Ethical Responsibility in the Off-Label Use of AI in Medical Imaging.

Abstract

AbstractArtificial intelligence in medical imaging (AI-MI), categorized by the U.S. Food and Drug Administration (FDA) as "Software as a Medical Device," can offer significant benefit to medical care. FDA approval-represented by a "label"-indicates that the device has demonstrated safety and efficacy for a specific clinical task and population for which the device is intended. Off-label use of AI-MI outside of the task and/or population can be medically and ethically problematic, yet benefits ma