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Who's on third? Regulation of third-party genetic interpretation services.
Genet Med 2019GM

Abstract

In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services' Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

Authors+Show Affiliations

Baylor College of Medicine, Center for Medical Ethics and Health Policy, Houston, TX, USA. guerrini@bcm.edu.Geisinger, Center for Translational Bioethics & Health Care Policy, Danville, PA, USA.Institute for Public Health Genetics, University of Washington, Seattle, WA, USA.Epstein Becker Green, Washington, DC, USA.Baylor College of Medicine, Center for Medical Ethics and Health Policy, Houston, TX, USA.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31402353

Citation

Guerrini, Christi J., et al. "Who's On Third? Regulation of Third-party Genetic Interpretation Services." Genetics in Medicine : Official Journal of the American College of Medical Genetics, 2019.
Guerrini CJ, Wagner JK, Nelson SC, et al. Who's on third? Regulation of third-party genetic interpretation services. Genet Med. 2019.
Guerrini, C. J., Wagner, J. K., Nelson, S. C., Javitt, G. H., & McGuire, A. L. (2019). Who's on third? Regulation of third-party genetic interpretation services. Genetics in Medicine : Official Journal of the American College of Medical Genetics, doi:10.1038/s41436-019-0627-6.
Guerrini CJ, et al. Who's On Third? Regulation of Third-party Genetic Interpretation Services. Genet Med. 2019 Aug 12; PubMed PMID: 31402353.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Who's on third? Regulation of third-party genetic interpretation services. AU - Guerrini,Christi J, AU - Wagner,Jennifer K, AU - Nelson,Sarah C, AU - Javitt,Gail H, AU - McGuire,Amy L, Y1 - 2019/08/12/ PY - 2019/03/29/received PY - 2019/07/22/accepted PY - 2019/8/13/entrez KW - ELSI KW - direct-to-consumer screening and testing KW - genetic privacy KW - genetic services KW - health policy JF - Genetics in medicine : official journal of the American College of Medical Genetics JO - Genet. Med. N2 - In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services' Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight. SN - 1530-0366 UR - https://www.unboundmedicine.com/medline/citation/31402353/Who's_on_third_Regulation_of_third-party_genetic_interpretation_services L2 - http://dx.doi.org/10.1038/s41436-019-0627-6 DB - PRIME DP - Unbound Medicine ER -