Direct-to-Consumer Laboratory Tests: An Empirical Assessment of Companies’ Policies
Thursday, October 12, 2023
2:30 PM – 3:45 PM ET
Location: Atlantic (Third Floor)
Direct-to-consumer (DTC) laboratory tests are offered to consumers with little-to-no involvement from a healthcare provider. Such testing raises ethical issues, including concerns regarding whether companies can be held liable for providing medical information, whether adequate privacy protections exist, and whether companies offer medical follow-up for consumers. Our study aimed to examine the saliency of these concerns by assessing the policies of DTC laboratory testing companies.
Methods: Through online searches, we identified companies offering DTC laboratory tests in the United States and analyzed their terms of service (ToS) and privacy policies. Furthermore, we assessed companies’ protocols regarding the delivery of abnormal results and the involvement of healthcare providers by analyzing information provided by companies, and by taking a subset of tests to gain insight into the consumer experience.
Results: Overall, 21 companies were included in our study, and 18 types of health-related tests were identified. All companies provided disclaimers that the tests were aimed for information purposes only. A minority declared compliance with the Health Insurance Portability and Accountability Act. While most companies provided consumers with the opportunity to follow-up with a healthcare professional after receiving abnormal results, this process was not always made clear.
Conclusions: Our results highlight the dissonance between companies marketing their services as being medically-oriented and ToS stating that tests are for information purposes. Companies’ policies were often unclear regarding privacy protections and procedures regarding follow-up with a medical provider. Companies should improve the clarity and transparency of their policies to enable informed decision-making by consumers.
Rebekah Choi – Department of Medical Ethics and Health Policy – University of Pennsylvania; Nina Wei – Department of Medical Ethics and Health Policy – University of Pennsylvania; Louiza Kalokairinou, PhD – ELSI Senior Researcher, Baylor College of Medicine