Artificial intelligence technology promises to redefine the practice of radiology. However, it exists in a nascent phase and remains largely untested in the clinical space. This nature is both a cause and consequence of the uncertain legal–regulatory environment it enters. This discussion aims to shed light on these challenges, tracing the various pathways toward approval by the US Food and Drug Administration, the future of government oversight, privacy issues, ethical dilemmas, and practical considerations related to implementation in radiologist practice.