1. Standards & Interoperability Framework Overview Doug Fridsma, MD, PhD Director, Office of Interoperability & Standards ONC IHE North American Connectathon 2011 Chicago, IL

2. Agenda and Goals for Today 2 »Opening Remarks and Introduction »Background on ONC/Office of Interoperability & Standards »Overview of the S&I Framework »Q&A Session

3. ONC HIT Organizational Chart 3 Office of Chief Scientist National Coordinator Office of Economic Analysis and Modeling Deputy National Coordinator for Operations Deputy National Coordinator for Programs & Policy Office of the Chief Privacy Officer Office of Communications Office of Oversight Office of Mission Support Office of Strategic Initiatives Office of Policy and Planning Office of Interoperability and Standards Office of Provider Adoption Support Office of State and Community Programs Office of Grants Management

4. Office of Interoperability & Standards Organizational Structure Standards Nationwide Health Information Network Certification and Testing Federal Health Architecture Teams Standards Teams Nationwide Health Information Network Teams Certification Teams Federal Health Architecture Teams 4 Interoperability & Standards CONNECTCertification Test Infrastructure Architecture Reference Implementations Emergent Pilots Tools Operations Use Cases Standards Support Harmonization Spec Factory

5. S&I Framework Mission »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. 5

6. THE ONC STANDARDS AND INTEROPERABILITY FRAMEWORK 6

7. Outline »The ONC S&I Framework (what is it, why is it, how does it work) Activities and Processes National Information Exchange Model Information Exchange Package Documentation »Model-Centric Specifications For Healthcare Data Exchange The Approach – Model Centric Specification 7

8. Why Do We Need an Interoperability Framework? 8

9. »Move toward more “computational” implementation specifications (IS) Scalable processes Ability to develop tools to increase the efficiency of IS development and maintenance The importance of developing IS that are explicit and subject to less interpretation »Link use cases and standards from inception to certification Keep the certification processes tightly linked to the standards and IS processes Support tool development for certification testing Develop the testing for compliance at the same time as developing the standards »Integrate multiple SDOs with different expertise across the process Transport packages Vocabulary Value sets Security »Provide repeatable mechanisms for harmonization and integration of existing standards across SDO 9

10. S&I Organizing Principles »Not a “waterfall” Process: Developing and harmonizing standards and service specifications across diverse communities necessitates concurrent, agile activities »Need for Structured Coordination: To manage coordination of the concurrent activities within the framework, we need well defined: Artifacts: We need to ensure the content and structure of the artifacts within the process are well defined and provide continuity within the activities and the tools. Roles: Clear “ownership” of significant artifacts and activities must be assigned to ensure coordination, to reduce duplication and to maintain continuity throughout the process. An example of this is the Use Case Steward, but there are additional roles throughout the process. Control Points: Need prioritization, validation or approval of artifacts to ensure quality and alignment with goals 10

11. Bottom Up Use Case Development Within a Top-down Coordination Framework NHIN Direct + Interoperability Framework = Focused Collaboration CORE PRINCIPLES Prioritization Transparency Engagement Rapid Results Focused Collaboration A Thousand Flowers Bloom Command and Control LowHigh Participation Classic Trade-Off Low High Focus 11

12. Standards and Interoperability Architecture Refinement and Management S&I Framework Overview The Standards and Interoperability (S&I) Framework is a set of integrated functions, processes, and tools being guided by the healthcare and technology industry to achieve harmonized interoperability for healthcare. VALUE / OUTPUTS 12

13. S&I Framework Overview HITPC HITSC SDOs Federal Partners ONC Healthcare Community S&I Steering Team Initiative Steering Committee S&I Framework ONC Policy Steering 13

14. 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 http://wiki.siframework.org 14

15. Contract Team Initiative Steering Committee Coordination should ensure alignment across and within initiatives Use Case Harmonization Implementation Specifications Reference Implementation Certification/Testing ( Certification/Testing ( Strategic Steering Committees Pilot Demonstrations LAB Consolidation project CLINICAL CARE SUMMARY (C32) SDOs and Community Stakeholders PRIORITY 4 VALUE/OUPUTS 15

16. Managing to outcomes and contracts through an agile process with iterative activities »Need to ensure that the leadership are aware of key lessons learned and risks and issues throughout the process. Need to discover specification gaps and ambiguities during design, not after publication during implementation. Need to ensure alignment across and within initiatives. »Key Requirements: Formal and Informal Feedback Loop Iterative activities and milestones Process for distinguishing between failed contractual performance and unattainable objectives. Use Case Harmonization Implementation Specifications Reference Implementation Certification/Testing Pilot Demonstrations LAB BENEFITS/VALUE/OUPUTS Feedback Loop Initiative Steering Committee Strategic Steering Committees

17. »Engages a wide community in defining use cases to be driven through the process »Focus on solving a real problem Determines scope Able to “test” if the use case solves the problem Prevents “analysis paralysis” Does not model in the abstract Open, transparent process »Output Business Scenarios should describe Services Standards Business rules, trust, policies »Output can be captured as Use Cases and Activity Diagrams Collaborations BPMN Etc… »Use-case driven (bottom up) with top down coordination »Multiple use cases might have overlapping standards, services or policies E-prescribing and adverse event reporting Clinical care summary and quality reporting Laboratory data exchange and clinical decision support »Need to have a strong harmonization framework that spans different standards organizations Use Case Development and Functional Requirements Harmonization of Core Concepts 17 S&I ACTIVITIES Use Cases and Harmonization

18. »As part of the use case development and harmonization process gaps in standards may arise »Gaps may exist in Data package Value Sets Services »Work with SDOs (NLM, HL7, IHE etc) to fill in gaps »Allows the standards work to proceed in parallel with development of the implementation specifications »Using a model-centric approach to provide sufficient details to support implementation »Implementation Specification is an explicit description of the Standards Services Policies »Specifications are packaged together to support use cases and business scenarios »Create guidelines for development of reference implementation 18 S&I ACTIVITIES Standards Development and Implementation Specs Standards Development Implementation Specifications

19. »Executable implementations of specifications »Can be used by others to help guide their own implementation or find problems with specifications »Encourages feedback to ONC »Reference implementations in use by stakeholders »Confirms use case is being supported »ONC helps provide coordination of pilot demonstrations 19 S&I ACTIVITIES Reference Implementation and Pilots Reference Implementation Pilot Demonstration Projects

20. Certification and Testing »Provides mechanisms and infrastructure for testing specification implementations »Includes conformance testing for individual specifications as well as interoperability testing for business scenarios »Tools and Tests can be used as part of ONC Certification »Tools and Repositories used to support the other S&I activities »Example IEPD and model repositories Vocabulary sets Modeling tools and guidelines Collaboration tools »Will leverage existing tools and repositories whenever possible »Many of the repositories and collaboration tools to be publically available Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) 20 S&I ACTIVITIES Certification and Testing and Tools and Services

21. Addressing Challenges for the Health Information Exchange Model ChallengeApproach Existence of disparate health information exchange standards and specifications and implementation approaches Map exchange requirements to existing standards & specifications and address any gaps, duplications, or overlaps Harmonization and management of several well-established, large vocabularies for semantic interoperability Leverage existing vocabulary repositories (e.g. PHIN VADS), coordinate with Unified Medical Language System (UMLS), and collaborate with standards development organizations Usability of existing HIT exchange protocols and specifications Use NIEM processes and adapt supporting tools to create computable, useable implementation specifications IEPD only addresses data content, but transaction behavior and security provisions are necessary for health information exchange Adapt structure and content of S&I IEPD to incorporate transport and security aspects of exchange Compatibility of S&I IEPDs with existing NIEM infrastructure and tools, as well as existing health information exchange protocols Develop and adapt NIEM and health information technology tools and framework to support NHIN goals 21

22. Model-centric Specification Development »The S&I Framework uses models to capture the information required to specify exchanges between parties on the NWHIN. This supports the 2 primary goals of the S&I Framework To aid in the creation of specifications that are less ambiguous than specs traditionally done using word processing tools. To support the creation of specifications by other groups »Models refers largely to the visual representation of exchange syntax, semantics, dependencies and rules. »By using models the S&I Framework intends to: Establish a repeatable pattern for evolution and traceability from requirements to implementation of specifications Provides for the implementation of specifications using multiple possible technologies Support the composability and reuse among specifications Support the creation of specifications by groups outside ONC by providing guidelines, patterns, repositories and tools 22

23. Requirements for a Model-centric Approach »The modeling approach used by the S&I Framework must Provide traceability from Use Case and Requirements through to one or more implementations Provide semantic and syntactic modeling constructs to support defining the information and behavior that are part of exchanges Support the need to harmonize with existing standards defined at different levels of abstraction Be adoptable by different organizations Be able to integrate into NIEM process 23

24. Model-centric Solution - MDA »Base S&I Framework modeling on the 3 OMG/MDA model abstractions. Computational Independent Model (CIM) Platform Independent Model (PIM) Platform Specific Model (PSM) »Define a mechanism to show traceability from Use Cases and Functional Requirements through to technical bindings defined in a PSM. »Define a flexible modeling foundation by which different types of specifications can be defined. »Provides ability for multiple technology bindings for the same set of logical specifications (multiple PSMs) 24

25. Specification Models NIEM Processes and Artifacts S&I Activities Harmonization of Core Concepts Implementation Specifications Reference Implementation and Pilots Business Processes, Use Cases Business Rules, Business Requirements Exchange Content Model, Mapping Document Exchange Schema, Subset/Constraint Schema, Main Document, IEPD Catalog, IEPD Metadata, Sample XML Vision Document, Process Model Use Case Model, Interaction Model, Domain Model Behavior Model Domain Model Web Services Schema and WSDL Use Case Development and Functional Requirements Certification and Testing CIM PIM PSM Scenario Planning Analyze Requirements Map and Model Publish and Implement Build and Validate Assemble and Document Model-centric Solution - NIEM 25

26. Prioritization and Backlog Lists Strategic Priorities Strategic Priorities Operational Priorities “Day to Day” Priorities within each functional team 26 PRIORITIZED CAPABILITIES AND TEAM BACKLOGS Strategic Prioritization Body Prioritizes high-level capabilities list based on established criteria Strategic Prioritization Body Prioritizes high-level capabilities list based on established criteria Scenario Prioritization Body Regularly prioritizes scenarios list based on business needs Scenario Prioritization Body Regularly prioritizes scenarios list based on business needs Use Case Team Maintain work backlog that maps into the master prioritized capabilities Use Case Team Maintain work backlog that maps into the master prioritized capabilities Spec Factory Team Maintain work backlog that maps into the master prioritized capabilities Spec Factory Team Maintain work backlog that maps into the master prioritized capabilities Team X.... Master Prioritized Capabilities Prioritized Business Scenarios Traceability and Alignment of Priorities Use Case Backlog Spec Backlog

27. Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation HITPC VLER NHIN CC FHA HIT SC VLER NHIN TC FHA Examples of Stakeholder Coordination SDOs Providers Venders 27 Consumers States HIEs Other important stakeholders:

28. What’s Next »Create a Health standards harmonization process and governance framework »Establish roadmap for existing NHIN standards, MU harmonization, and non-MU health information exchange specifications »Establish a repeatable, iterative process for developing widely reusable, computable implementation specifications »Establish the tooling and repositories needed »Establish the practices and guidelines for modeling »Enable semantic traceability so that useable code can be traced back to original requirements and definitions »Promote transparency and collaboration for a broad range of health stakeholders Scenario Planning Map & Model Map & Model Analyze Requirements Build & Validate Build & Validate Assemble & Document Assemble & Document Publish & Implement Publish & Implement Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation IEPD Lifecycle 28

29. Recently Launched Initiatives Transition of Care – Launched 1/7 Supports Meaningful Use Stage 1 requirements for exchange of data during Transition of Care Enable clinical summary validation services to ensure providers can understand information Reduce template development timeline Proposed timeline: Pilot & Testing complete by September 2011, revision to NPRM of Standards & Requirements by December 2011 29

30. Recently Launched Initiatives Lab Interface – Launched 1/7 Incorporate lab results into EHR as structured data. Supports objectives for Decision Support, Quality Reporting, Transitions in Care, and Electronic copies of Clinical Summaries and Discharge Instructions. Achieve cost savings of up to 90% due to lab interface development improvements by 2015 Reduce total lab interface implementation time by up to 20% by 2013 Proposed timeline: Pilot & Testing complete by September 2011, revision to NPRM of Standards & Requirements by December 2011 30

31. Recently Launched Initiatives Consolidation Project – Launched 1/4 Health Story, IHE, and HL7 are collaborating in this initiative to harmonize and consolidate current CDA implementation guides in order to ease implementation challenges. Volunteer effort is being hosted within ONC's Standards and Interoperability (S&I) Framework and facilitated with the support of ONC S&I Contractors. Consolidate the implementation guides for the eight HL7/Health Story clinical document types into a single library of CDA Templates and use model-driven tools to re-publish them from this library. Update and harmonize C32 while addressing known issues (ambiguity, gaps, etc.) Rapid demonstration of templated CDA as a data element centric paradigm for health information exchange, corresponding to PCAST recommendations Harmonize HL7 and IHE templates, establishing a strong process for future collaboration NOT a content review Proposed timeline: Pilot testing in June/July 2011, revision to NPRM of Standards & Requirements by October 2011 31

32. Bottom Up Use Case Development Within a Top-down Coordination Framework NHIN Direct + Interoperability Framework = Focused Collaboration CORE PRINCIPLES Prioritization Transparency Engagement Rapid Results Focused Collaboration A Thousand Flowers Bloom Command and Control LowHigh Participation Classic Trade-Off Low High Focus 32

33. Final Thoughts Don’t let perfect be the enemy of the good Incremental, iterative, and value-focused Don’t forget the little guy 33

34. Call for Participation »This is an Open Government Initiative »We value your input and seek your participation in S&I Framework Initiatives to help us achieve successful outcomes! »Complete information on how to get involved: http://jira.siframework.org/wiki/display/SIF/Getting+Started+as+a+Volunteer 34

35. QUESTIONS? 35 Learn more at http://wiki.siframework.orghttp://wiki.siframework.org

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