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The mental health app market has grown enormously over the past several years, ranging from mood-tracking tools and guided meditation to AI chatbots designed to simulate supportive conversation and, in some cases, apps marketed as delivering cognitive behavioural therapy techniques directly. Usage has grown fastest in exactly the gap where formal mental health services are hardest to access quickly — a genuinely useful function that has, at the same time, outpaced the regulatory frameworks meant to ensure these tools are safe and effective.
- Regulators in several countries have begun developing specific frameworks for digital mental health tools, but implementation has been slow relative to the pace of app releases.
- A small number of apps have gone through formal regulatory clearance as medical devices, typically for narrower, clinically validated uses such as insomnia treatment programmes.
- The vast majority of downloaded mental health apps have never been evaluated in a peer-reviewed clinical trial.
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