Regulating smart healthcare robots: the European approach

Excerpt

The legal framework for smart healthcare robots, an emerging field at the intersection of AI, machinery engineering and medicine, is still in its nascent stages. Currently, there is no universally accepted definition of a robot, leaving the process of regulating this topic on hold. The integration of artificial intelligence (AI) in healthcare robots introduces additional complexities into this already uncertain and partially unexplored field. These complexities need to be taken into account when elaborating the legal framework applicable to smart healthcare robots. The legal landscape for smart healthcare robots is intricate and fast evolving due to the continuous legislative activity of the European bodies. This chapter emphasises the need for a balanced legal framework and explores the multifaceted legal considerations surrounding smart healthcare robots, with a focus on their intended purpose, context of use and level of autonomy.