FDA Creates Medical App Regulation Maze - InformationWeek

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FDA Creates Medical App Regulation Maze
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MedicalQuack
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MedicalQuack,
User Rank: Moderator
3/3/2014 | 6:34:12 PM
Move ONC to the FDA as it's own entity
I said it months ago, move the ONC over to the FDA as it's own entity and stop the madness as the ONC would have direct access to FDA software engineers and would get more information and vice versa with the FDA with the clinical input beyond safety.  Some EHRs are now getting data from devices so this is opening a whole new door and to have both together would do well for all as both sides would be represented.  Might as well do this now as thing will be automating further and the consumer devices will be probably selling even more data.

http://ducknetweb.blogspot.com/2013/07/mhealth-why-battle-over-where.html


When I posted this a few months ago on Twitter, a couple of the ONC folks actually liked the idea. 
Alison_Diana
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Alison_Diana,
User Rank: Author
3/3/2014 | 5:19:49 PM
More Confusion Ahead
Unfortunately, the FDA ruling didn't answer as many questions as developers, healthcare professionals, and consumers would have liked. As wearables, Internet of Things, and good old mobile apps continue to evolve in sophistication and adoption, the blurry line will only get more confusing for us all. No doubt lawyers will try to figure it out in court when someone uses an app and something goes wrong. So many apps are helpful (even if they act only as reminders that's a great aid) that it would be a shame if over-regulation or fear of lawsuits hindered creativity and innovation. 


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