While studying at a university with top-notch engineering programs, I noted that many of my classmates pursued internships—or even founded start-ups—involving mobile applications. It is not surprising that so many engineers are interested in this emerging field, considering that more than half of Americans now own a smartphone. What really caught my attention is that many of these applications had to do with health, in one way or another.
There are, according to some estimates, about 40,000 mobile applications targeting health concerns, and they vary widely. Some perform simple functions, such as keeping track of the number of calories you consume or burn off. Others require you to input your symptoms and then suggest possible diagnoses. Still others measure your vital signs (pulse, blood pressure and respiratory rate) or analyze a urine sample.
But can these apps be trusted in terms of accuracy and privacy? The Food and Drug Administration (FDA) says maybe not.
In July, 2011, the FDA drafted guidelines on mobile medical apps and opened them up for public comments. It recently released the final guidelines, which exclude the majority of health-related apps from FDA purview and calls for the review only of those that present greater user risk if they fail. Included are two basic types of apps: those that are to be used as an accessory to a regulated medical device (for example, an app that allows your doctor to diagnose hypertension via data stored on a smartphone or tablet) and those that turn a smartphone or tablet into a medical device, like an app that measures blood pressure.
Prior to the late September release of the guidelines, the FDA had already started regulating some mobile apps. A company called Biosense Technologies Private Limited, located in Mountain View, CA, released an app called uChek Urine analyzer in February 2013. It was designed to analyze the colors on a urine-soaked strip and report to users the glucose, protein, leukocytes (inflammatory cells), blood and other constituents of their urine.
The app was initially distributed through Apple’s iTunes store, and it looked like a successful product launch. But a few months later, the company received a “wait, not so fast” letter from the FDA. Because the app is used to analyze and interpret the test strip, the agency informed Biosense that it needed to obtain FDA clearance for the device as a medical device. The app is now registered under FDA as a class I device. Consumers will once again be able to purchase the kit and app starting in December.
I agree with the FDA that all devices and apps that collect or interpret patient data should be subject to more scrutiny. If not, we will surely see many low-quality medical apps that offer inaccurate results—sometimes dangerously so. For example, a study on four apps that evaluate skin cancer found that three of the four apps were unreliable, incorrectly classifying at least 30 percent of melanomas as unconcerning, according to a group of researchers from the University of Pittsburgh.
I believe that health apps can have value; they can help promote health and healthy behaviors, such as aiding people in their attempt to quit smoking. I also believe that the mobile app developers deserve to know what rules they need to follow before releasing their products.