Tag Archives: government

FDA urges protection of medical devices from cyber threats

The U.S. Food and Drug Administration on Thursday urged medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats that could compromise the devices or patient privacy. It released that advisory in coordination with a separate alert from the Department of Homeland Security, which disclosed vulnerability in a wide variety of medical equipment that can make those devices vulnerable to remote attacks from hackers. “Over the past year, we've become increasingly aware of cyber security vulnerabilities in incidents that have been reported to us,” William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health, said in an interview. “Hundreds of medical devices have been affected, involving dozens of manufacturers,” Maisel said, adding that many were infected by malicious software, or malware. But he said all the infections appeared to be unintentional, largely due to malware and computer viruses that were circulating in hospital computer networks and jumped onto the devices. An alert published on the government's Industrial Control Systems Cyber Emergency Response Team website, cited research from Billy Rios and Terry McCorkle of the cyber security firm Cylance Inc, who said they have identified more than 300 pieces of medical equipment that are vulnerable to cyber attack. They include surgical and anesthesia devices, ventilators, drug infusion pumps, patient monitors and external defibrillators. The problem with the equipment is that it can be controlled using default passwords that can be obtained with relative ease by motivated hackers, Rios said in an interview. Those passwords give their holders complete control of the devices and in some cases can be used to gain that access remotely via the Internet, he said. “Somebody could take over the device and make it do whatever they want it to do and it would be almost impossible for hospital staff to know that it had been tampered with,” Rios said. Rios and McCorkle are among a group of security experts who in recent years have suggested that medical devices such as insulin pumps and pacemakers could be vulnerable to hacking. The FDA on Thursday said it is not aware of any patient injuries or deaths associated with devices and hospital computer networks that have been infected with malware and computer viruses. In an advisory on its website, however, the FDA said manufacturers, hospitals and patients need to protect themselves better from the introduction of malware in medical equipment and unauthorized access to settings that control devices. “Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches,” the agency said. The risk of breaches has grown as devices have become increasingly interconnected, via the Internet, hospital networks, other medical devices and smartphones, the FDA said. “Specifically we recommend that manufacturers review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices or compromise of the security of the hospital network that may be connected to the device,” the agency said. Among its recommendations, the FDA said manufacturers need to take steps to limit unauthorized device access to trusted users only, particularly for devices that are “life sustaining” or could be directly connected to hospital networks. User IDs, passwords and other security controls need to be strengthened, including potential use of biometrics, the agency said. Moreover, manufacturers need to assure that devices recover and continue to work once security has been compromised. “Cybersecurity incidents are increasingly likely,” the FDA said, “and manufacturers should consider incident response plans that address the possibility of degraded operation and efficient restoration and recovery.” The FDA also urged health care facilities to evaluate their network security, including restricting unauthorized access to the network and networked devices.source : http://www.foxnews.com/health/2013/06/14/fda-urges-protection-medical-devices-from-cyber-threats/

Dr. Manny: FDA loss of control on Plan B not surprising

I told you so - the government is bamboozling us about Plan B. The Obama administration announced on Monday that it will now allow girls and women of all ages to purchase the Plan B pill without a prescription. This is exactly what I have been warning the American public about. I am now totally convinced that our current federal government loves confusion. When you have a single agenda, and many ways to spin it, the American public never gets a clear answer and that is exactly what has happened with the Plan B emergency contraception controversy. Just last week, a U.S. appeals court ruled that the U.S. Food and Drug Administration (FDA) must make only certain forms of the emergency contraception pill available to children of all ages, without a prescription.  In a confusing ruling, the court stated that while the two-pill version of emergency contraception could be sold over-the-counter to women of all ages, the one-pill version would still only be sold to women age 17 or older. The court did not explain its reasoning. One has to remember that the FDA first approved this form of over-the-counter contraception for women of all ages back in 2011. When that initial FDA ruling came out, there was a loud public outcry and restrictions were quickly put in place barring women under the age of 17 from purchasing these pills. But of course, that was just one spin on the story. In April, a New York judge ruled that restricting access to Plan B was inappropriate, forcing the FDA to reconsider their initial finding that emergency contraception should be available to children of all ages. And then, we got another spin on the story, as the FDA tried to lower the age limit for access to emergency contraception to 15 last month. There was another outcry and more criticism, because we know perfectly well that a 15-year-old may not have a clear understanding of how to utilize emergency contraception. Now, we see that the FDA will get to do what they wanted to do in the first place. How convenient. So, what’s the message here?

5 reasons the government is not prepared to handle ObamaCare

The recent turn of events with the Obama Administration and a lack of transparency are a significant red flag to the impending catastrophe of how the proposed changes under the Affordable Care Act could be the next ensuing disaster. 1. Is the IRS capable of fairly enforcing penalties? A major part of the Affordable Care Act is providing insurance for those who don’t have it, or can’t afford it.  The assumption, originally, was that savings would be obtained by coaxing individuals to buy insurance sooner, and prevent the rising cost of catastrophic illness. The hope was that individuals would feel the pain of a financial penalty, enforced by the IRS, and hence opt-in for insurance as opposed to paying the fine.   But recent events, and the follies of the IRS, in using their authority to overstep the boundaries of fairness and jurisdiction, should cause concern.  How effective and unbiased can the IRS truly be in accurately indentifying those individuals who have not complied with the law and enforcing the penalties? …

What do we eat? New food map will tell us

Do your kids love chocolate milk? It may have more calories on average than you thought. Same goes for soda. Until now, the only way to find out what people in the United States eat and how many calories they consume has been government data, which can lag behind the rapidly expanding and changing food marketplace. Researchers from the University of North Carolina at Chapel Hill are trying to change that by creating a gargantuan map of what foods Americans are buying and eating. Part of the uniqueness of the database is its ability to sort one product into what it really is - thousands of brands and variations. Take the chocolate milk. The government long has long classified chocolate milk with 2 percent fat as one item. But the UNC researchers, using scanner data from grocery stores and other commercial data, found thousands of different brands and variations of 2 percent chocolate milk and averaged them out. The results show that chocolate milk has about 11 calories per cup more than the government thought. The researchers led by professor Barry Popkin at the UNC School of Public Health, are figuring out that chocolate milk equation over and over, with every single item in the grocery store. It's a massive project that could be the first evidence of how rapidly the marketplace is changing, and the best data yet on what exact ingredients and nutrients people are consuming. That kind of information could be used to better target nutritional guidelines, push companies to cut down on certain ingredients and even help with disease research. Just call it “mapping the food genome.” “The country needs something like this, given all of the questions about our food supply,” says Popkin, the head of the UNC Food Research Program. “We're interested in improving the public's health and it really takes this kind of knowledge.” The project first came together in 2010 after a group of 16 major food companies pledged, as part of first lady Michelle Obama's campaign to combat obesity, to reduce the calories they sell to the public by 1.5 trillion. The Robert Wood Johnson Foundation agreed to fund a study to hold the companies accountable, eventually turning to UNC with grants totaling $6.7 million. Aided by supercomputers on campus, Popkin and his team have taken existing commercial databases of food items in stores and people's homes, including the store-based scanner data of 600,000 different foods, and matched that information with the nutrition facts panels on the back of packages and government data on individuals' dietary intake. The result is an enormous database that has taken almost three years so far to construct and includes more detail than researchers have ever had on grocery store items - their individual nutritional content, who is buying them and their part in consumers' diets. The study will fill gaps in current data about the choices available to consumers and whether they are healthy, says Susan Krebs-Smith, who researches diet and other risk factors related to cancer at the National Cancer Institute. Government data, long the only source of information about American eating habits, can have a lag of several years and neglect entire categories of new types of products - Greek yogurt or energy drinks, for example. With those significant gaps, the government information fails to account for the rapid change now seen in the marketplace. Now more than ever, companies are reformulating products on the fly as they try to make them healthier or better tasting. While consumers may not notice changes in the ingredient panel on the back of the package, the UNC study will pick up small variations in individual items and also begin to be able to tell how much the marketplace as a whole is evolving. “When we are done we will probably see 20 percent change in the food supply in a year,” Popkin says. “The food supply is changing and no one really knows how.” For example, the researchers have found that there has been an increase in using fruit concentrate as a sweetener in foods and beverages because of a propensity toward natural foods, even though it isn't necessarily healthier than other sugars. While the soda and chocolate milk have more calories on average than the government thought, the federal numbers were more accurate on the calories in milk and cereals. Popkin and his researchers are hoping their project will only be the beginning of a map that consumers, companies, researchers and even the government can use, breaking the data down to find out who is eating what and where they shop. Is there a racial divide in the brand of potato chips purchased, for example, and what could that mean for health? Does diet depend on where you buy your food - the grocery store or the convenience store…

India developing cheap vaccine against major cause of diarrhea deaths in kids

The Indian government announced Tuesday the development of a new low-cost vaccine proven effective against a diarrhea-causing virus that is one of the leading causes of childhood deaths across the developing world. The Indian manufacturer of the new rotavirus vaccine pledged to sell it for $1 a dose, a significant discount from the cost of the current vaccines on the market. That reduced price would make it far easier for poor countries to vaccinate their children against the deadly virus, health experts said. Rotavirus, spread through contaminated hands and surfaces, kills about half a million children across the world each year, 100,000 of them in India. At a conference Tuesday, the government announced that Phase III trials of Rotavac proved that it was safe as well as effective. The clinical trial of 6,799 infants at three sites in India showed the vaccine reduced severe cases of diarrhea caused by rotavirus by 56 percent during the first year of life. “The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India,” said Dr. K. Vijay Raghavan, the secretary of the Department of Biotechnology. The vaccine still needs to be licensed before it can be distributed in India and would require further approval by the World Health Organization before it could be distributed globally. Two other vaccines have proven effective against rotavirus, but they are significantly more expensive. The GAVI Alliance, which works to deliver vaccines to the world’s poor, negotiated a significant discount last year with GlaxoSmithKline and Merck, obtaining the rotavirus vaccines from those pharmaceutical companies for $2.50 a dose. The alliance has programs for delivering those vaccines in 14 countries and plans to expand them to 30 countries. Dr. Seth Berkley, the GAVI Alliance’s CEO, said the announcement Tuesday was “a big deal.” “The cheaper the price the more children you can immunize,” he said, adding that it will still take some time before the vaccine is approved for use. In addition, having a third manufacturer for the vaccines would ease supply shortages and could drive down the costs charged by the other manufacturers, he said. “That would make a big difference in terms of changing the marketplace,” he said. Diarrhea is the second leading cause of death among young children in the world after pneumonia. A study of 22,568 children at sites in seven African and south Asian countries that was published Monday in the medical journal The Lancet showed that rotavirus was the leading cause of moderate to severe diarrhea in children under the age of two. The new vaccine was developed from a weakened strain of the virus taken from a child hospitalized in New Delhi more than a quarter century ago. It was the result of a broad global partnership that included the government, the Indian company Bharat Biotech, the Bill and Melinda Gates Foundation and the U.S. Centers for Disease Control and Prevention, among many others. Those involved said the broad cooperation reduced research costs for the manufacturer and helped keep the vaccine inexpensive. “This public-private partnership is an exemplary model of how to develop affordable technologies to save lives,” Bill Gates, co-chair of the Gates Foundation, said in a statement.source : http://www.foxnews.com/health/2013/05/15/india-developing-cheap-vaccine-against-major-cause-diarrhea-deaths-in-kids/