Martinez-Martin N, Kreitmair K. (2018). Ethical issues for direct-to-consumer digital psychotherapy apps: Addressing accountability, data protection, and consent. JMIR Mental Health. 5(2): e32. doi: 10.2196/mental.9423
Researchers examined ethical issues related to direct-to-consumer (commercially available; DTC) digital mental health services, highlighting issues surrounding data protection, accountability and liability, user safety, and informed consent. There is little regulation on how DTC digital mental health services can use information from consumers. DTC digital mental health services may sell information, share it in ways that put consumers at risk (e.g. sharing with employers), and analyze data in ways unknown to the consumer (e.g. using machine learning). Similarly, there is little guidance on the extent to which services are obligated protect consumers from harm. DTC digital mental health services vary widely in how rigorously the effectiveness and safety of the services have been evaluated. Where clinical researchers focus on evaluating effectiveness and safety of services, commercial developers put more emphasis on user engagement. Collaborations between clinical researchers and commercial developers may help maximize the effectiveness, safety, and engagement of DTC digital mental service. Finally, researchers highlight that user agreements are often written in complicated legal language that could be hard for users to understand and are often left unread, limiting the utility of these agreements in representing informed consent. Simplified user agreements with comprehension aids (e.g., videos, interactive elements) can address several ethical issues by providing information about data collection and use, benefits and risks to use, and information about adverse events. Of note, researchers mention that these ethical concerns are more salient in the United States because consumer protection laws are stronger in the European Union.