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 (
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.
Executive Summary
The article explores the legal, regulatory, and ethical frameworks necessary for the development of standards in artificial intelligence (AI) and autonomous robotic surgery. It highlights the unique challenges posed by AI and machine learning in the context of surgical robots, including issues of accountability, liability, and culpability. The authors conduct an extensive literature review and provide recommendations for improving frameworks and standards to ensure the safe and ethical deployment of these technologies.
Key Points
- ▸ The article focuses on the ethical, regulatory, and legal aspects of AI and autonomous robotic surgery.
- ▸ It discusses the challenges of applying general AI frameworks to surgical robots, such as Explainable AI and the black box problem.
- ▸ The authors classify responsibility into accountability, liability, and culpability, with culpability being the least clear.
- ▸ The article envisions a future where surgical robots perform routine tasks under human supervision, similar to autonomous vehicles.
Merits
Comprehensive Literature Review
The article provides an extensive review of current and emerging technologies, frameworks, and legal systems, offering a broad perspective on the topic.
Clear Classification of Responsibility
The classification of responsibility into accountability, liability, and culpability is a useful framework for understanding the complexities of AI and robotic surgery.
Demerits
Lack of Specific Case Studies
The article could benefit from specific case studies or real-world examples to illustrate the challenges and recommendations discussed.
Limited Discussion on Culpability
The discussion on culpability is brief and acknowledges the lack of clarity, which could be expanded with more detailed analysis.
Expert Commentary
The article makes a significant contribution to the discourse on AI and autonomous robotic surgery by systematically addressing the legal, regulatory, and ethical challenges. The classification of responsibility into accountability, liability, and culpability is particularly insightful, as it highlights the complexities involved in assigning responsibility in AI-driven surgical procedures. However, the article could benefit from more detailed case studies and a deeper exploration of the concept of culpability. The vision of surgical robots performing routine tasks under human supervision is compelling and aligns with the broader trend towards autonomous systems in various fields. The practical and policy implications are well-articulated, emphasizing the need for clear guidelines and regulatory frameworks to ensure the safe and ethical use of AI in surgery.
Recommendations
- ✓ Conduct further research with specific case studies to illustrate the challenges and recommendations discussed in the article.
- ✓ Expand the discussion on culpability to provide a more comprehensive understanding of the ethical and legal implications.
