Health Disparities and Reporting Gaps in Artificial Intelligence (AI) Enabled Medical Devices: A Scoping Review of 692 U.S. Food and Drug Administration (FDA) 510k Approvals

2024-05-20 health policy Title + abstract only

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Machine learning and artificial intelligence (AI/ML) models in healthcare may exacerbate health biases. Regulatory oversight is critical in evaluating the safety and effectiveness of AI/ML devices in clinical settings. We conducted a scoping review on the 692 FDA 510k-approved AI/ML-enabled medical devices to examine transparency, safety reporting, and sociodemographic representation. Only 3.6% of approvals reported race/ethnicity, 99.1% provided no socioeconomic data. 81.6% did not report the a...