[论文解读] On Healthcare Robots: Concepts, definitions, and considerations for healthcare robot governance

Eduard Fosch‐Villaronga, Hadassah Drukarch|arXiv (Cornell University)|Jun 7, 2021

Artificial Intelligence in Healthcare and Education被引用 9

一句话总结

本文建立了一个结构化的框架，用于根据其目的、技术特性和预期用途，对医疗机器人（外科、辅助和护理类）进行分类，解决了人工智能驱动医疗机器人领域中的监管模糊性问题。文章提出了政策建议，以使治理与不断发展的技术能力保持一致，强调在碎片化且快速发展的领域中，需要清晰、可适应的监管标准。

ABSTRACT

Although healthcare is a remarkably sensitive domain of application, and systems that exert direct control over the world can cause harm in a way that humans cannot necessarily correct or oversee, it is still unclear whether and how healthcare robots are currently regulated or should be regulated. Existing regulations are primarily unprepared to provide guidance for such a rapidly evolving field and accommodate devices that rely on machine learning and AI. Moreover, the field of healthcare robotics is very rich and extensive, but it is still very much scattered and unclear in terms of definitions, medical and technical classifications, product characteristics, purpose, and intended use. As a result, these devices often navigate between the medical device regulation or other non-medical norms, such as the ISO personal care standard. Before regulating the field of healthcare robots, it is therefore essential to map the major state-of-the-art developments in healthcare robotics, their capabilities and applications, and the challenges we face as a result of their integration within the healthcare environment. This contribution fills in this gap and lack of clarity currently experienced within healthcare robotics and its governance by providing a structured overview of and further elaboration on the main categories now established, their intended purpose, use, and main characteristics. We explicitly focus on surgical, assistive, and service robots to rightfully match the definition of healthcare as the organized provision of medical care to individuals, including efforts to maintain, treat, or restore physical, mental, or emotional well-being. We complement these findings with policy recommendations to help policymakers unravel an optimal regulatory framing for healthcare robot technologies

研究动机与目标

• 澄清医疗和工程语境下医疗机器人概念和定义上的模糊性。
• 梳理当前医疗机器人技术的前沿状况，重点关注外科、辅助和护理类机器人。
• 识别现有框架中在人工智能和机器学习系统方面的监管空白。
• 基于目的、用途和技术特性，提出一个结构化的医疗机器人分类体系。
• 为监管机构提供可操作的政策建议，以制定连贯、可适应的治理框架。

提出的方法

• 全面回顾机器人技术及医疗设备治理领域的现有文献、法规和标准。
• 基于功能、交互水平和预期医疗用途，构建医疗机器人的分类体系。
• 分析欧盟医疗器械法规（MDR）、ISO标准及非医疗规范。
• 识别分类中的关键挑战，特别是针对人工智能驱动和具备学习能力的机器人。
• 通过比较分析，突出医疗设备标准与非医疗标准之间的监管重叠与空白。
• 基于技术与伦理考量，提出面向未来监管设计的政策建议。

实验结果

研究问题

• RQ1 不同类型医疗机器人之间的核心概念和定义差异是什么？
• RQ2 当前的监管框架在多大程度上应对了医疗机器人中的人工智能与机器学习应用？
• RQ3 现有分类体系在多大程度上未能反映现代医疗机器人的复杂性与多样性？
• RQ4 在现行法律和技术标准下，管理人工智能驱动的医疗机器人面临哪些关键挑战？
• RQ5 监管框架应如何调整，以确保医疗机器人在安全、有效性与伦理一致性方面的保障？

主要发现

• 医疗机器人领域缺乏统一的分类体系，导致监管模糊和监督不一致。
• 外科、辅助和护理类机器人在目的和技术设计上各不相同，但常处于监管灰色地带。
• 现有的医疗设备法规难以应对在临床环境中具备学习与自适应能力的人工智能驱动机器人。
• 医疗设备标准与非医疗标准（如个人护理机器人的ISO标准）之间存在显著的监管重叠与冲突。
• 当前的治理格局未能充分考虑人工智能赋能医疗机器人所表现出的动态与自主行为。
• 亟需制定政策建议，以建立灵活、基于风险且技术中立的监管框架，以应对未来医疗机器人的发展。