Medical Apps: Can You Regulate the Ill-Defined?

There has been lots of bickering about medical apps recently and it is to do with regulation. Everyone wants their voice to be heard, from clinicians, developers, to individual patients. Many argue that not enough is being done to regulate medical apps. Developers would like more guidance but at the same time want the freedom to innovate. So what is the right answer? And how many of these medical apps are we dealing with? I decide to do a quick check on the Apple iTunes store to find out. Sure enough, there’s an app that can cater for pretty much every medical need. As I scan through the page, I can’t help noticing that there is no real categorization for these apps and it’s hard to distinguish the quality apps from all the clutter.

The medical apps market is huge. Apps can identify pills, perform medical calculations, and screen for diseases, among many other functions. And with new medical apps coming out every day it is only set to get bigger. More people than ever are self-diagnosing.  According to Susannah Fox, associate director of digital strategy for the Pew Internet Project, 31% of cell owners and 52% of smartphone owners have used their phone to look up health or medical information, while 19% of smartphone owners have downloaded an app specifically to track or manage health.  Moreover, a recent U.S. survey found that a quarter of Americans said they trust symptom checker websites, symptom check mobile apps or home-based vital sign monitors as much as they do their doctors.

Most of us are guilty of ‘googling’ or checking apps to see if our gut instincts about something being wrong are correct. But with literally thousands of medical apps to filter through, how do we know which ones are credible? Critics are blaming the lack of regulation in medical apps, saying that the guidelines for developers by the FDA are too ambiguous. In a way, one can sympathize with the FDA’s position. The FDA is under pressure to define clearer boundaries for app developers but if they come down too heavy on regulation, then they may come under fire for stifling creativity and innovation. In other words, they are damned if they do and damned if they don’t.  

Then there are those that say there is not enough medical input in the app development stage. Researchers at Ohio State University analyzed 222 pain-related smartphone apps available for Android, iPhone and BlackBerry devices. Of the apps that the researchers reviewed, a third had no input from a healthcare professional. For another third, it couldn’t be determined whether there was professional input. 27% of the apps had obvious input from an MD or DO, and 8% had input from a non-physician health care professional.

These are worrying statistics but it got me thinking – how can we begin to regulate when there is no standard definition of what a medical app actually is? When I am looking for a particular medical app, what should I be looking for in its description to give me assurance that the app is trustworthy? Happitique is attempting to solve this problem by its introduction of a certification program. The idea is to have all apps assessed both for technical proficiency and also for content. This should help in giving assurance to users and organizations that the apps are what they say they are. While I applaud their efforts, a quick look at their website shows it is hard to find a solid definition of a medical app. Apple is tightening restrictions on medical app developers by rejecting new medical apps that include drug dosages. But I look at the iTunes store and it’s the same story – about 20,000 apps to get through and no definition anywhere on how they have classified the apps.

Whilst the critics fuss and fight over tighter regulation, there is a larger point that we all could be missing. It has been said that a closer examination of these medical apps show a serious bias towards the consumer. According to Naomi Fried, PhD, Chief Innovation Officer at Boston Children’s Hospital, “80% of the health apps being released are for the consumer.” The remaining apps that are actually clinical in nature are just existing websites and tools being turned into a more user-friendly format. Basically, very few truly innovative apps are being created.

Whilst the developers are focusing on creating these apps for the consumer market, the consumers themselves appear to be disillusioned with the medical industry.  According to Harry Greenspun, senior advisor for healthcare transformation and technology, “Patient expectations for mobile healthcare aren’t necessarily in line with what the healthcare system thinks they are.” He goes on to say, “People want convenience, proximity and quickness, and they rate their doctors on results, not quality.”

We could argue till we are blue in the face about why there needs to be tighter regulation, but until we make it clear what a medical app actually is, we aren’t going to get anywhere and do what we should be doing: developing truly innovative apps. We need to go back to the drawing board.  


By Ayesha Salim, Copywriter, IDG Connect


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Ayesha Salim

Ayesha Salim is Staff Writer at IDG Connect

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