Will new FDA regulations be the death knell for medical apps?

Do you use a medical app on your smartphone? If so you’re in good company, as millions of people make use of the dozens of apps available on the different platforms – and that number is expected to grow to half a billion users by 2015. That growth is large enough that the U.S. Food and Drug Association is looking to regulate medical apps, and that has some people concerned.

The Washington Times – not known for its love of government regulation – published an Op/Ed piece warning of the chilling effect such regulations could have on the medical app ecosystem. Joel White’s not-so-subtly-titled piece “FDA’s assault on mobile technologies” makes the case that if the FDA chooses to regulate smartphone apps as “medical devices,” all of the innovation and vibrancy of the market may be squeezed out. In particular, White points out that the FDA takes an average of three years to approve medical devices, with an average cost of $75 million dollars. The costs of such a lengthy approval process could lead to a slowdown in medical app development, the end of free apps (as businesses pass their costs on to consumers), and the exodus of small app developers to other, non-medical fields.

That sounds pretty terrible, but luckily it turns out the FDA doesn’t want to regulate your copy of WebMD. A quick visit to the FDA’s website reveals their actual intent, including a copy of the proposed guidelines, “that outline the small number of mobile apps the agency plans to oversee”. So what type of apps does the FDA want to regulate? As luck would have it they provide examples:

• Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis.


• Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

 So you there you have it; the FDA doesn’t want to regulate your prescription tracker, your calorie counter, or your copy of the Merck manual that you got from your favorite app market. They want to regulate apps used by medical professionals doing things like looking at X-rays, or checking to see if you’re suffering a heart attack. The non-mobile-app versions of those tools are already regulated (and so the costs are already built in) and the FDA is trying to make sure that mobile platforms don’t become a loophole for professional medical technology companies.

We don't want to downplay the importance of the issue of industry regulation - we know it's a topic that is important to many of you. But White's article casts a very broad net, seeming to imply that all medical apps could be within the FDA's regulatory scopes, and luckily it turns out that's just not true.

If you’re of the political-activist persuasion and are concerned about how much (or how little) the FDA intends to regulate mobile apps used by medical professionals, by all means follow the source links and let your voices be heard through the appropriate channels. But for those of you who were concerned that your copy of Epocrates was going to be yanked off the market: Crisis averted.

sources: Washington Times via Textually; FDA, Proposed Guidelines