The health information technology arm at the Department of Health and Human Services (HHS) finalized a rule that aims to streamline the health IT certification program and reduce billions in compliance costs.
The deregulatory rule is an explicit effort to carry out President Donald Trump’s executive order 14192 “Unleashing Prosperity Through Deregulation,” according to the Office of the National Coordinator for Health Information Technology (ONC) within HHS.
The rule, called Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5), is projected to save more than $1.5 billion in regulatory costs, according to ONC.
For background, as part of the ONC Health IT Certification Program, developers must certify that their health IT modules conform to certain functional requirements, known as “certification criteria.”
The HTI-5 final rule significantly reduces administrative burdens for health IT developers participating in the ONC health IT certification program. These deregulatory changes free up resources for health IT developers that can now be applied toward enhancing user experiences for patients and clinicians, ONC leaders said.
“American doctors and patients need better technology, not more Washington paperwork,” said HHS Secretary Robert F. Kennedy, Jr. in a statement. “The Trump Administration is eliminating unnecessary regulations that cost more than $1.5 billion and hold back innovation. We are freeing America’s health technology innovators to build better tools, lower costs, and help doctors spend more time caring for patients.”
HHS estimates the changes to the certification program will save $1.55 billion in present-value regulatory costs and $108.1 million in annualized net savings beginning in 2027.
The final rule retains most of the core objectives from the December 2025 proposal, but ONC significantly scaled back its approach, stopping short of the sweeping overhaul of the health IT certification program it initially proposed. In the draft rule, ONC proposed to eliminate 34 out of 60 certification requirements for electronic health records and revise seven certification requirements. The proposal (PDF) would have altered nearly 70% of its existing requirements.
In the final rule, ONC removed 14 out of 60 certification criteria and revised seven criteria. ONC retained and made no changes to 39 certification criteria, which include the new and revised criteria that were adopted in the Health Data, Technology, and Interoperability: Electronic Prior Authorization and Real-Time Prescription Benefit (HTI-4) Final Rule.
“Through HTI-5, we have taken decisive action to significantly lower the administrative compliance burden for developers so that they can spend more of their time developing solutions that improve interoperability, automation, and better healthcare for Americans,” said Tom Keane, M.D., National Coordinator for Health IT, in a statement.
The HTI-5 final rule also signals ONC’s efforts to shift its certification program toward Fast Healthcare Interoperability Resources (FHIR)-based application programming interfaces (API). “This approach is consistent with the Cures Act’s reference to “successor technology or standards” within the API Condition of Certification. These requirements will support creative AI-enabled interoperability solutions,” ONC officials said.
According to ONC, the HTI-5 final rule reduces or removes certain long-standing, functionality-oriented and document-based certification criteria. These certification criteria include capabilities that are already well established in health IT products in the markets or impede innovation.
ONC finalized proposals to make conforming edits for several Conditions and Maintenance of Certification requirements, including the “Assurances” (§ 170.402), “Application Programming Interfaces” (§ 170.404), and “Attestations” (§ 170.406) Conditions and Maintenance of Certification requirements, according to a HHS fact sheet.
In addition, the HTI-5 final rule scaled back “Real World Testing” Condition and Maintenance of Certification requirements (§ 170.405) with deregulatory actions for real world testing plans, real world testing results, and the use of the Standards Version Advancement Process.
The “Insights” Conditions and Maintenance of Certification reporting requirements (§ 170.407) were reduced generally consistent with the enforcement discretion issued on April 29, 2025, except that the “use of FHIR bulk data access” measure was also retained.
The final rule also moves forward with removing the AI model-card transparency requirements for decision support interventions (established under HTI-1), mirroring the intent of the draft to reduce documentation overhead.
ONC says it intends to continue to address chronic disease, increase market competition and lower healthcare costs by improving the access, exchange and use of electronic health information (EHI). The agency plans to put forth proposals in the future to advance interoperability and EHI sharing through standards adoption; additional updates to the Certification Program to support expanded uses of application programming interfaces (APIs) and potential successor technologies; and targeted conditions of certification.
The HTI-5 rule does not finalize proposed changes to federal information blocking regulations. HHS said comments submitted in response to the HTI-5 proposed rule’s information blocking proposals remain under consideration.
The rule is scheduled for publication in the Federal Register on Oct. 28. Many of the provisions in the rule take effect 60 days after publication, while certain changes take effect Jan. 1, 2027. A PDF of the unpublished rule can be accessed here.