Date of Award
1-1-2015
Embargo Period
1-1-2025
Document Type
Dissertation
Degree Name
Doctor of Health Administration
College
College of Health Professions
First Advisor
Anne Osborne Kilpatrick
Second Advisor
Jillian B. Harvey
Abstract
On November 23, 2013, the Food and Drug Administration (FDA) sent a letter to 23andMe, a direct-to-consumer genetic testing company, ordering the company to cease and desist selling the "Personal Genome Service," a direct-to-consumer health-related genetic test. The FDA cited the company for using an unapproved medical device. However, the FDA used concerns regarding consumer/patient safety to justify its action. Using a grounded theory methodology, this work explores perceptions of safety related to direct-to-consumer personal genome testing using topic-specific academic literature and news source articles related to the actions of the FDA and 23andMe. This work suggests that complete and unregulated consumer/patient access to DTC personal genome testing does present justifiable concern based on various forms of identified jeopardy. Questions of analytical and clinical validity, clinical utility, and the protection of privacy show a lack of legal certainty under the law for consumer/patients using DTC personal genome services. Advances in information and diagnostic technologies will continue to drive the rise of autonomous consumerism in the health care market place. Advances in the genomic sciences will drive the cost of testing lower, breaking barriers to access and increasing utilization. It is at this juncture that the question of "who should establish the standards, set policy, and create the processes and procedures for DTC personal genome testing" should be considered. This work suggests the option of creating a hybrid government/private, non profit oversight authority for the DTC personal genome testing industry based on the model of The Joint Commission role of providing health service providers with credentialing services through accreditation.
Recommended Citation
Van Patton, Matthew A., "Consumer Jeopardy in an Emerging Technology: Direct-to-Consumer Personal Genome Testing" (2015). MUSC Theses and Dissertations. 1018.
https://medica-musc.researchcommons.org/theses/1018
Rights
All rights reserved. All rights reserved. Copyright is held by the author.
Comments
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