Today’s smartphone is a camera, a GPS system, an e-reader, a game console and even a remote car starter. Why can’t it also be a blood glucose meter, X-ray viewer, stethoscope or diagnostic aid?
That’s the idea behind many of the 17,000 health-related mobile applications available in major app stores, with nearly half aimed at health care professionals. Research consultancy research-2guidance projects that 500 million smartphone users will have used a mobile health application by 2015. Today, 80 percent of doctors use smartphones and mobile medical apps in their everyday practice, according to an industry report from physician recruitment firm Jackson & Coker.
In July, the Center for Devices released draft guidance on mobile medical apps and called for comments on the document for a period ending Oct. 19. A public workshop on the draft guidance was held Sept. 12-13. Patel says the goal of the document was to provide clarity among those who develop, use and invest in health-related mobile apps while supporting innovation.
Patel says finalized FDA guidance will aim to be clearer about what devices fall into a particular category, in response to comments. As for mobile apps that fall outside the guidance, the agency plans to monitor them and determine whether additional actions are necessary. It strongly recommends, however,that the makers of any mobile app that may qualify as a device follow the FDA’s Quality System rules, which specify good manufacturing and design practices.