jueves, 12 de junio de 2014

DLPSS|HEALTHCARE NEWS|June 12, 2014 ▲ Laboratory Science, Policy and Practice Program Office


Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services


June 12, 2014


View Previous Issues - Healthcare News Archive


Sebelius Hands Reins to Successor

Kathleen Sebelius handed leadership of the Health and Human Services Department to her successor on Monday and wished new Secretary Sylvia Matthews BurwellExternal Web Site Icon the best of luck. Sebelius, who oversaw the passage and implementation of ObamaCare at the agency, is concluding an up-and-down tenure. “Congrats and good luck to my friend Sylvia Mathews Burwell!” she said in a message on TwitterExternal Web Site Icon. She also expressed her gratitude to the HHS staff. Burwell went through a very quick and relatively painless nomination hearing to replace Sebelius. Last week she was appointed by the Senate in a 78-17 voteExternal Web Site Icon with 20 Republicans crossing the aisle to support her.


HealthCare.gov Gets a Redesign for Obamacare Enrollment’s 1st Birthday

HealthCare.gov is getting a makeover ahead of open season in November, when residents of 36 states may use the site to acquire or change their health care plans. The overhaul should make it faster and easier for consumers to determine their eligibility for insurance plans and simplify the sign-up process in general for most applicants, according to WiredExternal Web Site Icon, which got a preliminary outline of the redesign from the Centers for Medicare and Medicaid Services, the agency that operates the site. Running on Amazon Web Services, the site’s main page will have a new look and be optimized for mobile devices, according to The Wall Street JournalExternal Web Site Icon, which obtained slides from a recent presentation to insurers.


Inside the Beltway: CMS Covers Hepatitis C Test, but Mix of Lab, POC Testing Unclear

The Centers for Medicare & Medicaid Services announced June 2 it will cover screening for hepatitis C virus, a test that can be done in a physician's office thanks to the fact that OraSure Technologies (Bethlehem, Pennsylvania) has an FDA approved rapid test for the virus called OraQuick. The news bodes well for the firm, but exactly how much of the new demand for hepatitis C testing will go to labs and how much to the OraQuick remains to be seen.
As was the case in the draft coverage memo, the final memo not only addresses high-risk populations, but also all Baby Boomers as they become eligible for Medicare. CMS said it will cover "FDA approved/cleared laboratory tests" when those tests are used "in compliance with the Clinical Laboratory Improvements Act (CLIA) regulations," but the agency states later in the memo it would decline to spell out that point-of-care (POC) tests are also covered despite comment expressing concern over the potential for confusion.


Opening Up

The US Food and Drug Administration has launched openFDAExternal Web Site Icon, a new initiative that the agency says will make it easier for researchers, web developers, and the public access its large datasets. According to a press release from FDAExternal Web Site Icon, openFDA uses an API to collect and search through publicly available data. This initial pilot phase dataset includes some 3 million reports on adverse drug events and medication errors reported to FDA between 2004 and 2013.  The Hill addsExternal Web Site Icon that this move toward making medical data more accessible isn't only occurring at FDA; it notes that a number of drug makers and the National Institutes of Health have released clinical trial data to try to find new uses for existing drugs.


Independent Assessment of the Process for the Review of Device Submissions; Final Comprehensive Findings and Recommendations and First Implementation Plan

The Food and Drug Administration (FDA) is announcing Booz Allen Hamilton's final comprehensive findings and recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years (FYs) 2013-2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The final comprehensive findings and recommendations are the last of a series of deliverables, as outlined in the contract statement of work, to be published as part of Phase 1 of the assessment.


N.I.H. Seeks $4.5 Billion to Try to Crack the Code of How Brains Function

The National Institutes of Health set an ambitious $4.5 billion price tag on its part of President Obama’s Brain Initiative, stamping it as an effort on the scale of the Human Genome Project. “This is a realistic amount of money,” said Dr. Eric R. Kandel, director of the Kavli Institute for Brain Science at Columbia University, who, like some other neuroscientists, had been skeptical of what could be accomplished with the funding committed when the initiative was announced about a year ago. Gerald Rubin, the executive director of the Janelia Farm Research Campus in Virginia, also found that this budget request allayed some of his concerns, but not all. “I am much more concerned about convincing Congress to fund the Brain Initiative at this level,” he said. The institutes currently spend about $4.5 billion a year on existing neuroscience research. Dr. Francis S. Collins, director of the N.I.H., embraced the Brain Initiative with open arms, set up an all-star working group to study what research was needed and supported efforts to set a broad neuroscience agenda for the coming decade.


NASA Astronaut, NIH Officials Discuss Medical Research Being Done on Space Station

NASA astronaut Michael Hopkins met Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases on Tuesday at National Institutes of Health (NIH) campus in Bethesda, Maryland, where they discussed the importance of research taking place aboard the International Space Station, including NIH-funded investigations. Hopkins and his crewmates performed hundreds of experiments during Expeditions 37 and 38, including many with implications for health and medicine on Earth.
NASA astronauts have worked with NIH researchers to conduct experiments on the space station for more than a decade. Most recently, an investigation into T-cell activation in aging – a research package developed by former NASA space shuttle crew member Millie Hughes-Fullord, who now is at the Veterans Health Research Institute in San Francisco – launched to the orbiting laboratory aboard the third SpaceX commercial resupply flight April 18. Hughes-Fullord and her team will examine how the human immune system changes in space. The study could help researchers develop more effective means for disease prevention in the aging population, cancer patients and astronauts. 


Sphere Medical’s Real-Time In-Line Blood Analyzer Gets a Go in Europe

It’s often important to monitor the various levels of analytes in a hospitalized patient’s blood. This normally requires blood draws that are then placed in a nearby device or are sent to the hospital’s lab for analysis, a process that takes considerable time and delivers slow results. Sphere Medical out of Cambridge, England just received European CE Mark approval for its Proxima arterial blood analyzer, a device that provides real-time results of blood gas, hematocrit, and electrolyte measurements as often as necessary. Once a reading is performed, the sampled blood is returned back into the patient. 


Many Lyme Tests Unnecessary, Experts Say

A new Lyme disease testing report by investigators from the Centers for Disease Prevention and Control found that 62% of the 3.4 million serologic tests done by large commercial laboratories nationwide in 2008 adhered to the recommended 2-tiered antibody testing approach. However, just12% of the 2.4 million patients tested were infected with Borrelia burgdorferi, the researchers report in an article published onlineExternal Web Site Icon May 30 in Clinical Infectious Diseases.
"We've known that Lyme disease is a very big public health problem," lead author Alison F. Hinckley, PhD, from the CDC's Division of Vector-Borne Diseases, Fort Collins, Colorado, toldMedscape Medical News. "With these new data, we now also know that Lyme disease is considered commonly by health practitioners and that most of the testing by these large laboratories is in accordance with diagnostic recommendations." Dr. Hinckley said the number of reported cases in the United States has remained relatively stable since 2008 and that the researchers think the rate of infection has likely remained fairly consistent. The 12% infection rate raised questions about whether better use of clinical and exposure history might have reduced the $492 million estimated cost for testing. 


Four New Genes Confirmed to Increase Familial Breast Cancer Risk

Through the efforts of researchers at Huntsman Cancer Institute (HCI) at the University of Utah, who lead an international consortium working to find more gene mutations that cause inherited breast cancer susceptibilities, four new genes have been added to the growing list of those known to cause increased breast cancer risk when mutated.
“BRCA1 and BRCA2 aren’t the whole story when it comes to inherited breast cancer risk. We’ve known for a long time that more genes had to be responsible and several have since been discovered, by us and by others,” according to Sean Tavtigian, PhD, one of three joint-principal investigators on the study. “Originally, the gene we are currently studying, called RINT1, was not considered a human cancer susceptibility gene. But then we discovered there was a two- to threefold increase in risk for breast cancer in families that carry a mutation in that gene.” The RINT1 findings were published recently in the journal Cancer DiscoveryExternal Web Site Icon.


New Test Predicts if Breast Cancer Will Spread

A test that counts the number of locations in tumor specimens where tumor cells may invade blood vessels predicted the risk of metastasis for the most common type of breast cancer. The study was led by researchers at the National Cancer Institute (NCI)—designated Albert Einstein Cancer Center of Albert Einstein College of Medicine of Yeshiva University and Montefiore Einstein Center for Cancer Care and was published online today in the Journal of the National Cancer Institute (JNCI). "Tests assessing metastatic risk can help doctors identify which patients should receive aggressive therapy and which patients should be spared," said Thomas Rohan, M.D., Ph.D., the lead and corresponding author of the study and professor and chair of epidemiology & population health at Einstein and Montefiore.
To measure the test's effectiveness, the researchers used it on about 500 breast tumor specimens that had been collected over a 20-year period. The test proved more accurate in predicting the risk of distant tumor spread than a test closely resembling the leading breast cancer prognostic indicator on the market. The paper is titled "Tumor Microenvironment of Metastasis and Risk of Distant Metastasis of Breast Cancer." 


Babies May Get Allergy Protection From Cats, Even Roaches

Cockroaches might not seem to have much in common with farm animals. But a new study suggests urban newborns who share their homes with cockroaches, mice and cats might get the same kind of protection from allergies and asthma that farm children seem to get from the animals in their barns. The finding, published in the Journal of Allergy and Clinical Immunology, is no reason to stop exterminating cockroaches, researchers say. But it is the latest evidence for the "hygiene hypothesis" — the idea that allergies might be increasing because many children today grow up in relatively sterile environments. Immune systems that don't have to fight off many germs end up doing battle with harmless pollens, dust mites and animal dander instead, the theory goes.


Small eGFR Drops May Predict Kidney Outcomes

Declines in estimated glomerular filtration rate (eGFR) smaller than those that currently attract clinical attention may help predict the risk of end-stage renal disease (ESRD), researchers reported. In an analysis of data from the CKD Prognosis Consortium, a 30% decline in eGFR over 2 years was tied to a five -fold increase in risk of ESRD, Josef Coresh, MD, PhD, of Johns Hopkins University, and colleagues reported online in the Journal of the American Medical Association.


Semen Test for Prostate Cancer May Improve Diagnosis, Study Says

Semen contains prostate cancer biomarkers that could over time improve diagnosis of the condition, a group of Australian researchers said. After analyzing seminal fluid samples from 60 men, the researchers discovered tiny molecules called microRNAs known to be elevated in prostate cancer. Some of the molecules were “surprisingly accurate” in detecting the cancer and its severity, according to a study published in the journal Endocrine-Related Cancer. “While the PSA test is very sensitive, it is not highly specific for prostate cancer,” said Luke Selth, a research fellow at the University of Adelaide and the lead author of the study. “We have a long way until we can potentially use these biomarkers in a clinical test -- but it’s a promising development.”


Camels Confirmed as Source of Human MERS Infection

Saudi Arabian doctors say they've identified camels as one source of MERS infections in humans. The scientists report they matched genetic samples from the virus that killed a Saudi man last November to virus samples present in one of nine camels that he owned. They said the finding, published in the June 5 issue of the New England Journal of Medicine, proves that camels are a source -- but perhaps not the only source -- of the Middle East Respiratory Syndrome (MERS) virus. The illness is contagious, potentially lethal and has been largely confined to the Middle East so far.


Single Dose of Antibiotic Found Effective in Quelling MRSA

A single infusion of an antibiotic can clear serious bacterial skin infections — including methicillin-resistant Staphylococcus aureus, or MRSA — just as effectively as the 10-day regimen now used to treat patients, researchers reported. Many patients do not finish the complicated treatment for these infections, which requires two infusions of antibiotics daily, often in a hospital. Such incomplete treatments may breed resistance to antibiotics in surviving bacteria. A single-dose therapy may make it easier to treat these dangerous infections, said the authors of the new study, published in The New England Journal of Medicine.


In a First, Test of DNA Finds Root of Illness

Joshua Osborn, 14, lay in a coma at American Family Children’s Hospital in Madison, Wis. For weeks his brain had been swelling with fluid, and a battery of tests had failed to reveal the cause. The doctors told his parents, Clark and Julie, that they wanted to run one more test with an experimental new technology. Scientists would search Joshua’s cerebrospinal fluid for pieces of DNA. Some of them might belong to the pathogen causing his encephalitis. The Osborns agreed, although they were skeptical that the test would succeed where so many others had failed. But in the first procedure of its kind, researchers at the University of California, San Francisco, managed to pinpoint the cause of Joshua’s problem — within 48 hours. He had been infected with an obscure species of bacteria. Once identified, it was eradicated within days. The case, reported inThe New England Journal of Medicine, signals an important advance in the science of diagnosis. For years, scientists have been sequencing DNA to identify pathogens. But until now, the process has been too cumbersome to yield useful information about an individual patient in a life-threatening emergency.


Low Rate of Cholesterol Testing for Children, Adolescents

Although some guidelines recommend lipid screening for children and adolescents of certain ages, data indicate that only about 3 percent are having their cholesterol tested during health visits, according to a study in the May 7 issue of JAMA, a theme issue on child health. This issue is being released early to coincide with the Pediatric Academic Societies Annual Meeting.
Abnormal lipid values occur in 1 in 5 U.S. children and adolescents, and are associated with cardiovascular disease in adulthood. Universal pediatric lipid screening is advised by the National Heart, Lung, and Blood Institute (NHLBI) for those ages 9 to 11 years and 17 to 21 years, in addition to the selective screening advised by the American Academy of Pediatrics (AAP) and the American Heart Association. In contrast, the U.S. Preventive Services Task Force (USPSTF) did not find sufficient evidence to recommend any pediatric lipid screening, according to background information in the article. "Testing rates did not appear to increase after 2007-2008, perhaps reflecting the conflicting positions of the AAP and USPSTF," the authors conclude.


Tumor Exome Gene Sequencing Now Available for Fixed, Embedded Tissue

It seems like it's been a relatively long time in coming but there is now a "platform" for analyzing the entire exome of a patient's cancer and deriving therapeutic recommendations from the information (see: Making Sense of the Tumor ExomeExternal Web Site Icon). Here is an excerpt of the article describing the scenario: 
In the march toward personalized medicine, genotyping cancers has become more and more complex.Panels that pick up variations in hundreds of potentially important genes can help physicians determine how a particular tumor operates and the best course of treatment. Whole-exome sequencing...has been somewhat of a pipe dream for clinical oncology, but a [recent] study ...in Nature MedicineExternal Web Site Icon [introduced] a platform for analyzing the entire exome of cancer patients’ tumors....The new whole-exome platform extracts DNA from a preserved tumor sample, sequences all of the coding regions in the genome, and runs the data through an algorithm that can make sense of the variations uncovered and pick out those for which an available treatment might be appropriate. 


H10N8 Strain of Bird Flu Is 'Not a Current Threat to Public Health'

The recent H10N8 strain of bird flu is unlikely to result in a public health threat without further mutations in the virus that would allow it to spread between humans.  H10N8 is the latest in a line of continually evolving avian influenza viruses that can cause serious, potentially fatal disease in humans. 
At the Medical Research Council National Institute for Medical Research (MRC-NIMR), researchers have been investigating what potential the H10 family of viruses have for causing a pandemic. The virus will need to change receptor binding preference for more efficient transmission to humans. Where the H10 deviates from the H1 and H7 viruses, though, is in its preference of receptor. H1 and H7 viruses bind up to 100 times more strongly to human receptors than avian receptors. However, the H10 viruses bind with avian receptors about 150 times more strongly than with human receptors.  Receptor Binding by H10 Influenza VirusesExternal Web Site Icon, Sebastien G. Vachieri, et al., Nature, doi:10.1038/nature13443, published online 28 May 2014. 


Ebola’s ‘Fist’: U.Va. Unlocks How Deadly Virus Smashes Into Human Cells

May 30, 2014   Josh Barney
Researchers at the University of Virginia School of Medicine have discovered how the deadly Ebola virus punches its way into the cytoplasm of cells. The finding identifies an important target for blocking the infection process of this incurable disease that many fear may be used for bioterror.U.Va.’s new discovery offers important insight into how the virus works its way into cells. After the virus is engulfed by the cell, it is contained within a vesicle where it can do no harm. But Ebola quickly escapes the vesicle, and now scientists understand how. U.Va. researcher Lukas Tamm of the Department of Molecular Physiology and Biological Physics and his team discovered that the pH level inside the vesicle triggers the surface glycoprotein on the virus to form a “fist” that lets the virus punch its way into the cell’s cytoplasm, where it can effectively turn the cell into a factory for virus production. 
“Once you have visualized the molecular shape changes that these structures undergo upon cell entry, you can see what molecules or potential anti-viral drugs could interfere with this process,” Tamm said. 


Study Shows Ultraviolet Cleaning Reduces Hospital Superbugs by 20 Percent

Healthcare-associated vancomycin-resistant enterococcus (VRE), methicillin-resistantStaphylococcus aureus (MRSA), Clostridium difficile (CD), and other multidrug-resistant organisms (MDRO) were decreased among patients after adding ultraviolet environmental disinfection (UVD) to the cleaning regimen, according to a study published in the American Journal of Infection Control, the official publication of the Association for Professionals in Infection Control and Epidemiology (APIC).
"Use of UVD as an adjunct to routine discharge cleaning of contact precautions rooms was feasible and temporally associated with a significant decrease in hospital-acquired MDRO plus CD in our institution," conclude the authors.


Emory Awarded $7.2M From NIA for Proteomic Research Into Alzheimer's

Emory University said […] that its Alzheimer's Disease Research Center has been awarded a five-year, $7.2 million grant from the National Institute on Aging for research into proteins altered in Alzheimer's disease. The focus of the effort, which the university said will use mass spec to analyze brain tissues collected through several national studies of aging, is to identify new therapeutic targets for the disease. Emory will lead a team that includes researchers from five additional Alzheimer's disease research centers at Rush University, University of California, Los Angeles, University of Washington, University of Pennsylvania and Johns Hopkins University.


New Genetic Sequencing Methods Mean Quicker, Cheaper, and Equally Accurate Embryo Screening

Results from the first study of the clinical application of next generation DNA sequencing (NGS) in screening embryos for genetic disease prior to implantation in patients undergoing in-vitro fertilisation treatments show that it is an effective reliable method of selecting the best embryos to transfer, the annual conference of the European Society of Human Genetics will hear[….] Dr Francesco Fiorentino, from the GENOMA Molecular Genetics Laboratory, Rome, Italy, will say that his team's research has shown that NGS, a high throughput sequencing method, has the potential to revolutionise pre-implantation genetic screening (PGS). The technique can result in reduced cost, faster results, and accurate identification of good embryos resulting in more ongoing pregnancies [….]


Veterans to Benefit From Better Identification of War Wound Infections

War wounds that heal successfully frequently contain different microbial species from those that heal poorly, according to a paper published ahead of print in the Journal of Clinical Microbiology.These and other findings have important implications for improving wound healing, says first author Nicholas Be of Lawrence Livermore National Laboratory, Livermore, California. The problem the researchers were addressing is that culture-based identification, which has been used to assay war wound infections, misses the many species that are difficult or impossible to culture. But Be and his collaborators posited that using microarrays and whole genome sequencing to detect microbial species in wound samples would reveal infections caused by microbes that cannot be cultured, as these molecular methods can detect all species for which reference DNA is available.


Sequence That Bug

After a cheese product was found to be causing illness in consumers, the US Food and Drug Administration matched the Listeria strain in the product to a strain found in one of the processing facilities using genome sequencingExternal Web Site Icon, the agency writes on its Consumer Updates page. "This was the first time we used whole genome sequencing to match the environmental and food samples with the CDC's human biological samples and it helped support the agency in taking regulatory action," says Eric Brown, director of the microbiology division at FDA. "We were able to suspend food production at a facility to minimize an outbreak."


'Healthy' Component of Red Wine, Resveratrol, Causes Pancreatic Abnormalities in Fetuses

New research in The FASEB Journal suggests that although resveratrol improved blood flow through the placenta of macaque monkeys and protected against harmful aspects of obesity, resveratrol injured the fetal pancreas. Here's more evidence that pregnant women should be careful about what they eat and drink: a new research report appearing in the June 2014 issue ofThe FASEB JournalExternal Web Site Icon shows that when taken during pregnancy, resveratrol supplements led to developmental abnormalities in the fetal pancreas. This study has direct relevance to human health — resveratrol, found in red wine and frequently taken as a supplement, is widely used for its recognized health benefits, and is readily available over the counter. 


Analysis Shows Cancer Center Ads Heavy on Emotion, Light on Information

Emotional reactions to cancer center consumer advertisements may lead to unrealistic expectations and inappropriate treatments, according to an article being published in Annals of Internal MedicineExternal Web Site Icon. Researchers conducted a rigorous content review of 409 unique television and magazine advertisements for 102 cancer centers to characterize their informational and emotional content. The analysis showed that the majority of cancer centers (88 percent) promoted cancer treatments rather than screening (18 percent) or supportive services (13 percent). The authors suggest that cancer center ads that evoke emotions of fear and hope may lead patients to pursue care that is either unnecessary or unsupported by scientific evidence. 


Now This Is Disruption: Infusion Services by Your Local Grocery Store

While hospital-owned physician groups have responded by trying to make appointment scheduling more convenient and opening their own urgent care centers, retail clinics have secured a small, but growing, outpatient market share. According to a 2013 study by the Center for Studying Health System ChangeExternal Web Site Icon, 4.1 million American families reported using retail clinics in the previous 12 months, and higher-income families were nearly twice as likely as lower-income families to use retail clinics.
Launched last September by Schnucks, a grocery chain with a large Midwest presence, Schnucks Infusion Solutions' first Ambulatory Infusion CenterExternal Web Site Icon offers infusion therapy to treat a number of conditions including cancer, Crohn's, Multiple Sclerosis and Cystic Fibrosis. The freestanding infusion center offers evening and weekend hours, free Internet, cable TV and snacks, according to an Advisory Board briefingExternal Web Site Icon. It's staffed by registered nurses with certification from the Infusion Nurses Certification Corp., pharmacists and technicians.


Vaccination During 'Optimal Window' Is the Key to Saving Lives and Money in Next Flu Pandemic

Early vaccination could reduce morbidity, mortality, and health care costs associated with pandemic flu, according to an article being published in Annals of Internal Medicine. Response to a 2009 H1N1 pandemic was not optimal, with large-scale vaccination not occurring until nine months after outbreak. Using lessons learned from the 2009 pandemic, researchers sought to determine how quickly vaccination should be completed to reduce infections, deaths, and health care costs in a pandemic with characteristics similar to influenza A (H7N9) and A (H5N1), which are associated with high mortality rates. A delay of just four weeks leads to substantial increases in infection, deaths, and costs.


How Public Health Can Harness Big Data

The hype over Big Data is starting to settle down as it becomes clear that advanced comparative effectiveness and large-scale monitoring are still a ways away. But they are on the horizon, and headway is being made. For health organizations, especially public sector health agencies, there is first the often complicated task of linking disparate pieces of data across multiple sources. For federal, state and local health agencies, from CMS on down to the county health department, there is just as much potential to tear down data silos and start picking fruit that even in the early digital age has been slightly out of reach — from providing citizens with comprehensive web and mobile-friendly information on hospital quality, disease rates, pollution, and mass transit, to transforming how the country cares for the 65 million Americans on Medicaid.
A key to success in learning from big healthcare data “will be to remain focused on our ultimate goal: gaining actionable insights into the best ways to treat the patients in the care system,” as Sebastian Schneeweiss, MD, vice chief of pharmacoepidemiology at Brigham & Women’s Hospital, wrote in the New England Journal of MedicineExternal Web Site Icon 


Doctors Turn to Artificial Intelligence When They’re Stumped

“Electronic health records [are] like large quarries where there’s lots of gold, and we’re just beginning to mine them,” said Dr. Eric Horvitz, who is the managing director of Microsoft Research and specializes in applying artificial intelligence in health care settings. Increasingly, physician practices and hospitals around the country are using supercomputers and homegrown systems to identify patients who might be at risk for kidney failure, cardiac disease or postoperative infections and to prevent hospital readmissions, another key focus of health reform. Increasingly, physician practices and hospitals around the country are using supercomputers and homegrown systems to identify patients who might be at risk for kidney failure, cardiac disease or postoperative infections and to prevent hospital readmissions, another key focus of health reform. 
And they’re starting to combine patients’ individual health data—including genetic information—with the wealth of material available in public databases, textbooks and journals to help come up with more personalized treatments. Wary of the time and expense required for FDA approval, companies engineering the systems – at least for now– are careful not to describe them as diagnostic tools but rather as information banks. “The FDA would be down on them like a ton of bricks because then they would be claiming to practice medicine,” says MIT’s [Dr. Peter] Szolovits. At the moment, he said, the technology isn’t good enough to tell doctors with 100 percent certainty what the best course of treatment for a patient may be. Others agree.


Study: 9 in 10 Wikipedia Articles on Medical Conditions Contain Significant Inaccuracies

Wikipedia is one of consumers' top online sources for health information, and about half of physicians admitExternal Web Site Icon to having used it as a reference. However, a new study published in The Journal of the American Osteopathic AssociationExternal Web Site Iconsuggests the medical information found on Wikipedia is often inaccurate. Researchers analyzed the Wikipedia entries for 10 of the most costly medical conditions in the U.S. The study found "significant discordance" between information presented in nine of the 10 Wikipedia articles and the corresponding medical literature. 


Apple's New Release Features Mayo App

Apple on Monday touted its working with the Mayo ClinicExternal Web Site Icon as it rolled out an app that would piece together healthcare information from many third-party apps – including one from Mayo – to give consumers a comprehensive medical view on a mobile device. Although that data-sharing promises huge potential healthcare benefits, it also raises serious questions about security and privacy. "Who allowed that Mayo data to migrate to that other app?" would be the patient's question. "Our legacy is trusted and affordable care," said Dr. John Wald, the medical director for the Mayo Clinic's public affairs and marketing operation. "If we lose that trusted aspect, we've lost everything. We are committed to maintaining that trust."
Asked about the security and privacy issues surrounding the multi-app data-sharing model, Wald said that Apple has not gotten into many of those details yet. "We are absolutely aware of those concerns," Wald said. "Some of it will evolve over time." But Wald said he preferred this initial model – with technology companies like Apple working with healthcare leaders like Mayo – rather than the typical government legislative dictates. "It will follow all of the HIPAA regulations, but I like that healthcare will be driving some of these decisions. I think this can lead to some better solutions."


Advisory Panel OKs Privacy Standards

The HIT Standards Committee, a federal advisory panel created under the American Recovery and Reinvestment Act, has approved recommendations of its privacy and security workgroup. That moves the recommendations one step closer to being final, although they still face several more hurdles. The recommendations provide technical data standards and guidelines to support privacy and security requirements under the law's meaningful use provisions for certified electronic health record systems. They also clarify where options exist, such as where dual standards are required or an implementer is given a choice between Standard A and Standard B.


A Call To Action for a Nationwide Interoperable Health IT Infrastructure

Today we are pleased to release Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure. This paper describes ONC’s broad vision and framework for interoperability and is an invitation to health IT stakeholders – clinicians, consumers, hospitals, public health, technology developers, payers, researchers, policymakers, and many others – to join ONC in developing a defined, shared roadmap that will allow us to collectively achieve health IT interoperability as a core foundational element of better care, at a lower cost and better health for all. [ONC] will develop a shared agenda that focuses on five critical building blocks for a nationwide interoperable health IT infrastructure:
  1. Core technical standards and functions
  2. Certification to support adoption and optimization of health IT products and services
  3. Privacy and security protections for health information
  4. Supportive business, clinical, and regulatory environments
  5. Rules of engagement and governance
We invite you to read Connecting Health and Care for the Nation Adobe PDF fileExternal Web Site Icon and offer your feedback and ideas for making the vision a reality. Over the coming months we will offer several opportunities to provide input as we shape a national interoperability roadmap and encourage participation from all.

Source: http://www.healthit.gov/External Web Site Icon


Siemens and ASCP Award 173 Scholarships to Medical Laboratory Students in 2014

Siemens Healthcare Diagnostics and the American Society for Clinical Pathology (ASCP) awarded a combined $180,000 in scholarships to the nation’s top undergraduate and graduate medical laboratory students for the 2013-2014 academic year through the Siemens—ASCP Scholarship ProgramExternal Web Site Icon. According to spokespersons, the Program was established to address the nation’s shortage of qualified medical laboratory personnel, to defray education costs, and to promote the profession. Awards are available to eligible students in the U.S. pursuing associate bachelor or master’s degrees in medical laboratory science. Special Legacy Scholarships are awarded to students who follow family members into the laboratory profession. Scholarships are awarded by the ASCP, which also administers the program. 


U.S. Team to Read Pap Tests in Botswana Campaign Against Cervical Cancer

In a volunteer medical outreach venture organized by the American Society for Clinical Pathology (ASCP), Barbara M. Frain, MS, SCT (ASCP), CM, Clinical Assistant Professor at the Indiana University School of Medicine, Indianapolis, and 10 colleagues from around the country are helping medical officials in Botswana work through a backlog of Pap smears. “I’m interested in seeing how they do this in another part of the world, and I hope my skills can help someone out,” said Ms. Frain of the upcoming trip to Gaborone, the capital of Botswana. The Botswana government has initiated a national cervical cancer prevention program, which resulted in a large number of Pap exams but led to a shortage of professionals to read the slides, [….] 


Canada Approves Roche's HPV Test as a First-line Cervical Cancer Screen

Roche announced after the close of the market on Tuesday that Health Canada approved the cobas 4800 HPV Test as a first-line primary screening test for cervical cancer in women at least 25 years old. The announcement follows similar approval of the test by the US Food and Drug Administration in April.


Mosquito-Borne Chikungunya Virus Spreads in the Americas

Since December 2013, when the World Health Organization first reported local transmission of mosquito-borne chikungunya virus in the Western Hemisphere, local transmission has been detected in 17 Caribbean or South America countries or territories, according to a report publishedin the June 6 issue of the Morbidity and Mortality Weekly Report. The disease is seldom fatal but often debilitating, and the concern is that imported cases could spread locally‏. In the 2 weeks preceding May 30, the number of reported cases nearly doubled.
"Chikungunya virus is a mosquito-borne alphavirus transmitted primarily by Aedes aegypti andAedes albopictus mosquitoes," write Marc Fischer, MD, and J. Erin Staples, MD, from the Arboviral Diseases Branch, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC). "These vectors also transmit dengue virus and are found throughout much of the Americas, including parts of the United States. Humans are the primary amplifying host for chikungunya virus, and most infected persons develop symptomatic disease."
Source: http://www.medscape.com/External Web Site Icon


Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.

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