The Medicines and Healthcare products Regulatory Agency (MHRA) has published new resources that aim to prompt greater introspection into what apps and other digital tools individuals use to support their mental health.
Acknowledging that mental health tools such as symptom-tracking apps to virtual reality therapies and chatbots are now widely available, the MHRA highlighted that while certain tools of this ilk are used alongside UK National Health Service (NHS) and community care provisions, it is not always clear which are reliable, safe, or appropriate for an individual.
The new guidance, now available within a broader set of free online health resources the MHRA developed alongside NHS England, aims to help people make more informed choices and know what to do if something doesn’t feel right.
A core component of the MHRA’s guidance is to prompt individuals to cross-examine an app or digital mental health tool before they use it. The public, parents, carers and health professionals are urged to consider factors such as whether the function such tools may claim to perform are supported by evidence, how they process sensitive personal data, and if the tool in question is regulated as a medical device.
MHRA chair and professor of primary care at the University of Oxford, Professor Anthony Harnden, commented: “When someone turns to a tool to help with their mental health, they need to know it is safe, effective, and built on reliable evidence.
While emphasising that digital mental health technologies are not a replacement for professional healthcare, Harnden continued: “As a GP, I’ve seen how patients can benefit from accessing digital tools alongside traditional forms of care. This guidance supports better conversations between clinicians and patients and helps everyone ask the right questions about whether a tool is right for them.”
Release of the guidance is the latest development in a partnership the MHRA forged with the UK’s National Institute for Health and Care Excellence (NICE) in 2023 that is focused on developing proportionate regulation and evaluation for digital mental health technologies. In November 2025, the duo won a £2m ($2.76m) grant from the Wellcome Trust charity to advance their work.
AI chatbots’ role in supporting mental health
One of the digital tools being turned to most often for mental health support is artificial intelligence (AI)-based chatbots. Research by Mental Health UK from November 2025 found that 37% of UK adults report having used AI chatbots to support their mental health or wellbeing.
However, the rise of ‘AI psychosis’ suggests a more cautious approach to the technology is needed, given that using chatbots may exacerbate existing mental health conditions for some individuals. And lacking the ‘human touch’, experts’ view is that AI chatbots are an inadequate support tool in lieu of in-person therapy.
Speaking to Medical Device Network in August 2025, Kim Rippy, trauma and anxiety specialist and owner of US-based Keystone Therapy Group, highlighted that while AI chatbots are useful in helping users to summarise or organise their thoughts, they will likely miss things that are necessary to consider when generating responses to an individual who is struggling with their mental health.
