
ONC’s finalized rule drives health IT interoperability, mandates AI transparency, and promotes responsible use. It adopts USCDI v3, enhances patient data accuracy, and encourages early transition. The rule revises information-blocking definitions to support sharing and introduces exceptions for secure information exchange. Additionally, it implements the “Insights Condition” for reporting metrics, aiding ONC’s insights into certified health IT usage.
ONC’s final rule marks a significant stride in advancing health IT interoperability and ensuring transparency in AI utilization. Through this rule, AI algorithms in certified health IT must adhere to transparency standards, empowering clinicians with essential algorithmic information. USCDI v3 adoption promises improved patient data accuracy and completeness, aiming to reduce disparities and enhance public health interoperability. With revised information blocking definitions and new exceptions, secure data exchange gains momentum, aligning with the 21st Century Cures Act’s “Insights Condition” for reporting metrics.
The ONC has solidified a rule to bolster health IT interoperability and shed light on AI systems. This final rule, named Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1), follows the proposed rule released in April 2023.
Key elements of this final rule include:
1. Transparency for AI and Predictive Algorithms: This involves setting clear requirements for AI and other predictive algorithms used in certified health IT. The goal is to empower clinical users by providing fundamental information about these algorithms, ensuring they’re used responsibly and can be assessed for fairness, appropriateness, validity, effectiveness, and safety.
2. Adoption of USCDI Version 3 (v3): As of January 1, 2026, USCDI v3 becomes the baseline standard within the ONC Health IT Certification Program. However, certified health IT developers have the option to transition to USCDI v3 sooner. This version update focuses on enhancing patient data accuracy and completeness, ultimately promoting equity, reducing disparities, and supporting public health interoperability.
3. Revision of Information Blocking Definitions: Certain definitions and exceptions have been revised to support information sharing. A new exception has been introduced to encourage secure, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement (TEFCA).
4. Implementation of the “Insights Condition”: This fulfills the 21st Century Cures Act requirement, mandating certified health IT developers to report specific metrics as part of their participation in the ONC Health IT Certification Program. These metrics will provide ONC with valuable insights into how organizations utilize certified health IT.
Micky Tripathi, Ph.D., the national coordinator for health information technology, expressed gratitude for the extensive public feedback and participation in the HTI-1 process. Tripathi highlighted ONC’s commitment to building a solid digital foundation for healthcare, simplifying interoperability, and ensuring the appropriate use of digital tools to support patient access and enhance the health of all Americans.
The final rule will soon be submitted to the Office of the Federal Register (OFR) for further processing.
The ONC’s finalized rule embodies a pivotal moment in fostering health IT interoperability and responsible AI utilization. Embracing transparency for AI algorithms and adopting USCDI v3 sets a trajectory toward enhanced patient data quality and equitable healthcare. The rule’s revisions facilitate information sharing and secure data exchange while enabling ONC’s deeper understanding of certified health IT utilization through reported metrics. This stride aligns with ONC’s commitment to fortify healthcare’s digital foundation, simplify interoperability, and ensure judicious digital tools’ usage, ultimately benefiting patient access and improving Americans’ overall health and well-being.