Sen. Bill Cassidy, MD (R-LA), chair of the Senate Health, Education, Labor, and Pensions Committee, released a discussion draft of the Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act (PATIENT AI Act), which would establish a federal framework for AI-based health technologies.
The proposal would:
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Clarify when AI-based technologies are subject to the FDA or Office of the National Coordinator for Health Information Technology oversight.
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Give the FDA additional authority to review software changes on a rolling basis.
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Create a payment pathway to support adoption of AI-based health technologies.
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Direct the Department of Health and Human Services (HHS) to issue guidance to protect patient privacy and security as AI is deployed in health care.
What’s next: Sen. Cassidy is seeking stakeholder feedback on the discussion draft through December 1. Email all comments to patientai@help.senate.gov.