PATIENT AI Act Discussion Draft, AMA Issue Brief for Clinical AI Liability Released

Accountability and reimbursement for artificial intelligence (AI)-based technologies were highlighted topics of discussion last week. 

In an issue brief regarding liability for clinical AI, released Oct. 29, the AMA offered an approach to accountability that establishes responsibilities of physicians, developers, and deployers of AI-based technology: physicians are responsible for the clinical judgment they can meaningfully exercise; developers are responsible for the systems and the inherent risks within their control; and deployers are responsible for where and how the AI-based technology is applied.

Among the key issues raised was that of contract terms and disclaimers that may allocate financial responsibility for AI-related harm through indemnification provisions, liability limits, and other terms. The issue brief is the first part of a broader program looking at liability for clinical AI; the AMA Center for Digital Health and AI will work with various stakeholders to establish practical approaches to accountability.

Also on Oct. 29, Sen. Bill Cassidy, M.D. (R-La.), chairman of the Senate Health, Education, Labor, and Pensions Committee, released a legislative discussion draft that, if passed, would “create a more predictable and consistent framework to review and reimburse for AI-based technologies.”

The framework would remove unnecessary barriers to innovation, such as clarifying when an AI-based technology is subject to oversight by the U.S. Food and Drug Administration or the Office of the National Coordinator for Health Information Technology (ONC). Additionally, the FDA would be granted new authorities to review changes to software on a rolling basis, and a payment pathway would be implemented to facilitate the adoption of AI-based tools.

Cassidy has requested stakeholder feedback on the proposal by Dec. 1, 2026. All comments may be emailed to patientai@help.senate.gov.

Sources:

https://www.ama-assn.org/practice-management/digital-health/liability-clinical-ai

https://www.help.senate.gov/rep/newsroom/press/chairman-cassidy-unveils-discussion-draft-to-expand-access-to-ai-in-health-care-improve-care-for-patients