Course Description

Digital health is one of the hottest current areas of digital transformation. lt’s considered to be the next trillion dollar market and, at the same time, offers great opportunities to make a valuable impact in a field that is so vitally important to all of us: our health.

Yet, if you’re looking to contribute to digital health yourself, you will quickly find that it has quite a plethora of legal and regulatory strings attached. It’s not easy to get a comprehensive, practical overview of which requirements you have to consider and which of them actually apply to your application.

This course is here to do exactly that. In a 5 hour session (with breaks, don’t worry), you will learn

  • What requirements the European Medical Device Regulation (MDR) mandates for Software as a Medical Device (SaMD, including AI) and how to determine whether your application qualifies as a medical device or rather as a health and wellness device
  • Which requirements apply when processing personal data – and especially health data – in accordance to the European General Data Protection Regulation (GDPR)
  • How the generation of clinical evidence works and which different types of evidence exist
  • Which additional requirements apply to launching a DiGA (“Digitale Gesundheitsanwendung”, a German specificity)
  • Which other requirements and opportunities (next to DiGA) the German eHealth legislation by Jens Spahn introduced to fuel digitalisation in healthcare
  • What specific requirements apply to telemedical applications
  • What the legal boundaries are for marketing of a digital health application

All aspects are discussed with an emphasis on practical implications and applicability – and with ample time for your questions!

The course is delivered as an online workshop via Zoom and held in English. Should all participants be more comfortable with German, we will switch to German. Slides and handouts are in English.

About the instructors

Kristin Memm is a fully qualified lawyer with + 15 years of professional experience in consulting, supervising and representing physicians on the federal and state level as well as advising digital health and health tech startup companies, supporting first-time founders in healthcare from early stage to market access. She combined her studies of law with the study of medicine and is highly specialised in Medical Law and regulatory at Kanzlei KM.

Dr.-Ing. Johannes Starlinger is both a physician and a computer scientist, and a specialist for regulatory requirements of software as a medical device (TÜV-Süd). As a consultant here at Howto Health, he helps companies of various sizes navigate the maze of medical device regulatory and create innovative digital health applications, bringing in over a decade of experience in developing, researching and teaching in the areas of biomedical software and data-intensive applications in health and healthcare. Driven by a passion to share knowledge, Johannes is also an external lecturer at Humbolt-Universität zu Berlin, Charité – Universitätsmedizin Berlin, the University of Applied Sciences of the Grisons, and the University of Bern.

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