AI in Healthcare April 25, 2024
If a clinician you care about counts on AI to help make medical decisions, remind them: Tort law principles hold that doing so means risking liability should a patient sue over harm done.
The reminder comes from researchers in the anesthesiology department at Rutgers New Jersey Medical School. Saad Ali, MD, and co-authors had their commentary published in Biomedical Instrumentation & Technology, a peer-reviewed journal of the Association for the Advancement of Medical Instrumentation (AAMI).
Largely focusing on the “black box” problem and how it exposes clinicians to liability, Ali and colleagues cite last year’s draft guidance from the FDA discussing the information that manufacturers of AI-equipped medical devices should include in their product literature. [1]
Stating that the...