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Canonical FHIR Clinical Document IG, aligned with CDA (Jira PSS-2355)

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Basics

Canonical FHIR Clinical Document IG, aligned with CDA (Jira PSS-2355)

1877
Ballot - STU


FHIR Implementation Guide

Implementation Guide

Details

Proposal: Create a canonical FHIR Clinical Document IG.

We plan to create a FHIR R4 IG that contains, at a minimum, a FHIR Bundle and Composition profile, that can serve as the definitive FHIR correspondence to the CDA header. The Implementation Guide may need to profile other FHIR resources (e.g. profile the FHIR PractitionerRole to serve as a target for CDA's information recipient, author, etc), and will include descriptive text, examples, and a definitive CDA to FHIR mapping, which we will derive from the CDA Hierarchical Descriptor, as shown in the following figure.

The FHIR Clinical Document IG will be aligned with CDA, but not a mirror image of CDA. While the initial IG development will be based on CDA and will enable a straightforward mapping from CDA to FHIR, it will not necessarily provide a reverse mapping. Phase 2 activities and beyond will assess the need for additional profiles, and may add features that go beyond what is capable with today's CDA.

The work will be completed in Phases.

Phase 1 will be initial IG creation, primarily focused on creation of FHIR artifacts reflecting the CDA Header. IG content will include: (1) General overview and documentation; (2) New Bundle profile (plus documentation, plus at least one example); (3) New Composition profile (plus documentation, plus at least one example); (4) Other profiles as needed; (5) CDA to FHIR mapping spreadsheet.

Phase 2 and beyond may extend the IG to reflect additional CDA Header and Body constructs, and/or to add new features not present in CDA. CDA to FHIR mapping will be correspondingly revised.


The HL7 CDA Management Group has identified the need to create a canonical FHIR Clinical Document IG that is aligned with CDA.

Rationale: (1) there are currently HUNDREDS of existing Bundle and Composition profiles, many of which are designed for clinical documents, with no clear canonical pattern upon which future FHIR-based clinical documents work should be based; (2) There is no explicit guidance for CDA users wishing to migrate to a FHIR-based representation of clinical documents.

Existing profiles and IGs take many different approaches to representing various constructs in the CDA header. As a result, there are mapping discrepancies; lack of explicit mappings for some CDA Header components; and the use of extensions despite the availability of FHIR Core semantics.



FHIR IG R1 - Balloted STU - Target: September 2024 Ballot Cycle


fhir-clinical-document PSS: https://jira.hl7.org/browse/PSS-2355


None

Other (specify in Misc. Notes below),N/A

MyDirectives (ADVault) (United States); Elimu Informatics (United States); todormihai at gmail dot com (Italy); giorgio.cangioli at gmail dot com (Italy)

Long range CDA Roadmap requires preparing to smoothly transition from CDA documents to FHIR documents. Profiling work must be done at UV level to allow other countries to not have to solve this independently.

FHIR Clinical Document IG


N/A

N/A

No

2026 June: TSC approved an Unballoted STU Update Publication Request for HL7 FHIR® Implementation Guide: FHIR Clinical Document, Edition 1.1 2025 June: TSC approved the STU publication of HL7 FHIR® R4 Implementation Guide: FHIR Clinical Documents, Edition 1 for 2 years Stakeholders: Healthcare IT Vendors, Payer/Third Party Administrator, Standards Development Organizations (SDOs), Vendor/Manufacturer
Organization & Realm

Universal

People

Bob Dolin



Structured Documents Work Group


Status & Dates

Active

STU - Test Period/Accepting Comments

04/25/2024

01/01/2028

2028 Jan WGM/Ballot

05/01/2027

2027 May WGM/Ballot

2024 Sept Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 31 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: FHIR Clinical Document, Edition 1
Approvals

06/04/2024


Not Needed


All Received




CDA Management Group -- Agreed -- (PSS-2358)
FHIR Management Group -- Agreed -- (PSS-2360)
System Info

229293

PSS-2355

https://jira.hl7.org/browse/PSS-2355
View Ballot Items (with NIBs)



07/02/2026

Anne Wizauer
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