Health IT Pulse:

medical device regulation


February 24, 2015  1:39 PM

FDA funding leads to medical device surveillance plan

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
FDA, medical device regulation, medical device security, medical devices

Though it has a handle on measuring the safety and effectiveness of medical devices, the FDA isn't sure there's enough publically-accessible information for patients and clinicians to make fully-informed decisions about medical products. The road to a firm medical device surveillance policy began...

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 The FDA issued draft guidance saying they will not enforce any regulations that apply to medical device data systems (MDDS), medical image storage devices, and...


March 26, 2014  1:43 PM

FDA must be clearer with rules on mobile medical applications

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

A bipartisan group of six U.S. Senators pressed FDA Commissioner Margaret Hamburg to share the FDA's regulatory plans with the public to avoid consumer, vendor and healthcare practitioner confusion. The group also cautioned the FDA against overly-aggressive regulations.


November 12, 2013  12:31 PM

EHR Association cautions against increased medical device regulation

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
EHR Association, FDA, FDASIA, medical device regulation, medical devices

Electronic health record developers want health IT that isn't currently regulated as a medical device to remain that way, pending further review from the FDA, FCC and ONC. The HIMSS Electronic Health Record...

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