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.
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The authors wish to thank Meredith Trejo and Isabel Canfield for their research assistance.
G.H.J. discloses that Epstein Becker Green might now or in the future provide legal or regulatory advice to entities that operate as or are affiliated with third-party genetic interpretation services. A.L.M. discloses that she was a member of the committee of the US National Academies of Sciences, Engineering, and Medicine that produced the report, Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. C.J.G. was a consultant to the committee. The other authors declare no conflicts of interest.
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Guerrini, C.J., Wagner, J.K., Nelson, S.C. et al. Who’s on third? Regulation of third-party genetic interpretation services. Genet Med (2019) doi:10.1038/s41436-019-0627-6
- direct-to-consumer screening and testing
- genetic services
- genetic privacy
- health policy
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