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...
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Published in | Frontiers in molecular biosciences Vol. 11; p. 1407513 |
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Main Author | |
Format | Journal Article |
Language | English |
Published |
Frontiers Media S.A
05.08.2024
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Subjects | |
Online Access | Get full text |
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Summary: | 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 developed tests (LDTs) in providing accurate diagnostic genetic/genomic information for U.S. patient- and family-centered healthcare decision-making is significant. However, many LDTs are not fully vetted for sufficient analytic and clinical validity via current FDA and CMS regulatory oversight pathways. The U.S. Centers for Disease Control and Prevention’s Policy Analytical Framework Tool was used to identify the issue, perform a high-level policy analysis, and develop overview recommendations for a bipartisan healthcare policy reform strategy acceptable to diverse precision and systems medicine stakeholders. |
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Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Edited by: Francesca Nencini, University of Florence, Italy Reviewed by: Bharathikumar Vellalore Maruthachalam, Janssen Research and Development, United States Tony Badrick, Royal College of Pathologists of Australasia, Australia ORCID: Emma L. Kurnat-Thoma, orcid.org/0000-0002-5720-8932 |
ISSN: | 2296-889X 2296-889X |
DOI: | 10.3389/fmolb.2024.1407513 |