EKFZ | Lecture with Prof. Ariel D. Stern

The Digital Revolution in Regulated Medical Products: Clinical Trials, Digital Therapeutics, and Regulated AI Devices

This talk will present findings from three projects that explore the digital transformation of regulated medical products. The first and second parts of the presentation will demonstrate how large-scale data from clinical trial registries can be used to characterize (1) the growth of digital health technologies in clinical research and (2) to identify and classify clinical trials for digital therapeutics. The third part of cthe talk will present a forthcoming book chapter on regulated AI medical devices, including an empirical analysis of recent data from the U.S. market, including data on devices origins (by firm type and country), their safety profiles (as measured by associated adverse events and recalls), and concludes with a discussion of the implications of regulation for innovation incentives in medical AI.

Prof. Dr. Ariel D. Stern is a health economist and Humboldt Professor. She teaches and researches at the joint Digital Engineering Faculty of the University of Potsdam and the Hasso Plattner Institute.