Avoiding Liability and Other Legal Land Mines in the Evolving Genomics Landscape

Annu Rev Genomics Hum Genet. 2023 Aug 25:24:333-346. doi: 10.1146/annurev-genom-100722-021725. Epub 2023 Jan 11.

Abstract

This article reviews evolving legal implications for clinicians and researchers as genomics is used more widely in both the clinic and in translational research, reflecting rapid changes in scientific knowledge as well as the surrounding cultural and political environment. Professionals will face new and changing duties to make or act upon a genetic diagnosis, address direct-to-consumer genetic testing in patient care, consider the health implications of results for patients' family members, and recontact patients when test results change over time. Professional duties in reproductive genetic testing will need to be recalibrated in response to disruptive changes to reproductive rights in the United States. We also review the debate over who controls the flow of genetic information and who is responsible for its protection, considering the globally influential European Union General Data Protection Regulation and the rapidly evolving data privacy law landscape of the United States.

Keywords: data privacy; duty to warn; genomics; liability.

Publication types

  • Review
  • Research Support, N.I.H., Extramural

MeSH terms

  • Ambulatory Care Facilities*
  • Direct-To-Consumer Screening and Testing*
  • European Union
  • Family
  • Genomics
  • Humans