Evolution of the clinical simulation approach to assess digital health technologies.

Coronavirus 2019 (COVID-19) has catalysed digital transformation in the health space. However, it remains a challenge to generate timely and cost-effective evidence for digital health technologies (DHTs) to ensure their safety and efficacy. Traditional methods, such as randomised controlled trials (RCTs), are ill-suited for assessing DHTs for reasons of speed, agility, cost and context. Clinical simulation using high-fidelity synthetic patient cases is emerging as a promising yet underexplored method to evaluate DHTs. It offers several advantages, including conducting remote multi-site testing at low cost, inclusion of high-risk patient profiles that are usually excluded from RCTs and adaptability to different local clinical settings. This article shares some of the insights from studies using clinical simulation conducted at the Institute of Global Health Innovation (IGHI) at Imperial College London and describes the evolution of this approach as well as future opportunities.