A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
August 13, 2015
- Ebola Survivors Face Lingering Pain, Fatigue, and Depression
- AMP Meets with Senate HELP Committee and Presents a CLIA Modernization Proposal
- Medicare, Medicaid, and Children's Health Insurance Programs; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests
- Best Practices in Establishing Quality Control Parameters
- Genetic Testing for Developmental Disabilities
- Incorporating HIE Data into Care Cuts Use of Lab Tests
- UNC Scientists Pinpoint How a Single Genetic Mutation Causes Autism
- Researchers Strategize to Outsmart Bacteria
- HIV Cells Keep Duplicating Even When Treatments Are Working: Study
- High Tech Hope for Repelling Mosquitoes
- ACIP Updates Influenza Vaccine Recommendations
- Experimental MERS Vaccine Shows Promise in Animal Studies
- NIH Launches Website for New Genomic Data Sharing Policy
- CMS Corrects Recent ICD-10 Guidance for Physicians
- AHRQ Tool Gives Access to Hospital Discharge Data
- NIH Launches Website for New Genomic Data Sharing Policy
View Previous Issues - Healthcare News Archive
Hospitals Must Work Together to Prevent Superbug Spread, CDC Says
Ebola Survivors Face Lingering Pain, Fatigue and Depression
The Ebola outbreak that started more than a year ago seems to be waning at last. But now, West Africa faces another difficulty: More than 13,000 people survived the virus, and many have lingering health problems, psychological troubles like depression and post-traumatic stress disorder, and worries about returning to work to feed themselves and what is left of their families. About half the survivors seem to have chronic joint pain that is often severe enough to prevent them from working, said Dr. Daniel Bausch, a senior consultant for the W.H.O. and an infectious-diseases specialist at Tulane University. People who were the sickest, and therefore probably the most heavily infected, seem more likely to develop the pains, which often last for many months after the infection has cleared. The exact cause of the pain is not known, so all doctors can do is treat the symptoms. Many people who recover from the infection also have persistent headaches, extreme fatigue and difficulty concentrating. About a quarter of the survivors have eye problems, and some have lost vision or gone completely blind, Dr. Bausch said. Ebola sometimes invades the inside of the eye and lurks there for months, even in someone who has recovered from the acute illness and whose blood is free of the virus. The result is an inflammation, uveitis, that can threaten sight. People with this condition are not infectious, because the virus is contained inside the eyeball.
AMP Meets with Senate HELP Committee and Presents a CLIA Modernization Proposal
The Association for Molecular Pathology (AMP), announced its recommendation for modernization of The Clinical Laboratory Improvement Amendment (CLIA) regulations for laboratory developed testing procedures (LDPs), also known as laboratory developed tests (LDTs). The Senate Health, Education, Labor, and Pensions (HELP) Committee is in the process of drafting legislation that would provide avenues for enhanced support for medical innovation and patient access to new medicines and technologies. “In an effort to support the Senate HELP committee’s review of laboratory test regulation, we prepared a proposal that reflects the work of dedicated molecular pathology testing professionals whose common goal is high quality patient care,” said Roger D. Klein, MD, JD, AMP Professional Relations Chair. “While we maintain that there is no evidence of systemic problems with laboratory testing or LDPs that would necessitate an increase in what is already rigorous oversight, the CLIA statute and regulations are over 20 years old. Given the advances in technology and laboratory science, these regulations can be modernized to better fit with contemporary practice. Our proposal is a streamlined, cost-effective approach that enhances transparency, ensures quality, and preserves innovation.”
Medicare, Medicaid, and Children's Health Insurance Programs; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests
This notice announces 15 membership appointments to the Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and the first meeting date for the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on issues related to clinical diagnostic laboratory tests. The membership appointments are for 3 years. The first meeting of the Panel is scheduled to take place at CMS's headquarters in Baltimore, MD on Wednesday, August 26, 2015 beginning at 9:00 a.m., Eastern Daylight Time (EDT). The Panel will specifically recommend crosswalks for new laboratory codes, recommend an appropriate coding structure for drugs of abuse testing, and recommend crosswalks for such drugs of abuse testing.
Who Should Be on Statins
Cholesterol management guidelines issued by the American College of Cardiology and American Heart Association (ACC/AHA) scored high marks in a recent analysis. The results, published in the Journal of the American Medical Association (JAMA), indicated that the 2013 AHA/ACC guidelines did a better job at identifying risk of incident cardiovascular disease (CVD) than an earlier set of guidelines—particularly for individuals with intermediate CVD risk. The ACC/AHA guidelines ushered in a new approach for treating CVD, “focusing on absolute cardiovascular risk as estimated by the 10-year atherosclerotic CVD (ASCVD) score for statin treatment,” according to the JAMA article. Under these guidelines, about 13 million additional adults would meet eligibility criteria for statins, compared with the National Cholesterol Education Program’s 2004 Updated Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) guidelines.
Best Practices in Establishing Quality Control Parameters
Quality control (QC) is a foundational practice in the clinical laboratory and is a routine and mandatory task. QC encompasses the analysis of QC materials and comparison of the observed values to the expected distribution under stable operating conditions. QC materials act as surrogates for clinical samples and are measured in laboratories on a daily basis in the same manner as patient specimens. For non-waived tests, laboratory regulations require, at the minimum, analysis of at least two levels of control materials once every 24 hours for chemistry tests, and once every 8 hours for blood gases, hematology, and coagulation tests. A good practice for laboratories is to define the number of levels of QC material to be assayed for each analyte, ensuring that analyte concentrations are present in the control materials at clinically relevant levels. In addition, laboratories should define analytical run length, and in turn, frequency of QC material analysis. There is no standard protocol or guideline to establish analytical run length, so practice varies across different laboratory settings. Labs should define these parameters based on the expected stability of the analytical system, the number of patient specimens analyzed, cost of patient lookback, and access to patient data in the event of QC failure. Workflow patterns, internal resource capabilities, and the clinical impact of undetected errors that may occur before the next QC measurement also are important considerations in determining the analytical run length and frequency of QC material analysis.
Genetic Testing for Developmental Disabilities
AHRQ technical brief provides overview of the clinical uses of these tests
Clinicians increasingly rely on genetic tests as a diagnostic tool for developmental disabilities (DD). A technical brief issued by the Agency for Healthcare Research and Quality (AHRQ), “Genetic Testing for Developmental Disabilities, Intellectual Disability, and Autism Spectrum Disorder,” sheds some clarity on the clinical applications of these tests and which ones are available for use in the United States. “DDs are a group of conditions associated with functional impairment in physical, learning, language, or behavior areas,” AHRQ’s brief explained. DDs, as categorized by the Centers for Disease Control and Prevention, may include: autism spectrum disorder (ASD), hearing loss, vision impairment, learning disability, attention deficit/hyperactivity disorder, cerebral palsy, intellectual disability (ID), Tourette syndrome, and other conditions. DDs affect about 15% of children aged 3 to 17 years in the United States.
All genetic tests in the United States available for clinical use fall into one of two categories: a laboratory-developed test (LDT) or a test approved or cleared by the Food and Drug Administration (FDA). The GTR database search revealed that 63 laboratories in 29 U.S. states offer 672 LDT genetic tests for developmental disabilities. All of these tests were registered as “clinical tests” with “how to order” information. AHRQ identified one FDA-cleared, commercial genetic test that didn’t fall into the same category as the GTR tests.
Incorporating HIE Data into Care Cuts Use of Lab Tests
Leveraging clinical data from a health information exchange (HIE) can significantly reduce the number of duplicate laboratory tests and radiology assessments performed in the emergency room, according to a pilot study published online in the Journal of the American Medical Informatics Association. In this study, the use of scribes (clinical liaisons) ensured efficient flow of HIE data to the treating clinicians, but in the future it is hoped that improved hospital information technology resources will enable seamless coordination of HIE data into clinical workflow without additional employee resources.
"The salient effects of querying the HIE on reducing the number of test and examination orders further highlights the importance of integrating HIE queries with the routine workflow of emergency department providers," writes study author Niam Yaraghi, Ph.D., from The Brookings Institution (Washington, D.C.). "A hundred percent rate of querying which was implemented in this trial can be achieved by reengineering the workflow processes and implementing automatic querying technologies."
Defining Normal Test Results
Studies conducted by Canadian researchers shed new light on pediatric, adult, and geriatric reference intervals for 53 hematology, chemistry, and immunoassay-based biomarkers. The analysis paves the way to harmonize reference intervals across Canada and elsewhere. The Canadian Health Measures Survey (CHMS) and Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) collaborated on three studies that appeared in the August issue of Clinical Chemistry. Collectively, this work describes reference intervals for 16 hematology measures, 13 immunoassay-based special chemistry and endocrinology markers, and 24 biochemistry analytes.
Too Much Technology—or Just Enough?
When asked which techniques and instrumentation we use in our laboratory to identify hemoglobin variants, our reply is high-performance liquid chromatography (HPLC), capillary zone electrophoresis (CZE), alkaline and acid electrophoresis, a CBC (complete blood count), calipers… and a telephone, when needed. Many times, the response is, “Isn’t that a little bit of overkill?” The answer to that question is, simply, no. While not every patient specimen requires all of these technologies, the full force of clinical laboratory expertise and instrumentation is sometimes required to reliably identify a hemoglobin variant. A variant in the globin genes can cause a host of systemic disorders, from sickle cell and other forms of anemia to thalassemia. Reliable, precise identification and differentiation can have a significant impact on caring for patients with these and other blood disorders.
Magellan Obtains FDA Approval for Point-of-Care Lead Test
Magellan Diagnostics has received 510(k) regulatory approval from the U.S. Food and Drug Administration to market a new point-of-care test that would be used to test lead levels in blood. The LeadCare Plus system operates from a black box that is about the same size as an iPad mini. It analyzes blood samples placed on test strips and can run as many as 20 samples per hour. Turnaround time is three minutes per test.
Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas vaginalis Nucleic Acid Assay
The Food and Drug Administration (FDA) is classifying a Trichomonas vaginalis nucleic acid assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. This order is effective August 4, 2015. The device is assigned the generic name Trichomonas vaginalis nucleic acid assay, and it is identified as a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused byTrichomonas vaginalis.
UNC Scientists Pinpoint How a Single Genetic Mutation Causes Autism
Last December, researchers identified more than 1,000 gene mutations in individuals with autism, but how these mutations increased risk for autism was unclear. Now, UNC School of Medicine researchers have shown how one of these mutations disables a molecular switch in one of these genes and causes autism. Published in the journal Cell, the research shows that an enzyme called UBE3A can be switched off when a phosphate molecule is tacked onto UBE3A. In neurons and during normal brain development, this switch can be turned off and on, leading to tight regulation of UBE3A. But the research team led by Mark Zylka, PhD, found that an autism-linked mutation destroys this regulatory switch. Destruction of the switch creates an enzyme that cannot be turned off. As a result, UBE3A becomes hyperactive and drives abnormal brain development and autism.
Researchers Strategize to Outsmart Bacteria
The Rice lab of biochemist Yousif Shamoo identified a genetic mechanism that allows bacteria to develop resistance while simultaneously and quickly spreading the capability to others in a population. "This is really a double whammy," Shamoo said. "Our finding that these bacteria become more antibiotic-resistant while at the same time spreading their resistance more efficiently was really surprising and worrying." The researchers hope this knowledge will help predict when and how bacterial strains are likely to develop resistance to future antibiotics and perhaps act to halt -- or at least slow -- the process. The research appeared in the journal Molecular Biology and Evolution. Until now, the only effective way to keep antibiotics from losing their potency has been to use them sparingly, said Kathryn Beabout, a Rice graduate student and lead author of the new paper. "The best you can do is try to manage when you use the antibiotic," she said. "But our idea is that if we can predict how resistance is going to emerge, we can come up with strategies to use antibiotics in a more intelligent way."
HIV Cells Keep Duplicating Even When Treatments Are Working: Study
HIV can continue to multiply in patients who are responding well to antiretroviral therapy, U.K. researchers say. Treatment advances over the last 30 years mean that HIV -- the virus that causes AIDS -- is suppressed to almost undetectable levels in many patients, and they can live a long and healthy life. It was believed that after many years of successful therapy, a patient's body would naturally rid itself of HIV. "This research shows that sadly, the HIV virus has found yet another way to escape our treatments," study leader Anna Maria Geretti, a professor from the University of Liverpool in the United Kingdom, said in a university news release. During treatment, the virus tries to avoid destruction by hiding in blood cells that trigger an immune response. HIV does this by integrating its own genetic information into the DNA of immune system cells called CD4 cells, the investigators explained. Findings from the study were published Aug. 4 in the journal EBioMedicine.
Antibody Found That Fights MERS Coronavirus
An international team of researchers has found a MERS neutralizing antibody—a discovery that could perhaps lead to a treatment for people infected with the virus. In their paper published in Proceedings of the National Academy of Sciences, the team describes the study they undertook that led to the discovery and why they believe what they found might lead to both prevention and treatment for the oftentimes deadly disease. The researchers tested the antibody in mice (by both injection and inhalation) and found that doing so caused a steep reduction in the number of virus cells in the lungs. Notably, they found that they got nearly the same results whether the mice were given the antibody before or after they were infected. This suggests it might be possible to inject the antibody into people at risk to help them fight off the disease and also to use it as a treatment for those that already have it.
New Study Describes Development of Simoa Assays for C. Diff Toxin Detection
A team working with Quanterix to adapt its Simoa, or single-molecule array, technology for infectious disease diagnosis has published details about the development of a pair of Simoa assays that can sensitively and specifically detect the toxins responsible for the severe symptoms of Clostridium difficileinfection. The study, published online last month ahead of print in the Journal of Clinical Microbiology, provides clear evidence for the assays' ability to detect the presence of two different C. diff toxins with equivalent sensitivity but much lower limits of detection than currently used toxin immunoassays, as well as with much greater efficiency than the gold standard, cytotoxicity cell culture.
Pathogen Grows on Cold Smoked Salmon by Using Alternative Metabolic Pathways
The pathogen, Listeria monocytogenes grows on refrigerated smoked salmon by way of different metabolic pathways from those it uses when growing on laboratory media. The research could lead to reduced incidences of food-borne illness and death, said principal investigator Teresa Bergholz, PhD. The research appears July 24 in Applied and Environmental Microbiology, a journal of the American Society for Microbiology. In the study, the investigators showed that L. monocytogenes grows on cold smoked salmon by using different metabolic pathways to obtain energy from those it uses on laboratory media, even when the media was modified to have the same salt content and pH as the salmon. To grow on the salmon, the bacterium upregulates genes that enable it to use two compounds from cell membranes—ethanolamine and propanediol—as energy sources. “There may be ways we can use this information to control the pathogen both in foods as well as in infected people,” said Bergholz, assistant professor in the Department of Veterinary and Microbiological Sciences at North Dakota State University, Fargo.
Molecular Classification for Endometrial Cancer Revisited
Researchers have described a new method for identifying the four molecular subtypes of endometrial cancer. They say their method can be used in routine clinical practice and could alter management of some patients. The four subtypes of endometrial cancer are associated with different clinical outcomes, and so identifying them has potential to provide prognostic and predictive information for physicians and their patients. They were identified in a molecular classification based on the Cancer Genome Atlas (TCGA), but the cost and complexity of using whole-genome sequencing makes the approach unsuitable for wider applicability.
Now, a group from the University of British Columbia has bridged the gap by showing that this molecular classification is possible in routine clinical practice on formalin-fixed paraffin- embedded samples by applying "simple, lower-cost, molecular-based classification methodologies that can recover the TCGA subtypes." The study was published online June 30 in the British Journal of Cancer.
Implantable Biosensor Could Monitor Progress of Cancer Therapy
Now researchers from MIT's Koch Institute for Integrative Cancer Research have developed an implantable device that promises to provide readings about the state of a tumor as it happens. Such a device would give doctors a chance to change therapy dosing, and potentially reduce unnecessary side effects. The biosensor works by monitoring two biomarkers: pH (a measure of acidity) and dissolved oxygen. These are valuable indicators of how well the tumor is responding to treatment. When chemotherapy begins to take effect, the tumor tissue becomes more acidic. The tiny biosensor is so small it fits into the tip of a biopsy needle. It is made of a biocompatible plastic shell enclosing 10 ml of chemical contrast agents typically used in MRI scans, and some electronics for sending readings to an external device.
Myeloma Staging System Makes for Better Care
Staging for newly diagnosed myeloma improved significantly with the addition of genomics information and a simple lab test to the standard staging criteria, according to the International Myeloma Working Group (IMWG). Combining chromosomal abnormalities and serum lactate dehydrogenase (LDH) with the International Staging System (ISS), the revised criteria offer a "simple and powerful prognostic staging system" that should be used to evaluate patients with newly diagnosed myeloma, they wrote online in the Journal of Clinical Oncology.
Crime Scene Chemical Used to Kill Malaria in Blood Cells
A chemical used by police to detect blood at crime scenes was used by researchers to kill malaria parasites after they infected human red blood cells. Luminol, which glows blue when it comes in contact with hemoglobin in red blood cells, lets police see trace amounts of blood when sprayed on surfaces thought to have been bled on during crimes. In the lab study, researchers combined it with an amino acid and the common malaria drug artemisinin, causing a series of events that killed the parasites after they'd invaded cells. "The light that luminol emits is enhanced by the antimalarial drug artemisinin," said Dr. Daniel Goldberg, a professor of medicine and molecular microbiology at Washington University in St. Louis, in a press release. "We think these agents could be combined to form an innovative treatment for malaria."
High Tech Hope for Repelling Mosquitoes
In Alaska, mosquitoes outnumber people some 24 million to one. That makes it a great place to test the very latest in mosquito shields. On a recent trip home, I tried the newest products on the market: kid-safe bands treated with plant oils, fans with the repellent built in, chemically treated clothing and good old bug spray. I also tried a high-tech patch that is not set to be released until next year. What I found was this: All of the current products offered varying levels of protection, but nothing worked as well as traditional chemical repellent. Nothing, that is, until I tested the patch, which could very well remove humans from the mosquito food chain for good. The new compound works by confusing a mosquito’s senses, hindering its ability to target us based on the carbon dioxide we exhale, and confounding its capacity to locate us up close. The Kite compound was effective in the lab, but the ultimate test will come once it can be worn in all corners of the mosquito-covered planet. If that happens, it means that in the age-old battle of humans versus mosquitoes, humans may finally have a shot at winning.
ACIP Updates Influenza Vaccine Recommendations
All persons at least 6 months of age should have routine annual influenza vaccination unless they have specific contraindications, according to updated recommendations from the Advisory Committee on Immunization Practices (ACIP) for the 2015 to 2016 influenza season. The updated recommendations were published in the August 6 issue of the Morbidity and Mortality Weekly Report. "Optimally, vaccination should occur before onset of influenza activity in the community," write Lisa A. Grohskopf, MD, from the Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, and colleagues. "Health care providers should offer vaccination by October, if possible. Vaccination should continue to be offered as long as influenza viruses are circulating."
Experimental MERS Vaccine Shows Promise in Animal Studies
Researchers in the United States trying to develop a vaccine against the deadly Middle East Respiratory Syndrome (MERS) virus say they have had early signs of success in animal experiments. Using a two-step approach in mice and rhesus macaques, scientists at the vaccine research center of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said they had managed to provoke an immune response in the animals. The findings suggest this approach – centered on a viral protein called the "spike glycoprotein", which the MERS virus uses to enter cells – holds promise for developing a similar human MERS vaccination, the researchers said.
Strep's Evolution May Provide Clues for Developing a Vaccine
The same bacteria that cause simple strep throat sometimes trigger bloodstream or even flesh-eating infections instead, and over the years, dangerous cases have increased. Now researchers have uncovered how some strains of this bug evolved to become more aggressive. The bacterial sleuthing may offer clues for developing a vaccine against group A streptococcus, and for detecting and fighting outbreaks. The reason one person recovers easily from strep throat and another gets an invasive infection has lots to do with individual immune systems. But Monday's research found genetic changes can spur the germ to produce more of two key toxins, becoming more virulent. "These increased amounts of toxins are like throwing an accelerant onto the fire," said Dr. James M. Musser of the Houston Methodist Research Institute, who led the project being reported in the Journal of Clinical Investigation.
Scientists Discover How 'Bad' Fat Can Turn into 'Good' Fat
Unhealthy white fat can be transformed into calorie-burning brown fat, researchers report. Finding a way to burn calories without having to increase physical activity levels could prove crucial in fighting obesity and the health problems it causes, according to researchers from the University of Texas Medical Branch at Galveston. Previous studies have shown that when brown fat is "switched on" in people, it increases metabolism and lowers blood sugar levels. The study was published in the Aug. 4 issue of the journal Cell Metabolism.
CMS Corrects Recent ICD-10 Guidance for Physicians
CMS and AMA recently developed guidance on new ICD-10 flexibility for physicians during the first year of compliance. Now, at the request of stakeholders who found errors, CMS has substantially changed the guidance in Questions 3 and 5. Below is background on policy changes that necessitated the guidance. Under pressure from the AMA and other provider organizations, CMS agreed to:
- Not deny claims solely based on the specificity of diagnosis codes as long as they are in the appropriate family of codes, so physicians won’t be penalized because of a coding error;
- Not audit Medicare claims in the first year of ICD-10 based on specificity of diagnosis codes if in the appropriate family of codes;
- Authorize advance payments if Medicare contractors cannot process physician claims coded with ICD-10;
- Not penalize physicians via reduced reimbursements for errors in selecting and calculating quality codes for the EHR meaningful use, PQRS and Value-based Modifier reporting programs as long as they use codes within the appropriate family of codes. Penalties also will not be applied if CMS has difficulty calculating quality scores during the ICD-10 transition; and
- CMS will establish an ICD-10 Ombudsman office to help physicians resolve problems during the transition.
- Now, the agreement is significantly clarified with 13 specific questions and answers, including the changed guidance for Questions 3 and 5.
AHRQ Tool Gives Access to Hospital Discharge Data
A new free tool from the Agency for Healthcare Research and Quality enables analysis of data on hospital discharges. The service, called Fast Stats, includes all-payer data on discharges in 2014 from 17 states, showing the number of discharges paid for by Medicare, Medicaid, commercial insurers and the uninsured, and covering services such as surgical, mental health, maternal, injury and medical, according to AHRQ. The information can support analysis of the effects of Medicaid expansion, hospital utilization and payment sources, among other issues.
NIH Launches Website for New Genomic Data Sharing Policy
The National Institutes of Health announced that it has established a web resource to provide additional information on implementation of the Genomic Data Sharing Policy it put into effect earlier this year. In mid-2014, the NIH announced a policy laying out its expectations for the proper sharing of large-scale human and non-human genomic data generated from agency-funded research. "Sharing research data supports the NIH mission and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health," the NIH said at the time.
Medical Device Cybersecurity: The Internet of Things Could Kill You
The FDA’s warning about a flaw in Hospira‘s Symbiq drug infusion pump that hackers could exploit to take over the device has cybersecurity experts worried about the rise of the Internet of Things, as more and more medical devices are connected to the web. There’s no question that these vulnerabilities can be used to kill someone – we wrote an exploit that would do just that and gave the research to the Dept. of Homeland Security and the FDA,” Billy Rios, a former Google software engineer who now works as a security consultant, told the Washington Post. “These devices are actively connected to a hospital’s network – and depending on the set up of a hospital’s network someone might be able to potentially access that from the Internet,” added Jay Radcliffe, a diabetic who made headlines in 2011 after he hacked his own insulin pump. “We’re still in the process of getting all the companies to the same level of understanding, that if your device uses computers, you have to be prepared to patch them and update them.”
82% of Cloud Implementations in Government Went through FedRAMP, Reports GSA
The General Service Administration reports that 82 percent of cloud implementations in the federal government are now covered by a security authorization through the Federal Risk and Authorization Management Program, or FedRAMP. The new figures come from a baselining initiative underway at the GSA that seeks to understand where and how the cloud is being used across government. According to a six-month FedRAMP status report, published by GSA Aug. 6, GSA developed its baseline by analyzing agency PortfolioStat reports and customer surveys from cloud service providers. "The initial baseline shows over 1,400 cloud instances representing over 80 cloud services in use across the US Government," says the GSA report.
Digital health: Moving Toward a Healthcare Revolution
Runners were the first to discover the potential of wearable devices several years ago. They started using watches and pedometers to measure steps, location and heart rate. As technology became increasingly sophisticated, early technology adopters and fitness enthusiasts followed suit. Today, nearly 75 percent of adults are using a fitness tracker. And, it is projected that about 120 million wearable devices will be sold by 2018. The upshot? The eventual future of healthcare is one in which most patients will be hyper-connected to a network of devices and generating an astounding amount of data. Perhaps more important, though, is the fact that the following emerging trends are transforming the utilization of digital devices from a fad to a meaningful movement that can actually result in improved health:
Physicians are now leveraging patient-generated data to track patients’ post-hospital discharge in an effort to reduce the risk of infection and readmission.
- Healthcare providers are responding more quickly to a patient's health status, as they remotely monitor chronic conditions.
- Health systems are better tracking and engaging entire patient populations by integrating health data into patient engagement portals and EHRs.
- Health insurance companies are leveraging data to create improved risk management models to better reward members.
- Pharmaceutical companies are using the data to monitor clinical trials and conduct research studies on prescription drug side-effects.
- Employers and corporate wellness companies are using verified mobile health data to create more productive and engaging health incentives.
These are just some examples illustrating how digital health data is being used to improve healthcare.
Congress Takes Aim at Healthcare Technology Data Blocking in a Move That Might Benefit Many Clinical Pathology Laboratories
Federal health officials are taking steps to end technology vendors’ “data blocking” practices that inhibit the electronic transfer of patient information. This is a tactic that has proven costly for pathology groups and clinical laboratories that want to interface their laboratory information systems with providers’ or hospitals’ electronic healthcare records (EHRs). The fiscal year 2015 Omnibus Appropriations Bill passed by Congress in December directed the Office of the National Coordinator for Health Information Technology (ONC) to decertify electronic health record products that are knowingly interfering with the sharing of health information.
Crowdsourcing Challenge Winner Looking to Commercialize NIH Tech to Diagnose Brain Cancer
Startup IntelliPanel aims to commercialize a blood test for glioblastoma after succeeding in a crowdsourcing challenge that puts winning companies on the fast track to bringing government research to market. Glioblastoma is the most aggressive form of brain cancer, and accounts for about all cases of the disease. IntelliPanels' diagnostic would be a sharp improvement over invasive brain biopsies and unreliable MRI images.
FDA Nod for MR Software That Helps Diagnose Alzheimer's, Concussions
New MR software that may speed the diagnosis of Alzheimer’s disease, epilepsy and depression recently scored FDA approval. Brainreader’s Neuroreader works by detecting changes in brain volume in less than five minutes. The software can also be used to spot changes in brain volume as a result of concussions and other traumatic brain injuries. The radiologist uploads the MR image to the Brainreader server and the Neuroreader analyzes it and benchmarks it against an FDA-approved database of healthy brain tissues. Recent publications have shown the first evidence of functional and sustained improvement in neurodegenerative conditions. As therapeutic programs are developed, the volumes of multiple brain regions will become crucial information.
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