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Digital mental health tools to be regulated as medical devices


Digital mental health tools to be regulated as medical devices

NICE and the MHRA have been awarded £1.8m by charity Wellcome to look at ways to develop the regulatory frameworks around digital mental health tools, with a view to regulating these services as medical devices.

Announcing the funding yesterday (October 10), the MHRA said it would “help improve regulatory certainty and safety” in this fast-developing area, and will result in guidance on the “appropriate, risk-proportionate” regulation of digital mental health products.

The project will draw on medical device regulations to develop its recommendations, the MHRA, commented, adding: “ We will engage with and learn from people with lived experience, subject experts and patients to inform their conclusions, as well as working with international partners to help drive shared learning and consensus in digital mental health regulations globally.

“It is hoped that certain mental health software will be proportionately regulated as a medical device, meaning the public has access to effective and safe products that can significantly help protect or improve their mental health.”

Recent years have seen a growth in the number of digital services offering mental health support. Earlier this year, Boots UK laimched a number of on-demand mental health services including the Boots Online Doctor Depression & Anxiety Treatment. 

Dr Caroline Johnson, minister for mental health, 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.

“This funding will help us to better understand these products and give us the tools to make sure everyone who uses them has access to safe, effective support.

Johan Ordish, head of software and artificial intelligence at the MHRA, commented: “Digital mental health tools offer millions of people vital support and guidance to explore and help manage their mental health issues every day.

“However, 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.

“We need to make sure that we are able to answer these questions, to ensure that patients can be confident in the choices they make to support their mental health.”

NICE programme director Mark Salmon said: “This work is one way both organisations can simplify and streamline the process of getting wide-scale adoption of safe, clinical and cost-effective digital mental health products into the hands of the people who need them and help ease the pressure on the NHS.”

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