A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
June 20, 2013
View Previous Issues - Healthcare News Archive
Supreme Court Says Natural Human Genes Can't be Patented
The Supreme Court ruled unanimously that natural human genes cannot be patented by companies, but it said that synthetically produced genetic material can — a mixed ruling for the biotechnology industry. A naturally occurring piece of DNA is “a product of nature and not patent eligible merely because it has been isolated,” the court said.
The case centered on a Salt Lake City company called Myriad Genetics that was granted patents for isolating two human genes, known as BRCA1 and BRCA2, that indicate a higher risk of breast and ovarian cancer. The company now markets tests for those genes. The court said that Myriad had found something important and useful, but it ruled that “groundbreaking, innovative, or even brilliant discovery” does not by itself guarantee a patent.
After Patent Ruling, Availability of Gene Tests Could Broaden
Almost immediately after the Supreme Court ruled that human genes could not be patented, several laboratories announced they too, would begin offering genetic testing for breast cancer risk, making it likely that that test and others could become more affordable and more widely available. The ruling in effect ends a nearly two-decade monopoly by Myriad Genetics, the company at the center of the case. “It levels the playing field; we can all go out and compete,” said Sherri Bale, managing director of GeneDx, a testing company, which plans to offer a test for breast cancer risk. “This is going to make a lot more genetic tests available, especially for rare diseases.”
Just how many other tests are affected is a bit unclear. Experts say there are not that many tests offered exclusively by one company because of patents. But some other patents, like those on bacterial genes that might be useful in producing enzymes or biofuel, might also now be in jeopardy. Still, biotechnology industry officials and patent lawyers said that the decision should have little effect on the pharmaceutical industry and on developers of genetically engineered crops.
Molecular Biology and the Court
While the US Supreme Court ruling last week in the Association for Molecular Pathology v. Myriad Genetics gene patenting case was a unanimous decision, Justice Antonin Scalia wrote a short concurring opinion. In it, Scalia notes while he joins in the judgment of the court, there were aspects of the opinion, particularly surrounding its description of molecular biology, that he did not join with the other justices on. "I am unable to affirm those details on my own knowledge or even my own belief," he says.
Steven Salzberg in his column at Forbes notes that the Court's description of molecular biology contains a number of errors. For example, Salzberg points out that while the Court said that "the nucleotides that code for amino acids are 'exons,' and those that do not are 'introns'" that is not quite the case.
Supreme Court Split on Pharma ‘Pay for Delay’ Deals
So-called "pay-for-delay" arrangements between generic and brand-name drug companies are not inherently legal, and each instance must be considered on a case-by-case basis, the Supreme Court ruled. In the 5-3 decision overruling the 11th Circuit Court of Appeals, Justice Stephen Breyer, writing for the majority, listed five reasons why the appellate court erred in giving blanket immunity to pay-for-delay agreements, in which brand-name drugmakers pay or compensate generic drug companies in exchange for a later entry date of the cheaper generic version of a drug:
Senate Passes Bill to Allow Research on Organ Transplants for HIV Patients
The Senate passed a bill that would establish safeguards and standards of quality for research of organ transplants for people infected with human immunodeficiency virus (HIV). Sen. Barbara Boxer (D-Calif.) introduced the HIV Organ Policy Equity Act, S. 330, which would allow research on possible health risks for people with HIV receiving organs transplants from donors who also have HIV. The bill also directs the secretary of Health and Human Services (HHS) to develop and publish guidelines for the conduct of research relating to transplantation of organs from HIV-infected donors.
Medicare's Doctor Records Riddled With Errors
Wrong addresses, telephone numbers and licensing information for physicians have been found throughout the enrollment systems that Medicare uses to approve pay for beneficiary services, according to federal auditors. An estimated 58% of enrollment records in the Provider Enrollment, Chain and Ownership System were inaccurate, and 48% of records in the National Plan and Provider Enumeration System had errors, the Dept. of Health and Human Services Office of Inspector General stated in a report published May 28. The records also were inconsistent between the two systems, with nearly all records for health professionals in PECOS and NPPES containing mismatched information in 2010. “It is critical that data in PECOS be accurate and up to date to ensure the data on Physician Compare are also accurate and up to date,” CMS stated in the 2013 Medicare fee schedule. “CMS is evaluating other options for physicians, health professionals and group practices to update their information, and is looking at other available data sources to validate PECOS data to further improve accuracy as we continue to improve the data presented on Physician Compare.” A physician can correct an address error found on the website by revising his or her PECOS record. The agency will repopulate information online periodically. The American Medical Association has advocated for changes to Physician Compare, which is scheduled for an upgrade later in 2013. New functionality is expected to include the ability to search for a physician to treat a specific condition or organ system.
FDA Urges Protection of Medical Devices From Cyber Threat
The U.S. Food and Drug Administration urged medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats that could compromise the devices or patient privacy. It released that advisory in coordination with a separate alert from the Department of Homeland Security, which disclosed vulnerability in a wide variety of medical equipment that can make those devices vulnerable to remote attacks from hackers. "Over the past year, we've become increasingly aware of cyber security vulnerabilities in incidents that have been reported to us," William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health, said in an interview.
AdvaMed on the 510(k): Leave Well Enough Alone
Medical device industry lobbying group AdvaMed urges the FDA to avoid making needless changes to the 510(k) medical device review pathway, particularly to the rules for when device modifications merit a new application. The FDA's proposal to enhance regulatory oversight of modifications made to already-cleared devices ruffled some feathers among the medtech industry, which warned that more rigid oversight could triple the agency's work without conferring much benefit to public safety.
Microbiology Devices Panel Meeting
The Microbiology Devices Panel met on June 13, 2013 to discuss and make recommendations regarding the possible reclassification of rapid influenza detection devices, currently regulated as Class I, to Class II. The Panel discussed an FDA proposal for a new Class II regulation with specific Special Controls designed to ensure safety and effectiveness of these devices throughout their Total Product Life Cycle (TPLC). As these devices are the most broadly used tests to aid in the diagnosis of an influenza infection, especially in physician offices and outpatient clinics, their quality and reliability is crucial for proper patient management, for surveillance and for infection control. The discussion focused on (1) the minimum performance criteria that should be required for clearance of the rapid influenza detection devices; (2) what is the appropriate reference method to be used for evaluation of clinical performance; (3) the need for annual post-market reactivity testing of device performance due to the continuous genetic changes of seasonal influenza viruses and, how to communicate the ability of previously cleared rapid influenza detection devices to detect novel influenza virus strains; and (4) a provision for testing when a new influenza strain with a potential to become a public health emergency emerges.
Breast Cancer Screening Does Not Reduce Deaths Says Study of 40 Years of Mammograms
A new UK study suggests screening for breast cancer does not reduce deaths from the disease. The study, which looked at nearly 40 years of breast screening, adds to the controversy surrounding whether it is screening or improvement in treatment that accounts for the fall in rates of death from breast cancer. The researchers from the Department of Public Health at the University of Oxford, report their findings online in the June issue of the Journal of the Royal Society of Medicine. The findings contrast with a study reported in The Lancet in 2012 by an independent expert panel set up by the Department of Health that concluded patients who are invited for mammogram screening have a 20% lower relative risk of breast cancer death than those who are not invited. However, that review also found that for every death prevented by breast cancer screening, three patients will be over-diagnosed and treated for the disease.
Yinfa Ma, PhD, Curators’ Teaching Professor of chemistry at Missouri University of Science and Technology, has developed a new screening method that uses a urinalysis to diagnose breast cancer—and determine its severity—even before it can be detected with a mammogram. The clinical trial is ongoing at Mercy Breast Center in Springfield, Mo., and the researchers are actively seeking participants.
Genome Project Has Been Worth $1 Trillion, Battelle Says
A new Battelle study shows that the federal government’s efforts to finance research for the Human Genome Project have had nearly a $1 trillion impact on the U.S. economy during the past 25 years. It claims that $14.5 billion in federal research dollars from 1988 through 2012 helped create more than 53,000 jobs in the genome field, boosted personal income by $293 billion and helped expand the nation’s output by $965 billion. “As the largest single undertaking in the history of life sciences, the Human Genome Project has paid back extraordinary dividends on the U.S. government’s investment,” Carrie Wolinetz, president of United for Medical Research, said in a statement. “
Poking Holes in Genetic Privacy
Not so long ago, people who provided DNA in the course of research studies were told that their privacy was assured. Their DNA sequences were on publicly available Web sites, yes, but they did not include names or other obvious identifiers. These were research databases, scientists said, not like the forensic DNA banks being gathered by the F.B.I. and police departments.
But geneticists nationwide have gotten a few rude awakenings, hints that research subjects in fact could sometimes be identified by their DNA alone, or even by the way their cells were using their DNA. The latest shock came in January, when a researcher at the Whitehead Institute, which is affiliated with the Massachusetts Institute of Technology, managed to track down five people selected at random from a database using only their DNA, ages and the states in which they lived. And he did it in just hours. He also found relatives — a total of close to 50 people.
Under-Use of Genetic Testing Puts Health of Entire Families at Risk
A new study of the use of genetic testing for cancer-causing mutations in affected families in France has found that its take-up is very low. Professor Pascal Pujol, Head of the Cancer Genetics Department, Montpellier University Hospital, Montpellier, France told the annual conference of the European Society of Human Genetics that analysis of data from the French National Cancer Institute covering the years 2003 to 2011 showed that, although there had been a steady increase in tests performed for the breast and ovarian cancer-causing mutations BRCA1 and BRCA2, this was not the case with the MMR mutation, implicated in Lynch syndrome (a form of colorectal cancer). Only a third of relatives of individuals with either mutation underwent genetic testing themselves.
HbA1c Far From Perfect Diabetes Diagnostic
Using glycated hemoglobin (HbA1c) to diagnose diabetes may miss more than half of cases, researchers reported. In a review of national epidemiologic data, only about 43% of patients who met the criteria for diabetes based on fasting plasma glucose (FPG) were also diagnosed as diabetic using a typical HbA1c cutoff of 6.5%, Jinsun Choi, MD, of City of Hope National Medical Center in Duarte, Calif., and colleagues reported at the Endocrine Society meeting. "Based on this analysis, we can definitively say that the sensitivity of HbA1c of 6.5 is not very good; it's actually very low," Choi told MedPage Today. She concluded that using an HbA1c ≥ 6.5% to diagnose diabetes will truly catch less than 50% of diabetic patients defined by FPG. "In order to be consistent with diabetes diagnosed by FPG," she said, "we propose to use HbA1c ≥ 6.0% as a diagnostic criteria."
Only days ago we wrote about new breath sensing technology being developed at University of Pittsburgh and National Energy Technology Laboratory that uses titanium dioxide and single-walled carbon nanotubes to accurately measure acetone, a marker for blood glucose levels. The development has the potential to change the way diabetics keep an eye on their sugar levels.
Now we get word that a team from Korea Advanced Institute of Science and Technology (KAIST) has been working on its own breath sensor that has similar capabilities but works quite differently. It relies on tin dioxide (SnO2) nanofibers that are wound from wrinkled thin SnO2 nanotubes using electrospinning.
Innovative “Watch” Non-Invasively Measures Blood Pressure
Surprisingly, noninvasive blood pressure measurement technology has advanced little, but now STBL Medical Research AG, with the assistance of engineers from the Swiss Federal Laboratories for Materials Science and Technology (EMPA) have designed a device to make blood pressure monitoring as simple as wearing a watch. The blood pressure watch has the potential benefit of being a continuously monitoring device, which will help patients who tend to suffer from the “white coat” effect in which their blood pressure readings are abnormal due to nervousness around doctors. It has the potential of also being able to provide emergency alerts if one’s blood pressure ever reaches dangerous levels.
Blood Tests Could Detect Sexually-Transmitted Oral Cancers
Antibodies to a high-risk type of a virus that causes mouth and throat cancers when transmitted via oral sex can be detected in blood tests many years before onset of the disease, according to a World Health Organisation-led team of researchers. In a study in the Journal of Clinical Oncology, the researchers said their findings may in future lead to people being screened for human papillomavirus (HPV) antibodies, giving doctors a chance to find those at high risk of oral cancers. "Up to now, it was not known whether these antibodies were present in blood before the cancer became clinically detectable," said Paul Brennan, of the WHO's International Agency for Research on Cancer (IARC), who led the study and described the findings as "very encouraging".
Finnish Startup With Stanford Technology Offers NGS-based Testing for Inherited Disorders
Blueprint Genetics, a Finnish startup with ties to Stanford University, has launched its first diagnostic gene panels for inherited diseases, starting with cardiovascular disorders. The panels range in size from 5 genes to about 100 genes and cover cardiomyopathies, aortic dilatation, arrhythmia disorders, Brugada syndrome, long and short QT syndrome, Noonan syndrome, and other disorders. List prices range from €1,000 to €1,600 ($1,300 to $2,100) per panel,
Retractable Needle Reduces Stick Injuries
Using a retractable steel needle instead of a resheathable needle decreased the rate of accidental needle-stick injuries by almost half among nurses and phlebotomists at a large hospital in New York City. "We were getting approximately 50 needle sticks a year in our institution because of the cumbersome nature of the device we were using to draw blood," Alexandra Derevnuk, RN, coordinator of infection control and blood and body fluid exposure at the Mount Sinai Medical Center in New York City, told Medscape Medical News. "When we switched, this went down to 25 needle sticks per year. We are happy with this result, but our ultimate goal is to get that number down even lower, ideally to zero,"
Two scientists from Cold Spring Harbor Laboratory (CSHL) have published a mathematical method of simplifying and interpreting genome data bearing evidence of mutations, such as those that characterize specific cancers. Not only is the technique highly accurate; it has immediate utility in efforts to parse tumor cells, in order to determine a patient's prognosis and the best approach to treatment. CSHL Assistant Professor Alexander Krasnitz, who developed the new technique jointly with American Cancer Society Professor Michael Wigler, explains that it reduces the burden of interpretation by identifying what he and Wigler call COREs, an acronym for "cores of recurrent events." "In cancer," says Krasnitz, "we find intervals in the genome that are hit again and again. You might see this in many cells coming from a single patient's tumor; or you may see these repeating patterns in cells sampled from many patients with a similar cancer type." In either case, if you superimpose the location of each "hit" - whether a deletion or an amplification of DNA - against a map of the full human genome, "you end up with these wobbly pile-ups, stacks of 'hits' at the same locations in the genome."
Platelets Help Tackle Bacteria
Platelets may contribute to protection against bacterial infection, according to new research published June 16 in Nature Immunology. Scientists found that in the livers of mice, platelets collaborated with specialized white blood cells to capture and engulf blood-borne bacteria, and this interaction helped protect the animals from bacterial infection. “It’s an extremely exciting paper,” said Steve Watson, a platelet cell biologist at the University of Birmingham, who did not participate in the research. Though previous research had demonstrated that bacteria can activate platelets, “this work emphasizes that platelets play a day-to-day role in innate immune defense by helping remove bacteria in the liver.”
MERS Deaths at 33; Researchers Claim Progress
Studies carried out by researchers from Saudi Arabia and the United Kingdom have allowed them to map out the genetic characteristics of the MERS virus, the health ministry said in a statement. This is considered "a positive step to follow-up the development and mutation of the virus over the time, meanwhile, helping in the diagnostic steps, and to find out a quick mechanism of diagnoses," the ministry said.
The research was conducted in collaboration with scientists from University College London and the Wellcome Trust Sanger Institute. A full genetic series, obtained from four infected cases in Al-Ahsa, was recorded in the gene bank, said ministry spokesman Dr. Khalid Marghlani. The series is also available to the public on the National Center for Biotechnology Information website. The Centers for Disease Control and Prevention said it is "important that the Saudis released the sequences. It helps us understand the virologic evidence of person-to-person transmission."
Risk Score Identifies Patients Presenting With Pneumonia at Low Risk for MRSA
Methicillin-resistant Staphylococcus aureus (MRSA) represents an important pathogen in healthcare-associated pneumonia (HCAP). The concept of HCAP, though, may not perform well as a screening test for MRSA and can lead to overuse of antibiotics developed a risk score to identify patients presenting to the hospital with pneumonia unlikely to have MRSA. The researchers identified patients admitted with pneumonia (Apr 2005 -- Mar 2009) at 62 hospitals in the U.S. They only included patients with lab evidence of bacterial infection (e.g., positive respiratory secretions, blood, or pleural cultures or urinary antigen testing). They determined variables independently associated with the presence of MRSA based on logistic regression (two-thirds of cohort) and developed a risk prediction model based on these factors. The researchers validated the model in the remaining population.
New Layer of Human Eye, 'Dua's Layer,' Discovered Behind Cornea
Scientists have discovered a previously unknown layer lurking in the human eye.
The newfound body part, dubbed Dua's layer, is a skinny but tough structure measuring just 15 microns thick, where one micron is one-millionth of a meter and more than 25,000 microns equal an inch. It sits at the back of the cornea, the sensitive, transparent tissue at the very front of the human eye that helps to focus incoming light, researchers say.
The feature is named for its discoverer, Harminder Dua, a professor of ophthalmology and visual sciences at the University of Nottingham. Dua said in a statement that the finding will not only change what ophthalmologists know about human eye anatomy, but it will also make operations safer and simpler for patients with an injury in this layer.
Drug-injecting addicts who took a daily antiretroviral pill were half as likely to become infected with H.I.V. as those who did not, a major new study has found, providing the final piece of evidence that such treatments can prevent AIDS in every group at risk. Earlier clinical trials showed that the therapy can sharply reduce the risk of H.I.V. transmission from mother to child, and in gay and bisexual men and heterosexuals. “This provides the totality of the evidence that the drugs used to treat the infection are also very effective at preventing it,” said Dr. Salim S. Abdool Karim, a prominent South African AIDS researcher who wrote a commentary in The Lancet, which published the new study.
Long-Banned Chemicals Found in Pregnant Mothers' Blood
Hopkins-led study links fetal activity to contamination, sees higher toxic traces in richer women
As a reminder of just how persistent some toxic chemicals can be, a Johns Hopkins-led research team reports finding traces of long-banned DDT and PCBs along with other contaminants in the blood of 50 pregnant women checked from Baltimore and its suburbs. In a study posted online by the Journal of Exposure Science and Environmental Epidemiology, the scientists say they detected more frequent and vigorous fetal movements in the wombs of mothers with higher levels of contaminants.
While previous studies have looked for impacts of such contaminants on children's development after they're born, this one differed in that it saw effects in utero, explained the lead author, Janet DiPietro, a developmental psychologist and associate dean for research at the Bloomberg School of Public Health. Her co-authors included two other Hopkins researchers and one from Emory University's Rollins School of Public Health in Atlanta.
New Coating Makes Silicon Circuits Implantable in Human Tissue
Biosensors and implantable medical devices of the future will have to live in a climate that’s hostile to traditional silicon-based electronic circuits. Although silicon is biocompatible, our salty bodies are too conductive and interfere with bare silicon circuits. Plus, as with any other implants, there are concerns of material’s immunogenicity and toxicity. Researchers at Ohio State University have demonstrated a new coating made of aluminum oxide that can encapsulate silicon circuits to keep them dry from the electrolytes in bodily fluids. The coating is currently patent pending and researchers believe that it will soon find application in medicine, most notably in sensors that detect early signs of transplant organ rejection.
Future Vaccines Could be Delivered via Patch
A skin patch that can deliver vaccines cheaply and effectively has been shown off at the TEDGlobal conference in Edinburgh. Using a patch rather than a needle could transform disease prevention around the world, said its inventor. Prof Mark Kendall said the new method offered hope of usable vaccines for diseases such as malaria. Other medical experts welcomed the news, but warned it might be unsuitable for some patients.
Restless Legs May Mean Higher Mortality Risk
Restless legs syndrome may predispose men to dying sooner rather than later, an observational study suggested. After accounting for age, male health professionals who met criteria for restless legs syndrome were 39% more likely to die through up to 8 years of follow-up compared with those without the condition (HR 1.39, 95% CI 1.19-1.62), according to Xiang Gao, MD, PhD, of Brigham and Women's Hospital in Boston, and colleagues. Even after various additional statistical adjustments and the exclusion of men with a variety of chronic health conditions, the relationship remained significant, the researchers reported online in Neurology.
A low-fat, low-carb diet altered levels of lipid-depleted beta-amyloid peptides in a small clinical trial, suggesting a biochemical explanation for past observations connecting lifestyle factors to risk of Alzheimer's disease, researchers said. The researchers concluded that these effects of diet on lipid-depleted beta-amyloid "may be one of the mechanisms for how diets impart Alzheimer's disease risk or protection." In an accompanying editorial, Deborah Blacker, MD, ScD, of Massachusetts General Hospital in Boston, noted that the study did not address whether the biochemical changes would have a clinical effect. Nevertheless, Blacker said, the study is important in showing that dietary changes can affect amyloid chemistry in the brain, potentially a step toward solving the puzzle of Alzheimer's disease etiology. Previous studies have shown that insulin resistance and diabetes are risk factors for Alzheimer's disease, and that the Mediterranean diet and others considered relatively healthy are associated with lower incidence of the disorder.
Outbreak of Rare Hepatitis Continues to Grow in Western States
The Hepatitis A outbreak continues in eight western states with the case count as of June 14 rising to 106. Investigation by CDC, the U.S. Food and Drug Administration, and state and local health departments is ongoing. Costco notified its members who purchased this product since late February 2013, and has removed the “Townsend Farms Organic Antioxidant Blend” frozen berry and pomegranate mix from its shelves. FDA, according to the update, has also begun an inspection of the processing facilities of Townsend Farms located in Fairview, Oregon.
Wrong-Patient Medication Errors Examined by the Pennsylvania Patient Safety Authority
Over 800 wrong-patient medication errors were reported to the Pennsylvania Patient Safety Authority in a six-month period with errors most common during the transcribing and administration phases and least often during the dispensing and prescribing phases, according to information in the June Pennsylvania Patient Safety Advisory released. "While often thought to occur only during administration, wrong-patient events were identified across the continuum of the medication-use process from prescribing to monitoring of medications," Matt Grissinger, RPh, manager of medication safety analysis for the Pennsylvania Patient Safety Authority said. "The events involved a wide range of medications and occurred on various patient care units and departments."
Georgia: America’s Health IT State
As paper medical records become a thing of the past, digital records become the norm. Georgia industry has embraced the technology and the state has become the national leader for Health Information Technology Companies. Nine Georgia companies are now listed in the Healthcare Informatics Magazine top 100 Health IT firms in the U.S.McKesson Technology Solutions, based in Alpharetta, is ranked #1. Other Georgia-based companies making the top 100 include MedAssts, No.31, HealthPort Technologies, No. 35, Greenway, No. 53, Brightree, No. 79, Navicure, No. 85, Craneware, No. 89, Surgical Information Systems, No. 91, and Vendormate, No. 100.
Federal Officials Detail Health IT Industry Progress, Challenges
At the Healthcare Information and Management Systems Society's 2013 Government Health IT Conference, National Coordinator for Health IT Farzad Mostashari and other federal health officials discussed the nation's progress and challenges in adopting health IT, Government Health IT reports.
Mostashari's Comments on Industry Challenges
Mostashari said that the U.S. health system today is "so far from" his vision where "every encounter and every patient has access to all the world's knowledge." Mostashari said, "Today, my last visit doesn't contribute to my next visit in health care." He added that the goal "is not just [to] empower the players in the game, but [to] change the rules of the game so that hoarding data is not profitable -- so that collaborating on care is rewarded." Mostashari said that fulfilling his vision will require balancing standards and innovation, as well as a combination of IT and process changes. However, Mostashari said that interoperability progress has been made, and the results of that progress should start manifesting in the clinical realm over the next 10 years.
A new guide developed by the Agency for Healthcare Research and Quality (AHRQ) outlines a framework for primary care practices to connect to regional health information exchanges. “Regional Health eDecisions: A Guide to Connecting Health Information Exchange in Primary Care,” establishes a blueprint for assessing organizational readiness for connecting an electronic health record (EHR) to a Regional Health Information Organization (RHIO), creating leadership and clinician buy-in for information exchange, addressing technical issues, and ensuring that data acquired from information exchange is accessible within clinician workflows. Using practical insights from Oklahoma Physicians Resource/Research Network, the guide provides a framework for using information obtained from RHIOs for clinical decision making and the delivery of preventive services. Select to access the guide: http://www.healthit.ahrq.gov/RegionalHealtheDecisionsGuide.PDF [PDF 2.84MB].
Source: http://www.healthit.ahrq.gov/ [PDF 2.84MB]
First EHR Developer Code of Conduct Announced
The EHR Association announced on June 11 the creation of the EHR Developer Code of Conduct, an adoptable document that emphasizes data sharing across different EHR platforms as well as patient safety data reporting. EHRA, which is a collaboration of more than 40 EHR vendors, worked with provider organizations, consumer organizations and information technology executives to create the document.
The code focuses on five sections: patient safety; interoperability and data portability; clinical and billing documentation; privacy and security and patient engagement. Companies that adopt the code will also promise to work with customers to facilitate a move from one EHR to another. "There are some things we can compete on fiercely, and some things we're not going to compete on," said Farzad Mostashari, national coordinator for Health IT.
Your Smartphone Might Hold Key to Your Medical Records
Before a patient can download medical information to a computer or a smartphone, the files must first be stored electronically. And while electronic health record advocates note that there has been a sharp increase in the number of hospitals and doctors using EHRs, they acknowledge that a complete electronic system is a long way off. According to a 2012 CDC survey, while 72 percent of office-based physicians are using some sort of electronic system in their practice, only 40 percent of practices meet the definition of a “basic” system.
Power in The Hands Of The Patients?
The federal health law is designed to encourage patients to be more involved in managing their own health. Making medical records and test results accessible to smartphones is in line with those policy goals. The floodgates have opened for patients to use technology to manage their own care particularly those that have chronic, and expensive, diseases, said Jennifer Lundblad, CEO of Stratis Health, a nonprofit organization based in Minnesota, which aims to improve health care by translating research into practice. Lundblad said smartphones and health-related applications can become powerful tools to help people monitor and improve their health.
Despite Progress on Health IT Interoperability, Tough Questions Remain
Data-sharing in healthcare remains difficult, and despite assertions that the industry is on the cusp of a breakthrough, many are impatient with the slow pace of progress. Those attending the Digital Healthcare Conference in Madison, Wis., addressed some of the biggest questions about the sad state of interoperability, according to InformationWeek.
What to Expect From EHR Vendors During the ICD-10 Transition
Unfortunately, healthcare providers will not be able to buy or upgrade an electronic health record (EHR) system and call themselves ICD-10 compliant. But there are some things that EHR vendors can do to make the ICD-10 transition easier. ChartLogic's white paper "ICD-10 What You Need To Know To Be Ready" has some good advice on what to expect.Probably most important is to keep communicating with your EHR vendor and establish a timeline for ICD-10 compliance. Hopefully all updates will be installed by the end of 2013.
Four healthcare systems and technology giant IBM have joined the Premier healthcare alliance in a data analytics venture, making the second announcement this week of healthcare providers going in with a big-data partner. The health system members of what is being dubbed the Data Alliance Collaborative are the Carolinas HealthCare System, Charlotte, N.C.; Catholic Health Partners, Cincinnati; Fairview Health Services, Minneapolis; and Texas Health Resources, Arlington. Together the participants plan to develop data analytics methods to reduce healthcare costs and improve quality, initially by targeting medication noncompliance and preventable hospital readmissions.
Obamacare Shows Hospital Savings as Patients Make Gains
Less than five months before the Affordable Care Act fully kicks in, hospitals are improving care and saving millions of dollars with one of the least touted but potentially most effective provisions of the law. While much of the focus on Obamacare has been on the government rush to open insurance exchanges by Oct. 1, 252 hospitals and physician groups across the U.S. have signed up to join the administration’s accountable care program, in which they share the financial risk of keeping patients healthy.
Under the program, hospitals and physician practices take responsibility for tracking and maintaining the health of elderly and disabled patients. If costs rise beyond an agreed upon level, hospitals may become responsible for reimbursing the government. If they cut the cost of care while maintaining quality, hospitals share in the savings. The government expects the savings may be as much as $1.9 billion from 2012 to 2015. Early indications suggest they are starting to add up.
Fed Officials Caution Against Discriminatory Med School Admissions
The U.S. Department of Health & Human Services, Department of Justice and Department of Education are warning U.S. medical schools, nursing schools, dental schools and other health-related schools about discriminating against applicants with hepatitis B, HHS announced. The departments are investigating complaints against medical and dental schools for violating the Americans With Disabilities Act, federal health officials said in a letter. They attribute the schools' unlawful discrimination to a misunderstanding of the hepatitis B virus. The U.S. Department of Health & Human Services, Department of Justice and Department of Education are warning U.S. medical schools, nursing schools, dental schools and other health-related schools about discriminating against applicants with hepatitis B, HHS announced. "The Justice Department strongly urges health-related schools to review the [Centers for Disease Control and Prevention's] recommendations and to ensure that their policies and practices comply with federal nondiscrimination laws,"
AMA Addresses Care for Dual-Eligibles, Promotes Med School Innovation
There's a lot of news coming out of the American Medical Association, which voted during its annual meeting to adopt several new policies.
One new AMA policy aims to improve the way care is delivered to Medicare and Medicaid dual-eligibles by streamlining care plans and eliminating conflicting payment rules. The principles would customize benefits for this patient population and help maintain the patient-physician relationship.
The AMA also welcomed the Gay and Lesbian Medical Association (GLMA) to the AMA's policy-making body, which will foster AMA policy and programs that better reflect the diverse needs of gay, lesbian, bisexual and transgender (GLBT) patients.
Under another new policy, the AMA will work with other health profession organizations to advocate for reducing medical student loan interest rates and curb the rising student debt for future doctors.
Physician Business Leader Predicts Healthcare’s Winners and Losers as More Organizations Take Steps to Become Patient-centered Medical Homes
Certainly with the rapid consolidation that is occurring in the hospital arena, hospital systems will be fewer in number but larger,” he continued in his blog. “With the new payment methodologies of Accountable Care and bundled/global payments, hospitals that do not adapt and change their business paradigms may not survive. McGeeney then described what may happen to physicians. “There will also be losers in the physician space,” he said. “The expectations on primary care today are different than even two years ago. Many physicians recognize this, but many insist on holding on to outdated beliefs and expectations—putting their future in jeopardy.
Insights for Clinical Laboratory Managers
For pathologists and clinical laboratory managers, McGeeney’s observations about the reimbursement changes occurring in primary care settings are directly relevant to expectations that fee-for-service arrangements will soon go the way of the dinosaurs.
Surgeon General Regina Benjamin, MD, has announced she will leave her post in July after 4 years on the job. The outgoing surgeon general has indicated she wanted to spend time this summer volunteering at the rural health clinic in South Alabama she helped to found, a Health and Human Services (HHS) spokeswoman told MedPage Today. "I loved serving as #SGReginaBenjamin, putting prevention in all we do. I leave next month confident we created a more healthy & fit nation," the tweet read. No reason was immediately given about why the sudden announcement came.
Public Health Experts, Policymakers Convene to Discuss Global Burden of Disease Study
“More than 500 public health experts, policymakers and academics from 50 different countries have gathered in Seattle this week to dig deeper into what one of the leaders in the field characterized as having done for global health what the Human Genome Project has done for biomedical science and medicine” — the new Global Burden of Disease Study, “a massive worldwide assessment of what’s killing, injuring and disabling people around the planet,” development blogger Tom Paulson reports in the Humanosphere blog.
Novel Virus Found in Vietnam Brain Infection Patients
Researchers have discovered a new virus in patients in Vietnam suffering from severe brain infections, a team of scientists reported in mBio, the journal of the American Society for Microbiology.
The virus was detected in 28 of 644 patients who had severe brain infections and none of 122 patients who had non-infectious brain disorders, according to researchers at the Oxford University Clinical Research Unit, Wellcome Trust South East Asia Major Overseas Programme and the Academic Medical Center, University of Amsterdam. It’s tentatively called CyCV-VN and is part of a group of viruses known as Circoviridae known to circulate in animals such as birds and pigs, they said.
Salmonella Sickens Hundreds of Chinese Schoolchildren
At least 386 children in a Chinese province were hospitalized with suspected Salmonella infections, health officials announced. The students, who reside in the Meishan City area of Sichuan province, fell ill at the end of last week with symptoms of nausea, vomiting, fatigue and dizziness. Investigations suggest that a stainless steel cooking pot may have been the vehicle that transmitted the bacteria, according to the Global Times. This incident follows a similar one of food poisoning in Sichuan province in April of this year when 292 students at Yingjie Township Central Elementary School in the city of Ziyang fell ill with diarrhea, vomiting and fever linked to food poisoning.
HIV Tests Urged for 800 Million in India
Despite India’s enormous population, it would be cost-effective to fight its growing AIDS epidemic by testing all 800 million sexually active adults in the country every five years and treating all those infected, a new statistical study has concluded. With an organized medical system, cheap drugs and relatively low-paid doctors, India is probably one of the most cost-effective places for fighting AIDS, said the study’s lead author, Dr. Kartik K. Venkatesh of the Alpert Medical School at Brown University. Only 0.3 percent of Indian adults have H.I.V., but because the population is so large, it has the world’s third-largest epidemic, after South Africa and Nigeria.
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