Direct-to-consumer (DTC) laboratory tests -- for the thyroid, hormonal biomarkers, or diabetes and hemoglobin A1c, for example -- often had unclear terms of sale and vague privacy policies, a qualitative study showed.
Of 21 U.S. companies that offered DTC lab tests, less than half declared compliance with the Health Insurance Portability and Accountability Act (HIPAA), and less than a quarter specified protections for biological samples, according to Louiza Kalokairinou, PhD, of the Baylor College of Medicine Center for Medical Ethics and Health Policy in Houston, and co-authors.
More than half stated consumer data potentially could be used for research purposes, either internally or through a third party, Kalokairinou and colleagues reported in a research letter.
Some companies said other risks may occur, including inaccurate test results or the possibility of receiving unwanted information that could cause anxiety or stress. Only four of the 21 companies said consumers could ask to have their personal information deleted.
The DTC lab testing market is projected to be worth about $2 billion by 2025 and includes both start-ups and established corporations like and . Some tests involve swabs, samples, or finger-pricks at home; others require venipunctures performed at walk-in labs.
The tests raise several ethical questions, Kalokairinou observed. "These include concerns about liability, privacy for consumer data and protection of samples, and adequate follow-up with providers," she told 鶹ý.
"Often, the fine print says that these tests are not meant to inform healthcare decision-making, which contradicts the marketing of many of these tests," Kalokairinou pointed out.
Terms of sale and privacy policies often lacked specificity and limited a company's liability, she noted. "This, in effect, shifts responsibility to the consumer to evaluate the accuracy and usefulness of the information provided," Kalokairinou said.
"These policies are not uncommon for consumer goods," she acknowledged. "However, health-related products such as lab tests confer a greater level of risk to consumers, as they may form the basis of subsequent healthcare decisions and may involve particularly sensitive personal data."
"In conventional healthcare settings, many of these risks to consumers are mitigated by the doctor-patient relationship, which is usually absent in a DTC context," she said.
Kalokairinou and colleagues assessed 18 types of health-related DTC tests from 21 companies in their study. Thyroid tests, diabetes and hemoglobin A1c tests, and panels of biomarker and hormone tests marketed for women's and men's health were most commonly offered. Also prevalent were tests to assess vitamin levels, sexually transmitted infections, fertility, heart health, inflammation, or cancer.
All companies provided disclaimers that test results did not constitute medical advice. About half (48%) clarified that their services did not establish a physician-patient relationship. Nearly all (95%) included disclaimers of warranty and limited liability about their services and website information.
While most companies had privacy policies for data they collected about website users and for test results, some had less stringent policies limited to website data only.
Most companies offered an option to follow up with a healthcare professional, saying the follow-up would be initiated by the healthcare professional -- often a physician, but at times, a nurse, counselor, or health coach. Most companies didn't clarify whether the consultation would be by phone, email, or video chat.
"Given the sensitive nature of information provided by consumers to DTC laboratory testing companies and the unclear scope of many companies' privacy policies, there are concerns about whether data might be used for purposes beyond those that consumers anticipate," Kalokairinou and co-authors wrote.
"Moreover, the lack of clarity regarding health care professional follow-up may lead individuals to seek additional counsel from their primary care physicians, thereby creating challenges regarding interpretation of results and potential legal liability," they added.
The study was limited to companies that provided DTC lab tests analogous to tests available in traditional health care settings, the researchers noted.
"To our knowledge, this is the first empirical study to assess the terms and conditions and privacy policies of companies offering DTC lab tests, outside of genetic tests," Kalokairinou said.
Disclosures
This study was supported by the NIH.
Researchers reported no conflicts of interest.
Primary Source
JAMA Internal; Medicine
Kalokairinou L, et al "Policies of U.S. companies offering direct-to-consumer laboratory tests" JAMA Intern Med 2023, DOI: 10.1001/jamainternmed.2023.4726.