When AI Becomes “Medical”: Legal Responsibilities at the Frontier of Psychological Support Technologies

Artificial intelligence in mental health raises complex legal issues under the EU AI Act, MDR, and GDPR, from medical device qualification to liability.

Artificial intelligence is increasingly being used to support mental health and psychological well-being. From conversational chatbots offering emotional assistance to generative AI tools that analyze tone and mood, these solutions are becoming an integral part of the digital health ecosystem.

But what happens when AI crosses the line between simple wellness support and actual therapeutic intervention? Can a chatbot or digital assistant be considered a medical device under EU law? And if so, what are the liability and compliance implications for developers, healthcare providers, and users?

These are the questions I explore in the latest episode of my podcast 🎙️ Diritto al Digitale, titled “When AI Becomes ‘Medical’: Legal Responsibilities at the Frontier of Psychological Support Technologies.”

In the episode, Giulio Coraggio, Location Head of the Italian department of Intellectual Property & Technology at the global law firm DLA Piper, discusses how the EU Medical Devices Regulation (MDR) and the EU Artificial Intelligence Act interact in cases where AI systems perform diagnostic or therapeutic functions. A software that offers psychological advice, monitors symptoms, or suggests treatments may qualify as Software as a Medical Device (SaMD) — triggering strict certification, risk-management, and post-market obligations.

We also look at the legal consequences of non-compliance, including civil liability for harm, data protection challenges under the GDPR, and the growing debate on emotional dependency and AI-driven therapy. As AI increasingly engages with vulnerable users, the need for transparency, human oversight, and ethical safeguards becomes essential.

This episode offers a detailed framework for lawyers, compliance officers, and technology leaders navigating this new frontier — where innovation in mental health meets the rigor of medical regulation.

🎧 Listen to the full episode of Diritto al Digitale below

Also, you can listen it on Apple Podcasts, Google Podcasts, Spotify, and Audible and read the following article on the topic “How Artificial Intelligence is Revolutionizing Medical Devices Following the EU AI Act“.