Original Research Article

All your data (effectively) belong to us: data practices among direct-to-consumer genetic testing firms

  • Genetics in Medicine volume 19, pages 513520 (2017)
  • doi:10.1038/gim.2016.136
  • Download Citation



Direct-to-consumer genetic testing (DTC-GT) has become a convenient method to help people to understand their genetic makeup. Owing in part to concerns regarding confidentiality, privacy, and secondary use of data, professional and government bodies created guidelines to promote transparency among these companies. Using a comprehensive and systematic approach, this study assessed DTC-GT company compliance with international transparency guidelines.


A framework analysis was performed on 30 DTC-GT health and/or ancestry websites identified using a US-based online search strategy during the summer of 2015. A codebook was developed from a synthesis of relevant guidelines from seven DTC-GT guideline documents and applied to each website.


Although most companies met guidelines related to transparency regarding security protocols, storage procedures, and third-party disclosures, few met guidelines regarding sharing risks from data disclosures. Additionally, few companies disclosed how long data would be kept for services or research. Use of data for research was frequently mentioned only in privacy policies and terms of service documents, and only two-thirds of companies required an additional consent to use consumer data for health-related research.


Our analysis shows that DTC-GT companies do not consistently meet international transparency guidelines related to confidentiality, privacy, and secondary use of data.

Genet Med advance online publication 22 September 2016

  • Subscribe to Genetics in Medicine for full access:



Additional access options:

Already a subscriber?  Log in  now or  Register  for online access.


  1. 1.

    Where there’s a web, there’s a way: commercial genetic testing and the Internet. Community Genet 2003;6:46–57.

  2. 2.

    , , Direct-to-consumer sales of genetic services on the Internet. Genet Med 2003;5:332–337.

  3. 3.

    , , The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues. Annu Rev Genomics Hum Genet 2008;9:161–182.

  4. 4.

    , Direct-to-consumer genetic testing and personal genomics services: a review of recent empirical studies. Curr Genet Med Rep 2013;1:182–200.

  5. 5.

    , , Blurring lines. The research activities of direct-to-consumer genetic testing companies raise questions about consumers as research subjects. EMBO Rep 2010;11:579–582.

  6. 6.

    , , , Direct to consumer genetic testing: a systematic review of position statements, policies and recommendations. Clin Genet 2012;82:210–218.

  7. 7.

    US Food and Drug Administration. Warning Letter to 23andMe, Inc. 22 November 2013. . Accessed 6 June 2016.

  8. 8.

    , , Where are you going, where have you been: a recent history of the direct-to-consumer genetic testing market. J Community Genet 2010;1:101–106.

  9. 9.

    Direct-to-consumer pharmaceutical advertising: therapeutic or toxic? P T 2011;36:669–684.

  10. 10.

    US Food and Drug Administration. FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome. 23 February 2015. . Accessed 6 June 2016.

  11. 11.

    The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet 2012;13:415–431.

  12. 12.

    , Company disclosure and consumer perceptions of the privacy implications of direct-to-consumer genetic testing. New Genet Soc 2016;35:1–23.

  13. 13.

    , , , Informed choice in direct-to-consumer genetic testing (DTCGT) websites: a content analysis of benefits, risks, and limitations. J Genet Couns 2012;21:433–439.

  14. 14.

    , Ethical issues in consumer genome sequencing: Use of consumers’ samples and data. Appl Transl Genom 2016;8:23–30.

  15. 15.

    , , , Tilting at windmills no longer: a data-driven discussion of DTC DNA ancestry tests. Genet Med 2012;14:586–593.

  16. 16.

    ACMG Board of Directors. Direct-to-consumer genetic testing: a revised position statement of the American College of Medical Genetics and Genomics. Genet Med. 2015:1–2.

  17. 17.

    , , , , ; American Society of Clinical Oncology. American Society of Clinical Oncology policy statement update: genetic and genomic testing for cancer susceptibility. J Clin Oncol 2010;28:893–901.

  18. 18.

    , , , ; American Society of Human Genetics Social Issues Committee. ASHG Statement* on direct-to-consumer genetic testing in the United States. Obstet Gynecol 2007;110:1392–1395.

  19. 19.

    European Academies Science Advisory Council, Federation of European Academies of Medicine. Direct-to-Consumer Genetic Testing for Health-Related Purposes in the European Union: the view from EASAC and FEAM. 2012:1–36. . Accessed 22 June, 2015.

  20. 20.

    European Society of Human Genetics. Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes. Eur J Hum Genet 2010;18:1271–1273.

  21. 21.

    Human Genetics Commission. A Common Framework of Principles for Direct-to-Consumer Genetic Testing Services. 2010:1–15. . Accessed 22 June, 2015.

  22. 22.

    Nuffield Council on Bioethics. Chapter 9. Personal genetic profiling for disease susceptibility. In: Medical Profiling and Online Medicine the Ethics of Personalised Healthcare in a Consumer Age. 2010:142–163. . Accessed 22 June, 2015.

  23. 23.

    Qualitative research: thoughts on how to do it; how to judge it; when to use it. Genet Med 2005;7:155–158.

  24. 24.

    , , , , Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol 2013;13:117.

  25. 25.

    National Human Genome Research Institute. Genetic Information Nondiscrimination Act of 2008. 2015. . Accessed 6 June 2016.

  26. 26.

    , , , , Informational content, literacy demands, and usability of websites offering health-related genetic tests directly to consumers. Genet Med 2010;12:304–312.

  27. 27.

    National Library of Medicine M. How to Write Easy-to-Read Health Materials. 2016. . Accessed 6 June 2016.

  28. 28.

    , , , et al. Risk information exposure and direct-to-consumer genetic testing for BRCA mutations among women with a personal or family history of breast or ovarian cancer. Cancer Epidemiol Biomarkers Prev 2009;18:1303–1311.

  29. 29.

    Taking as giving bioscience, exchange, and the politics of benefit-sharing. Soc Stud Sci 2007;37:729–758.

  30. 30.

    , , , , , Genetic testing for Alzheimer’s and long-term care insurance. Health Aff (Millwood) 2010;29:102–108.

  31. 31.

    , , , From genetic privacy to open consent. Nat Rev Genet 2008;9:406–411.

  32. 32.

    , , , , Identifying personal genomes by surname inference. Science 2013;339:321–324.

  33. 33.

    , , , , , Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet 2015;23:141–146.

  34. 34.

    , , The food industry and self-regulation: standards to promote success and to avoid public health failures. Am J Public Health 2010;100:240–246.

  35. 35.

    US Federal Trade Commission. January 2014. Direct-to-Consumer Genetic Tests. . Accessed 24 July 2016.

Download references

Author information


  1. Joseph J. Zilber School of Public Health, University of Wisconsin–Milwaukee, Milwaukee, Wisconsin, USA

    • Linnea I. Laestadius
    • , Jennifer R. Rich
    •  & Paul L. Auer


  1. Search for Linnea I. Laestadius in:

  2. Search for Jennifer R. Rich in:

  3. Search for Paul L. Auer in:

Corresponding author

Correspondence to Linnea I. Laestadius.

Supplementary information