Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
March 27, 2014
- Primary Care Physicians’ Challenges in Ordering Clinical Laboratory Tests and Interpreting Results
- Centers for Medicare & Medicaid Services: Approval of the A2LA as an Accreditation Organization
- Cholesterol Guidelines Could Mean Statins for Half of Adults Over 40
- Home Stool DNA Test Detects Colorectal Tumors
- FDA Reviews DNA-based Colon Cancer Screening Kits
- New Study Supports Universal BRCA Testing in All Ovarian Cancer Patients
- Screening for Prostate Cancer With the Prostate-Specific Antigen Test
- In Urinalysis, Automated Microscopy Making the Difference
- Still Too Few Minority Participants in U.S. Clinical Trials, Study Finds
- Protein May Hold the Key to Who Gets Alzheimer’s
- CDC: Higher Cancer Risk for Kids Living Near Busy Roads
- Proposed Patient-Centered Telemedicine Policy Raises Licensing Questions
- Screening Immigrants For TB Pays Dividends In U.S.
- Air Pollution Linked to Seven Million Deaths Globally
View Previous Issues - Healthcare News Archive
Primary Care Physicians’ Challenges in Ordering Clinical Laboratory Tests and Interpreting Results
The Centers for Disease Control and Prevention’s Division of Laboratory Programs, Standards and Services sponsored a survey of general internal medicine and family medicine physicians to identify challenges they face related to diagnostic laboratory testing and solutions they believe are helpful and available to them. 1768 physicians (5.6%) responded to the survey. Physicians reported ordering diagnostic laboratory tests for an average of 31.4% of patient encounters per week. They reported uncertainty about ordering tests in 14.7% and uncertainty in interpreting results in 8.3% of these diagnostic encounters. The most common problematic challenges in ordering tests were related to the cost to patients and insurance coverage restrictions. Other challenges included different names for the same test, tests not available except as part of a test panel, and different tests included in panels with the same names. The most common problematic challenges in interpreting and using test results were not receiving the results and confusing report formats. Respondents endorsed a variety of information technology and decision support solutions to improve test selection and results interpretation, but these solutions were not widely available at the time of the survey. Physicians infrequently sought assistance or consultation from laboratory professionals but valued these consultations when they occurred.
Source: http://www.jabfm.org/
Centers for Medicare & Medicaid Services: Approval of the A2LA as an Accreditation Organization
In this notice, we [CMS] approve the American Association for Laboratory Accreditation (A2LA) as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements for all specialty and subspecialty areas under CLIA. We have examined the initial A2LA application and all subsequent submissions to determine its accreditation program's equivalency with the requirements for approval of an accreditation organization under subpart E of part 493. We have determined that the A2LA meets or exceeds the applicable CLIA requirements. We have also determined that the A2LA will ensure that its accredited laboratories will meet or exceed the applicable requirements in subparts H, I, J, K, M, Q, and the applicable sections of R.
Source: http://www.gpo.gov/
ASCP Applauds the Inclusion of Stark Reform in the President's FY 2015 Budget Proposal
The White House Administration demonstrated its support for Stark reform recently by including in its FY 2015 Budget a proposal that would amend the In-Office Ancillary Services (IOAS) exception to prohibit self-referrals for anatomic pathology, advanced imaging, radiation therapy, and physical therapy services. The American Society for Clinical Pathology (ASCP) applauds the Administration for its leadership, its response to a growing evidence-base in favor of Stark reform, and its efforts to encourage more appropriate use of Medicare services.
Psychiatric Genetics 'Exploding'
It was around 130 years ago that Sigmund Freud started using early psychoanalysis techniques to treat Viennese women for their unshakeable blues, and in the following century the scientific and cultural perceptions about mental illness would change forever. A similar revolution could be happening today, Psychiatry Online's Joan Arehart-Treichel writes, but this one is being launched not by sleuths uncovering layers of the subconscious life, but by investigators sorting through the human genome. Genetics is going to be the next big thing in treating mental illnesses, she writes, saying that the field of psychiatric genetics has "exploded" over the past five years as genome-wide studies have turned up more and more interesting variants.
Source: http://www.genomeweb.com/
New IHC Validation Guideline Improves Patient Safety by Ensuring Consistent Lab Test Results
Physicians and patients rely on accurate laboratory test results to guide treatment decisions. To ensure the accuracy of laboratory tests and reduce variation in laboratory practices, the College of American Pathologists has developed the first evidence-based guideline to validate all immunohistochemical (IHC) assays. The guideline, “Principles of Analytic Validation of Immunohistochemical Assays, is now available in the online edition of Archives of Pathology & Laboratory Medicine.
Source: http://www.newswise.com/
Cholesterol Guidelines Could Mean Statins for Half of Adults Over 40
When sweeping new advice on preventing heart attacks and strokes came out last November, it wasn’t clear how many more Americans should be taking daily statin pills to lower their risk. A new analysis provides an answer: a whole lot. Nearly 13 million more, to be precise. The new guidelines, formulated by the American Heart Association and the American College of Cardiology, are a major departure from those in place for decades. They throw out the notion that doctors should prescribe cholesterol-lowering drugs when a patient’s LDL, or bad cholesterol, reaches a certain threshold — in recent years, above 130. Instead, the new guidelines say everybody with known heart disease should be taking statins. And for adults over 40 without known cardiovascular disease, the new trigger for statin use is a 10-year risk of heart attack or stroke of 7.5 percent or more, according to a new risk calculator. The old guidelines, using a different calculator, prescribed statin use at a 10-year risk above 20 percent, along with an LDL-cholesterol reading above 130. Under the new guidelines, statin therapy is urged for everybody over 40 who has diabetes. The drugs are also recommended for younger adults if their LDL cholesterol is over 190.
New Study Supports Universal BRCA Testing in All Ovarian Cancer Patients
Women diagnosed with ovarian cancer, but lacking a family history suggestive of BRCA mutations still remain at significant risk for these mutations, according to a study published March 17 in the Journal of Clinical Oncology. The BRCAPRO risk assessment tool does not adequately identify women at low-risk of BRCA mutations, and thus, a universal genetic testing strategy should be utilized for all women diagnosed with high-grade serous ovarian cancers, the researchers say.
Source: http://www.g2intelligence.com/
Home Stool DNA Test Detects Colorectal Tumors
A stool DNA test detected significantly more colon cancers in average-risk patients as compared with a conventional fecal immunochemical test (FIT), a large prospective clinical study showed. The DNA test detected 92.3% of colorectal cancers versus 73.8% for FIT in a study involving almost 10,000 patients scheduled for colonoscopy. The DNA test also had an 20%+ absolute advantage for detecting advanced precancerous lesions. The FIT was associated with significantly fewer false-positive results, but the DNA test nonetheless had a much lower number needed to detect (166 versus 208), Thomas F. Imperiale, MD, of Indiana University in Indianapolis, and co-authors reported online in the New England Journal of Medicine.
Source: http://www.medpagetoday.com/
FDA Reviews DNA-based Colon Cancer Screening Kits
FDA scientists have questions about the accuracy and the potential real-world impact of the kits from Epigenomics and Exact Sciences, according to briefing documents posted online Monday. The agency released its reviews of the tests ahead of a two-day meeting that starts Wednesday. Both tests under review were more accurate at detecting tumors and worrisome growths than traditional blood stool tests. However, both tests also returned more false positives - reporting growths when none were actually present. Colonoscopy is the most accurate test but many adults are reluctant to undergo the invasive procedure, which requires several hours under sedation as doctors probe the colon with a camera-fitted catheter. Approving either of the new stool tests could reshuffle current testing practice, a fact reflected in the FDA's review.
Source: http://hosted.ap.org/
Clinical Trial Indicates High Sensitivity for Exact Sciences DNA-based Colorectal Cancer Screening Test
Researchers reported in the New England Journal of Medicine that, in a clinical study, a DNA-based colorectal cancer screening test was better able to detect instances of cancer than a standard immunochemical test. The test, Exact Sciences' Cologuard, examines DNA methylation markers, mutation markers, and more in combination with hemoglobin levels in patients' stool samples to determine the presence of colorectal cancer.
Source: http://www.genomeweb.com/
Blood Test Predicts Merkel Cell Carcinoma Metastases
A newly-available test based on the results of a simple blood draw has proved useful for detecting early recurrences of Merkel cell carcinomas in those patients who produce antibodies to the Merkel polyomavirus oncoprotein at initial diagnosis. Known as AMERK, the test can be used at diagnosis to determine which patients have the oncoprotein antibodies and performed at routine followups as an indicator of recurrence in asymptomatic, antibody-positive patients.
Source: http://www.oncologypractice.com/
Screening for Prostate Cancer With the Prostate-Specific Antigen Test
The decision whether to screen for prostate cancer with PSA should be shared between patient and clinician. As part of this discussion, the benefits and harms of screening should be presented, and a review of the current literature suggests that the European Randomized Study of Screening for Prostate Cancer (ERSPC) may provide the best estimates of outcomes relevant to a man making a decision about the value of PSA screening for his future health. After 11 years of follow-up, the ERSPC data suggest that a small but statistically significant reduction in prostate cancer mortality can be achieved with approximately 1 fewer death per 1000 men screened. This potential benefit must be weighed against the risks of false-positive results, the complications of prostate biopsy, and, most important, a higher risk of receiving a diagnosis of prostate cancer amounting to approximately 37 extra prostate cancer diagnoses per 1000 men screened.
Source: http://jama.jamanetwork.com/
New Sugar-Test to Reduce False-Positive Cancer Diagnoses
The world’s most widespread test for ovarian cancer reports false-positives in 94 of 100 diagnosed cases. Now, chemists at the University of Copenhagen working with clinical researchers at University College London have developed a method able to halve the number of false-positives. When fully developed, the new test will spare a significant number of women from unnecessary worry and further testing. Furthermore, global health care providers stand to save substantial sums – just by including a test on a certain sugar molecule in tandem with the currently prevailing diagnostic test. The method helps distinguish between cancer and otherwise benign conditions and is called glycoprofiling. It has been published in the esteemed Journal of Proteome Research, under the title “Microarray Glycoprofiling of CA125 Improves Differential Diagnosis of Ovarian Cancer”.
Source: http://news.ku.dk/all_news/
In Urinalysis, Automated Microscopy Making the Difference
Traditional urinalysis is messy. It’s tedious. It’s prone to variability. It’s nicknamed the “ugly stepchild” of the laboratory. Many are quick to note that it’s just a screening tool—with an emphasis on “just.” But in recent years, urinalysis has been quietly tiptoeing into a new era. “We’re in the period of resurgence, using automated urine microscopics and urine chemistry to their full potential,” says Keri Donaldson, MD, assistant professor of pathology, medical director of hematology and thrombosis, and medical director of molecular diagnostics at Pennsylvania State University’s Milton S. Hershey Medical Center. While automated methods for urine chemistry aren’t all that new, automated microscopy is transforming laboratories by allowing for more accurate, efficient, and standardized results.
Source: http://www.captodayonline.com/
California Doctors Speed up Valley Fever Diagnosis
California doctors have found a way to diagnose the fungal disease Valley fever through DNA testing, allowing treatment of patients to begin almost immediately, officials said. Community Regional Medical Center in Fresno is performing the DNA test that can identify the disease in as few as five hours, rather than waiting more than two weeks for the results of blood tests, officials said. Doctors still use the blood tests to confirm the results of the new approach, but the DNA testing is proving to be accurate, the Fresno Bee has reported.
Source: http://hosted.ap.org/
Metabolomic Study Uncovers Potential Biomarkers in Women with Preeclampsia
Pregnant women with preeclampsia have a metabolic profile that is distinct from those of healthy pregnant women and women who are not pregnant, researchers from the Norwegian University of Science and Technology reported in PLOS One. By comparing the serum and urine metabolomes of pregnant women with and without preeclampsia and non-pregnant women, researchers led by Norway's Tone Frost Bathen found nine urine metabolites that could distinguish pregnant women with preeclampsia from other pregnant women. Additionally, women with preeclampsia had higher levels of low- and very-low density lipoproteins and lower levels of high-density lipoproteins in their serum than either healthy pregnant women or women who were not pregnant.
Source: http://www.genomeweb.com/
Oxford Gene Technology and Emory Genetics Laboratory Develop New Molecular Arrays
Oxford Gene Technology (OGT), a UK-based molecular genetics company, has expanded its range of research-validated CytoSure Molecular Arrays to investigate DNA copy number variation (CNV) underlying a variety of genetic disorders. Designed and optimized in collaboration with experts at Emory Genetics Laboratory at Emory University School of Medicine, the arrays, which are for research use only, complement DNA sequencing by providing a tool for investigating the variety of aberrations underlying genetic disorders.
Source: http://www.mlo-online.com/
NeoGenomics Launches Two New Cancer Profiling Tests for MDS and Solid Tumors
NeoGenomics, Inc., a provider of cancer-focused genetic and molecular testing services, has launched the first two of a series of next generation cancer profiling tests for myelodysplastic syndrome, or MDS, and solid tumor cancers. The MDS next generation sequencing (NGS) test can be performed on bone marrow, peripheral blood and plasma samples. Plasma-based testing for MDS may be used to avoid bone marrow biopsies. It also has the potential to quantify and monitor tumor load and to detect the emergence of subclones. The MDS next generation profiling test covers 16 genes involved in the various pathways of MDS, including epigenomics, signal transduction, transcription regulation and spliceosomes. This test is particularly important for confirming and defining the diagnosis of MDS, which can be extremely difficult in early stages of the disease. The solid tumor cancer NGS profiling test covers 48 genes and is performed on paraffin-embedded tissue. This solid tumor profile is extensive and covers the driver genes involved in various types of solid tumor cancers.
Source: http://convergence.llesiant.com/
BIOCRATES Test Kit Helps Develop First Metabolomics-Based Blood Test for Alzheimer’s
The test is capable of predicting, with 90% accuracy, the risk of Alzheimer’s disease 2–3 years before it has actually become clinically manifest. The findings, published in Nature Medicine, were generated using the validated AbsoluteIDQ® p180 test kit by Austrian BIOCRATES Life Sciences AG. Although it will take some time to develop test versions fit for use in doctors’ offices, the findings by Mapstone et al. are an impressive example of the power of metabolomics in diagnosis and biomarker discovery.
Source: http://www.technologynetworks.com/
AdvanDx Announces FDA 510(k) Submission for mecA XpressFISH -- a New Method for Rapid Detection of Methicillin-Resistant Staphylococcus aureus (MRSA) From Positive Blood Cultures
AdvanDx announced that it has submitted to the U.S. Food and Drug Administration for 510(k) clearance its new mecA XpressFISH™ test for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from S. aureus positive blood cultures. This assay will provide physicians with a new way to rapidly identify MRSA enabling them to implement appropriate treatment for patients with bloodstream infections.
Source: http://www.technologynetworks.com/
AdvanDx Announces FDA 510(k) Submission for mecA XpressFISH -- a New Method for Rapid Detection of Methicillin-Resistant Staphylococcus aureus (MRSA) From Positive Blood Cultures
AdvanDx announced that it has submitted to the U.S. Food and Drug Administration for 510(k) clearance its new mecA XpressFISH™ test for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from S. aureus positive blood cultures. This assay will provide physicians with a new way to rapidly identify MRSA enabling them to implement appropriate treatment for patients with bloodstream infections.
FDA Recommends OK for Immucor Test
The U.S. Food and Drug Administration’s (FDA) Blood Products Advisory Committee voted to recommend approval of Immucor Inc.’s HEA Molecular BeadChip Test as a safe and effective evaluation for blood group typing. The test provides additional information about the composition of donor and patient blood, which may result in better matches for blood transfusion patients, especially for those who have received multiple transfusions.
Source: http://www.bizjournals.com/
New Guidelines Might Limit Need for Lymph Node Removal for Breast Cancer
Biopsies of so-called "sentinel" lymph nodes under the arms should become more widespread among breast cancer patients, according to updated guidelines from the American Society of Clinical Oncology (ASCO). The group, which represents cancer specialists, said the new recommendations should also restrict the number of women who will require further removal of multiple nodes after biopsy, cutting down on painful side effects.
Source: http://consumer.healthday.com/
Still Too Few Minority Participants in U.S. Clinical Trials, Study Finds
It's been 20 years since Congress required that research funded by the U.S. National Institutes of Health (NIH) include minorities, but non-whites still account for less than 5 percent of clinical trial participants, according to a new report. The study from University of California, Davis, and Comprehensive Cancer Center also revealed that less than 2 percent of clinical cancer studies focus on people of non-white races or ethnic groups. The findings, published online March 18 in Cancer, revealed that although black people have the highest rates of cancer, Hispanics and blacks have a participation rate of just 1.3 percent in cancer clinical trials.
Source: http://consumer.healthday.com/
Silicone Chip Recreates Cancer’s Microenvironment
Killing cancer cells growing on a petri dish is an entirely different beast than fighting cancer cells in the human body. To provide a more realistic platform for screening anticancer drugs, bioengineers have created a device that better replicates the environment around human tumors than conventional cell culture does. They designed a microfluidic chip that imitates the blood circulation system alongside a three-dimensional tumor (Anal. Chem. 2014, DOI: 10.1021/ac403899j). With further development, the chip should be useful for both high-throughput drug screening and for helping doctors quickly pinpoint the best cancer therapy for individual patients.
Source: http://cen.acs.org/
Stem Cells in Body's Fatty Folds Can Help Heal Diseased Kidneys
A new study has revealed that fatty fold of tissue within the abdomen that is a rich source of stem cells can help in fighting kidney failure. The study found that stem cells from within a chronic kidney disease patient's own abdomen could be used to preserve and possibly improve kidney function, New Scientist reported. However, such a treatment would require injecting cells frequently over a period of many months and years, as stem cells do not survive in the body for more than a few days after injection.
Protein May Hold the Key to Who Gets Alzheimer’s
It is one of the big scientific mysteries of Alzheimer’s disease: Why do some people whose brains accumulate the plaques and tangles so strongly associated with Alzheimer’s not develop the disease? Now, a series of studies by Harvard scientists suggests a possible answer, one that could lead to new treatments if confirmed by other research. The memory and thinking problems of Alzheimer’s disease and other dementias, which affect an estimated seven million Americans, may be related to a failure in the brain’s stress response system, the new research suggests. If this system is working well, it can protect the brain from abnormal Alzheimer’s proteins; if it gets derailed, critical areas of the brain start degenerating. “This is an extremely important study,” said Li-Huei Tsai, director of the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology, who was not involved in the research but wrote a commentary accompanying the study. “This is the first study that is really starting to provide a plausible pathway to explain why some people are more vulnerable to Alzheimer’s than other people.”
Source: http://www.nytimes.com/
Chronic Sleep Loss Could Lead to Loss of Brain Neurons, Mice Study Suggests
Chronic sleep deprivation could have more lasting effects on the brain than previously realized, according to a new study in mice. Researchers from the University of Pennsylvania Perelman School of Medicine and Peking University found that chronic sleep loss is associated with injury and loss of locus coeruleus (LC) neurons in the brain, which are needed for alertness and optimal thinking.
Source: http://www.huffingtonpost.com/
Researchers Discover Underlying Genetics, Marker for Stroke, Cardiovascular Disease
Scientists studying the genomes of nearly 5,000 people have pinpointed a genetic variant tied to an increased risk for stroke, and have also uncovered new details about an important metabolic pathway that plays a major role in several common diseases. Together, their findings may provide new clues to underlying genetic and biochemical influences in the development of stroke and cardiovascular disease, and may also help lead to new treatment strategies.
Source: http://www.nih.gov/
Salt, Obesity May Prematurely Age Young Cells
High sodium intake and obesity may act synergistically to accelerate cellular aging in adolescents, according to new research presented at the American Heart Association's EPI/NPAM Scientific Sessions 2014. The study examined the effect of a high salt diet on telomere length in normal weight and overweight/obese teens. After controlling for factors known to shorten telomeres, researchers observed a statistically significant interaction between weight and sodium intake.
Source: http://www.medpagetoday.com/
More of the Bugs Kids Get Are Resistant
The rate of antibiotic-resistant Gram-negative bacterial infections in children is increasing in inpatient and outpatient settings, a study reports. The prevalence of third-generation cephalosporin-resistant (G3CR) bacteria increased from 1.39% in 1999-2001 to 3% in 2010-2011, wrote Latania K. Logan, MD, of Rush University Medical Center in Chicago, and her co-authors online in the Journal of the Pediatric Infectious Disease Society.
Source: http://www.medpagetoday.com/
CDC: Higher Cancer Risk for Kids Living Near Busy Roads
Young children who are exposed to high levels of vehicle exhaust — such as what they'd encounter living near busy roads in urban areas — appear to have a greater risk of childhood leukemia, according to a Centers for Disease Control and Prevention review of seven previous studies. The CDC's systematic review, published in the April issue of the American Journal of Preventive Medicine, says that in the USA an estimated 30%-45% of people in large urban areas live near major roads, "suggesting increased exposure to traffic-related air pollution and risk of adverse health outcomes." The article says the studies reviewed by the CDC suggest "that childhood leukemia is associated with residential traffic exposure during the postnatal period, but not during the prenatal period."
Source: http://www.usatoday.com/
Ancient Skeleton Is the Earliest Case of Cancer Yet Detected
Researchers have discovered the earliest confirmed case of cancer in a young man who lived in ancient Egypt. The discovery of a diseased skeleton dating back to around 1,200 BC was made at the Amara West site in northern Sudan. The new finding suggests that the disease has its roots in the distant past. Details of the skeleton have been published in the Journal PLOS ONE.
Source: http://www.bbc.com/
Watson Project to Focus on Individualized Treatment of Brain Cancer
The New York Genome Center and IBM have announced a partnership to focus the Watson technology on helping oncologists deliver more personalized care to cancer patients, according to an announcement. The idea is that Watson can analyze patients' genomic data and pore through medical journals, new studies and clinical records to help doctors find the best drug to try on a particular patient, reports Forbes. The project initially will focus on 25 patients with glioblastoma multiforme, a rare brain cancer that is almost always fatal within months without treatment.
Source: http://www.fiercehealthit.com/
Room-Temperature Vaccine Could Be Boon to Developing Countries
Scientists have developed a revolutionary vaccine that does not require refrigeration or booster shots, making the so-called nanovaccine a potential “game-changer” in curbing disease in the developing world. Experts believe the drug, which is delivered in a nose spray, could extend immunization to millions of people who are not now vaccinated against dangerous, infectious diseases. Scientists say the vaccine is the first to use nanoparticles, a relatively new technology in medicine that embeds proteins from disease-causing organisms into tiny, polymer spheres five hundred times smaller than the width of a human hair.
Source: http://www.voanews.com/
Antibiotic Errors Common in Community Hospitals
More than one patient in three treated for a bloodstream infection in community hospitals got inappropriate antibiotic therapy, researchers reported. In a multicenter retrospective cohort study, 38% of patients in a network of community hospitals were treated incorrectly, according to Deverick Anderson, MD, of Duke University, and colleagues. The proportion varied across institutions, ranging from 22% to 71% with a median of 33%, they reported online in PLoS ONE. Most healthcare in the U.S. is delivered in community hospitals, the researchers noted, but analysis of how bloodstream infections are treated has usually been focused on tertiary care institutions.
Source: http://www.medpagetoday.com/
Identity Crisis Looms for US Healthcare
While the U.S. continues digitizing its healthcare industry, a huge challenge is arising: not only securing those systems but verifying identities. With a steady stream of HIPAA-covered data breaches continuing over the past few years, not to mention the debacle of Target’s recent customer financial information loss, some argue that current identity security approaches just aren’t adequate -- especially considering that criminal attacks on hospitals are increasing substantially. “Protecting sensitive personal information with passwords is akin to building a massive stone fortress and then securing the front door with the kind of lock I use to keep my two-year-old out of my bathroom,” said Jeremy Grant, a senior advisor on identity management at the National Institute of Standards and Technology, heading up the National Strategy for Trusted Identities in Cyberspace.
Source: http://www.healthcareitnews.com/
Proposed Patient-centered Telemedicine Policy Raises Licensing Questions
The Federation of State Medical Boards will vote next month on a new telemedicine policy (PDF) that codifies that medical care takes place where a patient, not a provider, is located. It also states that whether a physician and patient have a virtual or a face-to-face encounter, there should be no differences in standards of care. The proposed policy, which will be voted on during the FSMB's annual meeting April 24-25 in Denver, will serve as a model for other state boards to follow and as a guidepost for state legislators and regulators to develop their own telemedicine policies.
Source: http://www.modernhealthcare.com/
Senators Hammer on FDA's mHealth Priorities
A bipartisan group of senators has issued an open letter urging the FDA to provide more information on how it would classify apps. The latest action follows the FDA's release late last year of final guidance on how it would regulate mobile medical apps, a move that drew strong support from mHealth advocates but left some critics wondering if too much regulation would prevent the fast-paced industry from moving forward with much-needed innovations. While the senators praised the FDA for using a risk-based approach in classifying apps, they said the agency must be sure it doesn't go overboard with regulation.
Source: http://www.govhealthit.com/
David Blumenthal: Benefits of HIT Programs Will Surface With Time
An "asymmetry of benefits" for providers has kept the healthcare industry from ubiquitous adoption of health IT--and electronic health records, in particular--and thus realizing its full potential, according to David Blumenthal, former national coordinator for health IT and current president of The Commonwealth Fund. "From the patient's perspective, this is a no-brainer. The benefits are substantial," Blumenthal told The Atlantic in a recent interview. "But from the provider's perspective, there are substantial costs in setting up and using the systems. Until now, providers haven't recovered those costs, either in payment or in increased satisfaction, or in any other way."
Source: http://www.fiercehealthit.com/
Initiative Aims to Spur Use of Health IT in Emergency Medicine
The HHS Office of the Assistant Secretary for Preparedness and Response and the Office of the National Coordinator for Health IT have launched a new initiative designed to help spur the use of health IT in emergency medical services, EHR Intelligence reports. The Health Information Technology and EMS initiative aims "to connect the emergency care, EMS and HIT communities so they can share and discuss pilot projects, concepts and initiatives related to health information exchange," according to the forum's homepage.
Source: http://www.ihealthbeat.org/
HHS Lays Out 4-Part Health IT Strategic Plan
The Department of Health and Human Services has named health information technology as key to the “modernization of the American health care system” in its latest strategic plan. The plan has four major goals, which include:
1. Strengthen health care
2. Advance scientific knowledge and innovation
3. Advance the health, safety, and well-being of the American people
4. Ensure efficiency, transparency, accountability, and effectiveness of HHS programs
1. Strengthen health care
2. Advance scientific knowledge and innovation
3. Advance the health, safety, and well-being of the American people
4. Ensure efficiency, transparency, accountability, and effectiveness of HHS programs
Source: http://www.govhealthit.com/
Tech Advances Push Health IT Forward
The Indian Health Service (IHS) is in the midst of spending $14 million to upgrade its electronic medical records, and acting Chief Information Officer Dr. Howard Hays is already calling it money well spent. “This is our most pressing initiative,” he said. IHS is working to meet the Meaningful Use standard, a government effort to ensure medical providers have digital records capabilities and are actually using them. Hays is drawing heavily from IT tools to make it happen, including a patient-facing records portal, a secure messaging system for patients and providers, and a new system for calculating quality measures.
Source: http://www.federaltimes.com/
New Industry Emerging to Provide Cloud-based Computing Firepower Needed for Big Data Genomic Analyses of Healthcare and Medical Laboratory Information
Coming soon to a clinical laboratory near you: cloud-based “big data” genome analysis! A new industry is emerging dedicated to accepting, storing, and analyzing vast quantities of data generated by next-generation gene sequencing and whole human-genome sequencing. There are already examples of academic departments of pathology and laboratory medicine that have outsourced the storage and annotation of whole human genomes sequenced from tissue specimens collected from cancer patients. The annotated genomes are returned to the referring pathologists for analysis.
Source: http://www.darkdaily.com/
Screening Immigrants for TB Pays Dividends in U.S.
Hundreds of people with tuberculosis wishing to come to the U.S. have been stopped before they reached U.S. borders, says a new report from the Centers for Disease Control and Prevention. Physicians overseas picked up more than 1,100 cases in prospective immigrants and refugees prior to their arrival in the U.S. The cases include 14 people with multidrug-resistant TB, the CDC says.
Source: http://www.npr.org/
Air Pollution Linked to Seven Million Deaths Globally
Seven million people died as a result of air pollution in 2012, the World Health Organization estimates. Its findings suggest a link between air pollution and heart disease, respiratory problems and cancer. One in eight global deaths were linked with air pollution, making it "the world's largest single environmental health risk", the WHO said. Nearly six million of the deaths had been in South East Asia and the WHO's Western Pacific region, it found.
Source: http://www.bbc.com/
Deadly Ebola Virus Reaches Guinea Capital Conakry – UN
An outbreak of the Ebola virus - which has already killed 59 people in Guinea - has reached the capital Conakry, the UN's children agency has warned. Unicef said the haemorrhagic fever had spread quickly from southern Guinea, hundreds of kilometres away. Scores of cases have been recorded since the outbreak began last month. There is no known cure or vaccine.
Sour: http://www.bbc.com/
WHO Approves TB Diagnostic Test at Reduced Price, IPAQT Gears Up to Offer These Services
World Health Organisation (WHO) has now approved the gold standard for tuberculosis (TB) detection known as MGIT Liquid Culture to be made available at a subsidised ceiling price of Rs. 900. With this, select labs registered with Initiative for Promoting Affordable, Quality TB Tests (IPAQT), which is a coalition of over 60 private labs in India will have to make the WHO approved tests available at affordable prices to patients in the private sector. Liquid culture is faster, more accurate and more comprehensive than conventional solid media or sputa smear approaches. It is particularly valuable in its ability not only to detect drug resistant TB (MDR/XDR-TB) but also more effective than conventional approaches in diagnosing TB in patients co-infected with TB and HIV.
Source: http://www.pharmabiz.com/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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