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Laboratory Science, Policy and Practice Program Office

Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information

from The Division of Laboratory Science and Standards

October 03, 2013

News Highlights

Shutdown Curbs CDC's Ability to Fight Disease

Plenty of Uninsured Can Use ACA Exchanges, CDC Says

Unique Device Identification System; Final Rule

Senators Hear Push to Renew Infant Medical Screening Law

Advanced Breast Cancer First Diagnosed on Bone Marrow Biopsy

New Method Detects E. coli in Water

NIH to Fund Development of High-Throughput Screening Assays

A Farewell to Parasites

More Than 30 Specialty Societies to Release New Choosing Wisely Lists of Tests or Treatments to Question

Antibiotic Resistance: A Final Warning

NIH Launches Microbiome Cloud Project

FDA's Mobile Medical Apps Guidance

Key Part of EHR Incentive Program Halted due to Government Shutdown

View Previous Issues - Healthcare News Archive

Shutdown Curbs CDC's Ability to Fight Disease
The Centers for Disease Control headquarters in Atlanta felt deserted. Two thirds of the center's 13,000 employees worldwide have been furloughed, and its director, Dr. Thomas Frieden, is worried. "I usually don't lose sleep despite the many threats we face, but I am losing sleep because we don't know that we will be able to find and stop things that might kill people," he said. The shutdown means the CDC will not be able to produce the weekly national map that tracks flu outbreaks state by state. Flu season began last month. "We will be less able to determine when it's come, what kind of flu has come or to respond to outbreaks," Frieden said. More people are likely to get sick because there has been no warning to let them know what problem they have "What we won't know is what's happening with flu," Frieden said. "Where is it spreading? What types of flu are spreading? Should we be using one medication or another?" he asked. "Is it in nursing homes or elsewhere? This really interferes with our ability to protect people." Frieden worries about other outbreaks the CDC will not be able to track, including hepatitis A, salmonella, and measles.

Source: http://www.cbsnews.com/

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Plenty of Uninsured Can Use ACA Exchanges, CDC Says
Just before Americans begin shopping for subsidized health insurance online under the Affordable Care Act (ACA), the Centers for Disease Control and Prevention (CDC) confirmed that, yes, lack of coverage is still an elephant-sized problem, especially for adults younger than 65 years.

The number of Americans who were uninsured during the first 3 months of 2013 stood at 46 million, or 14.8% of the population, according to a new CDC survey. The 2013 number was about half a million more than that for 2012, when 14.7% were insured, but 2.6 million less than in 2010, when Congress passed the ACA. In that tumultuous year, 16% of Americans lacked coverage. Of the 46 million Americans without health insurance in the first quarter of 2013, only 300,000 were aged 65 years and older, reflecting how Medicare covers virtually all members of that demographic category. Subtract the elderly, and the statistical picture of the uninsured worsens. The percentage of Americans younger than 65 years who were not insured in the first quarter of 2013 was 17.1%, which is a tad up from the 16.9% recorded in 2012.The age group with the lowest rate of coverage (7.1%) was children aged 17 years and younger.
The CDC defines someone as uninsured if they do not have private health insurance, Medicare, Medicaid, Children's Health Insurance Program, a state-sponsored or any other government-sponsored health plan, or a military health plan. Source: Centers for Disease Control and Prevention

Source: http://www.medscape.com/

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Unique Device Identification System; Final Rule
The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

DATES: This rule is effective December 23, 2013, except Sec. Sec. 801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 are effective October 24, 2013. The incorporation by reference of Sec. 830.20 listed in the rule is approved by the Director of the Office of the Federal Register as of December 23, 2013.

Source: http://www.gpo.gov/

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Patient Access Rule Close to Being Finalized
A final rule that would allow patients to access their medical test results directly from labs is close to being finalized. Initially proposed in September 2011, the rule could make changes to the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA), giving labs permission to release results directly to patients and giving patient’s permission to request results directly from labs.

Once implemented, the rule will override some state laws requiring that test reports go directly to health care providers.

Source: http://g2intelligence.com/

NIH Calls for Research Projects Examining Violence—Particular Consideration to Be Given to Firearm Violence
The National Institutes of Health is opening funding opportunities calling for research on violence with particular focus on firearm violence. Applications will be accepted through fiscal year 2016. NIH developed this call for proposals in response to the Presidential memorandum in January 2013 directing science agencies within the U.S. Department of Health and Human Services to fund research into the causes of firearm violence and ways to prevent it. NIH plans to fund research projects over the next three years beginning in fiscal year 2014 into the causes and consequences of violence as it relates to the health of individuals and communities. The goal is to identify evidence-based strategies for preventing violence and incorporating them into clinical and community settings.

Source: http://www.nih.gov/

Senators Hear Push to Renew Infant Medical Screening Law
Joye Mullis of Raleigh, N.C., told a Senate hearing about how a screening test for newborns detected a heart problem in her son that could be treated with surgery, and she urged Congress to renew the law that supports the screening of every baby born in the United States. Every newborn today is screened for conditions that aren’t otherwise apparent but could cause developmental delays, illnesses or death if left untreated. The Newborn Screening Saves Lives Act, passed in 2008, established national guidelines and supported the screening in all states for five years. It expires with the end of the fiscal year on October 1st and must be renewed for another five years for the program to continue.

Source: http://www.mcclatchydc.com/

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Fee Changes Take a Toll on Lab Testing Industry
Many healthcare providers agree that Washington has rightfully gotten serious about unsustainable cost growth in healthcare and, specifically, in Medicare. However, proposed cuts to payments for vital cancer tests are so severe — nearly 75 percent in some cases — it would reduce payment to below the cost of laboratories to buy necessary materials to provide these services.

Source: http://www.miamiherald.com/

More Than 30 Specialty Societies to Release New Choosing Wisely Lists of Tests or Treatments to Question
In late 2013 and early 2014, leading medical specialty societies will release more than 30 new lists of specific tests or procedures they say are commonly ordered but not always necessary and could cause harm as part of the Choosing Wisely campaign, the ABIM Foundation announced. The new lists continue the Choosing Wisely campaign, which brings together national physician groups to develop evidence-based lists of five tests and procedures that may be overused in their specific field. First launched in April 2012, this marks the third wave of lists released as part of the Choosing Wisely effort. These new lists build on the library of more than 130 tests and procedures that have been identified as potentially harmful and should be discussed with patients and physicians. To date, 54 societies and 17 consumer groups have joined the Choosing Wisely effort.

Source: http://www.choosingwisely.org/

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AAFP Releases Third Choosing Wisely List
The American Academy of Family Physicians (AAFP) has released its third list of commonly prescribed tests and procedures that may not be necessary. The evidence-based recommendations, part of the American Board of Internal Medicine Foundation Choosing Wisely campaign, were released on September 24 and are:

"Do not prescribe antibiotics for otitis media in children aged 2-12 years with non-severe symptoms where the observation option is reasonable."

"Do not perform voiding cystourethrogram...routinely in first febrile urinary tract infection...in children aged 2-24 months."

"Do not routinely screen for prostate cancer using a prostate-specific antigen (PSA) test or digital rectal exam."

"Do not screen adolescents for scoliosis."

"Do not require a pelvic exam or other physical exam to prescribe oral contraceptive medications

"Has to Change"

"Evidence shows that much of the care delivered in America could be duplicative or unnecessary. In fact, according to a report from the Institute of Medicine, up to 30% of healthcare may be duplicative or unnecessary," Reid Blackwelder, MD, a family physician in Kingsport, Tennessee, and AAFP president as of September 25, said in a news conference. Family physicians treat people, not diseases," Dr. Blackwelder said in the news conference.

Source: http://www.medscape.com/

Cancelled Lab Tests—Study Analyzes Why
The authors of the Q-Probes study, ”Reasons for Test Cancellation,” looked at more than a million specimen accessions at several dozen institutions, to get a fix on why tests are being cancelled and to gain insight into how laboratories can bring that number down. As the study makes clear, there is definitely room for improvement. Participants in the study, 52 institutions of varying sizes, prospectively monitored all blood specimens accessioned in the laboratory, with the exception of blood cultures, on all shifts for six weeks, or until 75 test cancellation events were identified (Add-on test orders, orders received without a specimen, and specimens received without a test order were excluded.) Most cancellations occurred in the laboratory (90.4 percent), with 9.6 percent cancelled by the ordering source. The two main reasons for test cancellation are problems with the order and preanalytical problems with the specimen.

Source: http://www.cap.org/

PSA Screening Does More Harm Than Good, Says New Analysis
To the ongoing debate over whether routine screening for prostate cancer reduces prostate cancer mortality comes a new analysis that suggests that it does more harm than good. The total harms that men experience in terms of impotence, incontinence, and other side effects from prostate cancer treatment can severely affect their quality of life, lead author Mathieu Boniol, MD, said at the European Cancer Conference 2013 (ECCO-ESMO-ESTRO). Dr. Boniol and colleagues conducted a systematic review of the literature for data on results of prostate-specific antigen (PSA) testing, biopsy rates, and mortality/associated side effects from radical prostatectomy, as well as hospitalization rates associated with biopsy. They also used data from the European Randomized Study of Screening for Prostate Cancer, which is the study showing the most favorable outcomes for PSA screening. Overall, they found that the harms outweigh the benefits on a population level. This should further discourage the use of routine PSA testing for prostate cancer in the general population, Dr. Boniol said.

Source: http://www.medscape.com/

Most C. diff Infections Are 'Not Hospital Spread'
Most cases of C. difficile are not actually caused by the bug being spread round hospitals, a study suggests. A team from the University of Oxford said "more and more deep cleaning ain't going to do any good." Analysis of every C. diff infection in Oxfordshire for more than three years showed less than a fifth of cases had been spread between hospital patients. Researchers said there was a growing awareness of animal and community sources of infection. The gut bug is one of the most feared "hospital infections". It can be difficult to treat and deadly, especially in the elderly. Rising levels of a particularly dangerous strain of the bacterium, alongside problems with the MRSA superbug, led to a deep-clean campaign across hospitals in the UK, and infection rates fell. However, a study in the Oxford University Hospital NHS Trust area, between 2008 and 2011, showed that reducing cases even further may require a different approach.

Source: http://www.bbc.co.uk/

Advanced Breast Cancer First Diagnosed on Bone Marrow Biops
Bone marrow biopsy specimens can identify previously undiagnosed metastatic breast cancer, according to a new clinicopathologic study. Although this situation is rare — with a frequency less than 0.2% — pathologists should be aware of the potential, said lead investigator Yaolin Zhou, MD, a third-year pathology resident at the University of Alabama at Birmingham. All 3 of the women whose bone marrow biopsy led to an initial diagnosis of breast cancer presented with new-onset cytopenias, Dr. Zhou told Medscape Medical News. "Despite all the medical advances today, unexplained new-onset cytopenias can be indicative of metastatic tumor," she explained. "Clinicians and pathologists should be aware of this possibility."

Source: http://www.medscape.com/

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Study Evaluates Population-wide Testing, Early Treatment for HIV Prevention
A study in South Africa and Zambia will assess whether house-to-house voluntary HIV testing and prompt treatment of HIV infection, along with other proven HIV prevention measures, can substantially reduce the number of new HIV infections across communities. The trial, Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART), or HPTN 071, is sponsored and co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial is funded primarily by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), administered by the Office of the Global AIDS Coordinator.

Source: http://www.nih.gov/

New Method Detects E. coli in Water
A research team from the Univ. of Alberta has made a public health breakthrough by developing a device that detects E. coli bacteria in water much faster than previous methods. Mechanical engineering professor Sushanta Mitra’s team developed a sensor capable of detecting the potentially deadly bacteria in minutes — clearly improving on existing technology, which takes 24 to 48 hours to do the same job. The team hopes to tie the new test to cellphone technology to alert health workers and members of the public that a water source is contaminated. The team is working with an Indian partner, Tata Consultancy Services, to make the device capable of setting off an alarm. The idea is that when the new sensors detect E. coli, text message alerts in the local language would be sent to public health workers and people who rely on wells for drinking water.

Source: http://www.laboratoryequipment.com/

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With Molecular Testing, Better Infection Control
Rapid and accurate molecular assays have gradually infiltrated the field of bacterial diagnosis. For several potentially lethal nosocomial pathogens—Clostridium difficile, vancomycin-resistant enterococcus, Mycobacterium tuberculosis, and methicillin-resistant Staphylococcus aureus—FDA-approved molecular assays are making a difference. Not only have they improved the accuracy of diagnosis, benefiting patients and clinicians, they have also been a boon to infection control practitioners.

Source: http://digital.olivesoftware.com/

UK's Forsite Diagnostics Funded $728K to Develop Malaria MDx
The European Commission has awarded €540,000 ($728,438) to UK-based Forsite Diagnostics to help develop a rapid molecular diagnostic test for malaria, the company said. The test is being developed as part of a three-year project called Diagmal to develop a test using fresh blood samples to confirm the presence of Plasmodium parasites, which causes malaria. Currently no molecular tests exist on the market for Plasmodium, Forsite, one of the collaborators on Diagmal, said. The award is part of the EC's Framework Programme 7.

Source: http://www.genomeweb.com/

Medtronic Gets US Approval for Artificial Pancreas System With Auto Shut-off
Medtronic Inc. said that it has won U.S. government approval for what it said is the first artificial pancreas system that automatically stops insulin treatment for diabetics when the patient has had enough. The new device, called the “MiniMed 530G with Enlite,” works by sensing the amount of glucose in the patient’s blood stream, then turning itself off when glucose levels drop to predetermined level if the patient hasn’t already responded to an alarm.

Source: http://www.startribune.com/

Kelleher Lab IDs 5,000-plus Proteoforms in Largest Human Top-Down Analysis to Date
Northwestern University researchers have completed the largest top-down proteomics study of a human cell line to date, identifying 1,220 proteins and more than 5,000 proteoforms in H1299 cells. The study, detailed in a paper published last week in Molecular & Cellular Proteomics, focused in particular on mitochondrial proteins, identifying 347 such proteins, a figure representing roughly 23 percent of all annotated mitochondrial proteins and nearing the number of IDs made in comparable bottom-up experiments, which have typically identified in the range of 500 to 800 proteins.

Source: http://www.genomeweb.com/

Sonic to Buy Five Labs in Germany
Pathology and radiology provider Sonic Healthcare is buying German laboratory business Labco for 76 million euros ($A110.58 million). Labco operates five laboratories in west and south west Germany, generating annual revenue of 53 million euros ($A77.11 million). The business will be quickly integrated into Sonic's existing German operations, and synergies are expected to be realised progressively through the first year of ownership, Sonic said.

Source: http://www.tradingroom.com.au/

NIH to Fund Development of High-Throughput Screening Assays
The National Institutes of Health plans to fund research efforts to develop assays for high-throughput screening of specific biological targets and disease mechanisms, and to stimulate new collaborations with screening centers that have the tools to implement HTS assays for the discovery and development of small molecule chemical probes. In a funding announcement, the NIH said it aims to "establish a stream of scientifically and technologically outstanding assays" to be used by the NIH Molecular Libraries Production Centers Network, part of the Molecular Libraries Program, and by other academic centers. NIH has not set funding limits for these studies, although it said it expects projects will last up to three years.

Source: http://www.genomeweb.com/

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NIH Launches Microbiome Cloud Project
The National Institutes of Health has launched the first phase of the Microbiome Cloud Project, or MCP, a collaborative project with Amazon Web Services that aims to improve access to and analysis of data from the Human Microbiome Project. In this phase, five terabytes of genetic information from human microbes have been made available on the cloud. This makes it easy for researchers to access and analyze the data online without having to worry about time-consuming downloads or compute infrastructure.

Source: http://www.genomeweb.com/

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A Farewell to Parasites
Despite a fierce civil war, scientists led a 14-year grassroots campaign that has eradicated a parasitic disease from northern Sudan.

In 2002, they said it was impossible. At an international conference held in Atlanta, 64 experts on public health, human rights, and finance concluded that ridding Africa of river blindness—a parasitic disease more formally known as onchocerciasis—was unachievable. Several attendees at the 2002 summit, which included reps from the World Health Organization (WHO), the National Institutes of Health (NIH), the Pan American Health Organization (PAHO), and the World Bank, argued that future efforts in Africa should focus on limiting the spread of onchocerciasis, rather than complete eradication. But a group of scientists at The Carter Center already had different plans in mind for Sudan.

The area’s remoteness and high incidence of disease made it ideal for trying new eradication tactics. A major turning point for this campaign came in 2006 when Katabarwa’s team stepped up the frequency of treatments from a single annual dose to two per year, In May 2013, Katabarwa and his collaborators provisionally announced the eradication of onchocerciasis in Abu Hamad in the American Journal of Tropical Medicine and Hygiene.

Source: http://www.the-scientist.com/

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New Technology Presented at OSA's Frontiers in Optics Meeting Will Help Fight Cancer
Scientists seeking new ways to fight cancer often try to understand the subtle, often invisible, changes to DNA, proteins, cells, and tissue that alter the body's normal biology and cause disease. Now, to aid in that fight, a team of researchers has developed a sophisticated new optical imaging tool that enables scientists to look deep within tumors and uncover their inner workings. These techniques, created by Fukumura and his long-term collaborators at Massachusetts General Hospital and Harvard Medical School, combine two different high-tech optical imaging methods that were custom-built for the research.

Source: http://www.medicalnewstoday.com/

Removing One Protein from Adult Cells Enables Them to Efficiently Turn Back the Clock to a Stem-cell-like State
Embryonic stem cells have the enormous potential to treat and cure many medical problems. That is why the discovery that induced embryonic-like stem cells can be created from skin cells (iPS cells) was rewarded with a Nobel Prize in 2012. But the process has remained frustratingly slow and inefficient, and the resulting stem cells are not yet ready for medical use. Research in the lab of the Weizmann Institute's Dr. Yaqub Hanna, which appears in Nature, dramatically changes that: He and his group revealed the "brake" that holds back the production of stem cells, and found that releasing this brake can both synchronize the process and increase its efficiency from around 1% or less today to 100%. These findings may help facilitate the production of stem cells for medical use, as well as advancing our understanding of the mysterious process by which adult cells can revert back into their original, embryonic state.

Source: http://www.medicalnewstoday.com/

Gene Variants Found Associated With Human Immune System, Autoimmune Disease
Numerous studies have reported that certain diseases are inherited. But genetics also plays a role in immune response, affecting our ability to stave off disease, according to a team of international researchers. The new findings, from the SardiNIA Study of Aging, supported in part by the National Institute on Aging (NIA) at the National Institutes of Health, are published in the Sept. 26, 2013 issue of Cell. The SardiNIA researchers found 89 independent gene variants on the genome associated with regulating production of immune system cells. Five of these sites for the gene variants coincide with known genetic contributors to autoimmune diseases, and extend previous knowledge to identify the particular cell types that are affected by these genes.

Source: http://www.nih.gov/

Severe Blood Infections During Childbirth on Rise in U.S. Women
Sepsis-related deaths also increased sharply over decade, researchers say.

In a disturbing trend, rates of severe sepsis and deaths from sepsis during childbirth rose sharply in the United States over a 10-year period, a new study reveals. Severe sepsis—which can lead to multiple organ failure—occurred in about one in 11,000 women. The rate of severe sepsis approximately doubled from 1998 to 2008: from about one in 15,400 to one in 7,250 women in labor. Fatal sepsis occurred in about one in 106,000 cases. Both severe and fatal sepsis increased by about 10 percent per year, found the study in the October issue of the journal Anesthesia & Analgesia.

Source: http://consumer.healthday.com/

CDC: Hepatitis A Outbreak Now at 162 Cases in 10 States
The Centers for Disease Control and Prevention issued an update reporting that the number of Hepatitis A cases associated with Townsend Farms Organic Antioxidant Blend now totals 162, with 71 people having been hospitalized. No deaths have been reported. The cases were reported in 10 states: Arizona, California, Colorado, Hawaii, New Hampshire, New Jersey, New Mexico, Nevada, Utah and Wisconsin.

Source: http://www.foodsafetynews.com/

West Nile Virus Infections Top 1000 in US This Year
Cases of West Nile virus have been steadily developing across the country this year, continuing even as fall approaches. This mosquito-spread disease has now caused infections in nearly every US state during 2013. The latest counts from the Centers for Disease Control and Prevention (CDC) show that West Nile virus infections across the US have reached over 1,000 cases so far during 2013.

Source: http://www.dailyrx.com/

H1N1 Flu: Pregnant Women Can Safely Take Vaccine
The question of whether or not to vaccinate against the flu is just one of many decisions pregnant women must make. However, a new large national study may put some fears to rest after revealing evidence that the H1N1 vaccine is safe during pregnancy. A collaboration between researchers from the University of California-San Diego (UCSD), Boston University, and the American Academy of Allergy Asthma and Immunology (AAAAI) yielded one large national study and two companion papers published in the journal Vaccine.

Source: http://www.medicalnewstoday.com/

Antibiotic Resistance: A Final Warning
On Sept 16, the US Centers for Disease Control and Prevention (CDC) released its report Antibiotic Resistance Threats in the United States, 2013—their first ever report on this subject. From the outset the tone is clear: in his foreword, Tom Frieden, director of the CDC, states that “antimicrobial resistance is one of our most serious health threats. Infections from resistant bacteria are now too common”. The stated aim of this report is to increase awareness of the threat resistance poses and to encourage immediate action to address this threat. To put the problem of resistance into perspective the report presents some sobering statistics. The CDC estimates that antibiotic-resistant organisms are the cause of infections in more than 2 million people each year in the USA. Of these people, more than 23,000 die as a consequence of their infections. The CDC stresses that these are conservative estimates and so the true numbers are probably much higher.

Source: http://www.thelancet.com/

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Eliminating Life-Threatening Medical Errors the Aim of First Real-Time Detector for IV Delivered Drugs
Today, computerized smart systems can deliver drugs intravenously in exact volumes to hospital patients. However, these systems cannot recognize which medications are in the tubing nor can they determine the concentration of the drug in the tubing. This lack of precise information can lead to medication errors with serious consequences. Now, a new optical device developed by a team of electrical and computer engineering students at the University of Illinois at Urbana-Champaign (UIUC) can identify the contents of the fluid in an intravenous (IV) line in real-time, offering a promising way to improve the safety of IV drug delivery. The team, [is] led by Prof. Brian T. Cunningham, interim director of the Micro and Nanotechnology Laboratory at UIUC.

Source: http://www.medicalnewstoday.com/

HIV/AIDS Database Adds Information From More Than 100 Countries
The U.S. Census Bureau announced that it had updated its world HIV/AIDS database to include new data on more than 100 countries, including China, Ghana, Ethiopia, India and Cameroon. The update comes as United Nations officials are reporting "dramatic" progress in the fight against HIV/AIDS. In its annual global report, the Joint United Nations Program on HIV/AIDS said that new HIV infections among children had dropped 52%, while new infections among children and adults had dropped 33%. The U.S. Census Bureau HIV/AIDS Surveillance Database is a compilation of data from 219 countries or regions, and tracks the prevalence of HIV infection, AIDS cases and related deaths.

Source: http://www.latimes.com/

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3 Ways FCC is Fostering Telemedicine
Comparing visits to Alaska and California against her hometown of Washington, DC. Federal Communications Commission commissioner Jessica Rosenworcel said that telemedicine technologies are changing the way medicine is practiced in urban and rural areas and everywhere in between. As telehealth gains purchase in the industry a number of obstacles are emerging, Rosenworcel said at the HIMSS HIT Policy Summit during National Health IT Week. Healthcare professionals can strive to do great things with telemedicine, she said, but its potential will be limited if it is fenced in by state regulations and paperwork.
To that end, three things the FCC is doing to drive telemedicine:

Allocating $400 million for broadband.

Investigating novel healthcare uses for the spectrum

Coordination. By Rosenworcel’s count, some 16 federal agencies have a role in shaping telemedicine policy. “That’s a lot of seats at the table and people at the party,” she noted, which is why the FCC is working to build bridges with federal colleagues, as it has done with the FDA and ONC to propose recommendations on mobile medical applications – the idea being to avoid regulatory duplication.

Source: http://www.govhealthit.com/

Deloitte's 4 Medical Device Security Threats
Describing networked medical devices as “a double-edged sword,” Deloitte explained that they can pose threats and bring about unintended consequences.

The security leaders interviewed listed among their top perceived threats to networked medical devices:

Hacktivists (i.e., anonymous individuals) wishing to cause service interruption.

Thieves desiring to sell or monetize personal health information (PHI), engage in identity theft, commit financial fraud against individuals and/or the health care organization, or defraud Medicare and/or Medicaid.

Malicious groups or individuals seeking to cause harm to patients (possibly targeting VIP patients) or seeking to damage the health care organization’s brand.

Malware that evades existing antivirus engines and rules but is not specifically targeted at medical devices.

Source: http://www.govhealthit.com/

Top EHRs for Small Practices Named in Study
Athenahealth narrowly heads the list of electronic health record (EHR) vendors that deliver both a good product and helpful ongoing customer service to practices with 1 to 10 physicians, according to a new report from the research firm KLAS. SRSsoft and Practice Fusion are close behind, holding the number 2 and 3 spots. KLAS based its ranking on a survey of roughly 400 practices. It asked them not only how their EHR software performs but also how the vendor performs in terms of training, implementation, troubleshooting, and upgrades.

Source: http://www.medscape.com/

Three Reasons for Patient Skepticism about EHR Implementation
EHRs have quickly gone from being a luxury to an industry standard. Since 2008, certified EHR usage among physicians has increased from 17 percent to over 50 percent, according to a May 2013 HHS press release. While physicians are apparently buying in to the necessity for and potential benefits of EHR implementation, many patients remain skeptical.

Higher Healthcare Costs

A recent study by University of Michigan researchers, which was summarized by WebMD, investigated three Massachusetts communities and found that the use of EHR reduced average healthcare costs by $5.14 per patient per month.

Concerns about Privacy

Patients aren’t so concerned about physicians having access to too much of their medical data, but they do fear the likelihood of a privacy breach.

Drop in Quality of Care

As physicians endure the growing pains associated with EHR implementation, patients worry that their doctors will have less face-to-face time.

Source: http://www.physicianspractice.com/

EHR Developers under Pressure
Fewer systems ready for Stage 2, analysis shows. The long-anticipated shakeout in the EHR market is underway.

A Modern Healthcare analysis of federal records shows there has been a massive drop in the number of software developers with clinical computer systems tested and ready for use in the second phase of the federal electronic health record incentive payment program, portions of which go into effect this week. Hundreds of hospitals and thousands of office-based physicians caught with underrated EHRs are now facing the prospect of losing full Medicare reimbursements and missing millions of dollars in future payments from the health IT incentive program, which so far has pumped $16.2 billion in federal aid to the industry since 2011.

Source:: http://www.modernhealthcare.com/

Key Part of EHR Incentive Program Halted due to Government Shutdown
A key function of the electronic health-record incentive payment program were shut down Tuesday along with much of the federal government due to the failure of Congress to pass a continuing spending resolution. Multiple operations of HHS' Office of the National Coordinator for Health Information Technology stopped, according to a 13-page HHS contingency staffing plan.

Source: http://www.modernhealthcare.com/

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FDA's Mobile Medical Apps Guidance: Our Advisors Weigh in
While the U.S. Food and Drug Administration unveiled its long-awaited final guidance on the regulation of mobile medical applications, some in the healthcare industry weren't sure it went far enough. For instance, Bradley Merrill Thompson, who serves as general counsel for the mHealth Regulatory Coalition, said the final guidance was porous in some areas, such as the definition of what are regulated; disease intended uses compared to unregulated, wellness intended uses; and the exact meaning of an accessory to a medical device.

Source: http://www.fiercemobilehealthcare.com/

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U.S. Health Spending to Grow at a Consistent 6 Percent Pace for the Next 10 years, Says CMS
Health care spending in the U.S. is expected to grow at a steady 6 percent per year from 2014 through 2022, according to CMS as published in the journal Health Affairs. Health spending in 2013 is expected to increase at below 4 percent as a result of the residual effects of the recession, continued increases in cost-sharing for people with private health insurance, and slower growth in Medicare and Medicaid spending. The consistent 6 percent growth rate for the next decade is attributed to an improving economy and increased spending by Medicare.

Source: http://health.wolterskluwerlb.com/

IPCC Climate Report: Humans 'Dominant Cause' of Warming
A landmark report says scientists are 95% certain that humans are the "dominant cause" of global warming since the 1950s. The report by the UN's climate panel details the physical evidence behind climate change. On the ground, in the air, in the oceans, global warming is "unequivocal", it explained. It adds that a pause in warming over the past 15 years is too short to reflect long-term trends. The panel warns that continued emissions of greenhouse gases will cause further warming and changes in all aspects of the climate system.

Source: http://www.bbc.co.uk/

London 2012 Athletes 'Had Bad Teeth'
Dentists have found "striking" levels of bad teeth in athletes competing at the London 2012 Olympic Games.A fifth of athletes surveyed said their oral health actually damaged their training and performance. The study, published in the British Journal of Sports Medicine, suggested cavities, tooth erosion and gum disease were common. A team at University College London says many competitors had dental problems. "Our data and other studies suggest that, for a similar age profile, the oral health of athletes is poor. It's quite striking," said lead researcher Prof Ian Needleman. He said eating large amounts of carbohydrates regularly, including sugary energy drinks, was damaging teeth. He added that the stress on the immune system from intense training may leave athletes at risk of oral disease and that a fixation on training, preparation and other aspects of health may leave little time or awareness of oral health.

Source: http://www.bbc.co.uk/

Woman Sues Lab for R2m over Wrong HIV Result
A 27-year-old eThekwini woman is suing a laboratory, and its owner, for R2 million in damages for incorrectly finding that she tested HIV positive. Nearly four months after she tested positive she learnt that she was in fact HIV negative. Vineshree Govender had gone for two tests in September 2010, for insurance purposes. The laboratory is opposing the claim.

Source: http://www.iol.co.za/

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