Artificial intelligence in mental health raises complex legal issues under the EU AI Act, MDR, and GDPR, from medical device qualification to liability.
An AI risk assessment is the process of mapping where risks emerge during the lifecycle of an AI system, classifying them by severity and probability, and prioritizing which ones to mitigate first, all within the compliance framework imposed by the EU AI Act.
Regulating artificial intelligence is like driving a car: some prefer clear speed limits and guardrails, others enjoy an open road with minimal signs; the EU and the US exemplify these two different philosophies in AI regulation.
