In recent years, FDA has increasingly focused on honing its approach to regulating digital health tools and technologies, including those used in the research setting. This presentation focused on the Agency’s risk-based approach to regulation in the digital health space, with a focus on when clinical decision support and artificial intelligence/machine learning software may be considered a medical device subject to FDA regulation.
Released on: November 9, 2021
Topics: 1) The Regulation of Digital Health Tools and Software as a Medical Device, and 2) Update on the Application of the European Union’s General Data Protection Regulation to Research