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2/13/2014
09:06 AM
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Will Most Healthcare Apps Escape FDA Scrutiny?

PROTECT Act of 2014 proposes that Food and Drug Administration doesn't need to oversee "low risk" health IT products such as electronic health records and fitness apps.

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rjanakan
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rjanakan,
User Rank: Apprentice
2/14/2014 | 2:15:49 PM
Impact on stage 3 MU and PGHD
It'd be interesting to know what FDA's stand will be on part of regulations around stage 3 MU and Patient Generated Health Data(PGHD).
tnguyengp
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tnguyengp,
User Rank: Apprentice
2/13/2014 | 11:31:58 PM
Re: Modernizing Regs

Apps help us to monitor and track our behaviors, motivating us and providing real-time feedback to help us stay on a healthy track. They also allow you to have unprecedented access to your health record and to share information that's important to your health directly with your doctor. Why does the FDA need to get involved?

Than Nguyen

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Alison_Diana
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Alison_Diana,
User Rank: Author
2/13/2014 | 4:53:48 PM
Surprised at the Numbers
I was surprised at the relatively small number of apps that have been scrutinized by the FDA to date. That said, surely the number will explode, if not this year in 2015, as more developers look to get into this market. Sixty days doesn't sound like much -- unless you're competing with a company that filed 59 days before you. 
RobPreston
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RobPreston,
User Rank: Author
2/13/2014 | 1:13:34 PM
Re: Modernizing Regs
Do more with less. We've all lived it for the past decade. The FDA can live it too. Figure out how to get it done with existing resources/money.
Lorna Garey
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Lorna Garey,
User Rank: Author
2/13/2014 | 1:08:28 PM
Re: Modernizing Regs
On the face of it this seems to make sense. However, won't NIST need more manpower and a new set of expertise to evaluate HC-related apps? I don't see anything about beefing up that agency to handle these new duties.
RobPreston
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RobPreston,
User Rank: Author
2/13/2014 | 11:45:40 AM
Modernizing Regs
If it doesn't make sense to kill a regulation or regulatory body -- and food and drug approvals fall into that category -- it's reassuring to see the process being updated.
Research: Healthcare IT Priorities
Research: Healthcare IT Priorities
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