Food and Drug Administration (FDA)
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Health IT: The Coming Regulation
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
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
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 »
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(Continued) FDA Plays Chicken With Antibiotics: Newly Exposed Documents Reveal Agency's "High Risk" Gamble With Human Health
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 »
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10 Steps To Overcome Your Fear Of Using Open Source Software
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
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
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 »
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3Rs For Innovating Novel Antibiotics: Sharing Resources, Risks, And Rewards
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 »
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4 Ways to Shake Up the Clinical Trial Process and Cut Costs
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
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
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
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
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
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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9 Healthcare Innovations Driven By Open Data
...IBM and the Cleveland Clinic announced that Watson was turning to more serious pursuits and had "enrolled" in medical school. It's been a productive partnership: Last month, they launched a new Watson program using genomic data to find the best options for cancer patients...
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