Institute (PCORI) Projects • CDISC Clinical Data Acquisition Standards Harmonization (CDASH) • IHE/CDISC Retrieve Form for Data Capture (RFD) Profile • IHE Clinical Research Data Capture (CRD) and Retrieve Clinical Knowledge (RCK) Profile • Value Sets derived from accepted Meaningful Use Standards • Other S&I Initiatives: e.g. Public Health Reporting Initiative (PHRI), Query Health • Standards identified through the S&I Framework’s Standards Catalog: e.g. ONC DIRECT • Standards and approaches identified through related ONC Grant Programs: e.g. SHARP, HIE Challenge Grants And we welcome consideration of other efforts and standards suggested by the community 34

35. Jenny Brush, ONC Next Steps & Call for Participation

36. Structured Data Capture InitiativeCall for Participation • To make this initiative a success, we need the help of volunteers who are eager to make rapid progress on this important project • We need experts to develop standards, test beds ready to pilot new tools, innovators to push the envelope, and patients and providers willing to provide feedback • Minimum commitment: regular participation in community meetings (1-2 hours / week) and active contribution to one or more workgroups (1-3 hours / month). It is okay to participate in one phase and not another. • There will be opportunities for your organization to • Pilot new ways to give consumers access to information • Hear about and provide input to the latest policy and standard issues affecting information exchange and consumer access • Directly contribute to a potential game-changer for health care 36

37. Structured Data Capture InitiativeWiki Page http://wiki.siframework.org/Structured+Data+Capture+Initiative 37

38. Structured Data Capture InitiativeNext Steps • The Structured Data Capture Initiative is open for anyone to join. • This community will meet frequently by webinar and teleconference • We use Wiki pages to facilitate discussion • Information on how to join the Community can be found on the Structured Data Capture Sign Up Wiki: • http://wiki.siframework.org/Join+Structured+Data+Capture+Initiative • In order to ensure the success of our initiative and the subsequent pilot, we encourage broad and diverse participation from the community. • This is your chance to have an impact on the creation and implementation of a pilot program in this important area of health IT development. • Please review the Proposed Project Charter • http://wiki.siframework.org/http://wiki.siframework.org/Structured+Data+Capture+Project+Charter

39. Structured Data Capture CharterExpected Deliverables Draft Charter for S&I Community Formulation and Review on the Wiki Use Case(s) and Functional Requirements National standards for CDEs, structured forms for capturing those CDEs and standardized functions for how EHRs interact with those standards and forms Implementation guidance to assist researchers, patient safety personnel, software vendors and others in apply technical requirements for the customized use of structured forms/ templates Pilots to evaluate use of the specified form standard for CER and patient safety event reporting Proliferation and use of NLM-hosted CDEs for PCOR and AHRQ ‘Common Formats’ for patient safety event reporting 39

40. Structured Data Capture Initiative Schedule • Over the next 2 weeks, we will hold All Hands Meetings to finalize the project charter • All Hands Meetings will be held Thursdays from 3:30 to 4:30pm Eastern • SDC wiki page will be updated with meeting information • In Week 4, we will launch workgroups as agreed by the community, beginning with Use Case development • We are planning to host a series of presentations from related projects and initiatives • Similar to ‘concert series’ hosted by other S&I Initiatives • If you have an interest in participating, please contact the support team: Evelyn Gallego (evelyn.gallego@siframework.org ) and Jenny Brush (jennifer.brush@esacinc.com ) 40

41. Structured Data Capture Initiative Resources and Questions Please feel free to reach out to any member of the SDC Initiative team: • ONC Leads • Doug Fridsma (doug.fridsma@hhs.gov) • FarrahDarbouze (farrah.darbouze@hhs.gov) • Teaming Partner Leads • Lisa Lang (langl@mail.nlm.nih.gov) • Amy Helwig (amy.helwig@ahrq.hhs.gov) • Initiative Coordinator • Evelyn Gallego-Haag (evelyn.gallego@siframework.org) • Project Management • Jennifer Brush (jennifer.brush@esacinc.com) • Zachary May (zachary.may@esacinc.com) • Use Case & Functional Requirements Development • Presha Patel (presha.patel@accenture.com) • Jennifer T. Sisto (jennifer.t.sisto@accenturefederal.com) • Standards Development Support • Caryn K. Just (caryn.k.just@accenturefederal.com)