The HTI-1 Final Rule has been released in the wake of the April 2023 version, setting a standard for interoperability and transparency in health IT.
What happened?
In April 2023, the U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), proposed the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. This proposal marked a significant step towards enhancing health IT interoperability and transparency, particularly in the use of artificial intelligence (AI) and predictive algorithms in healthcare.
Following the proposal in April, the HHS has now finalized the HTI-1 rule.
One of the critical elements of this final rule is the establishment of first-of-its-kind transparency requirements for AI and predictive algorithms in certified health IT. The rule includes enhanced information-blocking requirements and new interoperability-focused reporting metrics as mandated by the 21st Century Cures Act.
These changes are designed to improve information sharing and provide insights into the use of certified health IT in care delivery.
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Updates from the HTI-1
The central aspects of the final rule include:
- Algorithm transparency requirements: The rule establishes first-of-its-kind transparency requirements for artificial intelligence (AI) and other predictive algorithms used in certified health IT.
- Adoption of USCDI Version 3: The United States Core Data for Interoperability Version 3 (USCDI v3) is adopted as the new baseline standard within the ONC Health IT Certification Program, effective from January 1, 2026.
- Enhanced information blocking requirements: The rule revises definitions and exceptions related to information blocking to support improved information sharing.
- New reporting metrics for certified health IT: In alignment with the 21st Century Cures Act, the rule introduces a new Condition of Certification, termed the "Insights Condition."
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What they're saying
"The public feedback and participation in the HTI-1 process was tremendous," Dr. Tripathi, national coordinator for health information technology, commented on the final rule. "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."
What's next?
As of the last update, the final rule had been announced but had not yet been submitted to the Office of the Federal Register (OFR), indicating that it is in the final stages of approval. The submission to the OFR is a necessary step for the rule to become officially recognized and enforceable. This rule represents a significant advancement in the digital foundation of healthcare in the U.S., focusing on patient access, interoperability, and the responsible use of digital tools in healthcare.
See also: What is health information management?
Kirsten Peremore
