Many people assume that companies offering direct-to-consumer lab tests protect their privacy just as a doctor’s office would. However, this is not necessarily the case.
“Many of these tests are controversial among scholars and physicians, as they raise concerns about, among other things, liability, privacy for consumer data, and protection of samples. Despite these concerns, however, very little is known about how these companies operate in practice,” says Louiza Kalokairinou, PhD, ELSI senior researcher at Baylor College of Medicine’s Center for Medical Ethics and Health Policy.
Kalokairinou and colleagues analyzed 18 types of health-related DTC tests from 21 companies, including thyroid, diabetes, and hemoglobin A1c tests, and tests to assess fertility, heart health, or cancer.1
A group of researchers found that most U.S. companies that offer DTC lab tests are not compliant with patient privacy regulations and acknowledge that consumer data could be used by third parties. Less than half of the 21 companies analyzed declared they were compliant with the Health Insurance Portability and Accountability Act. Less than one-fourth of the companies specified protections for biological samples. More than half stated that consumer data potentially could be used for research purposes — either internally at the company or by a third party. “Many of the policies were vague, especially with regard to the protection of consumers’ data, the fate of biological samples, and the potential of using this information for other purposes, such as research,” says Kalokairinou.
All of the companies provided disclaimers stating that test results did not constitute medical advice. About half of the companies stated that their services did not establish a doctor/patient relationship. Most companies offered consumers the option to follow up with a healthcare professional in case of abnormal test results, but without giving details on how it would happen. For instance, companies did not spell out who would initiate the follow-up and what form of communication people should use. “This lack of clarity could lead individuals to seek additional guidance from their primary care physicians, potentially creating challenges regarding interpretation of results and legal liability,” says Kalokairinou.
Many of the companies’ marketing materials imply that the products provide medical information. However, the fine print of the terms and conditions state that the tests are solely for informational/education purposes. “In addition, the sensitive nature of information provided by consumers raises privacy concerns about whether data might be used for purposes other than those that consumers anticipate,” adds Kalokairinou.
- Kalokairinou L, Choi R, Wei NY, et al. Policies of US companies offering direct-to-consumer laboratory tests. JAMA Intern Med 2023;Sep 18:e234726. doi: 10.1001/jamainternmed.2023.4726. [Epub ahead of print.]
