HHS finalizes HTI-5, cutting 14 health IT certification criteria and AI source labels
On Oct. 26, ONC finalized its HTI-5 deregulatory rule. It removes 14 of the 60 health IT certification criteria and revises seven. It also drops the requirement that certified EHRs show clinicians the source attributes behind AI and other predictive decision-support tools. ONC says the rule saves about $1.55B in net present value. The C-CDA and Direct sunset moves to 2030 and vendors must still publish their public FHIR endpoint URLs. Proposed changes to information blocking exceptions and disincentives were not finalized and remain under review.
Why it's notable: Certified EHRs that clinics use will carry fewer built-in AI transparency, privacy and security requirements, and ONC says algorithm safety oversight belongs with the FDA and nondiscrimination rules. Critics argue this weakens safety protections, while the rule also steers vendors toward FHIR-based exchange.