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Washington trims the health IT rulebook. The HHS Office of the National Coordinator for Health Information Technology (ONC) has finalized the HTI-5 rule, cutting 14 out of 60 certification criteria for health IT developers and revising seven more. The move is projected to save $1.55 billion in regulatory costs and is part of the Trump administration's broader deregulatory push — though it falls well short of the 34 cuts originally proposed.
Washington trims the health IT rulebook — but not as drastically as planned.
The HHS Office of the National Coordinator for Health Information Technology (ONC) has finalized the HTI-5 rule, removing 14 out of 60 certification criteria from the ONC Health IT Certification Program and revising seven more. The rule is a centerpiece of the Trump administration's deregulatory agenda, explicitly tied to Executive Order 14192 "Unleashing Prosperity Through Deregulation." Notably, health IT developers will no longer need to provide AI model card transparency data — including training, performance, and validation data — for tools using AI or machine learning.
The final rule is a scaled-back version of the December 2025 proposal, which had called for eliminating 34 criteria — nearly 70% of existing requirements. ONC also punted on proposed changes to information-blocking regulations, leaving those under consideration for a future rule.
By the Numbers:
Why it matters: While ONC certification is technically voluntary, it's required for participation in key federal programs like Medicare's Promoting Interoperability Program. Reducing the compliance burden could free up developer resources for innovation — though dropping AI transparency requirements removes a layer of oversight at a time when AI tools are becoming increasingly common in clinical settings.
