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

ONC's HTI-1 final rule implements provisions of the 21st Century Cures Act and makes updates to the ONC Health IT Certification Program (Certification Program) with new and updated standards, implementation specifications, and certification criteria. Provisions in the HTI-1 final rule advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.

Key aspects of the final rule include:

• 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 Agreement^SM (TEFCA^SM).
• New Interoperability-Focused Reporting Metrics for Certified Health IT: Implements the 21^st 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 notice includes corrections to the HTI-1 final rule that ensure the appropriate sections of the regulations are revised. There are no substantive changes in this notice and all corrections will be effective along with the provisions in the HTI-1 final rule on March 11, 2024.