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Therapy Chatbots And Medtech Laws: Why AI App Developers Must Tread Carefully

 
• By Eliza Slawther

With the rise of AI chatbots enabling rapid access to personalized mental health support and lifestyle advice, app developers must know when a product is legally a medical device. Medtech regulatory lawyer Erik Vollebregt explains what EU law says, and how to avoid mistakes.

Smartphone AI Therapy
• Source: Shutterstock

The first artificial intelligence (AI) chatbot was released in the 1960s, but it is only in recent years that similar - albeit far more sophisticated - technology has been adapted to provide mental health support. Emerging AI programs can not only direct patients to sources of information, but also simulate human conversation, meaning they have the potential to be used as virtual therapists.

But what does European law say about this software? Are AI chatbots that act as therapists considered medical devices? Do software manufacturers have a responsibility - both ethically and legally...

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More from Geography

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
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• By Brian Bossetta

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