This chapter focuses on the growing inclusion of social robots in therapy from the perspective of unresolved legal and ethical issues that include risks to patient autonomy, human dignity and trust, the potentially life-threatening effects of inaccurate or malfunctioning technology, diminished privacy due to the reliance on enormous amounts of personal (sensitive health) data, new challenges to data security due to the cyber–physical nature of robots, and the problem of how to obtain informed consent to medical treatments that depend on opaque AI decision-making. From this broad spectrum, the chapter focuses on the protection of the health and safety of patients and care recipients under EU law. A more detailed analysis shows that neither the Medical Device Regulation nor the proposal for an Artificial Intelligence Act adequately address the risks to patient health and safety that arise from human–machine interaction. Against this backdrop, the chapter provides recommendations as to which aspects should be regulated in the future and argues for a public discussion about the extent to which we, as a society, should replace human therapists with AI-enabled robotic technology.