Overview
The Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule would: (1) reduce burden on health IT developers by streamlining the ONC Health IT Certification Program (Certification Program) by removing redundant requirements; (2) update the information blocking regulations to better promote electronic health information access, exchange, and use so that patients’ access to their data is not blocked; and (3) advance a new foundation of AI-enabled interoperability solutions through modernized standards and certification.
Certification Criteria for Health Information Technology
ASTP/ONC proposes to reduce or remove certification criteria. These certification criteria include capabilities that are already well established in health IT products in the market, duplicative of other regulatory requirements, or impede innovation. Collectively, the proposed removals and revisions of certification criteria are intended to reduce burden and costs for health IT developers and providers.
In total, out of 60 certification criteria within the ONC Health IT Certification Program (Certification Program), ASTP/ONC proposes to remove 34 and revise seven. Of the revised criteria, one of the revisions would reduce the scope of the decision support interventions (DSI) certification criterion to fully remove the artificial intelligence (AI) “model card” requirements.
Conditions and Maintenance of Certification Requirements for Health IT Developers
ASTP/ONC proposes to make conforming edits for several Conditions and Maintenance of Certification requirements, including the “Assurances” (§ 170.402), “Application Programming Interfaces” (§ 170.404), and “Attestations” (§ 170.406) Conditions and Maintenance of Certification requirements.
In addition to conforming edits, ASTP/ONC also proposes to descope the “Real World Testing” Condition and Maintenance of Certification requirements (§ 170.405) with deregulatory actions for real world testing plans, real world testing results, and the use of the Standards Version Advancement Process (SVAP).
Lastly, ASTP/ONC proposes to remove and descope measures associated with the “Insights” Conditions and Maintenance of Certification requirements (§ 170.407) consistent with the enforcement discretion issued on April 29, 2025, which limits collection and reporting requirements to only the “use of FHIR in apps through certified health IT” measure.
A New Foundation for FHIR®
The HTI-5 Proposed Rule enables ASTP/ONC to reset the Certification Program’s regulatory scope and establish a new foundation on which to build Fast Healthcare Interoperability Resources® (FHIR®)-based application programming interface (API) requirements in the future. These requirements will support creative AI-enabled interoperability solutions.
While FHIR provides better ways to address emerging market needs and policy imperatives, more work is needed in certain use cases. ASTP/ONC will also sharpen the Certification Program’s focus to prioritize FHIR-based APIs that:
- enhance automation and performance;
- move beyond read-only interactions; and
- expand the scope of data available; specifically, data that supports clinical efficiency, patient-centered care, and timely reporting.
Information Blocking
Definitions
- ASTP/ONC proposes to add language to the definitions of “access” and “use” in § 171.102, to emphasize that the definitions include automated means of access, exchange, or use of electronic health information (EHI), including autonomous AI systems. In the alternative, ASTP/ONC proposes to make these revisions as well as similar revisions to the “exchange” definition.
Exceptions
- ASTP/ONC proposes to remove the ”third party seeking modification use” condition from the Infeasibility Exception (§ 171.204(a)(3)). This is to prevent abuse by actors, such as EHR developers, from unnecessarily inhibiting access, exchange, and use of EHI by their competitors or other third parties that patients and health providers want.
- ASTP/ONC proposes to revise or remove the “manner exception exhausted” condition (§ 171.204(a)(4)) from the Infeasibility Exception for similar reasons. ASTP/ONC believes this condition as currently codified is susceptible to misuse by actors holding EHI to unnecessarily inhibit access, exchange, and use of EHI.
- ASTP/ONC proposes to revise the “manner requested” condition (§ 171.301(a)) of the Manner Exception to provide enhanced certainty that the Manner Exception does not cover any contracts, agreements, or licenses that: are not at market rate, are contracts of adhesion, or include unconscionable terms. ASTP/ONC is concerned that some actors may be incorrectly citing the manner requested condition to persuade requestors that the exception applies to agreements and terms to which it has never applied.
- ASTP/ONC proposes to remove the TEFCA Manner Exception (§ 171.403) and associated definitions from 45 CFR part 171. ASTP/ONC believes the exception is now unnecessary and may be negatively impacting participants in the health information ecosystem.
Disclaimer: While every effort has been made to ensure the accuracy of this fact sheet, it is not a legal document. Please refer to the HTI-5 proposed rule for full details.