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FDA Mobile Apps Loophole Hazardous For Healthcare
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RendrewWolfson
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RendrewWolfson,
User Rank: Apprentice
7/31/2014 | 8:16:59 AM
Why Mobile Healthcare App Development Should be Taken Seriously?
There are certain types of mobile applications which are out of the purview of FDA guidelines. Let us have a look at which applications are not to be validated by the FDA guidelines - http://bit.ly/1cA2mPt
David F. Carr
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David F. Carr,
User Rank: Author
7/25/2014 | 5:34:56 PM
Re: Working without a net
Let's hope those hospitals don't innovate themselves right into the courtroom.
Alison_Diana
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Alison_Diana,
User Rank: Author
7/25/2014 | 5:02:58 PM
Re: Working without a net
That's a great point, especially when you think how many healthcare orgs now develop apps internally because it's comparatively simple. If they decide to take this approach, it's critical to ensure they're not going to run afoul of the government's rules (and patient safety).
Stephanie Kreml
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Stephanie Kreml,
User Rank: Apprentice
7/24/2014 | 11:15:31 AM
Re: Working without a net
Good point! This is quite timely, as some hospital systems are creating environments to foster innovation in this area.
Stephanie Kreml
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Stephanie Kreml,
User Rank: Apprentice
7/24/2014 | 11:12:34 AM
Re: Further Clarification?
Good questions! I think the FDA is overwhelmed at this point with limited resources, so they probably won't put forth any more guidance at this time. As for EMRs, my understanding is that the FDA hasn't really been involved with regulating these as they mainly store data for clinicians to use, and any treatment decisions ultimately are done by the clinician. Where the FDA is involved is when software includes clinical decision support (CDS). There have been some issues with stand-alone CDS software, and the FDA is working on draft guidance for these situations.

I don't know if the FDA has any plans to aid patients who want to correct EMR errors, or if the FDA would be the agency to involved for this scenario. These are definitely interesting times, and the story will continue to unfold!
asksqn
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asksqn,
User Rank: Ninja
7/23/2014 | 6:51:39 PM
FDA Regulation: Meh
Were I a physician, I wouldn't worry so much about FDA approval of medical mobile apps.  This is the same government agency, after all, that regurgitates exactly what Monsanto wants it to:  GMOs = good for you as is aspartame and fluoride.  And then cites the appropriate Monsanto-financed study as conclusive proof. Besides, with the right about of money/lobbyists, the FDA has proven that it can pretty much be bought off for any reason regardless of harm to the consumer.  
PedroGonzales
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PedroGonzales,
User Rank: Ninja
7/23/2014 | 10:58:37 AM
Re: Further Clarification?
I think that the FDA will have to do a better work in catching up with technology.  As you pointed out in your article,if some healthcare organizations can by pass the regulation, the impact of the app will have on a person's life could be a matter of life or death.
David F. Carr
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David F. Carr,
User Rank: Author
7/23/2014 | 10:37:15 AM
Working without a net
What I take from this is that app developers within healthcare organizations need to watch their steps because without this oversight the burden of doing the right thing falls entirely on them. Second guessing in the form of lawsuits and government intervention will follow if they make the wrong moves.
Alison_Diana
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Alison_Diana,
User Rank: Author
7/23/2014 | 9:30:39 AM
Further Clarification?
Do you expect the FDA will further clarify these rules any time soon, as more non-medical developers enter this market -- especially if they now target the specific area of non-patient-facing, medical professional, in-facility usage you describe in your interesting article? Since patients don't own their own medical records and, (as I'm discovering for an upcoming article on InformationWeek), have a lot of difficulty correcting EMR errors, how can patients ensure a software-created error doesn't become part of their permanent medical record, especially as FDA scrutiny of these types of apps apparently decreases?


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