Standards & Interoperability Framework Overview

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

2. Agenda and Goals for Today 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 National Coordinator Office of Chief Scientist Office of Economic Analysis and Modeling Office of the Chief Privacy Officer Deputy National Coordinator for Operations Deputy National Coordinator for Programs & Policy Office of Communications Office of Policy and Planning Office of Oversight Office of Interoperability and Standards Office of Mission Support Office of Provider Adoption Support Office of Strategic Initiatives Office of State and Community Programs Office of Grants Management

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

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.

6. THE ONC STANDARDS AND INTEROPERABILITY FRAMEWORK

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

8. Why Do We Need an Interoperability Framework? “Whitepapers Are Not Specifications” David Linthicum, OMG SOA Healthcare Conference 2010

9. Why Do We Need an Interoperability Framework? 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 • 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

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

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

12. S&I Framework Overview Standards and Interoperability Architecture Refinement and Management VALUE / OUTPUTS 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.

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

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

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

16. Managing to outcomes and contracts through an agile process with iterative activities Strategic Steering Committees Initiative Steering Committee LAB Harmonization Implementation Specifications Reference Implementation Use Case Certification/Testing Feedback Loop Pilot Demonstrations BENEFITS/VALUE/OUPUTS • 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.

17. S&I ACTIVITIESUse Cases and Harmonization Harmonization ofCore Concepts Use Case Developmentand Functional Requirements • 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

18. S&I ACTIVITIESStandards Development and Implementation Specs StandardsDevelopment ImplementationSpecifications • 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

19. S&I ACTIVITIESReference Implementation and Pilots ReferenceImplementation Pilot DemonstrationProjects 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

20. S&I ACTIVITIESCertification and Testingand Tools and Services Certification andTesting Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) 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

21. Addressing Challenges for the Health Information Exchange Model

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

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

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)

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

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

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

28. What’s Next Pilot Demonstration Projects Standards Development Harmonization ofCore Concepts (NIEM framework) Reference Implementation Implementation Specifications Certificationand Testing Use Case Developmentand Functional Requirements Publish & Implement Build & Validate Scenario Planning Analyze Requirements Assemble & Document Map & Model IEPD Lifecycle 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

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

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

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 fromthis 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

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

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

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

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