ONC Finalizes Rule to Drive Health IT Interoperability, AI Transparency

The Office of the National Coordinator for Health Information Technology (ONC) has finalized a rule to support health IT interoperability and artificial intelligence (AI) transparency.

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule follows the release of the HTI-1 proposed rule in April 2023.

The final rule:

• Establishes transparency requirements for AI and other predictive algorithms used in certified health IT to promote responsible AI. The requirements aim to make it possible for clinical users to access a baseline set of information about the algorithms they use to drive decision-making and the assessment of algorithms for fairness, appropriateness, validity, effectiveness, and safety.
• Adopts the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the baseline standard within the ONC Health IT Certification Program as of January 1, 2026. Certified health IT developers can also move to USCDI v3 sooner. USCDI v3 includes updates focused on advancing more accurate and complete patient data that aims to promote equity, reduce disparities, and support public health interoperability.
• Revises certain information blocking definitions and exceptions to support information sharing and adds a new exception to encourage secure, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement (TEFCA).
• Implements the 21st Century Cures Act’s requirement to adopt a Condition of Certification (the “Insights Condition”) for certified health IT developers to report certain metrics as part of participation in the ONC Health IT Certification Program. The metrics are set to give ONC more insight into how organizations use certified health IT.

“The public feedback and participation in the HTI-1 process was tremendous,” Micky Tripathi, PhD, national coordinator for health information technology, said in a press release.

“Through the HTI-1 final rule, our upcoming HTI-2 proposed rule, and our broader efforts, ONC continues its important work to build health care’s digital foundation, make interoperability easier, and ensure that digital information and tools are being appropriately used to support patient access and to improve the health and well-being of all Americans,” Tripathi added.

ONC will submit the final rule to the Office of the Federal Register (OFR) in the coming days.