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The Dangers of Mistaking Health & Wellness Apps for Medical Grade Tools

By Daniel Piekarz, Vice President of Business Development, Life Sciences for DataArt

The title of a recent mHealth article reads “Health apps ‘useless’ says health app expert”. That expert, George Margelis, received a bit of criticism for publicly stating what, from my experience, is an honest statement regarding how many doctors feel about health apps and wearables. Is mHealth useless to doctors, or are most doctors not seeing the big picture? I do not think Dr. Margelis meant that mHealth as a concept, or that all mHealth apps are useless to doctors. According to the New England Journal of Medicine, there were over 97,000 mHealth apps available on the market last year. Some experts suggest that the mHealth industry is exploding and expect to see 1.7 billion users by 2018, according to The Journal of mHealth. With all of the companies jumping into mobile health, and the huge number of users, there is obviously more value here and it is not all hype. 

With over 97,000 apps on the market today, how many of them actually provide medical benefit? Not a whole lot of them, unfortunately. As of today, the FDA has only reviewed and approved a very small number of mHealth applications, between 100-150. The FDA’s stance is that it intends to review any mobile apps that are to be used as an accessory to a regulated medical device, or to transform a mobile platform into a regulated medical device. There are a number of apps that have passed FDA approval, offering a wide variety of functionality, from diagnostic imaging, electrocardiograms, glucose monitoring, blood pressure monitoring, to ophthalmoscopes. Yet there are thousands and thousands of apps that claim to offer all sorts of medical diagnoses for diabetes, blood pressure, identification of skin cancer, and many other areas without FDA approval.

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How is it that these companies are able to release thousands of applications to handle all sorts of medical conditions marketed directly to patients without any oversight? Let’s take a look at Apple’s discussion with the FDA regarding wearables, as it gives a great example of the mHealth loophole. According to the FDA, “A glucometer, for example, may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition,” but not to treat diabetes. A quick peek at the disclaimer for Doctor Mole’s melanoma identification app specifies that it is for educational purposes. Other apps that seem to provide medical diagnosis specify that they are for entertainment or fitness. Apps like the blood pressure monitoring app I just downloaded say nothing about their intended use, but according to the app, I have low blood pressure and Bradycardia. This is a gross misdiagnosis as I know that my blood pressure is usually slightly elevated. Anyone who is to use such an app to keep track of their blood pressure may find themselves assuming they are fine when in fact they have dangerously high blood pressure levels.  

While Dr. Margelis’ comments may have been overly harsh, there is a ring of truth in what he is saying. A quick search on the internet for the best mHealth apps show that the majority of the apps available are focused on tracking fitness and nutrition. While there is obvious benefit to the users of these apps, most doctors are not going to be interested in monitoring your Fitbit data. The best mHealth apps that focus on treating or monitoring medical conditions do provide real clinical utility, but they are a needle in a haystack compared to all the inaccurate apps clogging the mHealth industry. Even worse than the fact that most mHealth apps are useless to doctors, is the fact that some of them may be dangerous to users who assume they are getting accurate information from the apps they download.  

So the real question is how do we control the mHealth industry and reduce the potential risk to end users without killing the rapid innovation that is hidden within? The FDA does not have the bandwidth to test and regulate every app that is released, but some level of regulation that makes sure app developers make it obvious if the app is medical quality (FDA approved), for education, fitness, or entertainment would be a great start. For now, the mHealth industry is buyer beware though.

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  1. Nice piece Daniel and I couldn’t have said it better. Not necessarily personalized medicine is it? Need some safety and security built in, or this in-and-of-itself will become the next global pandemic.

  2. Thanks Dan – Well written and explained. This very issue has had me concerned as mHealth and the future Health IoT developers and investors rush towards building an app/device and building a company to subsequently sell. Ultimately, will the app be beneficial, or might it potentially be harmful to actual or perceived health of the end-user? Your comment “how do we control the mHealth industry and reduce the potential risk to end users without killing the rapid innovation that is hidden within?” is well stated.

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