HHS Health,The health information technology arm of the Department of Health and Human Services has released a proposed rule that would significantly scale back its certification program for health IT products, reversing a large number of existing requirements for developers.
The proposal was issued by the Office of the Assistant Secretary for Technology Policy and the Office of the National Coordinator of Health IT. It is explicitly tied to President Donald Trump’s executive order 14192, titled “Unleashing Prosperity Through Deregulation,” and is presented as part of a broader effort to reduce regulatory requirements across federal agencies.
Under the proposal, the health IT office plans to eliminate 34 of its 60 current certification requirements for electronic health records and revise an additional seven. Taken together, the changes would alter nearly 70% of the existing certification criteria. The proposed rule was released on Monday and outlines a substantial restructuring of how certified health IT products are evaluated.
The agency states that the existing certification framework has become an obstacle for developers. According to the proposal, many of the current requirements restrict innovation and create regulatory barriers that make it more difficult for new companies to enter the certified health IT market. The office argues that these requirements no longer function as effective incentives for the adoption or implementation of certified technologies.
A stated goal of removing certification requirements is to support greater use of artificial intelligence through Fast Healthcare Interoperability Resources, or FHIR, application programming interfaces. The office said it intends to establish a new baseline for FHIR API requirements that would support what it described as creative AI-enabled interoperability solutions.
One specific change outlined in the proposal is the removal of certification requirements for clinical decision support algorithms. These requirements previously required developers to create model cards that disclosed specific source attributions for their algorithms. Although the requirement applied to a limited subset of AI applications, it was among the few federal regulations addressing the use of artificial intelligence in healthcare.
The proposal also identifies several additional certification requirements that would be eliminated. These include requirements related to family health history, audit reports, multifactor authentication, safety-enhanced design, and accessibility-centered design. The proposed rule states that these requirements are no longer necessary to advance interoperability and no longer serve as strong market drivers for the initial adoption and implementation of certified functionalities.
In addition to certification changes, the proposal would revise information blocking regulations. One significant modification would change how “access” and “use” are defined, allowing autonomous AI systems to retrieve and share health data. The proposal also includes plans to remove or revise multiple information blocking exceptions.
“The HTI-5 proposed rule delivers on President Trump’s directive to reduce regulatory burden and to enable American innovation through artificial intelligence,” said Tom Keane, M.D., assistant secretary for technology policy and national coordinator for health IT. He said the proposals are intended to remove redundant requirements on health IT developers, better ensure patient access to health information, and establish a foundation for AI-based data exchange.
Overview of the HHS Health IT Rollback Proposal
The HHS Health Office of the National Coordinator for Health Information Technology (ONC), part of the Department of Health and Human Services, has proposed a major rollback of electronic health record (EHR) certification rules. This deregulatory initiative, included in the broader HHS Health HTI-5 proposed rule, aims to reduce compliance burdens for health IT developers and providers by removing and revising many existing certification criteria.
Why HHS Health Is Changing EHR Certification Rules
Under the plan, dozens of current certification criteria could be eliminated or narrowed, focusing future requirements on modern standards such as Fast Healthcare Interoperability Resources (FHIR)-based APIs. The HHS Health proposal is designed to allow developers and providers more flexibility, streamline health IT certification, and help accelerate innovation in health data exchange and interoperability.
