With Macy Foundation Grant, Drexel Teams with 12 Institutions to Enhance Professionalism in Medical Education

The Josiah Macy Jr. Foundation has awarded a grant to Drexel University faculty to support the dissemination and enhancement of an online resource for teaching future health care providers about professionalism in medicine — including empathy, compassion, honesty, ethics and social justice.
Dennis Novack, MD, associate dean of medical education at the College of Medicine, was previously awarded a grant to create ProfessionalFormation.org (PFO), an online resource for professionalism learning, assessment, remediation and research in clinical education. With the support of the Macy Foundation, Novcack and Kymberlee Montgomery, DNP, chair of the Department of Advanced Practice Nursing in the College of Nursing and Health Professions, are working with a variety of institutions to disseminate and enhance this resource for over 30 health care education schools across the country.
“This generous grant will enable us to address the challenge of generating new educational resources for the entire health care education community. We will also publish educational research that contributes to a growing national understanding of the components of effective teaching and learning of professionalism and interprofessional care,” Novack said.
Teaming up with Drexel University are 12 institutions including: Alabama College of Osteopathic Medicine, Albert Einstein College of Medicine, Commonwealth Medical College, Duquesne University, Indiana University, Jefferson College, Ohio State University, Southeastern Louisiana University, Stony Brook, University of Pennsylvania, University of Texas – Rio Grande Valley and Western Michigan University School of Medicine. Each of these institutions is affiliating with colleges, such as nursing, pharmacy, physician assistants, dentistry and others for this unique collaboration.
“Leaders in health professions education have worried about the professional image of health care clinicians, and the public’s declining trust in health professionals. Managed care has grown, clinical care has become more fragmented, and there has been adverse publicity about errors in care,” Montgomery said. “A new paradigm for care demands commitments to professional values, and skills in working in teams. We are partnering with these institutions to enhance and expand their education in professionalism and interprofessional care. To practice together, it is essential to learn together.”
The American Board of Medical Specialties defines medical professionalism as a “belief system in which group members declare to each other and the public the shared competency standard and ethical values they promise to uphold in their work and what the public and individual patients can and should expect from medical professionals.” Central to those decelerations is a focus on an ethical value system, the knowledge and technical skills necessary for good medical practice and the interpersonal skills necessary for working with patients and colleagues.
Read More: http://snip.ly/4km9u#http://drexel.edu/now/archive/2017/September/Macy-Foundation-Grant-Professionalism/

What should Entities do to avoid HIPAA fines and penalties?

A look at the nature and numbers of HIPAA breaches over just the couple of years makes stark reading: On the one hand, in terms of numbers; 2016, with about 16 million records breached was a pretty good year compared to the previous year, in which about seven times that number, more than 113 million, were breached. But the bad news is that 2016 saw more Covered Entities reporting breaches than in any other year since the Office of Civil Rights (OCR) started publishing its data on healthcare record breaches.
These huge numbers show that not only is there a big demand for these records in the black market -they are in greater demand than even social security and credit cards -Covered Entities and Business Associates need to all that it takes to avoid HIPAA fines and penalties.

The federal government has not been lax on this aspect. It is being extremely vigilant about protecting healthcare records. It has been consistently urging the HHS to take a serious view of the increased incidence of cyberattacks that has resulted in medical records theft and has suggested many measures towards ensuring this. The fact that there has been a steady increase in the global spending on cybersecurity-related hardware, software, and services and could reach $100 billion in 2020, according to estimates by the International Data Corporation (IDC), suggests the seriousness with which this issue is being viewed not just in the US, but all over the world.
One of the primary requirements that Business Associates need to comply with is adherence to HIPAA mandates regarding the handling and use of health information. This is spelt out in the HITECH Act, a recent update made to overall HIPAA regulations. It is mandatory for a Business Associate to comply with a wide range of regulatory obligations, which include certain privacy obligations, security standards, and breach notification requirements.

However, there is a lot of confusion and misunderstanding among Business Associates about their roles and requirements. They must be completely knowledgeable about all the aspects of their roles, functions and requirements before they enter into agreements of contracts with subcontractors and vendors for their services
Learning about ways of avoiding HIPAA fines and penalties
Jay Hodes, who is President and Founder, Colington Security Consulting, LLC, will be providing thorough understanding of the roles and requirements of a Business Associate and Covered Entities in HIPAA enforcement at a webinar that is being organized by MentorHealth, a leading provider of professional trainings for the healthcare industry. Please visit What should Entities do to avoid HIPAA fines and penalties? to get complete clarity of the ways of avoiding HIPAA fines and penalties.
Clarity on how to avoid HIPAA fines and penalties

The aim of this learning session is to help businesses understand what it means to be a Business Associate and know what required safeguards, policies and procedures must be in place or make sure that their current compliance program is adequate and can withstand government scrutiny.
Jay will highlight the importance of being compliant with the HIPAA requirements for an organization if it has to avoid HIPAA fines and penalties. The ways by which a Business Associate or Covered Entity can provide the appropriate patient rights and controls on its uses and disclosures of Protected Health Information (PHI) and what all it has to have in place for doing so, will all be explained.
He will cover the following areas at this session:

• Why was HIPAA created?
• Who Must Comply with HIPAA Requirements?
• What are the HIPAA Security and Privacy Rules?
• What are the Consequences of being a Business Associate
• What is a HIPAA Compliance Program for a Business Associate?
• What is a HIPAA Risk Management Plan?
• What is a HIPAA Risk Assessment?
• What is the Role of the HIPAA Security Official?
• What are HIPAA training requirements?
• What is a HIPAA data breach and what happens if it occurs?
• What are the penalties and fines for non-compliance and how to avoid them
• Case Examples of HIPAA Data Breaches
• Creating a Culture of Compliance
• Q&A.

Man (35) in vegetative state for 15 years ‘showing signs of consciousness’

A 35-year-old man who had been in a vegetative state for 15 years is showing signs of consciousness after receiving a pioneering treatment based on nerve stimulation.

In the month since a vagus nerve stimulator was put into his chest, the man, who was injured in a car accident, has begun responding to simple orders that had been impossible before.

The findings reported in Current Biology may help to show that by stimulating the vagus nerve “it is possible to improve a patient’s presence in the world”, according to lead researcher Angela Sirigu of Institut des Sciences Cognitives Marc Jeannerod in Lyon, France.
The researchers say it may challenge the view that a vegetative state which lasts for more than 12 months is irreversible.

“Other scientists have hailed it as “a potentially very exciting finding” but have also urged caution.
After treatment, it was reported the patient could follow an object with his eyes, turn his head on request and his mother said there was an improved ability to stay awake when listening to his therapist reading a book.

The vagus nerve connects the brain to many other parts of the body, including the gut.
It is known to be important in waking, alertness, and many other essential functions.

The patient, who was picked because he had been lying in a vegetative state for more than a decade with no sign of improvement, also appeared to react to a “threat”.
Researchers spotted that he reacted with surprise by opening his eyes wide when the examiner’s head suddenly approached his face.

Read More: http://snip.ly/sfxny#http://www.independent.ie/life/health-wellbeing/health-features/man-35-in-vegetative-state-for-15-years-showing-signs-of-consciousness-36173341.html

A range of exercises and medications can help with fibromyalgia

Dear Doctor: My daughter, who is in her 40s, has fibromyalgia. Is there any cure for this painful condition, or any natural remedies? I hate to see her suffer.
Dear Reader: The word “suffer” perfectly sums up fibromyalgia, and my heart goes out both to your daughter and to you, who can see the condition’s terrible effect on her. A chronic pain disorder initially termed “fibrositis syndrome” in the mid-19th century, fibromyalgia has been an official diagnosis only since 1990. The condition causes widespread musculoskeletal pain and fatigue, as well as sleep problems and difficulties in concentration and with memory.
In the United States, 2 to 3 percent of the population suffers from fibromyalgia, with women affected twice as often as men. Blood tests can’t detect fibromyalgia, so the diagnosis is based on a person’s symptoms, including the tender points identified during a physical examination. That said, people with fibromyalgia have shown abnormal biochemical responses to painful stimuli, and those responses can help guide treatment.

The first step in treating fibromyalgia is to understand the illness and what triggers a flair of symptoms. Anxiety and depression are common with fibromyalgia, and the resulting emotional stress can create a cycle of worsening pain and even lower energy levels.
Let’s take a look first at non-medical interventions. Practicing good sleep hygiene is vital because poor sleep can worsen fibromyalgia pain and fatigue, and trigger the cycle mentioned above. Relaxation techniques and therapy can relieve anxiety and depression, while meditation training can ease pain. Further, reflexology and acupuncture have each shown benefits in small studies at easing a variety of symptoms.
Exercise is a crucial component of therapy. Multiple studies have shown that it decreases pain, increases flexibility and boosts energy. Note that if exercise is too vigorous or of high impact, it may cause a flair of symptoms. The key is to start slowly with low-impact exercise, such as walking, biking, swimming or water aerobics. As symptoms improve, patients can increase their level of exercise.
Although they don’t cure the illness, various drugs and supplements can improve specific symptoms.
Read More: http://snip.ly/hdpbv#http://elkodaily.com/lifestyles/a-range-of-exercises-and-medications-can-help-with-fibromyalgia/article_39f0864b-c24a-5926-bcdd-c02488b1b52c.html

Rise in HIV diagnoses among people over 50 in Europe

Between 2004 and 2015, the number of new HIV diagnoses increased by 2.1% each year among this age group, with people over 50 accounting for 17.3% of new HIV cases diagnosed in Europe in 2015.
Experts argue sexual health programs should increasingly target this demographic, as well as the younger population.

“Our findings suggest a new direction in which the HIV epidemic is evolving,” said Lara Tavoschi, a scientific officer at the European Center for Disease Prevention and Control (ECDC), who led the study published Tuesday in the medical journal Lancet HIV. “We see a steady increase in the number of new (HIV) diagnoses among older adults in the region.”
The route of transmission was mostly heterosexual, Tavoschi confirmed.
“We need to increase awareness campaigns among older age groups,” she told CNN.

Rise for some, fall for others

Using routine annual surveillance data from 31 countries, reported to the European Surveillance System between 2004 and 2015, the team at the ECDC analyzed new HIV diagnoses among people aged 15 and above.
The rate of HIV diagnosis among people over 50 increased in 16 countries, including Germany, Ireland and Belgium, and decreased in just one country, Portugal.
Rates were highest in Estonia, Latvia and Malta, where more than seven new cases were diagnosed per 100,000 older people by 2015. Numbers also increased among younger people in these countries, aged 15 to 49 years.

View this interactive content on CNN.com

In certain countries, however, such as the United Kingdom and Norway, new diagnoses went down among young people, but increased in the over-50 population, with more than a 3.6% increase in newly diagnosed HIV cases each year in both of these nations.
“This is a result of successful awareness campaigns that may not have targeted older adults enough,” Tavoschi said, speculating on one reason behind the trend.
England has a national HIV prevention program in place, for example, using local activities and social marketing to promote national HIV testing weeks and a campaign called “It starts with me” to increase testing and condom use, reduce stigma and inform people about sexually transmitted infections and practicing safe sex.
Previous studies have shown a stigma attached to older people having a sex life being at play, added Tavoschi, and the lack of sex assumed among this age group “is not a real reflection of what is happening in this group today,” she said, preventing health care providers from discussing sexual health with older patients.

The data also showed that while diagnoses among men are rising among younger and older people across Europe, the numbers are decreasing among younger women, but increasing among older ones. For now, “it’s unknown why,” Tavoschi told CNN.

Read More: http://snip.ly/hhins#http://edition.cnn.com/2017/09/26/health/hiv-increase-among-older-50s-europe-study/index.html

Healthcare’s Dangerous Fee-For-Service Addiction

For its many users, healthcare’s fee-for-service reimbursement methodology is like an addiction, similar to gambling, cigarette smoking and pain pill abuse. Doctors and hospitals in the clutches of this flawed payment model have grown dependent on providing more and more healthcare services, regardless of whether the additional care adds value.
I don’t use this metaphor lightly, nor wish to trivialize our nation’s growing problem with addiction. Rather, as a physician and former healthcare CEO, I am increasingly concerned with the impact this payment structure is having on American health. And I worry about whether providers are willing to “kick the habit” before it’s too late.
Addictive Qualities
The Affordable Care Act, signed into law March 2010, included several provisions encouraging doctors to focus on increasing value (instead of simply maximizing the volume) of healthcare services. And yet, seven years later, between 86% and 95% of U.S. healthcare providers are still paid for each individual test, procedure and treatment they provide, an arrangement that continues to drive up healthcare costs with little to show for it. According to the latest Commonwealth Fund report, the United States spends more on healthcare than any other industrialized country but ranks at or near the bottom in almost every measure of comparative quality.
As with any addiction, America’s dependence on fee-for-service has dire financial and health consequences. This year, the estimated cost of care for an insured family of four will reach nearly $27,000, paid for through a combination of employer health insurance ($15,259), payroll deductions ($7,151) and out-of-pocket expenses at the point of care ($4,534). Year over year, patients are on the hook for a higher percentage of their total healthcare costs, which rose 4.3% compared to just a 1.9% increase in the U.S. GDP last year. This is a major warning sign. If medical costs continue to surge 2% to 3% higher than our nation’s ability to pay, the healthcare system will soon reach a breaking point. Businesses, the government and insurers will have no choice but to ration care or slowly eliminate coverage for the nation’s poor, middle-class and elderly populations.
As with all addictions, the fee-for-service model has mind-altering effects, distorting the perceptions of its users in ways that make them unaware of their growing dependence. When providers are paid for doing more, that’s what they do: They increase utilization of services and ratchet up the cost of care without even realizing they’re part of the problem. According to one study, just 36% of practicing physicians were willing to accept “major” responsibility for reducing healthcare costs. Of course, the first step, as with other habits, is to recognize the problem. Only then can we explore treatment options.

Read More: http://snip.ly/hlh5h#https://www.forbes.com/forbes/welcome/?toURL=https://www.forbes.com/sites/robertpearl/2017/09/25/fee-for-service-addiction/&refURL=&referrer=

FDA approves first commercial product for peanut allergy prevention

The approach towards preventing peanut allergies has changed dramatically in recent years. Now the US Food and Drug Administration has approved the first commercial product, called Hello, Peanut!, to help inform the public that early peanut introduction and regular consumption can reduce the risk of peanut allergy in young children.
The Hello, Peanut! introduction kit offers convenience in the form of packets of peanut powder blended with oat given in increasing quantities for seven days, as long as children tolerate it well. After which maintenance packets are recommended for use up to three times a week. The introduction kit is $25, and the maintenance kit sells for $20 for eight packets.
The FDA decision was informed by the landmark Learning Early About Peanut Allergy study published in 2015. It showed that high-risk children who regularly consumed peanut in infancy had far fewer peanut allergies by age 5 than their counterparts who avoided peanut over the same span of time. This understanding led to new guidelines published in 2017 by National Institutes of Health about giving peanut to babies to protect against peanut allergy.
Infants who have severe eczema or egg allergy are considered at high-risk of developing a peanut allergy. By offering peanut early in life – between 4-6 months of age – and continuing with regular consumption, we can prevent the onset of peanut allergy in many of these children. High-risk children should see their doctor before parents introduce peanut protein in any form. The physician may decide to do skin or blood testing.  If the test is negative, age-appropriate peanut products can be given at home. However, if a child tests positive, introduction to peanut is done under clinical supervision. If the child is deemed already allergic to peanuts, the guidelines recommend strict avoidance of peanut and ready access to epinephrine auto-injectors.
Read More: http://snip.ly/ktety#http://www.philly.com/philly/health/kids-families/fda-approves-first-commercial-product-for-peanut-allergy-prevention-20170926.html

Depression: Is brain inflammation tied to suicidal thoughts?

A new study confirms the link between inflammation of the brain and the prevalence of suicidal thoughts in people diagnosed with major depression. This is the first study of its kind to measure relevant biomarkers in living individuals.

Major depression is a very common mental condition, with 6.7 percent of all adults in the United States having had at least one severe depressive episode in 2014 or 2015.
According to the World Health Organization (WHO), depression is also currently the leading cause of years spent with disability worldwide.
Some people diagnosed with major depression experience suicidal thoughts, which may result in suicide attempts. In the U.S., “suicide is the 10th leading cause of death.” Now, researchers wonder whether or not suicidal ideation in people with major depression may be linked to abnormal inflammation of the brain.
Dr. Peter Talbot and other researchers based at the University of Manchester in the United Kingdom have conducted a study testing the levels of a biomarker associated with brain inflammation in the systems of people diagnosed with clinical depression.
The scientists’ findings were reported in the journal Biological Psychiatry.

Read More: https://www.medicalnewstoday.com/articles/319526.php?utm_campaign=sniply&utm_medium=sniply&utm_source=sniply

6 Ways To Start Improving Your Gut Health Today

Brooke Lark / Unsplash

Considering the rapid rise in kombucha, sauerkraut and probiotic products, it’s pretty clear gut health is on everyone’s minds. And with good reason — more and more research is emerging showing just how important good gut health is for overall wellbeing.
“Having a healthy gut is so important,” accredited practising dietitian and sports dietitian Chloe McLeod told HuffPost Australia.
“It’s linked to a number of different medical conditions. When your gut isn’t healthy it can have an impact on mental health, weight, mood and a number of other digestive disorders. Keeping your gut nice and healthy can help keep the rest of your body healthy.”

Brooke Lark / Unsplash

How do you know if you have good gut health?

“Signs of good gut health include not getting bloating, gas, diarrhoea and constipation,” McLeod said.
“You find you feel better in general — better mood, more energy, a healthy weight and not feeling fatigued. These are all more pronounced when your gut is healthier.”

How do you know if you have bad gut health?

“If you have poor gut health you may have loose, unformed stools, or you’re really constipated, maybe your faeces are foul smelling, you feel gassy, feel foggy headed or have poor mood. These are some of the most common signs,” McLeod explained.

What can negatively affect gut health?

There are a number of diet and lifestyle-related factors which can impact the health of your gut.
“From a nutrition perspective, factors that negatively impact gut health include poor diet, alcohol and having a high fat intake,” McLeod said.
“Also, if you are someone with food intolerances, any large quantity of those trigger foods can have a negative effect on your gut health.
“Being highly stressed all the time impacts cortisol levels, and stress can be a factor for some people. Some medications can also affect gut health.”

Read More: http://snip.ly/r70uc#http://www.huffingtonpost.com.au/2017/09/24/6-ways-to-start-improving-your-gut-health-today_a_23218661/

Immune cells may heal bleeding brain after strokes

Credit: Courtesy of Aronowski lab, University of Texas Health Science Center, Houston.

While immune cells called neutrophils are known to act as infantry in the body’s war on germs, a National Institutes of Health-funded study suggests they can act as medics as well. By studying rodents, researchers showed that instead of attacking germs, some neutrophils may help heal the brain after an intracerebral hemorrhage, a form of stroke caused by ruptured blood vessels. The study suggests that two neutrophil-related proteins may play critical roles in protecting the brain from stroke-induced damage and could be used as treatments for intracerebral hemorrhage.

“Intracerebral hemorrhage is a damaging and often fatal form of stroke for which there are no effective medicines,” said Jaroslaw Aronowski, M.D., Ph.D., professor, department of neurology, at the University of Texas Health Science Center at Houston, and senior author of the study published in Nature Communications. “Our results are a hopeful first step towards developing a treatment for this devastating form of stroke.”
Accounting for 10 to 15 percent of all strokes, intracerebral hemorrhages happen when blood vessels rupture and leak blood into the brain, often leading to death or long-term disability. Chronic high blood pressure is the leading risk factor for these types of strokes. The initial phase of damage appears to be caused by the pressure of blood leaking into the brain. Over time, further damage may be caused by the accumulation of toxic levels of blood products, infiltrating immune cells, and swelling.

Decades of research suggest that neutrophils are some of the earliest immune cells to respond to a hemorrhage, and that they may both harm and heal the brain. In this study, the researchers found that interleukin-27 (IL-27), a protein that controls the activity of immune cells, may shift the role of neutrophils from harming the brain to helping with recovery.
Injections of IL-27 after a hemorrhage helped mice recover. Days after the strokes, the treated mice had better mobility, including walking, limb stretching and navigating holes in a floor. In contrast, injections of an antibody that blocked natural IL-27 activity slowed recovery. The brains of the mice treated with IL-27 also showed less damage. They had less swelling around the hemorrhages and lower levels of iron and the blood protein hemoglobin, both of which are toxic at high
Read More: http://snip.ly/5llk8#https://scienmag.com/immune-cells-may-heal-bleeding-brain-after-strokes/

Monitoring the heart’s mitochondria to predict cardiac arrest?

Credit: Dr. John Kheir, Boston Children’s Hospital & Shutterstock

A new device can assess in real time whether the body’s tissues are receiving enough oxygen and, placed on the heart, can predict cardiac arrest in critically ill heart patients, report researchers at Boston Children’s Hospital and scientists from Cambridge device maker Pendar Technologies. Their study, conducted in animal models, is the cover article in today’s issue of Science Translational Medicine.

“With current technologies, we cannot predict when a patient’s heart will stop,” says John Kheir, MD of Boston Children’s Heart Center, who co-led the study. “We can examine heart function on the echocardiogram and measure blood pressure, but until the last second, the heart can compensate quite well for low oxygen conditions. Once cardiac arrest occurs, its consequences can be life-long, even when patients recover.”
The device uses a technology called resonance Raman spectroscopy to measure whether enough oxygen is reaching the mitochondria, the organelles that provide cells with energy. In critically ill patients with compromised circulation or breathing, oxygen delivery is often impaired, making it hard for mitochondria to do their job. This is especially a problem for the heart, which has constant high energy needs.
The current standard for measuring tissue oxygenation, known as mixed venous saturation (SvO2), requires repeated blood draws, adding extra risk in critically ill patients. More importantly, SvO2 cannot tell whether oxygen supply is sufficient to meet the dynamic demands of heart muscle.
“We wanted to create an organ-specific, continuous, reliable readout of how adequately mitochondria are being fed oxygen,” says Kheir. “This is the first demonstration of a device that can monitor mitochondria in living tissues to predict impending organ failure.”
Using light to monitor mitochondria
This technology is the product of a collaboration between the Translational Research Lab in Boston Children’s Heart Center, co-led by Kheir and Brian Polizzotti, PhD, and Pendar Technologies (Cambridge, Mass.). “At the bedside, we saw patients who had a limitation to coronary blood flow, and wanted a device that could provide an early warning sign,” Kheir says.
The team created a metric they call 3RMR that uses light readings generated by resonance Raman spectroscopy to quantify oxygenation and mitochondrial function in real time.

Read More: http://snip.ly/bt6o8#https://scienmag.com/monitoring-the-hearts-mitochondria-to-predict-cardiac-arrest-2/

Mental health staff on long-term stress leave up 22%

Image caption Some trusts saw the number of staff taking long-term leave double in five years

The number of NHS mental health staff who have had to take sick leave because of their own mental health issues has risen by 22% in the past five years.

Those taking long-term leave of a month or more rose from 7,580 in 2012-13 to 9,285 in 2016-17, BBC freedom of information requests found.
The union Unite said cuts to staff and services were putting extra pressure on front-line mental health workers.
The Department of Health said it was transforming mental health care.
Out of 81 mental health authorities in England, Scotland, Wales and Northern Ireland, 58 provided the BBC with comparable information.

Looking after ourselves

One mental health doctor who had to take mental health leave told 5 live anonymously: “I don’t think I realised it was happening until quite a long way down the road.”
She explained that she was getting irritable with her partner, her sleep was disturbed and she couldn’t switch off from work.
“In the end, I went to my GP who offered me a sick note. I was quite taken aback that it was quite so obvious to my GP that I needed to be off work.” she said.

Media captionFormer mental health nurse on why she had to leave the NHS

“As mental health practitioners, we are pretty rubbish at putting our own mental health first. You need to put your own oxygen mask on first before putting it on to someone else.”
5 live also spoke to a group of community mental health nurses at the Leeds and York Partnership NHS Foundation Trust about how they cope with the pressure of the role.
“I think when you’re so passionate about something it’s very easy to overlook just how much you are taking on,” said Kate Ward, an occupational therapist working as a care co-ordinator in the team.
Read More: http://snip.ly/okuj8#http://www.bbc.com/news/health-41172805

Understanding the FDA’s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries

 Tobacco, an age-old addiction, dishes out some chilling, unpleasant facts. Tobacco is the US’ leading cause of preventable deaths. Between four and five percent of the entire American population -some 16 million people -live with diseases associated with smoking. Cigarette smoking consumes close to half a million American lives every year, about an eleventh of whom never smoked, meaning that they are second hand smokers who contract diseases just by being in close physical proximity of smokers. The harmful effects of smoking are such that at this current rate of smoking; seven percent of all Americans who are alive today will die a premature death. The average lifespan of a smoker is a good decade shorter than that of a nonsmoker.
The FDA intervenes strongly

Given the gravity of this situation; the FDA formulated a landmark law in August 2016, which vastly improved and expanded its powers to regulate smoking. It builds on an earlier ruling, The Family Smoking Prevention and Tobacco Control Act of 2009. The law of 2016 arms the FDA with greater powers to enforce laws on smoking, one of the highlights of which is restricting the sale of tobacco products to minors all over the country, since this population is very vulnerable to exposure to smoking.  The FDA now requires proof of age of the buyer of cigarettes, banning the sale of tobacco products through public vending machines, and prohibiting the distribution of free samples to minors.
Other highpoints of this amended legislation include requiring manufacturers of smokeless tobacco products to enter clearer warning signs on the products, requiring them to disclose the contents; strengthens local and state authority in enforcing these laws, and requires manufacturers to provide scientific proof of claims of moderate risk from these tobacco products.
The amended rule aims at hitting producers of tobacco products hard and brings a wide variety of activities under its regulatory net:

• Mixing e-liquids
• Manufacturing or modify any type of vaping device
• Mixing loose tobacco and making it available to smoke in a pipe
• Rolling or blending tobacco for cigars
• Manufacturing loose tobacco that enables consumers to roll their own cigarettes
• Importing of tobacco products
• Manufacturing of any tobacco product

The FDA’s regulations on cigarettes and other tobacco products also apply to sellers. The main intention of this modified regulation of August 2016 is that it reviews the ingredients of tobacco products that are sold, the ingredients that go into them, and creates awareness of the dangers of these products, all of which were missing in the earlier legislation.
Learning about all aspects of this regulation

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer a complete explanation of this law. Carolyn Troiano, IT Program Manager and FDA Compliance Consultant, Smart Resources, Inc., who has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, will be the Director of this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
This seminar will describe the best practices for developing a compliance strategy, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.

She will cover the following areas at this seminar:

• FDA Tobacco Control Act
• Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
• Details of the August 8, 2016 FDA “Deeming” Regulation
• Pre-Marketing Tobacco Application (PMTA) Submission
• FDA Oversight and Compliance Strategy
• Computer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC)
• Cost vs. Compliance
• Policies and Procedures
• Leveraging Vendors
• Industry Best Practices
• FDA Trends.

Understanding the FDA’s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries

RPS says pharmacists must always be present in pharmacies

The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement.

Source: Alamy.com

The leaked document, prepared by a working group of the Department of Health’s Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, suggested that current legislation could be changed to allow a registered pharmacy professional, which could include a technician, to take responsibility for the sale and supply of pharmacy and prescription-only medicines.

The Royal Pharmaceutical Society (RPS) has said it believes a pharmacist should always be present in a pharmacy, apart from occasional short periods of time.
Responding to a leaked document produced for the Department of Health (DH) on the issue of whether pharmacy technicians should be allowed to supervise pharmacies, the RPS has issued an eight-point position statement on the role of registered technicians supervising the sale and supply of medicines.

Read More: http://snip.ly/3pujp#http://www.pharmaceutical-journal.com/news-and-analysis/news/rps-says-pharmacists-must-always-be-present-in-pharmacies/20203609.article

Brain Activity and Good Diet May Prevent Insomnia-Related Depression

While lack of sleep is a major risk factor for depression, not everyone who tosses and turns at night becomes depressed. According to a study, individuals whose brains are more attuned to rewards may be protected from the negative mental health effects of poor sleep. The findings revealed that students with poor quality sleep were less likely to have symptoms of depression if they also had higher activity in a reward-sensitive region of the brain.”This helps us begin to understand why some people are more likely to experience depression when they have problems with sleep,” said Ahmad Hariri, Professor at the Duke University in North Carolina, US. “This finding may one day help us identify individuals for whom sleep hygiene may be more effective or more important,” Hariri added. For the study, appearing in The Journal of Neuroscience, the team examined a region deep within the brain called the ventral striatum in 1,129 college students. Ventral striatum helps regulate behaviour in response to an external feedback as well as reinforce behaviours that are rewarded, while reducing behaviours that are not. The results showed that those who were less susceptible to the effects of poor sleep showed significantly higher brain activity in response to positive feedback or reward compared to negative feedback.

^{The effects of poor sleep showed significantly higher brain activity}

“Poor sleep is not good, but you may have other experiences during your life that are positive. And the more responsive you are to those positive experiences, the less vulnerable you may be to the depressive effects of poor sleep,” Hariri said.

Read More: http://snip.ly/ttax2#http://food.ndtv.com/health/brain-activity-and-good-diet-may-prevent-insomnia-related-depression-1753267

Graham-Cassidy health care bill: What you need to know

Sens. Lindsey Graham of South Carolina and Bill Cassidy of Louisiana have drafted the latest Republican attempt to repeal Obamacare. The bill would overhaul or eliminate major sections of the health care law, including its subsidized insurance coverage and Medicaid expansion. Instead, states would receive block grants, or a lump sum of money from the federal government, which they could use largely as they see fit.

How Graham-Cassidy would alter federal funding

Center on Budget and Policy Priorities analysis

The liberal-leaning think tank Center on Budget and Policy Priorities released estimates of how federal funding would change if the bill became law. In its analysis, California would be hardest hit, losing $27.8-billion in funding.

• $-15,000
• $-10,000
• $-5,000
• $0
• $5,000
• $8,500

ALAKAZARCACOCTDEDCFLGAHIIDILINIAKSKYLAMEMDMAMIMNMSMOMTNENVNHNJNMNYNCNDOHOKORPARISCSDTNTXUTVTVAWAWVWIWY

SOURCE: Estimated federal funding change, in 2026 (in $millions)

Graham-Cassidy-Heller-Johnson block grant model

Cassidy’s office released its own estimates. Massachusetts takes the hardest hit with a more than $5 billion loss in funding. Overall, Southern states that did not expand Medicaid are poised to receive more in federal funding.

• $-5,000
• $-2,000
• $0
• $1,000
• $3,000
• $5,000
• $10,000
• $16,000

ALAKAZARCACOCTDEDCFLGAHIIDILINIAKSKYLAMEMDMAMIMNMSMOMTNENVNHNJNMNYNCNDOHOKORPARISCSDTNTXUTVTVAWAWVWIWY

SOURCE: Estimated federal funding change, in 2026 (in $millions)

The bill comes after three failed GOP repeal attempts in the Senate, and a proposal from Sen. Bernie Sanders to extend the reach of government subsidized health care to all Americans.
But Republicans are up against a tight deadline. Their budget reconciliation bill, which allows them to overhaul Obamacare with a simple majority, expires on Sept. 30. The deadline could work to Graham’s and Cassidy’s advantage, however, by spurring hesitant Republicans to seize what may be their last opportunity to deliver on their seven-year promise to repeal Obamacare.

Read More: http://snip.ly/v5ygq#http://www.politico.com/interactives/2017/graham-cassidy-health-care-bill-what-you-need-to-know/

Shipley Center Website Offers Prostate Cancer Facts for Patients

One in every seven men in the United States will get prostate cancer, making it the second most common type, after skin cancer, for American men. It tends to be a slow-growing disease, but can sprint to life-threatening severity if detected too late. Screening for prostate cancer can yield false-positive findings, but those most at risk for the disease—men whose father or a brother had prostate cancer, African American men, overweight men, and those in their 60s and 70s who are in good health and could expect years more of life—still should ask their doctors whether screening makes sense for them.

The website for the Shipley Prostate Cancer Research Center provides basic information about the prostate gland and how disease affects it.

That information comes from the just-launched website of the Shipley Prostate Cancer Research Center at the School of Medicine. Created with a $10.5 million gift from BU trustee Richard Shipley (Questrom’68,’72), the center’s labs will be in the Conte Building on the Medical Campus when it opens. The center’s research will be focused on finding genomic approaches to determine which prostate cancers are aggressive and need treatment, and which can simply be monitored.
The center’s website and its Facebook page and Twitter account are up and running now, offering easy-to-follow, impartial information on practically everything anyone needs to know about prostate cancer. There’s “Prostate 101,” an overview about the prostate, information about prostate cancer and getting a second opinion, and a checklist of symptoms; information on screening; treatment options; and the state of research.
This knowledge is available to patients everywhere, “irrespective of where they choose to get their medical care or where they are in terms of testing, diagnosis, or treatment,” says site editor Gretchen Gignac, a School of Medicine associate professor of hematology and medical oncology.

Most cases of prostate cancer are slow-growing tumors that have a very high cure rate, but some cases are fast-growing.

For its founding donor, the center is as much a beacon of information to patients as an incubator for medical research. Shipley was diagnosed with prostate cancer in 2014 and chose focal laser ablation, a new and less invasive treatment than surgery and other therapies.
“The website will be unique in that it will provide up-to-date information, both on diagnostic and treatment options, in a form the layman can easily understand,” Shipley says.
Read More: http://snip.ly/olj5q#http://www.bu.edu/today/2017/shipley-center-website-offers-prostate-cancer-facts-for-patients/

Hermetic Packaging, Connectors for Medical Implant Industry

Hermetic Implantable Packaging and Connectors for Medical Components

PA&E works with leading medical implant designers to advance integration and performance for hermetic implantable packaging and connectors in one of the most unique and critical environments known: the human body.
PA&E has created proprietary materials and encapsulations with hermetic seals that enable implantable medical devices to bypass the human body’s natural defenses and perform with greater reliability.

Precision Machining of Implantable Devices

PA&E’s unique precision machining techniques for materials and components are used to create implantable packaging and connectors for applications such as: cochlear implants, pacemakers, and other cardiac-function implants.

Here’s what PA&E can offer to medical implant designers:

PA&E’s unique brazing technologies allows materials like titanium and zirconia to be hermetically joined for applications that require an RF transparent package.

Medical Implantable Packaging — Devices implanted in the human body are at the leading edge of medical science. Advancing that technology and making more implantable medical components and devices possible requires overcoming several complex challenges. For example, medical implants must be as small as possible. However, the performance of new devices is often constrained by material selection and thickness. External communication with the implant is critical. Current communication technology relies on case material and size. Reliability and implantable viability are always issues because it is important that the body does not reject a newly-implanted device.
Read More: http://snip.ly/14fsc#http://pacaero.com/industries/medical/

Teens also at risk for organ damage from high blood pressure

And the damage to the heart and blood vessels can occur in youth at blood pressure levels that are below the clinical definition of hypertension in youth.
High blood pressure in youth is defined differently than it is in adults. In childhood, high blood pressure is based on percentiles, rather than blood pressure level. Researchers looked at whether organ damage in teens develops below the 95th percentile, which is the clinical definition of high blood pressure in youth.
Researchers studied blood pressure and measured organ damage in 180 teenagers (14-17 years old, 64 percent white, 57 percent males). They found evidence of organ damage even among the youth categorized as “normal” with blood pressure less than in the 80th percentile. They also found heart and vessel damage in the mid-risk group, which had blood pressures in the 80th to 90th percentiles and the high-risk group, with blood pressures above the 90th percentile.

Read More: http://snip.ly/0v63t#https://medicalxpress.com/news/2017-09-teens-high-blood-pressure.html

Pharmacist in deadly meningitis outbreak heading to trial

After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again.
A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible may help, he says.
“I believe as surely as I’m talking to you right now that if something isn’t done, we will repeat this again,” the North Carolina man said.
Glenn Chin, the supervisory pharmacist at the now-closed New England Compounding Center in Framingham, about 22 miles (35 kilometers) west of Boston, is to go on trial Tuesday for his role in the 2012 fungal meningitis outbreak that killed 76 people and sickened hundreds of others.
Chin faces up to life in prison if convicted of all counts of second-degree murder under federal racketeering law.
Experts, and Chin’s defense attorney, believe prosecutors have a stronger case against Chin than they did against the co-founder of the compounding pharmacy, Barry Cadden. Cadden was sentenced in June to nine years in prison after being acquitted of second-degree murder charges but convicted on conspiracy and fraud charges.
Chin ran the so-called clean rooms where steroid injections were made. He is accused of failing to properly sterilize the drugs, among other things. Chin also faces conspiracy, mail fraud and other charges.
“I’m just a little concerned that the judge and the jury might be a little more harsh on Glenn Chin because he was doing the work in the clean room,” Chin’s attorney, Stephen Weymouth, said.
Throughout Cadden’s trial, the co-founder’s lawyers tried to push the blame onto Chin. Chin intends to point the finger back at Cadden.
Weymouth said he will argue that Chin was essentially a “puppet” for Cadden, who made working in the clean rooms so difficult that “mistakes might have been made.” Cadden was the one calling the shots and pushing the orders to line his own pockets, Weymouth said.

Read More: http://snip.ly/kx5et#http://abcnews.go.com/US/wireStory/pharmacist-deadly-meningitis-outbreak-heading-trial-49907214

Hurricane Harvey HIPAA Reminder

Disasters, which can ultimately lead to a data breach, come in various forms – natural, man-made and technical. HIPAA, the HITECH Act, the Federal Trade Commission and the Securities and Exchange Commission are just a handful of entities requiring that the confidentiality, integrity and availability of the sensitive information (e.g., protected health information (PHI) and personally identifiable information (PII)) remain intact. Although federal HIPAA has distinct categories (e.g., covered entity, business associate, and subcontractor), other state or federal government entities use “covered entity” to mean any person that creates, receives, maintains or transmits PHI or PII.
HIPAA sets forth three main categories of safeguards: administrative, physical, and technical safeguards. Often times, these categories overlap. For example, the administrative requirement of a sanction policy compliments the physical requirement of two-factor identification for building access.
Below are a couple of select sections from the Code of Federal Regulations (CFR), which organizations should be particularly vigilant about in relation to disasters.
•45 CFR §164.310 (Physical) – requires that policies and procedures for facility access in order to restore lost data under the disaster recovery and emergency access plan.
•45 CFR §164.308 (Administrative Safeguards) – multiple requirements are set forth under this particular section of the CFR. For example:
•Security management process
•Annual risk analysis
•Information activity review
•Workforce clearance procedure
•Security awareness training
•Contingency plan

Read More: http://snip.ly/duepz#http://www.diagnosticimaging.com/blog/hurricane-harvey-hipaa-reminder