Health IT Pulse:

mobile medical apps

June 24, 2014  11:01 AM

FDA guidance steers clear of regulating medical device data systems

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
FDA, medical device regulation, medical devices, mobile medical apps

Healthcare providers can breathe a sigh of relief after the FDA passed up a chance to throw another health IT requirement their way. The FDA issued draft guidance saying they will not enforce any regulations that apply to medical device data systems (MDDS), medical image storage devices, and...

June 13, 2013  3:34 PM

Biosense case proves need for mobile medical applications regulations

Ed Burns Ed Burns Profile: Ed Burns
FDA, mHealth, mobile medical apps, regulation

The Food and Drug Administration (FDA) created a stir this week when it sent a letter to app developer Biosense Technologies asking the company why it has not sought clearance for its uChek Urine Analyzer app. It...

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