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
翻译:虽然医疗保健是一个非常敏感的应用领域,对世界实行直接控制的系统可能以人类不一定能够纠正或监督的方式造成伤害,但目前尚不清楚的是,医疗保健机器人目前是否以及如何管理或应当加以管理。现有条例主要没有准备为这样一个迅速变化的领域提供指导,并容纳依赖机器学习和AI的装置。此外,医疗保健机器人领域非常丰富和广泛,但在定义、医疗和技术分类、产品特点、目的和预定用途方面仍然非常分散和不明确。因此,这些装置往往在医疗装置条例或其他非医疗规范之间,例如标准化组织个人护理标准之间运行。因此,在规范医疗保健机器人领域之前,必须规划保健机器人、其能力和应用方面的主要最新发展,以及我们因将其纳入医疗保健环境而面临的种种挑战。这种贡献填补了这一空白,并填补了目前在医疗保健机器人内部及其治理方面经历的不清晰性。通过对目前确定的主要类别、其预定目的、使用和主要医疗护理标准等非医疗规范进行周密的介绍和进一步阐述。因此,在管理机器人领域,在管理机器人、其能力和应用方面,我们明确注重这些监管努力,并恢复对机制技术的准确性定义。我们所组织起来,恢复了对机理的医学和机理学定义。