Regulatory
December 23, 2025

A proposed federal rule would remove the model card requirement for clinical AI

A proposed HHS rule (HTI-5) would drop the model-card transparency mandate for clinical AI, shifting the due-diligence burden onto health systems.

HHS HTI-5 proposed rule on clinical AI transparency

HHS's ASTP/ONC has proposed the HTI-5 rule, which would remove the certification requirement that clinical decision support and predictive AI developers publish model cards disclosing data sources and model attributes. Nelson Mullins notes these represented some of the only existing federal transparency guardrails for healthcare AI. If the rule is finalized, a health system can no longer assume a vendor's transparency documentation will be federally required. The due-diligence burden shifts inward: whatever a governance committee needs to know about a model's training data, intended population, and known limitations, it will have to ask for and verify itself. Worth tracking through the comment period.

Source
Nelson Mullins
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