Understanding ONC’s Health AI Transparency | April 2024

Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework


The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC), went into effect on March 11, 2024, and establishes a new regulatory framework for certain artificial intelligence (AI) and machine learning technologies that support decision-making in health care. Compliance is required beginning December 31, 2024.

This Special Report provides an overview of the final rule’s algorithmic transparency and risk management requirements and the types of technologies that may be in scope. ONC released an initial proposal for this health AI regulatory paradigm in its HTI-1 proposed rule in April 2023, which we summarized in a previous Special Report. Throughout this Special Report we note some key differences between the proposed and finalized certification criterion for decision support interventions (DSIs).

We provided an overview of the final rule’s updates to certain standards and other certification criteria in the ONC’s Health IT Certification Program (certification program) in a separate On the Subject, and discussed the final rule’s information blocking provisions in another On the Subject.