HHS Finalizes HTI-5 Rule to Streamline Health IT Certification While Punting Information Blocking Proposals

The Department of Health and Human Services (HHS) and the Office of the National Coordinator for Health IT (ONC) have finalized a deregulatory rule aimed at streamlining the ONC Health IT Certification Program. According to agency projections, the policy change is expected to save more than $1.5 billion in regulatory and compliance costs for health information technology developers. Officials stated that the measure directly responds to executive directives focused on reducing administrative burdens and fostering market competition across the healthcare technology sector.

Overview of the HTI-5 Final Rule

Under the ONC Health IT Certification Program, developers are required to certify that their health technology modules meet specific functional benchmarks known as certification criteria. The newly finalized Health Data, Technology and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) rule removes 14 out of 60 existing certification criteria and revises seven additional criteria. However, the final policy retains 39 criteria without modification.

During a press briefing, National Coordinator for Health IT Tom Keane noted that the rule aims to reallocate developer resources away from paperwork and toward technological innovation. HHS estimates that the adjustments will yield $1.55 billion in present-value regulatory savings alongside $108.1 million in annualized net savings starting in 2027. Agency leadership emphasized that the regulation seeks to lower healthcare costs and improve electronic health information exchange capabilities for clinicians and patients alike.

Key Modifications and Scaled-Back Proposals

While the initial draft proposal released in December pitched sweeping changes—including the potential elimination of 34 out of 60 certification requirements—the final rule adopts a more targeted approach. ONC scaled back several components of the framework:

• Removed 14 functionality-oriented and document-based certification criteria that were already well-established in commercial products or considered impediments to innovation.
• Revised seven specific criteria to align with modern industry standards.
• Streamlined Real World Testing conditions and maintenance requirements.
• Reduced certain Insights reporting mandates, while retaining the use of Fast Healthcare Interoperability Resources (FHIR) bulk data access.
• Eliminated artificial intelligence model-card transparency requirements for decision support interventions that were previously established under the HTI-1 rule.

Information Blocking Provisions Postponed

Notably, ONC decided to punt several proposed updates regarding information blocking regulations to a later date. The initial draft rule had suggested altering definitions such as access and use to facilitate autonomous artificial intelligence retrieval and sharing of health data, alongside removing or revising multiple information blocking exceptions.

HHS confirmed that public comments submitted regarding those proposals remain under consideration. Agency officials outlined two potential pathways for the deferred provisions: ONC could finalize the existing proposals in a separate standalone rule utilizing previously gathered feedback, or initiate a brand-new rulemaking process that may involve additional public comment periods.

Despite deferring the information blocking proposals, HHS maintained that its enforcement stance remains unchanged. Officials reiterated that the agency collaborates closely with the Office of Inspector General (OIG) to hold accountable entities that engage in information blocking practices. Future regulatory efforts, including a prospective draft HTI-6 rule outlined in the 2026 Unified Agenda, are anticipated to address ongoing standards adoption, expanded application programming interface (API) uses, and further updates to certification conditions.