Applied AI governance at Mayo Clinic: reviewing AI tools before they reach practice
Mayo Clinic reviews, approves and implements AI-enabled digital health tools on a risk-based model that applies to vendor products and internally developed tools alike. This keynote is an overview of how that works: what triggers a review, how risk tier sets the depth of evaluation, who sits on the reviewing body, and what evidence a tool has to produce before it is permitted into clinical practice.
The session draws on Mayo Clinic’s Software as a Medical Device Review Board, the internal accountability body that reviews AI tools prior to deployment into clinical practice, and on the frameworks that have carried more than 100 software-based innovations into practice at Mayo. It covers where a vendor’s own evidence is sufficient and where it is not, how internally built tools are held to the same bar, and what happens when a tool is already in use before governance reaches it.
It closes on how institutional governance connects to the national and international work at CHAI, the MRCT Center at Brigham and Women’s Hospital and Harvard, and the World Health Organization, and what a health system can adopt from those frameworks today.
About the speaker
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.