HHS Finalizes HTI-1 Rule to Advance Patient Access and Health Data Interoperability

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The U.S. Department of Health and Human Services (HHS) has recently finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. This move comes after the release of the proposed HTI-1 rule in April 2023 and aims to improve patient access, interoperability, and standards in health data.

Algorithm Transparency

As part of this new rule, HHS establishes pioneering transparency requirements for artificial intelligence (AI) and other predictive algorithms used in certified health IT. Given that ONC-certified health IT supports care delivered by over 96% of hospitals and 78% of office-based physicians nationwide, these regulations will facilitate responsible AI use. They will also enable clinical users to access a consistent set of information about the algorithms they use in decision-making and assess such algorithms for fairness, appropriateness, validity, effectiveness, and safety.

USCDI Version 3

The HTI-1 rule 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) starting from January 1, 2026. However, developers of certified health IT can adopt USCDI v3 sooner. The updates in USCDI v3 concentrate on advancing more accurate and complete patient characteristics data, which could promote equity, reduce disparities, and support public health data interoperability.

Enhanced Information Blocking Requirements

The rule revises certain information blocking definitions and exceptions to encourage information sharing. It adds a new exception to promote 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

The final rule implements the 21st Century Cures Act’s requirement to adopt a Condition of Certification (the “Insights Condition”) for developers of certified health IT. Developers must report certain metrics as part of their participation in the Certification Program, providing more insight into how certified health IT is used in support of care delivery.

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Micky Tripathi, Ph.D., the national coordinator for health information technology, lauded public participation in the HTI-1 process and expressed optimism about ONC’s continued efforts to build healthcare’s digital foundation, enhance interoperability, and ensure appropriate use of digital information and tools to improve health and well-being across America.

The HTI-1 final rule can be viewed at HealthIT.gov/HTI-1.

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