12 September 2012The mobile health industry has a problem: It has grown too quickly. Consumers can now download medical apps for at-home monitoring of just about any obscure ailment, and apps for general wellness, diet, and fitness are proliferating. According to one recent count, the iTunes app store now contains 13 000 health and wellness apps.

But the public health agencies, big pharmaceutical companies, and start-ups that have pushed out apps in the past few years have outpaced U.S. government regulators. While its assumed that some medical apps are subject to regulations, the U.S. Food and Drug Administration (FDA) has not defined the scope of its oversight and has issued few enforcement actions.

Thats about to change. The agency is expected to finalize guidelines within the next two months for medical apps, more than a year after releasing draft guidelines. For the industry, the expected rules bring both relief and trepidation: App makers are eager for clarity on how much red tape theyll encounter in the future, but theyre also nervous that overly broad rules will stifle innovation.

While waiting for the final guidelines to be published, we surveyed notable industry figures on what theyd like to see in the rules. Here are their top-five requests to the FDA.

1. Clarify the difference between a medical app and a wellness app.

The FDA has the authority to regulate medical devices and software that diagnose or treat disease, but not those that simply contribute to general wellness. However, the line between these two categories has been blurred as people have gained a better understanding of how daily life choices contribute to disease risk.

Take the example of a workout-tracking app, says Brad Thompson, a health-care lawyer with the firm Epstein Becker & Green and general counsel for the mHealth Regulatory Coalition. An app that records how many miles I run in a given week is just an exercise app, he says. But if that same app says, If you are challenged by obesity, you need to exercise more, and you can use this app to track your exercise, then its linked to a disease. By presenting exercise as a treatment for the disease of obesity, the app may have crossed the line from a wellness app to a medical app. Once the FDA has more clearly defined the line, says Thompson, app makers will have to be more careful with their marketing claims.

2. Clarify the difference between diagnosing and monitoring.

If an app allows a user to take a picture of a mole on his skin and it tells him if he has melanoma, thats clearly a medical app thats subject to FDA oversight, says Ben Chodor, the CEO of Happtique. His company curates the health and wellness apps in the iTunes store to help users find the most effective offerings, and it is trying to establish an app prescription system for doctors. But what if an app offers a photo gallery of skin conditions, including photos of melanoma? If it doesnt provide a diagnosis, is it just a reference guide? Thats a gray area, Chodor says. Thats where developers come to us and say, Hey, do we need to go to the FDA for certification?

3. Establish the risk-level threshold for FDA enforcement.

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The FDA Takes On Mobile Health Apps