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The Streetlight Effect: Regulating Genomics Where the Light Is.

Barbara J Evans1

  • 1Barbara J. Evans, J.D., Ph.D., LL.M., is Mary Ann and Lawrence E. Faust Professor of Law and Director, Center for Biotechnology & Law, University of Houston Law Center. She is also Professor of Electrical and Computer Engineering, University of Houston Cullen College of Engineering.

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|April 29, 2020
PubMed
Summary

Genomic testing regulation may be biased, favoring old rules that don't fit new technology. This can lead to legal issues and incomplete solutions for genetic privacy and data use.

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Area of Science:

  • Genomic Medicine
  • Biotechnology Law
  • Health Policy

Background:

  • Genomic testing offers significant potential but presents unique regulatory challenges.
  • Existing regulatory frameworks may not adequately address the complexities of genomic data.
  • Biases in policy can lead to suboptimal or legally problematic approaches.

Purpose of the Study:

  • To analyze regulatory policy biases in genomic testing.
  • To examine the implications of applying existing frameworks to genomic technologies.
  • To identify areas where current regulations may be inadequate or counterproductive.

Main Methods:

  • Review of genetic privacy regulations.
  • Analysis of oversight for clinical genomic information use.
  • Examination of regulations governing genomic software.

Main Results:

  • Identified biases favoring established regulatory approaches over tailored solutions.
  • Found instances where existing frameworks create unintended legal consequences for genomic testing.
  • Highlighted poor tailoring of current regulations to the specific challenges of genomic data.

Conclusions:

  • Overreliance on expedient, existing regulatory frameworks can hinder the development of comprehensive solutions for genomic testing.
  • There is a need for adaptive and specific regulatory strategies for genomic technologies.
  • Current regulatory approaches may not fully protect genetic privacy or ensure safe clinical use.