Abstract
The law on human genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Newer genomic assays, such as gene panels, whole exome and whole genome sequencing that can assess many or all of a patient’s genetic variants are different from former genetic assays that consist of assessing for variants in specific genes that indicate risk for medical conditions and for single-gene Mendelian disorders. Overall, single-gene genetic testing has primarily been used for risk prediction, disease diagnosis, and assessing carrier status, whereas genomic analysis is enabling additional functions, such as disease prognosis and treatment selection. However, these advances in functionality do not come without potential consequences. A pending lawsuit in South Carolina, for example, raises the question of whether genomics laboratories and clinicians are potentially liable for interpreting a genomic variant as a “variant of uncertain significance” (VUS) rather than a “likely pathogenic” variant, given the differences in clinical implications between the two variant classifications, and for failure to recontact the patient with an interpretive update as understanding evolved. Another lawsuit pending in Alaska raises the question of whether a direct-to-consumer (DTC) genetics genealogy service is liable for publicly sharing a customer’s genetic information. ...
Document Type
Article
Publication Date
2020
Recommended Citation
Lauren Clatch et al., Key Expert Stakeholder Perceptions of the Law of Genomics: Identified Problems and Potential Solutions, 48 J.L. Med. & Ethics 87 (2020).
Included in
Health Law and Policy Commons, Medical Jurisprudence Commons, Science and Technology Law Commons
