Artificial intelligence in mental health raises complex legal issues under the EU AI Act, MDR, and GDPR, from medical device qualification to liability.
On 17 September 2025, the Italian Senate approved a landmark law on artificial intelligence (AI), making Italy the first EU country to enact a national law specifically regulating AI while aligning with the EU AI Act.
A backbone of the requirements provided by the EU AI Act for high-risk AI systems is the establishment, implementation, and documentation of an AI risk management system.
