Patient safety and healthcare quality of U.S. laboratory developed tests (LDTs) in the AI/ML era of precision medicine

This policy brief summarizes current U.S. regulatory considerations for ensuring patient safety and health care quality of genetic/genomic test information for precision medicine in the era of artificial intelligence/machine learning (AI/ML). The critical role of innovative and efficient laboratory...

Ausführliche Beschreibung

Bibliografische Detailangaben

1. Verfasser:	Emma L. Kurnat-Thoma
Format:	Artigo
Sprache:	Inglês
Veröffentlicht:	Frontiers Media S.A. 2024-08-01
Schriftenreihe:	Frontiers in Molecular Biosciences
Schlagworte:	laboratory developed tests (LDTs) FDA proposed rule CMS clinical laboratory improvement amendments (CLIA) genomic tests return of results (RoR) regulatory compliance
Online-Zugang:	https://www.frontiersin.org/articles/10.3389/fmolb.2024.1407513/full
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