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[projectvrm] FDA tells mobile health app developers what it plans to regulate


Chronological Thread 
  • From: Peter Cranstone < >
  • To: 'ProjectVRM list' < >
  • Subject: [projectvrm] FDA tells mobile health app developers what it plans to regulate
  • Date: Tue, 24 Sep 2013 14:27:06 +0000
  • Accept-language: en-US


On Monday, the F.D.A. said its oversight will apply to two broad categories of apps:

Those intended to be used as “an accessory to a regulated medical device” – for example, an app that enables a healthcare provider to diagnose a condition by viewing a medical image from a picture archiving or communication system on a smartphone or tablet; or

Apps that “transform a mobile platform into a regulated medical device” – for example, apps that turn smartphones into an electrocardiography (ECG) machine that can detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Skating to where the puck is going. Health Care is the poster child for VRM if you can make it simple for the consumer to use.


Peter


  • [projectvrm] FDA tells mobile health app developers what it plans to regulate, Peter Cranstone, 09/24/2013

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