Brenna Loufek
Research & Governance

How should institutions govern rapidly evolving AI technologies when technological capability outpaces regulatory frameworks?

Healthcare is a deeply developed real-world case study of this broader problem. My work sits at the intersection of regulatory science, institutional design, and health policy — connecting high-level technology policy with what actually happens when institutions must make consequential decisions about deploying emerging technologies.

Doctoral Research

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 — asking not just what the rules say, but whether they actually work once technologies reach clinical practice.

Frameworks & Institutional Mechanisms

SaMD Review Board

Co-created and administered Mayo Clinic's internal Software as a Medical Device Review Board, establishing the institutional process for determining when digital-health and AI technologies constitute regulated medical devices.

Physician-Led Risk Categorization Model

A generalizable framework for tiering AI systems by potential for harm, calibrating the level of independent review each tool requires before and after deployment.

Interpreting the Licensed-Practitioner Exemption

Led enterprise-wide alignment on risk-based use of the licensed-practitioner exemption for AI-enabled clinical decision support — a provision written for simple rule-based software now being stretched to cover adaptive machine-learning and LLM-based tools.

AI Best Practice Checklist & Clinical AI Inventory

Directed development of governance requirements for vended and internally developed non-device AI tools, and established the tracking infrastructure that became Mayo Clinic's enterprise Clinical AI Inventory.

Open Questions I'm Working On

Selected frameworks and tools will be published here as they become publicly shareable.