Health IT Pulse:

FDASIA


March 12, 2014  11:40 AM

ONC asks for $14 million health IT budget increase for 2015

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
FDASIA, health IT budget, Karen DeSalvo, ONC

The Office of the National Coordinator for Health IT's budget request for 2015 is $14.3 million more than the enacted budget for 2014. The 2015 health IT budget request comes in at $74.7 million...

February 19, 2014  11:07 AM

Electronic submission of medical device reports now a requirement

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
FDA, FDASIA, investigational device exemption, UDI

The Food and Drug Administration's finalized rule for medical device surveillance requires manufacturers to submit reports for individual medical device adverse events. The medical device reports (MDRs) are now required to be submitted electronically to the FDA, which can then analyze and store the...


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...

0 Comments     RSS Feed     Email a friend


Forgot Password

No problem! Submit your e-mail address below. We'll send you an e-mail containing your password.

Your password has been sent to: