Guidance launched to ensure safety of digital mental health tech

  • 4 February 2025
Guidance launched to ensure safety of digital mental health tech
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  • The MHRA has issued guidance to help manufacturers ensure that digital mental health technologies are effective, reliable and safe
  • Manufacturers of digital mental health technologies should review the guidance to ensure compliance before bringing their products to market
  • It is one of the outputs from a three-year Wellcome-funded project

New guidance to ensure that digital mental health technologies are effective, reliable and acceptably safe, has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

Digital mental health technologies, such as apps, AI-powered assessments, and virtual reality therapy, are increasingly used by individuals and the NHS to support mental health.

The guidanceĀ for manufacturers, published on 3 February 2025, sets out how medical devices regulations apply to software, which products are regulated, how they are assessed, and what evidence is required.

Rob Reid, deputy director of innovative devices at MHRA, said: ā€œEffective and acceptably safe digital tools have huge potential to improve mental health support, making help more accessible than ever.

ā€œThis new guidance aims to support safe access to these important tools by clarifying when a product needs regulatory approval and the steps developers must take.

ā€œMaintaining clear and proportionate regulatory standards will ensure that the public can trust these technologies and benefit from the safe, effective mental health support they can provide.ā€

The guidance is one of the outputs from a three-year Wellcome-funded project, launched in 2023, to explore the regulation of digital mental health products.

Developed by the MHRA, with input from the National Institute for Health and Care Excellence (NICE), NHS experts, researchers, healthcare professionals, and people with lived experience, it aims to meet clinical and real-world needs, to address the growing mental health crisis in the UK.

Mark Chapman, director of HealthTech at NICE, said: ā€œProviding more detailed guidance to the developers of digital mental health technologies helps us to ensure that technologies being considered for NICE assessments have received an appropriate level of regulatory scrutiny to assure their safety.

ā€œThere are many types of technologies available, and it is important people can understand how regulations apply to different products.

ā€œThis guidance will help inform our evaluations and ensure that NICE is able to publish useful, usable, and timely guidance that allows people with mental health conditions to access safe and effective innovations faster.ā€

The intention is that manufacturers of digital mental health technologies should review the guidance to ensure compliance before bringing their products to market.

Professor Miranda Wolpert, director of mental health at Wellcome, which funded the project, said: ā€œWith millions of people around the world held back by mental health problems, digital mental health therapies have huge potential to be scalable and accessible.

ā€œIt is not easy to navigate between over and under regulation in this area.

ā€œIn a fast-moving and continuously evolving digital space, these thoughtful guidelines appear well positioned to strike a pragmatic balance between making digital mental health technologies accessible to those with a range of mental health needs whilst also ensuring they are safe, effective and as transparent as possible.ā€

In January 2025, MHRA issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes when the post-market surveillance (PMS) regulation for medical devices comes into force across England, Scotland and Wales on 16 June 2025.

This episode of Digital Health Unplugged explores the regulation of digital mental health technologies.

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