The Office of the National Coordinator for Health IT (ONC) released the Health Data, Technology and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) final rule, building on the HTI-5 proposed rule from December 2025, to streamline the ONC Health IT Certification Program, update information blocking regulations and support AI-enabled FHIR-based interoperability.

The final rule scales back portions of the federal Health IT Certification Program to reduce developer burden, increase flexibility and support innovation. Although narrower than the previous proposed rule, it removes and simplifies several certification, testing and reporting requirements while preserving key privacy, security, accessibility, public health and interoperability protections.

For clinical AI, the rule eliminates standardized "model card" disclosures and predictive decision-support risk-management requirements. As a result, certified health IT developers will no longer be required to provide consistent information about an AI tool's intended use, training, performance, limitations and risks through ONC certification.

The final rule also reinforces FHIR as the long-term interoperability standard while allowing additional time to transition from older exchange methods. Additional details are below.

• The final rule removes 14 of 60 certification criteria, revises seven and retains 39 criteria, compared with the proposed rule's plan to remove 34.
• ONC maintains privacy, security, accessibility-centered design, quality measurement, implantable device information and selected public health reporting requirements that were initially proposed for removal.
• The final rule reduces real-world testing and insights reporting obligations and replaces detailed safety-enhanced-design testing requirements with a less prescriptive, attestation-based approach.
• Most provisions take effect 60 days after publication. Some changes are effective Jan. 1, 2027. Specified transitions-of-care changes are delayed until Jan. 1, 2030.
• The final rule addresses only a subset of the provisions proposed in 2025. Proposals not finalized under the final rule remain under consideration and may be addressed through subsequent rulemaking.

For more information on the HTI-5 final rule, review the full text and accompanying press release.

Keywords: ACC Advocacy, Artificial Intelligence, Public Health, Privacy, Certification, Technology