Digitalisation 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, HBW Insight speaks to regulatory expert Jamie Hatzel 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 briefly outlines the UK and EU regulatory approaches to SaMDs, before we discuss specific examples such as symptom trackers, wellness apps and digital therapeutics. In the second part, we talk about artificial intelligence, how incoming AI regulations impact SaMDs and whether OTC firms should take the plunge into this highly regulated but nevertheless very exciting space.