Legal Implication in Utilizing Automated Robots: A Written Informed Consent Form Proposal

IF 2.3 3区医学 Q2 SURGERY

International Journal of Medical Robotics and Computer Assisted Surgery Pub Date : 2025-04-22 DOI:10.1002/rcs.70064

Maria Teresa Contaldo, Sonia Triggiani, Giacomo Vignati, Daniele Bracchi, Gianpaolo Carrafiello

{"title":"Legal Implication in Utilizing Automated Robots: A Written Informed Consent Form Proposal","authors":"Maria Teresa Contaldo, Sonia Triggiani, Giacomo Vignati, Daniele Bracchi, Gianpaolo Carrafiello","doi":"10.1002/rcs.70064","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Robotic systems enhance physicians' capabilities by replicating hand movements in real-time, ensuring precise control and a quick return to conventional procedures if patient safety is compromised. Physicians performing robot-assisted procedures bear ultimate responsibility, sharing potential liability with manufacturers for malfunctions.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This study, conducted by a transdisciplinary team of interventional radiologists and a legal expert, evaluates the integration of robotic systems in interventional radiology through a comprehensive literature review, addressing potential legal contingencies.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>This paper aims to define liability in this context and examines how workflows and doctor-patient relationships might be reshaped: patients must be informed about treatment options, including details about robot-assisted procedures and associated risks.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>These systems could significantly impact interventional radiology practice. A dedicated informed consent process is necessary to ensure clear communication and protect the decision-making process and patient-centred care; thereby, an informed consent is proposed to comprehensively address these needs.</p>\n </section>\n </div>","PeriodicalId":50311,"journal":{"name":"International Journal of Medical Robotics and Computer Assisted Surgery","volume":"21 2","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/rcs.70064","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Medical Robotics and Computer Assisted Surgery","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/rcs.70064","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Robotic systems enhance physicians' capabilities by replicating hand movements in real-time, ensuring precise control and a quick return to conventional procedures if patient safety is compromised. Physicians performing robot-assisted procedures bear ultimate responsibility, sharing potential liability with manufacturers for malfunctions.

Methods

This study, conducted by a transdisciplinary team of interventional radiologists and a legal expert, evaluates the integration of robotic systems in interventional radiology through a comprehensive literature review, addressing potential legal contingencies.

Results

This paper aims to define liability in this context and examines how workflows and doctor-patient relationships might be reshaped: patients must be informed about treatment options, including details about robot-assisted procedures and associated risks.

Conclusions

These systems could significantly impact interventional radiology practice. A dedicated informed consent process is necessary to ensure clear communication and protect the decision-making process and patient-centred care; thereby, an informed consent is proposed to comprehensively address these needs.

查看原文本刊更多论文

使用自动化机器人的法律含义：书面知情同意书提案

背景机器人系统通过实时复制手部动作来提高医生的能力，确保精确控制，并在患者安全受到影响时迅速恢复到传统程序。执行机器人辅助手术的医生要承担最终责任，与制造商共同承担故障的潜在责任。方法本研究由介入放射学专家和法律专家组成的跨学科团队进行，通过全面的文献综述评估介入放射学中机器人系统的整合情况，解决潜在的法律突发事件。结果本文旨在界定这种情况下的责任，并探讨如何重塑工作流程和医患关系：必须告知患者治疗方案，包括机器人辅助手术的细节和相关风险。结论这些系统会对介入放射学实践产生重大影响。有必要制定专门的知情同意程序，以确保清晰的沟通，并保护决策过程和以患者为中心的护理；因此，建议制定知情同意程序，以全面满足这些需求。

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

International Journal of Medical Robotics and Computer Assisted Surgery 医学-外科

CiteScore

4.50

自引率

12.00%

发文量

131

审稿时长

6-12 weeks

期刊介绍： The International Journal of Medical Robotics and Computer Assisted Surgery provides a cross-disciplinary platform for presenting the latest developments in robotics and computer assisted technologies for medical applications. The journal publishes cutting-edge papers and expert reviews, complemented by commentaries, correspondence and conference highlights that stimulate discussion and exchange of ideas. Areas of interest include robotic surgery aids and systems, operative planning tools, medical imaging and visualisation, simulation and navigation, virtual reality, intuitive command and control systems, haptics and sensor technologies. In addition to research and surgical planning studies, the journal welcomes papers detailing clinical trials and applications of computer-assisted workflows and robotic systems in neurosurgery, urology, paediatric, orthopaedic, craniofacial, cardiovascular, thoraco-abdominal, musculoskeletal and visceral surgery. Articles providing critical analysis of clinical trials, assessment of the benefits and risks of the application of these technologies, commenting on ease of use, or addressing surgical education and training issues are also encouraged. The journal aims to foster a community that encompasses medical practitioners, researchers, and engineers and computer scientists developing robotic systems and computational tools in academic and commercial environments, with the intention of promoting and developing these exciting areas of medical technology.