The Streetlight Effect: Regulating Genomics Where the Light Is

J Law Med Ethics. 2020 Mar;48(1):105-118. doi: 10.1177/1073110520916998.

Abstract

Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.

Publication types

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

MeSH terms

  • Biomedical Technology / legislation & jurisprudence*
  • Centers for Medicare and Medicaid Services, U.S.
  • Genomics / legislation & jurisprudence*
  • Government Regulation*
  • Health Insurance Portability and Accountability Act
  • Humans
  • Laboratories
  • Software
  • United States
  • United States Food and Drug Administration