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AI Software Needs a ‘Distinct’ Regulatory Review Process, Researchers Say

February 23, 2023

To help prevent the approval of AI medical devices that “mirror or exacerbate” existing health disparities, the FDA should develop a “distinct regulatory process” for artificial intelligence (AI)-driven software as a medical device (SaMD), say several academic researchers.

Isabel Yannatos, University of Pennsylvania, and colleagues note in the Journal of Science Policy & Governance that AI-driven SaMDs can aid in healthcare delivery and reduce health disparities, but the tools also “have the potential to codify bias in healthcare settings,” adding that some AI-driven SaMDs have “displayed substandard performance among racial and ethnic minorities.”

This underperformance can occur because AI technology learns from data and “biases in the dataset — such as underrepresentation of minority groups, unequal amounts of missing or inaccurate data, or existing disparities that are reflected in data — can be encoded into the technology’s predictions,” they contend.

The authors urge the FDA to create a new process that includes a panel of “experts in algorithmic justice and healthcare equity” to develop benchmarks and requirements for the investigation of bias at every development stage “from the datasets used to develop the device to post-market performance.”

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