The Food and Drug Administration (FDA) recently released guidance highlighting just how hands off they intend to be when it comes to health apps.
When the FDA released its first guidance on which health apps it intended to regulate, it quickly became clear that they intended to focus on a pretty narrow part of the market. In general, the FDA has used a risk-based approach, trying to focus on health apps & devices that could cause harm if they fail to work as advertised.
In that original guidance, they alluded to general wellness and health apps as areas in which they would exercise enforcement discretion (i.e. not apply oversight to). In this latest guidance, however, they really define what kinds of health apps and devices fall into that category. And it’s a pretty broad, and in some areas seemingly arbitrary, group. Here’s how they define this group:
A general wellness product…has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that
healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
That category includes many health apps that I think most people would agree are probably outside the purview of the FDA – weight loss apps and activity apps for example. These health apps are really aimed at promoting generally healthy lifestyles. Even though we frequently recommend them to people with a variety of chronic conditions, they aren’t necessarily intended to treat, say, diabetes or heart disease.
Other examples included may be more surprising like brain training apps or devices to monitor heart rate or even collisions during athletics and exercise. It may be confusing, in particular, given recent action by the Federal Trade Commission (FTC) against brain training company Lumosity or developers of an app that provided “vision training” for athletes. That discrepancy though highlights the importance of “intended use” to the FDA. For example, an app that claims to help you lose weight is ok per this guidance but an app that claims to “treat” obesity is not. On the other hand, the FTC is really looking at “truth in advertising,” or whether the health app does what it claims to do. And while that’s important and useful, it’s an approach that’s inherently limited to making an example out of a few bad actors in a very large and rapidly growing market.
And while the evolving regulatory rules may seem confusing to most clinicians, this new FDA guidance highlights more so than ever the need for clinicians to take the lead in rigorously evaluating health apps so that we can make informed recommendations to our patients.