Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic's guide.

Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention.

Introduction of a novel service model to improve uptake and adherence with cardiac rehabilitation within Buckinghamshire Healthcare NHS Trust.

Background: Buckinghamshire Healthcare NHS Trust (BHT) carried out a cardiac rehabilitation (CR) service redesign aimed at optimising patient recruitment and retention and decreasing readmissions.

Methods: A single centre observational study and local service evaluation were carried out to describe the impact of the novel technology-enabled CR model. Data were collected for adult patients referred for CR at BHT, retrospectively for patients referred during the 12-month pre-implementation period (Cohort 1) and prospectively for patients referred during the 12-month post-implementation period (Cohort 2).