News: HHS finalizes rule to streamline health IT certification program to save on regulatory costs
The United States Department of Health and Human Services (HHS) information technology (IT) arm finalized a rule to streamline the health IT certification program with the intent to save billions in compliance costs. The deregulatory rule is an explicit effort to carry out Executive Order 14192 "Unleashing Prosperity Through Deregulation," according to the Office of the National Coordinator for Health Information Technology (ONC) within HHS.
The rule, titled Health Data, Technology and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5), is part of the ONC Health IT Certification Program. Under the ruling, developers must certify that their health IT modules conform to certain functional requirements, known as “certification criteria.”
The HTI-5 final ruling seeks to reduce administrative burdens for health IT developers participating in the ONC health IT certification program, ONC officials said. 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.
As outlined in the 2026 Unified Agenda, ONC plans to issue a draft HTI-6 rule that would include proposals for standards adoption, certification of health IT to support expanded uses of APIs, and updates to information blocking regulations.
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. 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).
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 market or impede innovation. 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.
Editor’s note: To read the final rule, click here. To read additional coverage from Fierce Healthcare, click here.