HHS Releases HTI-5 Rule

On October 26, 2026, the Department of Health and Human Services (HHS) released the HTI-5 final rule, entitled, Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity. In the final rule, the Office of the National Coordinator for Health Information Technology (ONC) has retained all existing privacy and certification criteria and the associated certification framework. Additionally, ONC codified its previously announced 2025 enforcement discretion policies, providing greater flexibility for adopting new health IT standards and easing real-world testing and reporting requirements. The rule also eliminates AI model-card transparency requirements and defers changes to federal information blocking regulations to future rulemaking. HHS notes that the HTI-5 Final Rule significantly reduces administrative burdens for health IT developers participating in the ONC Health IT Certification Program, reallocating resources for health IT developers that can be applied toward enhancing user experiences for patients and clinicians.

The final rule may be found here. The HHS press release may be found here. The ONC fact sheet may be found here and the ONC HTI-5 final rule certification criteria fact sheet may be found here.