Reassessing Low Risk

Abstract

Health apps have been praised as having the potential to solve seemingly intractable problems with the health care system, improve population and individual health, and democratize medicine. With health apps for everything—from mental health to menstruation to dermatology—the possibilities to disrupt and improve health indeed appear boundless. But there is a catch: the vast majority of health apps are not medical devices or health care at all, at least as far as regulation is concerned. But whether an app is “unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” may be less obvious from the consumer’s perspective. That these products exist side-by-side with, look like, and even perform similar functions to apps that are medical devices and telemedicine tools in smartphone app stores only exacerbate this confusion and may even result in consumers viewing low-risk wellness apps as perfect substitutes for more effective, evidence-based products. This Article considers the convoluted market that spans everything from highly regulated health apps to worthless “digital snake oil.” It argues that current approaches to health app regulation result in market failures in which consumers cannot tell the difference between products that help and those that harm. It concludes with recommendations for voluntary disclosures to address the information asymmetries that create a health app market for lemons.