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Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

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Page 1: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Standards & InteroperabilityKickoff

HHS – ONCSeptember 20, 2010

Office of Standards and Interoperability

1

Page 2: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Agenda and Goals for Today

» Opening Remarks and Introduction» Background on ONC » Overview of the S&I Framework » Break» Brief presentations from each of the S&I Teams» Q&A Session » Break» Administrative Session – This will be a closed section (limited to only

S&I Team members and contractors)

04/10/23

Page 3: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

ONC Organizational Chart

04/10/23

Page 4: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Standards and Interoperability Organizational Structure

Standards and InteroperabilityStandards and Interoperability

StandardsStandards National Health Information Network

National Health Information Network

Certification and Testing Certification and Testing

FHAFHA

Standards Teams

Standards Teams

NHIN TeamsNHIN Teams Certification Team

Certification Team

FHA TeamsFHA

Teams

Use Cases(Accenture)Use Cases(Accenture)

Standards Development

(TBD)

Standards Development

(TBD)

Harmonization(Deloitte)

Harmonization(Deloitte)

Spec Factory(Deloitte)

Spec Factory(Deloitte)

ArchitectureArchitecture

Reference Implementations

(Lockheed Martin)

Reference Implementations

(Lockheed Martin)

Emergent Pilots(Lockheed Martin)Emergent Pilots

(Lockheed Martin)

Tools(Stanley)

Tools(Stanley)

Operations(Stanley)

Operations(Stanley)

Certification(Stanley/Deloitte)

Certification(Stanley/Deloitte)

Test Infrastructure

(Stanley/Deloitte)

Test Infrastructure

(Stanley/Deloitte)

CONNECT(TBD)

CONNECT(TBD)

Page 5: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

S&I Mission

» Promote a sustainable ecosystem that drives increasing interoperability and standards adoption

» Create a collaborative, coordinated, incremental standards process that is led by the industry in solving real world problems

» Leverage “government as a platform” – provide tools, coordination, and harmonization that will support interested parties as they develop solutions to interoperability and standards adoption.

Page 6: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

THE ONC STANDARDS AND INTEROPERABILITY FRAMEWORK

An Introduction to S&I Framework and NIEM

Page 7: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Outline

» The ONC S&I Framework (what is it, why is it, how does it work)

• Activities and Processes

• National Information Exchange Model

• Information Exchange Package Documentation

» Model-Centric Specifications For Healthcare Data Exchange

• The Approach – Model Centric Specification

» Next Steps (discussion)

Page 8: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

ONC Standards and Interoperability Framework

8

Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

(Stanley)

Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

(Stanley)

Use Case Developmentand Functional Requirements(Accenture)

Use Case Developmentand Functional Requirements(Accenture)

Standards Development

(TBD)

Standards Development

(TBD)

Certificationand Testing

(Stanley/Deloitte)

Certificationand Testing

(Stanley/Deloitte)

Harmonization ofCore Concepts

(Deloitte)

Harmonization ofCore Concepts

(Deloitte)

Implementation Specifications

(Deloitte)

Implementation Specifications

(Deloitte)

Pilot Demonstration Projects

(Lockheed Martin)

Pilot Demonstration Projects

(Lockheed Martin)

Reference Implementation

(Lockheed Martin)

Reference Implementation

(Lockheed Martin)

Page 9: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Why do we need an interoperability framework?

Page 10: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Why do we need an 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» Integrate multiple SDOs with different expertise across the process

• Transport packages• Vocabulary• Value sets• Security

» Provide repeatable mechanisms for harmonization and integration of existing standards across SDOs04/10/23

Page 11: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

S&I Organizing Principles

• Not a “waterfall” Process: Developing and harmonizing standards and service specifications across diverse communities necessitates concurrent, agile activities

• Need for Structured Coordination: To manage coordination of the concurrent activities within the framework , we need well defined:

• Artifacts: We need to ensure the content and structure of the artifacts within the process are well defined and provide continuity within the activities and the tools.

• Roles: Clear “ownership” of significant artifacts and activities must be assigned to ensure coordination, to reduce duplication and to maintain continuity throughout the process. An example of this is the Use Case Stewart, but there are additional roles throughout the process.

• Control Points: Need prioritization, validation or approval of artifacts to ensure quality and alignment with goals

Page 12: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

S&I Activities Use Cases and Harmonization

» Engages a wide community in defining use cases to be driven through the process

» 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

» Output Business Scenarios should describe• Services• Standards• Business rules, trust, policies

» Output can be captured as • Use Cases and Activity Diagrams• Collaborations• BPMN• Etc…

» Use-case driven (bottom up) with top down coordination

» 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

» Need to have a strong harmonization framework that spans different standards organizations

12

Use Case Developmentand Functional Requirements

Harmonization ofCore Concepts

Page 13: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

S&I ActivitiesStandards Development andImplementation Specs

» As part of the use case development and harmonization process gaps in standards may arise

» Gaps may exist in

• Data package

• Value Sets

• Services

» Work with SDOs (NLM, HL7, IHE etc) to fill in gaps

» Allows the standards work to proceed in parallel with development of the implementation specifications

» Using a model-centric approach to provide sufficient details to support implementation

» Implementation Specification is an explicit description of the

• Standards

• Services

• Policies

» Specifications are packaged together to support use cases and business scenarios

» Create guidelines for development of reference implementation

13

Standards Development

Implementation Specifications

Page 14: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

S&I ActivitiesReference Implementation and Pilots

» Executable implementations of specifications

» Can be used by others to help guide their own implementation or find problems with specifications

» Encourages feedback to ONC

» Reference implementations in use by stakeholders

» Confirms use case is being supported

» ONC helps provide coordination of pilot demonstrations

14

Pilot Demonstration Projects

Reference Implementation

Page 15: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

S&I ActivitiesCertification and Testing and Tools and Services

» Provides mechanisms and infrastructure for testing specification implementations

» Includes conformance testing for individual specifications as well as interoperability testing for business scenarios

» Tools and Tests can be used as part of ONC Certification

» Tools and Repositories used to support the other S&I activities

» Example• IEPD and model repositories• Vocabulary sets• Modeling tools and guidelines• Collaboration tools

» Will leverage existing tools and repositories whenever possible

» Many of the repositories and collaboration tools to be publically available

15

Tools and Services(Use Case Development, Harmonization Tools, Vocabulary

Browser, Value Set Repository, Testing Scripts, etc)Certificationand Testing

Page 16: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

S&I Coordination (Artifacts, Roles and Controls)

04/10/23

Core artifacts are versioned and controlled

Core artifacts are versioned and controlled

Artifacts are “packaged”

and released

Artifacts are “packaged”

and released

Each artifacts has a

responsible role

Each artifacts has a

responsible role

Artifacts and releases have prioritization and approval

points, or “controls”

Artifacts and releases have prioritization and approval

points, or “controls”

Page 17: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

What is an IEPD?

» An Information Exchange Package Documentation (IEPD) is a collection of artifacts that describe the construction and content of an information exchange

• Developed to provide the business, functional, and technical details of the information exchange through predefined artifacts

• Created with a core set of artifacts in a prescribed format and organizational structure to allow for consistency

• Designed to be shared and reused in the development of new information exchanges through publication in IEPD repositories

• IEPDs contain design specifications for an information exchange but may not include supplementary information such as implementation decisions.

04/10/23

Page 18: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

NIEM Process

From NIEM website http://www.niem.gov/index.php

IEPD: Information Exchange Package Documentation

Page 19: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

The IEPD Artifacts

IEPDs contain both required and

recommended artifacts

Required : Bold

Recommended : Italic

Note: Best practices for most

organizations include many of the

optional artifacts listed here

Scenario Planning

Analyze Requirements

Map & Model

Build & Validate

Assemble & Document

Publish & Implement

No required artifacts. Publish the IEPD to a repository and implement the exchange

Page 20: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

S&I NIEM Harmonization Strategy

» ONC’s Office of Interoperability and Standards is building a Health Information Exchange Model (NIEM Health) that is harmonized with NIEM

» Health and Human Services petal to serve as bridge between NIEM and NIEM Health

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Human Services

Page 21: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

CapabilityElaboration

Capability Formulation

Construction Release & Publication

Use Case Development

Spec Development

Harmonization

Reference Impl

Cert &Testing

S&I Development Phases

S&I Governance

Health Community

Participants

Scenario PlanningScenario Planning Analyze Requirements

Analyze Requirements Map & ModelMap & Model Build &

ValidateBuild & Validate

Assemble & Document

Assemble & Document

Pub. & Impl.

Pub. & Impl.NIEM Lifecycle

S&I NIEM Process Harmonized

Page 22: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Addressing Challenges for the Health Information Exchange Model

Challenge Approach

Existence of disparate health information exchange standards and specifications and implementation approaches

Map exchange requirements to existing standards & specifications and address any gaps, duplications, or overlaps

Harmonization and management of several well-established, large vocabularies for semantic interoperability

Leverage existing vocabulary repositories (e.g. PHIN VADS), coordinate with Unified Medical Language System (UMLS), and collaborate with standards development organizations

Usability of existing HIT exchange protocols and specifications

Use NIEM processes and adapt supporting tools to create computable, useable implementation specifications

NIEM only addresses data content, but transaction behavior and security provisions are necessary for health information exchange

Adapt structure and content of S&I IEPD to incorporate transport and security aspects of exchange

Compatibility of S&I IEPDs with existing NIEM infrastructure and tools, as well as existing health information exchange protocols

Develop and adapt NIEM and health information technology tools and framework to support NHIN goals

Page 23: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Model Centric Specification Development

» The S&I Framework uses models to capture the information required to specify exchanges between parties on the NHIN. This supports the 2 primary goals of the S&I Framework

• To aid in the creation of specifications that are less ambiguous than specs traditionally done using word processing tools.

• To support the creation of specifications by other groups» Models refers largely to the visual representation of exchange syntax,

semantics, dependencies and rules. » By using models the S&I Framework intends to:

• Establish a repeatable pattern for evolution and traceability from requirements to implementation of specifications

• Provides for the implementation of specifications using multiple possible technologies

• Support the composability and reuse among specifications

• Support the creation of specifications by groups outside ONC by providing guidelines, patterns, repositories and tools

Page 24: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Requirements for a Model Centric Approach

» The modeling approach used by the S&I Framework must• Provide traceability from Use Case and Requirements

through to one or more implementations• Provide semantic and syntactic modeling constructs to

support defining the information and behavior that are part of exchanges

• Support the need to harmonize with existing standards defined at different levels of abstraction

• Be adoptable by different organizations• Be able to integrate into NIEM process

Page 25: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Model-Centric Solution - MDA

» Base S&I Framework modeling on the 3 OMG/MDA model abstractions.

• Computational Independent Model (CIM)• Platform Independent Model (PIM)• Platform Specific Model (PSM)

» Define a mechanism to show traceability from Use Cases and Functional Requirements through to technical bindings defined in a PSM.

» Define a flexible modeling foundation by which different types of specifications can be defined.

» Provides ability for multiple technology bindings for the same set of logical specifications (multiple PSMs)

Page 26: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Specification ModelsNIEM Processes and ArtifactsS&I Activities

Harmonization ofCore Concepts

Harmonization ofCore Concepts

Implementation Specifications

Implementation Specifications

Reference Implementation

and Pilots

Reference Implementation

and Pilots

Business Processes, Use

Cases

Business Rules, Business

Requirements

Exchange Content Model, Mapping

Document

Exchange Schema,

Subset/Constraint Schema,

Main Document, IEPD Catalog,

IEPD Metadata, Sample XML

Vision Document, Process Model

Use Case Model, Interaction Model,

Domain Model

Behavior ModelDomain Model

Web Services Schema and WSDL

Use Case Development

and Functional Requirements

Use Case Development

and Functional Requirements

Certification and Testing

Certification and Testing

CIM

PIM

PSM

Scenario Planning

Analyze Requirements

Map and Model

Publish and Implement

Build and Validate

Assemble and Document

Model Centric Solution - NIEM

Page 27: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Prioritization and Backlog Lists

04/10/23

Strategic Priorities Strategic Priorities

Operational Priorities

Operational Priorities

“Day to Day” Priorities within each functional

team

“Day to Day” Priorities within each functional

team

Page 28: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Examples of stakeholder coordination

04/10/23

HITPCHITPC

VLERVLER

NHIN CCNHIN CC

FHAFHA

HIT SCHIT SC

VLERVLER

NHIN TCNHIN TC

FHAFHA

Other important stakeholders:•SDOs•Providers•Venders•Consumers•States •HIEs

Page 29: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

What’s Next

» Create a NIEM Health standards harmonization process and governance framework» Establish roadmap for existing NHIN standards, MU harmonization, and non-MU

health information exchange specifications» Establishes a repeatable, iterative process for developing widely reusable,

computable implementation specifications» Establishing the tooling and repositories needed» Establishing the practices and guidelines for modeling» Enables semantic traceability so that useable code can be traced back to original

requirements and definitions» Promotes transparency and collaboration from broad range of health stakeholders

ScenarioPlanning

Use Case Development

and Functional Requirements

Use Case Development

and 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

NIEM IEPD Lifecycle

Page 30: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

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

30

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

Page 31: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

Final Thoughts

» Don’t let perfect be the enemy of the good» Incremental, iterative, and value-focused» Don’t forget the little guy

04/10/23

Page 32: Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1

QUESTIONS?

04/10/23