- Describe the classification of mHealth apps and understand appropriate levels of evidence for safe and effective digital health technologies.
- Evaluate an app-based digital health technology and its potential value (if any) to the product portfolio.
- Understand relevant regulatory standards for app-based digital health technologies.
This workshop will be split into three parts as follows
- Presentation: Introduction to mHealth, how to classify mHealth apps, standards for safety and efficacy. (20min)
- Group exercise: evaluation of proposed digital assets. (40min)
- Presentation: Partnering with a digital therapeutic company. (15 min plus 15 min Q+A)
Meet your facilitator - Dr Simon Rowland
Dr Rowland is employed as Global Medical Director at Besins Healthcare. He was previously Head of Global Medical Affairs at Natural Cycles Nordic AB, a digital health start-up based in Stockholm, Sweden. At Natural Cycles, Dr Rowland led a medical affairs team specialised in working on digital products. By leveraging the digital platform to collect real world data from more than 200,000 women globally, his team achieved 6 peer-reviewed publications in the 2019 calendar year including a manuscript in Nature Digital Medicine which was covered by global mainstream media outlets including the BBC, The Times and Newsweek in the US. The research was used as part of a successful FDA clearance for the app. Dr Rowland has since continued his work in digital health through an Honorary position at Imperial College London, publishing a comprehensive review of apps in healthcare in Nature Digital Medicine in January 2020 and provides expert advice to Digital Health start-ups across Europe.
About FPM Education Week