Direct-to-Consumer Genetic Testing Data Privacy: Key Concerns and Recommendations Based on Consumer Perspectives.

Rachele M Hendricks-Sturrup,Christine Y Lu

doi:10.3390/jpm9020025

Abstract

Direct-to-consumer genetic testing (DTC-GT) companies are engaging health consumers in unprecedented ways and leveraging the genetic information they collect to further engage health companies. This has produced controversy about DTC-GT consumer expectations, standards, and perceptions of privacy. In this commentary, we highlight recent events involving DTC-GT companies and controversy about privacy that followed those events and discuss recent studies that have explored DTC-GT consumer concerns about privacy. We discuss DTC-GT company standards of upholding consumer privacy and the general accessibility of DTC-GT company terms of use agreements and privacy policies that are written at reading levels above that of many consumers. We conclude that broader discussions and more research are needed to identify DTC-GT consumer concerns about and expectations of privacy. We anticipate that our recommendations will advance discussions on consumer privacy expectations and protections in an era of increasing engagement in DTC-GT.

Highlights

Direct-to-consumer genetic testing (DTC-GT) companies are engaging health consumers in unprecedented ways and leveraging the genetic information they collect to further engage health companies
Next-generation sequencing has ushered in this new market for individuals who are eager to understand how their genetics influence their likelihood of manifesting a diverse array of phenotypes
From a health care professional perspective, DTC-GT is concerning; one study shows that the mere provision of genetic health risk information without a health care intermediary can lead to potential psychological effects in DTC-GT consumers [1]

Summary

Controversy over DTC-GT Company Activities

Using the latest advancements in next-generation sequencing technology, DTC-GT companies provide consumers with genealogy or ancestry services; DTC-GT companies have seamlessly entered the health care market to give consumers health reports that interpret or infer disease risks or predispositions based on the consumers’ genetic information. Med. 2019, 9, 25 timely regulation of and oversight over the DTC-GT health market An example of this struggle was seen in 2013 when the FDA warned DTC-GT company 23andMe to scale back a massive marketing campaign which sought to promote 23andMe’s genetic health risk testing services without prior FDA approval [3]. Media controversy about consumer privacy followed a three-year collaboration that ended in 2018 between DTC-GT company Ancestry and Calico, a Google spinoff company [4,8,9] This collaboration granted Calico access to Ancestry’s databases, tools, and algorithms to analyze and investigate the role and influence of genetics across families that experience unusual longevity [10,11,12]. Media controversy about consumer privacy followed GlaxoSmithKline in 2018 when it announced that it would leverage information from 23andMe’s databases to identify and select pharmaceutical targets [7,13,14,15,16]

DTC-GT Consumer Comprehension of Terms of Use Agreements and Privacy Policies

Findings

Consumer Concerns and Perceptions about DTC-GT Information Privacy