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1a. Project Name

Conformance, Guidance and Best Practices for FHIR Implementation Guides

1b. Project ID


1c. Is Your Project an Investigative Project (aka PSS-Lite)?


1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?


1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG


2b. Co-Sponsor WG

Architecture Review Board

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor Update Periods


2b. Co-Sponsor WG 2

FHIR Infrastructure

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2b. Co-Sponsor WG 3


2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2d. Project Facilitator

Ioana Singureanu

2e. Other Interested Parties (and roles)

NIST (Rob Snelick), Sequoia Project (Did Davis), Department of Veterans Affairs

2f. Modeling Facilitator

Ioana Singureanu

2g. Publishing Facilitator


2h. Vocabulary Facilitator


2i. Domain Expert Representative

Matt Greene (VA), Daniel Rutz(?), Hans Buitendijk(?), Frank Oemig

2j. Business Requirements Analyst

2k. Conformance Facilitator


2l. Other Facilitators

2m. Implementers

Department of Veterans Affairs,
MITRE/Inferno Project (
Sequoia Project

3a. Project Scope

• This specification has to two major objectives: to provide rules that lead to consistency across implementation guides, across the US realm and implementers with clear guidance and best-practices to implement FHIR IGs successfully
• Where appropriate, this specification clarifies how extensions and "must support" data elements should be used improve patient outcomes and safety. Test cases may also be produced by this project, if needed.
• This specification will provide testing guidance across US-Realm specifications (implementation guides -see "Project Dependencies) such that provider, payers, public health, and research organization can make effective use of FHIR APIs to meet national policy objectives (see "External Drivers").
• This project will leverage successful testing approaches developed by implementers using other APIs (e.g. SOAP, ebXML) and HL7 standards (e.g. HL7 V2, CDA). It includes best-practices for data quality, first principles for effective testing, and testing guidance.
• The purpose of this project is to enable effective use of FHIR conformance constructs to test both application/clients and FHR server that use FHIR resources and FHIR-related specifications (e.g. SMART, CDS Hooks, etc.). This project is intended to bridge the gap between implementation guides and test case development and assist early adopters of FHIR APIs in the US.
• Even though the guidance is intended to assist US early adopters in the short term, it will be applicable worldwide.


3b. Project Need

FHIR-based APIs are a new paradigm in health IT that will require expanded conformance and testing capabilities. Other industries have had a great of experience with APIs but healthcare is new to this approach.
Until now, vendors have been using self-attestation to claim conformance to FHIR and FHIR-related specifications. As FHR-related APIs become ubiquitous, the importance of consistency across implementations will be crucial. Rather than conforming with a specific FHIR implementation, systems will have to conform to a common set of data and service specifications. The future success of such an environment depends on using best-practices to test and validate implementation against national specifications and local enterprise needs.

3c. Security Risk


3d. External Drivers

Notice of Proposed Rulemaking to Improve the Interoperability of Health Information

3e. Objectives/Deliverables and Target Dates

Informative Ballot : September 2020
Publication : December 2020

3f. Common Names / Keywords / Aliases:

3g. Lineage

3h. Project Dependencies

US-realm IGs including:
• US Core R4 IG
Da Vinci Projects:
• Coverage Requirements Discovery (CRD)
• Documentation Templates and Rules ( DTR)
CAIRN Alliance

3i. HL7-Managed Project Document Repository URL:

3j. Backwards Compatibility


3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?


3l. Reason for not using current V3 data types?

3m. External Vocabularies


3n. List of Vocabularies

3o. Earliest prior release and/or version to which the compatibility applies


4a. Products

FHIR Resources, Guidance (e.g. Companion Guide, Cookbook, etc)

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Supplement to a current standard, Implementation Guide (IG) will be created/modified

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?


5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type


5c. Additional Ballot Info

5d. Joint Copyright


5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.


6a. External Project Collaboration

6b. Content Already Developed

6c. Content externally developed?


6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?


6f. Stakeholders

6f. Other Stakeholders

6g. Vendors

EHR, PHR, Health Care IT, Lab, HIS, Other

6g. Other Vendors


6h. Providers

Healthcare Institutions (hospitals, long term care, home care, mental health)

6h. Other Providers

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

Aug 06, 2019

7a. Management Group(s) to Review PSS


7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

Aug 15, 2019

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date