Abstract

Artificial Intelligence (AI) is transforming the landscape of clinical care, offering tools that range from decision support to fully autonomous diagnosis and treatment. Yet this innovation has outpaced the development of clear legal frameworks. Traditional tort law and product liability doctrines strain to accommodate a world in which responsibility for harm may be buried within opaque algorithms or distributed across an intricate web of systems, developers, and institutions. This review examines the emerging legal landscape applicable to healthcare AI solutions, comparing U.S. and EU regulatory approaches and drawing on key case law to explore liability boundaries. We argue that tort law is adaptable to the AI revolution in healthcare. But this evolving legal framework only works if courts, developers, healthcare enterprises, and clinicians acknowledge the shifting terrain of transparency, autonomy, and accountability.

Keywords: Artificial intelligence; European union; Food & drug administration: Healthcare; Law; Legal; Medicine; Robotics; Surgery