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AI Transparency on FHIR (Jira PSS-2579)

Basics

AI Transparency on FHIR (Jira PSS-2579)

1931
Ballot - STU


FHIR Implementation Guide

Implementation Guide

Details

This project will develop a FHIR Implementation Guide that defines standard methods for representing the use of generative AI and LLMs in FHIR resources and operations. The IG will address two main areas:

1. AI Content Transparency

2. AI Operations Framework

See description in Jira PSS-2579 for the full details (https://jira.hl7.org/browse/PSS-2579)


The AI Transparency in FHIR Project is necessary to establish standards for documenting and tracking the use of outputs from AI systems or inference algorithms, including generative AI and Large Language Models (LLMs), within FHIR resources and operations. This project may help to inform regulatory requirements such as the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) Health Technology Infrastructure (HTI-1) final rule requirements for AI transparency in certified health IT. Design patterns identified in this project may also apply to its representation in other HL7 product families like Clinical Document Architecture (CDA) and HL7v2.

Artificial Intelligence (AI) represents amazing potential to improve outcomes in healthcare. However, it comes with a number of challenges, such as it is generally probabilistic in nature, can be influenced by bias, and can suffer from AI-generated hallucinations (inaccurate or misleading information). It is critical that we provide guidance for how to tag data coming from AI in a way that it can be used responsibly by downstream systems and users.



FHIR IG - R1 - Ballot STU - Target Ballot Cycle: 2026 January


PSS: https://jira.hl7.org/browse/PSS-2579


AI Data Lifecycle

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

MITRE, Vantiq


AI Transparency on FHIR


N/A

N/A

No

Stakeholders: Academic/Research, Association/Goverment Agency, Healthcare IT Vendors, Healthcare Provider/user, Patients, Payer/Third Party Administrator, Pharmaceutical/Biotech, Regulatory Agency, Standards Development Organizations (SDOs), Vendor/Manufacturer, Healthcare Educators (e.g.: health coaches, social workers, surrogates, etc.)
Organization & Realm

Universal

People

Sam Schifman



Electronic Health Records Work Group


Status & Dates

Active

Active Project (Resources assigned to pjt)

03/11/2025

01/01/2028

2028 Jan WGM/Ballot

01/01/2027

2027 Jan WGM/Ballot

2026 Jan Cycle; STU ballot. Met basic vote requirements with 26 negatives to reconcile. Ballot name: HL7 FHIR® Implementation Guide: AI Transparency on FHIR, Edition 1
Approvals

04/15/2025


Not Needed


All Received




FHIR Management Group -- Agreed -- (PSS-2602)
System Info

253607

PSS-2579



04/09/2026

Anne Wizauer