The first rule of FDA regulation of mHealth: You don’t talk about FDA regulation of mHealth

See on Scoop.ithealthcare technology

Unique from the medical device and pharma markets that the FDA already attempts to regulate the mHealth market is up against large countermarkets that the FDA has no influence over eg. mobile advertising is being used to draw associations between sport and fructose syrup soft drinks and sugary sweets, sell adult rated content to minors, promote 2 for 1 offers on fast food, etc, etc.


If you’re unfamiliar with these issues please read “Another 500 million reasons why I think the FDA has got it all wrong about mHealth regulation“

A sign that the FDA has no intention of impacting on this critically important counter market can be seen in the definition given for a “mobile medical app manufacturer” that lets mobile app store’s (the gatekeepers for in-app and app-store ads) completely off the hook:

“is defined as any person or entity that manufactures mobile medical apps in accordance with 21 CFR Parts 803, 806, and 807.7 This term does not include entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions; examples of such distributors may include owners and operators of “android market”, “iTunes store”, and “BlackBerry App World””


To begin to appreciate this consider that this definition essentially enables a situation to exist in which you can develop a healthy eating app that Doctors could prescribe to patients, jump through all the necessary hoops with the FDA and then patients using your app can be bombarded by the app store ad networks with location based ads everytime they’re in the proximity of a fast food store.

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