1. Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting Director, Office of Interoperability & Standards, Office of the National Coordinator for Health Information Technology (ONC)

2. Goals of the Standards and Interoperability Framework »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 and IS »Integrate multiple SDOs with different expertise across the process Transport packages Vocabulary Value sets Security 10/17/2015

3. Bottom up use case development within a top- down coordination framework 3 National Health Information Network (NHIN) Direct + Interoperability Framework = Focused Collaboration Focused Collaboration A Thousand Flowers Bloom CORE PRINCIPLES Prioritization Transparency Engagement Rapid Results Command and Control LowHigh Participation Classic Trade-Off Low High Focus

4. Bottom Up Innovation within a Coordination Framework 4 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

5. Use Case Development and Functional Requirements »Example of a use case provider wants to send a referral to a specialist electronically »Use case describes Services Standards (package) Business rules, trust, policies That are necessary to satisfy the use case The process should »Engage a wide community in defining the use cases »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 »Establish a “use case steward” to shepherd the use cases through the entire process »Output is a clear description (in a computable form) that describes the standards, services and policies necessary to describe the use case 5 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

6. Harmonization of Core Concepts »Need to have a strong harmonization framework that spans different standards organizations eXtensible Markup Language (XML)/Unified Modeling Language (UML) computational descriptions of the use cases Strong governance and transparent processes Use-case driven (bottom up) with top down coordination »Harmonization processes need to describe Standards Services Policies In standard ways 6 Harmonization of Core Concepts (NIEM framework) »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 Standards Development Use Case Development and Functional Requirements Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

7. Harmonization of Core Concepts »Standards harmonization Leverage best practices Use the National Information Exchange Model (NIEM) processes Create explicit data exchange package that describe the data elements, vocabularies and value sets »Service harmonization Information model Services description Conformance description Governance (business rules) descriptions »Policy descriptions Harmonization of policies is a challenge 7 Harmonization of Core Concepts (NIEM framework) »Three parts to harmonization Description of the standards (the data that is exchanged) Description of the services (the functions that will be supported in the exchange) Description of the policy (trust, business rules, 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 Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

8. What is the NIEM process? »National Information Exchange Model »Started as a Department of Justice (DoJ) initiative, but the processes have been generalized Supported data integration and reporting for Recovery.gov Used by Department of Health & Human Services (HHS) to support child and family services Recommended by Office of Management and Budget (OMB) as best practice Used by state and local governments 8 Reference Implementation Harmonization of Core Concepts (NIEM framework) Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

9. What is the NIEM framework? »A common core of concepts, explicitly defined, that are shared across different use cases or domains »Naming and modeling conventions that allow different groups to work independently but harmonize the work together »Based on the ISO-11179 metadata standard used by the (NCI), NLM, and standards organizations. 10/17/2015 Patient Discovery Quality reporting Discharge Summary Provider address lookup Future Domains E-prescribingLab data exchange PHR exchange Patient summary Child and Family Services Common Core Harmonization of Core Concepts (NIEM framework)

10. Standards Development »Gaps in existing standards Data package Value sets Services »Can be identified as part of the use case development and harmonization process »Work with SDOs (NLM, HL7 etc) to fill in gaps »Allows the standards work to proceed in parallel with development of the implementation specifications 10 Standards Development Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

11. Implementation Specifications »If the standards, services and policies are the ingredients, then the implementation specification is the recipe »Packaged together to support use cases »Guides development of reference implementation »Interim Final Rule requires creation of Implementation Specifications where they don’t exist 11 Implementation Specifications »An implementation specification becomes a explicit description of the Standards Services Policies »That conform to adopted standards and have sufficient detail to be implemented Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

12. Reference Implementation »Specification must be tested to make sure they can be implemented »Can be used by others to help guide their own implementation or find problems with specifications »Encourages feedback to ONC 12 Reference Implementation »Example: CONNECT software could potentially be the reference implementation of NHIN specifications and standards Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

13. Pilot Demonstration Projects »Reference implementation in use by stakeholders »Confirms use case is being supported »ONC should provide coordination of pilot demonstrations 13 Pilot Demonstration Projects »NHIN Trial Implementations »NHIN Limited Production Exchange »NHIN Direct Project Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

14. Certification and Testing »Culmination of prior activities »NIST can help create test harnesses to ensure conformance with specifications 14 Certification and Testing National Institute of Standards and Technology (NIST) Conformance tools Tools and resources for certification processes Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

15. Tools and Services »Make the process as automated and self-serve as possible »Leverage tools & services in future efforts 15 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

16. Bottom Up Innovation within a Coordination Framework 16 Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) Information Model, Services, and Value Sets Harmonized/ Implementation Specification Integration Testing and Implementation Reference Code Set Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation

17. S&I and HITSC Activities NHIN Direct Activities J J A S O N D J F M A M J J A S O N 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 Reference Implementation Implementation Specifications Pilot Demonstration Projects Reference Implementation HITPC Activities HITPC P&S Tiger Team Policy Framework HITPC + HITSC Specification Policy Review HITPC + HITSC Specification Policy Review HIT Standards Committee Review NHIN Inclusion Evaluation Other Standards Governance Evaluations NHIN Direct Example