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.
Bibliographical noteFunding 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.
© 2020 American Society of Law, Medicine & Ethics.
Copyright 2020 Elsevier B.V., All rights reserved.
PubMed: MeSH publication types
- Journal Article
- Research Support, N.I.H., Extramural