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The introduction of artificial intelligence (AI) in interventional radiology (IR) will bring about new challenges and opportunities for patients and clinicians. AI may comprise software as a medical device or AI-integrated hardware and will require a rigorous evaluation that should be guided based on the level of risk of the implementation. A hierarchy of risk of harm and possible harms are described herein. A checklist to guide deployment of an AI in a clinical IR environment is provided. As AI continues to evolve, regulation and evaluation of the AI medical devices will need to continue to evolve to keep pace and ensure patient safety.
Warren et al. (Wed,) studied this question.