Is Artificial Intelligence (AI) a Pipe Dream? Why Legal Issues Present Significant Hurdles to AI Autonomy

Abstract

Proponents of artificial intelligence (AI) technology have suggested that in the near future, AI software may replace human radiologists. Although assimilation of AI into the specialty has occurred more slowly than predicted, developments in machine learning, deep learning, and neural networks suggest that technologic hurdles and costs will eventually be overcome. However, beyond these technologic hurdles, formidable legal hurdles threaten the impact of AI on the specialty. Legal liability for errors committed by AI will influence the ultimate role of AI within radiology and also influence whether AI remains a simple decision support tool or develops into an autonomous member of the health care team. Additional areas of uncertainty include the potential application of products liability law to AI and the approach taken by the U.S. FDA in potentially classifying autonomous AI as a medical device. The current ambiguity of the legal treatment of AI will profoundly influence development of autonomous AI given that vendors, radiologists, and hospitals will be unable to reliably assess their liability associated with implementing such tools. Advocates of AI in radiology and health care in general need to lobby for legislative action to better clarify the liability risks of AI in a way that does not deter technologic development.

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