The article examines the applications of robotic surgery, and the legal, ethical, and financial challenges associated with its use, with a particular focus on advanced systems like Da Vinci and Watson. While these technologies have revolutionized the medical field by enhancing surgical precision and diagnostic efficiency, their use raises critical issues regarding safety, liability, and sustainability. The Da Vinci system, primarily utilized for complex uro-oncological and gynecological procedures, enables surgeons to operate with unprecedented accuracy. However, high costs and the complexity of training limit the widespread adoption of such technologies. The Watson system, based on artificial intelligence, supports physicians in diagnosis and treatment planning, reducing the time required to integrate new scientific evidence but posing challenges in decision-making transparency. A key aspect of the discussion is medical liability in cases of patient harm during robot-assisted procedures. Complications may arise from human error, technical malfunctions, or software defects. Currently, the attribution of liability involves multiple stakeholders: surgeons, robot manufacturers, maintenance technicians, and healthcare institutions. Existing regulatory frameworks, such as the European Directive on defective products, are inadequate to address the specific challenges posed by advanced robotic systems, particularly regarding the collection of evidence in litigation cases. The “opacity” of decision-making based on artificial intelligence and the lack of transparency in robot-generated data further complicates the legal process. In conclusion, while robotic surgery represents a promising frontier, more specific regulations are needed to balance innovation with patient protection. This includes policies for mandatory insurance, increased operational transparency, and strengthening informed consent as a cornerstone for safeguarding patients’ rights. The aim of the research is to examine the current applications of robotic surgery and analyze the legal, and ethical challenges associated with their use. The research intends to explore the benefits of these systems in surgery, but also the issues related to safety, legal liability, and sustainability, with the goal of identifying the need for more specific regulations to balance innovation with patient protection.

Legal and Forensic Implications in Robotic Surgery / De Paola, L; Treglia, M; Napoletano, G; Treves, B; Ghamlouch, A; Rinaldi, R. - In: LA CLINICA TERAPEUTICA. - ISSN 1972-6007. - 176:2(2025), pp. 233-240. [10.7417/CT.2025.5211]

Legal and Forensic Implications in Robotic Surgery

De Paola, L;Napoletano, G
;
Treves, B;Ghamlouch, A;Rinaldi, R
2025

Abstract

The article examines the applications of robotic surgery, and the legal, ethical, and financial challenges associated with its use, with a particular focus on advanced systems like Da Vinci and Watson. While these technologies have revolutionized the medical field by enhancing surgical precision and diagnostic efficiency, their use raises critical issues regarding safety, liability, and sustainability. The Da Vinci system, primarily utilized for complex uro-oncological and gynecological procedures, enables surgeons to operate with unprecedented accuracy. However, high costs and the complexity of training limit the widespread adoption of such technologies. The Watson system, based on artificial intelligence, supports physicians in diagnosis and treatment planning, reducing the time required to integrate new scientific evidence but posing challenges in decision-making transparency. A key aspect of the discussion is medical liability in cases of patient harm during robot-assisted procedures. Complications may arise from human error, technical malfunctions, or software defects. Currently, the attribution of liability involves multiple stakeholders: surgeons, robot manufacturers, maintenance technicians, and healthcare institutions. Existing regulatory frameworks, such as the European Directive on defective products, are inadequate to address the specific challenges posed by advanced robotic systems, particularly regarding the collection of evidence in litigation cases. The “opacity” of decision-making based on artificial intelligence and the lack of transparency in robot-generated data further complicates the legal process. In conclusion, while robotic surgery represents a promising frontier, more specific regulations are needed to balance innovation with patient protection. This includes policies for mandatory insurance, increased operational transparency, and strengthening informed consent as a cornerstone for safeguarding patients’ rights. The aim of the research is to examine the current applications of robotic surgery and analyze the legal, and ethical challenges associated with their use. The research intends to explore the benefits of these systems in surgery, but also the issues related to safety, legal liability, and sustainability, with the goal of identifying the need for more specific regulations to balance innovation with patient protection.
2025
Da Vinci surgical system; Watson AI; legal/regulatory frameworks; liability profiles; machine-/deep-learning; robotic surgery
01 Pubblicazione su rivista::01g Articolo di rassegna (Review)
Legal and Forensic Implications in Robotic Surgery / De Paola, L; Treglia, M; Napoletano, G; Treves, B; Ghamlouch, A; Rinaldi, R. - In: LA CLINICA TERAPEUTICA. - ISSN 1972-6007. - 176:2(2025), pp. 233-240. [10.7417/CT.2025.5211]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1740551
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