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Interoperability Framework OverviewHealth Information Technology (HIT) Standards Committee
June 24, 2010
Presented by:
Douglas Fridsma, MD, PhDActing Director, Office of Interoperability & Standards, Office of the National Coordinator for Health Information Technology (ONC)
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
04/20/23
Bottom up use case development within a top-down coordination framework
3
National Health Information Network (NHIN) Direct + Interoperability Framework = Focused Collaboration
FocusedCollaboration
A Thousand Flowers Bloom
CORE PRINCIPLES
Prioritization
Transparency
Engagement
Rapid Results
Commandand Control
Low High
Participation
Classic
Trade-Off
Lo
wH
igh
Focus
Bottom Up Innovation within aCoordination Framework
4
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Use Case Developmentand Functional Requirements
Use Case Developmentand Functional Requirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)
Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
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 Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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 ofCore Concepts (NIEM
framework)
Harmonization ofCore 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
Standards Development
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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 ofCore Concepts (NIEM
framework)
Harmonization ofCore 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 Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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
Reference Implementation
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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.
04/20/23
Patient Discovery
Qualityreporting
DischargeSummary
Provider address lookup
FutureDomains
E-prescribingLab data exchange
PHR exchange
Patient summary
Child and Family
Services
CommonCore
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)
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
StandardsDevelopment
StandardsDevelopment
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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
ImplementationSpecifications
ImplementationSpecifications
» 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 Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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
Reference Implementation
» Example: CONNECT software could potentially be the reference implementation of NHIN specifications and standards
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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
Pilot Demonstration Projects
» NHIN Trial Implementations» NHIN Limited Production
Exchange» NHIN Direct Project
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Certification and Testing
» Culmination of prior activities» NIST can help create test
harnesses to ensure conformance with specifications
14
Certificationand TestingCertificationand Testing
National Institute of Standards and Technology (NIST) Conformance tools
Tools and resources for certification processes
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand Testing
Certificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
Bottom Up Innovation within aCoordination Framework
16
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
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
ReferenceCode Set
Use Case Developmentand Functional Requirements
Use Case Developmentand Functional Requirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)
Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
J J A S O N D J F M A M J J A S O NJ 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)
Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Use Case Developmentand FunctionalRequirements
Use Case Developmentand FunctionalRequirements
Standards Development
Standards Development
Certificationand TestingCertificationand Testing
Harmonization ofCore Concepts (NIEM
framework)
Harmonization ofCore Concepts (NIEM
framework)Implementation Specifications
Implementation Specifications
Reference Implementation
Reference Implementation
Implementation Specifications
Implementation Specifications
Pilot Demonstration Projects
Pilot Demonstration Projects
Reference Implementation
Reference Implementation
HITPC P&S Tiger Team Policy Framework
HITPC P&S Tiger Team Policy Framework
HITPC + HITSCSpecification Policy Review
HITPC + HITSCSpecification Policy Review
HIT Standards Committee Review
HIT Standards Committee Review
NHIN Inclusion Evaluation
NHIN Inclusion Evaluation
Other Standards Governance Evaluations
Other Standards Governance Evaluations
NHIN Direct Example