Mobi Health News came out with an article a few days ago reporting that the FDA had issued a draft guidance about the regulation of mobile medical apps. The highlights of this article confirm the rumors of what some of us have been talking about in hush-hush tones for some time now, that lots of medical applications that have gotten quite promiscuous in the healthcare provider segments, might have to go through some sort of yet-to-be defined FDA regulatory process. What that is, or how it will work are good questions. Working at a company that produces FDA 21 CFR Part 11 compliant software (for clinical trials), we go through an extensive validation, testing & QA process for our software to document and prove that our system does what it claims to do. This doubles our development time, but keeps us a rigorous and validated software technology provider. I’m not sure if our platform would also be subject to FDA regulations as a health-app, since Mi-Forms is used in several hospitals like Sutter Health, Children’s Hospital Boston, Cooper Clinic and more, so we stay tuned as much as you do to find out more…excerpts from the Mobi Health article are below:
As part of its draft guidance the FDA, of course, had to sketch out its very particular definition of a mobile medical app. The agency broke the definition into three parts: mobile platform, mobile app, and mobile medical application. A mobile platform is a commercial off-the-shelf computing platform “with or without wireless connectivity” that is handheld. Mobile apps are software that can be run on a mobile platform or a Web-based software application that is designed for the mobile platform. Finally, a mobile medical app is one that meets the definition of “device” according to the FD&C Act, but for this set of draft regulation it also must be “used as an accessory to a regulated medical device” or it must “transform a mobile platform into a regulated medical device.”
Among the apps that fall outside of the FDA’s definition of a mobile medical app, there may be some that do fall under the broader definition of a medical device. “Right now we are only interested in those mobile medical devices that fall into this definition. We are starting off with the very small tip of the pyramid,” Bakul Patel, policy advisor at the FDA’s CDRH, told MobiHealthNews. “The bottom of the pyramid might include health and wellness apps. The middle of the pyramid may include some health and wellness and pure medical apps. At this time, however, those are not of interest.” That’s not to mean the FDA won’t regulate these other apps in the future.