The MHRA has issued guidance on digital mental health apps, with five checks to help users judge whether tools are safe and evidence-based.
The advice forms part of free online resources developed with NHS England for the public, parents, carers and health, social care and education professionals who use or recommend these tools.
More people in the UK, particularly young people, are turning to digital tools for mental health support, from symptom-tracking apps to virtual reality therapies.
However, it is not always clear which products are reliable, safe or right for an individual.
The resources use short animations and real-world examples to show what safe, well-evidenced digital mental health technologies look like in practice, and explain how to report concerns through the MHRA Yellow Card scheme.
MHRA chair and professor of primary care at the University of Oxford Professor Anthony Harnden said: “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.
“Our aim is to give people clear, practical advice they can use in everyday life, so they understand what good looks like and when to speak up if something doesn’t feel right.”
He added: “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.
“Digital mental health technologies are not a replacement for professional healthcare. Anyone experiencing mental health difficulties should seek support from trained professionals.”
Some digital mental health technologies are classed as medical devices, meaning they must meet safety standards and display a CE or UKCA mark.
People can also check whether a product is registered using the MHRA’s online public register. Other products are classed as wellbeing or lifestyle tools and may not have been through the same checks.
If a regulated digital mental health technology causes harm or distress, concerns can be reported through the MHRA Yellow Card scheme.
The resources were developed by the MHRA in partnership with NHS England’s MindEd Technology Enhanced Learning programme as part of a Wellcome-funded project.
Since 2023, the MHRA has worked with the National Institute for Health and Care Excellence (NICE) on proportionate regulation and evaluation of digital mental health technologies, collaborating with people with lived experience, mental health specialists, developers and international partners.
NICE chief scientific officer Dr Nick Crabb said: “Our role at NICE is to help practitioners and commissioners get the best care to people, fast, while ensuring value for the taxpayer.
“As digital mental health technologies become more widely used, it’s vital that people can access tools that are safe, effective and built on robust evidence.
Crabb added: “These new resources will help people ask the right questions and make informed choices.
“This matters now more than ever, as the government’s 10 Year Health Plan expands NICE’s technology appraisal process to cover devices, diagnostics and digital products for the first time.”
British Psychological Society president Dr Roman Raczka added: “As more people turn to mental health therapy apps for support, it is timely that the MHRA has introduced this new guidance to help users make an informed choice in an ever-growing market.
“However, we must remember that while AI can deliver significant benefits, it must never replace the human support which is fundamental to effective mental health care.
“Instead, it must be integrated thoughtfully to support human-led care, not replace it entirely.
“AI cannot replicate genuine human empathy and can create an illusion of connection rather than meaningful interaction.”
