Food and Drug Administration (FDA)

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Health IT: The Coming Regulation

Andy Oram | Health IT | April 14, 2014

The Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?  The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.

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"Game-Changing" Study Links Cellphone Radiation to Cancer

Josh Harkinson | Mother Jones | May 27, 2016

It's the moment we've all been dreading. Initial findings from a massive federal study, released on Thursday, suggest that radio-frequency (RF) radiation, the type emitted by cellphones, can cause cancer. The findings from a $25 million study, conducted over two and a half years by the National Toxicology Program (NTP), showed that male rats exposed to two types of RF radiation were significantly more likely than unexposed rats to develop a type of brain cancer called a glioma, and also had a higher chance of developing the rare, malignant form of tumor known as a schwannoma of the heart. The effect was not seen in females...

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'Moral Bankruptcy of Capitalism': UK’s Top Public Doctor Shames Western Society Over Ebola

Staff Writer | RT News | August 3, 2014

Western countries should tackle drugs firms’ “scandalous” reluctance to invest in research into the virus which has already killed over 700 people in West Africa, the UK’s top public doctor said, adding, “They’d find a cure if Ebola came to London.” The pharmaceutical industry are reluctant to invest in research to produce treatments and vaccines “because the numbers involved are, in their terms, so small and don't justify the investment,” said Professor John Ashton, president of the UK Faculty of Public Health, an independent body for specialists in public health in the United Kingdom. Read More »

'Opening Up' the FDA

The President's Executive Order on Open Government Data states, "Government information shall be managed as an asset throughout its life cycle to promote interoperability and openness, and, wherever possible and legally permissible, to ensure that data are released to the public in ways that make the data easy to find, accessible, and usable." Interestingly, the Department of Health and Human Services (HHS), which includes the Food & Drug Administration (FDA), has a tradition of expansive disclosure of information and/or data it generates or collects – contrary to current practices at the FDA. Hopefully, changes being made to 'open up' the FDA will start to accelerate. Read More »

(Continued) FDA Plays Chicken With Antibiotics: Newly Exposed Documents Reveal Agency's "High Risk" Gamble With Human Health

Carmen Cordova | Switchboard | January 27, 2014

Just to offer a little more insight on FDA’s inaction, discussed broadly in a previous blog, I’ve detailed the history of just one of the antibiotic additives in question here. Read More »

10 Steps To Overcome Your Fear Of Using Open Source Software

Shahid Shah | Med Device Online | October 8, 2014

The entire Internet runs on open source software (OSS) and, if we used it more in medical devices, it would lead to reduced costs and increase the quality of devices. If you ask some regulatory affairs folks in medical device companies, they think OSS is too “dangerous” for use in safety critical systems...

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10 Steps To Overcome Your Fear Of Using Open Source Software

Shahid Shah | MED Device Online | October 8, 2014

The entire Internet runs on open source software (OSS) and, if we used it more in medical devices, it would lead to reduced costs and increase the quality of devices. If you ask some regulatory affairs folks in medical device companies, they think OSS is too “dangerous” for use in safety critical systems...

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3 Things mHealth Startups Need To Know Now About Regs

Jeff Rowe | Government Health IT | December 2, 2013

When entrepreneurs eyeing the mobile healthcare technology space start planning their new venture, they probably don’t have “regulatory strategy” on their task list. They forget that they’re entering one of the most heavily regulated industries, and how they manage that can have a significant impact on whether they're successful. Read More »

3Rs For Innovating Novel Antibiotics: Sharing Resources, Risks, And Rewards

Anthony D So, Quentin Ruiz-Esparza, Neha Gupta, Otto Cars | BMJ | April 3, 2012

The stream of new antibiotics is struggling to keep up with emerging bacterial resistance. Anthony So and colleagues examine what can be done to increase innovation... Read More »

4 Ways to Shake Up the Clinical Trial Process and Cut Costs

Stephanie Baum | MedCity News | February 1, 2012

A drug developer wants to shake up the clinical trial process through crowdsourcing as well as using telemedicine and greater data transparency. It believes implementing these together can cut the cost of doing clinical trials by 50 percent in the next two years.

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5 Digital Health Trends You'll See In 2015

Leyl Master Black | Mashable | December 16, 2014

2014 has been a huge year for health tech. According to digital health incubator StartUp Health, digital health funding in the first three quarters of 2014 has already surpassed $5 billion, close to double what was invested in all of 2013 ($2.8 billion)...

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5 Health Challenges The World Will Face In 2015

Julia Belluz and Steven Hoffman | Vox | December 23, 2014

What comes next for the future of the world's health?... But these are the issues reason would suggest will set the world's health agenda next year...

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5 Health IT Pieces Of Congress Agenda For 2015

Staff Writer | Government Health IT | January 6, 2015

With Republican majorities poised to take control of the Senate and House of Representatives, the 2015 Congress is expected to address several health IT programs. Although controlling spending and promoting free enterprise remain GOP tenants, the approach by Congress to various health IT issues will vary...

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7 Google Ventures Poised To Revolutionize Healthcare

Erica Garvin | HIT Consultant | December 22, 2014

Forget the “sky’s the limit.” Google is reaching for the moon when it comes to healthcare innovation...

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8 Factors To Consider Before Taking The Open-Source Software Leap in Healthcare

Renjith Ponnappan | Med Device Online | April 29, 2014

Affordable healthcare is a major concern today, especially for companies developing solutions to enter emerging markets. Global companies are finding it exceedingly difficult to compete in comparatively less-regulated markets, with locally developed products.

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