HHS Finalizes HTI-5 Rule Removing AI Model‑Card Requirements

Overview

• The Department of Health and Human Services finalized the HTI-5 rule on Oct. 26, 2026, removing 14 federal health IT certification criteria and revising seven more.
• HTI-5 drops the source‑attribute or model‑card requirements that HTI‑1 had required for decision‑support tools in certified EHRs so vendors will no longer have to support access to those algorithm details through certification.
• HHS projects $1.55 billion in present‑value regulatory cost savings from the rule, which it says mainly reflects lower developer compliance costs and translates to about $108.1 million in annualized net savings starting in 2027.
• The rule is set for Federal Register publication on Oct. 28 with most provisions effective 60 days later, a set of changes effective Jan. 1, 2027, and one transitions‑of‑care revision set for Jan. 1, 2030; CMS is already updating program references to align with the changes.
• HTI‑5 leaves proposed changes to federal information‑blocking rules unresolved and signals further rulemaking on expanded APIs, interoperability standards, and targeted certification conditions that could restore or reshape disclosure and access requirements in the future.