Algorithm Change Protocols in the Regulation of Adaptive Machine Learning–Based Medical Devices

Stephen Gilbert   ^{1, 2} , BSc, BVMS, MRes, PhD ;   Matthew Fenech   ^{1, 3} , MD, PhD ;   Martin Hirsch   ^{1, 4} , PhD ;   Shubhanan Upadhyay   ¹ , MD ;   Andrea Biasiucci   ^{5, 6} , PhD ;   Johannes Starlinger   ⁷ , MD, PhD

¹ Ada Health GmbH, Berlin, Germany

² Else Kröner-Fresenius Center for Digital Health, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany

³ Una Health GmbH, Berlin, Germany

⁴ Institute for AI in Medicine, University Hospital of Giessen and Marburg, Marburg, Germany

⁵ Laboratory for Investigative Neurophysiology, University Hospital Center and University of Lausanne, Lausanne, Switzerland

⁶ confinis ag, Sursee, Switzerland

⁷ Howto Health GmbH, Berlin, Germany