On Healthcare Robots: Concepts, definitions, and considerations for\n healthcare robot governance

Abstract

Although healthcare is a remarkably sensitive domain of application, and\nsystems that exert direct control over the world can cause harm in a way that\nhumans cannot necessarily correct or oversee, it is still unclear whether and\nhow healthcare robots are currently regulated or should be regulated. Existing\nregulations are primarily unprepared to provide guidance for such a rapidly\nevolving field and accommodate devices that rely on machine learning and AI.\nMoreover, the field of healthcare robotics is very rich and extensive, but it\nis still very much scattered and unclear in terms of definitions, medical and\ntechnical classifications, product characteristics, purpose, and intended use.\nAs a result, these devices often navigate between the medical device regulation\nor other non-medical norms, such as the ISO personal care standard. Before\nregulating the field of healthcare robots, it is therefore essential to map the\nmajor state-of-the-art developments in healthcare robotics, their capabilities\nand applications, and the challenges we face as a result of their integration\nwithin the healthcare environment.\n This contribution fills in this gap and lack of clarity currently experienced\nwithin healthcare robotics and its governance by providing a structured\noverview of and further elaboration on the main categories now established,\ntheir intended purpose, use, and main characteristics. We explicitly focus on\nsurgical, assistive, and service robots to rightfully match the definition of\nhealthcare as the organized provision of medical care to individuals, including\nefforts to maintain, treat, or restore physical, mental, or emotional\nwell-being. We complement these findings with policy recommendations to help\npolicymakers unravel an optimal regulatory framing for healthcare robot\ntechnologies\n

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