AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers

MedTech Dive February 16, 2023
Nick Paul Taylor

Dive Brief:

• Academics have called for the Food and Drug Administration (FDA) to create a regulatory process to prevent AI-driven software as a medical device (SaMD) from exacerbating health disparities.
• Writing in the Journal of Science Policy & Governance, researchers at the University of Pennsylvania and Oregon Health & Science University warn that “AI-driven tools have the potential to codify bias in healthcare settings” but note the FDA lacks regulations to examine bias in AI healthcare software.
• The researchers want the FDA to create a distinct regulatory process for AI devices and to appoint a panel of experts in “algorithmic justice and healthcare equity” to develop bias benchmarks and requirements.

Dive Insight:

Because AI is trained on existing...

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