Artificial Intelligence in Healthcare and Regulation Challenges: a Mini Guide for (Mental) Health Professionals.

Artificial intelligence (AI) offers new perspectives in the healthcare sector, ranging from clinical decision support tools to new treatment strategies or alternative patient remote monitoring. However, as a disruptive technology, AI is associated with potential barriers, limitations and challenges for appropriate integration in medical practice. To avoid potential patient safety risks and harm, a robust regulatory framework is crucial to guide health professionals in their AI adoption in clinical practice. The European Union offers a new legal framework for the development and deployment of AI systems, the AI Act. This regulation was approved in March 2024 and will be fully applicable by 2025 to ensure that AI technologies are safe, transparent, and respect fundamental rights. However, these new regulatory concepts may be obscure for clinicians. This article aims to provide health professionals with the preliminary key points of regulation needed to interact adequately with these new AI applications and consider the potential risks of AI systems to patient safety.