Brenna Loufek

Director – AI at Mayo Clinic

Brenna Loufek (she/her) is Director of Artificial Intelligence – Regulatory & Quality at Mayo Clinic, where she provides strategic oversight for governance and regulatory compliance of AI-enabled technologies, ensuring safe, effective, and ethically responsible clinical integration. She also served for four years as the Administrator of Mayo Clinic’s Software as a Medical Device Review Board, an internal accountability body that reviews AI tools prior to deployment into clinical practice. Recognized as a subject matter expert in regulatory strategy for intelligent technologies, Ms. Loufek’s career includes leadership roles in healthcare institutions and the medical device industry, with positions at Medtronic and Philips. Her expertise spans FDA regulatory submissions, global market access, and enterprise quality systems. At Mayo Clinic, she has led frameworks enabling the translation of over 100 software-based innovations into clinical practice. Ms. Loufek engages in national and international policy initiatives, contributing to the Coalition for Health AI (CHAI), the Multi-Regional Clinical Trials (MRCT) Center at Brigham and Women’s Hospital and Harvard, and the World Health Organization. Her scholarship addresses AI governance, risk-based evaluation, and regulatory harmonization. She also contributes to digital health and regulatory science curricula at Mayo Clinic and Oxford University. She holds a master’s degree in Patient Safety and Healthcare Quality from the Johns Hopkins Bloomberg School of Public Health and is pursuing a Doctorate of Public Health, with research focused on governance of emerging digital health technologies.