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1a. Project Name

Conformance Testing and Validation of FHIR-based APIs

1b. Project ID


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


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


2a. Primary/Sponsor WG

Community Based Care and Privacy

2b. Co-Sponsor WG

Emergency Care

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


2d. Project Facilitator

Ioana Singureanu

2e. Other Interested Parties (and roles)

NIST (Rob Snelick), Sequoia Project (Did Davis)

2f. Modeling Facilitator

Ioana Singureanu

2g. Publishing Facilitator


2h. Vocabulary Facilitator


2i. Domain Expert Representative

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

2k. Conformance Facilitator


2m. Implementers

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

3a. Project Scope

• This specification provides guidance related to conformance testing of FHIR-based APIs.
• 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 : May 2020
Ballot Reconciliation: June 2020 WGM
Publication : July 2020

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


3l. Using Current V3 Data Types?


3m. External Vocabularies


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


4a. Products

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

5a. Project Intent

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

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


5b. Project Ballot Type


5d. Joint Copyright


6c. Content externally developed?


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


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)

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS


7b. Sponsoring WG Approval Date

May 21, 2019

7d. US Realm Approval Date

Aug 06, 2019