Health AI Central
Peer-Reviewed Publication
BJPsych Open2024;10(4):e126.June 3, 2024Journal Article

Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context.

Rayan Taher1, Palak Bhanushali1, Stephanie Allan2, Mario Alvarez-Jimenez3,4, Heather Bolton5, Laura Dennison6, Brian E Wallace7, Heather D Hadjistavropoulos8, Charlotte L Hall9, Amy Hardy1, Alasdair L Henry10, Sam Lane11, Tess Maguire6, Adam Moreton12, Talar R Moukhtarian13, Elvira Perez Vallejos9, Sukhi Shergill1,14, Daniel Stahl15, Graham R Thew16,17, Ladislav Timulak18, David van den Berg19, Noemi Viganò11, Ben Wensley Stock20, Katherine S Young11,21, Jenny Yiend1
1Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
2Institute of Health and Wellbeing, University of Glasgow, UK.
3Centre for Youth Mental Health, University of Melbourne, Australia.
4Orygen, Parkville, Australia.
5Unmind, London, UK.
6School of Psychology, University of Southampton, UK.
7Calmsie, Warsaw, Poland.
8Department of Psychology, University of Regina, Canada.
9NIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK.
10Big Health Ltd, London, UK.
11SilverCloud by Amwell, Boston, USA.
12ORCHA, Daresbury, UK.
13Mental Health and Wellbeing Unit, Warwick Medical School, University of Warwick, UK.
14Kent and Medway Medical School, Canterbury, UK.
15Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
16Department of Experimental Psychology, University of Oxford, UK.
17Oxford Health NHS Foundation Trust, Oxford, UK.
18School of Psychology, Trinity College Dublin, Ireland.
19Department of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, Netherlands.
20University of Oxford Medical Sciences Division, University of Oxford, UK.
21Social Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
PubMed PMC DOI PDF

Abstract

BACKGROUND: Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform…

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