Ethics & Regulatory Affairs
Our team works closely with norm-setting and regulatory health bodies to support the development of safe, ethical, and equitable policies and guidelines for digital architecture.
The Ethics and Regulatory Affairs hub works in collaboration with all other six hubs to ensure fairness, morality, and accountability of the produced interventions.
Relevant Projects
Advancing Health Equity in AI/ML in Health Regulation and Policy
This study examines how the Federal Drug Administration (FDA)-approved artificial intelligence (AI) tools might produce or reproduce racial disparities in health and limit health equity, research the landscape of national activities centering on AI and health equity, and identify how input from organizations that focus on racial and ethnic minority health and/or health disparities could inform policy development and FDA regulatory guidance for AI tools in medicine.
Advancing a Regulatory Framework for Racial Equity in the Medical Device Market
Using pulse oximetry as a focal case, this interdisciplinary research project explores the use of race in device regulation, explores equity-focused evidentiary standards, and deploys a survey of device purchasers with the long-term goal of facilitating a market for equity-focused medical devices.