Health apps need regulation, the question is, how much?

Although the health app market is exploding—with more than 165,000 health and wellness apps available for download—the apps are not necessarily achieving the goal of keeping people healthy. It is undisputed that health apps present significant promise for innovation and the integration of health and technology. However, in the current and largely unregulated health app market, innovation is outpacing oversight and, in many cases, the result is that health apps are not helpful, or, worse, are harming users. In some cases, as University of Michigan Professor Dr. Karandeep Singh put it, “It’s like having a really bad doctor.”


The potential uses for health apps are broad. Developers have designed apps for health uses from the identification of skin cancer to detection of early onset dementia. Other apps (some of which are useful and others that are fraudulent) include those that remind users to drink water, track heart rate, measure sun exposure, treat acne, test urine samples, and monitor sleep. While the level of assistance provided by a reminder to drink water is arguable, the lifesaving potential of some apps is unquestionably dramatic. For example, apps that allow continuous, remote heart rhythm monitoring can help doctors identify whether someone is having a heart attack—turning smartphones into an electrocardiogram (EKG).


A Commonwealth Fund study authored by Singh evaluating the usefulness of 1046 health care related and patient-facing apps determined that 43 percent of iOS apps and 27 percent of Android apps appeared likely to be useful. The study evaluated the apps for usefulness in terms of patient engagement, quality, and safety. While some apps were deemed helpful, many were not. In the worst cases, physicians and regulators are alarmed. For example, Nathan Cortez, a medical technology law and regulation expert at Southern Methodist University’s law school in Dallas, warned, “There’s just no plausible medical way that some of these apps could work.”


There is some regulation of apps. For example, those that perform higher-risk functions—EKGs and blood glucose measurers—require FDA approval before they can be marketed. However, in some cases, there are concerns that the current regulatory protections aren’t enough. Some diabetes apps, for example, don’t prompt users to call 911 if their blood sugar drops dangerously low (low enough to cause a diabetic coma) and instead rewards users for entering data. The emphasis on data entry as opposed to treatment is common. Other apps devoted to depression and post-traumatic stress disorder asks users to log mood states but does not take steps to encourage users to access a suicide hotline if they report feeling suicidal. Or, in more dire cases, for example, Cortez cautioned “If you’re diabetic and your app is misreading your blood glucose levels, you may give yourself more insulin than you need and go into diabetic shock.” Regulators have stopped some fraudulent app developers—in 2011, the FTC fined the developer of AcneApp who claimed that his app could treat acne with the light from an iPhone screen.


At the same time that regulation seems necessary to prevent harm and stop fraud, there is concern that too much regulation would be worse than the status quo because it would stifle important innovation; and the innovation is increasingly significant. The Mental Indicator App (MIa), developed by Virginia Tech students is a prime example of the pace of progress. The app seeks to replace traditional paper-based mental aptitude tests for dementia with a test that can be administered by a user, anytime, and be remotely sent to a physician to allow a more comprehensive, day-to-day analysis of a patient’s mental health. The concern is that if innovation becomes too bogged down in regulation, students like MIa’s developers could be discouraged from undertaking similar groundbreaking efforts.