Brenna Loufek
AI Governance & Risk Research  ·  Institutional Oversight  ·  Health Policy

Building the oversight systems that make AI trustworthy in clinical care

I design governance structures, risk frameworks, and review processes that help health systems adopt AI responsibly, translating emerging technology and evolving regulation into oversight that protects patient safety without stalling innovation.

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About

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.

My research examines how health policy shapes the governance of digital technologies in clinical care. 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) Decision-Making Under Uncertainty Cross-Sector Advising
450+
AI-enabled technologies evaluated for regulatory risk
87
Medical device status determinations led
40+
External organizations advised on AI regulatory risk

Selected Publications

  1. Vidal DE, Loufek B, Kim YH, Vidal NY. Navigating US Regulation of Artificial Intelligence in Medicine—A Primer for Physicians. Mayo Clin Proc Digit Health. 2023;1(1):31–39.
  2. Sendak MP, et al., Loufek B, et al. Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. J Am Med Inform Assoc. 2024;31(7):1622–1627.
  3. Loufek B, Vidal D, McClintock DS, et al. Embedding Internal Accountability Into Health Care Institutions for Safe, Effective, and Ethical Implementation of Artificial Intelligence Into Medical Practice: A Mayo Clinic Case Study. Mayo Clin Proc Digit Health. 2024;2(4):574–583.
  4. Korfiatis P, Kline TL, et al., Loufek BT, et al. Implementing Artificial Intelligence Algorithms in the Radiology Workflow: Challenges and Considerations. Mayo Clin Proc Digit Health. 2025;3(1):100188.
  5. Corso MM, Kim PT, Loufek BT, et al. Bridging the gap: aligning clinical decision support regulation with clinical practice in the era of artificial intelligence. Lancet Digit Health. 2026;8(3):100964.

Additional publications, presentations, academic contributions, and FDA interactions available upon request.

Advisory & Consulting

I work with health systems, digital health companies, and AI-enabled medtech teams navigating regulatory ambiguity — translating governance principles into structures that actually hold up under review.

Risk Tiering & Categorization

Design defensible, risk-based frameworks for classifying AI systems by potential for harm ahead of deployment.

Governance & Oversight Board Design

Structure review bodies, policies, and quality-management processes for accountable, auditable AI oversight.

Regulatory Strategy for AI-Enabled Health Tech

Navigate SaMD classification, labeling boundaries, and exemption pathways for AI/ML tools built in-house.

Startup & Growth-Stage Advising

Support early-stage teams on product safety and deployment considerations for novel AI-enabled solutions.

Speaking & Affiliations

Selected Presentations, 2026
  • Hospitalar: AI in Healthcare — Strategies to Scale (Keynote)
  • Conference on Health IT and Analytics (CHITA), Johns Hopkins (Speaker)
  • AI Device Talks — Promise, Risk, and the Path to Market (Panelist)
  • AI Innovation Summit — AI Governance in Healthcare (Speaker)
Affiliations
  • MRCT Center (Harvard/Brigham and Women's Hospital) — AI Ethics & Human Subjects Task Force
  • Coalition for Health AI (CHAI) — Risk Management Working Group
  • World Health Organization — AI governance initiatives
  • Adjunct Faculty, Healthcare Management — University of Minnesota
  • AI Curriculum Advisor — Johns Hopkins University; University of Oxford
  • HIMSS Chapter Board Member; Member, RAPS, Digital Medicine Society, AMIA

Let's talk

Whether it's a governance framework, a regulatory strategy question, or a research collaboration, reach out.

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