Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
September 25, 2014
- Estimating the Future Number of Cases in the Ebola Epidemic — Liberia and Sierra Leone, 2014–2015
- FDA Allows Expanded Use of Experimental Ebola Drug
- Screen All Sexually Active Women for Chlamydia, Gonorrhea
- Finding Risks, Not Answers, in Gene Tests
- Urine HPV Test as Alternative to Cervical Smear
- Breath Test for TB Developed
- One-minute Point-of-care Anemia Test Shows Promise in New Study
- Protein Secrets of Ebola Virus
- Researchers Discover How Bacteria Resist Antibiotics in Hospitals
- How Epigenetic Memory is Passed Across Generations
- Artificial Sweeteners Could Cause Spikes in Blood Sugar
- HIV Treatment Works, Says CDC
- EHR Systems 'Immature, Costly,' AMA Says
- Patient Data can be Shared With Same-sex Spouses Under HIPAA: HHS
View Previous Issues - Healthcare News Archive
Leading News
Estimating the Future Number of Cases in the Ebola Epidemic — Liberia and Sierra Leone, 2014–2015
The first cases of the current West African epidemic of Ebola virus disease (hereafter referred to as Ebola) were reported on March 22, 2014, with a report of 49 cases in Guinea. By August 31, 2014, a total of 3,685 probable, confirmed, and suspected cases in West Africa had been reported. To aid in planning for additional disease-control efforts, CDC constructed a modeling tool called EbolaResponse to provide estimates of the potential number of future cases. If trends continue without scale-up of effective interventions, by September 30, 2014, Sierra Leone and Liberia will have a total of approximately 8,000 Ebola cases. A potential underreporting correction factor of 2.5 also was calculated. Using this correction factor, the model estimates that approximately 21,000 total cases will have occurred in Liberia and Sierra Leone by September 30, 2014. Reported cases in Liberia are doubling every 15–20 days, and those in Sierra Leone are doubling every 30–40 days. The EbolaResponse modeling tool also was used to estimate how control and prevention interventions can slow and eventually stop the epidemic. In a hypothetical scenario, the epidemic begins to decrease and eventually end if approximately 70% of persons with Ebola are in medical care facilities or Ebola treatment units (ETUs) or, when these settings are at capacity, in a non-ETU setting such that there is a reduced risk for disease transmission (including safe burial when needed). In another hypothetical scenario, every 30-day delay in increasing the percentage of patients in ETUs to 70% was associated with an approximate tripling in the number of daily cases that occur at the peak of the epidemic (however, the epidemic still eventually ends). Officials have developed a plan to rapidly increase ETU capacities and also are developing innovative methods that can be quickly scaled up to isolate patients in non-ETU settings in a way that can help disrupt Ebola transmission in communities. The U.S. government and international organizations recently announced commitments to support these measures. As these measures are rapidly implemented and sustained, the higher projections presented in this report become very unlikely.
The first cases of the current West African epidemic of Ebola virus disease (hereafter referred to as Ebola) were reported on March 22, 2014, with a report of 49 cases in Guinea. By August 31, 2014, a total of 3,685 probable, confirmed, and suspected cases in West Africa had been reported. To aid in planning for additional disease-control efforts, CDC constructed a modeling tool called EbolaResponse to provide estimates of the potential number of future cases. If trends continue without scale-up of effective interventions, by September 30, 2014, Sierra Leone and Liberia will have a total of approximately 8,000 Ebola cases. A potential underreporting correction factor of 2.5 also was calculated. Using this correction factor, the model estimates that approximately 21,000 total cases will have occurred in Liberia and Sierra Leone by September 30, 2014. Reported cases in Liberia are doubling every 15–20 days, and those in Sierra Leone are doubling every 30–40 days. The EbolaResponse modeling tool also was used to estimate how control and prevention interventions can slow and eventually stop the epidemic. In a hypothetical scenario, the epidemic begins to decrease and eventually end if approximately 70% of persons with Ebola are in medical care facilities or Ebola treatment units (ETUs) or, when these settings are at capacity, in a non-ETU setting such that there is a reduced risk for disease transmission (including safe burial when needed). In another hypothetical scenario, every 30-day delay in increasing the percentage of patients in ETUs to 70% was associated with an approximate tripling in the number of daily cases that occur at the peak of the epidemic (however, the epidemic still eventually ends). Officials have developed a plan to rapidly increase ETU capacities and also are developing innovative methods that can be quickly scaled up to isolate patients in non-ETU settings in a way that can help disrupt Ebola transmission in communities. The U.S. government and international organizations recently announced commitments to support these measures. As these measures are rapidly implemented and sustained, the higher projections presented in this report become very unlikely.
Source: http://www.cdc.gov/
Health Agency’s New Assessment of Epidemic is More Dire Still
New figures published by the World Health Organization reveal a far worse outlook than it had previously anticipated for the Ebola epidemic in West Africa. In addition to predicting many more cases and deaths, the new report for the first time raises the possibility that the epidemic will not be brought under control and that the disease will become endemic in West Africa, meaning that it could reach a steady state and become a constant presence there. “The epidemiologic outlook is bleak,” the report said. If control does not improve now, there will be more than 20,000 cases by Nov. 2, and the numbers of cases and deaths will continue increasing from hundreds to thousands per week for months to come, according to the report. The death rate is about 70 percent in each of the heavily affected countries, Guinea, Liberia and Sierra Leone. The new estimates were published online in The New England Journal of Medicine by a team of more than 50 scientists. An earlier prediction by the health organization was far less dire, saying there might be 20,000 cases in nine months.
New figures published by the World Health Organization reveal a far worse outlook than it had previously anticipated for the Ebola epidemic in West Africa. In addition to predicting many more cases and deaths, the new report for the first time raises the possibility that the epidemic will not be brought under control and that the disease will become endemic in West Africa, meaning that it could reach a steady state and become a constant presence there. “The epidemiologic outlook is bleak,” the report said. If control does not improve now, there will be more than 20,000 cases by Nov. 2, and the numbers of cases and deaths will continue increasing from hundreds to thousands per week for months to come, according to the report. The death rate is about 70 percent in each of the heavily affected countries, Guinea, Liberia and Sierra Leone. The new estimates were published online in The New England Journal of Medicine by a team of more than 50 scientists. An earlier prediction by the health organization was far less dire, saying there might be 20,000 cases in nine months.
Source: http://www.nytimes.com/
U.N. Security Council Passes Historic Resolution to Confront Ebola
Ebola’s devastation in three West African countries compelled the U.N. Security Council to convene its first emergency meeting ever to discuss a public health crisis. It unanimously passed a resolution that declared the spread of the virus a “threat to international peace and security” and called on the world to send more health care workers and supplies to Liberia, Sierra Leone, and Guinea, and not to isolate those countries. Several speakers stressed that the epidemic is especially tragic because the three countries have made significant progress in their development in the past few years. U.S. Ambassador to the United Nations Samantha Power, who chaired today's meeting, noted that the resolution had 130 co-sponsors, more than any previous one in the history of the Security Council.
Ebola’s devastation in three West African countries compelled the U.N. Security Council to convene its first emergency meeting ever to discuss a public health crisis. It unanimously passed a resolution that declared the spread of the virus a “threat to international peace and security” and called on the world to send more health care workers and supplies to Liberia, Sierra Leone, and Guinea, and not to isolate those countries. Several speakers stressed that the epidemic is especially tragic because the three countries have made significant progress in their development in the past few years. U.S. Ambassador to the United Nations Samantha Power, who chaired today's meeting, noted that the resolution had 130 co-sponsors, more than any previous one in the history of the Security Council.
Source: http://news.sciencemag.org/
FDA Allows Expanded Use of Experimental Ebola Drug
An experimental Ebola drug that's still in development may now be used to treat more people with the disease, according to Tekmira Pharmaceuticals Corporation. The drug company said the U.S. Food and Drug Administration has authorized expanded use of TKM-Ebola under its Investigational New Drug application rule. Expanded access allows patients outside of a clinical trial to be treated with an investigational drug if they have a life-threatening disease and have exhausted any other approved treatment options. The FDA allows this kind of access on a case-by-case basis.
An experimental Ebola drug that's still in development may now be used to treat more people with the disease, according to Tekmira Pharmaceuticals Corporation. The drug company said the U.S. Food and Drug Administration has authorized expanded use of TKM-Ebola under its Investigational New Drug application rule. Expanded access allows patients outside of a clinical trial to be treated with an investigational drug if they have a life-threatening disease and have exhausted any other approved treatment options. The FDA allows this kind of access on a case-by-case basis.
Source: http://www.cnn.com/
White House Has Plan to Fight Resistance to Antibiotics
The White House announced a plan to improve antibiotics as President Obama's chief science adviser called the problem of antibiotic resistance a potential threat to the nation and the world. "The rise in antibiotic-resistant bacteria represents a serious domestic and international challenge to human and animal health, national security and the economy," John Holdren, director of the White House Office of Science and Technology Policy, said at a news conference. The plan aims to rein in the misuse of antibiotics, encourage the development of new drugs and spur development of ways to quickly diagnose bacterial infections that will help doctors and veterinarians decide when antibiotics are truly needed. Antibiotic resistance, the failure of antibiotics to adequately treat bacterial infections, is connected to at least 23,000 deaths and 2 million illnesses each year, Tom Frieden, director of the Centers for Disease Control and Prevention, said at the news conference. In addition to addressing infections such as pneumonia, "treatment of conditions like cancer, arthritis and asthma are often complicated by infections," Frieden said. "If we lose the ability to treat these, we will undermine much of our current medical care system."
The White House announced a plan to improve antibiotics as President Obama's chief science adviser called the problem of antibiotic resistance a potential threat to the nation and the world. "The rise in antibiotic-resistant bacteria represents a serious domestic and international challenge to human and animal health, national security and the economy," John Holdren, director of the White House Office of Science and Technology Policy, said at a news conference. The plan aims to rein in the misuse of antibiotics, encourage the development of new drugs and spur development of ways to quickly diagnose bacterial infections that will help doctors and veterinarians decide when antibiotics are truly needed. Antibiotic resistance, the failure of antibiotics to adequately treat bacterial infections, is connected to at least 23,000 deaths and 2 million illnesses each year, Tom Frieden, director of the Centers for Disease Control and Prevention, said at the news conference. In addition to addressing infections such as pneumonia, "treatment of conditions like cancer, arthritis and asthma are often complicated by infections," Frieden said. "If we lose the ability to treat these, we will undermine much of our current medical care system."
Source: http://www.usatoday.com/
Screen All Sexually Active Women for Chlamydia, Gonorrhea
All sexually active women 24 years and younger should be screened for two of the most common sexually transmitted infections: chlamydia and gonorrhea, according to new recommendations from the U.S. Preventive Services Task Force. The influential panel of experts also recommend testing for the two infections for all older women deemed to be at increased risk of infection. Most women with chlamydia and gonorrhea don't develop noticeable symptoms. As a result, many infections go undetected. If left untreated, these sexually transmitted infections can cause serious complications for both women and unborn babies. Although chlamydia and gonorrhea are most common among young women, older women who engage in risky sexual behaviors -- such as having multiple partners and not using condoms -- are also at risk, said a news release from the American College of Physicians. If women develop new risk factors for these sexually transmitted infections since their last negative test result, they should be screened again, according to the recommendations published in Annals of Internal Medicine. Pregnant women who test positive for chlamydia or gonorrhea in the first trimester should be re-tested three months after being treated.
There are no significant risks associated with screening for chlamydia and gonorrhea. The task force noted there was not enough evidence to provide recommendations on chlamydia and gonorrhea screening for men.
All sexually active women 24 years and younger should be screened for two of the most common sexually transmitted infections: chlamydia and gonorrhea, according to new recommendations from the U.S. Preventive Services Task Force. The influential panel of experts also recommend testing for the two infections for all older women deemed to be at increased risk of infection. Most women with chlamydia and gonorrhea don't develop noticeable symptoms. As a result, many infections go undetected. If left untreated, these sexually transmitted infections can cause serious complications for both women and unborn babies. Although chlamydia and gonorrhea are most common among young women, older women who engage in risky sexual behaviors -- such as having multiple partners and not using condoms -- are also at risk, said a news release from the American College of Physicians. If women develop new risk factors for these sexually transmitted infections since their last negative test result, they should be screened again, according to the recommendations published in Annals of Internal Medicine. Pregnant women who test positive for chlamydia or gonorrhea in the first trimester should be re-tested three months after being treated.
There are no significant risks associated with screening for chlamydia and gonorrhea. The task force noted there was not enough evidence to provide recommendations on chlamydia and gonorrhea screening for men.
Source: http://consumer.healthday.com/
State Issues Enterovirus Clinical Advisory, Urging Laboratory Testing in 'severe cases'
The Massachusetts' Public Health Department has issued an advisory to the state's clinicians and clinical laboratory directors, on EV-D68, the strain of enterovirus, that has been keeping hospitals, in several states in the Midweast, busy treating hundreds of patients, many of them children with asthma, with suspected, as well as confirmed cases, cases of this virus. The clinical advisory stresses the need for laboratory identification of the virus strain, in "severe" cases of respiratory distress, and conditions caused by this large family of viruses. "The Massachusetts Department of Public Health (MDPH) is advising clinicians to consider EVD68 as a potential cause of illness in children and adults, and to pursue laboratory diagnosis in cases of severe respiratory illness without other explanation, particularly in young children," the advisory reads.
The Massachusetts' Public Health Department has issued an advisory to the state's clinicians and clinical laboratory directors, on EV-D68, the strain of enterovirus, that has been keeping hospitals, in several states in the Midweast, busy treating hundreds of patients, many of them children with asthma, with suspected, as well as confirmed cases, cases of this virus. The clinical advisory stresses the need for laboratory identification of the virus strain, in "severe" cases of respiratory distress, and conditions caused by this large family of viruses. "The Massachusetts Department of Public Health (MDPH) is advising clinicians to consider EVD68 as a potential cause of illness in children and adults, and to pursue laboratory diagnosis in cases of severe respiratory illness without other explanation, particularly in young children," the advisory reads.
Source: http://www.masslive.com/
Detailed Hospital Checklist for Ebola Preparedness
The U.S. Department of Health and Human Services (DHHS), Centers for Disease Control and Prevention (CDC), and Office of the Assistant Secretary for Preparedness and Response (ASPR), in addition to other federal, state, and local partners, aim to increase understanding of Ebola virus disease (EVD) and encourage U.S. hospitals to prepare for managing patients with EVD and other infectious diseases. Every hospital should ensure that it can detect a patient with ebola, protect healthcare workers so they can safely care for the patient, and respond in a coordinated fashion. Many of the signs and symptoms of EVD are non-specific and similar to those of many common infectious diseases, as well as other infectious diseases with high mortality rates. Transmission can be prevented with appropriate infection control measures. In order to enhance our collective preparedness and response efforts, this checklist highlights key areas for hospital staff -- especially hospital emergency management officers, infection control practitioners, and clinical practitioners -- to review in preparation for a person with EVD arriving at a hospital for medical care. The checklist provides practical and specific suggestions to ensure your hospital is able to detect possible EVD cases, protect your employees, and respond appropriately.
Source: http://www.cdc.gov/ The U.S. Department of Health and Human Services (DHHS), Centers for Disease Control and Prevention (CDC), and Office of the Assistant Secretary for Preparedness and Response (ASPR), in addition to other federal, state, and local partners, aim to increase understanding of Ebola virus disease (EVD) and encourage U.S. hospitals to prepare for managing patients with EVD and other infectious diseases. Every hospital should ensure that it can detect a patient with ebola, protect healthcare workers so they can safely care for the patient, and respond in a coordinated fashion. Many of the signs and symptoms of EVD are non-specific and similar to those of many common infectious diseases, as well as other infectious diseases with high mortality rates. Transmission can be prevented with appropriate infection control measures. In order to enhance our collective preparedness and response efforts, this checklist highlights key areas for hospital staff -- especially hospital emergency management officers, infection control practitioners, and clinical practitioners -- to review in preparation for a person with EVD arriving at a hospital for medical care. The checklist provides practical and specific suggestions to ensure your hospital is able to detect possible EVD cases, protect your employees, and respond appropriately.
Laboratory Testing / Diagnostics
Finding Risks, Not Answers, in Gene Tests
The new tests build on the success of earlier ones for inherited risks of breast, ovarian and colon cancer, which can give people options for prevention, like getting screened more often, taking a drug to lower breast cancer risk, or having their breasts or ovaries removed. But some doctors worry that the newer tests for up to 30 genes may open a can of worms, because the ability to find mutations has outpaced the understanding of what they mean. In some cases, tests find cancer-associated mutations for which there are no preventive measures, and the patient is left with a bleak prognosis. Some genes were included “because they could be tested, not necessarily because they should be,” said Dr. Kenneth Offit, chief of clinical genetics at Memorial Sloan Kettering Cancer Center in New York. He said that the testing companies are “rushing headlong into this era,” and that “individuals are getting results we’re not fully educated to counsel them on.”
The new tests build on the success of earlier ones for inherited risks of breast, ovarian and colon cancer, which can give people options for prevention, like getting screened more often, taking a drug to lower breast cancer risk, or having their breasts or ovaries removed. But some doctors worry that the newer tests for up to 30 genes may open a can of worms, because the ability to find mutations has outpaced the understanding of what they mean. In some cases, tests find cancer-associated mutations for which there are no preventive measures, and the patient is left with a bleak prognosis. Some genes were included “because they could be tested, not necessarily because they should be,” said Dr. Kenneth Offit, chief of clinical genetics at Memorial Sloan Kettering Cancer Center in New York. He said that the testing companies are “rushing headlong into this era,” and that “individuals are getting results we’re not fully educated to counsel them on.”
Source: http://www.nytimes.com/
Risk Management Steps Up Labs’ QC Game Under IQCP
Industrial risk management. It may not seem all that sexy as a concept, but in the field of laboratory quality control, risk management has become about as buzz-worthy as is possible. One of the key reasons: The Centers for Medicare and Medicaid Services has embraced risk management as the foundation of a new option for meeting CLIA quality control standards called IQCP, or Individualized Quality Control Plan. A voluntary QC option under CLIA, IQCP aims to give labs greater flexibility in achieving QC compliance by customizing lab QC plans to each unique testing environment via the use of risk-management strategies. Employing electronic/integrated controls, IQCP intends to adapt to future technological advances and strengthen manufacturer-laboratory partnerships.
Industrial risk management. It may not seem all that sexy as a concept, but in the field of laboratory quality control, risk management has become about as buzz-worthy as is possible. One of the key reasons: The Centers for Medicare and Medicaid Services has embraced risk management as the foundation of a new option for meeting CLIA quality control standards called IQCP, or Individualized Quality Control Plan. A voluntary QC option under CLIA, IQCP aims to give labs greater flexibility in achieving QC compliance by customizing lab QC plans to each unique testing environment via the use of risk-management strategies. Employing electronic/integrated controls, IQCP intends to adapt to future technological advances and strengthen manufacturer-laboratory partnerships.
Urine HPV Test as Alternative to Cervical Smear
A simple urine test for human papillomavirus (HPV) may be a more acceptable alternative to conventional screening methods that require a cervical smear, and could increase uptake in hard-to-reach subgroups. Detecting HPV in urine could also potentially be used for post-vaccination HPV surveillance programs, where pelvic examination is not practical. These suggestions come from a group of authors who report meta-analysis of published studies showing that DNA detected in urine had good accuracy for the presence of cervical HPV. The study was published online on September 16 in BMJ. However, a related editorial suggests that although the idea of a urine HPV test is appealing, especially in underresourced countries, there is still a lot of work to be done, and the urine test needs to be validated alongside vaginal self-sampling.
A simple urine test for human papillomavirus (HPV) may be a more acceptable alternative to conventional screening methods that require a cervical smear, and could increase uptake in hard-to-reach subgroups. Detecting HPV in urine could also potentially be used for post-vaccination HPV surveillance programs, where pelvic examination is not practical. These suggestions come from a group of authors who report meta-analysis of published studies showing that DNA detected in urine had good accuracy for the presence of cervical HPV. The study was published online on September 16 in BMJ. However, a related editorial suggests that although the idea of a urine HPV test is appealing, especially in underresourced countries, there is still a lot of work to be done, and the urine test needs to be validated alongside vaginal self-sampling.
Source: http://www.medscape.com/
Breath Test for TB Developed
Researchers have developed the first breath test for TB in the laboratory. It provides rapid information on drug resistance that takes up to six weeks using standard methods, US scientists report in the journal, Nature Communications. The bacteria emit a unique gas signature within 10 minutes of exposure to an inhaled antibiotic in rabbits. TB infects 8.6m people each year worldwide and kills 1.3m, second only to HIV. Early diagnosis and treatment are a priority in the global fight against TB, according to the World Health Organization. The new research used an inhaled form of isoniazid - an antibiotic commonly used to treat the disease - which is activated by a TB enzyme. The test exploits the fact that this enzyme is unique to TB, said Dr Graham Timmins, Associate Professor at the University of New Mexico, US, who led the research.
Researchers have developed the first breath test for TB in the laboratory. It provides rapid information on drug resistance that takes up to six weeks using standard methods, US scientists report in the journal, Nature Communications. The bacteria emit a unique gas signature within 10 minutes of exposure to an inhaled antibiotic in rabbits. TB infects 8.6m people each year worldwide and kills 1.3m, second only to HIV. Early diagnosis and treatment are a priority in the global fight against TB, according to the World Health Organization. The new research used an inhaled form of isoniazid - an antibiotic commonly used to treat the disease - which is activated by a TB enzyme. The test exploits the fact that this enzyme is unique to TB, said Dr Graham Timmins, Associate Professor at the University of New Mexico, US, who led the research.
Source: http://www.bbc.com/
One-minute Point-of-care Anemia Test Shows Promise in New Study
A simple point-of-care testing device for anemia could provide more rapid diagnosis of the common blood disorder and allow inexpensive at-home self-monitoring of persons with chronic forms of the disease. The disposable self-testing device analyzes a single droplet of blood using a chemical reagent that produces visible color changes corresponding to different levels of anemia. The basic test produces results in about 60 seconds and requires no electrical power. A companion smartphone application can automatically correlate the visual results to specific blood hemoglobin levels. A paper describing the device and comparing its sensitivity to gold-standard anemia testing was published August 30 in The Journal of Clinical Investigation. Development of the test has been supported by the FDA-funded Atlantic Pediatric Device Consortium, the Georgia Research Alliance, Children's Healthcare of Atlanta, the Georgia Center of Innovation for Manufacturing and the Global Center for Medical Innovation. The work showed that the results of the one-minute test were consistent with those of the conventional analysis.
A simple point-of-care testing device for anemia could provide more rapid diagnosis of the common blood disorder and allow inexpensive at-home self-monitoring of persons with chronic forms of the disease. The disposable self-testing device analyzes a single droplet of blood using a chemical reagent that produces visible color changes corresponding to different levels of anemia. The basic test produces results in about 60 seconds and requires no electrical power. A companion smartphone application can automatically correlate the visual results to specific blood hemoglobin levels. A paper describing the device and comparing its sensitivity to gold-standard anemia testing was published August 30 in The Journal of Clinical Investigation. Development of the test has been supported by the FDA-funded Atlantic Pediatric Device Consortium, the Georgia Research Alliance, Children's Healthcare of Atlanta, the Georgia Center of Innovation for Manufacturing and the Global Center for Medical Innovation. The work showed that the results of the one-minute test were consistent with those of the conventional analysis.
Source: http://news.emory.edu/
DNA Blood Test Might Identify Status of Prostate Cancer
A blood test that measures DNA from a prostate cancer tumor could provide doctors with a better assessment of the state of a man's disease, a new study suggests. If used routinely, this blood test could reveal when treatment for advanced prostate cancer stops working and actually begins promoting tumor growth, the researchers suggested. Using a blood test to measure circulating tumor DNA levels is less expensive and less invasive than needle biopsies. This test could be an effective way to monitor the emergence of treatment-resistant prostate cancer, the study published on Sept. 17 inScience Translational Medicine suggested.
A blood test that measures DNA from a prostate cancer tumor could provide doctors with a better assessment of the state of a man's disease, a new study suggests. If used routinely, this blood test could reveal when treatment for advanced prostate cancer stops working and actually begins promoting tumor growth, the researchers suggested. Using a blood test to measure circulating tumor DNA levels is less expensive and less invasive than needle biopsies. This test could be an effective way to monitor the emergence of treatment-resistant prostate cancer, the study published on Sept. 17 inScience Translational Medicine suggested.
Source: http://consumer.healthday.com/
Mismatched DNA Test May Transform Organ Transplant Process
Scientists at Johns Hopkins say they have identified a highly sensitive means of analyzing tiny amounts of DNA that could increase the ability of forensic scientists to match genetic material in some criminal investigations. It could also prevent the need for a painful, invasive test given to transplant patients at risk of rejecting their donor organs and replace it with a blood test that reveals traces of donor DNA, according to the researchers.
Scientists at Johns Hopkins say they have identified a highly sensitive means of analyzing tiny amounts of DNA that could increase the ability of forensic scientists to match genetic material in some criminal investigations. It could also prevent the need for a painful, invasive test given to transplant patients at risk of rejecting their donor organs and replace it with a blood test that reveals traces of donor DNA, according to the researchers.
Source: http://www.genengnews.com/
Pregnant Women Confident in New Blood Test for Down Syndrome
Currently, at around 12 weeks, all pregnant women are offered routine Down syndrome screening which estimates the risk of the baby being born with the condition. Women at high risk are offered invasive testing, where a needle is inserted into the abdomen, but this procedure carries a small risk of miscarriage. A new non-invasive maternal blood test is being trialed in the UK for medium- and high-risk women, which is safer and has detection rates of around 99%. The test is being trialed at 8 antenatal clinics in the UK. The study is ongoing, and the research will be completed by mid-2015.
Currently, at around 12 weeks, all pregnant women are offered routine Down syndrome screening which estimates the risk of the baby being born with the condition. Women at high risk are offered invasive testing, where a needle is inserted into the abdomen, but this procedure carries a small risk of miscarriage. A new non-invasive maternal blood test is being trialed in the UK for medium- and high-risk women, which is safer and has detection rates of around 99%. The test is being trialed at 8 antenatal clinics in the UK. The study is ongoing, and the research will be completed by mid-2015.
Source: http://www.medicalnewstoday.com/
FDA Allows Marketing of the First Test to Identify Five Yeast Pathogens Directly From a Blood Sample
The U.S. Food and Drug Administration allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei. Traditional methods of detecting yeast pathogens in the bloodstream can require up to six days, and even more time to identify the specific type of yeast present. The T2Candida Panel and T2Dx Instrument (T2Candida) can identify these five common yeast pathogens from a single blood specimen within three to five hours. Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida, physicians should perform blood cultures to confirm T2Candida results. “By testing one blood sample for five yeast pathogens—and getting results within a few hours—physicians can initiate appropriate anti-fungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections,” said Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.
The U.S. Food and Drug Administration allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei. Traditional methods of detecting yeast pathogens in the bloodstream can require up to six days, and even more time to identify the specific type of yeast present. The T2Candida Panel and T2Dx Instrument (T2Candida) can identify these five common yeast pathogens from a single blood specimen within three to five hours. Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida, physicians should perform blood cultures to confirm T2Candida results. “By testing one blood sample for five yeast pathogens—and getting results within a few hours—physicians can initiate appropriate anti-fungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections,” said Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.
Source: http://www.fda.gov/
OvaGene, Hitachi Collaborate on mRNA Biomarkers for Gynecological Cancers
Molecular diagnostics firm OvaGene announced an R&D collaboration with Hitachi Chemical Research Center to develop novel mRNA-based signatures for gynecological cancers. The agreement, which leverages Hitachi's exosome technologies and OvaGene's research, clinical validation, and translational expertise, focuses on the development of blood-based mRNA signatures to guide the selection of therapy and to monitory therapy response for ovarian cancer. The partners will also seek to identify novel mRNA signatures for diagnosing the early onset of ovarian or endometrial cancer in high-risk women, OvaGene said.
Molecular diagnostics firm OvaGene announced an R&D collaboration with Hitachi Chemical Research Center to develop novel mRNA-based signatures for gynecological cancers. The agreement, which leverages Hitachi's exosome technologies and OvaGene's research, clinical validation, and translational expertise, focuses on the development of blood-based mRNA signatures to guide the selection of therapy and to monitory therapy response for ovarian cancer. The partners will also seek to identify novel mRNA signatures for diagnosing the early onset of ovarian or endometrial cancer in high-risk women, OvaGene said.
Source: http://www.genomeweb.com/
OPKO Health Launches New Blood Test for Prostate Cancer in Europe
OPKO Health, Inc., a biopharmaceutical and diagnostics company has announced the European launch of the 4Kscore Test, a blood test that identifies risk for prostate cancer, through its wholly owned subsidiary, OPKO Health Spain. The 4Kscore is a blood test that provides a patient his individualized risk for aggressive prostate cancer. The panel of biomarkers utilized in the 4Kscore is based on over a decade of clinical research conducted in Europe by investigators from Memorial Sloan-Kettering Cancer Center and leading European medical institutions involving over 10,000 patients. The 4Kscore Test was developed and validated by OPKO Lab in a 1,012 patient blinded, prospective study in the US in 2014.
OPKO Health, Inc., a biopharmaceutical and diagnostics company has announced the European launch of the 4Kscore Test, a blood test that identifies risk for prostate cancer, through its wholly owned subsidiary, OPKO Health Spain. The 4Kscore is a blood test that provides a patient his individualized risk for aggressive prostate cancer. The panel of biomarkers utilized in the 4Kscore is based on over a decade of clinical research conducted in Europe by investigators from Memorial Sloan-Kettering Cancer Center and leading European medical institutions involving over 10,000 patients. The 4Kscore Test was developed and validated by OPKO Lab in a 1,012 patient blinded, prospective study in the US in 2014.
Source: http://convergence.llesiant.com/
Development of Frozen Section Technology is Subject of Newspaper Story Highlighting the Value Pathology Brings to Medicine
Newspaper in Rochester, Minnesota, tells the story of how the 19th century use of frozen sections by pathologists at Mayo Clinic played key role in developing intra-operative diagnostics It’s a good thing for pathologists each time a local newspaper runs a story that highlights the contribution of pathology to the practice of medicine. Since pathologists typically don’t see patients, media stories about the pathologist’s role in diagnosing disease are effective ways to educate consumers. This was the case when Rochester, Minnesota-based PostBulletin.com recently ran a story about—who else—but the pathology laboratory at the Mayo Clinic. The story highlighted the early development of the frozen section technique (FST) at Mayo Clinic. This newspaper story created community exposure about the role of pathology and pathologists in delivering quality healthcare.
Source: http://www.darkdaily.com/Newspaper in Rochester, Minnesota, tells the story of how the 19th century use of frozen sections by pathologists at Mayo Clinic played key role in developing intra-operative diagnostics It’s a good thing for pathologists each time a local newspaper runs a story that highlights the contribution of pathology to the practice of medicine. Since pathologists typically don’t see patients, media stories about the pathologist’s role in diagnosing disease are effective ways to educate consumers. This was the case when Rochester, Minnesota-based PostBulletin.com recently ran a story about—who else—but the pathology laboratory at the Mayo Clinic. The story highlighted the early development of the frozen section technique (FST) at Mayo Clinic. This newspaper story created community exposure about the role of pathology and pathologists in delivering quality healthcare.
Research and Development
Protein Secrets of Ebola Virus
Now, a team at the University of Virginia (UVA), USA – under the leadership of Dr Dan Engel, a virologist, and Dr Zygmunt Derewenda, a structural biologist – has obtained the crystal structure of a key protein involved in Ebola virus replication, the C-terminal domain of the Zaire Ebola virus nucleoprotein (NP) [Dziubanska et al. (2014). Acta Cryst. D70, 2420-2429; doi:10.1107/S1399004714014710]. The UVA team produced the Ebola protein using an engineered form of Escherichia coli bacteria as a protein factory. This allowed them to identify the boundaries of two globular domains and to crystallize the unique C-terminal domain spanning amino-acid residues 641 to 739. The study revealed a molecular architecture unseen so far among known proteins, the team says.
Now, a team at the University of Virginia (UVA), USA – under the leadership of Dr Dan Engel, a virologist, and Dr Zygmunt Derewenda, a structural biologist – has obtained the crystal structure of a key protein involved in Ebola virus replication, the C-terminal domain of the Zaire Ebola virus nucleoprotein (NP) [Dziubanska et al. (2014). Acta Cryst. D70, 2420-2429; doi:10.1107/S1399004714014710]. The UVA team produced the Ebola protein using an engineered form of Escherichia coli bacteria as a protein factory. This allowed them to identify the boundaries of two globular domains and to crystallize the unique C-terminal domain spanning amino-acid residues 641 to 739. The study revealed a molecular architecture unseen so far among known proteins, the team says.
Source: http://www.iucr.org/
Purdue Expert Showed Ebola Can Enter Cells That Line the Trachea and Lungs; Says Airborne Transmission is not an Impossibility
The idea of the Ebola virus becoming airborne is not far-fetched and its ability to enter cells that line the trachea and lungs has been shown under controlled laboratory conditions, a Purdue University virus expert says. A research team led by Sanders and collaborators from the University of Iowa established that the Zaire strain of Ebola virus could enter the epithelial cells that line the human airway in a paper published in the Journal of Virology in 2003. The experiment used a pseudotyped virus, which was built with the Ebola virus envelope proteins, or outer shell. This is not how the virus is currently known to spread, but it is evidence that it has some of the necessary components for respiratory transmission."
The idea of the Ebola virus becoming airborne is not far-fetched and its ability to enter cells that line the trachea and lungs has been shown under controlled laboratory conditions, a Purdue University virus expert says. A research team led by Sanders and collaborators from the University of Iowa established that the Zaire strain of Ebola virus could enter the epithelial cells that line the human airway in a paper published in the Journal of Virology in 2003. The experiment used a pseudotyped virus, which was built with the Ebola virus envelope proteins, or outer shell. This is not how the virus is currently known to spread, but it is evidence that it has some of the necessary components for respiratory transmission."
Source: http://www.purdue.edu/
Researchers Discover How Bacteria Resist Antibiotics in Hospitals
Scientists have uncovered a key factor to explain why antibiotic-resistant bacteria can thrive in a hospital setting. Tiny circles of DNA called plasmids appear to be the culprit. They can easily enter bacteria and move from one bacteria to another, and some carry a gene that makes bacteria drug-resistant, a new study finds. "The plasmids we are talking about carry an antibiotic-resistant gene to a class of antibiotic called carbapenems," said the study's co-author, Dr. Tara Palmore, an infection control specialist at the U.S. National Institutes of Health. Carbapenems are antibiotics of last resort, and carbapenem-resistant Enterobacteriaceae (CRE) are bacterial pathogens that pose a "formidable" threat to hospitalized patients, according to the research.
Scientists have uncovered a key factor to explain why antibiotic-resistant bacteria can thrive in a hospital setting. Tiny circles of DNA called plasmids appear to be the culprit. They can easily enter bacteria and move from one bacteria to another, and some carry a gene that makes bacteria drug-resistant, a new study finds. "The plasmids we are talking about carry an antibiotic-resistant gene to a class of antibiotic called carbapenems," said the study's co-author, Dr. Tara Palmore, an infection control specialist at the U.S. National Institutes of Health. Carbapenems are antibiotics of last resort, and carbapenem-resistant Enterobacteriaceae (CRE) are bacterial pathogens that pose a "formidable" threat to hospitalized patients, according to the research.
Source: http://consumer.healthday.com/
How Epigenetic Memory is Passed Across Generations
Researchers traced markers of gene repression through cell division and showed that both sperm and eggs transmit a memory of gene repression to embryos. A growing body of evidence suggests that environmental stresses can cause changes in gene expression that are transmitted from parents to their offspring, making "epigenetics" a hot topic. Epigenetic modifications do not affect the DNA sequence of genes, but change how the DNA is packaged and how genes are expressed. Now, a study by scientists at UC Santa Cruz shows how epigenetic memory can be passed across generations and from cell to cell during development.
Researchers traced markers of gene repression through cell division and showed that both sperm and eggs transmit a memory of gene repression to embryos. A growing body of evidence suggests that environmental stresses can cause changes in gene expression that are transmitted from parents to their offspring, making "epigenetics" a hot topic. Epigenetic modifications do not affect the DNA sequence of genes, but change how the DNA is packaged and how genes are expressed. Now, a study by scientists at UC Santa Cruz shows how epigenetic memory can be passed across generations and from cell to cell during development.
Stem Cells Act as 'first aid kits' in Repairing Damaged Immune Response
A new study has revealed that stem cell therapy can also work through a mechanism other than cell replacement. According to the study led by the researchers at University of Cambridge, stem cells "communicate" with cells by transferring molecules via fluid filled bags called vesicles, helping other cells to modify the damaging immune response around them. Stefano Pluchino from the Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, who led the study, said that these tiny vesicles in stem cells contain molecules like proteins and nucleic acids that stimulate the target cells and help them to survive - they act like mini "first aid kits".
Source: http://www.business-standard.com/A new study has revealed that stem cell therapy can also work through a mechanism other than cell replacement. According to the study led by the researchers at University of Cambridge, stem cells "communicate" with cells by transferring molecules via fluid filled bags called vesicles, helping other cells to modify the damaging immune response around them. Stefano Pluchino from the Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, who led the study, said that these tiny vesicles in stem cells contain molecules like proteins and nucleic acids that stimulate the target cells and help them to survive - they act like mini "first aid kits".
Public Health and Patient Safety
Artificial Sweeteners Could Cause Spikes in Blood Sugar
Artificial sweeteners might be triggering higher blood-sugar levels in some people and contributing to the problems they were designed to combat, such as diabetes and obesity, according to new findings published in the journal Nature. Although the precise reasons behind the blood-sugar changes remain uncertain, researchers suspect that artificial sweeteners could be disrupting the microbiome, a vast and enigmatic ecosystem of bacteria in our guts. In a series of experiments, researchers found that several of the most widely used types of non-calorie sweeteners in food and drinks — saccharin, sucralose and aspartame — caused mice to experience increased risk of glucose intolerance, a condition that can lead to diabetes. “We are talking about very dramatic increases,” said one of the study’s co-authors, Eran Segal, a computational biologist at the Weizmann Institute of Science in Israel.
Artificial sweeteners might be triggering higher blood-sugar levels in some people and contributing to the problems they were designed to combat, such as diabetes and obesity, according to new findings published in the journal Nature. Although the precise reasons behind the blood-sugar changes remain uncertain, researchers suspect that artificial sweeteners could be disrupting the microbiome, a vast and enigmatic ecosystem of bacteria in our guts. In a series of experiments, researchers found that several of the most widely used types of non-calorie sweeteners in food and drinks — saccharin, sucralose and aspartame — caused mice to experience increased risk of glucose intolerance, a condition that can lead to diabetes. “We are talking about very dramatic increases,” said one of the study’s co-authors, Eran Segal, a computational biologist at the Weizmann Institute of Science in Israel.
Source: http://www.washingtonpost.com/
HIV Treatment Works, Says CDC
Encouraging People to Seek Treatment is Key
With the input of more than 100 people living with HIV, the Centers for Disease Control and Prevention (CDC) launched a new ad campaign today called “HIV Treatment Works.” The message: If you’re HIV positive, get treatment early and stick with it. Many people don’t immediately start or stay on medication for a variety of reasons, including the cost of the drugs, poor access to health care, a lack of knowledge about effective treatments, and stigma about the disease, says Dr. Nick DeLuca, Chief of the Prevention Communication Branch in the Division of HIV/AIDS Prevention at CDC. Of the 1.1 million Americans living with HIV, only 1 in 4 have an undetectable viral load, the CDC says, which means that the viral levels in their blood are suppressed and are unlikely to be transmitted to other people. At least some of that rate, the CDC says, is due to a lack of adherence to medication.
Encouraging People to Seek Treatment is Key
With the input of more than 100 people living with HIV, the Centers for Disease Control and Prevention (CDC) launched a new ad campaign today called “HIV Treatment Works.” The message: If you’re HIV positive, get treatment early and stick with it. Many people don’t immediately start or stay on medication for a variety of reasons, including the cost of the drugs, poor access to health care, a lack of knowledge about effective treatments, and stigma about the disease, says Dr. Nick DeLuca, Chief of the Prevention Communication Branch in the Division of HIV/AIDS Prevention at CDC. Of the 1.1 million Americans living with HIV, only 1 in 4 have an undetectable viral load, the CDC says, which means that the viral levels in their blood are suppressed and are unlikely to be transmitted to other people. At least some of that rate, the CDC says, is due to a lack of adherence to medication.
Source: http://time.com/
US scientist: Ebola Unlikely to Become Airborne
It's incredibly unlikely that Ebola would mutate to spread through the air, and the best way to make sure it doesn't is to stop the epidemic, a top government scientist told concerned lawmakers. "A virus that doesn't replicate, doesn't mutate," Dr. Anthony Fauci of the National Institutes of Health told a House Foreign Affairs subcommittee. Fauci said U.S. researchers are monitoring for mutations in the virus.
It's incredibly unlikely that Ebola would mutate to spread through the air, and the best way to make sure it doesn't is to stop the epidemic, a top government scientist told concerned lawmakers. "A virus that doesn't replicate, doesn't mutate," Dr. Anthony Fauci of the National Institutes of Health told a House Foreign Affairs subcommittee. Fauci said U.S. researchers are monitoring for mutations in the virus.
Source: http://hosted.ap.org/
First UK Volunteer Gets Experimental Ebola Vaccine
British scientists say a former nurse has become the first person in the country to receive an experimental Ebola vaccine in an early trial to test its safety. Ruth Atkins, 48, got the injection in Oxford, the first of 60 healthy volunteers in the U.K. who will receive the vaccine. It was developed by the U.S. National Institutes of Health and GlaxoSmithKline and targets the Zaire strain of Ebola, the cause of the ongoing outbreak in West Africa. A trial of the same vaccine has already begun in the U.S.
British scientists say a former nurse has become the first person in the country to receive an experimental Ebola vaccine in an early trial to test its safety. Ruth Atkins, 48, got the injection in Oxford, the first of 60 healthy volunteers in the U.K. who will receive the vaccine. It was developed by the U.S. National Institutes of Health and GlaxoSmithKline and targets the Zaire strain of Ebola, the cause of the ongoing outbreak in West Africa. A trial of the same vaccine has already begun in the U.S.
Source: http://hosted.ap.org/
Boston Based Partners in Health Leaps Into Ebola Crisis
An advance team from Boston-based Partners In Health heads for Ebola-stricken Liberia. Four doctors, including co-founder Paul Farmer, and two operations staff will lay the groundwork for an ambitious two- to three-year project that will require well over 100 volunteer doctors, nurses, lab techs and public health workers. The budget for just the first year is $35 million.“We are at a dangerous moment with Ebola,” said Farmer as he prepared for the trip. “Even though this is a huge jump for PIH, I am confident we will succeed.” PIH will work with two established groups, Last Mile Health in Liberia and Wellbody Alliance in Sierra Leone, to strengthen existing public health clinics and train several hundred new community health workers. In addition, PIH will open two 50-bed Ebola treatment centers in rural areas of each country.
An advance team from Boston-based Partners In Health heads for Ebola-stricken Liberia. Four doctors, including co-founder Paul Farmer, and two operations staff will lay the groundwork for an ambitious two- to three-year project that will require well over 100 volunteer doctors, nurses, lab techs and public health workers. The budget for just the first year is $35 million.“We are at a dangerous moment with Ebola,” said Farmer as he prepared for the trip. “Even though this is a huge jump for PIH, I am confident we will succeed.” PIH will work with two established groups, Last Mile Health in Liberia and Wellbody Alliance in Sierra Leone, to strengthen existing public health clinics and train several hundred new community health workers. In addition, PIH will open two 50-bed Ebola treatment centers in rural areas of each country.
Source: http://commonhealth.wbur.org/
The Joint Commission Warns Hospitals of Deadly Medical Tubing Mistakes
Misconnected IV, drug, and feeding tubes are expected to be less likely when new tubing connector standards, now in development, are in widespread use, The Joint Commission says. With at least 21 hospital patient deaths and nearly 100 other adverse events occurring because plastic tubing intended to deliver food instead went into an IV, a Joint Commission Sentinel Event Alert urges healthcare providers to be extra diligent to avoid such mistakes. The first set of standards have already been adopted, the agency said in its alert. "Small-bore (less than 8.5 mm inner diameter) connectors will be engineered to make it nearly impossible to connect one delivery system to another delivery system that serves a completely different function," the commission said.
Misconnected IV, drug, and feeding tubes are expected to be less likely when new tubing connector standards, now in development, are in widespread use, The Joint Commission says. With at least 21 hospital patient deaths and nearly 100 other adverse events occurring because plastic tubing intended to deliver food instead went into an IV, a Joint Commission Sentinel Event Alert urges healthcare providers to be extra diligent to avoid such mistakes. The first set of standards have already been adopted, the agency said in its alert. "Small-bore (less than 8.5 mm inner diameter) connectors will be engineered to make it nearly impossible to connect one delivery system to another delivery system that serves a completely different function," the commission said.
More Than 700 Infants Exposed to TB at Texas Hospital
More than 700 infants and 40 health care workers have been exposed to tuberculosis, commonly called TB, at a hospital in El Paso, Texas, according to the city's Department of Public Health. Health officials are not yet saying if any of the people exposed have tested positive for the disease. An employee at Providence Memorial Hospital in El Paso came to work with an active case of TB sometime between September 2013 and August 2014. He or she worked with infants in the nursery and in the post-partum unit at the hospital, the health department says. The hospital has identified 706 infants and 43 workers who were exposed to the disease during that time period. The family of each patient was sent a certified letter and is being contacted via telephone with instructions on how to get tested for TB. Any necessary follow-up care will be provided free of charge by the health department and the hospital.
Source: http://www.cnn.com/More than 700 infants and 40 health care workers have been exposed to tuberculosis, commonly called TB, at a hospital in El Paso, Texas, according to the city's Department of Public Health. Health officials are not yet saying if any of the people exposed have tested positive for the disease. An employee at Providence Memorial Hospital in El Paso came to work with an active case of TB sometime between September 2013 and August 2014. He or she worked with infants in the nursery and in the post-partum unit at the hospital, the health department says. The hospital has identified 706 infants and 43 workers who were exposed to the disease during that time period. The family of each patient was sent a certified letter and is being contacted via telephone with instructions on how to get tested for TB. Any necessary follow-up care will be provided free of charge by the health department and the hospital.
Health IT
EHR Systems 'Immature, Costly,' AMA Says
The president-elect of the American Medical Association says there is "a crying need" to make electronic health record systems "time-saving rather than efficiency-diminishing." Electronic health record systems are so complicated and poorly designed that they are impacting the quality of doctors' clinical decisions and challenging the sustainability of their practices. Those were messages from the American Medical Association, which has published an eight-point wish list for technology vendors to improve EHR usability. "We do not want to go back to paper records," Steven J. Stack, MD, president-elect of the American Medical Association and chair of the AMA's advisory committee on EHR usability said during a teleconference. "But today's current EHR products are immature, costly, and are not well designed to improve clinical care."
The president-elect of the American Medical Association says there is "a crying need" to make electronic health record systems "time-saving rather than efficiency-diminishing." Electronic health record systems are so complicated and poorly designed that they are impacting the quality of doctors' clinical decisions and challenging the sustainability of their practices. Those were messages from the American Medical Association, which has published an eight-point wish list
for technology vendors to improve EHR usability. "We do not want to go back to paper records," Steven J. Stack, MD, president-elect of the American Medical Association and chair of the AMA's advisory committee on EHR usability said during a teleconference. "But today's current EHR products are immature, costly, and are not well designed to improve clinical care."Calls for Stage 2 Changes Grow Louder
In a pointed letter sent to HHS Secretary Sylvia Matthews Burwell, a who's-who of industry stakeholders complained of "immediate concerns" about their members' ability to continue meaningful use participation. The letter, co-signed by an array of groups – including CHIME, HIMSS, MGMA, AHA, AMA and others – was also sent to CMS Administrator Marilyn Tavenner and National Coordinator for Health IT Karen DeSalvo, MD. The very existence of meaningful use "hinges on addressing the 2015 reporting period requirements," they state. Rather than requiring 365 days worth of attestation data, HHS should "provide for a shortened, 90-day EHR reporting period in 2015, which would give time for providers to continue their transition without having to drop out of the program," they write.
In a pointed letter sent to HHS Secretary Sylvia Matthews Burwell, a who's-who of industry stakeholders complained of "immediate concerns" about their members' ability to continue meaningful use participation. The letter, co-signed by an array of groups – including CHIME, HIMSS, MGMA, AHA, AMA and others – was also sent to CMS Administrator Marilyn Tavenner and National Coordinator for Health IT Karen DeSalvo, MD. The very existence of meaningful use "hinges on addressing the 2015 reporting period requirements," they state. Rather than requiring 365 days worth of attestation data, HHS should "provide for a shortened, 90-day EHR reporting period in 2015, which would give time for providers to continue their transition without having to drop out of the program," they write.
Source: http://www.healthcareitnews.com/
Patient Data can be Shared With Same-sex Spouses Under HIPAA: HHS
Providers can share patient data for one partner with the other in a same-sex marriage without violating privacy rules in the Health Insurance Portability and Accountability Act, the Office for Civil Rights at HHS says in a new interpretation. “Legally married same-sex spouses, regardless of where they live, are family members for the purposes of applying this provision,” the guidance said. The interpretation is posted on the Office for Civil Rights' website as a guidance for the U.S. Supreme Court's 2013 decision in United States v. Windsor, which overturned the portion of the Defense of Marriage Act providing that federal law would only recognized opposite-sex marriages. The Office for Civil Rights statement said it also plans to issue “additional clarifications through guidance or to initiate rulemaking” covering the role of same-sex spouses as a patient's personal representative under the HIPAA privacy rule.
Source: http://www.modernhealthcare.com/Providers can share patient data for one partner with the other in a same-sex marriage without violating privacy rules in the Health Insurance Portability and Accountability Act, the Office for Civil Rights at HHS says in a new interpretation. “Legally married same-sex spouses, regardless of where they live, are family members for the purposes of applying this provision,” the guidance said. The interpretation is posted on the Office for Civil Rights' website as a guidance for the U.S. Supreme Court's 2013 decision in United States v. Windsor, which overturned the portion of the Defense of Marriage Act providing that federal law would only recognized opposite-sex marriages. The Office for Civil Rights statement said it also plans to issue “additional clarifications through guidance or to initiate rulemaking” covering the role of same-sex spouses as a patient's personal representative under the HIPAA privacy rule.
Other News
NIH Funds Next Phase of Tissue Chip for Drug Screening Program
The National Institutes of Health will award funds to support the next phase of its Tissue Chip for Drug Screening program to improve ways of predicting drug safety and effectiveness. Researchers will collaborate over three years to refine existing 3-D human tissue chips and combine them into an integrated system that can mimic the complex functions of the human body. Led by the National Center for Advancing Translational Sciences (NCATS), the program will support 11 institutions at $17 million in 2014 with additional support over the remaining two years if funds are available.
The National Institutes of Health will award funds to support the next phase of its Tissue Chip for Drug Screening program to improve ways of predicting drug safety and effectiveness. Researchers will collaborate over three years to refine existing 3-D human tissue chips and combine them into an integrated system that can mimic the complex functions of the human body. Led by the National Center for Advancing Translational Sciences (NCATS), the program will support 11 institutions at $17 million in 2014 with additional support over the remaining two years if funds are available.
Source: http://www.nih.gov/
FDA Goes HIVE: New Cloud-based Computing Tool Will Help Agency Handle Regulatory Submissions that Employ Next-generation Sequencing
The Food and Drug Administration (FDA) is prepping a new cloud-based computing tool called HIVE (High-Performance Integrated Virtual Environment) in order to handle what it expects will be “massive amounts of data from submissions employing next-generation sequencing (NGS),” according to published news reports. The agency expects to receive an increasing number of applications for medications, devices, and companion diagnostics that use NGS, as NGS becomes more popular. “This technology produces sets of data that are so large and complex that they overwhelm the ability of most computer systems to store, search, and analyze it, or to transfer it to other computer systems,” according to an FDA Voice blog post written by Carolyn A. Wilson, PhD, associate director for research at the FDA’s Center for Biologics Evaluation and Research (CBER).
Source: http://www.aacc.org/The Food and Drug Administration (FDA) is prepping a new cloud-based computing tool called HIVE (High-Performance Integrated Virtual Environment) in order to handle what it expects will be “massive amounts of data from submissions employing next-generation sequencing (NGS),” according to published news reports. The agency expects to receive an increasing number of applications for medications, devices, and companion diagnostics that use NGS, as NGS becomes more popular. “This technology produces sets of data that are so large and complex that they overwhelm the ability of most computer systems to store, search, and analyze it, or to transfer it to other computer systems,” according to an FDA Voice blog post written by Carolyn A. Wilson, PhD, associate director for research at the FDA’s Center for Biologics Evaluation and Research (CBER).
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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