ONC Publishes HTI-1 Certification Final Rule

The Office of the National Coordinator for Health Information Technology (ONC) published the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule on Dec. 13. The new rule requires new and updated standards, implementation specifications and certification criteria for electronic health records and health information technology modules for certification through the ONC certification program. 

Most notably, the final rule mandated that certified Health IT must adopt version 3 of the United States Core Data for Interoperability (USCDI v3) no later than Jan. 1, 2026. The USCDI v3 standard, which consists of health data classes and constituent data elements required to facilitate interoperable health information exchange, is currently available and can be implemented sooner than the deadline by health IT developers and their customers. 

HIMSS recommended a Jan. 1, 2026, deadline to allow for time to successfully complete the extensive work required to implement and test the new and revised criteria across the healthcare ecosystem in a manner ensuring that quality, safety and patient privacy would not be compromised; and that healthcare delivery sites caring for underserved communities were not left behind. The implementation of new standards and certification criteria associated with USCDI v3 were also delayed.

“HIMSS applauds ONC on the release of today’s HTI-1 final rule, which takes a realistic path to achieving greater information sharing to aid patient safety and accelerates digital health transformation in the U.S.,” said Tom Leary, senior vice president and head of government relations at HIMSS. “We appreciate ONC listening to stakeholders to establish a timeline to successfully complete the extensive work required to implement the new and revised criteria in a manner ensuring that quality, safety and patient privacy are not compromised; and that healthcare delivery sites caring for underserved communities aren’t left behind.”

The rule also establishes:

• Certification criteria establishing requirements for providing the source attribution for predictive algorithms called “decision support interventions” that are part of or interact with health IT and health IT modules seeking certification. These requirements include mechanisms to allow end-users to provide feedback through a web-based tool. These new requirements will need to be implemented no later than Jan. 1, 2025.
• The establishment of the “Insights Condition” EHR reporting program, which includes measures and reporting periods for health IT developers looking to maintain certification for their health IT and health IT modules.
• Modifications to the Information Blocking requirements for the developers of certified health IT, including modifications to the Feasibility Exception (requiring the uncontrolled event to be directly responsible for information blocking activity to meet the exception) and the Content and Manner Exception, which will allow actors to provide requested information using TEFCA even if that isn’t the manner requested by the party seeking the requested information.

ONC will host a series of listening sessions to go over the provisions of the HTI-1 final rule. In addition, HIMSS will publish a series of resources to help the community understand the provisions of the HTI-1 final rule on the HIMSS 21^st Century Cures Act resource page in the coming weeks.