Posts Tagged ‘medical apps’

Five Tips for Folding FDA’s New Medical App Oversight into Your Business Strategy

March 27th, 2014
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In my post for InformationWeek Healthcare (available here), I discussed the implications of the U.S. Food and Drug Administration’s (FDA) final guidance for medical apps. While the September 2013 guidance specified that it would require clearance of any app intended to diagnose, treat, mitigate or prevent a disease, it left an open door to exercise “enforcement discretion” if an app meets the technical definition of a medical device but poses a low risk to the patient.


In this post, I will discuss the practical challenges resulting from this guidance, and how the evolving environment of app regulations should be folded into your business strategy.


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FDA Creates Medical App Regulation Maze

March 3rd, 2014
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This post is published on InformationWeek Healthcare, March 3, 2014


When the US Food and Drug Administration (FDA) issued its final guidance for medical apps, inventors and investors alike pored through the document, seeking answers on what was to be regulated and what wasn’t. While they indeed found more specific information than has been available from the agency, the guidance also showed the agency’s uncertainty over how the world of medical apps is going to evolve.


Read full post on  InformationWeek Healthcare.

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