Food and Drug Administration (FDA)

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Untested mHealth apps proliferate, but few good ones work well

Andrew Litt, MD | ComputerWorld | December 11, 2013

There are more than 43,000 healthcare apps available through the Apple iTunes App Store. That sounds like a wealth of useful apps, but the truth is that only a handful of them are actually being used. Read More »

Upcoming Digital Health Opportunities: Codeathons And The SXSW Accelerator

Steven Randazzo | HealthData.gov | October 1, 2012

For the past three years, through the Health Data Initiative, the Department of Health and Human Services (HHS) has focused on the liberation of health data... Read More »

US And UK Share Health Data Via Cloud

Anthony Brino | Healthcare IT News | November 15, 2013

About half a century after epidemiology studies in Massachusetts and the United Kingdom helped build the world’s understanding of cardiovascular disease and health risks, public health and population data is being opened up by the U.S. and joining international datasets. Read More »

VA Purchases an Additional 20 ReWalk Exoskeleton Systems for First Ever Multi-Center Exoskeleton Clinical Trials

Press Release | ReWalk Robotics Ltd. | May 5, 2016

ReWalk Robotics Ltd...announced that the U.S. Department of Veterans Affairs ("VA") has purchased an additional 20 ReWalk Personal Systems to support initiation of their national multi-center clinical trial. The VA clinical trial is the first-ever U.S. study to examine the impact of exoskeleton use in the home or daily life setting. The study will include 160 participants across the country, with six VA medical centers participating in the first phase across California, Florida, Massachusetts, Texas and Virginia...

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VA Tackles Medical Device Vulnerabilities and Cyberthreats

VA recently signed partnerships with Massachusetts General Hospital and Shepherd University. This collaboration's research will address cybersecurity and compatibility measures needed in devices used for VA patient care. It will also refine existing and emerging cybersecurity standards and practices for network connectable medical devices, medical data systems and other related technology. Beyond VA, the agreements could have a broad impact in standardizing cybersecurity and safety requirements within the larger public health sector. VA is contributing to industry-wide awareness of both medical device vulnerabilities and threats, while applying further tests of the Underwriters Laboratories criteria and other emerging standards.

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VA Wants Application To View VistA Images On Mobile Devices

Mike Bassett | FierceMedicalImaging | November 18, 2012

The Department of Veterans Affairs wants to develop an application that will allow clinical images stored on its Veterans Health Information Systems and Technology Architecture electronic health record to be viewed on mobile devices. Read More »

Warren Questions FDA Commissioner About Antibiotics Guidance

Lydia Zuraw | Food Safety News | March 14, 2014

The issue of antibiotics in animal feed reared its head again Thursday as U.S. Sen. Elizabeth Warren (D-MA) questioned Food and Drug Administration Commissioner Margaret Hamburg about the effectiveness of Guidance 213 during a Senate Committee on Health, Education, Labor and Pensions (HELP) hearing. Read More »

Web-Based Data Tool Designed to Enhance Drug Safety

Press Release | Cincinnati Children's Hospital Medical Center | July 8, 2016

A new online open-access database has been developed by scientists to allow the clinical responses of more than 5 million patients to all FDA-approved drugs to be used to identify unexpected clinical harm, benefits and alternative treatment choices for individual patients, according to a study appearing July 8 in Nature Biotechnology. Developed by scientists in the Division of Biomedical Informatics and the Clinical and Translational Sciences Program at Cincinnati Children's Hospital Medical Center, the database has the potential to help reduce negative side effects from prescription drugs and identify opportunities to reposition existing drugs for new uses, report the study's authors.

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What Pain Killers Can Teach Us About Open Government

Joseph Marks | Nextgov | January 4, 2012

Looking for an example of how open government data is being used by the private sector? Google the words “aspirin,” “ibuprofen” or “amoxicillin” and check out the upper right hand corner of the webpage. Read More »

When Should Open Source Be Written Into Law?

Jon Buys | Ostatic | January 22, 2012

I would suggest three areas of software which should be available upon request, without question. 1. Medical Implants. Unequivocally, any programmable electronic device which we put into our bodies should be available for review...

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When To Regulate mHealth Apps?

Diana Manos | Government Health IT | January 8, 2013

With events such as the Consumer Electronics Associations’ 2013 International CES conference this week in Las Vegas, featuring a dizzying 3,000 global app companies and a digital health summit, there is a lot of hype around what apps can do for healthcare. Read More »

White House Actions On Antibiotic Resistance: Big Steps, Plus Disappointments

Maryn McKenna | WIRED | September 22, 2014

The United States government proposed several important steps last week that, if accomplished, will significantly change how this country attempts to counter the advance of antibiotic resistance, bringing us within reach of the more complete programs which exist in Europe. But as significant as it is, the new program has some perplexing gaps that left experts attending to the issue disappointed...

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Who Owns the Data?

Susan M. Love | Huffington Post | November 8, 2011

Everyday, thousands of altruistic men and women participate in clinical research projects. They carefully fill out questionnaires, give samples of tissue or body fluids, and take drugs or placebos, all in an effort to improve our understanding and/or our treatment of diseases. Read More »

Who should regulate Mobile Health?

Eric Wicklund | Government Health IT | July 12, 2013

Not everyone is eager to see the U.S. Food and Drug Administration [FDA] issue its final guidance on mobile medical app regulation. Read More »

WHO Sounds Alarm On Widespread 'Superbug' Infections

Kim Painter | USA Today | April 30, 2014

Disease-causing bacteria that resist antibiotic treatment are now widespread in every part of the world and have reached "alarming levels" in many areas, says the first global report on the issue from the World Health Organization. Read More »