Thomas Keane, MD, MBA, Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology (ASTP/ONC) | Official Website
The U.S. Department of Health and Human Services (HHS) has introduced the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule. This rule is part of efforts to implement President Trump’s Executive Order 14192, “Unleashing Prosperity through Deregulation,” and supports the administration's focus on maintaining U.S. leadership in artificial intelligence.
The HTI-5 Proposed Rule aims to achieve three main objectives: reducing regulatory burdens for health IT developers by eliminating redundant requirements in the voluntary Health IT Certification Program; updating information blocking regulations to improve access, exchange, and use of electronic health information; and establishing a new foundation for Fast Healthcare Interoperability Resources (FHIR)-based application programming interfaces (APIs) that support AI-driven interoperability solutions.
According to HHS, these changes are projected to save $1.53 billion overall, with $650 million in savings expected over the next five years for health IT developers, providers, and other stakeholders.
“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, MD, Assistant Secretary for Technology Policy and National Coordinator for Health IT. “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.”
Under the proposal, more than half of the ONC Health IT Certification Program’s criteria would be removed or revised to lower compliance demands on developers. The proposed changes are estimated to save certified health IT developers over 1.4 million compliance hours in the first year alone—an average reduction of up to 4,000 hours per developer—freeing resources for further innovation.
The rule also suggests updates based on stakeholder feedback regarding information blocking regulations. It proposes revising or removing certain terms and exceptions that could be misused or abused, aiming to strengthen enforcement capabilities related to patient data access.
These measures align with President Trump’s broader deregulatory agenda as outlined in Executive Orders 14192 and 14267 (“Reducing Anti-Competitive Regulatory Barriers”). HHS encourages stakeholders in the health IT sector to review the full HTI-5 Proposed Rule when it is published in the Federal Register; public comments will be accepted for 60 days following publication.
Further details about the proposal can be found at healthit.gov/hti5 or through ASTP/ONC’s X account @HHS_TechPolicy.
Additionally, ASTP/ONC announced it is withdrawing some previously unfinalized proposals from its earlier HTI-2 proposed rule.
