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

Int J Med Robotics Comput Assist Surg. 2018; e1968. DOI/10.1002/rcs.1968

Posted: 10 Jan 2019

See all articles by Shane O'Sullivan

Shane O'Sullivan

University of São Paulo (USP) - Department of Pathology

Nathalie Nevejans

Artois University

Colin Allen

University of Pittsburgh - Department of History and Philosophy of Science

Andrew Blyth

University of New South Wales (UNSW)

Simon Leonard

Johns Hopkins University

Ugo Pagallo

University of Turin, Department of Law

Katharina Holzinger

University of Hamburg

Andreas Holzinger

Medical University of Graz

Mohammed Imran Sajid

NHS Foundation Trust - Wirral University Teaching Hospital

Hutan Ashrafian

Imperial College London - Institute of Global Health Innovation; Imperial College London - Department of Surgery and Cancer

Date Written: November 5, 2018

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.

Keywords: Robot Law, Ethics of Artificial Intelligence, Ethics in Technology, Bioethics, Robot Ethics, Surgical Robot, Roboethics, Governance of AI

JEL Classification: I18, I19, I28, K13, K19

Suggested Citation

O'Sullivan, Shane and Nevejans, Nathalie and Allen, Colin and Blyth, Andrew and Leonard, Simon and Pagallo, Ugo and Holzinger, Katharina and Holzinger, Andreas and Sajid, Mohammed Imran and Ashrafian, Hutan, Legal, Regulatory, and Ethical Frameworks for Development of Standards in Artificial Intelligence (AI) and Autonomous Robotic Surgery (November 5, 2018). Int J Med Robotics Comput Assist Surg. 2018; e1968. DOI/10.1002/rcs.1968, Available at SSRN: https://ssrn.com/abstract=3313585

Shane O'Sullivan (Contact Author)

University of São Paulo (USP) - Department of Pathology ( email )

Brazil

Nathalie Nevejans

Artois University

9 Rue Temple
Arras, Pas de Calais 62000
France

Colin Allen

University of Pittsburgh - Department of History and Philosophy of Science

1017 Cathedral of Learning
4200 Fifth Avenue
Pittsburgh, PA 15260
United States

Andrew Blyth

University of New South Wales (UNSW)

Kensington
High St
Sydney, NSW 2052
Australia

Simon Leonard

Johns Hopkins University

Baltimore, MD 20036-1984
United States

Ugo Pagallo

University of Turin, Department of Law ( email )

Italy

Katharina Holzinger

University of Hamburg ( email )

Von-Melle-Park 5
20146 Hamburg
Germany

Andreas Holzinger

Medical University of Graz

Auenbruggerpl. 2
Graz, 8036
Austria

Mohammed Imran Sajid

NHS Foundation Trust - Wirral University Teaching Hospital

United Kingdom

Hutan Ashrafian

Imperial College London - Institute of Global Health Innovation

South Kensington Campus
Exhibition Road
London, Greater London SW7 2AZ
United Kingdom

Imperial College London - Department of Surgery and Cancer

Praed Street
London, NW1 1SQ
United Kingdom

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Abstract Views
519
PlumX Metrics