1. Interoperability Framework Overview March 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting Director, Office of Interoperability & Standards ONC HIT Standards Committee

2. Lessons learned from HITSP »Standards are not imposed, they are adopted To improve adoption, solve real problems, not abstract ones Engage the community for a sense of ownership »Standards should be harmonized and commissioned based on clearly articulated priorities Governance is necessary to coordinate and prioritize »Adoption is accelerated by tools including vocabulary registries and easy to use sources for implementation guidance. Tools improve adoption Make implementation specifications easy to use and, well, specific »Keep it as a simple as possible but no simpler - the parsimony principle Don’t boil the ocean Solve real focused, problems »Perfection is the enemy of the good Iteratively improve 6/28/2015

3. Continuing the work of HITSP »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 6/28/2015

4. Bottom up use case development within a top- down coordination framework 4 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

5. Bottom Up Innovation within a Coordination Framework Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) 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

6. 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 6 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Use Case Development and Functional Requirements Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

7. Harmonization of Core Concepts »Need to have a strong harmonization framework that spans different standards organizations XML/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 7 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation 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 Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

8. Harmonization of Core Concepts »Standards harmonization Leverage best practices Use the NIEM processes Create explicit data exchange package that describe the data elements, vocabularies and value sets »Service harmonization Leverage services aware enterprise framework (SAEF) –Information model – Services description –Conformance description –Governance (business rules) descriptions »Policy descriptions Harmonization of policies is a challenge 8 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation 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) Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

9. What is the NIEM process? »National Information Exchange Model »Started as a DoJ initiative, but the processes have been generalized Supported data integration and reporting for Recovery.gov Used by HHS to support child and family services Recommended by OMB as best practice Used by state and local governments 9 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) Harmonization of Core Concepts (NIEM framework) 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

10. 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. 6/28/2015 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)

11. Additional services and tools for harmonization 6/28/2015 Use Case Model Repository OpenMDR Based Metadata Repository Service Registry LexGrid Based Vocabulary Services Use Case Development and Functional Requirements Harmonization of Core Concepts Implementation Specifications

12. 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 12 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Standards Development Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

13. 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 13 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation 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 Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

14. Reference Implementation »Specification must be tested to make sure they are implementable »Can be used by others to help guide their own implementation or find problems with specifications »Encourages feedback to ONC 14 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation »Example: CONNECT software could potentially be the reference implementation of NHIN specifications and standards Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

15. Pilot Demonstration Projects »Reference implementation in use by stakeholders »Confirms use case is being supported »ONC should provide coordination of pilot demonstrations 15 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Pilot Demonstration Projects »NHIN Trial Implementations »NHIN Limited Production Exchange »NHIN Direct Project Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

16. Certification and Testing »Culmination of prior activities »NIST can help create test harnesses to ensure conformance with specifications 16 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation Certification and Testing NIST Conformance tools Tools and resources for certification processes Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

17. Tools and Services »Make the process as automated and self-serve as possible »Leverage tools & services in future efforts 17 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

18. Bottom Up Innovation within a Coordination Framework 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 18 Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation