HHS finalizes HTI-1 rule promoting patient access, interoperability, and standards in health information technology, including algorithm transparency for AI; rule updates data interoperability standards and revises information blocking definitions

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December 13, 2023 (press release) –

The U.S. Department of Health and Human Services (HHS) through the Office of the National Coordinator for Health Information Technology (ONC) today finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. This follows the release of the HTI-1 proposed rule in April 2023. The HTI-1 final rule advances patient access, interoperability, and standards, including the following:

  • Algorithm Transparency: Establishes first of its kind transparency requirements for the artificial intelligence (AI) and other predictive algorithms that are part of certified health IT. ONC-certified health IT supports the care delivered by more than 96% of hospitals and 78% of office-based physicians around the country. HHS’ leading-edge regulatory approach will promote responsible AI and make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision making and to assess such algorithms for fairness, appropriateness, validity, effectiveness, and safety.
  • USCDI Version 3: Adopts the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program (Certification Program) as of January 1, 2026. Developers of certified health IT will also have the ability to move to USCDI v3 sooner. USCDI v3 includes updates to prior USCDI versions focused on advancing more accurate and complete patient characteristics data that could help promote equity, reduce disparities, and support public health data interoperability.
  • Enhanced Information Blocking Requirements: Revises certain information blocking definitions and exceptions to support information sharing, and adds a new exception to encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common AgreementSM (TEFCASM).
  • New Interoperability-Focused Reporting Metrics for Certified Health IT: Implements the 21st Century Cures Act’s requirement to adopt a Condition of Certification (the “Insights Condition”) for developers of certified health IT to report certain metrics as part of their participation in the Certification Program. These metrics will give more insight into how certified health IT is used in support of care delivery.

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

The HTI-1 final rule is posted at HealthIT.gov/HTI-1 and will be submitted to the Office of the Federal Register (OFR) in the coming days. For more information, resources, and educational events on ONCs regulatory programs, please visit HealthIT.gov.

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