viernes, 21 de febrero de 2014



Centers for Disease Control and Prevention (CDC) Healthcare News Update - REVISION


Healthcare News

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


February 20, 2014


View Previous Issues - Healthcare News Archive


U.S. Launches New Global Initiative to Prevent Infectious Disease Threats

Faced with what they describe as a perfect storm of converging threats from infectious-disease epidemics, U.S. officials launched a global effort with more than two dozen countries and international organizations to prevent deadly outbreaks from spreading. The goal is to prevent, detect and respond to infectious-disease threats where they start. That’s more effective and less costly than treating sick people after diseases spread. The new initiative is intended to bolster security at infectious-disease laboratories, strengthen immunization programs and set up emergency-response centers that can react to outbreaks within two hours. Despite advances in medicine and technology, Americans are at greater risk than ever from new infectious diseases, drug-resistant infections and potential bioterrorism organisms, said Thomas Frieden, director of the Centers for Disease Control and Prevention, which is spearheading the initiative.


CDC: 5 Ways Diseases in Other Countries Can Kill You

The world is smaller and people are more mobile than at any time in history. This makes it easier than ever for what's happening anywhere on the globe to harm Americans' health.  Here are five ways diseases in other countries pose a threat:
  • The flu could threaten millions.
  • Antibiotic resistance is on the rise.
  • Diseases don't respect borders.
  • "Foreign" diseases are now domestic threats.
  • Emerging infections: What's the next HIV?


Medical Device Reporting: Electronic Submission Requirements

The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting will improve the Agency's process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). This final rule is effective August 14, 2015


EHR Rethink May Reduce Unneeded Tests

When it comes to America's healthcare costs, spiraling ever upward, one of the main culprits is unnecessary testing. Some 130 oft-overused screenings and treatments should be curtailed, according to the two-dozen organizations affiliated with the American Board of Internal Medicine Foundation's "Choosing Wisely" campaign. Indeed, as Scientfic American pointed out in its article about that initiative, the Instiute of Medicine estimates that $750 billion – three-quarters of a trillion dollars! – was spent on unnecessary services and excessive administrative costs in 2009. "We are, I hope, at a turning point in American health care where we're realizing you want to have the right health care, not just more health care," Baylor College of Medicine pediatrics professor Virginia Moyer told the magazine. Well, not quite yet. Many thousands of docs are all too happy to order excessive lab work and imaging – and defensive medicine may be a big reason why. As Doug Campos-Outcalt, a Phoenix, Ariz.-based family physician, told Kaiser Health News, "Nobody ever gets sued for ordering unnecessary tests."


Premier Collaborative Saved 136,000 Lives, $11.65 Billion, Report Finds

More than 350 hospitals across the U.S. collectively saved $11.65 billion and prevented 136,375 deaths during the past five years by adhering to evidence-based standards for best practices, according to a report released by Premier. The hospitals were all a part of the company's QUEST collaborative, a national quality improvement program started in 2008, which requires members to use proven methods of quality, safety and efficiency based on standards set by observing the program's top performing healthcare providers. As hospitals across the nation attempt to improve ratings and have better outcomes, several studies are finding that getting clinicians to follow through on adopted evidence-based standards is a significant challenge. Premier's QUEST collaboration served as a blueprint for Medicare's hospital value-based purchasing program initiated by the CMS Services in October 2012 under the Patient Protection and Affordable Care Act. 


Harvard Researchers Create Chip-based, Liquid Biopsy Device That Offers a Novel Way to Monitor Treatment of Ovarian Cancer Patients and Only Costs $1

The ATC Chip identifies ovarian cancer cells floating in ascites and may be useful for diagnosing other types of malignancies that involve ascites, like pancreatic cancer.

Pathologists will be interested to learn that researchers at Harvard Medical School and Massachusetts General Hospital are developing a “liquid biopsy” technology specifically to enable point-of-care monitoring of the progress of patients undergoing treatment for certain types of cancers. The goal is to develop a method that community hospitals can use to monitor treatment of ovarian cancer patients without the need for expensive medical laboratory equipment, noted a report published by Researchers estimate that their ‘liquid biopsy’ technology could cost as little as $1 per test when eventually cleared for use in clinical settings. The research team created a microchip device—called the ATC chip—that simplifies monitoring of a patient’s response to treatment for ovarian cancer and certain other malignancies. The device captures, isolates, and identifies tumor cells from ascites (ATCs).


Credit Card-Sized Device Could Analyze Biopsy, Help Diagnose Pancreatic Cancer in Minutes

Routine screenings for breast, colon and lung cancers have improved treatment and outcomes for patients with these diseases, largely because the cancer can be detected early. University of Washington scientists and engineers are developing a low-cost device that could help pathologists diagnose pancreatic cancer earlier and faster. The prototype can perform the basic steps for processing a biopsy, relying on fluid transport instead of human hands to process the tissue. The team presented its initial results this month (February 2014) at the SPIE Photonics West conference and recently filed a patent for this first-generation device and future technology advancements.


Researchers Identify Protein Markers for Predicting Severity, Hospitalization in Flu Cases

A team led by researchers at the St. Jude Children's Research Hospital in Memphis, Tenn., has identified protein biomarkers that could help predict severity of flu infections. In a study published in December in the American Journal of Respiratory and Critical Care Medicine, the researchers determined that increased patient levels of nasal lavage MCP-3, IFNα2, and plasma IL-10 predicted progression to severe disease while increased plasma IL-10, MCP-3, and IL-6 levels predicted patient hospitalization. The study also identified MCP-3 as a potential standalone marker for identifying patients likely to be hospitalized, St. Jude researcher Paul Thomas, lead author on the paper, told ProteoMonitor.


Lasers Used in Meningitis Tests by Strathclyde University Scientists

Scientists at Strathclyde University have developed a new test to speed up the diagnosis of bacterial meningitis. It uses nanoparticles and lasers to "fingerprint" more than one bacterium at a time - and so opens the way for targeted treatment. Unless caught quickly, bacterial meningitis can lead to blood poisoning and brain damage. Details of the new test have been published in the journal Chemical Science.


Quick Test Finds Signs of Diarrheal Disease

Bioengineers at Rice University and the University of Texas Medical Branch (UTMB) at Galveston have developed a simple, highly sensitive and efficient test for the diarrheal disease cryptosporidiosis that could have great impact on global health. Results from the diagnostic developed by the lab of Rice bioengineer Rebecca Richards-Kortum are read from a paper strip that resembles a pregnancy test. Lines on the strip tell whether samples taken from the stool of a patient contain genetic DNA from the parasite that causes the disease. The research is detailed online in a new paper in the American Chemical Society journal Analytical Chemistry.


Test 'Predicts' Teen Depression Risk

A tool for predicting the risk of clinical depression in teenage boys has been developed by researchers. Looking for high levels of the stress hormone cortisol and reports of feeling miserable, lonely or unloved could find those at greatest risk. Researchers at the University of Cambridge want to develop a way of screening for depression in the same way as heart problems can be predicted. However, their method was far less useful in girls.


In Novel Test, CHOP Applies Next-Generation Sequencing to HLA Typing

Researchers at The Children’s Hospital of Philadelphia (CHOP) have deployed the power of next-generation sequencing technology to advance human leukocyte antigen (HLA) typing. The new laboratory test, introduced this month at CHOP, could improve transplantation outcomes and expedite the process of selecting bone marrow donors. CHOP plans to offer the test for patient testing as a service to medical and academic centers. 


Myriad Reveals Results Showing That its Prolaris Test Modifies Prostate Cancer Treatment Decisions

Myriad Genetics, Inc; has announced results from PROCEDE 500, a clinical utility study with its Prolaris prognostic test, at [the] 2014 ASCO Genitourinary Cancers Symposium. According to company representatives, the study demonstrates the significant clinical value of Prolaris for physicians who are treating men with prostate cancer. Prolaris, which predicts prostate cancer-specific death and metastases, has been validated in 11 clinical studies with more than 5,000 patients. Results for these interim data show that in 65% of cases, physicians changed their intended therapy and selected a different treatment based on the Prolaris test score.  In 40% of patients, physicians reduced the therapeutic burden on patients and opted for conservative management options such as active surveillance and watchful waiting.  


Illumina and a Billionaire Want to Jump-Start Genomics Upstarts

Illumina, the top seller of gene sequencing machines, announced a deal in tandem with Yuri Milner, the billionaire Russian investor behind Facebook (FB), Twitter (TWTR), and many other Web companies, to provide some aid to a select group of genomics startups. Illumina will carve out a laboratory at its San Francisco research facility for startups and provide them with sequencing equipment, $100,000 for such things as chemical reagents, and coaching on how to start and run their businesses. Milner and Silicon Valley Bank will lend financial support as well.


Molecular Diagnostics Are in a Rut. The Industry Needs the FDA

Some of the more exciting ideas in biotech are coming up in molecular diagnostics. There’s cool science at work. A number of tests have potential to cut down on overtreatment, reduce waste in healthcare, and give physicians clever new ideas on how to help patients. But this industry, which accounts for less than 2 percent of healthcare spending, is stuck in neutral.


A New Kind of Transplant Bank

Nearly a year ago, Mark Smith, a 27-year-old doctoral candidate, and three colleagues launched OpenBiome, the nation’s first human stool bank. Its mission: to provide doctors with safe, inexpensive fecal material from screened donors to treat patients with Clostridium difficile, a gastrointestinal infection that kills at least 14,000 Americans a year. “People are dying, and it’s crazy because we know what the solution is,” Mr. Smith said. “People are doing fecal transplants in their basements and may not be doing any of the right screening or sterile preparation. We need an intermediate solution until there are commercial products on the market.” But where to get healthy donor stool?  For doctors, it’s a tedious, time-consuming process, and some patients turn awkwardly to relatives or friends. Since September, OpenBiome has delivered more than 135 frozen, ready-to-use preparations to 13 hospitals. The nonprofit project fields dozens of requests from doctors, hospitals and patients every week. (The preparations are not sent directly to patients.)


Chips Can 'Listen' to Bacteria

In a study published in Nature Communications, a research team led by Ken Shepard, professor of electrical engineering and biomedical engineering at the Columbia Univ. School of Engineering and Applied Science, and Lars Dietrich, assistant professor of biological sciences at Columbia Univ., has demonstrated that integrated circuit technology, the basis of modern computers and communications devices, can be used for a most unusual application — the study of signaling in bacterial colonies. They have developed a chip based on complementary metal-oxide-semiconductor (CMOS) technology that enables them to electrochemically image the signaling molecules from these colonies spatially and temporally. In effect, they have developed chips that "listen" to bacteria. The next step for the team will be to develop a larger chip that will enable larger colonies to be imaged at higher spatial and temporal resolutions.


Shape-sifting: NIST Categorizes Bio Scaffolds by Characteristic Cell Shapes

Getting in the right shape might be just as important in a biology lab as a gym. Shape is thought to play an important role in the effectiveness of cells grown to repair or replace damaged tissue in the body. To help design new structures that enable cells to "shape up," researchers at the National Institute of Standards and Technology (NIST) have come up with a way to measure, and more importantly, classify, the shapes cells tend to take in different environments. With the notable exception of Flat Stanley, we all live, and are shaped by, a 3-dimensional world. Biologists have accepted that this dimensional outlook is just as important to growing cells. A key challenge in tissue engineering—the engineering of living cells to grow into replacement or repair tissues such as bone, heart muscle, blood vessels or cartilage—is creating 3-D scaffolds to support the cells as they grow and provide an appropriate environment so that they develop into viable tissue.


Scientists Spot 7 New Regions of DNA Tied to Type 2 Diabetes

The discovery of seven new regions of DNA linked to type 2 diabetes could lead to new ways of thinking about diabetes and new treatments for the disease, researchers suggest. The findings were among the results of the largest study to date on the genetics of diabetes, which compiled genetic information on people from four different ethnic groups, the study authors said.

The study involved more than 48,000 diabetes patients and nearly 140,000 people who did not have the disease. By examining more than 3 million DNA variants, the investigators were able to pinpoint regions that have even a small effect on people's risk for type 2 diabetes.


Vast Study Casts Doubts on Value of Mammograms

One of the largest and most meticulous studies of mammography ever done, involving 90,000 women and lasting a quarter-century, has added powerful new doubts about the value of the screening test for women of any age. It found that the death rates from breast cancer and from all causes were the same in women who got mammograms and those who did not.  And the screening had harms: One in five cancers found with mammography and treated was not a threat to the woman’s health and did not need treatment such as chemotherapy, surgery or radiation.


Human Lung Made in Lab for First Time

For the first time, scientists have created human lungs in a lab -- an exciting step forward in regenerative medicine, but an advance that likely won't help patients for many years. "It's so darn cool," said Joan Nichols, a researcher at the University of Texas Medical Branch. "It's been science fiction and we're moving into science fact." If the lungs work -- and that's a big if -- they could help the more than 1,600 people awaiting a lung transplant. Lungs are one of many body parts being manufactured in the lab -- some parts, such as tracheas and livers, are even further along.


Designer Nanoparticles Offer Best-ever Gene Silencing

Inspired by tiny particles that carry cholesterol through the body, MIT chemical engineers have designed nanoparticles that can deliver snippets of genetic material that turn off disease-causing genes. This approach, known as RNA interference (RNAi), holds great promise for treating cancer and other diseases. However, delivering enough RNA to treat the diseased tissue, while avoiding side effects in the rest of the body, has proven difficult. The new MIT particles, which encase short strands of RNA within a sphere of fatty molecules and proteins, silence target genes in the liver more efficiently than any previous delivery system, the researchers found in a study of mice. The MIT team is now trying to learn more about how the particles behave and what happens to them once they are injected, in hopes of further improving the particles’ performance.


New Method Developed for Ranking Disease-Causal Mutations Within Whole Genome Sequences

Researchers from the University of Washington and the HudsonAlpha Institute for Biotechnology have developed a new method for organizing and prioritizing genetic data. The Combined Annotation–Dependent Depletion, or CADD, method will assist scientists in their search for disease-causing mutation events in human genomes. The new method is the subject of a paper titled “A general framework for estimating the relative pathogenicity of human genetic variants,” published in Nature Genetics. The goal in developing the new approach was to take the overwhelming amount of data available and distill it down into a single score that can be more easily evaluated by a researcher or clinician.


Production of an Exceptionally Large Surface Protein Prevents Bacteria From Forming Clumps and Reduces Their Ability to Cause Disease

A genetic mechanism that controls the production of a large spike-like protein on the surface of Staphylococcus aureus (staph) bacteria alters the ability of the bacteria to form clumps and to cause disease, according to a new University of Iowa study. The new study is the first to link this genetic mechanism to the production of the giant surface protein and to clumping behavior in bacteria. It is also the first time that clumping behavior has been associated with endocarditis, a serious infection of heart valves that kills 20,000 Americans each year. The findings were published in the journal PLOS Pathogens. "Our study suggests that clumping could be a target for therapy," says Horswill. "If we could find drugs that block clumping, I think they would be potentially really useful for blocking staph infections." 


Cancer: 'Tumour monorail' Can Lead Cancers to Their Doom

Cancer "monorails" can be used to kill tumours by luring them into toxic pits or areas of the body that are safer to operate on, say US researchers. A team at the Georgia Institute of Technology designed nanofibres thinner than a human hair which cancers "choose" to travel down.  Animal studies showed brain tumours could be shrunk by tricking cancer cells into migrating down the fibres. Cancer Research UK said it was a fascinating idea.


Clues for Battling Aggressive Cancers From Twin Sisters Study

Analyzing the genomes of twin sisters -- one healthy and one with aggressive leukemia -- led an international team of researchers to identify a novel molecular target that could become a way to treat recurring and deadly malignancies. The study points to a molecular pathway involving a gene called SETD2, which can mutate in blood cells during a critical step as DNA is being transcribed and replicated. In comparing the blood cells of both twin sisters, these researchers identified a chromosomal translocation generated what is known as the MLL-NRIP3 fusion leukemia gene. When they activated the MLL-NRIP3 gene in laboratory mouse models, the animals developed the same type of leukemia, but it took a long period of time for them to do so. Researchers said this suggested that there had to be additional cooperative epigenetic and molecular events in play to induce full-blown leukemia. Scientists in China and the United States report their findings online Feb. 9 in Nature Genetics.


New Application of Physics Tools Used in Biology

A Lawrence Livermore National Laboratory physicist and his colleagues have found a new application for the tools and mathematics typically used in physics to help solve problems in biology. Specifically, the team used statistical mechanics and mathematical modeling to shed light on something known as epigenetic memory – how an organism can create a biological memory of some variable condition, such as quality of nutrition or temperature. "The work highlights the interdisciplinary nature of modern molecular biology, in particular, how the tools and models from mathematics and physics can help clarify problems in biology," said Ken Kim, a LLNL physicist and one of the authors of a paper appearing in the Feb. 7 issue of Physical Review Letters. Not all characteristics of living organisms can be explained by their genes alone. Epigenetic processes react with great sensitivity to genes' immediate biochemical surroundings – and further, they pass those reactions on to the next generation.


Scripps Florida Scientists Invent Breakthrough Approach to Quickly Identify New Drug Candidates from Genome Sequence

In research that could ultimately lead to many new medicines, scientists from the Florida campus of The Scripps Research Institute (TSRI) have developed a potentially general approach to design drugs from genome sequence. “This is the first time therapeutic small molecules have been rationally designed from only an RNA sequence—something many doubted could be done,” said Matthew Disney, PhD, an associate professor at TSRI who led the study. The technique, described in the journal Nature Chemical Biology online ahead of print on February 9, 2014, was dubbed Inforna.


Tracing Ancestry, Researchers Produce a Genetic Atlas of Human Mixing Events

The rise and fall of empires, the march of armies, the flow of trade routes, the practice of slavery — all these events have led to a mixing of populations around the world. Such episodes have left a record in the human genome, but one that has so far been too complex to decipher on a global scale. Now, geneticists applying new statistical approaches have taken a first shot at both identifying and dating the major population mixture events of the last 4,000 years, with the goal of providing a new source of information for historians.


Could Infections Harm Memory in Older Adults?

Exposure to several types of common infections could be associated with memory problems, a new study suggests. The authors caution, however, that further research is needed to draw concrete conclusions. Scientists from the University of Miami and Columbia University in New York City were scheduled to present their research at an American Stroke Association meeting in San Diego.


Could Statins Be Used to Fight a Deadly Viral Infection?

Two Perelman School of Medicine microbiologists may have found a way to use statins, the well-known blockbuster cholesterol-lowering drugs, to fight the hantavirus, a mysterious and lethal microorganism that appeared suddenly in the US southwest over 20 years ago. That first outbreak led to the deaths of more than a dozen people, most of them in their prime. The last reported outbreak happened in Yellowstone Park in 2012. A PLOS Pathogens paper by Penn microbiologists Paul Bates, PhD, and Kenneth Briley, PhD, published reports that four proteins key to cholesterol synthesis and uptake are highjacked by the hantavirus to enter human host cells. 


Vitamin C Linked With Reduced Stroke Risk

Making sure you get enough vitamin C could help protect you from stroke, a small new study suggests. Research presented at the annual meeting of the American Academy of Neurology shows that risk of hemorrhagic stroke -- which is more deadly, but rarer, than ischemic stroke -- is lower among people who have normal vitamin C levels, compared with people with depleted vitamin C levels. “Our results show that vitamin C deficiency should be considered a risk factor for this severe type of stroke, as were high blood pressure, drinking alcohol and being overweight in our study,” study researcher Dr. Stéphane Vannier, M.D., of Pontchaillou University Hospital in France, said in a statement. “More research is needed to explore specifically how vitamin C may help to reduce stroke risk. For example, the vitamin may regulate blood pressure.”


Itching: More Than Skin-Deep

The experiment was not for the squirmish. Volunteers were made to itch like crazy on one arm, but not allowed to scratch. Then they were whisked into an M.R.I. scanner to see what parts of their brains lit up when they itched, when researchers scratched them and when they were finally allowed to scratch themselves. The scientific question was this: Why does it feel so good to scratch an itch? Itching and scratching engage brain areas involved not only in sensation, but also in mental processes that help explain why we love to scratch: motivation and reward, pleasure, craving and even addiction. What an itch turns on, a scratch turns off — and scratching oneself does it better than being scratched by someone else. The study results were published in December in the journal PLOS One.


In California, Thousands Exposed to Measles

Thousands of San Francisco Bay Area residents may have been exposed to measles this month when an unvaccinated student at the University of California, Berkeley, attended classes and rode the area's BART transit system. Public health officials in Contra Costa County, outside of San Francisco, said anyone riding BART from Feb. 4 to Feb. 7 during the morning or late evening commutes could have been exposed to the highly contagious respiratory virus. The young man in his 20s lives in the county and was confirmed to have measles. He was likely infected while traveling recently in Asia, health officials said.


18 May Have Been Exposed to Incurable Disease

Doctors and hospital officials from Novant Health Forsyth Medical Center in Winston-Salem, North Carolina, are notifying 18 neurosurgery patients that they might have been exposed to Creutzfeldt-Jakob disease, a serious and incurable neurological disorder. "It is important to note that there are multiple variations of CJD and this case is not related to mad cow disease," Novant Health said in a statement. The hospital confirmed that on January 18, an operation was performed on a patient with CJD symptoms who later tested positive for the illness.


IVF Births Set Record in 2012

More than 60,000 babies were born in the U.S. in 2012 through the use of reproductive technology, mainly in vitro fertilization (IVF), according to a report from a reproductive specialty group. The annual report from the Society for Assisted Reproductive Technology (SART) tallied 61,740 live births in the U.S. in 2012 -- an increase of more than 2,000 infants from 2011. The group's results were based on data from 379 clinics throughout the U.S., which performed 165,172 cycles of assisted reproductive technologies in 2012. IVF accounted for 99% of procedures; the remaining 1% was comprised of gamete intrafallopian transfer (GIFT) and zygote intrafallopian transfer (ZIFT).


A Watchful Eye in Hospitals

Despite the intensely personal moments that happen in hospitals, patient privacy can be elusive. Hospitals are multimillion-dollar corporations that look like shopping malls and function like factories. Doctors knock on exam room doors to signal they are about to enter — not to ask permission. The curtain that encircles the hospital bed always lets in a crack of light. Yet we do expect some degree of privacy in hospitals. We trust doctors with our secrets in part because they take a 2,000-year-old Hippocratic oath to respect our privacy, an oath enforced by laws like the Health Insurance Portability and Accountability Act. But sometimes, doctors have to weigh patients’ privacy against their health and safety, and that’s when things get complicated. Hidden cameras should be a last resort. Hospitals should notify patients that covert video monitoring may be used in unusual circumstances, and only with the oversight of a hospital ethics committee. Institutions should then track the use of covert video monitoring to ensure that it remains rare and appropriate, while letting hospitals marshal technology to protect our most vulnerable patients.


How VA is Driving Telemedicine

There's a quiet revolution going on in health care that has big implications for the future of medicine. Although most of the technology underlying telemedicine is not particularly advanced, a confluence of circumstances is conspiring to take telemedicine out of the realm of specialized and rural care and into everyday programs. Beginning in 2003, VA began a deliberate policy of building a national telemedicine program to expand its reach, reduce travel costs and increase the levels of care available to veterans. VA runs three basic types of telemedicine programs: Clinical video is designed to replicate face-to-face interactions between caregivers and patients using videoconferencing; home monitoring allows doctors to keep tabs on patients with chronic conditions such as diabetes; and the teleradiology service on VA's My HealtheVet website allows clinicians to share imaging information on individual cases for help in diagnostics and care.


AAFP Panel: Telemedicine Can Help Expand Care

Telemedicine offers a way for doctors to treat more patients as the Patient Protection and Affordable Care Act brings in more people seeking care. And the quality of care is not compromised, panelists told a recent forum hosted by the Robert Graham Center for Policy Studies in Family Medicine and Primary Care in Washington, D.C. "Telemedicine is not different medicine," said Jason Mitchell, M.D., director of the American Academy of Family Physicians' Center for Health IT. "It's a different interaction." Patients say they value having to take less time off work, less travel and greater convenience, according to an AAFP article.


Senators Introduce Bill to Reduce Health IT Regulatory Burden

Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced legislation that would clarify FDA's regulatory framework for health IT and ensure that "low-risk" products are not the focus of oversight, Healthcare IT News reports.

Details of the Bill

The Preventing Regulatory Overreach To Enhance Care Technology -- or PROTECT -- Act of 2014 is the Senate companion bill to the bipartisan House SOFTWARE Act (HR 3303). The Senate bill would provide FDA guidance on regulating mobile medical applications. Specifically, it would clarify the agency's regulatory process to make sure it primarily focuses on technologies that pose the most health risks.

The bill also would exempt certain health IT software from being charged a 2.3% medical device tax, including:
  • Electronic health records;
  • Scheduling software; and
  • Wellness applications.


US Health IT Market Expected to Grow at 20% CAGR During 2014-2018

The US health IT market is expected to grow at a CAGR of nearly 20% during 2014-2018, according to RNCOS latest “US Healthcare IT Market Outlook 2018” research study. The report reveals the future growth of the health IT market will likely be driven by:
  • rapid introduction of new products
  • growing government support
  • declining implementation cost of healthcare IT
  • continued growth and adoption of cloud computing


2014 Edition EHR Certification Includes New Transparency Requirements

ONC’s 2014 Edition EHR Certification Criteria define the requirements that EHR technology must meet in order to be used by eligible professionals (EPs), eligible hospitals (EHs), and critical access hospitals (CAHs) participating in the Medicare and Medicaid EHR Incentive Programs.  In addition to these criteria, ONC made some policy changes to the HIT Certification Program. Starting with the 2011 Edition certification, EHR technology developers were required to disclose certain information about their certified products.  This information included: the date the product was certified; the product version certified; the unique certification number or other specific product identification; the clinical quality measures to which the product was certified; any additional software the product relied upon to demonstrate its compliance with certification criteria; and the certification criterion or criteria to which an EHR Module had been certified.


Health IT Chief DeSalvo Says Interoperability a 'Top Priority' for 2014

At the annual Health Care Innovation Day, National Coordinator for Health IT Karen DeSalvo said interoperability will be the Office of the National Coordinator for Health IT's "top priority for 2014," Healthcare IT News reports. In an effort to boost care experience, improve population health and reduce costs, DeSalvo cited five ONC priorities:
  • Increasing health IT adoption;
  • Establishing standards to enable interoperability;
  • Providing incentives to help facilitate interoperability;
  • Ensuring the privacy and security of personal health information
  • Providing health IT governance and structure


HIPAA Data Breaches Climb 138 Percent

Take 29.3 million, for instance, the number of patient health records compromised in a HIPAA data breach since 2009, or 138 percent, the percent jump in the number of health records breached just from 2012. These numbers, compiled in a February 2014 breach report by healthcare IT security firm Redspin, though, don't tell the whole story, as these are numbers reported to the U.S. Department of Health and Human Services by HIPAA covered entities. Many healthcare breaches still go unreported, industry officials point out, and many breach offenders don't make the list of shame. Moreover, breaches involving the health records of fewer than 500 individuals are not required to be publicly reported, which also skews the final numbers. 


5 Tips for Avoiding Data Breaches

There have been a total of 804 large breaches of protected health information affecting more than 29.2 million patients since HITECH came out in 2009. The findings of a new report from Redspin, Inc., show many healthcare organizations have been struggling to comply with HIPAA. The sheer number of large personal health information breaches in 2013 — the year saw a 138 percent increase — is perhaps all the evidence needed to back up that assertion.

How can you keep your organization from being one of the casualties of these HIPAA breaches? This year's Redspin report also includes these tips:

1. Conduct an annual HIPAA security risk analysis

2. Inoculate yourself by encrypting data-at-rest

3. Conduct more frequent vulnerability assessments and penetration testing

4. Invest in the security awareness of your workforce

5. Engage with your business associates


Google Cloud Platform to be HIPAA Compliant, Support BAAs

Google, following up on its move late last year to enter into business associate agreements enabling its Google Apps customers to support HIPAA-regulated data, recently announced that its cloud platform will support BAAs [Business Associate Agreements], as well. In a Feb. 5 blog post, Google Cloud Platform Product Manager Matthew O'Connor talked about the difficulties with needing to comply with HIPAA for developers building healthcare-related applications. "Not only do you need the right code and a reliable user experience, sometimes it feels like you need to be a lawyer, too," O'Connor said. "When building in the cloud, it can be challenging to ensure that you're complying with [HIPAA] regulations."


DoD Seeks Software Licenses, Dental EHR System

 The U.S. Department of Defense is seeking enterprise software licenses specific to its variety of hospitals and clinics, according to a notice posted on the federal contract website. It's also looking to procure a Dental Electronic Health Record System (D-EHR) to be part of the EHR system it's creating. The dental system should be able to manage 17,000 patient appointments a day, reports Nextgov.


Poor Nations Seek New Hepatitis C Drug

Now that wealthy nations have a simple pill regimen that can cure hepatitis C, calls are mounting from representatives of poor nations for the same drugs. In December, the Food and Drug Administration approved sofosbuvir, from Gilead Sciences. Under the brand name Sovaldi in the United States, it is expected to cost $84,000 per treatment. Four other companies are developing similar pills expected to reach the market in the next three years, with similarly high price tags. Worldwide, at least 150 million people — nearly five times the number with H.I.V. — are believed to have hepatitis C, which can cause liver damage and cancer. The Access Campaign of Doctors Without Borders has estimated that cocktails of sofosbuvir and similar drugs can be made for $250 or less, and it is lobbying to make that possible, said Rohit Malpani, the campaign’s policy chief. It will ask the World Health Organization to put sofosbuvir on its list of drugs the agency tests for countries too poor to have their own drug regulatory agencies.


Medical Errors That Shook Greece

From incorrect medical assessments and contaminated blood transfusions, to errors that left patients paralyzed or with serious disabilities, physicians in Greece have also had their share of failures over the past years and were involved in medical errors. On the occasion of the Papageorgiou Hospital in northern Greece which is planning to introduce a mobile phone signal jammer for its operating rooms so that physicians won’t be able to use their cell phones while operating.


County’s Largest Laboratory Goes Digital

A multi-million shillings pathology laboratory has been opened in Moi Hospital in Voi sub-county in Taita-Taveta County which is expected to improve the delivery of health services for thousands of residents in the region. As part of a promotion package to usher in an era of modernized and improved laboratory services for the residents, the hospital announced a 14-day offer for free lab services to patients who required routine or specialized tests as part of an introductory medical package on the services the ultra-modern facility will be offering. In what appears to be a quantum leap into the process of digitization of laboratory activities, the facility’s servers and computerized operations are interlinked with web-based networks of other LANCET labs across the country where diagnosis can be done simultaneously by doctors manning those labs.
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