The Department of Health and Human Services has released a proposed rule aimed at streamlining federal health IT certification requirements, strengthening patient protections against information blocking and laying new groundwork for artificial intelligence-enabled data exchange across the healthcare system.
HHS said Monday that the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity proposed rule, known as HTI-5, advances the administration’s deregulation and AI leadership agenda.
The proposal was released through the assistant secretary for technology policy and Office of the National Coordinator for Health Information Technology.
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How Would HTI-5 Change the Health IT Certification Program?
HTI-5 proposes a significant reset of the ONC Health IT Certification Program by removing more than half of the existing certification criteria and revising others to eliminate duplication and reduce compliance burden for developers.
HHS projects that these reforms will save health IT developers over 1.4 million compliance hours in the first year alone. This reduction in administrative burden is expected to generate $1.53 billion in total economic savings, including $650 million in direct cost reductions for stakeholders over the next five years.
The revised certification framework would prioritize standards-based application programming interfaces, with a specific focus on Fast Healthcare Interoperability Resources.
What Updates Are Proposed for Information Blocking Rules?
The rule also proposes targeted revisions to information blocking definitions, exceptions and conditions. HHS said the updates are intended to address stakeholder concerns about potential misuse of existing provisions while reinforcing patient access to electronic health information.
According to the department, the changes would ultimately strengthen enforcement by clarifying regulatory expectations and reducing ambiguity around permitted data exchange practices.
The proposed rule is published in the Federal Register and open for public comment for 60 days.
The proposal aligns with recent HHS efforts to accelerate AI adoption across clinical care, including a request for information seeking public input on how regulatory, reimbursement and research levers can better support AI use.
