HHS “HTI-1” Final Rule Addresses Artificial Intelligence & Information Sharing

The U.S. Department of Health and Human Services (HHS), through its Office of the National Coordinator for Health Information Technology (ONC), recently finalized its “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” (HTI-1) Rule.  The HTI-1 Rule “implements provisions of the 21st Century Cures Act and makes updates to the ONC Health IT Certification Program with new and updated standards, implementation specifications, and certification criteria.”  Components of the HTI-1 Rule address four key areas:  Algorithm Transparency – Establishes transparency requirements for the artificial intelligence and other predictive algorithms of certified health IT (which supports care delivered by over 96% of hospitals and 78% of office-based physicians in the U.S.).  United States Core Data for Interoperability (USCDI) Version 3 (v3) – Adopts USCDI v3 as the new baseline standard within the ONC Health IT Certification Program (as of 1/1/2026); USCDI v3 includes “more accurate and complete patient characteristics data that could help promote equity, reduce disparities, and support public health data interoperability.”  Enhanced Information Blocking Requirements – Supports information sharing and encourages “secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement^SM.  New Interoperability-Focused Reporting Metrics – Adopts a Condition of Certification for certified health IT developers to report certain metrics that “will give more insight into how certified health IT is used in support of care delivery.”  The text of the HTI-1 Final Rule is available on the HealthIT.gov HTI-1 Final Rule page.