Health Technologies

New guidelines to boost pipeline of digital mental health innovations in the UK

New guidance impacting on developers of digital mental health technologies have been launched in the UK market. 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance to help manufacturers meet UK medical devices regulations and ensure digital mental health technologies are “effective, reliable and acceptably safe”.

The guidance is aimed at the range of mental health-focused innovations, including apps, AI-powered assessments, VR therapy and digital mental health technologies; used both in public health settings and individually.

The MHRA believes that some manufacturers are perhaps unsure how medical devices regulations apply to software, which products are regulated, how they are assessed, and what evidence is required.

This new guidance explains how to define and communicate the intended purpose of a digital mental health technology and when a digital mental health technology is considered a medical device under UK law. It also explains how risk classification is determined, ensuring proportionate regulation for different types of technologies.

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

It was 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 both clinical and real-world needs, to address the growing mental health crisis in the UK.

Rob Reid, deputy director of innovative devices at the MHRA, says: “Effective and acceptably safe digital tools have huge potential to improve mental health support, making help more accessible than ever. This 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. Maintaining 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.”

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 both clinical and real-world needs, to address the growing mental health crisis in the UK.

Mark Chapman, director of HealthTech at NICE, said: “Providing 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.

“There are many types of technologies available, and it is important people can understand how regulations apply to different products. This 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.”

The full guidance is available here.

You may also like

Health Technologies

Accelerating Strategies Around Internet of Medical Things Devices

  • December 22, 2022
IoMT Device Integration with the Electronic Health Record Is Growing By their nature, IoMT devices are integrated into healthcare organizations’
Health Technologies

3 Health Tech Trends to Watch in 2023

Highmark Health also uses network access control technology to ensure computers are registered and allowed to join the network. The