On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the Health Data, Technology and Operability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule. HTI-1 will impact healthcare providers, developers of certified health IT, health information networks (HINs), and health information exchanges (HIEs). According to ONC, the goal of the finalized rule is “to increase algorithm transparency to support a dynamic and high-quality market for predictive AI in electronic health records.”
Key aspects of HTI-1 include (1) establishing transparency and risk management requirements for artificial intelligence (AI) and other predictive algorithms that are part of certified health IT, (2) adopting the United States Core Data for Interoperability (USCDI) Version 3 as the baseline standard within the ONC Health IT Certification Program (Certification Program) by January 1, 2026, (3) enhancing information blocking requirements by revising definitions and adding an exception to encourage sharing of electronic health information under the Trusted Exchange Framework and Common Agreement (TEFCA), and (4) implementing the 21st Century Cures Act’s requirement to adopt a Condition of Certification requiring certified health IT developers to report certain metrics to participate in the Certification Program.