How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agenci...

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Bibliographic Details
Published in:The Journal of law, medicine & ethics medicine & ethics, 2020-03, Vol.48 (1), p.44-68
Main Authors: Evans, Barbara J., Javitt, Gail, Hall, Ralph, Robertson, Megan, Ossorio, Pilar, Wolf, Susan M., Morgan, Thomas, Clayton, Ellen Wright
Format: Article
Language:English
Subjects:
Centers for Medicare and Medicaid Services, U.S
Diagnostic tests
Genes
Genetic testing
Genomes
Genomics - legislation & jurisprudence
Genomics - methods
Genomics - standards
Government agencies
High-Throughput Nucleotide Sequencing
Humans
Laboratories - legislation & jurisprudence
Medicaid
Medical Device Legislation
Medical diagnosis
Medical laboratories
Medicare
Patients
Quality of care
Quality of Health Care
Sequence Analysis, DNA
Software - legislation & jurisprudence
United States
United States Food and Drug Administration
Validity
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Summary:Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
ISSN:1073-1105
1748-720X
DOI:10.1177/1073110520916995