Tuesday, September 24, 2013

Final FDA Ruling Released on Medical Apps

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Almost two years after the draft guidance was released for the FDA's oversight on medical apps, final rulings were released yesterday.  The FDA will only be regulating those apps that when used can cause harm to a customer - most of the time - an app that turns portable devices into medical devices.  Most notable about this regulation is it leaves the platform and distributors alone and looks at the functionality of the device.  The majority of mHealth apps are left out of the zone of regulation including pedometers, health rate monitors and wellness tools.  Find out more from the FDA's Official Announcement.

So now that we have official guidance, how will the Pharma industry respond?  Earlier this year, Research2Guidance looked at how they're currently working in the market place - not well - and who Pharma companies can embrace the practices of other app makers to really and truly reach the market.  Many are failing to make the app connectable with social media which can often drive the use and viral spread of apps.  They are also focusing on very niche topics - specific disease states or medical references - making a general app to appeal to a wider audience would allow for Pharma apps to be more usable for a general market.  And finally, many times, integration of the app into core marketing and other initiatives don't allow apps to reach their full potential.  

This winter at ePharma Summit 2014, we'll be hosting the eMarketing University.  Year over year, attendees come to this portion of the event to discuss the keys to any Pharma marketers job including channel strategies, content creation and integrated marketing.  We'll be releasing the agenda soon.  For the latest news and information on the event, be sure to sign up to receive email updates.

Now that the FDA has set out rules for the mHealth App industry, do you think that Pharma will look into diving deeper into the health app industry?
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