ONC Publishes HTI-1 Final Rule
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule was published in the Federal Register today (January 9, 2024) by the HHS’ Office of the National Coordinator for Health Information Technology (ONC) and will take effect on March 11, 2024.
The Final Rule implements provisions of the 21st Century Cures Act and updates the ONC Health IT Certification Program with new and updated standards to promote valid, safe, effective, and fair development and implementation of AI systems, in line with the principles and priorities of President Biden’s Executive Order 14110: Safe, Secure and Trustworthy Development and Use of Artificial Intelligence. The Final Rule is intended to advance ONC-certified health IT interoperability, algorithm transparency, and data standardization to improve patient outcomes and reduce healthcare costs and implements.
The Final Rule establishes new requirements for transparency for AI and other predictive algorithms that are part of ONC-certified health IT, which is utilized by more than 96% of hospitals and 78% of office-based physicians in the United States. The transparency requirements allow clinical users of systems that incorporate AI and machine learning algorithms to access a consistent, baseline set of information about the algorithms and assess them for fairness, appropriateness, validity, effectiveness, and safety.
The Final 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. USCDI v3 includes updates to prior USCDI versions that are aimed at advancing more accurate and complete patient characteristics data to promote equity, reduce disparities, and support public health data interoperability. While the Final Rule is now in effect, developers of certified health IT have until January 1, 2026, to move to USCDI v3, although that can make that move sooner.
The Final Rule also introduced new information blocking requirements to support information sharing, revised some information blocking definitions, and added a new exception to encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement (TEFCA).
The Final Rule also introduced new interoperability-focused reporting metrics for certified Health IT to give better insights into how certified health IT is used to support care delivery, such as the 21st Century Cures Act requirement to adopt a Condition of Certification for developers of certified health IT to report metrics as part of their participation in the Certification Program.
