HHS targets information-blocking, certification cuts in new rule

The U.S. Department of Health and Human Services on Dec. 22 proposed a rule that would significantly reduce federal health IT certification requirements, revise information-blocking policies and establish a framework to support AI-enabled interoperability.

The proposed rule, Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity, or HTI-5, was issued by the Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health Information Technology. In a Dec. 22 news release, HHS said the proposal aims to reduce regulatory burden, strengthen patient access to electronic health information and modernize data exchange standards.

Here are five things to know:

1. If finalized, the rule would eliminate more than 50% of the certification criteria in ONC’s voluntary Health IT Certification Program and revise other requirements to reduce compliance burdens for health IT developers. ASTP/ONC estimates the changes would save certified developers more than 1.4 million compliance hours in the first year — or about 4,000 hours per developer, on average.
   
   
2. The proposal is expected to save $1.53 billion in total, including $650 million over five years for health IT developers, providers and other stakeholders.
   
   
3. The proposed rule would also permanently implement previous enforcement discretion notices and reset the certification program’s scope to focus on standards-based application programming interfaces — including Fast Healthcare Interoperability Resources, or FHIR — and AI-enabled interoperability solutions.
   
   
4. HTI-5 proposes updates to federal information-blocking regulations. Based on stakeholder feedback, ASTP/ONC plans to revise or remove certain terms, conditions and exceptions that could be misused or abused, with the goal of strengthening enforcement and preventing barriers to patient access to electronic health information.
   
   
5. HHS said the proposals align with Executive Order 14192 on deregulation and Executive Order 14267 addressing anti-competitive regulatory barriers, both issued under President Donald Trump.
   

The HTI-5 proposed rule is on display in the Federal Register and will be open for public comment for 60 days following publication. ASTP/ONC also said it is withdrawing certain proposals from the earlier HTI-2 rule that were not yet finalized.