의료 인공지능의 활용을 둘러싼 법적 과제: 규제의 진화 및 책임의 배분을 중심으로

초록

Technological advances in artificial intelligence (AI) are transforming health care by assisting healthcare providers and improving patient care. However, AI medical devices may err and adversely affect the physician’s decision-making, resulting in patient harm. Therefore, regulating AI medical devices and allocating liability arising from algorithm inaccuracy is critical for patient safety and innovation in clinical care. This paper provides an overview of the three evolutional stages in regulating AI medical devices and highlights the remaining issues for the regulatory agencies to be addressed. Moreover, this study considers multiple stakeholders beyond clinicians and alternative policy options in its liability analysis and identifies questions that call for deeper investigation and discussion in the future.

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