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ONC Finalizes AI Transparency Rule

Faridat Animashaun
December 18, 2023

A Dec. 13 final rule from the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) establishes nationwide transparency requirements for artificial intelligence (AI) and algorithms used in health information technology (IT).

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule:

  • Requires developers of AI and other predictive algorithms that are part of certified health IT to comply with transparency requirements. The rule aims to encourage responsible AI use and ensure access to a baseline set of information about the algorithms used in health care settings, including how to assess the algorithms for fairness, appropriateness, validity, effectiveness, and safety.
  • Revises some information blocking definitions and exceptions to support information sharing and encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement.
  • 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. 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.

The HTI-1 final rule will be submitted to the Office of the Federal Register in the coming days.

Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.

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