Editor's note: This is a breaking news story that may be updated.
The health information technology arm at the Department of Health and Human Services (HHS) released a rule that proposes to gut its certification program for health IT, rolling back years of requirements for developers.
The deregulatory rule is an explicit effort to carry out President Donald Trump’s executive order 14192 "Unleashing Prosperity Through Deregulation."
In total, the office for health IT plans to eliminate 34 out of 60 certification requirements for electronic health records and revise seven certification requirements. The proposal (PDF), which the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator of Health IT (ASTP/ONC) at the HHS released Monday, would alter nearly 70% of its existing requirements.
Its rationale, the proposed rule states, is that the majority of the existing requirements are a hindrance to health IT developers, preventing them from innovating and erecting regulatory barriers to new entrants in the certified health IT market.
One of the goals of axing certification requirements is to promote the use of AI through FHIR APIs. The office said it aims to “establish a new foundation” for FHIR API requirements to “support creative AI-enabled interoperability solutions.”
The ASTP/ONC proposes to remove the certification requirements for clinical decision support algorithms, which required health IT developers to create a model card to disclose specific source attributions to their models. While the Biden-era requirement only applied to a narrow swath of AI applications, it was one of few regulations on the books for the use of AI in healthcare.
Some of the other requirements the office proposes to remove are family health history, audit reports, multifactor authentication, safety-enhanced design and accessibility-centered design. The proposed rule says the requirements “are no longer necessary to advance interoperability and no longer provide a strong market driver for initial adoption and implementation of the certified functionalities.”
The proposed rule also makes changes to information blocking regulations. One significant change the office plans to make is to alter the definition of “access” and “use” to allow autonomous AI to retrieve and share health data.
The ASTP/ONC also proposes to remove or revise many 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,” Tom Keane, M.D., assistant secretary for technology policy and national coordinator for health IT, said in a press release. “These proposals reflect a commonsense approach that removes redundant requirements on health IT developers, that better ensures seamless patient access to their information and that sets a foundation for AI-based data exchange.”
Major EHR player Oracle reacted positively to the news. Executive Vice President and General Manager of Oracle Health and Life Sciences, Seema Verma, was the administrator of CMS during the first Trump administration.
“We are highly encouraged that ASTP/ONC is recognizing the need for regulatory burden reduction in the Health IT Certification Program and taking tangible actions to address it," Verma said in a statement to Fierce Healthcare. "The scope of the HTI-5 NPRM represents a major step forward in reducing redundant, outdated requirements, and we look forward to reviewing the rule in more detail.”
"Even the best regulatory frameworks need to be revisited and refocused from time to time to ensure they are keeping up with innovation," Kristen McGovern, partner at Sirona Strategies, said in a statement to Fierce. "HTI-5 recognizes the foundation that has been laid and seeks to adapt the EHR Certification Program for modern information sharing approaches."