Food and Drug Administration (FDA)

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Coming Next: Using an App as Prescribed

Joshua Brustein | New York Times | August 19, 2012

Before long, your doctor may be telling you to download two apps and call her in the morning. Smartphone apps already fill the roles of television remotes, bike speedometers and flashlights. Soon they may also act as medical devices, helping patients monitor their heart rate or manage their diabetes, and be paid for by insurance.

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Commentary: Is mHealth Bound For Same Ambiguous Fate As Health IT?

Tom Sullivan | Government Health IT | December 2, 2013

Deep in the back offices of Silicon Valley startups and stalwarts, you won’t commonly encounter phrases like "automotive IT" or "plastic injection molding IT" – yet all through the healthcare industry, such vague-almost-to-the-point-of-confusing terms pepper the conversation. Read More »

Computer Viruses Are "Rampant" On Medical Devices In Hospitals

David Talbot | MIT Technology Review | October 17, 2012

A meeting of government officials reveals that medical equipment is becoming riddled with malware. Read More »

Congressional Hearing To Focus On Entrepreneurs, Mobile Medical Apps

Greg Slabodkin | FierceMobileHealthcare | June 21, 2013

The House Small Business Subcommittee on Health and Technology will hold a hearing on June 27 to highlight entrepreneurs creating healthcare apps, according to the subcommittee's announcement. Read More »

Continua Lauds FDA's Medical Device Interoperability Standards

Chuck Parker | mHealth News | August 15, 2013

Reviewing media coverage of the U.S. Food and Drug Administration’s recent announcement that it will recognize standards for medical device interoperability could give a misleading impression that the measure is of little importance. [...] Read More »

Crowdfunding The Next Medical Cure

Mohana Ravindranath | The Washington Post | July 8, 2013

Creating a new medical device is not an inexpensive exercise. There are development costs, clinical trial expenses, and the lengthy process of getting a piece of new equipment approved by the Food and Drug Administration. Read More »

Dallas Hospital Had The Ebola Screening Machine That The Military Is Using In Africa

Patrick Tucker | Nextgov.com | October 17, 2014

The military is using an Ebola screening machine that could have diagnosed the Ebola cases in Texas far faster, but government guidelines prevent hospitals from using it to actually screen for Ebola...

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Dangerous Drug Attorney Jeffrey D. DeCarlo Comments On ‘OpenFDA’ Website’s Benefit To Consumers

Press Release | openFDA | August 17, 2014

Attorney Jeffrey D. DeCarlo, P.A. weighs in on the launch of the openFDA website, allowing consumers easier access to label information, recalls and other information about defective drugs and medical devices...

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Data Management for Large-scale COVID-19 Immunization: This is all not as simple as it seems

There is a global race for the development of a vaccine for the SARS-CoV-2 virus that causes COVID-19. Finding a vaccine that works and receives approval is only part of the process. There are a series of other steps that need to be taken so that the vaccine can be delivered. These include the mass production of the vaccine, shipment, administration and record-keeping. This may be even more complex as there may be several vaccines. In this article we review some of these issues with a particular focus on the United States.

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Debate Over FDA Oversight Of Apps Continues

Eric Wicklund | Government Health IT | February 18, 2014

A new bill aimed at calling off the FDA on over-regulation of medical apps is taking some heat. It seems some industry experts feel the bill won’t accomplish what drafters of the bill intended. Read More »

Definitive Link Confirms Antibiotic-Resistant Bacteria Transmits From Livestock To Humans

Press Release | Congresswoman Louise M. Slaughter | March 28, 2013

Today, Congresswoman Louise Slaughter (NY-25), the only microbiologist in Congress, reacted to a new study that conclusively identified transmission of methicillin-resistant Staphylococcus aureus (MRSA) from livestock to humans. Currently, MRSA kills more Americans each year than HIV/AIDS. Read More »

Device Interoperability Effort Seeks Hospital Leaders

Ken Terry | InformationWeek | September 24, 2013

Center for Medical Interoperability, funded by the Gary and Mary West Foundation, aims to solve incompatibilities between medical devices and health IT systems. Read More »

Digital Health Records’ Risks Emerge As Deaths Blamed On Systems

Jordan Robertson | Bloomberg | June 25, 2013

When Scot Silverstein’s 84-year-old mother, Betty, starting mixing up her words, he worried she was having a stroke. So he rushed her to Abington Memorial Hospital in Pennsylvania... Read More »

Disease Detectives Are Solving Fewer Foodborne Illness Cases

Eliza Barclay | The Salt | April 7, 2014

Recall, if you will, some of the biggest foodborne illness outbreaks of the past decade. There was the nasty of listeria from cantaloupe in 2011 that killed 33 people. And the ugly Salmonella Heidelberg from Foster Farms chicken [...] But according to a released Monday by the Center for Science in the Public Interest, the Centers for Disease Control and Prevention has been reporting and solving fewer and fewer outbreaks over the past decade. Read More »

DIY Health to the Rescue

Experts often compare how slowly the health care system is "reforming" to how hard it is to turn a battleship.  They're so big that they can't turn on a dime (much less on $3 trillion!), and there is as much risk in trying to oversteer as in not turning at all.  Things are changing, we're assured, but it will take time to get on the desired new course. Maybe.  But maybe it is time to jump off the obsolete battleship onto something more nimble. Some call it Do-It-Yourself Health (there are both .org and .com sites devoted to the topic, among others).  PwC declared it to be one of the top ten trends of 2015.  Dave Chase believes that "DIY health reform is now leading the way for the highest performing reform" -- not Medicare, health insurers, not even employers...