Extension - Effective regulation and evaluation of digital mental health technologies (360G-Wellcome-338128_Z_25_Z)

As the UK safety regulator for healthcare products, we (the MHRA) are undertaking a programme to deliver bold improvements to the regulatory framework for software as a medical device. Further work was needed to translate these broad requirements into specific and accessible requirements for digital mental health products, and the initial grant enabled us to initiate significant activities to support this vision. Additionally, the National Institute for Health and Care Excellence (NICE) are prioritising digital technology evaluations and mental health continues to be recognised as a priority area. The aim of the original project was to enable access to safe and effective products, to help improve mental health care and sought to achieve this by ensuring that digital mental health products are regulated in a risk proportionate manner and evaluated consistently. We successfully achieved much of this ambitious aim by collaboratively working with NICE and other key stakeholders however have identified that further work is required to realise the full potential of the original project aims and objectives. We are therefore proposing an extension of the existing project to complement the work achieved to date outlining a DMHT Airlock, International engagement and regulatory compliance impacts.