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krisi
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which ones?
krisi   12/3/2013 5:57:13 PM
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It will be interesting to see which medical apps FDA decides to regulate

rick merritt
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Re: which ones?
rick merritt   12/3/2013 6:26:58 PM
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Examples Maisel gave included blood glucose meter apps and and smartphone medical image readers, citing the need for accuracy.

rick merritt
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Is the FDA keeping pace?
rick merritt   12/3/2013 6:28:02 PM
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How do you think the FDA is doing keeping pace with the rise of mobile health?

How does it compare with regulators in Europe and Asia?

krisi
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CEO
Re: which ones?
krisi   12/3/2013 6:57:06 PM
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thanx Rick...there is an app to monitor your skin for cancerous spots (sounds useful, I was wondering whether to use it), would that be example of FDA regulated app as it requires some decent accuracy in diagnosis?...one could argue that if the software alerts you would go to dermatogolist anyways so there is no really a downside...Kris

daleste
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Re: which ones?
daleste   12/3/2013 8:43:38 PM
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It does seem that the US government likes to stand in the way of progress.  If medical manufacturers go to Europe or Asia because they can get their devices approved quicker, than the FDA needs to change.  It sounds like they want to, but I would be surprised if they really do.

daleste
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CEO
Re: which ones?
daleste   12/3/2013 8:45:19 PM
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Anyone have any experience with the new wrist bands that monitor your activity?  It seems like a good way to help improve your activity and sleep cycles with feedback.  I hope the FDA will not decide to regulate these.

Clard1957
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Rookie
At what cost, regulation?
Clard1957   12/3/2013 10:48:26 PM
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The use of mobile computing devices holds much promise for improving disease treatment and quality of medical care.  It would be a shame to watch the cost of these devices exponentially rise because of demands of overbearing regulation.

______________________

Tammy

rick merritt
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Author
Re: which ones?
rick merritt   12/4/2013 12:03:04 AM
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@daleste: I would be very surprised if the FDA would try to regulate fitness devices given what I heard today.

prabhakar_deosthali
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CEO
Statutory Warning
prabhakar_deosthali   12/4/2013 7:01:24 AM
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If all those medical apps are forced to have a statutory message saying

" The results provided by this App  are indicative only. Please consult your doctor for the final diagnosis of the symptoms"


then majority of the concerns of a potential risk to the patients can be addressed. The patient using the app is always advised to visit a doctor to take the second opinion when the situation warrants.

And this regulation can be effected more quickly than the time consuming certification of the Apps.

zewde yeraswork
User Rank
Blogger
Re: which ones?
zewde yeraswork   12/4/2013 9:17:05 AM
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I suppose it is an advantage to know that any and all apps in medical use have gone through a proper process in order to determine whether they're appropriate for use in that way. But it's likely, as part of a trade-off, that American vendors and manufacturers will continue to complain as long as the US government gets in their way with painstaking regulations.

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