Cited by 437Digitalization, Law, and RegulationArtificial Intelligence in Healthcare and EducationEthics and Social Impacts of AI

Legal, regulatory, and ethical frameworks for development of standards in artificial intelligence (AI) and autonomous robotic surgery

O'Sullivan, Shane, Nevejans, Nathalie, Allen, Colin, Blyth, Andrew, Leonard, Simon, Pagallo, Ugo, Holzinger, Katharina, Holzinger, Andreas +2 more·2019·The International Journal of Medical Robotics and Computer Assisted 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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Registry

Crossref · 10.1002/rcs.1968

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57 of 57 references verified0 citation errors · 0 not checkable

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  • Many AIs are forms of intelligence expressed by some artifact that interacts with humans at various levels, such as robots and self-driving cars.

    “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

  • 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.

    “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”
  • The rapid evolution of AI technologies has outpaced the formulation of comprehensive ethical guidelines, raising concerns about potential misuse and unintended consequences.

    “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].”

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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)
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
  • Social Sciences › Safety Research › 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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