viernes, 19 de junio de 2015

DLS|HEALTHCARE NEWS|June 18, 2015 ► A Weekly Compilation of Clinical Laboratory and Related Information


A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems

June 18, 2015

News Highlights

  • Updated Information and Guidelines for Evaluation of Patients for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Infection
  • NIH Approves Strategic Vision to Transform National Library of Medicine
  • Prenatal DNA Test Patent Invalid, U.S. Appeals Court Says
  • Don't Order a Test Just Because You Can
  • Prepublication Standards – Standards Revisions for Laboratories
  • Holographic Microscopy Identifies Single Bacterium at Point of Care
  • Red Blood Cell Study Could Help in Anti-Malaria Fight
  • Brain Tumor’s Genetic Makeup Critical in Treatment, Research Finds
  • Blood Proteins May Provide Early Clue to Alzheimer's
  • Recent CDC Evaluation of Commercial MERS MDx Could Be Boon in Light of New Outbreak
  • Microneedle Patch for Measles Vaccination Could Be a Global Game Changer
  • The Race for Faster Tuberculosis Tests
  • House Bill Would Clarify HIPAA Guidance
  • AMA Adopts Health IT-Related Policies at Annual Meeting
  • White House Mandates HTTPS Connection for Federal Publicly Accessible Websites

View Previous Issues - Healthcare News Archive

Leading News

Updated Information and Guidelines for Evaluation of Patients for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Infection
The Centers for Disease Control and Prevention (CDC) continues to work with the World Health Organization (WHO) and other partners to closely monitor Middle East Respiratory Syndrome Coronavirus (MERS-CoV) globally, including the cases of MERS-CoV infection recently reported by China and the Republic of Korea, to better understand the risks to public health. The purpose of this HAN Advisory is to provide updated guidance to state health departments and healthcare providers in the evaluation of patients for MERS-CoV infection, which have been revised in light of the current situation in the Republic of Korea. Healthcare providers and public health officials should maintain awareness of the need to consider MERS-CoV infection in ill persons who have recently traveled from countries in or near the Arabian Peninsula1 or in the Republic of Korea as outlined in the guidance below. Please disseminate this information to healthcare providers, especially infectious diseases specialists, intensive care physicians, internists, infection preventionists, and to emergency departments and microbiology laboratories.
NIH Approves Strategic Vision to Transform National Library of Medicine
National Institutes of Health Director Francis S. Collins, M.D., Ph.D., approved a federal report (PDF - 163KB) that lays out the long-term scientific vision for the NIH’s National Library of Medicine (NLM), the world’s largest biomedical library. This vision, presented at the 110th meeting of the Advisory Committee to the Director (ACD), calls for NIH to position the NLM as a unifying force in biomedicine that promotes and accelerates knowledge generation, dissemination and understanding in the United States and internationally. The report also cites the need to make NLM the epicenter for biomedical data science, not just at NIH, but across the biomedical research enterprise. In addition, the report recommends dramatically expanding NLM’s activities to include research conducted beyond NIH’s walls to funded institutions, enabling it to have a greater and wider impact on data science than ever before. NIH plans to work with Congress to implement the necessary infrastructure changes to move this vision forward.
Prenatal DNA Test Patent Invalid, U.S. Appeals Court Says
A U.S. appeals court said that the discovery of a new form of prenatal testing that avoids the risks of invasive medical techniques was good for science but did not deserve a patent. The U.S. Court of Appeals for the Federal Circuit in the District of Columbia said a patent held by genetic testing company Sequenom Inc on detecting fetal DNA in a pregnant woman's blood was invalid. The decision by the nation's top patent court upholds a ruling by a lower federal court in California and clears Roche Holding AG unit Ariosa Diagnostics of infringement. The appeals said the DNA's presence in the blood fell under the U.S. Supreme Court's rule against patenting natural phenomena. The decision is the latest to interpret two Supreme Court decisions from 2012 and 2013 that made it harder to obtain patents on naturally occurring substances and the tests used to detect them, potentially putting a wide swath of biotech patents at risk.
Former Brain-Eating Papua Tribe Offers Clues on Deadly Diseases
Research involving a former brain-eating tribe from Papua New Guinea is helping scientists better understand mad cow disease and other so-called prion conditions and may also offer insights into Parkinson's and dementia. People of the Fore tribe, studied by scientists from Britain and Papua New Guinea, have developed genetic resistance to a mad cow-like disease called kuru, which was spread mostly by the now abandoned ritual of eating relatives' brains at funerals. Experts say the cannibalistic practice led to a major epidemic of kuru prion disease among the Fore people, which at its height in the late 1950s caused the death of up to 2 percent of the population each year. In findings published in the scientific journal Nature, the researchers said they had identified the specific prion resistance gene -- and found that it also protects against all other forms of Creutzfeldt-Jakob disease (CJD). "This is a striking example of Darwinian evolution in humans, the epidemic of prion disease selecting a single genetic change that provided complete protection against an invariably fatal dementia," said John Collinge of the Institute of Neurology's prion unit at University College London, which co-led the work.

Laboratory Testing / Diagnostics

Don't Order a Test Just Because You Can
Community-acquired pneumonia (CAP) is a clinical diagnosis based on typical features, including fever, cough with sputum production, and pleuritic chest pain, supported by physical examination findings of lung consolidation, laboratory evidence of leukocytosis or bandemia, and new infiltrates on chest imaging. Urinary antigen tests for Legionella pneumophila serotype 1 and Streptococcus pneumoniae are used frequently in the inpatient evaluation of patients with suspected CAP. These urinary antigen assays have the advantage of being obtained noninvasively and with rapid results; however, given their widespread availability and ease of acquisition, these molecular tests run the risk of being overused at a cost that potentially outweighs their benefit. As with all diagnostic tests, providers should be aware of disease prevalence and test characteristics when ordering and interpreting urinary pneumonia antigen tests. Careful consideration of the limited impact that these assays have in the management of routine cases of CAP also may prevent overuse. The sensitivity of the urinary L. pneumophila serotype 1 assay is 74% with a specificity of 99%.  The similarly high specificity of S. pneumoniae urinary antigen testing (96%) yields few false-positives but sensitivity also is limited to approximately 70%. Depending on an individual's pretest probability of infection by these two microbes, these relatively low sensitivities may not clinically exclude CAP caused by them, given the intrinsic rate of false-negative test results.
Prepublication Standards – Standards Revisions for Laboratories
In order to capture emerging trends in laboratories and maintain alignment with the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) regulations, The Joint Commission has identified two areas of the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB) that require updating. The first revision pertains to the use of a negative control for polymer-based immunohistochemistry methods. The Joint Commission also revised standards to align with the January 9, 2015 revisions of the CMS CLIA ’88 Interpretive Guidelines (IGs) that removed all references to the Clinical and Laboratory Standards Institute (CLSI) and CLSI documents. As a result of the revisions, microbiology laboratories are now required to comply with all CLIA ‘88 QC regulations. Prepublication Standards – Effective January 1, 2016
Researchers Call for Regulatory Oversight of Genomic Tests
Three researchers have suggested that the success of genomic testing depends on post-market data collection and analysis to help determine its safety and effectiveness. They further claim that Congressional action is needed to “incentivize the development of the massive data systems that doctors and regulators will need in order to make these tests safe and effective for patients.” A Special Report by the researchers, based at the University of Washington, School of Medicine and the University of Houston Law Center, was published in the May 27 on-line issue of the New England Journal of Medicine.
Holographic Microscopy Identifies Single Bacterium at Point of Care
Rapid point of care identification of bacterial infections remains an elusive goal in many instances, with labs around the world relying on culturing that can take days. The other option is for path labs to employ real-time polymerase chain reaction that can be too expensive for many clinics. Now researchers at the Korea Advanced Institute of Science and Technology (KAIST) report in journal Optics Express on a new microscopy technique that can identify the strain of a bacterial pathogen from a single example of the microorganism. The team built a device they call quantitative phase imaging unit (QPIU) that converts a traditional microscope into one capable of doing microscopic holography. The new imaging technique relies on illuminating the bacterium with laser light and analyzing the resulting hologram using special computer algorithms. The holograms are processed using Fourier transforms and then compared to previously acquired scans of known bacteria.
New Sensor to Detect Cancer, HIV, Hepatitis
Researchers have developed a highly sensitive nanomechanical sensor that can detect cancerous tumours as well as viral disease markers for HIV, hepatitis and herpes. Researchers from Moscow Institute of Physics and Technology (MIPT) developed the ultracompact nanomechanical sensor for analysing the chemical composition of substances and detecting biological objects. The sensor can detect viral disease markers, which appear when the immune system responds to incurable or hard-to-cure diseases, including HIV, hepatitis, herpes, and many others. The sensor will also enable doctors to identify tumour markers, whose presence in the body signals the emergence and growth of cancerous tumours.
Ventana ALK IHC Test Gets FDA Approval as CDx for Pfizer's Xalkori
The US Food and Drug Administration has approved an immunohistochemistry companion diagnostic developed by Roche subsidiary Ventana Medical Systems, the firm announced. The ALK (D5F3) CDx Assay will be another FDA-approved tool that healthcare providers can use to identify lung cancer patients who express ALK and are likely to respond well to Pfizer's Xalkori (crizotinib). The drug was approved in 2011 for ALK-positive non-small cell lung cancer patients alongside Abbott Molecular's Vysis ALK Break Apart Fluorescence In Situ Hybridization (FISH) test.
OraSure Awarded $10.4 Million HHS Contract to Advance Rapid Ebola Test Clinical Development
OraSure Technologies, Inc., provider of point-of-care diagnostic tests and specimen collection devices, has been awarded a contract for up to $10.4 million in funding from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response's Biomedical Advanced Research and Development Authority (BARDA), related to the company's OraQuick Ebola Rapid Antigen Test. The three-year, multi-phased contract includes an initial commitment of $1.8 million and options for up to an additional $8.6 million to fund certain clinical and regulatory activities.
Veritas Genetics Enters BRCA1/2 Space with $199 Test
Saying it wants to make genetic testing for cancer more widely available, startup Veritas Genetics recently launched its first test for BRCA1 and BRCA2 testing for $199, the first of what its CEO said will be several tests that the company will make available over the remainder of 2015 and beyond. The firm is making its test, called myBRCA, available without the need for insurance approval, though a physician requisition is needed. At $199, myBRCA costs a fraction of other BRCA1/2 tests.

Research and Development

Red Blood Cell Study Could Help in Anti-Malaria Fight
Scientists in Singapore have discovered new information about how red blood cells change as they age, and the discovery could lead to new ways to fight malaria infections. Red blood cells are essentially pouches filled with haemoglobin, a protein which carries oxygen to the rest of the body. In order to reach every cell in the body, the red blood cells must be able to squeeze through blood vessels, or capillaries, half their diameter or thinner. They discovered that, over time, the damage causes the cell's membrane to stiffen. Its internal scaffolding, also called the cytoskeleton, becomes compressed. The cell then becomes less flexible and unable to move through the network of capillaries, making it unable to circulate oxygen. But the scientists, whose laboratories focus partly on malaria infection, also discovered that this skeletal compression works against the malaria parasite. Assistant professor Rajesh Chandramohanadas explained: "The malaria has to make a hole in the red blood cell's membrane to get into the cell to infect it."  When the red blood cell becomes stiffer and the skeleton is clumped together, the parasite cannot make these holes. "He noted that this information improves researchers' understanding of malaria infection, as old cells in blood are often not infected by malaria. The team now plans to study how this new information could be explored for developing new ways to fight malaria. The team's work was published last month in the journal Scientific Reports, which is part of the prestigious Nature Publishing Group.
Brain Tumor’s Genetic Makeup Critical in Treatment, Research Finds
Doctors can more effectively treat many brain tumors by first ascertaining their genetic characteristics, rather than studying tissue samples under a microscope, the standard practice, two teams of researchers reported. The findings could alter diagnosis and treatment decisions for thousands of patients, experts said, and mark an important advance in so-called precision medicine, in which cancer treatments are customized according to the genetic makeup of the patient’s tumors. “Prognosis is going to be more accurately delineated by these kinds of genetic subtypes, outstripping the value of looking through a microscope,” said Dr. David J. Langer, the chief of neurosurgery at Lenox Hill Hospital in New York, who was not involved in the research. Previous research had identified these genetic markers as important. Many brain surgeons have used genotyping along with standard biopsy ratings to guide treatment. But the new papers conclude that the genetic markers should be central in diagnosis and prognosis, rather than complementary.
Blood Proteins May Provide Early Clue to Alzheimer's
Certain brain proteins can be detected in the blood of people long before they develop Alzheimer's disease and may offer a way to diagnose and treat the disease earlier, a new study suggests. The proteins – called lysosomal proteins – play a role in the removal of damaged nerve cell material. The researchers discovered that blood levels of these proteins were higher in people with normal memory and thinking abilities up to 10 years before they developed Alzheimer's disease. The findings were published online June 10 in the journal Neurology.
K-State Team Gets U.S. Patent on Early Cancer Detection Technology
Researchers at Kansas State University have received a U.S. patent on a new technology to detect cancer cells and tumors in early stages, even before the appearance of physical symptoms. The technology uses iron oxide-core nanoparticles coated with amino acids and fluorescent dyes that interact with enzymes in a patient’s blood sample. Enzymes known as proteases that are unique to each type of cancer tumor — a kind of genetic fingerprint, researchers say — can be identified in about 30 minutes. Researchers say the technology has a 95 percent success rate of detecting cancers at the stage 1 level and above.
Epigenetic Maps of the Human Body’s Major Organs
Researchers have constructed the most comprehensive map yet of methyl groups that influence which genes are expressed and when. For more than a decade, scientists have had a working map of the human genome, a complete picture of the DNA sequence that encodes human life. But new pages are still being added to that atlas: maps of chemical markers called methyl groups that stud strands of DNA and influence which genes are repressed and when. Now, Salk scientists have constructed the most comprehensive maps yet of these chemical patterns–collectively called the epigenome–in more than a dozen different human organs from individual donors (including a woman, man and child). While the methylation does not change an individual’s inherited genetic sequence, research has increasingly shown it has a profound effect on development and health.
UGA Researchers Find Potential Treatment for Fatal Lung Diseases
Researchers at the University of Georgia have discovered that the drug triciribine may reverse or halt the progression of pulmonary fibrosis and pulmonary hypertension, two respiratory diseases that are almost invariably fatal. They published their findings recently in the British Journal of Pharmacology. "The average life expectancy for people with these diseases is only about five years after diagnosis, and while the drug treatments we currently have may help improve quality of life, they don't reduce mortality," said Somanath Shenoy, co-author of the paper and associate professor in UGA's College of Pharmacy. "Our tests show that treatment with triciribine can halt disease progression and may even reverse some of the damage to lung tissue."

Public Health and Patient Safety

Recent CDC Evaluation of Commercial MERS MDx Could Be Boon in Light of New Outbreak
In April, at the Clinical Virology Symposium in Daytona Beach, Florida, researchers from the US Centers for Disease Control and Prevention presented a small, preliminary evaluation of three commercial assays for Middle East Respiratory Syndrome coronavirus, also called MERS or MERS-CoV. The evaluation may be somewhat timely, as MERS — which in April 2013 was deemed by the US Food and Drug Administration to pose a significant enough risk for a public health emergency — is again emerging, with a new outbreak in South Korea causing a public health crisis.  PCR is the preferred method to test for MERS, a CDC spokesperson told GenomeWeb in an email. The technique is sensitive enough to detect only a few viral particles, and assays are easy to develop since reagents are commercially available and primers and probes can be quickly synthesized. The technique is also relatively safe, unlike viral culture, and it can be coupled to sequencing to support molecular epidemiology studies, the spokesperson noted. The CDC has been consulting with the National Institute of Health and Korea Center for Disease Control and Prevention "to offer assistance with viral genomic sequencing, sequence analysis, and serology," the CDC spokesperson said. In the US, the current CDC interim guidelines explain that many state health department laboratories are approved for MERS testing using the CDC rRT-PCR assay. Viral culture is not recommended, and "must be performed in a BSL-3 facility using BSL-3 work practices." Differential diagnostic testing for common respiratory pathogens by molecular or antigen detection methods, but not by viral culture, is also strongly recommended.
Microneedle Patch for Measles Vaccination Could Be a Global Game Changer
A new microneedle patch being developed by the Georgia Institute of Technology and the Centers for Disease Control and Prevention (CDC) could make it easier to vaccinate people against measles and other vaccine-preventable diseases. The microneedle patch is designed to be administered by minimally trained workers and to simplify storage, distribution, and disposal compared with conventional vaccines. The microneedle patch under development measures about a square centimeter and is administered with the press of a thumb. The underside of the patch is lined with 100 solid, conical microneedles made of polymer, sugar, and vaccine that are a fraction of a millimeter long. When the patch is applied, the microneedles press into the upper layers of the skin; they dissolve within a few minutes, releasing the vaccine. The patch can then be discarded. Georgia Tech and CDC's Global Immunization Division and Division of Viral Diseases recently completed a study that showed the new microneedle patch produces a strong immune response in an animal model. No adverse effects or health issues were noted during the study. These findings have cleared the way for developing proposals for human clinical trials, which could begin as early as 2017.
The Race for Faster Tuberculosis Tests
As drug-resistant strains of TB develop, researchers strive to detect it sooner.
As U.S. health officials treat an Indian woman who entered the country with drug-resistant tuberculosis, scientists at Texas A&M Health Science Center are trying to develop faster and more accurate ways to diagnose the infectious disease. The timely detection of TB remains one of the greatest difficulties in dealing with the condition. The main symptoms, like long-lasting cough and fever, are common to other illnesses. The bacteria are also slow-growing. That’s why patients with TB often aren’t diagnosed until they’ve had the infection for many months, risking infecting others. The increase in drug-resistant versions of the bug adds to the urgency in detecting TB more quickly. Researchers, such as Jeff Cirillo and colleagues at the Texas A&M facility in Bryan, Texas, are working on faster, cheaper diagnosis alternatives. They have developed a test that signals when enzymes produced only by TB bacteria are present, whittling the process to just 10 minutes from several days. They now are studying how it could be used to determine drug-resistance as well.
Doctors Worry about Return of Vaccine-Preventable Ills in Kids
Although most U.S. children are getting their routine vaccinations, recent trends have experts concerned that Americans will lose some of the "herd immunity" that has long protected many from serious infections. The vast majority of U.S. kids are up-to-date with routine jabs against once-common infections like polio, measles, mumps, whooping cough and chickenpox. But that "coverage" varies from state to state, according to the latest figures from the U.S. Centers for Disease Control and Prevention. In 2013, there were 17 states where less than 90 percent of 1.5- to 3-year-olds had gotten their first dose of the measles-mumps-rubella (MMR) vaccine, the CDC found.
Sand Fly Saliva Proves a Good Monkey Vaccine for Leishmaniasis
A vaccine against leishmaniasis based on the saliva of sand flies has worked well in monkeys and may have potential to work in humans, according to a new study. Leishmaniasis, caused by a parasite injected by the bite of bloodsucking sand flies, infects about one million people a year, mostly in the Middle East and South America. It can cause long-lasting skin sores — known to American troops in Iraq as the “Baghdad boil.” Another form, called kala azar, found in India and Africa, is caused by a related parasite that attacks internal organs and can be fatal. There is currently no human vaccine, and the drugs that kill the parasites have harsh side effects.
Heart Attack Risk Increases 16-21% with Use of Common Antacid
Adults who use proton pump inhibitors are between 16 and 21 percent more likely to experience a heart attack than people who don't use the commonly prescribed antacid drugs, according to a massive new study by Houston Methodist and Stanford University scientists. An examination of 16 million clinical documents representing 2.9 million patients also showed that patients who use a different type of antacid drug called an H2 blocker have no increased heart attack risk. The findings, reported in PLOS ONE, follow a Circulation report in 2013 in which scientists showed how – at a molecular level – PPIs might cause long-term cardiovascular disease and increase a patient's heart attack risk.
Could Daily Aspirin Prevent Breast Cancer?
Conducted by Dr. Sushanta Banerjee, research director of the Cancer Research Unit at the Veterans Affairs Medical Center in Kansas City, MO, and colleagues, the study revealed how low-dose aspirin impaired the ability of breast cancer cells to renew. The researchers say their findings suggest a daily dose of aspirin – a medication commonly used to relieve pain and prevent blood clots – could prevent breast cancer development and recurrence in women. For their study, Dr. Banerjee and colleagues set out to investigate how aspirin would affect incubated breast cancer cells in laboratory dishes and breast cancer tumors in mouse models.

Health IT

House Bill Would Clarify HIPAA Guidance
In an effort to help patients suffering from mental illness, a newly proposed House bill looks to clarify and formalize guidance on HIPAA privacy rules. The guidance looks to clarify when HIPAA allows providers to:
  • Communicate with people involved in a patient's care, including family members and friends
  • Communicate with the parent of a patient who is a minor
  • Consider the patient's capacity to agree or object to the sharing of their information
  • Communicate with family members, law enforcement, or others when the patient presents a serious and imminent threat of harm to self or others
AMA Adopts Health IT-Related Policies at Annual Meeting
The American Medical Association adopted several health IT-related policies at its annual meeting.
  • Electronic Health Record Training Policy
During the meeting, AMA adopted a policy to provide medical students with "hands-on" experience and training for electronic health records, Health Data Management reports.
  • ICD-10 Policy
AMA also adopted a policy that calls for a two-year transition period for ICD-10,
  • Prescription Drug Monitoring Programs Policy
In addition, AMA adopted a policy to bolster states' use of prescription drug monitoring programs. The policy also urges to states to fully fund their PDMPs, as well as modernize such systems to allow for data to be shared across state lines.
  • Web-based Initiative to Improve Professional Satisfaction
Meanwhile, AMA announced that it has launched a Web-based platform to improve professional satisfaction among physicians and reduce burnout rates.
  • Ethical Guidelines for Telehealth Use
Meanwhile, AMA ethical guidelines for the use of telehealth failed to gain the approval of the full House of Delegates.
White House Mandates HTTPS Connection for Federal Publicly Accessible Websites
The White House June 8 issued a directive instructing federal agencies with publicly accessible websites to provide service only through a secure HTTPS connection that encrypts nearly all information during communication between the website and user. The move follows the commercial sector adoption of the HTTPS standard that is intended to better protect website visitors and services as well as to limit vulnerabilities and potential exposure of sensitive data such as browser identity, website content, search terms and information submitted by users. Federal Chief Information Officer Tony Scott, who wrote about the shift in a blog post, issued a memorandum (pdf) that requires such agencies to meet the new standard by Dec. 31, 2016.
ONC Seeks Input on EHR, Health IT Certification
The Health and Human Services Department agency that certifies electronic health records and health information technology meets the standards and specifications required under "meaningful use" requirements wants feedback on its testing methodology. In order to receive Medicare and Medicaid incentive program payments, clinicians and hospitals must employ tools that meaningfully use health IT in a way that drives improved health outcomes.  In a June 9 notice in the Federal Register, the Office of the National Coordinator for Health Information Technology asked the public for recommendations for procedures, tools and test data to use in the EHR certification program.
Health IT Privacy Workgroup Discusses Big Data Challenges
The Privacy and Security Workgroup of the Health IT Policy Committee is working on recommendations for dealing with big data, according to an article at Healthcare Informatics. In its meeting, members discussed the challenges presented both for HIPAA-covered entities and the marketplace not covered by HIPAA. Those issues include data de-identification, security and other areas. Workgroup chair Deven McGraw, a partner in the healthcare practice of Manatt, Phelps and Phillips, noted that consumers don't have clearly defined rights for accessing information collected about them by organizations not covered by HIPAA. The panel wants to remind the National Coordinator for Health IT that the Federal Trade Commission can enforce voluntarily adopted codes of conduct, some of which are still being developed. It also discussed whether the Federal Credit Reporting Act could be used to provide patients with more transparency about the algorithms healthcare organizations use to make decisions about patients and populations.
7 Conditions Necessary for Interoperability
Standards alone are not sufficient to achieve interoperability, according to David McCallie, M.D., senior vice president of medical informatics for Cerner. To that end, he cites seven conditions required for interoperability. According to McCallie:
  1. A business process must exist for which standardization is needed
  2. A proven standard then needs to be developed, via an iterative process that involves repeated real-world testing and validation
  3. A group of healthcare entities must choose to deploy and use the standard, in service of some business purpose
  4. A "network architecture" must be defined that provides for the identity, trust and security frameworks necessary for data sharing in the complex world of healthcare
  5. A "business architecture" must exist that manages the contractual and legal arrangements necessary for healthcare data sharing to occur
  6. A governance mechanism with sufficient authority over the participants must ensure that the network and business frameworks are followed
  7. All of the ancillary infrastructure (such as directory services, certificate authorities, and certification tests) must be organized and deployed in support of the standard

Other News

California Assembly Unanimously Approves Cytotechnologist Bill
On April 30, legislation to clarify that California licensed cytotechnologists may perform molecular and genetic testing pertaining to cytology was approved unanimously by the California State Assembly. The measure, AB 599, was introduced by Assembly Business and Professions Committee (BPC) Chairwoman Susan Bonilla (D.-Concord) and would clarify that cytotechnologists in California would have the same scope of practice as cytotechnologists elsewhere in the United States.
Lab Nears Settlement over Pricey Medicare Drug Tests
Nation's largest drug-testing lab aims to end allegations that it billed the government for unnecessary tests. The nation's largest drug-testing laboratory, Millennium Health LLC, is negotiating a major settlement over allegations it billed the federal government for unnecessary tests, the latest sign of a crackdown on the fast-growing industry. Settlement talks come as the federal Medicare agency is proposing broad changes to the way it pays for urine drug tests that could save taxpayers money and cut into drug testers' revenue. Such tests can search for drugs including narcotic pain pills and illegal substances such as angel dust and club drugs like MDMA.

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