The American Medical Association (AMA) has introduced a new framework for assigning responsibility when artificial intelligence (AI) systems used in clinical care contribute to patient harm. The framework calls for responsibility to be distributed among technology developers, health care organizations, and physicians according to their authority and ability to prevent or mitigate harm.

According to an AMA press release, existing liability frameworks were not designed for technologies in which physicians, developers, and health care organizations each exercise different levels of control over clinical AI systems. As a result, physicians may face liability for risks they cannot reasonably prevent, while patients may struggle to seek remedies when AI causes harm.

The framework, being advanced by the AMA Center for Digital Health and AI, outlines proposed responsibilities for each party:

• Developers and manufacturers should demonstrate and maintain the safety and effectiveness of their products and address risks within their control.
• Health care organizations and other deployers should be accountable for how AI systems are selected, implemented, governed, and monitored in real-world settings.
• Physicians should be responsible for the clinical judgment they can meaningfully exercise, based on the system’s intended use, known limitations, and the information available at the point of care.
• Patients must retain meaningful avenues for seeking accountability and appropriate remedies when harm results from defective AI systems or other actionable failures.

“Patients must have meaningful avenues for recourse when clinical AI causes harm, and physicians must be able to use these technologies with confidence that responsibility reflects what they can reasonably know and control,” said AMA President Willie Underwood III, MD, MSc, MPH, in the press release. “As AI assumes more clinical functions, developers, health care organizations, and physicians each have important responsibilities. We need clear expectations that protect patients, support sound clinical judgment, and ensure accountability remains with those best positioned to prevent harm.” 

The framework also recognizes that multiple parties may bear liability for the use of AI when something goes wrong, with accountability aligned with each party’s ability to prevent harm. It also emphasizes that physician oversight cannot substitute for adequate evidence, appropriate system design, or the conditions necessary to make clinical review meaningful. RP