Brenna Loufek
About

How health systems determine regulatory status, assess AI risk, validate tools, and govern them over time

As Director of AI Governance at Mayo Clinic, I collaborate with clinicians, researchers, engineers, and organizational leaders to develop the oversight systems that support responsible AI adoption across clinical practice. My work translates emerging technologies, evolving regulatory expectations, and organizational priorities into scalable governance strategies — enabling innovation while safeguarding patient safety, clinical excellence, and institutional accountability.

Before focusing on enterprise AI governance, I built substantial medical-device regulatory experience in industry, including FDA-facing roles at Medtronic and Philips spanning 510(k) submissions, Software as a Medical Device, and quality systems — experience that grounds my approach to technology governance in the practical realities of regulatory implementation, not just policy analysis.

My doctoral research at the Johns Hopkins Bloomberg School of Public Health examines the efficacy of regulatory and ethical frameworks in managing patient harms associated with AI/ML-enabled digital-health technologies and clinical decision-support software — connecting technology policy, regulation, institutional governance, implementation, and patient safety into one line of inquiry. I contribute to national and international initiatives advancing the responsible use of AI in healthcare, including the MRCT Center's AI Ethics and Human Subjects Task Force, the Coalition for Health AI, and the World Health Organization.

Areas of Expertise
Risk Categorization & Tiering Institutional Oversight Board Design Safety & Audit Frameworks AI Governance Policy Regulatory Science (US FDA) SaMD & 510(k) Strategy Decision-Making Under Uncertainty Cross-Sector Advising
Education
DrPH, Health Policy (in progress) — Johns Hopkins Bloomberg School of Public Health
MS, Patient Safety & Healthcare Quality — Johns Hopkins Bloomberg School of Public Health
BA, Political Science, Anthropology, Spanish — University of Minnesota – Twin Cities