Developers, Marketers Relieved Over FDA Guidance on Mobile Medical Apps

By Nancy Meyer

Now that the U.S. Food & Drug Administration (FDA) has issued its final guidance on how it will regulate health-related smartphone applications, the marketing and developer community have heaved a collective sigh of relief.

Relief because, in its own words, the FDA said it will limit its focus on the small niche of apps that can be considered “mobile medical devices” that pose the greatest risk to patients. The definition is a narrow one.

In its statement, the agency defined those apps as ones that have the following characteristics:

• Intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet
• Transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack

This, in effect, amounts to a small sliver of the thousands of apps released each year. According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. These users include health care professionals, consumers, and patients. The FDA said it has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.

Adding to the developers’ relief, the FDA further said it clearly “does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors such as the iTunes App store or the Google Play store.”

What pharma marketers and developers need to know: the new rules are not stifling creativity, but paving the way for even more healthcare apps. Just be aware that if your team comes up with an idea for the next great app that looks and smells like a medical device and helps diagnose or manage the user’s health, you should partner with an app developer who’s already been approved by the FDA. It’ll make the development and approval process much easier.