Who’s on third? Regulation of third-party genetic interpretation services

• Published in: Genetics in medicine Vol. 22; no. 1; pp. 4 - 11
• Main Authors: Guerrini, Christi J., Wagner, Jennifer K., Nelson, Sarah C., Javitt, Gail H., McGuire, Amy L.
• Format: Journal Article
• Language: English
• Published: New York Nature Publishing Group US 01.01.2020; Elsevier Limited
• Subjects: Biomedical and Life Sciences; Biomedicine; Centers for Medicare and Medicaid Services, U.S; Direct-To-Consumer Screening and Testing; Genetic Services - legislation & jurisprudence; Genetic Services - organization & administration; Genetic Testing - legislation & jurisprudence; Human Genetics; Humans; Laboratory Medicine; Regulatory agencies; Review Article; Risk Assessment; Third party; United States; United States Dept. of Health and Human Services; United States Federal Trade Commission; United States Food and Drug Administration; United States; United States > US; genetic services; genetic privacy; health policy; direct-to-consumer screening and testing; ELSI
• ISSN: 1098-3600; 1530-0366; 1530-0366
• DOI: 10.1038/s41436-019-0627-6

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.