Federal government steps in
But that's starting to change. In May 2012, the FDA approved the first iPhone-enabled blood glucose meter for sale at retail. The iBGStar Diabetes Manager allows users to analyze blood glucose levels and insulin injections and share that information with healthcare providers. Another company called Philosys recently filed for FDA approval for its GMate Smart app, a blood glucose monitor that works with the iPhone and iPad.
Mobile apps for diabetes management are a hot spot in the app world. A 2012 study from the eHealth Initiative found that diabetes management apps for diabetes have increased by nearly 400% over the past three years—from 60 smart phone apps to more than 260 in 2012—making it "the fastest-growing sector of the patient-centered tools industry."
With the floodgates now open, the FDA is working to craft a framework for regulating and approving mobile healthcare apps. In July 2012, the FDA issued a draft guidance document for Mobile Medical Applications as part of its effort to "help clarify the types of mobile apps to which the FDA intends to apply its authority."
In its draft guidance overview, the FDA noted that "as is the case with traditional medical devices, mobile medical apps can pose potential risks to public health" but that they may pose "additional and different risks due to the unique characteristics of the platform."
For example, it noted that "the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platforms" and that it intends to "take these limitations into account in assessing the appropriate regulatory oversight."