Are Canadian and U.S. Based Direct-to-Consumer Genetic Testing Companies Complying with the ‘Accuracy Principle’ Outlined in PIPEDA?

The websites of 26 Direct-to-Consumer Genetic Testing (DTC-GT) companies based in the United States and or Canada selling health-related genetic testing services to Canadian residents were analyzed to determine whether the companies are complying with the ‘Accuracy Principle’ outlined in the ‘Personal Information Protection and Electronic Documents Act’ (PIPEDA). The main web pages of the DTC-GT companies’ websites along with their Privacy Policies and Terms of Service were examined to assess the statements made about the clinical and analytical validity of their genetic tests. The findings show that the majority of the DTC-GT companies’ websites (17 of 26) made contradictory statements relating to the accuracy of their genetic tests on one or more of their website tabs as compared to their Privacy Policies and Terms of Service. The results indicate that DTC-GT companies are not clearly articulating the limits to the requirement for accuracy, and their genetic tests are not sufficiently accurate for the purposes for which they are to be used, contrary to the requirements of Principles 4.6, 4.6.1 and 4.6.3 of the ‘Accuracy Principle’ outlined in PIPEDA.