On Oct. 28, 2026, the Department of Health and Human Services published a final rule removing or revising several health information technology certification requirements. The rule removes 14 certification criteria and revises seven others to reduce regulatory compliance tasks for health technology developers.
According to the Office of the National Coordinator for Health Information Technology, the changes affect developers of certified health technology and the healthcare providers who use those systems. The agency stated the rule will lower barriers to entry for new developers, increase market competition, and give providers more choices by eliminating the need to prepare, test, and certify certain functionalities.
The rule aligns with executive orders on deregulation and reducing anti-competitive regulatory barriers, according to the document. The agency noted that certification is likely no longer a primary factor driving improvements in the removed areas. The changes return resources to developers so they can focus on third-party integration and customer needs.
The regulation removes long-standing criteria that are not based on the Fast Healthcare Interoperability Resources standard. The agency said this approach resets the program’s scope to prioritize application programming interfaces that enhance automation, move beyond read-only interactions, and expand data availability. Removing the older criteria allows for emerging super intelligence solutions that combine the Fast Healthcare Interoperability Resources standard with newer standards, the document said.
Among the seven revised criteria, the agency reduced the scope of decision support interventions by completely removing super intelligence model card requirements for source attribute support and modification. The program retained 39 certification criteria. These include newly adopted criteria for electronic prior authorization and real-time prescription benefits.
The agency made conforming edits to terms and definitions, including the removal of the term “Common Clinical Data Set” and revisions to the definition of a base electronic health record. The final rule also updates the program’s administrative requirements, removing references to the Assistant Secretary for Technology Policy from the Trusted Exchange Framework and Common Agreement. Additionally, the rule descopes conditions regarding real world testing plans and updates requirements for assurances and attestations.
The agency estimated the final rule will result in $0 in implementation and compliance costs for certified health technology developers, while generating a present value of $1.55 billion in cost savings. Annualized net cost savings are projected at $108.1 million beginning in 2027. However, the agency estimated costs of $1,293,508 for 616 reviewers who reviewed the rule.
The final rule takes effect on Dec. 28, 2026. Certain amendatory instructions will take effect on Jan. 1, 2027.