×

To enhance security, Multi-Factor Authentication (MFA) is mandatory for all HL7 users. More information

 

FHIR at Scale (FAST): Scalable Registration, Authentication, and Authorization for FHIR Ecosystem Participants (Jira PSS-2631)

Basics

FHIR at Scale (FAST): Scalable Registration, Authentication, and Authorization for FHIR Ecosystem Participants (Jira PSS-2631)

1689
Ballot - STU to Normative

FHIR

FHIR Implementation Guide

Implementation Guide

Details

Updated Information 2025:

The project is no longer sponsored by the US government but does receive funding, in kind, from CMS for technical services. The project is paid for by members of FAST and through volunteer work. The IG has gone through two ballots and one unballoted update and is closing out the second ballot reconciliation in preparation for STU2.

The aim of this project is to expand upon the existing work by UDAP.org within the HL7 consensus process to produce a more complete set of implementation guides targeted at implementers of both client and server systems using FHIR for data exchange, standardizing how implementers integrate the UDAP profiles identified by the FAST Security Tiger Team into existing OAuth 2.0 and OpenID Connect workflows.

Among other things, the deliverables of this project would provide the FHIR community with detailed instructions to implement the following:

- integration of existing public key infrastructure mechanisms with registration, authentication, and authorization processes to establish robust trust networks with reusable credentials to identify actors

- trusted dynamic client registration

- client app submissions of self-assertions, third party certifications, or other endorsements to servers, and vice-versa

- client app assertions of additional information for a given session so that resource holders can more finely scope access tokens, including information related to consent or purpose of use

- increase security and assurance in identity of all actors by using asymmetric cryptographic methods for authentication, including specific protocols to support network-wide revocation of credentials

- dynamic federation of user credentials to facilitate reuse of credentials and single sign-on



2025 Update:

The FAST Accelerator has published version 1.1 of this IG and would like to have STU2 published as Universal Realm to address the needs presented to them from Europe, China and the Middle East Gulf States.

The current IG Is published here: https://hl7.org/fhir/us/udap-security/ with the STU2 work being done here: https://build.fhir.org/ig/HL7/fhir-udap-security-ig/

The European Health Data System and the Gulf States Health System are reviewing this project for potential use as the basis for the security for each. The [https://digital-strategy.ec.europa.eu/en/policies/eidas-regulation|eIDAS] and [https://ec.europa.eu/digital-building-blocks/sites/display/DIGITAL/eID+@SEMIC+2024|eID] are easily supported by the FAST Security IG. For the Gulf States, it is seen as a way to improve interchange with communities in remove countries that travel to the region.

Original 2022 Project Need:

As the FHIR ecosystem grows and the number of deployed servers and clients multiplies, several aspects of the registration, authentication, and authorization processes that occur before the exchange of FHIR resources can take place have been identified as potential bottlenecks. To facilitate the effective scaling of the ecosystem, automated approaches for application registration and more robust mechanisms to reliably identify participants and manage credentials are needed. For larger ecosystems with numerous requestors and responders, a distributed system of authoritative information can be leveraged using digital certificates to enable a scalable dynamic solution for client (i.e., FHIR client / requestor) registration.

The registration problem alone is exemplified by statistics shared from a scenario analysis that considered manual registration of 60 current BlueButton API clients across 907 US Health Plans. Extrapolating from the CMS experience, the time required by human facilitated administrative activities at the Health Plans to register 60 applications (e.g., review meetings, actual generation & sharing of API credentials with app developer, etc.) was estimated at 73 person-years (Seib A and Scrimshire M, 'Making it easier for Patients and Data Holders', EHNAC AHIP Webinar, 2020). This estimate only addresses one type of registration interaction (payer/consumer), with additional registration effort required for all provider/consumer, provider/provider, provider/payer, and payer/payer pairings. The Healthcare dollars expended in non-value, manual related client registration activities can be recaptured many times over as this solution is adopted across the FHIR API ecosystem nationwide.

The ONC FHIR at Scale Taskforce’s Security Tiger Team was formed in late 2018 to investigate these issues and identify potential solutions. The Tiger Team identified the Unified Data Access Profiles (UDAP) for Dynamic client registration, client authentication, client authorization, and Tiered OAuth as building blocks to be used by implementers to address the issues above and enhance the overall scalability of the FHIR ecosystem, a recommendation that has received positive feedback from numerous cybersecurity subject matter experts.



Ballot for STU1 - Target: Sept 2021 Reconciliation for STU1 - Target: Sept - Dec 2021 Publication STU1 - Target: Jan 2022 Ballot for STU2 - Target: Jan 2023 Ballot Reconciliation - Target: Jan - April 2023 Publication - Target: May 2023 Ballot for Normative - Target: Jan 2025 Ballot Reconciliation - Target: Jan-April 2025 Publish Normative - Target: May 2025


New PSS in Jira: https://jira.hl7.org/browse/PSS-2631 https://github.com/HL7/fhir-udap-security-ig/

ONC FHIR at Scale Taskforce (FAST) UDAP.org https://www.udap.org/udap-ig-consumer-facing-health-apps.html https://www.udap.org/udap-ig-b2b-health-apps.html


Clinical and Public Health Laboratories, Immunization Registries, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors,Clinical and Public Health Laboratories; Emergency Services; Local and State Departments of Health; Medical Imaging Service; Healthcare Institutions (hospitals, long term care, home care, mental health),Pharmaceutical; EHR, PHR; Equipment; Health Care IT; Clinical Decision Support Systems; Lab; HIS

Humana, Cigna

None

Keywords: UDAP, FAST, Security, Authentication, Authorization, Registration

New PSS in Jira: https://jira.hl7.org/browse/PSS-2631 PSS in Confluence: https://confluence.hl7.org/display/SEC/FHIR+at+Scale+%28FAST%29%3A+Scalable+Registration%2C+Authentication%2C+and+Authorization+for+FHIR+Ecosystem+Participants https://confluence.hl7.org/display/SEC/FAST%3A+Scalable+Registration%2C+Authentication%2C+and+Authorization+for+FHIR+Ecosystem+Participants

N/A

N/A

Yes

2025 December: TSC approved an STU Publication Request for HL7 FHIR® Implementation Guide: FAST UDAP Security for Scalable Registration, Authentication, and Authorization, Edition 2 - US Realm 2025 October: TSC approved updated PSS 2025 July; Updated PSS to Universal Realm; added to jira and sent back to consensus review 2024 July: TSC approved Unballoted STU Update Publication Request for FHIR at Scale (FAST): Scalable Registration, Authentication, and Authorization for FHIR Ecosystem Participants 2022 Sept: TSC approved STU Publication Request HL7 FHIR Implementation Guide: Security for Registration, Authentication, and Authorization, Release 1- US Realm.
Organization & Realm

Universal

People

Luis Maas and Brett Stringham



Security Work Group


Status & Dates

Active

STU - Reconcile

02/02/2021

05/15/2028

2028 May WGM/Ballot

05/15/2028

2028 May WGM/Ballot

2026 May Ballot Cycle Info: STU Ballot Results: Met basic vote requirements. 2 Negatives to reconcile Document Name: HL7 FHIR® Implementation Guide: FAST UDAP Security for Scalable Registration, Authentication, and Authorization, Edition 2 2025 Jan Ballot Cycle Info: STU Ballot Results: Did not meet basic vote requirements. 39 Negatives to reconcile Document Name: FHIR Implementation Guide: FAST UDAP Security for Scalable Registration, Authentication, and Authorization, Edition 2 - US Realm 2021 Sept Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 20 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Security for Registration, Authentication, and Authorization, Release 1- US Realm
Approvals

10/01/2025


Received


Received




FHIR Management Group -- Agreed -- (PSS-2646)
System Info

258896

PSS-2631



06/25/2026

Anne Wizauer