Effective Regulation and Evaluation of Digital Mental Health Technology

There is a growing mental health illness burden for individuals and society. The National Health Service Long Term Plan and Life Science Vision has committed to improving mental health care.

At the same time there has been a significant increase in the number of digital mental health products available and used, giving hope of a way to help those in need, but these products present many regulatory challenges.

As the UK safety regulator for healthcare products, we (the MHRA) recently outlined a programme to deliver bold improvements to the regulatory framework for software as a medical device.

Further work is needed to translate these broad requirements into specific and accessible requirements for digital mental health products.

Additionally, the National Institute for Health and Care Excellence (NICE) are prioritising digital technology evaluations and mental health is scheduled as a speciality area. The aim of this project is to enable access to safe and effective products, to help improve mental health care.

It will do this by ensuring that digital mental health products are regulated in a risk proportionate manner and evaluated consistently. We propose to meet this ambitious aim by collaboratively working with NICE and other key stakeholders.