interoperability framework overview health information technology (hit) standards committee june 24,...

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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)

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Page 1: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 2: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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

Page 3: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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

Page 4: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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

Page 5: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 6: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 7: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 8: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 9: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 10: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 11: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 12: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 13: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 14: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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)

Page 15: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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

Page 16: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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

Page 17: Interoperability Framework Overview Health Information Technology (HIT) Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting

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