TY - JOUR
T1 - How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?
AU - for the LawSeq Quality Task Force
AU - Evans, Barbara J.
AU - Javitt, Gail
AU - Hall, Ralph
AU - Robertson, Megan
AU - Ossorio, Pilar
AU - Wolf, Susan M.
AU - Morgan, Thomas
AU - Clayton, Ellen Wright
N1 - Publisher Copyright:
© 2020 American Society of Law, Medicine & Ethics.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - 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.
AB - 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.
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U2 - 10.1177/1073110520916995
DO - 10.1177/1073110520916995
M3 - Article
C2 - 32342785
AN - SCOPUS:85084169280
SN - 1073-1105
VL - 48
SP - 44
EP - 68
JO - Journal of Law, Medicine and Ethics
JF - Journal of Law, Medicine and Ethics
IS - 1
ER -