FDA issues recs on when a medical device update requires a recall

The FDA issued new guidance that aims to clarify whether a change in a medical device may require a recall – or is simply an “enhancement.” According to a notice published last week in the Federal Register, companies may have trouble determining whether an update to their product meets the criteria for a recall. The guidance formally defines an enhancement and presents a Q-and-A as well as sample scenarios to illustrate its recommendations. “It will make the process of determining whether a modification is an enhancement that much clearer, and companies can proceed with more confidence that they’re doing the right…

HHS Buyers Club set for ramp up after first procurement

Just six weeks after releasing a request for proposals in August, the Department of Health and Human Services Buyers Club — an agile approach to making procurement more effective — awarded its first contract to close out fiscal year 2014. While the program is still being evaluated for initial successes and/or failures, HHS Buyers Club has been cleared to ramp up.

Mark Zuckerberg pledges $25 million to CDC’s Ebola response

Facebook CEO Mark Zuckerberg announced Tuesday he and his wife, Priscilla Chan, will donate $25 million to the Centers for Disease Control and Prevention Foundation to help combat the spread of Ebola.

CMS publishes Sunshine Act data amid controversy

Health care advocates have criticized the launch of the Open Payments database for falling short in several areas. Although many industry trade groups support the open data initiative, they are weary of the lack of context provided with the data.

CMS extends Healthcare.gov Terremark IT contract, further delaying HP transition

Healthcare.gov’s second open enrollment period was supposed to be hosted by HP Enterprises Services, but the Centers for Medicare and Medicaid Services has yet again extended a contract with the site’s original Web host, Terremark, further delaying the transition to HP’s cloud services.

FDA releases guidance on medical device cybersecurity

The Food and Drug Administration released final guidance Wednesday recommending that manufacturers take those security concerns into account from the inception of their design to mitigate cyber risks.

CDC tries to disrupt public health education with video games

Video games and public health education don’t typically go hand-in-hand, but a disruptive Centers for Disease Control and Prevention event is merging the two worlds this weekend to continue fighting what it calls a winnable battle against HIV and AIDS.

White House releases new open government initiatives

Criticized for his administration’s lack of transparency, President Barack Obama announced a series of new open government initiatives Wednesday designed to improve online accessibility, education and innovation.

Are the keys to interoperable health IT hidden outside the health care field?

Some leading health IT experts say the key to finding new ideas to modernize the health care industry is to not look in the health care industry. So where are those ideas hiding?

White hat hackers try breaching Healthcare.gov, find ‘critical vulnerabilities’

White hat hackers within the Department of Health and Human Services’ Office of the Inspector General set out to test the integrity of Healthcare.gov security earlier this year and found critical vulnerabilities, according to an IG report released Tuesday.

3 innovative ways agencies are leveraging mobile apps

From geo-coded big data to finding HIV care and leveraging Google Glass to inspect GSA’s buildings, mobile apps are changing the face of government forever.

Healthcare.gov hearing reveals user data was disclosed

The recent breach a Healthcare.gov test server might not have put users’ personal information at risk, but a congressional oversight hearing Thursday revealed that early glitches during the site’s launch did.

GAO questions Healthcare.gov security on eve of major hearing

The Centers for Medicare and Medicaid Services has not done enough to secure Healthcare.gov and the personal information belonging to millions of Americans stored on the system remains at unnecessary risk, a new government audit revealed.

Todd Park could be subpoenaed to testify on Healthcare.gov breach

He may not be the chief technology officer of the U.S. anymore, but Todd Park, the technology lead under President Obama during the rollout of the Affordable Care Act last year, is already wanted back in Washington to answer for a recent breach of the Healthcare.gov website.

Issa demands answers after Healthcare.gov hack

News of a security breach at Healthcare.gov has reinvigorated the Republican-led effort to convince Americans the law and the website are broken. And now the chairman of the House Oversight and Government Reform Committee is demanding answers from the Obama administration’s point person at the Centers for Medicare and Medicaid Services.

What to expect at NIST’s Global Cities Challenge

The Internet of Things, and the ways cities can leverage this emerging technology, is evolving at a rapid pace. Some cities have embraced it fully, while others are trying to keep up. Sokwoo Rhee, a presidential innovation fellow who is working at the National Institute of Standards and Technology, hopes to close that gap during an upcoming conference where innovators will meet with global city planners in order to bring everyone up to speed. Rhee on Friday laid out the plans for NIST’s Global Cities Challenge, which will be held later this month at the agency’s Gaithersburg, Maryland, headquarters. The…

Healthcare.gov responds to server breach

The Department of Health and Human Services confirmed Thursday that Healthcare.gov experienced its first hack last month.

CMS extends EHR incentive timeline for health care providers

Thanks to the Centers for Medicare and Medicaid’s final ruling on electronic health records Friday, more health care providers should be able to meet meaningful use standards and earn incentives in 2014 due to an extension in years-old standards. Health IT advocates, however, fear it could do more harm than good.

Government can successfully embrace consumer concepts like CRM

Government can embrace consumer technologies like CRM to improve services. Microsoft Dynamics CRM is helping at the state level.

How the FDA regulates 3-D printed devices

As personalized medicine becomes more commonplace, the FDA will be tasked with regulating an endless continuum of customizable devices and making sure the benefits always outweigh the risks. The scientists behind the regulation of 3-D printed devices with the FDA, however, said it’s not much different than managing a normally-manufactured item.

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