Health IT Pulse:

medical devices


January 20, 2016  4:58 PM

FDA gets tougher on IoT medical device cybersecurity

Shaun Sutner Shaun Sutner Profile: Shaun Sutner
cybersecurity, FDA, Internet of Things, medical devices

Manufacturers and users of connected medical devices should take steps to ensure the cybersecurity of such devices, the FDA said in a new guidance document. The draft...

August 12, 2015  3:47 PM

Live hacking an infusion pump

Shaun Sutner Shaun Sutner Profile: Shaun Sutner
Health IT, medical devices

As the Internet of Things (IoT) penetrates healthcare at a fast clip, concern is mounting across the health IT world about the


March 17, 2015  2:11 PM

Nurses would trade time spent on medical devices for patient care

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
device interoperability, Interoperability, medical devices, nurses, transcription

Nurses would spend more time at patients' bedsides if they could cut down on how often they have to operate medical devices. That sentiment was shared by 91% of 526 nurses that took part in a survey commissioned by Gary and Mary West Health Institute and conducted online by Harris Poll. More than...


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...


October 7, 2014  5:00 PM

FDA’s plans through 2018 include postmarket surveillance reform

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

The FDA offered a glance into its future that envisions improvements to current methods of enforcing health IT safety. Regulators plan to continue their migration from passive to active monitoring of postmarket surveillance of FDA-regulated devices. In the FDA's


August 20, 2014  4:15 PM

FDA issues gender guidance in medical device testing

Shaun Sutner Shaun Sutner Profile: Shaun Sutner
demographic reporting, draft guidance, FDA, medical devices

The FDA has waded into gender issues in studying the safety of medical devices. The agency – which effectively deregulated consumer health...

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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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September 24, 2013  12:59 PM

Final FDA rule sets up UDI system for medical devices

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
medical device security, medical devices, mHealth applications, UDI

The U.S. Food and Drug Administration (FDA) released its long-awaited final rule for unique device identification (UDI) system for medical...


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