The reign of the smartphone, with its bells and whistles, is undeniable. As we’ve shared before [Medical Monday: The Importance of Mobile in 2011], by 2015 an estimated 500 million people will be using mobile apps on smartphones. It is clear that companies across industries have embraced the mobile app as a way to reach key audiences, and the healthcare industry is no exception.
So as you can imagine, when the Food & Drug Administration (FDA) announced draft guidance on the use of mobile apps last week, it was met with much fanfare. The guidance focuses largely on defining what is and isn’t considered a mobile medical app, and therefore what would and would not be subject to FDA regulation.
The guidance applies to m-health (mobile health) apps that meet the following criteria:
Apps that are used as an accessory to a regulated medical device
Apps that transform a mobile platform into a regulated medical device
The FDA used the examples of an app that allows healthcare professionals (or HCPs) to view medical images and make a diagnosis or an app that gives smartphone abilities to detect abnormal heart rhythms both would fall under the Agency’s regulation. As Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health noted, the guidance calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.
Luckily, the FDA not only defined what would require regulation, but also described those apps that would not fall within its realm. This includes apps that provide copies of medical textbooks, as well as apps that are used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness and that are not intended to diagnose a specific health condition.
So what does this mean for us as communications professionals? Although it will take time for these guidelines to be finalized and enacted, we can take a cue from the FDA and safely keep this guidance in mind as we begin to strategize ways to utilize mobile apps for our clients. This latest document also provides insight into the FDA’s point of view, as regulators learn how to navigate these ever-changing technologies. It comes as no surprise that we can expect the Agency to base future guidelines upon existing definitions and policies as much as possible, but this will prove challenging as new platforms continue to emerge.
The FDA has given the public 90 days to comment on these guidelines. Are you planning to comment? If so, what are your thoughts?