HHS Proposes HTI-5 Rule to Streamline Certification Program, Further Protect Patients from Information Blocking, and Foster an Artificial Intelligence-enabled Future

Executing on President Trump's Executive Order (EO) 14192 titled "Unleashing Prosperity through Deregulation" and the President's mandate to ensure the United States' continued leadership in artificial intelligence (AI), the U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), today released the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule.

Today's HTI-5 Proposed Rule has three core goals: (1) reducing burden on health IT developers by streamlining ASTP/ONC's voluntary Health IT Certification Program by removing redundant requirements; (2) updating the information blocking regulations to better promote electronic health information access, exchange, and use so that patients' access to their data is not blocked; and (3) advancing a new foundation of Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces (APIs) that promote AI-enabled interoperability solutions through modernized standards and certification. The HTI-5 proposed rule is expected to save $1.53 billion in total, including $650 million 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."

HTI-5 proposes to remove over 50% of the ONC Health IT Certification Program's (Certification Program) certification criteria; to revise several other criteria so as to reduce health IT developer compliance burdens; and to permanently implement prior enforcement discretion notices. Taken together, these proposals are estimated to save certified health IT developers more than 1.4 million compliance hours in their first year (an average savings of up to 4,000 hours per developer) - giving developers new capacity to deliver innovative solutions for their customers. These proposals seek to reset the Certification Program's scope to focus its future on standards-based APIs like FHIR and AI-enabled interoperability solutions.

The HTI-5 Proposed Rule also proposes updates to the information blocking regulations. Based on broad stakeholder feedback, ASTP/ONC proposes to revise or remove certain information blocking terms, conditions, and exceptions to address the potential for misuse or abuse. These proposals would ultimately strengthen HHS's ability to enforce the information blocking regulations.

Collectively, the proposals in the HTI-5 Proposed Rule directly align with President Trump's goals as outlined in EO 14192 and EO 14267 (Reducing Anti-Competitive Regulatory Barriers). ASTP/ONC encourages the broader health IT community to carefully review the HTI-5 Proposed Rule in its entirety to understand the full suite of provisions being proposed. The proposed rule is on display at the Federal Register and it will be available for public comment for 60 days upon publication.

More information can be found at healthit.gov/hti5 and via ASTP/ONC's X account, @HHS_TechPolicy

ASTP/ONC is also withdrawing certain proposals not yet finalized from the HTI-2 proposed rule.