U.S. Sen. Bill Cassidy, MD, R-La., has released a discussion draft of the PATIENT AI Act, proposing to clarify whether the FDA or ONC oversees healthcare AI tools and to create a federal payment pathway for AI-based services.
The Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act comes from Dr. Cassidy, who chairs the Senate Health, Education, Labor and Pensions Committee. AI applications that don’t qualify as FDA-regulated devices would be added to the definition of ONC’s certified health IT.
The FDA would get a risk-based review process for software-based devices, including authority to accept premarket software changes and review updates on a rolling basis. HHS would certify third-party bodies to review low- to moderate-risk software. The Oct. 29 draft also applies existing federal preemption of state product liability laws to integrated and software-based devices.
On reimbursement, HHS would build a coverage evaluation framework for AI-based services, propose payment methodologies and establish a process to use Healthcare Common Procedure Coding System Level II codes for them. The Center for Medicare and Medicaid Innovation would test a payment model for AI applications that deliver care autonomously.
HHS would also issue HIPAA compliance guidance for AI use and commission a nonprofit to recommend approaches to AI liability.
Implementing AI in healthcare “must be done responsibly and to the benefit of patients, innovators, and consumers,” Dr. Cassidy said.
Dr. Cassidy is accepting stakeholder feedback by Dec. 1 at patientai@help.senate.gov.
The draft follows Dr. Cassidy’s Health Care Cybersecurity and Resiliency Act, which the Senate passed by unanimous consent, and his Health Information Privacy Reform Act, which the HELP Committee approved unanimously in July.
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