1. Interoperability Framework
Overview
HIT Standards Committee
June 24, 2010
Presented by:
Douglas Fridsma, MD, PhD
Acting Director, Office of Interoperability & Standards
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
6/25/2010

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

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

5. Use Case Development Use Case Development and
and Functional
Requirements Functional Requirements
Standards Pilot Demonstration
Development Projects
The process should
Use Case Development Harmonization of
» Engage a wide community in
and Functional
Requirements
Core Concepts (NIEM
framework)
Implementation
Specifications
Reference
Implementation
Certification
and Testing
defining the use cases
» Focus on solving a real problem
Tools and Services
(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) • Determines scope
• Able to “test” if the use case
solves the problem
» Example of a use case • Prevents “analysis paralysis”
• provider wants to send a referral • Does not model in the abstract
to a specialist electronically • Open, transparent process
» Use case describes » Establish a “use case steward” to
• Services shepherd the use cases through the
• Standards (package) entire process
• Business rules, trust, policies » Output is a clear description (in a
That are necessary to satisfy the use computable form) that describes the
case standards, services and policies
necessary to describe the use case

6. Harmonization of
Core Concepts (NIEM
framework)
Harmonization of Core Concepts
Standards Pilot Demonstration
Development Projects
» Need to have a strong
harmonization framework that
Use Case Development Harmonization of
Implementation Reference Certification
spans different standards
organizations
and Functional Core Concepts (NIEM
Specifications Implementation and Testing
Requirements framework)
• XML/UML computational
Tools and Services
(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
descriptions of the use cases
• Strong governance and
transparent processes
• Use-case driven (bottom up)
» Multiple use cases might with top down coordination
have overlapping standards, » Harmonization processes need
services or policies to describe
• E-prescribing and adverse • Standards
• Services
event reporting
• Policies
• Clinical care summary and In standard ways
quality reporting
• Laboratory data exchange
and clinical decision
support

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

8. Harmonization of
Core Concepts (NIEM
framework)
What is the NIEM process?
Standards Pilot Demonstration
Development Projects
» National Information Exchange
Use Case Development
and Functional
Harmonization of
Core Concepts (NIEM
Implementation
Specifications
Reference
Implementation
Certification
and Testing
Model
Requirements framework)
» Started as a DoJ initiative, but the
Tools and Services
(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
processes have been generalized
• Supported data integration
and reporting for
Patient
Recovery.gov
• Used by HHS to support child
Discovery
Lab data E-prescribing
exchange
Provider Future and family services
address lookup Domains
Common • Recommended by OMB as
Discharge Core
Summary Quality
reporting
best practice
PHR
Child and • Used by state and local
Family
exchange
Patient summary
Services
governments

9. Harmonization of
Core Concepts (NIEM
framework)
What is the NIEM framework?
» A common core of concepts,
explicitly defined, that are shared
across different use cases or
Patient
Discovery
domains
Lab data E-prescribing
exchange » Naming and modeling
Provider
address lookup
Future conventions that allow different
Domains
Common
groups to work independently but
Discharge Core
Quality harmonize the work together
Summary
reporting
» Based on the ISO-11179 metadata
Child and
PHR Family
standard used by the NCI, NLM,
exchange
Patient summary
Services and standards organizations.
6/25/2010

10. Standards
Development
Standards Development
Standards Pilot Demonstration
Development Projects
» Gaps in existing standards
Use Case Development
and Functional
Requirements
Harmonization of
Core Concepts (NIEM
framework)
Implementation
Specifications
Reference
Implementation
Certification
and Testing
• Data package
• Value sets
• Services
Tools and Services
(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
» 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

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

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

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

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

15. Tools and Services
Standards Pilot Demonstration
Development Projects
» Make the process as
Use Case Development
and Functional
Harmonization of
Core Concepts (NIEM
Implementation
Specifications
Reference
Implementation
Certification
and Testing
automated and self-serve as
Requirements framework)
possible
Tools and Services
(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
» Leverage tools & services in
future efforts

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

17. NHIN Direct Example
J J A S O N D J F M A M J J A S O N
S&I and HITSC NHIN Direct
Activities
Implementation Reference Pilot Demonstration
Specifications Implementation Projects
Standards
Development NHIN Inclusion
HIT Standards Committee Review
Activities
Evaluation
Use Case Development Harmonization of
Implementation Reference Certification
and Functional
Requirements
Core Concepts (NIEM
framework)
Specifications Implementation and Testing Other Standards
Governance
Evaluations
Tools and Services
(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
HITPC Activities
HITPC P&S Tiger Team Policy
Framework
HITPC + HITSC
Specification Policy Review