Know Thy Health App: Physicians, Government Warn Some May Be Harmful
With the rapid influx of thousands of apps available in Apple’s App Store and Google Play, doctors have raised major concerns about the safety of those purporting to track symptoms and provide preventive screening information for diseases and medical conditions.
While these apps oftentimes carry the disclaimer that they are for entertainment purposes only, physicians are concerned that people who download medical apps will take information provided by the apps as seriously as they would a diagnosis from their own doctor. The software and devices purport to measure, among other things, blood oxygen levels, sugar levels, cholesterol levels, sleep quality, heart rate, and the presence of conditions such as epilepsy or jaundice.
For example, the app Instant Blood Pressure, as the name suggests, is supposedly capable of taking one’s blood pressure through the user’s iPhone. The app, at $3.99, encourages its user to determine his or her own blood pressure by pressing the iPhone against his or her chest. Unfortunately, according to medical doctor and director of the Scripps Translational Science Institute, Eric Topol, these apps have not undergone the testing required by generally accepted reference standards.
While the app concedes that it is not cleared by the FDA, not only is the disclaimer not readily observable, but the app purports to use a patent-pending process developed by researchers at Johns Hopkins University; a claim which incurred the wrath of of the university itself, which sent its developer a cease-and-desist letter, insisting that the app no longer invoke the name of the university. Another app called the Pulse Oximeter, readily available in the iTunes Store, carries with it the emphatic disclaimer that it is not to be relied upon for medical use. According to Damoun Nassehi, a physician and chief executive of digiDoc Technologies, which developed the app, “We always say that people should not use it to monitor their diseases…I don’t want them to rely on our app in any way.”
Fortunately, the government is taking action to protect users of these apps from potentially misleading claims, intervening if an app is deemed inadequate relative to standard regulatory requirements. In one instance, the Federal Trade Commission penalized AcneApp with a fine for claiming to be able to treat acne with light from an iPhone. It has since been removed from the iTunes store. The FDA defines these mobile health apps as “medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.”
An admittedly small subset of such medical apps have been approved by the organization. WellDoc Diabetes Management system is one of these. It allows patients to upload blood glucose readings and enjoy real-time feedback from physicians or other members of WellDoc’s research team. During a year-long clinical trial, the app was found to produce improvements in medication adherence, exercise and diet in its users. Other FDA-approved apps can be found on the organization’s website.
On the other hand, the FDA is cracking down on apps which either do not meet accepted medical standards for what they claim to accomplish, or fail to provide adequate disclaimers in cases where the app is purely for recreational purposes. According to Christopher Rush, a former FDA investigator and current president of FDA Quality and Regulatory consultants, products which purport to measure vital signs require clearing by the FDA.