HHS’ tech office proposes to gut and reset health IT policy

Editor’s note: This is a breaking news story that may be updated.

The health IT arm at the Department of Health and Human Services released a rule that proposes to gut its certification program for health information technology, rolling back years of requirements for developers. 

The deregulatory rule is an explicit effort to carry out President Donald Trump’s executive order (EO) 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 7 certification requirements. The proposal (PDF), which the Office of the Assistant Secretary for Technology at HHS released on 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.”

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 attributes 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, multi-factor 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” allow autonomous AI to retrieve and share health data.

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.”