FDA

A Senate HELP Committee discussion draft of the PATIENT AI Act proposes clearer FDA and ONC oversight boundaries, rolling review of software changes, expanded HHS AI use with privacy and security guidance, and a reimbursement pathway. Stakeholders may comment through December 1, 2026; the proposal is not enacted law, and a separate House proposal addresses clinician review of AI-involved medical-necessity denials.

The FDA has updated Compliance Program 7304.004, enhancing pesticide residue monitoring in foods. Contractors in food safety and laboratory services should prepare for increased demand and updated regulatory requirements stemming from these changes.