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跨境远程手术程序中的法律和伦理考量。

The legal and ethical considerations in cross-border telesurgical procedures.

作者信息

Elendu Chukwuka, Amaechi Dependable C, Elendu Tochi C, Amaechi Emmanuel C, Elendu Ijeoma D, Omokore Olutomiwa A, Onubogu Nwamaka C, Omeludike Janet C, Aregbesola Eunice T, Fajimi Oluwagbemiga O, Idowu Omoyelemi F, Emechebe Sopuruchukwu L, Uyanwune Mbanefo C, Yonni Johnson

机构信息

Federal University Teaching Hospital, Owerri, Nigeria.

Igbinedion University, Okada, Nigeria.

出版信息

Ann Med Surg (Lond). 2025 May 12;87(6):3660-3672. doi: 10.1097/MS9.0000000000003344. eCollection 2025 Jun.

DOI:10.1097/MS9.0000000000003344
PMID:40486583
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12140691/
Abstract

Telesurgery, or remote surgery, represents a transformative fusion of medicine and technology, enabling surgeons to perform procedures on patients located miles away using robotic systems and advanced telecommunications. However, its widespread adoption remains limited, with fewer than 50 documented fully remote telesurgical procedures in the past two decades. While robotic-assisted surgery is increasingly common - accounting for over 1.2 million procedures in 2019 - true cross-border telesurgery is rare due to technological, legal, and ethical barriers. The lack of a unified regulatory framework presents jurisdiction, licensing, liability, and data security challenges, particularly when procedures span international borders. The absence of standardized legal mechanisms creates uncertainty, especially in surgical complications or malpractice claims. A global regulatory framework should address these challenges, incorporating mutual recognition of medical licenses, standardized liability agreements, and uniform data protection protocols aligned with General Data Protection Regulation and Health Insurance Portability and Accountability Act. Additionally, real-time 5G-enabled monitoring systems could mitigate latency issues, reducing the risk of surgical errors due to connectivity disruptions. Ethically, telesurgery raises concerns regarding informed consent, equitable access, and accountability. Language barriers, differing cultural attitudes toward robotic surgery, and disparities in healthcare infrastructure complicate ethical oversight. Establishing an international telesurgical ethics board could ensure adherence to standardized consent procedures and promote equitable access through global partnerships. Investment in telesurgical training programs and AI-driven risk mitigation strategies could enhance patient safety. While technological advancements will continue to drive telesurgery's growth, addressing these legal and ethical considerations through harmonized global regulations and strategic policy interventions is crucial for sustainable and equitable integration into modern healthcare.

摘要

远程手术,即远距离手术,代表了医学与技术的变革性融合,使外科医生能够使用机器人系统和先进的通信技术对数英里外的患者进行手术。然而,其广泛应用仍然有限,在过去二十年中,记录在案的完全远程的远程手术操作少于50例。虽然机器人辅助手术越来越普遍——2019年超过120万例——但由于技术、法律和伦理障碍,真正的跨境远程手术很少见。缺乏统一的监管框架带来了管辖权、许可、责任和数据安全方面的挑战,尤其是当手术跨越国界时。缺乏标准化的法律机制会产生不确定性,特别是在手术并发症或医疗事故索赔方面。全球监管框架应应对这些挑战,纳入对医疗执照的相互认可、标准化的责任协议以及与《通用数据保护条例》和《健康保险流通与责任法案》相一致的统一数据保护协议。此外,启用5G的实时监测系统可以减轻延迟问题,降低因连接中断导致手术失误的风险。在伦理方面,远程手术引发了对知情同意、公平获取和问责制的担忧。语言障碍、对机器人手术的不同文化态度以及医疗保健基础设施的差异使伦理监督变得复杂。建立一个国际远程手术伦理委员会可以确保遵守标准化的同意程序,并通过全球伙伴关系促进公平获取。对远程手术培训项目和人工智能驱动的风险缓解策略的投资可以提高患者安全。虽然技术进步将继续推动远程手术的发展,但通过协调全球法规和战略政策干预来解决这些法律和伦理问题,对于可持续和公平地融入现代医疗保健至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e55d/12140691/1335deeccd06/ms9-87-3660-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e55d/12140691/366d60f522a2/ms9-87-3660-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e55d/12140691/1335deeccd06/ms9-87-3660-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e55d/12140691/366d60f522a2/ms9-87-3660-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e55d/12140691/1335deeccd06/ms9-87-3660-g002.jpg

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AI solutions for overcoming delays in telesurgery and telementoring to enhance surgical practice and education.人工智能解决方案可克服远程手术和远程指导中的延迟问题,从而增强手术实践和教育。
J Robot Surg. 2024 Nov 11;18(1):403. doi: 10.1007/s11701-024-02153-9.
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Telesurgery: humanitarian and surgical benefits while navigating technologic and administrative challenges.
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J Robot Surg. 2024 Nov 5;18(1):393. doi: 10.1007/s11701-024-02156-6.
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Evaluating the efficacy of telesurgery with dual console SSI Mantra Surgical Robotic System: experiment on animal model and clinical trials.评估双控制台 SSI Mantra 手术机器人系统远程手术的疗效:动物模型实验和临床试验。
J Robot Surg. 2024 Nov 1;18(1):391. doi: 10.1007/s11701-024-02148-6.
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Evaluating the Status and Promising Potential of Robotic Spinal Surgery Systems.评估机器人脊柱手术系统的现状和发展潜力。
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