Saturday, 9 July 2016

Weekly Overseas Health IT Links – 9th July, 2016.

Weekly Overseas Health IT Links – 9th July, 2016.

Note: Each link is followed by a title and few paragraphs. For the full article click on the link above title of the article. Note also that full access to some links may require site registration or subscription payment.
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‘Medicalized’ smartphones to put health data in hands of patients

Published July 01 2016, 6:42am EDT
The world is on the verge of a fourth industrial revolution, characterized by artificial intelligence, robots, big data, and deep learning and analytics, but medicine is still stuck at the beginning of the third industrial revolution, which has already brought digital capabilities to billions of people worldwide.
That’s the contention of Eric Topol, MD, director of the Scripps Translational Science Institute and chief academic officer of Scripps Health in La Jolla, Calif., who says that the digital revolution has been occurring since the middle of the last century. Even so, the healthcare industry continues to only minimally leverage information technology.
However, Topol, a practicing cardiologist at Scripps Health and author of The Patient Will See You Now: The Future of Medicine is in Your Hands, sees mobile devices as the technological enabler for the “democratization” of medicine by giving patients control of their own health data, which has historically been the exclusive domain of doctors.
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Mobile ransomware jumps, blocking access to phones

Kaspersky Lab has detected a spike among its own Android users

IDG News Service | Jun 29, 2016 1:48 PM PT
The number of users infected with mobile ransomware is skyrocketing, as hackers try to expand the number of potential victims they can target.
Compared with a year ago, almost four times as many users are being attacked by mobile ransomware, security firm Kaspersky Lab said on Wednesday.
Enterprise mobile management suites are adding app- and content-management features to the roster of
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HIT Think Why interoperability is essential for population health success

Published June 29 2016, 4:07pm EDT
Delivering high-quality healthcare and improving overall outcomes, while simultaneously containing the rising costs of doing so, is a major challenge of the U.S. healthcare system.
Electronic medical records (EMR), health information exchanges (HIE) and patient portals provide valuable methodologies to providers; however, the problems and challenges of those systems have been widely reported. As the value-based model of healthcare continues to gain acceptance among providers and payers, population health management is becoming the future of healthcare delivery.
Population health management provides the methodologies for providers and payers to contain and lower their costs, which increases operational efficiencies. With a system that spends almost 50 percent more on healthcare than the next highest-income country, yet has some of the worst health outcomes than any other developed nation, providers must be able to streamline care and improve treatment outcomes. In order to successfully transition to this broader, holistic approach, the integration of interoperability is crucial.
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eRedbook linked up to screening data

Ben Heather
28 June 2016
Parents in London are being invited to register to use the eRedbook personal child health record.
In an update on its website, Sitekit, the Scottish company that developed the digital alternative to the familiar ‘Redbook’, said Central London Community Healthcare has become the first in the capital to invite parents to register.
Parents in Barnet, Hammersmith and Fulham, Kensington and Chelsea, and Westminster who want to use the record have to record some key details on the site, sign up for a Microsoft HealthVault account, and then confirm their details with a health visitor to gain access.
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Brexit: What it could mean for digital health

Ben Heather
24 June 2016
The people have voted and it’s unlikely to be good news for either the NHS’s finance or efforts to give it a digital makeover.
Even before the United Kingdom voted to leave Europe on Thursday, the financial clouds were gathering for the NHS and, consequentially, Health IT projects around the country.
Quentin Cole, health industries lead partner at PwC, was among the first out of the block predicting added pain for the NHS.
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3 tips for defending patient information from hacker attacks

Jun 30, 2016 10:50am
Physicians typically have access to sensitive personal information on large numbers of patients, which makes their devices prime targets for hackers looking to steal that information, writes Paul Cerrato in Medscape.
News that a hacker acquired personal information on nearly 10 million patients and put it up for sale online indicates a worrisome shift from ransomware attacks on hospitals targeting access to personal information, as our sister publication, FierceHealthIT, recently reported. Doctors with lax information security practices expose themselves to Health Insurance Portability and Accountability Act violations and large fines, in addition to putting their patients’ information at risk, Cerrato says.
Doctors can protect sensitive patient information, as well as their own reputations, by sticking to some common-sense guidelines.
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Editor's Corner: Physician EHRs are stuck in a time warp

Jun 30, 2016 10:07am
Last week, I lamented that there’s little progress when it comes to government rulemaking--that the government appears stuck, proposing many of the same requirements for the electronic clinical quality measures (eCQMs) in the new Inpatient Prospective Payment System that it proposed for the Meaningful Use program, even though some of them didn’t work and in some cases changed.
But it’s not only the government stuck in neutral. The private sector seems just as stuck on its own merry-go-round when it comes to electronic health records.
First, there’s a new study about EHR workarounds, which found them to be “common.” Physicians are still resorting paper crutches, such as sticky notes and faxes, in order to help them in their practices, even though they run the risk of inaccuracies and creating barriers to tracking information. For example, doctors are using paper memory aids because they can’t go back and find test result information in the EHR once it’s been reviewed; the massive number of intrusive alerts still creates an inefficient overload.
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Lessons from the MedStar Health ransomware attack

Jun 30, 2016 10:09am
The ransomware attack that paralyzed MedStar Health computer systems in March taught some painful lessons, according to Craig DeAtley, the organization's director of emergency management.
In a recent interview, DeAtley explains to The Exchange--the newsletter from the Assistant Secretary for Preparedness and Response (ASPR) and the Healthcare Emergency Preparedness Information Gateway (TRACIE)--that the Columbia, Maryland-based health system was caught off guard by the speed in which most of its systems were compromised and locked down.
“We were practiced at individual workarounds, but we had never really rehearsed losing everything, much less all at once,” he says.
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Why a new defense strategy is needed to stop ransomware

Published June 30 2016, 3:52pm EDT
In February, the nation witnessed one of the most high-profile ransomware attacks in history, which led a major U.S. hospital to pay a $17,000 ransom to the hackers who seized control of the hospital’s computer system.
This wasn’t an isolated incident. Many more hospitals were infected by ransomware throughout the first half of the year, and even more are likely to be hit in the next six months.
Unlike most forms of malware, ransomware almost immediately encrypts all of the victim’s files as soon as it gains access to a system. Even the smallest vulnerability can result in total encryption and loss. This drastic effectiveness, paired with the low cost to entry for criminals to adopt ransomware-based attacks, means that unless an organization changes its approach to security, it’s only a matter of time until all its files are rendered inaccessible.
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IBM’s Watson to work with VA on Vice President Biden's Cancer Moonshot

The effort will help doctors boost access to precision medicine for 10,000 VA veterans with cancer.
June 29, 2016 09:14 AM
The Department of Veterans Affairs and IBM Watson Health today launched a public-private partnership to provide veterans with cancer a better shot at recovery.
IBM announced the initiative at Vice President Joe Biden’s National Cancer Moonshot Summit today,
IBM Watson Health will help doctors expand access to precision medicine over the next two years for 10,000 American veterans.
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Clinical IT not ready for precision medicine

Jeff Rowe
Jun 27, 2016
Precision medicine has been a frequent topic of conversation among healthcare stakeholders and policymakers for quite some time, but the underlying reality is that, from the standpoint of IT infrastructure, healthcare organizations still aren’t up to the challenge.
That’s according to Nephi Walton, biomedical informaticist and genetics fellow at Washington University School of Medicine, who spoke recently at the HIMSS Big Data and Healthcare Analytics Forum in San Francisco. "We're really not in near as good a position as we should be to take advantage of the data that's here right now," he said. “Our technology to produce data from genetic medicine is far more advanced than our ability to use it in a clinical environment. Our IT infrastructure is grossly inadequate to meet the demands of precision medicine today.”
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Data drives historic fraud takedown

Jun 28, 2016 9:30am
For years, authorities had been chasing Aleksandr Pikus, who was charged with orchestrating a kickback scheme in New York involving more than $86 million in false claims submitted to Medicare, according to Marketplace. But over the last several years, investigators were able to build a better case against Pikus using real-time billing data.
“In the past, when we didn’t have the kind of computing capability that we do now. Trying to determine a national scope, could take weeks, months, sometimes even years,” Ann Maxwell, assistant inspector general at the Department of Health and Human Services (HHS) Office of Inspector General (OIG) told Marketplace. “Now we are talking about a couple of hours.”
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David Blumenthal: Data ownership at the heart of healthcare evolution

Jun 29, 2016 12:00pm
Freeing patients’ data to move with them remains one of the biggest obstacles in the healthcare information revolution, writes Commonwealth Fund President David Blumenthal in an article in The Wall Street Journal.
Doctors and hospitals have legitimate reasons to be unwilling to share data, writes Blumenthal, the former National Coordinator for Health IT. After all, if a patient’s records can go elsewhere, the patient’s business can, too.
But questions remain about who actually owns that data. One solution, he says, would be to put patients in charge of their own data so they can decide who has access to it and when. Patients could designate particular doctors or facilities that should have access, as well as certain family members or caretakers. They could decide whether to provide it to researchers or public health authorities.
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Healthcare hacks continue to evolve

Jun 29, 2016 1:48pm
News Tuesday that a hacker is selling 9.3 million patient records on the dark web illustrates an evolution in the modus operandi of data thieves and other cybercriminals.
In 2015, nearly 100 million records from four health insurers--Anthem, Excellus BlueCross BlueShield, Premera Blue Cross and CareFirst BlueCross BlueShield--were stolen by hackers.
Then came a shift. 
This year, ransom for control of IT systems took center stage. Several hospitals have been hit, including California-based Hollywood Presbyterian Medical Center, Chino Valley Medical center and Desert Valley Hospital, MedStar Health in Maryland and Titus Regional Medical Center in Texas.
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Most organizations unprepared for data theft by employees

Published June 27 2016, 3:26pm EDT
As organizations spend billions of dollars a year trying to protect their data from hacking, they face another threat closer to home—data theft by their own employees.
That’s one of the findings in a survey published by management consultant Accenture and HfS Research on Monday.
Of 208 organizations surveyed, 69 percent “experienced an attempted or realized data theft or corruption by corporate insiders” over the past 12 months, the survey found, compared with 57 percent that experienced similar risks from external sources. Media and technology firms, and enterprises in the Asia-Pacific region reported the highest rates—77 percent and 80 percent, respectively.
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AMDIS Award-winner on Data Security and MACRA

Scott Mace, June 28, 2016

Medstar Health's Peter Basch, MD, says the March data breach that crippled its systems and sparked an FBI investigation, "helped us as an organization to be more prepared for the next time."

Each year, the Association of Medical Directors of Information Systems (AMDIS) recognizes outstanding achievements in the field of applied medical informatics.
This year's individual winner, announced last week at AMDIS' 25th Annual Physician-Computer Connection Symposium, is Peter Basch, MD, senior director for IT quality and safety, research and national health IT policy at Medstar Health in Washington D.C.
In an interview, Basch discussed MACRA, EHRs, and life in the data breach era. The transcript below has been lightly edited.
HealthLeaders: With all the changes in medicine and technology, are you optimistic or pessimistic right now? It's a crunch year.
Basch: Part of being a doctor, and I am a practicing doctor, is to bring cautious optimism into everything we do, whether it's for the patient who is fearful, or whether it's with a patient who might have a serious illness.
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Low-cost technology may improve rehab for stroke victims

Published June 24 2016, 6:38am EDT
New technology being developed at the Tandon School of Engineering at New York University is designed to help stroke victims more quickly regain lost motor skills compared with conventional therapies.
The technology, projected to cost $1,000 for each unit, can be placed in patient homes, negating the need for frequent trips to a hospital or clinic for rehabilitation.
The project uses “mechatronic devices,” which is a marriage of mechanical and electrical engineering disciplines to make smart products with embedded intelligence, says Vikram Kapila, a professor of mechanical and aerospace engineering at NYU’s Tandon School of Engineering. An example of such devices is airbags in a car, he explains. Sensors detect a crash, and the bags deploy.
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IBM Watson, X Prize team up to offer a $5 million artificial intelligence challenge

X Prize CEO Marcus Shingles said the idea is to use AI to solve the world’s hardest challenges, including those in healthcare.  
June 24, 2016 03:06 PM
IBM Watson joined forces with the X Prize Foundation to launch an open $5 million challenge to build an artificial intelligence app for healthcare that could also be used in other industries, including education, energy, the environment, global development or even exploration.
“In the coming decade, as X Prize strives to achieve its impact mission through incentive competitions and crowd-sourcing, we see tremendous opportunity in this emerging generation of problem solvers to use AI to solve humanity’s grandest challenges," X Prize CEO Marcus Shingles said in a statement. "The IBM Watson AI X Prize is intended to promote and progress the notion of ‘AI for impact’ among the global bold innovator crowd, both the established community of practitioners, as well as encourage newcomers to experiment and ultimately demonstrate how AI can be used as a tool for good.”
Unlike previous X Prizes, including the Tricorder X Prize, in which companies are vying to develop a handheld medical scanner, and the original Ansari X Prize for suborbital flight, this contest allows the participants to define their own goals and to focus on solving different problems.
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Paper workarounds still 'common' for EHR users

Jun 27, 2016 10:33am
Physicians using electronic health records still resort to the paper workarounds, according to a study published recently in Applied Clinical Informatics.
EHRs can improve patient care, but they still suffer from design problems causing physicians to compensate by using workarounds, which can cause inaccuracies and make it much harder to track information. The researchers examined data from 2,554 primary care physicians in the Department of Veterans Affairs system and reviewed workarounds in test results management.
They found that 43 percent of the respondents used workarounds to follow up on test results. Of those, 70 percent used paper-based workarounds such as sticky notes, faxes and paper lists. More than 22 percent used a combination of paper and electronic methods, such as e-calendars, to follow up.
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Healthcare workers choose efficiency over password security

Jun 27, 2016 10:58am
In an era of increased anxiety over the security of healthcare data, hospitals don’t guard passwords nearly as closely as they should, according to a new study from the University of Pennsylvania.
Despite the sensitive information housed in hospital systems, researchers, led by Ross Koppel, found that hospital employees often write passwords on sticky notes and keypad-protected doors, share passwords, and use computers without logging out to make things more convenient for whoever uses them next. Not only do such workarounds typically go unpunished, they’re rarely acknowledged at all, according to the report.
While hospital workers understand the importance of data security, it often isn’t practical to go through the full security process in a setting where time may make the difference between life and death. However, some also believe that lack of data security adversely affects innovation within healthcare.
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How to Prevent a Heart Attack: Text Patients on Healthy Habits

Study finds messages from care providers help patients improve their health and change routines

By Lisa Ward
June 26, 2016 10:01 p.m. ET
A recent study has found evidence suggesting text messages could reduce one’s odds of a second heart attack.
A six-month clinical trial in Australia found that patients recovering from a heart attack were more likely to maintain lower blood pressure, less body fat and lower cholesterol levels than a control group when the patients received text messages asking and giving suggestions about their health routines. Patients receiving the texts also were more likely to be active and to quit smoking than the patients in the control group, who didn't receive such texts.
Repeat heart attacks make up more than a quarter of all heart attacks in the U.S., according to the Centers for Disease Control and Prevention. Many of these attacks could be prevented by lifestyle changes. But while health systems have gotten very good at treating heart attacks, they struggle to connect with patients recovering from heart attacks after they return home.
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HIT Think Why the EHR documentation burden needs to be solved

Published June 27 2016, 3:19pm EDT
It wasn’t so long ago that patient records consisted of paper documents created from hand-scribbled notes made by the doctor. Transcriptionists deciphered the details, compiled them, and stuffed them into manila folders tabbed with the first few letters of a patient’s last name. It was inefficient and time consuming, but it worked.
Then came dictation in the 1980s, giving doctors the option of speaking their notes into a voice recorder, from which the transcriptionist interpreted the encounter details and entered data into the patient file. Then came voice recognition software, which ended the bulk of word-for-word typing by transcriptionists. Now, paper files have given way to electronic medical records—digitized information now resides in vast databases accessible at the touch of a button.
Common sense would say advanced technology makes a doctor’s job of capturing and reporting information about daily patient encounters easier. Reality says something quite different. Documenting encounter information into the EMR costs physicians time they could be spending with patients.
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Electronic Tools Fan the Flames of Physician Burnout

HealthLeaders Media News, June 27, 2016

Physicians who use EHRs and CPOEs are not just less satisfied with their clerical burdens, but also at higher risk for professional burnout, according to a national study.

Tait Shanafelt
Add electronic health records systems to the list of factors that contribute to physician burnout.
So far, EHRs and computerized physician order entry systems aren't making good on their promise to make physicians' lives easier.
To the contrary, physicians who use EHRs and particularly CPOEs within their electronic practice environments are not just less satisfied with their clerical burden, but also at higher risk for professional burnout, according to a national study of physicians led by Mayo Clinic.
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Docs using EHRs, CPOE less satisfied, more likely to burn out

Jun 28, 2016 2:35pm
Use of electronic health records and computerized physician order entry (CPOE) reduces physician satisfaction and contributes to higher rates of burnout, according to a new study from the Mayo Clinic published in Mayo Clinical Proceedings.
The researchers surveyed 6,560 physicians in active clinical practice nationwide between August and October 2014. Most (84.5 percent) indicated that they used EHRs; 82.5 percent used CPOE. However, the number of physicians unhappy with the systems outweighed those who were happy with them.
Of those who used EHRs, only 36 percent were satisfied or very satisfied with them; 43.7 percent were dissatisfied or very dissatisfied. Of those who used CPOE, 38 percent were satisfied or very satisfied; 41.9 percent were dissatisfied or very dissatisfied.
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How Telemedicine Is Transforming Health Care

The revolution is finally here—raising a host of questions for regulators, providers, insurers and patients

By Melinda Beck
June 26, 2016 10:10 p.m. ET
After years of big promises, telemedicine is finally living up to its potential.
Driven by faster internet connections, ubiquitous smartphones and changing insurance standards, more health providers are turning to electronic communications to do their jobs—and it’s upending the delivery of health care.
Doctors are linking up with patients by phone, email and webcam. They’re also consulting with each other electronically—sometimes to make split-second decisions on heart attacks and strokes. Patients, meanwhile, are using new devices to relay their blood pressure, heart rate and other vital signs to their doctors so they can manage chronic conditions at home.
Telemedicine also allows for better care in places where medical expertise is hard to come by.
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Enjoy!
David.
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Physicians go flatline on EHR enthusiasm

In a new study, physicians' enthusiasm levels for EHR's seem to resemble this EKG:




Do physicians really experience a satisfaction 'J-curve' with EHRs?
Max Green 
July 6, 2016 
http://www.beckershospitalreview.com/healthcare-information-technology/do-physicians-really-experience-a-satisfaction-j-curve-with-ehrs.html 

There's a school of thought about EHR adoption that suggests physicians experience an initial decrease in their positive perceptions of the technology, but over time those levels creep back up and ultimately surpass their pre-implementation perceptions. But does that J-curve actually exists for EHRs? A new study in the Journal of the American Medical Informatics Association says no. 

That "school of thought" must be from U.B.H. (Univ. of Blind Hyperenthusiasts) and O.U. (Ostrich University).

"[W]e did not find evidence for a J-curve pattern with respect to positive perceptions eventually exceeding baseline measures," the authors concluded. "Some measures followed a U-curve (returned to baseline), or flatlined, while most followed an L-curve (fell and remained below baseline)."

Translation: doctors hate the technology in its present form.

The study is based on a prospective longitudinal survey of Ann Arbor-based University of Michigan Health System physicians over the course of two years, from when they dropped their homegrown CareWeb EHR, for Epic's. Although all physicians received training on the new system and the system "invested substantial resources developing customized content," according to the paper, the only significant increase over baseline perception after two years of the new EHR was for documenting while in the exam room with patients. 

Surely, that accomplishment is worth the investment of hundreds of millions of dollars ...

"Future research is warranted to determine if positive perceptions eventually surpass baseline, and what interventions can help physicians use EHRs more effectively," the authors concluded.

The answer is "likely not."

In fact, the results of the new study are not surprising considering the not-so-glowing reviews of EHRs forwarded on to HHS in Jan. 2015 by the list of medical societies below (see link to the letter at my Jan. 28, 2015 post "Meaningful Use Not So Meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):


American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery

But, as the EHR pollyannas say, it'll all be better in ver. 2.0.

-- SS
Baca selengkapnya

Friday, 8 July 2016

This Is A Problem That The New ePIP Regulations Will Just Add To. E-Health Fatigue And Burnout!

This Is A Problem That The New ePIP Regulations Will Just Add To. E-Health Fatigue And Burnout!

This appeared last week.
27 June, 2016

E-health linked to doctor burnout

Posted by ruby
While it is supposed to improve healthcare for both doctors and patients, shifting from a paper to an electronic practice may actually make doctors less happy and more burnt out, a new study suggests.
In particular, use of electronic health records and computerised physician order entry were the two factors linked to the most professional dissatisfaction and the highest rates of burnout, Mayo Clinic researchers have found.
“Although electronic health records, electronic prescribing and computerised physician order entry have been touted as ways to improve quality of care, these tools also create clerical burden, cognitive burden, frequent interruptions and distraction – all of which can contribute to physician burnout,” said lead author Dr Tait Shanafelt, a Mayo Clinic physician.
“Burnout has been shown to erode quality of care, increase risk of medical errors, and lead physicians to reduce clinical work hours, suggesting that the net effect of these electronic tools on quality of care for the US health care system is less clear,” the authors wrote.
Their survey on a national sample of 6560 doctors from the American Medical Association database used a validated questionnaire to assess burnout, and is one of number of studies published by the researchers on physician welfare.
Out of all the specialties, GPs were the least happy with the amount of time they spent on tasks unrelated to patient care, barring urologists.
And behind urologists, family medicine doctors were the most burnt-out of the group.
Professional burnout normally manifested as emotional exhaustion, loss of meaning in work, and feelings of ineffectiveness, the authors said.
The underlying problem was the ways doctors were supposed to record information did not align very well with the existing clinical workflow, Dr Nathan Pinskier, chair of the RACGP’s Expert Committee eHealth and Practice Systems.
“The reality is that what we’ve done so far in terms of electronic health records is essentially just converting pen and paper records into an electronic form,” he said.
“We haven’t done anything more sophisticated, and yet we’ve upped the ante in terms of demanding clinicians to become clerks. They’re now required to add more information to more and more documents.”
On top of that, doctors were working in an environment that was more highly regulated and with more compliance demands than they were 50 years ago, Dr Pinskier said.
These were likely to be contributing factors to increasing fatigue and less job satisfaction, he said.
More here:
With the clunkiness of the present myHR and its rather poor implementation it seems that things in Australia are just going to get more involved and complicated.
Dr Pinskier’s point on the rising demands of compliance is well made!

Here is another link covering the same problem:

http://time.com/4383979/doctor-burnout-electronic-health-records/
 
David.
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Bad Apple or Bad Orchard? - A Narrative of Alleged Individual Research Misconduct that Sidestepped the Pharmaceutical Corporate Context

Bad Apple or Bad Orchard? - A Narrative of Alleged Individual Research Misconduct that Sidestepped the Pharmaceutical Corporate Context

Tales of medical research misconduct seem increasingly prevalent in the media, and are getting increasing attention.    They often may present a simple narrative, like this recent story in the New York Times, "An NYU Study Gone Wrong, and a Top Researcher Dismissed."

The Narrative Arc

A Renowned Researcher

The researcher in question was one Dr Alexander Neumeister.  Oddly enough, the article provided very little information about his background, but made it clear he was at New York University, and was a "top researcher."

The Potentially Ground-Breaking Studies

The NY Times article noted that the studies were of "an experimental, mind-altering drug."  In particular,

In one of the shuttered studies, people with a diagnosis of post-traumatic stress caused by childhood abuse took a relatively untested drug intended to mimic the effects of marijuana, to see if it relieved symptoms.

The study was ground-breaking, in that

It’s a critical time for two important but still controversial areas of psychiatry: the search for a blood test or other biological sign of post-traumatic stress disorder, which has so far come up empty, and the use of recreational drugs like ecstasy and marijuana to treat it.

The drug was not identified, but the article noted that it was

a drug intended to produce some of marijuana's effects, made by Pfizer

and was thus like the drug in "a French trial," that caused six patients to be "hospitalized with severe neurologic problems."

The study was apparently a small short-term randomized controlled trial

Some participants took the drug over a seven-day period; others took a placebo pill. The N.Y.U. team performed scans on each person to see whether brain activation patterns correlated with symptom relief.

The study called for recruiting 50 people with a PTSD diagnosis, according to study documents.

Research Misconduct Discovered

Initially, apparently,

Dr. Charles Marmar, the chairman of the psychiatry department at N.Y.U., said that people working with Dr. Neumeister had reported concerns about the lab’s compliance with research standards.

This led to

The federal inspection, from July 16 to Aug. 5 last year, found that the research team had failed to assess at least three subjects 24 hours after they had taken the experimental drug, contrary to study protocol, according to the F.D.A. letter. In several instances, the agency found, Dr. Neumeister had falsified documents by signing a fellow investigator’s name on reports. 'However, in fact, you or another study employee actually conducted these study procedures,' not the colleague, the F.D.A. concluded.

In summary

The violations 'jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site,' the F.D.A. said in a letter
Note that the article did not explain why the FDA was called upon to investigate this problem.



Aggrieved Research Subjects

The article focused on one Ms Diane Ruffcorn, who "writes a popular Facebook blog on trauma,"

'I think their intent was good, and they were considerate to me,' said one of those subjects, Diane Ruffcorn, 40, of Seattle, who said she was sexually abused as a child. 'But what concerned me, I was given this drug, and all these tests, and then it was goodbye, I was on my own. There was no follow-up.'

After the trial, she was concerned because

Ms. Ruffcorn said she had several odd symptoms after the trial, including a hyper, wired sensation that occurred without the usual memories of abuse.  For months, she tried to find out whether those reactions were tied to the experimental drug, but because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not tell her whether she had taken the drug or placebo.

However,

Earlier this month, after much persistence, she found out that she’d taken the placebo. 'It was a big relief,' she said.

Note that the article did not explain why Pfizer owned the data, and would not reveal it. 

The Researcher Punished

The researcher did not agree that things were so bad,

Georges Lederman, a lawyer for Dr. Neumeister, said there may have been protocol violations, 'but N.Y.U. has taken the position that those violations were more egregious than we believe they actually were.' The issues could have been easily remedied, he said, and noted that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut it down.

Note that the article did not explain why Pfizer was empowered to shut such a study down.

In any case,

Dr. Neumeister and N.Y.U. continue to disagree over the seriousness of the research violations, both sides said. But the university has tossed out all of the data as unreliable, and tracked down the study participants to check on their health, Dr. Marmar said.

And apparently Dr Neumeister quit, or was fired, although the article only said NYU "parted ways with a top researcher."

Summary

So, in summary, the story was that a prominent researcher was doing cutting edge research at a big university, but people onsite noted some problems, the government was called in to investigate, the investigation found problems, the research was stopped, and the researcher lost his job.  However, while the article mentioned that Pfizer sponsored the study, Pfizer had control of the study's data, and Pfizer had the power to shut the study down, the article did not comment on whether the involvement of Pfizer could have had any relationship to the narrative of alleged individual researcher misconduct.

Research Misconduct as a Problem with Bad Apples

Thus, in my humble opinion, this story followed the usual narrative arc of research misconduct stories: an individual scientist over-reaches, possibly in pursuit of fame and money, is discovered and punished, and things get back to normal.  The implication is that research misconduct is a bad-apple problem, although fueled by a hyper competitive research environment.  For example, last week the (UK) Times Higher Education Suppplement published an article entitled, "Is There a Problem with Research Integrity," that opened,

For many academics today, research is not about pushing intellectual boundaries. It is not about investigating a fascinating issue so much as it is about churning out publications, demonstrating impact and generating revenue in order to meet the performance targets upon which institutional reputation and individual careers depend.

The temptation to cut corners is immense. Tricks include getting your name on a paper that you contributed little towards, or “salami-slicing” the same research across several publications. More seriously, some researchers falsify – misrepresent – their data, or even fabricate them entirely. Some universities tacitly encourage such behaviour and the boundary between academic integrity and malpractice is becoming blurred.

The current case seems to be on of attempted falsification, misrepresentation of research data.

Notice the use of the pronoun "you," emphasizing that research misconduct is about individual misconduct.  Similarly, tha THE article included commentaries by various individuals.  One was by a "research integrity expert," who began,

Having positive and preferably spectacular research findings is wonderful. It helps you to get a publication in a journal with a high impact factor, which will be cited often and may attract a lot of media attention. This is not only a pleasant ego boost but may also be instrumental in getting your next grant or strengthening your academic position. So, in an ever more competitive and metrics-driven scientific environment, it is tempting to make such results occur by any means necessary.

All this is true as far as it goes.  But in my humble opinion, the usual research misconduct narrative is vastly oversimplified, as is the case reported by the New York Times.

We have been writing for years about massive problems with manipulation of clinical research to increase the likelihood that the results would satisfy vested interests, and suppression of research whose results remain unsatisfactory after such manipulation.  The vested interests are most commonly pharmaceutical, biotechnology or device companies and those working with them.  Such suppression and manipulation may make treatments that do not work look efficacious, and treatments that are dangerous look safe, and may lead to excess costs, and worse, harms to patients.  This kind of research misconduct may be facilitated by individual researchers seeking fame and fortune, but is hardly an individual sport.

Focusing on individual research misconduct thus leaves the larger problem of vested interests dominating clinical research anechoic.

Looking carefully at the NYU/ Neumeister case as reported, and a little research on the web suggests that there may be more involved than just the conduct of one researcher.  But that could only be confirmed, or refuted, by investigation beyond what this humble blogger can do.

A Pharmaceutical Company Sponsored, Likely Pharmaceutical Company Designed, Phase II Drug Study Gone Wrong

The NY Times article acknowledged, almost parenthetically, that the study on which the article was focused was sponsored by Pfizer, although it first did so in the context of Dr Neumeister's lawyer arguing that the problems with the study were not that serious:

[he] noted that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut it down.

Later, the article stated,

Pfizer said that N.Y.U. was responsible for conducting the trial,

but noted

the company had previously tested the same drug, known as an F.A.A.H. inhibitor, for osteoarthritic pain, without significant side effects. 'The safety profile we observed does not preclude future development of our compound,' a Pfizer spokesman said by email.

So this was not a case of a company funding a study merely to advance medical science.  The implication was that the company was testing its own compound in hopes of seeking approval from the US Food and Drug Administration. That must be why it was the FDA that investigated the research misconduct, particularly to the extent that the conduct of the research violated a "protocol" to which the FDA was apprently privy.

More evidence that the study was under the control of Pfizer, rather than of Dr Neumeister, could be inferred from the problems Ms Ruffcorn had in determining whether she had taken the drug or placebo.

For months, she tried to find out whether those reactions were tied to the experimental drug, but because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not tell her whether she’d taken the drug or a placebo.

Note that the "data belonged to Pfizer," not to NYU or Dr Neumeister.

In fact, in perhaps the only critical look given to this story, in a post on Neuroskeptic

I believe the compound in question is PF-04457845.

I believe this because ClinicalTrials.gov lists a trial of PF-04457845 for PTSD, a trial which was recently terminated. NYU was one of the research sites. I also think that this trial is the fateful one, as it matches the NYT’s description of that study. Interestingly, ClinicalTrials.gov says that the trial was stopped 'based on Pfizer portfolio prioritization and not due to safety and/or efficacy concern or change in benefit:risk assessment of PF-04457845'.

So given that the study was a small randomized controlled trials of patients, not of healthy volunteers, it appeared to be a Pfizer sponsored, Pfizer designed, Pfizer controlled Phase II study being done in the hope of eventually marketing PF-04457845.

As noted in an article about agreements between academia and industry on the conduct of randomized controlled trials(1),

Many randomized clinical trials (RCTs) are designed and sponsored by for-profit companies. Companies typically contract academic investigators to identify, recruit, and manage patients. Clinical research under these circumstances is a business transaction that bears the potential for conflicts of interest, including those regarding the publication of trial results

It also appears that Pfizer was spending a more than tiny sum on this work.   A Politico article from 2014 revealed that Dr Neumeister at that time had a $1.7 million grant from Pfizer, presumably for this particular study.  Thus this drug trial was likely providing NYU with more than negligible monetary support, most likely including salary support for Dr Neumeister.

Dr Neumeister apparently has had some previous involvement with pharmaceutical companies, and with Pfizer specifically.  A search of the ProPublica Dollars for Docs 2009-13 database revealed that Dr Neumeister received consulting, travel funds and a more than $227,000 grant from Eli Lilly.  Dr Neumeister apparently is currently on the advisory board for Fiorello Pharmaceuticals.  In a 2015 article in the Journal of Clinical Psychiatry(2), Dr Neumeister acknowledged that he "has received consulting fees from Pfizer."

Conclusion

So it seems that in this case a study which may not have been conducted according to research standards was likely a pharmaceutical sponsored, designed, and controlled Phase II trial done as part of an effort to seek approval for a new drug.  Hence this case was not only about allegations of individual research misconduct, but about yet more problems with the implementation of commercially controlled human experiments designed to ultimately further marketing as well as science.  Yet none of the public discussion so far of this case was about whether Pfizer had any responsibilities to assure the quality of the research in which it was so involved, much less whether interactions between the company, the university which was being funded by the company, and the researcher employed by the university but whose salary was probably partially underwritten by the company might have affected how the study was implemented.

There may be many problems with individual misconduct affecting clinical research.  But failure to consider how this research is now mainly conducted within a commercial milieu seems to be missing the elephant in the room.  If we cannot plainly discuss research misconduct as part of the larger picture of health care dysfunction, we will not be able to do much about it.  True health care reform would help end the taboo on discussion about how powerful organizations and their wealthy and powerful leaders distort health care.  

ADDENDUM (11 July, 2016) - This post was re-published on the Naked Capitalism blog

References

1. Kasenda B, von Elm E, You JJ, Blumie A et al. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Med 13(6): e1002046. doi:10.1371/journal.pmed.1002046. Link here.

2.  Mota N, Sumner JA, Lowe SR, Neumeister A et al. The rs1049353 Polymorphism in the CNR1 Gene Interacts With Childhood Abuse to Predict Posttraumatic Threat Symptoms. J Clin Psychiatr 2015; 76(12):e1622–e1623. Link here.
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Thursday, 7 July 2016

The Macro View – Post - Election  And Health News Relevant To E-Health And Health In General.

The Macro View – Post - Election And Health News Relevant To E-Health And Health In General.

July 07  Edition.

Election Outcome.

I deliberately deferred writing the blog until today – confident that we would have an election result and that I would be in a position to comment.
To catch me out – this is definitely not the case! As everyone knows we are not there yet and as of 1:30pm we do not have a result.
Looks like 74 / 71 / 5 or 75/ 72 /5 will be the outcome. With the order being Coalition /Labor / Others according to the ABC Election Computer. Namely a hung parliament with all that comes with that!
This is a good link to watch for the next day or so!
To also just shake things up a little we have also had this happen.

S&P adjusts Australia's credit outlook to negative

Ratings agency S&P has revised its ratings outlook for to negative from stable on Thursday.
In a statement, the agency said it had also affirmed a AAA long-term and A-1+ short-term unsolicited sovereign credit ratings.
At the same time, S&P revised its outlook on Export Finance & Insurance Corporation to negative from stable and affirmed its AAA long-term and A-1+ short-term issuer credit rating on the wholly owned government company. 
"The negative outlook on Australia reflects our view that without the implementation of more forceful fiscal policy decisions, material government budget deficits may persist for several years with little improvement," S&P said in a statement. 
"Ongoing budget deficits may become incompatible with Australia's high level of external indebtedness and therefore inconsistent with a AAA rating."
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Needless to say this has set off a lot of discussion – and concern to just what it means!
Since the election there have been some interesting articles – which I have linked below – but the most interesting little factoid I noted were a number of suggestions that the Health Minister had really done badly failing to counter Labor on health and was at risk of being re-located. Maybe a new minister might see what nonsense the myHR is????
Sadly another major macro issue has also emerged!

Forget Brexit -- Italy is poised to tear Europe apart

Jul 6, 2016, 6:45 AM
Italy is on the cusp of tearing Europe apart but the economic and political crisis brewing in the nation is largely going unnoticed.
All eyes have turned to Britain’s vote to leave the European Union as having the most drastic political and economic impact onto the 28-nation state but if you look at the country’s economic data, bank issues, and the impending constitutional referendum coming up, Italy is like a bomb waiting to explode.
The Italian financial system, to put it gently, is in a major state of flux right now. While Britain’s EU referendum in June was seismic in terms of having economic and political repercussions across the bloc, there is another referendum of equal importance, coming up in Italy in October, and the result could fundamentally alter the state of the already delicate Italian economy.
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What a mess!

General Budget Issues.

Hello, Pauline, Derryn, Nick, Jacqui, let’s negotiate: why the budget is toast

All those nice shiny figures in the May budget showing a path back to surplus are now just figments of Scott Morrison’s imagination
 ‘While the old Senate was tough enough, the likelihood is that the LNP will need nine extra votes to get legislation passed in the new Senate.’ Pictured: Jacqui Lambie and Nick Xenophon Photograph: Mick Tsikas/AAP
It is entirely apt given the government used the budget as its de facto election campaign launch that we now find after the election result that the budget is completely trashed.
Launching the campaign so closely after the budget meant none of the key measures contained in it have been presented before parliament. That budget included a large number of spending cuts which failed to get through the old parliament; they have even less of a chance now. In the old parliament, the issue was the merely the Senate, now there is a strong possibility the cuts wouldn’t even pass the lower house.
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Health Budget Issues.

Federal Election 2016: Voters tell Turnbull to leave Medicare alone

July 3, 20168:45pm

Election 2016: Turnbull confident his government will be returned

Sue Dunlevy News Corp Australia Network
VOTERS have told politicians to keep their hands off Medicare and medical groups say billions of dollars in cuts must be reversed after health emerged as the key issue in the election.
Acknowledging a powerful Labor Party “Mediscare” campaign could have cost him the government Prime Minister Malcolm Turnbull said he wanted a criminal investigation into Medicare text message to voters on Saturday.
The Australian Federal Police confirmed on Sunday they had been asked to investigate the texts.
“The Australian Federal Police (AFP) can confirm it received a referral on Saturday 2 July 2016 in relation to the receipt of text messages allegedly sent from Medicare,” a spokeswoman said.
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Federal election 2016: How Labor’s Mediscare plot was hatched

  • The Australian
  • 12:00AM July 4, 2016

Pamela Williams

With the temperature outside fit to freeze, Malcolm Turnbull ­arrived at the Coalition’s campaign headquarters in Canberra at close to 1.45pm last Thursday. He had wrapped up a successful speech to the National Press Club and now he would thank excited campaign staff for their hard work.
They would win “with the luck of the gods”, he told the crowd as it gathered in a bland room adorned with a few posters on the wall. It was now up to the judgment of the Australian people. He added optimistically: “I think Labor’s lies have started to wear thin.”
Turnbull did not reveal the bad news he had just received. In a ­private office, party director Tony Nutt had walked the Prime Minister through the numbers. It was not a happy picture. The ­Coalition’s recovery in the polls had stalled. The advertising blackout had begun. They could not counter Labor’s ground campaign with mass union volunteers. And with seats up-ended by the exodus to independents, the outcome was unclear.
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Election 2016: 'Mediscare' campaign worked because voters were already scared

Date July 3, 2016 - 6:39PM

Peter Martin

Economics Editor, The Age

COMMENT
Scare campaigns only work when they reinforce or add to what is already known. 
The scare campaign worked because Medicare's supporters were already scared 
Within weeks of its election in 2013 the Coalition entertained a proposal from a former advisor to Tony Abbott as health minister to end free visits to the doctor by requiring a mandatory co-payment of $6. Anyone who didn't like it would be invited to take out private health gap insurance.
Its Commission of Audit recommended a co-payment of $15 per visit and $5 per concession card holder, and then its first budget announced that "previously bulk-billed patients can expect to contribute $7 towards to cost of standard consultations." Medicare Rebates would be cut by $5 and bulk billing incentives would "only be paid to providers when they collect the $7 patient contribution". It encouraged public hospitals to charge public patients who walked in off the street in order to stem the leakage from doctors.
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The real winners of the Mediscare campaign are doctors and the medical industry

Date July 6, 2016 - 12:00AM

Ross Gittins

The Sydney Morning Herald's Economics Editor

The success of Labor's "Mediscare" in this election is worrying - but not for the reason you may imagine. Its greatest effect may be to fatten the incomes of medical specialists and corporate medical suppliers.
Scare campaigns are often effective politically, but they can impose a high price on the country's good government. 
Scare campaigns are often effective politically, but they can impose a high price on the country's good government.
Tony Abbott's highly successful scare about depredations of the carbon tax at the last election has left us bereft of an effective and relatively low-cost means of reducing our greenhouse gas emissions at a time when climate change is worsening and we've been obliged by international pressure to agree to a tighter target.
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Federal election 2016: Medicare can’t be a ‘money pit’

  • The Australian
  • 12:00AM July 7, 2016

David Crowe

David Uren

Malcolm Turnbull and Scott Morrison are staring down Labor demands for a spending splurge on Medicare as the nation faces a $93 billion bill for the universal health service over the next four years, prompting the Treasurer to warn it cannot become a “money pit” for taxpayer funds.
Medicare is the third-largest government cost behind payments to the states and the Age Pension and has also been one of the fastest growing. The Medicare levy, which ­extracts 2 per cent from all ­income, only covers just over half the cost of the scheme, with the remainder financed by taxes and government borrowing. The total cost for each taxpayer is $1850 a year.
The Coalition is mobilising against Bill Shorten’s campaign for higher Medicare spending in a renewed political fight that will decide whether the vast health system is locked away from major reform despite concerns about whether its costs can be ­sustained.
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Health Insurance Issues.

Tax not the big driver for health insurance

  • The Australian
  • 12:00AM July 5, 2016

Sarah-Jane Tasker

The fight to form government in Australia continues but one message from both major parties that cut through was “buyer beware” on health insurance, with fewer policies taken out to avoid tax.
Financial research and comparison site Canstar has reported a significant drop in the number of Australians shopping for cheap health insurance policies specifically to avoid additional tax.
Canstar editor in chief Justine Davies said usually there was a build-up at the end of the financial year in the proportion of visitors to the website looking for a health policy in order to avoid tax.
The figures normally peaked in June, with 8.45 per cent of visitors to the site last year looking for a health insurance policy just to avoid tax.
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Craig Drummond has problems to fix at Medibank Private

  • The Australian
  • 12:00AM July 6, 2016

John Durie

Craig Drummond faces a monumental task to get Medibank Private into shape amid falling market share and what promises to be a regulatory overhaul no matter which team takes government.
The private health insurance sector is over-capitalised and in the process of being hit with a digital revolution, which should remove the fundamental im­balances that limit consumer choice and inhibit competition.
Drummond started his new job on Monday, replacing 14-year veteran George Savvides, who left earlier than the market was expecting, less than two years into life as a listed company.
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Superannuation Issues.

Australian federal election 2016: Malcolm Turnbull faces superannuation backlash as postmortem begins

Date July 3, 2016 - 12:46PM

Michael Gordon

Political editor, The Age

Malcolm Turnbull is coming under massive pressure from within to recast the superannuation changes he took to the election amid widespread anger and despair in Liberal ranks over his election campaign.
My phone hasn't stopped ringing this morning from people saying it serves them right. 
Insiders are convinced the superannuation changes contributed to the loss of so many Coalition seats and the prospect of a hung parliament.
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Federal election 2016: Morrison urged to retreat on super changes

  • The Australian
  • 12:00AM July 4, 2016

David Uren

Scott Morrison is under pressure from conservatives within the Coal­ition to roll back the budget changes to superannuation taxation, with former minister Eric Abetz claiming they contributed to the loss of three Coalition seats in Tasmania.
Super fund members affected by the budget changes can expect months of uncertainty as whichever party is able to form government reaches a final position to be negotiated with a difficult Senate.
The most controversial of the changes, the lifetime $500,000 cap on non-concessional super contrib­utions, took effect on budget night, May 3, and covers contributions backdated to July 2007.
Anyone who was about to breach that threshold would not know their position. Both Coal­ition members and many sectors of the super industry contend that the changes breach the principle that new regulation should not ­affect the treatment of investments that have already been made. Senator Abetz said this principle was “very dear to the core base of the Liberal Party”.
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I look forward to comments on all this! It really is a bit of a mess for all of us!
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David.
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