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Government Accountability Office

GAO: HHS, other feds blew $321M on redundant IT | MassDevice.com On Call

September 17, 2013 By Brad Perriello Leave a Comment

GAO: HHS, other feds blew $321M on redundant IT | MassDevice.com On Call

MASSDEVICE ON CALL — The U.S. Dept. of Health & Human Services and 2 other federal agencies may have blown some $321 million on IT systems that were already in place, according to a Government Accounting Office report.

The GAO identified 12 "potentially duplicative" investments at HHS, the Dept. of Homeland Security and the Defense Dept., out of the 590 it reviewed.

Filed Under: Health Information Technology, News Well Tagged With: Dept. of Health & Human Services (HHS), Government Accountability Office, MassDevice.com, On Call

FDA urged to develop security plan for wireless implantable medical devices

October 2, 2012 By MassDevice Leave a Comment

Global Medicine

By Stewart Eisenhart, Emergo Group

The US Government Accountability Office (GAO) has issued recommendations that the Food and Drug Administration develop a comprehensive plan to improve the agency’s ability to review and monitor active implantable medical devices that rely on wireless and other advanced technologies.

Filed Under: Blog, Food & Drug Administration (FDA), News Well Tagged With: Cybersecurity, Emergo Group, Government Accountability Office

Medtech hacking: More security may compromise reliability, experts say

October 1, 2012 By Arezu Sarvestani Leave a Comment

information security illustration

Medical device companies under increasing pressure to bolster cybersecurity measures warned that heightened security comes at a cost.

Adding new layers of security into devices like pacemakers and insulin pumps, which have proven hack-able in recent years, may require compromises in features like battery life, device makers told the Government Accountability Office.

Filed Under: News Well Tagged With: Cybersecurity, Government Accountability Office

GAO report calls for more oversight of medical device hack-ability, HHS agrees

September 28, 2012 By Arezu Sarvestani Leave a Comment

hacking a pacemaker illustration

The FDA needs to step up its information security review standards to identify, monitor and address the threat of malicious medical device hacking, according to a newly released report from the Government Accountability Office.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Cybersecurity, Dept. of Health & Human Services (HHS), Government Accountability Office

Device hacking: Federal agencies urge heightened review of device cybersecurity

May 24, 2012 By Arezu Sarvestani Leave a Comment

hacking

A handful of government bodies are asking federal regulators to establish medical device software security protocols as part of the FDA’s regular review of medical devices.

The U.S. Dept. of Homeland Security joined the Information Security & Privacy Advisory Board of the National Institute of Standards & Technology in calling for heightened review of medical devices, citing security weaknesses that may leave them vulnerable to "malicious tampering."

Filed Under: Food & Drug Administration (FDA), Health Information Technology, News Well, Software / IT Tagged With: Cybersecurity, Dept. of Health & Human Services (HHS), Dept. of Homeland Security, Government Accountability Office, McAfee, U.S. Congress

Michigan U launches medical device wiki | MassDevice.com On Call

April 27, 2012 By MassDevice staff Leave a Comment

MassDevice On Call

MASSDEVICE ON CALL — A team of University of Michigan students built an online compendium of innovative medical devices "designed for use and/or implemented within resource-limited settings."

The database, intended for health care providers in developing countries, already contains more than 100 devices, including a pedal-powered nebulizer, wax-filled sleeping bags for warming infants and a salad-spinner centrifuge for blood samples.

Filed Under: Healthcare Reform, News Well Tagged With: Government Accountability Office, Healthbox, Insurance, On Call, University of Michigan, VGo Communications

St. Jude touts CE Mark for next-gen high-energy ICD | Regulatory Roundup

April 17, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

Filed Under: 510(k), News Well Tagged With: Cardiac Rhythm Management, Government Accountability Office, Integra LifeSciences, LifePort, Organogenesis Inc., Regulatory Roundup, Renal, SHL Telemedicine, Sotera Wireless, Sree Medical, stjudemedical

MassDevice.com +7 | The top 7 med-tech stories for the week of March 26, 2012.

March 30, 2012 By MassDevice staff Leave a Comment

Happy 3rd birthday, MassDevice!

Plus Seven

Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.

Filed Under: Food & Drug Administration (FDA), Healthcare Reform, Legal News, News Well, Robotics, Wall Street Beat Tagged With: 510(k) reforms, Government Accountability Office, Hillrom, Intuitive Surgical, Personnel Moves, Plus 7, stjudemedical

GAO: FDA “inconsistent” in meeting performance goals

March 30, 2012 By MassDevice staff Leave a Comment

upanddowngraph

The FDA lacks consistency in review times for medical device pre-market approval applications, missing most goals for submissions marked "expedited," according to report by the Government Accountability Office.

"For FYs 2003 through 2010, FDA met most of the goals for original PMAs but fell short on most of the goals for expedited PMAs," according to the GAO report. "In addition, FDA review time and time to final decision for both types of PMAs generally increased during this period."

Filed Under: 510(k), Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA) Tagged With: Dept. of Health & Human Services (HHS), Government Accountability Office

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