Over The Counter 24 July 2023: What Is ‘Software As A Medical Device’ And How Is It Regulated In Europe? With Bristows’ Jamie Hatzel
Executive Summary
Digitalization is a hot topic in consumer health, and “digital health” covers a broad spectrum of applications, from wellness apps to virtual reality therapeutics. In this episode of Over The Counter, HBW Insight speaks to Jamie Hatzel, regulatory associate at law firm Bristows, to get some clarity on “software as a medical device” – a subset of medical device regulatory frameworks within which many digital health applications are classified. In the first part of a two-part podcast, Hatzel outlines the UK and EU regulatory approaches to SaMDs, before we discuss specific examples such as symptom trackers, wellness apps and digital therapeutics.
Further Reading
Bayer Consumer Health’s Evendon-Challis On The ‘Huge Potential’ Of OTC Digital Therapeutics, AI
‘Faster, Better, More Efficient’ – Why Bayer Is Investing In ‘Precision Health’
Haleon's Nick Tate: Tech Partnerships Key To Unlocking Digital Consumer Health Future
MHRA To Prepare Guidance On Regulation Of Mental Health Apps
UK Recommends Digital Therapy App For Insomnia Sufferers
What Regulators Want To See From AI And Software-Based Devices
Further Listening
Over The Counter, 28 June 2021: The Promise Of Digital Health, with PAGB's Michelle Riddalls
Medtech Connect Episode 1: How Do We Regulate Software As A Medical Device?
These and all other podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud and TuneIn - and also now on Spotify Podcasts - and via smart speakers if one of these platforms has been set up as your default podcast provider.
Over The Counter Theme Music:
Warm Vacuum Tube by Admiral Bob (c)
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