Who's on third? Regulation of third-party genetic interpretation services.
Centers for Medicare and Medicaid Services, U.S.
Direct-To-Consumer Screening and Testing
Genetic Services
/ legislation & jurisprudence
Genetic Testing
/ legislation & jurisprudence
Humans
Risk Assessment
United States
United States Dept. of Health and Human Services
United States Federal Trade Commission
United States Food and Drug Administration
ELSI
direct-to-consumer screening and testing
genetic privacy
genetic services
health policy
Journal
Genetics in medicine : official journal of the American College of Medical Genetics
ISSN: 1530-0366
Titre abrégé: Genet Med
Pays: United States
ID NLM: 9815831
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
29
03
2019
accepted:
22
07
2019
pubmed:
14
8
2019
medline:
9
6
2020
entrez:
13
8
2019
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31402353
doi: 10.1038/s41436-019-0627-6
pii: S1098-3600(21)01135-7
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
4-11Références
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