The Medicines and Healthcare products Regulatory Agency (MHRA) has rolled out fresh guidance to help people, carers, parents, and professionals understand which digital mental health technologies are safe, reliable, and effective.
The new resources, developed with NHS England, aim to give practical advice on navigating apps, virtual therapies, and other digital tools.
Why This Guidance Matters
Digital tools for mental health are increasingly popular, especially among young people.
From mood trackers to virtual reality therapy, these apps are now a common part of the mental health landscape.
However, it can be difficult to know which tools are trustworthy or suitable for an individual’s needs.
MHRA’s guidance is designed to give clear, actionable advice to help people make informed choices and respond if something feels wrong.
Professor Anthony Harnden, MHRA Chair and GP, highlighted the importance of safety and evidence: “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.
This guidance supports better conversations between clinicians and patients and helps everyone ask the right questions about whether a tool is right for them.”
He also emphasized that digital tools are not a replacement for professional care.
Anyone experiencing mental health difficulties should seek support from trained professionals.
Five Key Checks Before Using a Mental Health App
MHRA outlines five things to consider when choosing a mental health tool:
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Understand its claims – Does the app provide general wellbeing support or claim to diagnose, treat, or manage a mental health condition? Evidence should back any medical claims.
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Know the intended users – Tools for adults may not suit children or teenagers. Check age recommendations.
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Check the evidence – Look for clinical studies or trials that prove the app works. Be cautious of apps making big promises without proof.
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Data protection – Mental health apps collect sensitive personal information. Clear information on how your data is used is essential.
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Regulatory status – Apps claiming to manage medical conditions may be regulated as medical devices and display a CE or UKCA mark, giving assurance they meet UK safety standards.
Not all apps are regulated as medical devices; some focus on general wellbeing and may not have undergone the same checks.
If a regulated app causes harm, concerns can be reported via the MHRA Yellow Card scheme.
What the New Resources Offer
The MHRA guidance includes short animations and real-world examples to show what safe, evidence-based tools look like.
It also explains how to report concerns, helping protect others from unsafe products.
The resources are aimed at anyone using these technologies, plus parents, carers, and professionals such as teachers, GPs, nurses, and mental health practitioners who recommend them.
Partnerships and Expert Insights
The resources were developed with NHS England’s MindEd Technology Enhanced Learning programme as part of a Wellcome-funded initiative.
Since 2023, MHRA and NICE have collaborated on proportionate regulation and evaluation, working with people with lived experience, mental health specialists, developers, and international partners.
Dr Nick Crabb, Chief Scientific Officer at NICE, said: “These resources will help people ask the right questions and make informed choices.
As digital mental health tools become more widely used, ensuring safety and evidence is vital.”
Matthew Brown from Wellcome added: “These technologies offer transformative opportunities, but we need better evidence to understand what works for whom and in which contexts.
Our partnership with MHRA and NICE is helping ensure safe and effective support reaches those who need it.”
Support From Health Leaders
Health Minister for Northern Ireland, Mike Nesbitt, praised the guidance: “Apps give people information at their fingertips, helping them understand their conditions better and take greater control over their mental health.
This resource will allow people to make informed choices about which apps are safe and effective.”
Stephen Buckley from Mind also highlighted the importance of understanding what good digital support looks like: “Digital tools can provide valuable information and help alongside traditional mental health support.”
How to Access Guidance and Report Concerns
MHRA encourages anyone using mental health apps—or supporting someone who is—to explore the new online guidance.
Users are urged to report safety concerns via the Yellow Card scheme, ensuring better protection for everyone.
Resources for the public and for health, social care, and education professionals are available on the MindEd website.
Those experiencing mental health difficulties should contact trained professionals, NHS services, or charities like Mind for support.
About MHRA
The MHRA regulates all medicines and medical devices in the UK to ensure they work safely and effectively.
It operates as an executive agency of the Department of Health and Social Care, providing evidence-based guidance to protect public health.
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