Archive for March, 2014



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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WEF’s Top 10 Innovations for 2014: How May These Impact the Future of Healthcare?

March 24th, 2014
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The World Economic Forum (WEF) recently issued its predictions for the top 10 emerging technological innovations. At least three of these apply directly to healthcare and have been in the sights of the Popper and Company team and our clients. And even the innovations highlighted by WEF that aren’t immediately relevant to a healthcare issue might end up contributing to medical advances.

 

The three Forum predictions tied to healthcare include:

 

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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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