ONC Finalizes Rule on Interoperability, AI Transparency

Dec. 13, 2023
Among other new standards, HTI-1 establishes transparency requirements for predictive algorithms that are part of certified health IT

The Office of the National Coordinator for Health Information Technology (ONC) has finalized a rule that touches on patient access, interoperability, and algorithm transparency. 

The rule, “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” is called HTI-1 for short. Here are some of the highlights:
• Algorithm Transparency: Establishes transparency requirements for the artificial intelligence (AI) and other predictive algorithms that are part of certified health IT. The regulatory approach is designed to 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 as of Jan. 1, 2026. Version 3 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 (TEFCA).
• 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, in a statement. “Through the HTI-1 final rule, our upcoming HTI-2 proposed rule, and our broader efforts, ONC continues its important work to build healthcare’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.”

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