viernes, 27 de septiembre de 2013



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards


September 26 2013

View Previous Issues - Healthcare News Archive

Office of Civil Rights (OCR) Delays Required Changes to Notices of Privacy Practices for Laboratories

The HHS Office of Civil Rights (OCR) has granted certain clinical laboratories a temporary reprieve from the requirement to update their Notices of Privacy Practices (NPPs) by September 23, 2013, the deadline imposed by the HIPAA Omnibus Rule. As a result, OCR will not take enforcement action or impose civil money penalties against laboratories that have not revised their NPPs by the deadline. Additionally, OCR plans to issue a public notice at least 30 days in advance of the end of the enforcement delay. This enforcement delay, however, does not apply to laboratories that operate as a part of a larger covered entity (e.g., a hospital) because those laboratories do not have NPPs separate from the larger entity.
The HIPAA Omnibus Rule requires that all covered entities make significant updates to their NPPs, including adding statements regarding:

  • the prohibition on the covered entity’s sale of personal health information (PHI) without an individual’s authorization;

  • permissible uses of certain PHI for marketing communications (pursuant to limitations on third-party funding of such marketing communications);

  • permissible uses of certain PHI for fundraising purposes, along with the patient’s opt-out rights from such fundraising communications;

  • the individual’s rights to restrict covered entity communications of PHI to health plans when he or she has paid for services out-of-pocket;

  • an individual’s right to receive copies of PHI delivered either to the individual or to a third party identified by the individual, if maintained in that form by the covered entity;

  • the covered entity’s obligation to account for treatment, payment and health care operation disclosures if it maintained an electronic health record after January 1, 2007; and

  • the individual’s right to receive notification in the event of a breach as well as the covered entity’s ability to use PHI to provide such breach notifications.

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Most Federally Run Exchanges Will Offer More Plans, Lower Premiums Than Expected, HHS Report Shows

An eagerly awaited report by HHS released on health plan premiums and participation in the 36 states where the federal government is fully or partly running the new insurance exchanges shows that consumers in most of those states will have many plans to choose from and that premiums will be significantly lower than expected in 2014. The number of local plan choices available to consumers on the federally facilitated exchanges will range from six to 169. On average, there are eight different health insurers participating in each of the exchanges, ranging from one to 13. The report found that premiums tend to be lower in states with more participating insurers. The new HHS report, combined with previous reports from states running their own exchanges that showed similar results, bolsters the Obama administration's case that the Patient Protection and Affordable Care Act is achieving its goal of fostering competition in the health insurance marketplace and producing affordable premiums for consumers. The HHS report provides an unprecedented look at health plan premiums within and across states, presenting weighted average premiums for all federally approved bronze- and silver-tier plans in 48 states.

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U.S. Government Scales Back Obamacare Impact for 2014

The U.S. government scaled back its projections for Obamacare's impact in 2014, saying the law would generate slower healthcare spending growth and provide coverage to only half as many of America's uninsured as anticipated last year. The biggest factor in the change stems from the U.S. Supreme Court verdict last year allowing each state to decide whether to expand the public Medicaid program for the poor under President Barack Obama's healthcare reform law. Republican leaders in nearly half of the nation's 50 states have rejected the expansion. The U.S. Department of Health and Human Services now expects 11 million uninsured Americans to obtain coverage next year, down from about 22 million projected a year ago, according to the report, which appeared in the journal Health Affairs. It said healthcare spending would rise 6.1 percent in 2014, partly due to the implementation of Obamacare, compared with a previous projection of an increase of 7.4 percent.

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FDA Opens a Smart Phone Unit

The FDA is in the App Store, or at least its regulators are browsing the store. Noting that some smart phone apps are now functioning as diagnostic devices, the FDA said that it will begin regulating apps that meet its criteria as diagnostic devices. Translation: calorie counters are off the FDA radar, ultrasound readers are fair game.

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UDI Rule Is Here, but Is it Enough?

The Food and Drug Administration announced a long-awaited final rule for the unique device identification system intended to provide a consistent way to identify medical devices. The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule, FDA officials said in announcing the final rule.

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FDA and NIH Create First-of-kind Tobacco Centers of Regulatory Science

The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as part of an on-going interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research in fiscal year 2013 to create 14 Tobacco Centers of Regulatory Science (TCORS). Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease. A new, first-of-its-kind regulatory science tobacco program, TCORS is designed to generate research to inform the regulation of tobacco products to protect public health. Using designated funds from FDA, TCORS will be coordinated by NIH’s Office of Disease Prevention, directed by David M. Murray, Ph.D., and administered by three NIH institutes — the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung, and Blood Institute.

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New York Genome Center Officially Launches in Manhattan

The New York Genome Center officially launched at its new facility in downtown Manhattan with a ribbon-cutting ceremony that featured statements by NYGC President and Scientific Director Robert Darnell and New York City Mayor Michael Bloomberg. Nearly two years after the plan for the center was unveiled, NYGC has effectively completed the build-out of its seven-floor, 170,000-square-foot facility, and it is currently working to hire the bioinformatics, genome sequencing, and lab specialists who will fill the space. The center is actually a consortium of 16 institutional members, mostly academic research institutions and hospitals from the New York region, as well as Jackson Laboratory, and each of the faculty members on its staff will hold joint appointments with both NYGC and their home institution.

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As Healthcare Systems Make Patient Safety a Greater Priority, the Public Reporting of Pathology Errors in Canada Has No Comparable Track Record in the United States

Errors in anatomic pathology testing in the Canadian provinces of Nova Scotia and Saskatchewan made media headlines this summer. In each case, it was just a limited number of cases where errors at pathology labs resulted in inaccurate diagnoses and, in at least one case, a needless mastectomy for a patient. At a time when health systems in Canada, the United States, and other developed nations are giving great emphasis to patient safety, disclosure of life-changing diagnostic errors to patients is appropriate. Consumers are holding physicians—including surgical pathologists—to a higher standard of care.

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Advance in Using Biopsy Samples in Understanding Environmental Causes of Cancer

In an advance in determining the role of environmental agents in causing cancer, scientists described development of a long-sought way to use biopsy samples from cancer patients to check on human exposure to substances that damage the genetic material DNA in ways that can cause cancer. Their report on the method, which taps into a treasure trove of medical information in biopsy samples of patients, was part of the 246th National Meeting of the American Chemical Society (ACS), the world's largest scientific society. "This is the first successful use of archived biopsy samples in analyzing exposure and DNA damage, by mass spectrometric methods, of cancer patients to an environmental carcinogen," said Robert J. Turesky, Ph.D., who led the research. "It clears the way for use of this huge resource of archived biopsy samples for gaining insights into cancer and other diseases."

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Study Finds as Many as One-Third of Patients Have Unnecessary Repeat Lipid Testing, a Conclusion That Supports the Experiences of Clinical Laboratory Pathologists

Up to one-third of coronary heart disease (CHD) patients undergo lipid testing that may be unnecessary. This is one finding from a credible study involving 28,000 patients that could focus more attention on the overuse of lipid tests and similar medical laboratory tests by physicians. Most pathologists and clinical laboratory managers will welcome the findings of this study. It is widely recognized within the laboratory medicine profession that many physicians regularly order inappropriate medical tests. This has been a problem for decades and is the source of much wasteful spending. The lipid testing study is significant because of the large volume of lipid tests performed annually in the United States. Any attention to this problem can help improve utilization of this important test and result in substantial savings to the healthcare system.

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The Simple Test That Saved My Baby

The pregnancy was without complications. The delivery itself lasted all of 12 minutes. After a couple of days at Greenwich Hospital in Connecticut, we were packing up when a pediatric cardiologist came into the room. We would not be going home, she told us. Our son had a narrowing of the aorta and would have to be transferred to the neonatal intensive care unit at NewYork-Presbyterian Hospital at Columbia, where he would need heart surgery. It turned out that our son was among the first in Connecticut whose lives may have been saved by a new state law that requires all newborns to be screened for congenital heart defects. It was just by chance that we were in Connecticut to begin with. We live in New York, where such tests will not be required until next year. But our doctors were affiliated with a hospital just over the border, where the law took effect Jan. 1. As we later learned, congenital heart problems are the most common type of birth defect in the United States. The Centers for Disease Control and Prevention estimate that about one in 555 newborns have a critical congenital heart defect that usually requires surgery in the first year of life.

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NIH Scientists Develop New Tests to Detect Drug-Resistant Malaria

Researchers have developed two tests that can discern within three days whether the malaria parasites in a given patient will be resistant or susceptible to artemisinin, the key drug used to treat malaria. The tests were developed by researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, working with French and Cambodian colleagues in Cambodia. They offer a more rapid, less costly advantage over current drug-responsiveness tests, which require malaria patients to be hospitalized for blood draws every six hours over the course of several days. In both tests, young parasites are briefly exposed to a high dose of artemisinin, mimicking the way parasites are exposed to the drug in people being treated for malaria, and their survival is measured 72 hours later.

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Simplifying the Diagnosis of Urinary Tract Infections

Researchers in Amsterdam offer a sophisticated analysis of different approaches to diagnosing acute uncomplicated urinary tract infections in women and propose a model that reduces the number of questions asked and urine investigations needed.  Analyzing data on 196 women presenting with painful and/or frequent micturition, researchers find that three questions, sometimes followed by a urine dipstick test, can provide a practical level of accuracy.
Specifically, they recommend asking:

  1. does the patient think she has a UTI

  2. is there at least considerable pain on micturition and

  3. is there vaginal irritation?

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Testing Child’s Urine may Help Doctors Identify Risk for High Blood Pressure

Measuring sodium in a child’s urine may help doctors identify those at risk for having high blood pressure later in life, according to a study presented at the American Heart Association High Blood Pressure Research Scientific Sessions 2013. In a small study, researchers used a new protocol to quickly screen 19 children who were 10-19-year-olds. Researchers found that of the eight who retained sodium seven had high blood pressure. The inability to properly excrete sodium in the body can occur during stress, such as when kids get nervous while in a doctor’s office, so the children were asked to provide a urine sample before and after their visit to a physician. Sodium retention increases fluid in the blood vessels, which can impact blood pressure. High blood pressure can develop over time if the body can’t properly regulate sodium, and is a serious risk factor for heart disease and stroke.
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New Test Rapidly Distinguishes Viral, Bacteria Infections

A new test that analyzes patients' immune responses, rather than the pathogens themselves, can rapidly distinguish viral infections from bacterial infections, according to an article published in the September 18 issue of Science Translational Medicine. If carried into clinical use after further evaluation, the assay could help physicians better decide which patients need antibiotics and avoid inappropriate prescribing of antibiotics to patients who will not benefit. Aimee K. Zaas, MD, MHS, associate professor of medicine at the Duke Institute for Genome Sciences and Policy, Durham, North Carolina, and colleagues previously reported that they could classify individuals according to respiratory viral infections based on microarray profiles of blood samples — work that has been reproduced by other researchers. In the current study, the researchers used a Taqman low-density array (TLDA) platform to develop a reverse transcription–polymerase chain reaction (RT-PCR) assay and a predictive algorithm to test the blood of patients presenting with infection symptoms.

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Urinary Pneumococcal Antigen Testing ‘Useful in Children’

Urinary antigen testing is effective in detecting invasive pneumococcal pneumonia in children, say the authors of a UK-based case–control study. The study involved 160 children under the age of 16 years (median 2.6 years) with radiologically confirmed pneumonia, and 122 control children who gave urine samples while attending the pediatric renal service. The team, led by Mohamed Elemraid from the Great North Children’s Hospital in Newcastle upon Tyne, found that children with pneumonia were significantly more likely to test positive for urinary pneumococcal antigen than controls, at 28.3% versus 7.4%. This finding was also true among the youngest patients, under the age of 5 years, for whom the respective rates were 23.5% and 9.5%.

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New Test Enables Early Diagnosis of Liver Cancer

They have developed a test that will help pathologists clearly distinguish early liver cancer cells from nearly identical normal liver cells by giving them a distinctive red-brown hue. The inability to definitively tell the difference often means the disease is detected late when treatment options are less effective, said Dr. Ravindra Kolhe, pathologist and Medical Director of the Georgia Esoteric, Molecular Labs, LLC, at the Medical College of Georgia at Georgia Regents University. "There is no definitive test for early diagnosis of liver cancer," said Kolhe, lead author of the study being presented at the American Society of Clinical Pathology 2013 Annual Meeting in Chicago, Sept. 18-21. "Our test adds a level of comfort for making the diagnosis."

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Screening Test Evaluated for Early Detection of Ovarian Cancer

A protein that has long been recognized for predicting ovarian cancer recurrence now shows promise as a screening tool for the initial phases of the disease. The simple blood test could offer a much-needed screening tool to detect ovarian cancer in its early stages, even in the most aggressive forms, in postmenopausal women at average risk for the disease. Scientists at the MD Anderson Cancer Center (Houston, TX, USA) collaborating with other institutions, enrolled 4,051 women from seven sites across the USA, for a prospective, single-arm, 11-year study.

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New Test Can Help Detect Breast Cancer a Decade Before it Develops

Imagine being able to detect breast cancer a decade before it develops. Doctors are saying that dream may soon become a reality with a new test called ForeCYTE. “The idea is to get cells from the ducts of the breast – that's where most cancers form,” said Dr. Jonathan Herman, OB-GYN for Elite Women’s Healthcare in Hyde Park, NY.  “We pump the breast (with a special breast pump) and collect that on a very thin membrane, put a fixative on it and send that off to get to the lab."

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Study Supports Potential of PCR-based Blood Test for Respiratory Virus Infection

In a study appearing online in Science Translational Medicine, researchers from Duke University and elsewhere described a gene expression signature assay that's showing promise for distinguishing individuals with viral infections, such as influenza, from those with bacteria-based maladies. Using a few dozen genes that show differential expression in blood samples from those with acute respiratory viral infections, the team came up with a reverse transcription PCR assay based on a TaqMan low-density array system to detect viral infection. From their findings so far, those involved believe the approach may eventually yield an alternative or complement to tests designed to pick up the presence of a particular pathogen in infected individuals.

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Markers in Blood May Help Assess Alzheimer's Risk

Researchers appear to be homing in on clinically useful blood-based biomarkers indicating risk of Alzheimer's disease in mildly impaired or asymptomatic individuals, several presentations here indicated. Serum or plasma levels of apolipoprotein E (apoE), complexes of albumin and beta-amyloid protein, and a mystery substance described only as "protein Z" showed significant correlations with Alzheimer's disease pathology and/or progression of cognitive impairment to overt dementia in separate studies reported at the World Congress of Neurology in Vienna. Meanwhile, another study presented here confirmed that levels of beta-amyloid and tau proteins in cerebrospinal fluid (CSF) can be used with high sensitivity and specificity to predict conversion of mild cognitive impairment to clinically definite Alzheimer's disease. At this point, CSF markers still outperform any blood-based factor for gauging dementia risk but are less than optimal for screening purposes because of the pain and risks associated with lumbar puncture. As a result, interest in blood biomarkers remains strong.

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High Serum Calcium Linked to Developing Diabetes: IRAS Study

High concentrations of serum calcium—but not necessarily calcium intake—are associated with an increased risk of developing type 2 diabetes, results from the Insulin Resistance Atherosclerosis Study(IRAS) show. Moreover, calcium concentration appears to act independently of glucose, insulin secretion, and insulin resistance, according to Dr Carlos Lorenzo (University of Texas Health Science Center, San Antonio).

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NanoString Technologies Receives FDA 510(k) Clearance for Prosigna™ Breast Cancer Prognostic Gene Signature Assay

The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years, and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score, or ROR Score, in the scientific literature, including the TransATAC study recently published in the Journal of Clinical Oncology) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate or high risk, while node-positive patients are classified as low or high risk.

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CDC, NYC Dept. of Health, Scholars Respond to IOM Report on Sodium

The Centers for Disease Control (CDC) and the New York City Department of Health and Mental Hygiene (NYC DOHMH) have published their first official responses to a controversial Institute of Medicine (IOM) report that challenged current national guidelines recommending sodium intake as low as 1,500 milligrams for many Americans. The responses, whose authors include CDC Director Thomas Frieden and NYC DOHMH Commissioner Thomas Farley, will be published on September 16 in a series of commentaries and editorials in American Journal of Hypertension. They argue that the CDC and NYC DOHMH should - and will - continue to promote current established guidelines for reduced sodium intake despite the IOM's findings, which may suggest that those guidelines are not only ineffective at controlling hypertension, but could actually generate other public health risks.

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Want to Better Understand the Accuracy of Your Human Genome Sequencing?

As new high-throughput "Next Generation" DNA sequencing methods are moving into clinical applications, understanding accuracy of variants is critical. Numerous recent studies have demonstrated that different sequencing and bioinformatics analysis methods can result in very different variant calls, often at 100,000's of positions across the human genome. With help from the Genome in a Bottle Consortium ( and the FDA, NIST is developing well-characterized whole human genomes as Reference Materials, as well as the methods to use these Reference Materials to understand performance of sequencing and bioinformatics methods, including false positive and false negative rates.

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Gene Sequences of Deadly Saudi Virus Show Complex Transmission

Genetic analysis of samples of the deadly MERS virus that has killed 58 people in the Middle East and Europe shows the disease has jumped from animals to humans several times, scientists said .After conducting genome sequencing studies of the virus - from the same coronavirus family as the one that caused SARS a decade ago, British and Saudi researchers found several infection transmission chains and said they painted a picture of what they called lively "pathogenic chatter" between species. "Our findings suggest that different lineages of the virus have originated from the virus jumping across to humans from an animal source a number of times," said Paul Kellam, a professor of viral pathogenesis at Britain's Sanger Institute and University College London (UCL), who led the research.

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Gene Therapy With a Difference

The idea behind exon skipping is an ingenious one: a disease can be cured, or at least ameliorated, not by replacing a defective gene, as is done in gene therapy, but by correcting it. “We’re sort of manipulating what the gene is ultimately making,” said Adrian R. Krainer, a professor of molecular genetics at the Cold Spring Harbor Laboratory. Hopes for the new technique suffered a big blow when the results of the first large randomized clinical trial of a drug designed to induce exon skipping were announced. The drug, called drisapersen, was no better than placebo in preserving muscle function of boys with Duchenne muscular dystrophy.  The announcement was devastating to some parents of boys with muscular dystrophy and has raised questions about whether exon skipping will ever work. But some scientists and parents of children with muscular dystrophy said it was too early to write off the technique.

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Live Imaging Reveals for the First Time Gene Motion in Cell Nucleus

An international team of scientists led by the UK’s John Innes Centre and including scientists from Australia, Japan, the US and France has perfected a way of watching genes move within a living plant cell. Using this technique scientists watched glowing spots, which marked the position of the genes, huddle together in the cold as the genes were switched “off”. “The movement of genes within the nucleus, captured here using live imaging, seems to play a role in switching their activity on and off”, said first author Stefanie Rosa from the John Innes Centre. “What is remarkable about this finding is that we saw genes move in response to changes in the environment, and that this movement seems to be involved in genetic control,” said Associate Professor Josh Mylne.

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Early Detection, ART Decreased HIV Transmission

Patients who were given early access to antiretroviral therapy (ART) decreased their HIV transmission risk by as much as 90% in a recent study, highlighting the importance of early detection and treatment, according to researchers. “Such a protective effect of early ART against HIV transmission had been previously demonstrated among the specific population of stable serodiscordant couples, but the present study enlarges this result to a more general population of people living with HIV,” Kévin Jean, a PhD candidate in public health epidemiology at Université Versailles Saint-Quentin, France, told Infectious Disease News.

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Gene Discovery Could Lead to New Types of HIV Treatments

Scientists have identified a gene which they say may have the ability to prevent HIV, the virus that causes AIDS, from spreading after it enters the body. In an early-stage study in the journal Nature, researchers said the gene, called MX2, appears to play a key role in how HIV is controlled in human cells, so using it could lead to the development of new, less toxic treatments that harness the body's natural defenses and mobilize them against the virus.

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In Life, Man Immune to HIV Helped Scientists Fight Virus

Stephen Crohn, a man best known for staying alive during the early days of the AIDS epidemic, died Aug. 23 at age 66. Throughout his lifetime, the New York artist helped researchers uncover vital clues about HIV and how to stop it. Crohn's partner was one of the first people to die from AIDS in 1978. Over the years, Crohn watched boyfriends and acquaintances die from the disease. But he never got sick. Knowing that there was something unique about himself, Crohn volunteered to be studied. Eventually, scientists realized that Crohn had a genetic anomaly that made him resistant to HIV infection. Less than 1 percent of the population carries this protective mutation.

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Russian Mushrooms Kill HIV, Institute Says

A treatment for HIV may be found in Siberian mushrooms that have been used in Russia since the 16th century as a folk remedy, a group of Russian scientists says. The scientists from the Vector research institute in southwestern Siberia say they have identified three types of mushroom found in that region that can be developed into antiviral medicines, the institute said in a statement on its website.“Strains of these mushrooms demonstrated low toxicity and a strong antiviral effect” against influenza, smallpox and HIV, the virus that causes AIDS, the statement said. Tests showed the most effective to be the Chaga mushroom, which grows on birch trees.

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Colonoscopy Screenings Every 10 Years Could Prevent 40% of Colorectal Cancers

In the early stages of colorectal cancer, symptoms may be hard to identify. And because the symptoms don't often become apparent until the disease has progressed beyond the initial stages, regular screenings have always been recommended. And now it appears that regular screenings are even more important than previously thought. A large, long-term study from Harvard School of Public Health found that 40 percent of all colorectal cancers might be prevented if people underwent regular colonoscopy screening. The new research lends credence to existing guidelines recommending that people with an average risk of colorectal cancer have a colonoscopy every 10 years. In the past, there has been some skepticism about whether regular colonoscopies actually help limit the prevalence of colorectal cancer. But this study -- which appears in the New England Journal of Medicine -- seems to indicate that the screenings are, indeed, beneficial.

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Scientists Take Big Step Towards Universal Flu Vaccine

Scientists say they have made a significant leap towards creating a vaccine that would protect against every form of flu. The influenza virus is a constantly shifting target so seasonal flu vaccines rapidly become useless and new ones are needed each year. A team at Imperial College London say they have made a "blueprint" for a universal flu vaccine. Their discovery is published in the journal Nature Medicine. Influenza is able to change the proteins that protrude from the surface of the virus as readily as people change outfits. However, the material on the inside is common to many strains of flu. Vaccine researchers believe targeting the core of the virus may be the way to develop a universal vaccine.

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CDC: Half of Kids With Disabilities Skip Flu Shots

Despite an increased risk for complications from the flu, many children with intellectual disability, cerebral palsy and other disorders are not vaccinated to protect against the virus.
Just half of children with neurologic or neurodevelopmental conditions receive the flu vaccine each year, according to a report published in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report. That’s similar to the vaccination rate for all children, but presents a dilemma because kids with special needs face bigger risks of hospitalization or even death if they contract the flu, officials said.

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CDC Sets Threat Levels for Drug-resistant 'Superbugs'

Health officials have been warning us about antibiotic overuse and drug-resistant "superbugs" for a long time. But now the Centers for Disease Control and Prevention is sounding the alarm in a new way. For the first time, the CDC is categorizing drug-resistant superbugs by threat level. That's because, in their conservative estimates, more than 2 million people get antibiotic-resistant infections each year, and at least 23,000 die because current drugs no longer stop their infections.

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Should Hospitals be More Like Walmart?

We've heard about how healthcare should be more like the airline industry or customer-friendly online retailers such as Amazon or But a new article in MIT Technology Review argues that after the information technology revolution, medicine will be more like superstore Walmart. Author David M. Cutler, professor of applied economics at Harvard University, writes that infusing IT into hospitals and physician practices will make healthcare more like retail or finance. "Healthcare will be provided by big institutions, in a more standardized fashion, with less overall cost, but less of a personal touch," Cutler writes.

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Scans More Likely if Doctors Have Financial Stake

A new study has found that patients are more likely to have magnetic resonance imaging scans that indicate nothing is wrong if they are referred by a doctor who owns the machine. The scientists conclude that doctors with a financial interest in the machines may be more likely to order M.R.I.s even when clinical findings suggest they are unnecessary.

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Stephen E. Malawista, Lyme Disease Researcher, Dies at 79

Dr. Stephen Malawista, an infectious-disease researcher who orchestrated the detective work that in the mid-1970s led to the discovery of Lyme disease, died at his home in Hamden, Conn. He was 79. The cause was metastatic melanoma, his wife, Tobé, said. Last month, the Centers for Disease Control and Prevention said Lyme disease is diagnosed in 300,000 Americans each year.

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Genomics in Electronic Health Records

As health records are converted to digital form, the most likely place to store and retrieve genomic information will be Electronic Health Records (EHR). But when and how that happens will depend on having good models to build upon.
Now, in the first collection of its kind, the October 2013 issue of Genetics in Medicine, the official peer-reviewed journal of the American College of Medical Genetics and Genomics, provides a series of research articles detailing challenges and solutions for integrating genomic data into EHR. The issue features the insights of research teams actively engaged in integrating genomic medicine into clinical care. Most of the contributions derive from the experiences of individual sites that comprise the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium funded by the National Institutes of Health, but additional perspective is provided by a commercial EHR vendor and by the Clinical Sequencing Exploratory Research (CSER) consortium, a cooperative group exploring applications of genomic sequencing.

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ONC Launches eHealth Resource Site

For healthcare providers and organizations looking to brush up on laws and policies surrounding electronic health information exchange, or wanting some tips on patient eConsent engagement, look no further. The U.S. Department of Health and Human Services on Wednesday launched a meaningful consent online resource to help providers effectively engage patients in choosing how they want their electronic patient health information shared.  The site addresses laws, policies and issues related to health information exchange, and includes strategies and tools that can be used to spur patient engagement and further educate patients, officials said.

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Hospitals Ready for Meaningful Use Now

Approximately 68 percent of hospitals have purchased technology from a software vendor that has been certified to the 2014 Edition certification criteria, according to data collected through June 2013 in the HIMSS Analytics Database.  The study was released Sept. 18 during National Health IT Week in Washington, D.C.
Research highlights include:

  • At least 60 percent of hospitals in the sample have met the requirements for at least nine of the core metrics that define Stage 2 meaningful use; and

  • Some 70 percent of respondents across all metrics are actively moving toward meeting Stage 2 meaningful use requirements.

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5 Ways to Link Health Information Technology, Quality Measurement

AHRQ report compiles advice on engaging patients, connecting data and more
A new report Adobe PDF fileExternal Web Site Icon from the Agency for Healthcare Research and Quality (AHRQ) summarizes the comments it received on its July 2012 request for information and from focus groups on how to enhance quality measurement through health information technology. The 111-page report breaks the input down into three types of findings: "Perspectives" notes that different stakeholders have different views, and their opinions might vary in different situations. The perspectives section focus on linking quality measurement with systemic improvement, maximizing the capabilities of health IT, and understanding the tradeoffs involved in incorporating measurement with workflow. "Pathways" outlines critical topic areas to be addressed. "Practical guidance" outlines more than 100 practical steps organizations can take.
Here are five suggestions from the report:

  • Measure development:

  • Identify data elements:

  • Connect data sources:

  • Engage patients:

  • Collaborate and educate:

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6 Things You Need to Know About Meaningful Use and EHR Certification in 2014

With the 2014 EHR reporting period for meaningful use right around the corner, here are 6 key pieces of information you need to know:
1. Does meaningful use (MU) Stage 1 change in 2014?
Yes, the 2014 reporting period marks the beginning of a restructured meaningful use Stage 1.
2. Do all EPs, EHs, and CAHs need to upgrade to 2014 Edition certified EHR technology in 2014?
Yes, starting with the 2014 meaningful use reporting period all EPs, EHs, and CAHs need to upgrade to 2014 Edition EHR technology only – regardless of the meaningful use stage they need to meet.
3. What is the meaningful use reporting period length in 2014?
2014 has a special MU reporting period length for all non-first time EPs, EHs, and CAHs.
As a result, no EP, EH, or CAH (that previously demonstrated MU before 2014) has to start MU at the beginning of the Federal Fiscal Year (FY) [October 1, 2013] or Calendar Year (CY) [January 1, 2014].
4. What happens if a Medicare EP, EH, or CAH skips meaningful use in 2014 or applies for a hardship exception in 2014 (to avoid the 2016 payment adjustment)?
Once a Medicare EP, EH, or CAH starts meaningful use, it is required to continue to meet higher meaningful use stages according to the regulatory schedule set by the Centers for Medicare & Medicaid Services.
5. When is the last year Medicare EPs can start meaningful use to get incentive payments?
2014 is the last year in which an EP can begin to get incentive payments.
6. How does 2014 meaningful use performance relate to Medicare payment adjustments?
2014 meaningful use performance is the basis for 2016 Medicare payment adjustments.

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Health IT Advocates Press for Interoperability

The great promise of electronic health records (EHR) and health information exchanges -- that patients' health information can pass seamlessly among providers, vendors and health care systems -- will never be realized until those systems run on a set of common standards and achieve a greater level of interoperability. That was one of the messages that scores of health IT advocates from around the country took to Capitol Hill last as they met with lawmakers from their home states to press for congressional action on an array of issues concerning the use of technology in health care.

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Government Healthcare IT Plans Hinge on Open Data

The white-hot controversy surrounding President Obama's healthcare overhaul – grabbing headlines again amid the latest round of budget fights – has largely overshadowed other areas where the administration is crafting health policy, including how to wring more value from the vast stores of data maintained by the federal government.  Historically, data sets about disease rates, clinical records, Medicare billing and other issues have been kept tight under lock and key within the sprawling confines of the country's largest health-data warehouse.
Freeing Data to Public
HHS's efforts fall within a broader administration initiative to advance open data policies. Most recently, that effort produced an executive order directing agencies to establish open, machine-readable formats as the default for government information. At HHS, the push toward open data led to the creation of, a clearinghouse for data sets encompassing everything from vaccination rates to hospital comparisons freely available for download.

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5 EHR Vendors Lead Pack in Ambulatory Care Niche

More than 135,000 physicians, dentists, optometrists, podiatrists and chiropractors working in ambulatory care have relied on just five vendors of complete electronic health-record systems to help them achieve meaningful use under Medicare's electronic health record incentive payment program, federal data show.
These five EHR developers and their market shares are

  • Epic Systems Corp., 21.7%;

  • Allscripts, 11.1%;

  • eClinicalWorks, 7.5%;

  • NextGen Healthcare, 6.8%; and

  • GE Healthcare, 5.7%.

Together, their software is used by 52.7% of the 257,512 physicians and other eligible professionals who have become meaningful users of a complete EHR in an ambulatory-care setting and been paid by the government's incentive program, according to data from the CMS and HHS' Office of the National Coordinator for Health Information Technology. Healthcare analysis reported in May. The rest of the market is split among the remaining 439 vendors who have had at least one customer achieve meaningful use and get paid by the federal government. The top 25 vendors control 79.9% of this key market niche, federal data shows.

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French Court of Auditors Call for 7.5% Cut in Medical Laboratory Fees to Help Balance the Nation’s Healthcare Budget

To justify its decision, the Cour des comptes cited vast increases in the number of certain medical laboratory tests. For example, it called attention to the 60% increase in volume of clinical laboratory tests ordered for vitamin D levels over the last 10 years. In France, there is also a problem with duplication in the number of medical tests ordered. There will be widespread pain from these cuts in reimbursement, stated Francois Blanchecotte, noting that cuts would cost medical laboratories about €316 million (US$481 million) annually. As many as 8,000 jobs may be lost, noted Blanchecotte. He is the Président of the Syndicat des Biologistes, which is one of three professional groups representing French laboratories. Blanchecotte is also Vice President of the Union Nationale des Professions de Santé (National Union of Health Professionals).
England Consolidating Lab Services into ‘Super Labs’
Balancing the healthcare budgets on the backs of medical laboratories is a growing trend. Last year, government health administrators in both England and Australia began closing hospital-based clinical labs to achieve economies of scale. Medical laboratory closures in both countries have been in small communities, where a full-service lab testing facility was not economically justifiable.
Australians Restructuring Hospital Labs, Laying off Staff to Save Money
Similarly, state governments in Australia have closed clinical laboratories in selected hospitals and axed laboratory staff to reduce healthcare costs, noted the Dark Daily article. For example, the Queensland State Government’ Department of Health restructured pathology services last year and eliminated 105 laboratory jobs.
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