Mayo Clinic - Center for Digital Health
Brenna Loufek, MS is the Director of Regulatory & Quality in the Center for Digital Health at Mayo Clinic. Brenna partners with user-innovators to create regulatory strategies that offer the least burdensome pathway to market for digital health technologies developed internally. Her subject matter expertise is in the nuanced application of US FDA regulatory policies for AI-enabled software functionalities.
Brenna brings extensive experience guiding teams through domestic and international regulations and standards. With previous roles at Medtronic and Philips, Brenna has managed complex regulatory submissions and advised on studies for digital health products including AI/ML-based technologies, telehealth platforms, and in-clinic management tools. In addition to program support, Brenna is an instructor for various courses that provide training for and interpretation of FDA regulations.
Brenna has a master’s degree in Patient Safety & Healthcare Quality from Johns Hopkins. She is a PhD candidate at the University of Oxford with a research focus on patient harms that can result from use of AI-enabled clinical decision support software in healthcare institutions.
Monday, November 18, 2024
3:30 PM – 4:45 PM PT