Document Type

Article

Publication Title

Annals of Health Law and Life Sciences

Publication Date

Winter 2009

ISSN

0042-2533

Page Number

153

Keywords

malpractice, clinical laboratories, health law

Disciplines

Health Law and Policy | Law

Abstract

From a legal perspective, is a clinical laboratory a healthcare provider? Physicians are clearly healthcare providers who owe their patients the associated fiduciary duties. It is less clear, however, which-if any-legal duties genetic testing labs owe to the individuals who seek their services.

The question of whether clinical genetics laboratories are healthcare providers for legal purposes may be thornier than it could initially appear. Clinical genetics laboratories perform multiple tasks. Most significantly, they sequence genetic samples and then interpret the results. As "next generation sequencing" has become more accessible,' labs can generate and interpret more sequence data for a growing number of clinical indications. While standardized methods for generating and processing sequence data are in place, the way labs interpret genetic data remains in flux. And, increasingly, how a given laboratory interprets genetic data has become more salient because physicians rely on those interpretations in their medical practices. These changes in data interpretation have brought new medical and legal challenges.

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