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

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

SUBMITTER: Taher R 

PROVIDER: S-EPMC11363077 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature