Advancing safe, effective, and accountable implementation of AI in clinical practice
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.
Co-created Mayo Clinic's SaMD Review Board
Built the institutional process for determining when digital-health and AI technologies constitute regulated medical devices, and led 87 such determinations.
Physician-Led AI Risk Categorization Model
Co-designed a generalizable framework for tiering AI systems by potential for harm, calibrating the level of oversight required for each tool.
Doctoral Research on Regulatory Efficacy
Examining how well regulatory and ethical frameworks manage patient harms associated with AI/ML-enabled digital health and clinical decision-support software. Read more →
Enterprise Governance Policy Suite
Co-authored the governance policies and quality-management infrastructure now adopted enterprise-wide at Mayo Clinic for AI-enabled tools.
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.
Let's talk
Whether it's a governance framework, a regulatory strategy question, or a research collaboration, reach out.