Proposed rule would revise federal health IT certification requirements, including provisions affecting AI-enabled technologies and model transparency.
The Trump administration on Monday moved to reshape federal oversight of artificial intelligence in health information technology with a proposed rule that would reduce certification requirements and revise how AI-enabled tools are addressed under the Office of the National Coordinator for Health Information Technology’s certification program.
The Department of Health and Human Services (HHS), acting through the Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health Information Technology (ASTP/ONC), released the proposed rule, titled Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5), for public inspection on December 23. The proposal is scheduled for publication in the Federal Register on December 29 and will be open for public comment for 60 days.
The HTI-5 proposal would substantially revise the voluntary Health IT Certification Program, which establishes criteria that health information technology developers may use to certify electronic health records and related systems. Under the proposal, ASTP/ONC would remove 34 of the program’s 60 existing certification criteria and revise seven others, including requirements related to transparency and documentation for predictive and AI-enabled technologies.
The proposed rule would scale back requirements introduced in earlier rulemakings that required developers of certified health IT containing artificial intelligence or algorithmic decision support to disclose detailed information about model development, training data, and performance characteristics. HHS said the changes are intended to reduce regulatory burden while maintaining baseline transparency for AI functionality used in clinical settings.
The proposal also would amend information blocking regulations governing the access, exchange, and use of electronic health information, including clarifying obligations for certified health IT developers and other regulated entities that deploy AI-driven features within their systems.
“These proposals advance the administration’s directive to reduce unnecessary regulatory burden while continuing to support patient access to electronic health information,” ASTP/ONC said in the proposed rule.
The HTI-5 proposal would apply to health information technology developers seeking certification, as well as to health care providers, health information networks, and health information exchanges subject to information-blocking rules.
Written comments must be submitted within 60 days of publication in the Federal Register.