Legal, Regulatory, and Ethical Frameworks for Development of Standards in Artificial Intelligence (AI) and Autonomous Robotic Surgery

Abstract

Background: This paper aims to move the debate forward regarding the potential for artificial intelligence (AI) and autonomous robotic surgery with a particular focus on ethics, regulation and legal aspects (such as civil law, international law, tort law, liability, medical malpractice, privacy and product/device legislation, among other aspects). Methods: We conducted an intensive literature search on current or emerging AI and autonomous technologies (eg, vehicles), military and medical technologies (eg, surgical robots), relevant frameworks and standards, cyber security/safety‐ and legal‐systems worldwide. We provide a discussion on unique challenges for robotic surgery faced by proposals made for AI more generally (eg, Explainable AI) and machine learning more specifically (eg, black box), as well as recommendations for developing and improving relevant frameworks or standards. Conclusion: We classify responsibility into the following: (1) Accountability; (2) Liability; and (3) Culpability. All three aspects were addressed when discussing responsibility for AI and autonomous surgical robots, be these civil or military patients (however, these aspects may require revision in cases where robots become citizens). The component which produces the least clarity is Culpability, since it is unthinkable in the current state of technology. We envision that in the near future a surgical robot can learn and perform routine operative tasks that can then be supervised by a human surgeon. This represents a surgical parallel to autonomously driven vehicles. Here a human remains in the ‘driving seat’ as a ‘doctor‐in‐the‐loop’ thereby safeguarding patients undergoing operations that are supported by surgical machines with autonomous capabilities.

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