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21 Houston Journal of Health Law and Policy 9 (2021)


As the coronavirus pandemic swept across the globe in April 2020, the US Food and Drug Administration (FDA) made an unusual decision. The agency announced that it would relax its enforcement of compliance rules for “digital therapeutics”—smartphone apps designed to address mental health disorders. The measure was a response to widely reported upticks in symptoms of anxiety, depression, and substance abuse brought on by the pandemic. As an added benefit, the agency explained, digital therapeutics could promote social distancing by removing patients’ need to visit health care providers.

This essay explores the possible lasting effects of the FDA’s temporary suspension of its rules. After the FDA put its waiver into effect, makers of unapproved apps branded as “wellness” tools rebranded their products as medical interventions. That rebranding could harm patient privacy. Many “wellness” apps that have rebranded themselves as health interventions operate outside of the confidentiality and privacy laws that bind therapists and other healthcare providers. Many of these apps share user data more liberally than health care providers. The FDA’s temporary suspension of its enforcement could provide a glut of highly sensitive information to app developers and the partners they transmit user data to.

The FDA’s suspension of its rules could also suppress consumer confidence and, by extension, future innovation investments. Clinical studies do not back many wellness apps’ recent medical claims. If some of these apps are ineffective, consumers may categorically lose confidence in app-based mental health interventions—including treatments that are effective. Suppressed consumer demand could lead to a kind of mental health app “winter”—a period in which investment and research dry up. This possibility highlights the relationship between innovation and consumer behavior. Regulations on advertising could have an unintended impact on innovation.

This essay begins with an explanation of how digital therapeutics fit into the history of mental health treatment. To anchor these concepts, I begin by offering a short introduction to the history and treatment of anxiety disorders—the most common class of mental health disorders in the United States. I then explain how the FDA regulates the marketing of mental health apps. Through before-and-after images of company websites, I show how the FDA’s 2020 suspension enforcement appears to have led app makers to rebrand their devices as medical interventions. Drawing on original interviews, press reports, and legal analysis, I postulate on the potential long-term consequences of the FDA’s temporary waiver.