The UK Medicines and Healthcare products Regulatory Agency (MHRA), along with the National Institute for Health and Care Excellence (NICE), have received a funding injection of £1.8 million from the Wellcome Trust to address regulatory challenges around whether such software is a medical device or not, it was announced on 10 October.
The funding, which is to be awarded over three years, will be used by the health authorities to develop a framework for regulating digital mental health tools, and for reviewing the upcoming
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