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[DOI] [PMC free article] [PubMed] [Google Scholar] 179.Nick JA, Dedrick RM, Gray AL, Vladar EK, Smith BE, Freeman KG, Malcolm KC, Epperson LE, Hasan NA, Hendrix J, Callahan K, Walton K, Vestal B, Wheeler E, Rysavy NM, Poch K, Caceres S, Lovell VK, Hisert KB, de Moura VC, Chatterjee D, De P, Weakly N, Martiniano SL, Lynch DA, Daley CL, Strong M, Jia F, Hatfull GF, Davidson RM

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The European Union (EU) AI Act classifies diagnostic AI as high risk, requiring algorithm traceability, bias audits, and public model documentation (European Parliament, 2023)

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