Artificial intelligence in healthcare faces regulatory challenges: balancing innovation with human oversight.

Artificial intelligence (AI) has experienced unprecedented growth in the healthcare sector, promising to revolutionise diagnosis, care, treatment, and biomedical research. This viewpoint article discusses the challenges in this sector and highlights the evolution of the regulatory framework surrounding AI in healthcare and its concrete consequences on innovation. Layered regulatory developments, notably the Medical Device Regulation of 2021 and the AI Act of 2024, have introduced stricter requirements for traceability, clinical performance, risk management, transparency, and human oversight. Although these changes are expected to foster greater trust and accountability among healthcare stakeholders, they also increase the complexity and cost of compliance. These regulatory and organisational challenges represent a turning point for innovative projects in healthcare. Many projects are moving from complex systems toward simpler human-centred tools, whereas others are pushing for collaboration between stakeholders to harmonise existing regulatory frameworks. These combined efforts could lead to more compliant, understandable, and user-friendly solutions for routine care.