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

Rayan Taher, Palak Bhanushali, Stephanie Allan, Mario Alvarez-Jimenez, Heather Bolton, Laura Dennison, Brian E. Wallace, Heather D. Hadjistavropoulos, Charlotte L. Hall, Amy Hardy, Alasdair L. Henry, Sam Lane, Tess Maguire, Adam Moreton, Talar R. Moukhtarian, Elvira Perez Vallejos, Sukhi Shergill, Daniel Stahl, Graham R. Thew, Ladislav TimulakDavid Van Den Berg, Noemi Viganò, Ben Wensley Stock, Katherine S. Young, Jenny Yiend*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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 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.

Original languageEnglish
Article numbere126
JournalBJPsych Open
Volume10
Issue number4
DOIs
Publication statusPublished - 3 Jun 2024

Keywords

  • consensus
  • Digital mental health interventions
  • mental health
  • MHRA
  • safety

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