1. Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

2. Agenda and Goals for Today »Opening Remarks and Introduction »Background on ONC »Overview of the S&I Framework »Break »Brief presentations from each of the S&I Teams »Q&A Session »Break »Administrative Session – This will be a closed section (limited to only S&I Team members and contractors) 2/11/2014

3. ONC Organizational Chart 2/11/2014

4. Standards and Interoperability Organizational Structure Standards and Interoperability Standards National Health Information Network Certification and Testing FHA Standards Teams NHIN Teams Certification Team FHA Teams Use Cases (Accenture) Use Cases (Accenture) Standards Development (TBD) Standards Development (TBD) Harmonization (Deloitte) Harmonization (Deloitte) Spec Factory (Deloitte) Spec Factory (Deloitte) Architecture Reference Implementations (Lockheed Martin) Reference Implementations (Lockheed Martin) Emergent Pilots (Lockheed Martin) Emergent Pilots (Lockheed Martin) Tools (Stanley) Tools (Stanley) Operations (Stanley) Operations (Stanley) Certification (Stanley/Deloitte) Certification (Stanley/Deloitte) Test Infrastructure (Stanley/Deloitte) Test Infrastructure (Stanley/Deloitte) CONNECT (TBD) CONNECT (TBD)

5. S&I 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 An Introduction to S&I Framework and NIEM

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 »Next Steps (discussion)

8. ONC Standards and Interoperability Framework 8 Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) (Stanley) Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) (Stanley) Use Case Development and Functional Requirements (Accenture) Use Case Development and Functional Requirements (Accenture) Standards Development (TBD) Standards Development (TBD) Certification and Testing (Stanley/Deloitte) Certification and Testing (Stanley/Deloitte) Harmonization of Core Concepts (Deloitte) Harmonization of Core Concepts (Deloitte) Implementation Specifications (Deloitte) Implementation Specifications (Deloitte) Pilot Demonstration Projects (Lockheed Martin) Pilot Demonstration Projects (Lockheed Martin) Reference Implementation (Lockheed Martin) Reference Implementation (Lockheed Martin)

9. Why do we need an interoperability framework?

10. »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 SDOs 2/11/2014

11. 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 Stewart, but there are additional roles throughout the process. Control Points: Need prioritization, validation or approval of artifacts to ensure quality and alignment with goals

12. S&I Activities Use Cases and Harmonization »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 12 Use Case Development and Functional Requirements Harmonization of Core Concepts

13. S&I Activities Standards Development and Implementation Specs »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 13 Standards Development Implementation Specifications

14. S&I Activities Reference Implementation and Pilots »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 14 Pilot Demonstration Projects Reference Implementation

15. S&I Activities Certification and Testing and Tools and Services »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 15 Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) Certification and Testing

16. S&I Coordination (Artifacts, Roles and Controls) 2/11/2014 Core artifacts are versioned and controlled Artifacts are packaged and released Each artifacts has a responsible role Artifacts and releases have prioritization and approval points, or controls

17. What is an IEPD? »An Information Exchange Package Documentation (IEPD) is a collection of artifacts that describe the construction and content of an information exchange Developed to provide the business, functional, and technical details of the information exchange through predefined artifacts Created with a core set of artifacts in a prescribed format and organizational structure to allow for consistency Designed to be shared and reused in the development of new information exchanges through publication in IEPD repositories IEPDs contain design specifications for an information exchange but may not include supplementary information such as implementation decisions. 2/11/2014

18. NIEM Process From NIEM website http://www.niem.gov/index.php IEPD: Information Exchange Package Documentation

19. The IEPD Artifacts IEPDs contain both required and recommended artifacts Required : Bold Recommended : Italic Note: Best practices for most organizations include many of the optional artifacts listed here Business Process Use Cases Sequence Diagrams Business RulesBusiness Requirements Exchange Content Model Mapping Document Subset Schema Exchange Schema XML Wantlist Constraint Schema Extension Schema Main Document IEPD Catalog IEPD Metadata Sample XML Instances XML Stylesheets Scenario Planning Analyze Requirements Map & Model Build & Validate Assemble & Document Publish & Implement No required artifacts. Publish the IEPD to a repository and implement the exchange

20. S&I NIEM Harmonization Strategy »ONCs Office of Interoperability and Standards is building a Health Information Exchange Model (NIEM Health) that is harmonized with NIEM »Health and Human Services petal to serve as bridge between NIEM and NIEM Health 20 Human Services Health and Human Services

21. Capability Elaboration Capability Formulation Construction Release & Publication Use Case Development Spec Development Harmonization Reference Impl Cert &Testing S&I Development Phases S&I Governance Health Community Participants Scenario Planning Analyze Requirements Map & Model Build & Validate Assemble & Document Pub. & Impl. NIEM Lifecycle S&I NIEM Process Harmonized

22. 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 NIEM 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

23. Model Centric Specification Development »The S&I Framework uses models to capture the information required to specify exchanges between parties on the NHIN. 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

24. 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

25. 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)

26. 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

27. Prioritization and Backlog Lists 2/11/2014 Strategic Priorities Strategic Priorities Operational Priorities Day to Day Priorities within each functional team

28. Examples of stakeholder coordination 2/11/2014 HITPC VLER NHIN CC FHA HIT SC VLER NHIN TC FHA Other important stakeholders: SDOs Providers Venders Consumers States HIEs

29. Whats Next »Create a NIEM Health standards harmonization process and governance framework »Establish roadmap for existing NHIN standards, MU harmonization, and non-MU health information exchange specifications »Establishes a repeatable, iterative process for developing widely reusable, computable implementation specifications »Establishing the tooling and repositories needed »Establishing the practices and guidelines for modeling »Enables semantic traceability so that useable code can be traced back to original requirements and definitions »Promotes transparency and collaboration from broad range of health stakeholders Scenario Planning Map & Model Analyze Requirements Build & Validate Assemble & Document 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 NIEM IEPD Lifecycle

30. Bottom up use case development within a top- down coordination framework 30 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

31. Final Thoughts »Dont let perfect be the enemy of the good »Incremental, iterative, and value-focused »Dont forget the little guy 2/11/2014

32. QUESTIONS? 2/11/2014