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UK MHRA · UK · 27 Jan 2026 · Guidance

MHRA issues new guidance for people using mental health apps and technologies

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The MHRA has published new guidance on 27 January to help people choose safe and effective mental health apps and digital tools. The guidance, developed with NHS England, advises users to check whether products claim medical benefits, state their intended age group, provide evidence of effectiveness, protect personal data, and carry CE or UKCA regulatory marks. The resources include animations and examples for the public, parents, carers, and professionals, and explain how to report concerns through the MHRA Yellow Card scheme.

From UK MHRA

New advice on using apps and other digital tools to support mental health is being published by the Medicines and Healthcare products Regulatory Agency (MHRA) today (27 January), as part of free online resources developed with NHS England for the public, parents, carers and 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, these products are now widely available and often used alongside NHS and community care, but it is not always clear which are reliable, safe or right for an individual. The new guidance aims to help people make more informed choices and know what to do if something doesn’t feel right.

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.

“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.”

1. What is it claiming to do?

Does the product offer general wellbeing support, or does it claim to diagnose, treat or manage a mental health condition? Claims about medical benefit should be clearly explained and supported by evidence.

2. Who is it for?

A tool built for adults may not be suitable for teenagers or children. Age and intended users should be clearly stated.

3. Is there evidence it works?

Trustworthy products will explain how they have been tested or evaluated, for example in a clinical study. Be cautious of products making big promises without clear supporting information.

4. What happens to your data?

These tools often collect very sensitive personal information. You should be able to easily find out how your data is stored and used.

5. Is it is regulated as a medical device?

Some digital mental health technologies are classed as medical devices, for example those claiming to diagnose, treat or manage a mental health condition. These must meet safety standards and display a CE or UKCA mark. People can look for the marking and check whether the product is registered using the MHRA’s online public register. This gives you extra reassurance, as it means it meets UK safety standards, is registered with the MHRA and is monitored once in use.

Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗