HHS Releases Final Regulation Updating Cures Act EHR Certification Requirements

On December 13, the U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) released its latest set of requirements for certified health information technology (HIT), including electronic health records (EHR) systems. ONC took the occasion of its annual public stakeholder meeting in Washington, D.C. to announce the release of its final regulation, titled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” (nicknamed “HTI-1” by ONC),

Updates to the certification criteria come in the form of new criteria, revisions to existing criteria, and updated standards. However, unlike in the past when ONC rules bundled a long list of certification updates into in a single new edition of certified EHR (e.g., 2015 Edition), the final rule requires certified HIT developers to update certification criteria according to a staggered (and potentially rolling) set of deadlines.

Key aspects of the final rule include:

• Adoption of United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program as of January 1, 2026;
• An assortment of other technical requirements, addressing things like clinical decision support, requirements for API technology, and an “internet-based method” for patients to request restrictions on the use and disclosure of their electronic health information;
• Revised information blocking definitions and exceptions to support Cures Act information sharing requirements;
• New interoperability-focused reporting Metrics for Certified Health IT (known as the “Insights Condition”) as a condition of certification; and
• Algorithm transparency requirements for the use of artificial intelligence (AI) as part of certified HIT

NextGen Healthcare is in the process of studying the final rule to determine its impact on both our clients and company, including the timing for certification and deployment of software updates. We urge clients to visit the Health Reform Simplified page on the client Success Community to view the December 21 webinar, due to be posted shortly after the holiday.

Also, be sure to check out the brand-new blog from our Government Affairs Advisor Chris Emper, to learn more about how the advent of new Al-enabled ambient listening solutions can reduce the time physicians have to spend on documenting and/or dictating notes.