Brenna Loufek, MS is a regulatory and digital health leader serving as Director of Artificial Intelligence – Regulatory & Quality at Mayo Clinic. In this role, she leads enterprise-wide regulatory strategy, governance, and quality oversight for AI-enabled digital health technologies, with a focus on patient safety, risk stratification, and alignment with U.S. FDA Software as a Medical Device frameworks. She also served as Administrator of Mayo Clinic’s SaMD Review Board, supporting consistent classification, evidence expectations, and lifecycle oversight across hundreds of AI tools deployed in clinical practice.
Prior to joining Mayo Clinic, she held regulatory roles at Medtronic and Philips, advising on submissions and development strategies for AI-enabled software, telehealth platforms, and clinical decision support tools. She holds a master’s degree in Patient Safety and Healthcare Quality and is pursuing a doctorate in Public Health in Health Policy and Management.