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Digital mental health tools to be regulated


Recent years has seen a large, and rapid, growth in the availability of digital mental health tools. Do an online search for 'NHS Mental Health Apps' and an abundance of options will appear.

These online tools can be helpful for people experiencing mental health problems, however, the Medicines Health and Regulatory products Agency (MHRA) said, they "present regulatory challenges" - such as clarity around whether they are medical devices and, if so, which risk classification they fall under.

"Digital mental health tools offer millions of people vital support and guidance to explore and help manage their mental health issues every day," said Johan Ordish, head of software and artificial intelligence (AI) at the MHRA. He pointed out, however, that there are a number of "regulatory complexities" in establishing when these products should be regulated and what evidence they must have to demonstrate safety and effectiveness.

Minister for Mental Health, Dr Caroline Johnson, said: "Digital mental health tools can be incredibly useful to help build resilience and prevent problems worsening, but it’s crucial these are regulated properly."

To address these vital issues MHRA and NICE will explore and produce guidance on regulating digital mental health tools, using £1.8m funding by Wellcome over 3 years.

The project will review key aspects of medical device regulations to produce guidance that will support digital mental health in several significant areas – including:

  • Determining what qualifies as a medical device.
  • The risk classification the devices would fall under.
  • A review of the current evidence base for the devices.

The MHRA explained that to achieve this it will "engage with" and "learn from" those with lived experience, subject experts, and patients, to inform their conclusions. 

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Source: Medscape UK, 11 October 2022

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