Tuesday, July 19, 2011

@FDAapps FDA takes position on #mHealth Apps...

@FDAapps FDA takes position on #mHealth Apps. It has been a busy day on the Web for the Feds. A BlueButton Challenge has been laid down to get the #BlueButton on 25,000 Physician web sites. I applaud that move, even if it is causing some debate check out http://challenge.gov/VAi2/198-blue-button-for-all-americans . On the same day the FDA has published information about what it intends to regulate in the world of mHealth Apps. See the info here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm263332.htm

The interesting part is that the FDA is proposing to oversee mobile medical apps that:
- Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
- Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
I think this means that if you connect your FDA-Approved Glucose meter to a mHealth app on a smartphone then the mHealth App will need FDA Approval.

Blue Button for All Americans
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