@Atul_Gawande @atulbutte Yes, if they are medical devices used for diagnosis like @AliveCor ECG (my device )!
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@DrDave01@Atul_Gawande@atulbutte@AliveCor Regulate? Yes. To extent that Rx is required? No. -
@tbouthillet@atul_gawande@atulbutte Now if we make a smartphone AED, that will need an FDA pma. -
@DrDave01@Atul_Gawande@atulbutte We need inexpensive OTC AEDs! Nice complement to@PulsePoint! -
@tbouthillet@atul_gawande@atulbutte@pulsepoint Absolutely! $499.00!
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@Atul_Gawande@atulbutte FDA should definitely regulate mobile apps, given that doctors plan to "prescribe" them: http://thehealthcareblog.com/blog/2013/03/13/how-should-apps-be-prescribed/ …Thanks. Twitter will use this to make your timeline better. UndoUndo
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@Atul_Gawande@atulbutte This would be the same FDA that approved Avandia & has a hand in drug shortages?Thanks. Twitter will use this to make your timeline better. UndoUndo
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@Atul_Gawande@atulbutte Check out NHS. Health apps for public-reviewed not regulated: http://apps.nhs.uk @healthappslib@ProfSteveFieldThanks. Twitter will use this to make your timeline better. UndoUndo
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V v important discussion kicked off by
@Atul_Gawande: Should FDA regulate mobile health apps as medical devices?Thanks. Twitter will use this to make your timeline better. UndoUndo
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@Atul_Gawande your view re: FDA regs of mobile apps? Process doesn't seem fit for it currently. Will stifle new ones. Maybe not bad?Thanks. Twitter will use this to make your timeline better. UndoUndo
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@Atul_Gawande nope. apps change behaviors. Not physiology. Docs already can recommend behavior change w/o an Rx.Thanks. Twitter will use this to make your timeline better. UndoUndo
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@Atul_Gawande@medsceptic http://feedproxy.google.com/~r/jkOnTheRun/~3/m2qOu35DJvE/story01.htm … FDA should not regulate harmless devices. Already sanctions too many harmful drugs.Thanks. Twitter will use this to make your timeline better. UndoUndo
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@Atul_Gawande@atulbutte FDA should not regulate harmless devices. Already sanctions too many harmful drugs.Thanks. Twitter will use this to make your timeline better. UndoUndo
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@Atul_Gawande@atulbutte It really depends on our definition of intervention. A form of regulation is needed though.Thanks. Twitter will use this to make your timeline better. UndoUndo
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@Atul_Gawande@atulbutte oh my god no. Quantified self, etc. are so important for pts with diseases like mine. We need tools 4 self care.Thanks. Twitter will use this to make your timeline better. UndoUndo
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