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Apple works hard to avoid FDA regulations


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A year ago Apple met with the FDA and rumors started swirling about health-related products and services. Now, a successful “freedom of information” request from the FDA has produced a summary memo of that meeting. Here are the main points they covered:

FDA Accommodation

In an update to the list of apps under “regulatory discretion” the FDA has included one that sounds like it was added specifically for Apple:

Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014].

For healthcare marketers this is about as clear as it gets. If your app collects data for later use with an HCP then you’re not regulated, but if your app provides diagnostic or treatment advice then you better learn how to get through 510(k) certification.

Other news from MobiHealthNews:

Source: MobiHealthNews

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