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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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“many AIs are forms of intelligence expressed by some artifact (Bryson & Theodorou, 2019) that interacts with humans at various levels, such as robots and self-driving cars (Manoharan, 2019; O’Sullivan et al., 2019).”
From Ethical principles for artificial intelligence in education (2023) · cites this paper as O’Sullivan et al., 2019
In the citing paper
“The safety issues of medical AI are the risks and harms that occur in its practices, such as program errors, being affected by cybersecurity, the need for adequate testing, difficult software certification, etc., covering various legal and ethical issues”
From Ethics and governance of trustworthy medical artificial intelligence (2023) · cites this paper as [47]
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“The rapid evolution of AI technologies has outpaced the formulation of comprehensive ethical guidelines, raising concerns about the potential misuse and unintended consequences of these powerful tools [32], [33].”
From Ethical Framework for Harnessing the Power of AI in Healthcare and Beyond (2024) · cites this paper as [32]
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Metadata
- Authors
- O'Sullivan, S., Nevejans, N., Allen, C., Blyth, A., Leonard, S., Pagallo, U., Holzinger, K., Holzinger, A., Sajid, M. I., & Ashrafian, H.
- Affiliations
- Department of Pathology, Faculdade de Medicina Universidade de São Paulo São Paulo Brazil
- Université d'Artois (FR)
- University of Pittsburgh (US)
- University of South Wales (GB)
- Department of Computer Science Johns Hopkins University Baltimore Maryland
- University of Turin (IT)
- SBA Research (AT)
- Medical University of Graz (AT)
- Wirral University Teaching Hospital NHS Foundation Trust (GB)
- Imperial College London (GB)
- ORCID
- Venue
- The International Journal of Medical Robotics and Computer Assisted Surgery
- Publisher
- Wiley
- Published
- 2019-01-09
- Volume
- 15
- Issue
- 1
- Pages
- e1968-e1968
- ISSN
- 1478-5951 (ISSN-L)
- 1478-596X
- OpenAlex
- W2899881299
- Cited by
- 437
- References
- 58
- Citations by year
- 2026: 46 · 2025: 71 · 2024: 93 · 2023: 72 · 2022: 60 · 2021: 59 · 2020: 28 · 2019: 8
- FWCI
- 45.81
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Medical Robotics and Computer Assisted Surgery (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
- Funders
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Topics
- Social Sciences › Law › Digitalization, Law, and Regulation
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Physical Sciences › Computer Science › Artificial Intelligence › Ethics and Social Impacts of AI
- Keywords
- artificial intelligence, autonomous robotic surgery, surgical robots, AI standards, legal framework, regulatory framework, AI ethics, liability, accountability, culpability, explainable AI, black box problem, medical malpractice, tort law, privacy, artificial intelligence in warfare, autonomous vehicles
- MeSH terms
- Algorithms, Artificial Intelligence, Ethics, Medical, Europe, Humans, United States, Computer Security, Medical Errors, Robotic Surgical Procedures
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