TY - JOUR
T1 - From Genetics to Genomics
T2 - Facing the Liability Implications in Clinical Care
AU - for the LawSeq Liability Task Force
AU - Marchant, Gary
AU - Barnes, Mark
AU - Evans, James P.
AU - LeRoy, Bonnie
AU - Wolf, Susan M.
N1 - Funding Information:
Prof. Marchant, Prof. LeRoy, and Prof. Wolf report grants from the NIH during the conduct of the study. Mark Barnes is a partner at an international law firm that represents multiple academic medical centers, universities, research institutions, genomics research entities, and pharmaceutical and biotech companies, all of which have interests in the issues addressed in this paper.
Funding Information:
Preparation of this article was funded by National Institutes of Health (NIH) National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) grant #1R01HG008605 on “LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application.” (Susan M. Wolf, Ellen Wright Clayton, Frances Lawrenz, Principal Investigators). Thanks to Susan Berry, Wylie Burke, Ellen Wright Clayton, Barbara Evans, Hank Greely, Gail Javitt, Michelle Penny, Pilar Ossorio, Mark Rothstein, and Leslie Wolf for helpful comments and to Lauren Clatch, Kate Hanson, Daniel Moss, and Jon Watkins for excellent research assistance.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both health care and legal actors to address and manage those liability risks.
AB - Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both health care and legal actors to address and manage those liability risks.
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U2 - 10.1177/1073110520916994
DO - 10.1177/1073110520916994
M3 - Article
C2 - 32342786
AN - SCOPUS:85084170349
VL - 48
SP - 11
EP - 43
JO - Journal of Law, Medicine and Ethics
JF - Journal of Law, Medicine and Ethics
SN - 1073-1105
IS - 1
ER -