Hi friend,

There are some similarities in how the US, the UK and Europe regulate mental health AI.

They start with the same question: is your AI product a medical device? When it comes to AI, they are all adapting existing medical device frameworks, rather than writing entirely new AI-specific ones.

But after that, the strategies start to diverge.

Europe is layering AI legislation on top of an already complex medical device regime. The UK is redesigning its framework around software and AI while positioning itself closer to some other regulators like the US FDA. 

These differences have strategic implications for leaders of AI mental health organisations considering these markets. The order in which you seek approval could materially affect cost, speed and market access. In Europe and the UK alike, understanding reimbursement pathways — whether Germany's DiGA programme or NICE's role in NHS adoption — is becoming as important as understanding the regulators themselves.

In this Hemingway Guide, we go deep into the regulatory regimes across the UK and Europe, how they’re changing and what that means for leaders navigating these regions.

Let’s get into it.