De Paola L, Treglia M, Napoletano G, Treves B, Ghamlouch A, Rinaldi R
Department of Anatomical, Histological, Forensic and Orthopedic Sciences, Sapienza University of Rome, Rome, Italy.
Department of Surgical Sciences, University of Tor Vergata, Rome, Italy.
Clin Ter. 2025 Mar-Apr;176(2):233-240. doi: 10.7417/CT.2025.5211.
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.
本文探讨了机器人手术的应用，以及与之相关的法律、伦理和财务挑战，特别关注了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给医学领域带来了变革，但其使用引发了关于安全性、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精度进行操作。然而，高昂的成本和培训的复杂性限制了此类技术的广泛应用。基于人工智能的沃森系统在诊断和治疗规划方面为医生提供支持，减少了整合新科学证据所需的时间，但在决策透明度方面带来了挑战。讨论的一个关键方面是机器人辅助手术过程中患者受到伤害时的医疗责任。并发症可能源于人为错误、技术故障或软件缺陷。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、维护技术人员和医疗机构。现有的监管框架，如欧洲关于缺陷产品的指令，不足以应对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”以及机器人生成数据缺乏透明度，进一步使法律程序复杂化。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。这包括强制保险政策、提高操作透明度以及加强知情同意作为保障患者权利的基石。该研究的目的是考察机器人手术的当前应用，并分析与之相关的法律和伦理挑战。该研究旨在探索这些系统在手术中的益处，以及与安全性、法律责任和可持续性相关的问题，目标是确定需要更具体的法规来平衡创新与患者保护。
