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

Understand

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.