With millions of apps capable of performing an equally immense number of tasks, it may seem like smartphones can do just about anything. And while app manufacturers would certainly prefer that users believe wholeheartedly in smartphones’ universal utility, inconsistencies in that story arise when comparing some apps’ performance to reality—especially the over 156,000 apps claiming the ability to monitor and relay health-related info.
These apps exist largely unvetted on the market, subject to little or no FDA regulation. Recently, in an attempt to reign in questionably branded health apps, the New York Attorney General’s Office settled a case involving three apps that purported to measure users’ heart rates through smartphone cameras. The apps, which included Runtastic, Cardiio, and My Baby’s Beat, agreed to pay a combined $30,000 penalty, change their marketing rhetoric, and update privacy policies to better inform users of data collection practices.
So far, one of the FDA’s only attempts to stem the overflow of dubious health apps into online marketplaces was in 2015, when it introduced legislation separating health apps into distinct groups. The first describes apps that offer a clear medical service, such as measuring urine content or diagnosing melanoma in moles; these apps are subject to clinical testing.
“Wellness” apps that measure things like sleep, steps, or calories fall into another group,and they are completely free of FDA oversight. Apps that dodge the FDA’s jurisdiction include those that may perform as medical tools (i.e. the FDA regulated category) but don’t necessarily market themselves that way. In fact, any app that doesn’t fall cleanly into the two FDA specified categories will likely escape government notice.
The government’s rationale for this is that if an app isn’t going to trick most people into believing a fatal misdiagnosis, it’s probably not worth the effort to regulate it. Health lawyer Bradley Merrill Thompson supports this strategy, stating that “Consumers will shut down any business where the truth is easily discoverable.”
A few apps that managed to slip by unpursued by the FDA drew the attention of another government agency. The Federal Trade Commision took it upon itself to fine a few app makers guilty of wild claims, forcing them to rebrand products which previously asserted an ability to perform such wonders as identifying cancer, or restoring lost eyesight.
Recently, however, the FTC has lightened its pursuit of fraudulent health apps. Ex-Bureau of Consumer Protection Head Jessica Rich, who left the agency earlier this year, was a primary force behind its previously hard stance; Rich had stated “if consumer health data is used for unanticipated, harmful purposes, consumers could lose confidence in the health IT sector.”
In recognition of the pressing need for greater oversight, the FDA recently established a digital health unit under the purview of its Center for Devices and Radiological Health to apply policies and facilitate product approvals. The FDA has been very proactive in its thinking, and hopefully, other global regulatory agencies take similar steps to protect both consumers and healthcare providers.