Legal and Forensic Implications in Robotic Surgery.

Q2 Medicine
L De Paola, M Treglia, G Napoletano, B Treves, A Ghamlouch, R Rinaldi
{"title":"Legal and Forensic Implications in Robotic Surgery.","authors":"L De Paola, M Treglia, G Napoletano, B Treves, A Ghamlouch, R Rinaldi","doi":"10.7417/CT.2025.5211","DOIUrl":null,"url":null,"abstract":"<p><strong>Abstract: </strong>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 collec-tion 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.</p>","PeriodicalId":50686,"journal":{"name":"Clinica Terapeutica","volume":"176 2","pages":"233-240"},"PeriodicalIF":0.0000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Terapeutica","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.7417/CT.2025.5211","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

Abstract

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 collec-tion 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.

机器人手术的法律和法医意义。
摘要:本文探讨了机器人手术的应用,以及与其使用相关的法律、伦理和财务挑战,特别关注达芬奇和沃森等先进系统。虽然这些技术通过提高手术精度和诊断效率彻底改变了医疗领域,但它们的使用引发了有关安全性、责任和可持续性的关键问题。达芬奇系统主要用于复杂的泌尿肿瘤和妇科手术,使外科医生能够以前所未有的准确性进行手术。然而,高昂的费用和训练的复杂性限制了这种技术的广泛采用。基于人工智能的沃森系统支持医生进行诊断和治疗计划,减少了整合新科学证据所需的时间,但对决策透明度提出了挑战。讨论的一个关键方面是在机器人辅助手术过程中患者受伤的医疗责任。并发症可能由人为错误、技术故障或软件缺陷引起。目前,责任归属涉及多个利益相关者:外科医生、机器人制造商、维修技术人员和医疗机构。现有的监管框架,如欧洲缺陷产品指令,不足以解决先进机器人系统带来的具体挑战,特别是在诉讼案件中的证据收集方面。基于人工智能的决策“不透明”,以及机器人生成的数据缺乏透明度,使法律程序进一步复杂化。总之,虽然机器人手术代表了一个有前途的前沿领域,但需要更具体的法规来平衡创新与患者保护。这包括强制性保险政策、提高业务透明度和加强知情同意,将其作为保障患者权利的基石。这项研究的目的是检查机器人手术的当前应用,并分析与它们的使用相关的法律和伦理挑战。该研究旨在探索这些系统在外科手术中的好处,以及与安全性,法律责任和可持续性相关的问题,目的是确定需要更具体的法规来平衡创新与患者保护。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Clinica Terapeutica
Clinica Terapeutica PHARMACOLOGY & PHARMACY-
CiteScore
2.50
自引率
0.00%
发文量
124
审稿时长
6-12 weeks
期刊介绍: La Clinica Terapeutica è una rivista di Clinica e Terapia in Medicina e Chirurgia, fondata nel 1951 dal Prof. Mariano Messini (1901-1980), Direttore dell''Istituto di Idrologia Medica dell''Università di Roma “La Sapienza”. La rivista è pubblicata come “periodico bimestrale” dalla Società Editrice Universo, casa editrice fondata nel 1945 dal Comm. Luigi Pellino. La Clinica Terapeutica è indicizzata su MEDLINE, INDEX MEDICUS, EMBASE/Excerpta Medica.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信