Institute of Health and Wellbeing, University of Glasgow, UK
Mario Alvarez-Jimenez
Centre for Youth Mental Health, University of Melbourne, Australia Orygen, Parkville, Australia
Heather Bolton
Unmind, London, UK
Laura Dennison
School of Psychology, University of Southampton, UK
Brian E. Wallace
Calmsie, Warsaw, Poland
Heather D. Hadjistavropoulos
Department of Psychology, University of Regina, Canada
Charlotte L. Hall
NIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK
Amy Hardy
Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK
School of Psychology, University of Southampton, UK
Adam Moreton
ORCHA, Daresbury, UK
Talar R. Moukhtarian
Mental Health and Wellbeing Unit, Warwick Medical School, University of Warwick, UK
Elvira Perez Vallejos
NIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK
Sukhi Shergill
Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK Kent and Medway Medical School, Canterbury, UK
Daniel Stahl
Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK
Graham R. Thew
Department of Experimental Psychology, University of Oxford, UK Oxford Health NHS Foundation Trust, Oxford, UK
Ladislav Timulak
School of Psychology, Trinity College Dublin, Ireland
David van den Berg
Department of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, Netherlands
Noemi Viganò
SilverCloud by Amwell, Boston, USA
Ben Wensley Stock
University of Oxford Medical Sciences Division, University of Oxford, UK
Katherine S. Young
SilverCloud by Amwell, Boston, USA Social Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK
Jenny Yiend
Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK
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 led by the MHRA and the National Institute for Health and Care Excellence. Aims The aim of this study was to generate an experts’ consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs. Method An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health. Results Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general. Conclusion The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.
