AI Transparency on FHIR
1.0.0 - release International flag

AI Transparency on FHIR, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/aitransparency-ig/ and changes regularly. See the Directory of published versions

Changes

Page standards status: Informative

This page tracks the signficant changes. All changes are tracked in Jira and on GitHub.

1.0.0-current

Since the ballot publication, this version refines the scope and terminology and clarifies how AI involvement is identified and recorded in FHIR resources. It strengthens guidance for resource labeling and Provenance, updates the representation of AI systems and their model cards and prompts, adds a way to convey inference confidence, and expands implementation guidance and future considerations.

  • FHIR-54280 and FHIR-54580 AIAST meta labeling is required always.
  • FHIR-54894 refine use of "observability" and "transparency" in the document (previously applied)
  • FHIR-55024 Description of algorithm deterministic/nonderministic/hybird (previously applied)
  • FHIR-57918 Remove experimental provenance codes
  • FHIR-54801 Remove code AIRPT
  • FHIR-54141 Remove experimental codes
  • FHIR-54368 Revise codes in AIdeviceTypeVS - different AI technologies and fleshes out a bit the scenarios and data types.
  • FHIR-54244 Include an extension to capture the certainty of an AI inference
  • FHIR-57756 More narrative explanation of element level Provenance explaining the extensions
  • FHIR-54267 Require DocumentReference, and put futures on independent informative page.
  • FHIR-54180 Describe plans for R5/R6
  • FHIR-53975 Order of Relationship between Device and Model-Card
  • FHIR-54527 Remove use of Device.note to reduce variability on R4 AI device modeling
  • FHIR-54734 For better readability, switch section 2 and 3
  • FHIR-54371 AI Device representation and its elements
  • FHIR-54391 Provide a position on the preferred model card - indifferent
  • FHIR-54528 Describe how to exchange AI provenance via RESTful create
  • FHIR-54279 and FHIR-54281 Explain how to discover that AI was used, and how to find the provenance or label that indicates this.
  • FHIR-54885 Add some clarifying text to the Scope section that detection is not in scope
  • FHIR-54893 Clarify AI vs non-AI scope to avoid inconsistent observability implementations.
  • FHIR-54726 Scope needs some refinement
  • FHIR-54233 Elaborate the Operation section
  • FHIR-53973 Clarification on input data
  • FHIR-54723 AI device conflicting type binding and property fixed values and extension
  • FHIR-54725 Remove unusable AI-Data Profile on Resource as not usable.
  • FHIR-54707 Refrain from using Tag, use Label
  • FHIR-54280, FHIR-54580 address if labeling is mandatory or optional – make the resource level labeling mandatory
  • FHIR-54894 refine use of "observability" and "transparency" in the document
  • FHIR-55024 Description of algorithm deterministic/nonderministic/hybird
  • FHIR-54757 clarify combining AIdevice profile with other device profiles such as a smart watch.
  • FHIR-54583 clarify use of AI Transparency in post market surveillance

1.0.0-ballot

Initial Public-Comment

1.0.0-alpha

  • Rewrite guidance page (Sam, need ticket numbers here)
  • FHIR-54421, FHIR-54264, FHIR-54577, FHIR-54259 - Add a profile of DocumentReference for AI Input Prompts as distinct from Model-Cards
  • FHIR-54149 - AIinputsCS - CodeSystem title inconsistent with computable name