The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance aimed at helping people make safer, more informed choices when using mental health apps and digital technologies, as the use of digital tools for emotional wellbeing continues to grow across the country.
The guidance is designed for people using mental health apps, as well as careers, families, and healthcare professionals who may recommend them. It provides practical advice on how to assess whether a digital mental health tool is trustworthy, evidence-based, and appropriate for individual needs.
“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,” said Anthony Harnden, Chair of the MHRA. He added that the guidance is intended to help users and clinicians ask the right questions before relying on digital support.
Mental health apps and digital technologies including wellbeing trackers, therapeutic apps, and virtual reality tools are increasingly used alongside traditional care. However, their quality and purpose can vary widely. Some tools offer general wellbeing support, while others claim to diagnose, treat, or manage mental health conditions.
The MHRA’s guidance addresses this complexity by setting out five key checks users should consider before using or recommending a mental health app.
What does the app claim to do?
Before using a mental health app, users should understand exactly what the tool says it can do. Claims about supporting, managing, diagnosing, or treating mental health conditions should be clearly explained and backed by reliable evidence, rather than vague or promotional language.
Who is the app designed for?
Not all mental health apps are suitable for everyone. Users should check whether the app is intended for adults, children, or young people, as tools designed for one group may not be appropriate or safe for another.
Has the app been properly tested?
The guidance advises users to look for information on whether the app has been tested or evaluated. Evidence may include clinical studies, trials, or structured assessments that show the tool works as intended.
How is personal and mental health data handled?
Because mental health apps often collect sensitive personal information, users should understand how their data is collected, stored, shared, and protected. Clear and transparent data policies help users make informed decisions and build trust.
Is the app regulated as a medical device?
Some mental health apps are legally classed as medical devices. If so, they should meet regulatory standards and be registered with the appropriate authority, providing reassurance that safety and quality checks have taken place.
If a regulated digital mental health tool causes harm or distress, users can report concerns through the MHRA’s Yellow Card scheme, which allows the regulator to monitor safety issues and take action when needed.
The MHRA has also published free online resources, including short animations and real-world examples, to help people better understand what good-quality digital mental health support looks like.
“Digital mental health technologies are not a replacement for professional healthcare,” Professor Harnden said, emphasising that people experiencing serious or ongoing mental health difficulties should seek support from trained professionals.
The guidance was developed in collaboration with NHS England’s MindEd Technology Enhanced Learning programme and funded through a Wellcome Trust project, reflecting a broader effort to ensure digital mental health tools are used safely, effectively, and with confidence.
(Rh/ARC)
