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

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

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Interoperability Framework Overview

March 24, 2010

Presented by:

Douglas Fridsma, MD, PhDActing Director, Office of Interoperability & Standards ONC

HIT Standards Committee

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

04/18/23

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

04/18/23

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

FocusedCollaboration

A Thousand Flowers Bloom

Commandand Control

Low High

Participation

Classic

Trade-Off

Lo

wH

igh

Focus

Bottom Up Innovation within aCoordination Framework

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)

5

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

6

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

Use Case Developmentand FunctionalRequirements

Use Case Developmentand FunctionalRequirements

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

• 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 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

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

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 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 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

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)

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 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 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 ofCore Concepts (NIEM

framework)

Harmonization ofCore Concepts (NIEM

framework)

Patient Discovery

Qualityreporting

DischargeSummary

Provider address lookup

FutureDomains

E-prescribingLab data exchange

PHR exchange

Patient summary

Child and Family

Services

CommonCore

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.

04/18/23

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)

Additional services and tools for harmonization

04/18/23

Use Case Model

Repository

Use Case Model

Repository

OpenMDR Based

Metadata Repository

OpenMDR Based

Metadata Repository

Service RegistryService Registry

LexGrid Based Vocabulary

Services

LexGrid Based Vocabulary

Services

Use Case Development

and Functional Requirements

Use Case Development

and Functional Requirements

Harmonization ofCore Concepts

Harmonization ofCore Concepts

Implementation Specifications

Implementation Specifications

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 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

StandardsDevelopment

StandardsDevelopment

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

13

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

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

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 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 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

Reference Implementation

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)

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

15

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

Pilot Demonstration Projects

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)

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

16

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

Certificationand TestingCertificationand 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)

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

17

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

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

18

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