A scoping review of reporting gaps in FDA-approved AI medical devices.

ABSTRACT: 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-approved AI/ML-enabled medical devices approved from 1995-2023 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 age of study subjects. Only 46.1% provided comprehensive detailed results of performance studies; only 1.9% included a link to a scientific publication with safety and efficacy data. Only 9.0% contained a prospective study for post-market surveillance. Despite the growing number of

SUBMITTER: Muralidharan V 

PROVIDER: S-EPMC11450195 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature