Effective Regulation and Evaluation of Digital Mental Health Technology

The UK’s medicines regulator is rewriting the rulebook for smartphone apps, chatbots, and other digital tools that claim to treat or manage mental health conditions. The Medicines and Healthcare products Regulatory Agency (MHRA) has already committed to overhauling how it regulates software used as a medical device, but the new rules remain too vague for digital mental health products specifically. At the same time, the National Institute for Health and Care Excellence (NICE) is preparing to evaluate these technologies, yet no consistent framework exists to judge whether they actually work or are safe. This project will translate the MHRA’s broad regulatory ambitions into concrete, accessible requirements tailored to mental health apps and platforms. Working jointly with NICE and other stakeholders, the team aims to create a risk-proportionate system—meaning a simple mood-tracking app would face lighter scrutiny than an AI tool that diagnoses depression. If successful, the work would give clinicians and patients a clear signal about which digital products are safe and effective, while preventing unsafe or useless tools from reaching the NHS and the public. It would also set a precedent for how the UK evaluates digital health technologies more broadly.