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Wednesday, 27 May 2015

Princess Health and Government backs down on some requirements for digital medical records. Princessiccia

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EHR utopian dreams have taken some pronounced hits in recent years.

In recent months, the hyper-enthusiasts and their government allies have had to eat significant dirt, and scale back their grandiose but risible - to those who actually have the expertise and competence to understand the true challenges of computerization in medicine, and think critically - plans.

(At this point I'll give them the benefit of the doubt and not call the utopians and hyper-enthusiasts corrupt, just stupid.)

USA Today published this article today outlining the retreat:

Government backs down on some requirements for digital medical records
http://www.usatoday.com/story/news/nation/2015/05/25/athenahealth-epic-safety-reliability-electronic-health-records/27499877/ 

Jayne O'Donnelland Laura Ungar, USAToday  
May 26, 2015

Government regulators are backing down from many of their toughest requirements for doctors' and hospitals' use of digital medical records, just as Congress is stepping up its oversight of issues with the costly technology.

They needed to back down because the technology, vastly over-hyped and over-sold as to capabilities, and vastly undersold as to the expertise required for proper design and implementation, has impaired the practice of medicine significantly - and caused patient harms:

... Now the Department of Health and Human Services is proposing a series of revisions to its rules that would give doctors, hospitals and tech companies more time to meet electronic record requirements and would address a variety of other complaints from health care professionals.
"The problem is we're in the EHR 1.0 stage. They're not good yet," says Terry Fairbanks, a physician who directs MedStar's National Center for Human Factors in Healthcare. The federal government "missed a critical step. They spent billions of dollars to finance the implementation of flawed software."

The "EHR 1.0" stage?  The actual problem is that an industry that's existed regulation-free for decades now was believed, against the advice of the iconoclasts, myself included, when it spoke of this experimental technology as if it were advanced and perfected.

Our leaders all the way up to the last two Presidents were suckered by this industry.  In Feb. 2009 I wrote:

http://www.wsj.com/articles/SB123492035330205101

Dear WSJ:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For �12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.
The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

Nobody was listening.

Back to USA Today:


... William McDade, a Chicago anesthesiologist, checks the medical records of patient Jacob Isham. McDade has moved into electronic medical records but isn't convinced they improve record-keeping, and meanwhile they're expensive and they take time away from patients. 

These digitized records remain the bane of many doctor and patient relationships, as physicians stare at computer screens during consultations.And there's the issue of time. University of Chicago Medicine anesthesiologist William McDade, who has switched from paper to electronic records, says that while EHRs put information at doctors' fingertips, those doctors must take extra time to enter data, and some systems are not intuitive.

The model of physicians as data-entry clerks was experimental from the start, especially in busy inpatient settings and critical care areas.  I opine that particular experiment is a failure.  Paper is far faster, followed by transcription by those without clinical obligations.  That's expensive, of course; but reality is a harsh master.

Praveen Arla of Bullitt County Family Practitioners in Kentucky says even though he's "one of the most tech-savvy people you're ever going to meet," his practice has struggled mightily with its system. It cost hundreds of thousands of dollars to put into place, he says, and it doesn't even connect with other systems in hospitals and elsewhere.

Physicians should not have to be "tech-savvy".  Software, as I've written before, needs to be physician-savvy.  As much of it is written without clinical leadership, we have the results outlined in USA Today.


... The federal government "should've really looked at this more closely when EMRs were implemented. Now, you have a patchwork of EMR systems. There's zero communication between EMR systems," he says. "I am really glad they're trying to look back and slow this down."

I repeatedly called for a slowdown or moratorium of national EHR rollout on this blog.  See 2008 and 2009 posts here and here for example.  My calls were due to the prevalence of bad health IT (BHIT), hopelessly deficient if not deranged talent management practices (especially when compared to clinical medicine) in the health IT industry, and complete lack of regulation, validation and quality control of these potentially harmful medical devices. 

I also called the HITECH stimulus act 'social policy malpractice.'  See my Sept. 2012 post "At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professional".

USA Today then calls out issues of reliability, safety and liability.

Of course, there's always a straddle-the-fence defender of EHRs, with a "EHRs have problems, BUT..." refrain,  even when almost 40 medical societies have complained about safety and usability issues (http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):

... Physician Robert Wachter, author of The Digital Doctor, is a proponent of,EHRs, but sounded several cautionary notes in his book about the problems. At the University of California San Francisco, where he chairs the department of medicine, a teenage patient nearly died of a grand mal seizure after getting 39 times the dose of an antibiotic because of an EHR-related issue. But Wachter says he believes patients are safer with EHRs than they were with paper.

Wachter's book to my belief omitted known cases of EHR fatality - in my view a milquetoast, spineless approach to EHR risk at best.  (I'm trying to be kind and objective, but such spinelessness of others about EHRs put my mother in her grave, http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html.)

Further, the belief that EHRs are safer than paper are not the views in my mind of a critical-thinking scientist, as the true rates of EHR-related harms is unknown, yet the incidences of mass "glitches" affecting potentially thousands of patients at a time and impossible with paper are well-known.

See my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), especially points #1 through 4, and the query link http://hcrenewal.blogspot.com/search/label/glitch.

5/27/2015 addendum:  The author of this USA Today article Jayne O'Donnell informed me that the following appeared in the print edition, but not the electronic version:

But Wachter  and Sally Murphy, former chief nursing officer at HHS' health information technology agency, say they both believe patients are safer with EHRs than they were with paper.

"Is there broad proof that electronic health records have impacted quality? No, " says Murphy, "But you just have to pay attention to the unintended consequences and continue to study them."

First, that response seems the classic salesman's tactic of redirection, to deflect from fully answering to the cruel reality of the evidence.  The second part of the response strikes me as a non-sequitur, in fact.

Second, Murphy and Wachter both seem unable to grasp that the myriad en masse risks to potentially large numbers of patients these systems in their current state cause, impossible with paper (as, for instance, in the many posts at the link above), combined with the lack of evidence about (mass-hyped) "quality improvements", could make patients less safe under electronic enterprise command-and-control systems, which in hospitals is what these systems really are.

Try getting thousands of prescriptions wrong, for instance (see http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or stealing hundreds of thousands of paper records (see for example http://hcrenewal.blogspot.com/2012/06/more-electronic-medical-record-breaches.html).

Compare to well-staffed paper systems led by health information management professionals (not IT geeks), especially those supplemented with document imaging systems.

This type of statement - "EHRs are bad today, BUT they're still better than paper" - strikes me as reflecting, I'm sad to say, limited imagination, limited critical thinking, Pollyanna attitudes, and unfettered faith in computers.

Third, Murphy's somewhat disconnected response "But you just have to pay attention to the unintended consequences and continue to study them" is a bit surprising considering the statement made by the same ONC office just a few years ago:

Contrast to former ONC Chair David Blumenthal, see second quote at my April 27, 2015 essay "Pollyanna Rhetoric, Proximate Futures and Realist's Primer on Health IT Realities in 2015" at http://hcrenewal.blogspot.com/2015/04/pollyanna-statements-proximate-futures.html from an April 30, 2010 article entitled "Blumenthal: Evidence of adverse events with EMRs "anecdotal and fragmented":

... The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety."  (David Blumenthal, former head of ONC at HHS, http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented)

Sadly and tragically, my mother was seriously injured by EHR-related medication reconciliation failure and abrupt cessation of a heart rhythm medication just weeks after Blumenthal said he was unconcerned about risk and that we should go full steam ahead.  That misadventure began on May 19, 2010 to be exact.

It is my belief HHS and ONC still do not take risk seriously and would revert to a Pollyanna stance in a heartbeat without the pressures of the iconoclasts.

Back to the USA Today article:

... Some proponents of EHRs say the government has been thwarting efforts to improve them.

That's laughable.  A review of Australian computer scientist/informtics expert Jon Patrick's analysis of the Cerner ED EHR product, for example, gives insight into just how crappy this industry and its products are, and government was certainly not the cause.   See: Patrick, J. A Study of a Health Enterprise Information System. School of Information Technologies, University of Sydney. Technical Report TR673, 2011 at http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146.


... In addition to extending the deadline for implementing EHR requirements, a series of HHS proposed rules extends the time doctors, hospitals and tech companies have to meet EHR requirements, cuts how much data doctors and hospitals have to collect and reduces how many patients have to access to their own electronic records from 5% of all their patients to just one person.

"That is a slap in the face to patient rights and all the advocates because we worked so hard and for so long to ensure patients could access their data," says patient advocate Regina Holliday.

Holliday became an electronic records advocate after her husband died of kidney cancer in 2009 at age 39. His care was adversely affected because hospitals weren't reading his earlier EHRs and she had trouble getting access to the records.

I met Regina Holliday in Australia during my 2012 keynote presentation to the Health Informatics Society of Australia on health IT trust (http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html).  As I recently mentioned to her, it's even worse that the requirements for a tamper-proof audit trail are also being relaxed.

Without a complete and secure audit trail, electronic records can be altered without detection by hospitals, e.g., after a medical misadventure, to their advantage.   This represents a massive conflict of interest is a violation of patient's rights to a secure and unaltered record in the event of a mishap, in my opinion.

The 2014 Edition EHR CERTIFICATION CRITERIA, 45 CFR 170.314 spells out in great detail specs for such an audit trail (see page 7 at http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf), but compliance has been 'conveniently' relaxed, after hospital and industry lobbying I'm sure.

(The certified electronic health record technology definition proposed by CMS would continue to include the �Base EHR� definition found in the �2015 Edition Health IT Certification Criteria� in addition to CMS� own objectives and criteria.  This definition does not include mandatory tamper resistant audit trails. The audit trail requirement is not proposed to be included in the 2015 definition of �Base EHR."  Neither is this criterion found in CMS� own definition of CEHRT; rather it is �strongly recommended� that providers ensure the audit log function is enabled at all times when the CEHRT is in use, since the audit log function helps ensure protection of patient information and mitigate risks in the event of any potential breach.)

"Strongly recommended" in this industry in my opinion equates to "safely ignore" if it impacts margins.


... EHRs "have made our lives harder" without improving safety, says Jean Ross, co-president of National Nurses United. Last year, the nurses' union called on the Food and Drug Administration "to enact much tougher oversight and public protections" on EHR use.

Meanwhile, the medical industry is urging HHS to give them even more time and flexibility to improve their systems.

"The level of federal involvement and prescriptiveness now is unhealthy," says Wachter, who chairs the UCSF department of medicine. "It has skewed the marketplace so vendors are spending too much time meeting federal regulations rather than innovating."

Here's Wachter again, in essence, kissing the industry's ass.  Government EHR regulation is still minimal, and prior to MU was nearly non-existent.  Where was the "innovation" (more properly, quality, usability, efficacy and safety) then, I ask?

... Sen. Lamar Alexander, R-Tenn., chairman of the Senate health committee, and Sen. Patty Murray, D-Wash., announced a bipartisan electronic health records working group late last month to help doctors and hospitals improve quality, safety and privacy and facilitate electronic record exchange among health care providers and different EHR vendors.

 "It's a great idea, it holds promise, but it's not working the way it is supposed to," Alexander said of EHRs at a recent committee hearing

 At a Senate appropriations subcommittee meeting last month, Alexander told HHS Secretary Sylvia Burwell that he wanted EHR issues at the top of his committee and HHS' priority list to be addressed through regulation or legislation.

I have spoken to the Senator's healthcare staff, who are aware of my Drexel website and my writings on this blog.  They were stunned by the reality of health IT, and I hope they have relayed my concerns and writings to the senator and that this contributed to his mandate.


... Minnesota lawmakers became the latest state this week to allow health care providers to opt out of using EHRs. But MedStar's Fairbanks says doctors would welcome well-designed, intuitive EHRs that made their jobs easier instead of more difficult � and that would improve safety for patients, too.

It is my view that under current approaches to health IT, in terms of talent management, leadership, product conception, design, construction, implementation, maintenance (e.g., correction of reported bugs), regulation, and other factors, that dream is simply impossible.

The entire EHR experiment needs serious re-thinking, by people with the appropriate expertise to know what they're doing.

I note that excludes just about the entire business-IT leadership of this country, who, lacking actual clinical experience, are one major source of today's problems.



Today, Pinky, we're going to roll out national health IT ... tomorrow, we TAKE OVER THE WORLD!

-- SS
Princess Health and Health care professionals strongly endorse new federal dietary guidelines, which say to eat less red and processed meat .Princessiccia

Princess Health and Health care professionals strongly endorse new federal dietary guidelines, which say to eat less red and processed meat .Princessiccia

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A group of 700 physicians and other health care professionals sent a letter of strong endorsement to the secretaries of the Department of Agriculture and the Department of Health and Human Services praising the recommended federal dietary guidelines that emphasize eating less red and processed meat, Whitney Forman-Cook reports for Agri-Pulse, a Washington newsletter.

The letter said the �shift toward a more plant-based diet� in the Dietary Guidelines Advisory Committee's recommendations is a potentially �powerful tool for health promotion� that would help reduce healthcare costs, Forman-Cook writes.

�Three of the four leading causes of preventable death, heart disease, cancer, and stroke -- are diet-related,� the letter reads. �Heavy meat consumption, especially red and processed meat, is associated with increased risks of heart disease, diabetes and some cancers, while plant-based diets are associated with decreased risks of all three.�

They also noted that 75 percent of U.S. health-care costs and diminished labor supply and worker productivity is caused by chronic and preventable diseases, costing the country "$1 trillion in lost economic output and billions more in rising healthcare cost," Forman-Cook writes.

For the first time, the guidelines include environmental standards and sustainability language. Agriculture Secretary Tom Vilsack "has not said he is opposed to including sustainability concerns in the final guidelines," Forman-Cook writes. He told her that "he would be personally involved" in writing the new guidelines, keeping them "narrowly focused on nutrition."

U.S. meat producers and many farm organizations have pushed back against the recommendations and the sustainability language.

The health-care professionals also endorsed the DGAC's recommendations on sustainability and calls for the DGAC to "explicitly" list the "common names" of foods in the guidelines and identify appropriate "non-animal protein sources" to help consumers modify their eating habits.

The guidelines, which are revised every five years to reflect advancements in scientific knowledge, are used to guide federal nutrition programs, including school meal standards, and to inform consumers. They are expected to be published later this year.

Princess Health and Beshear is Communicator of the Year for efforts with Kynect.Princessiccia

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Governor Steve Beshear ?has been named 2014 Communicator of the Year by ?the Public Relations Society of America's Thoroughbred chapter.

He received the award for his communication to Kentucky residents about Kynect, the state's online healthcare marketplace created under federal health-care reform.

More than half a million Kentuckians have gotten coverage through Kynect, most of them through Medicaid, which Beshear expanded under the federal law.
Princess Health and Bluegrass Family Health changes name to Baptist Health Plan.Princessiccia

Princess Health and Bluegrass Family Health changes name to Baptist Health Plan.Princessiccia

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Bluegrass Family Health, the insurance arm of Baptist Health, is changing its name to Baptist Health Plan.

This change will make the Lexington-based health insurance carrier, which has offered insurance through area employers for more than 20 years, be more readily identified with its parent organization, which is based in Louisville, a news release said. It will take a few months for the name transition to be completed.

�As health care continues to evolve, it�s important to bring together the different parts of the Baptist Health system so everyone knows our entire organization is working toward the same goals of improving the health of our communities,� Baptist CEO Stephen C. Hanson said.

Bluegrass Family Health has nearly 80,000 members in Kentucky and parts of adjoining states.

�We look forward to continuing to expand our insurance business, bringing our products and services to both existing and new markets in Kentucky, Indiana, Ohio, Illinois, West Virginia and Tennessee,� James Fritz, president of the plan, said in the release.

Tuesday, 26 May 2015

Princess Health and Obesity and depression may contribute to daytime sleepiness.Princessiccia

Princess Health and Obesity and depression may contribute to daytime sleepiness.Princessiccia

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Obesity and depression, not just lack of sleep, contribute to daytime drowsiness, according to Penn State College of Medicine researchers. Daytime drowsiness or sleepiness affects up to 30 percent of the U.S. population. It can reduce work productivity and cause car accidents. According to the States of Obesity report, 33.2 percent of Kentucky adults are obese.

The Penn State study used physiologic sleep data to show a connection between obesity and depression or sleepiness. Study participants filled out a comprehensive sleep history and physical examination and were evaluated in a sleep laboratory. "Obesity and weight gain predicted who was going to have daytime sleepiness," said Julio Fernandez-Mendoza, assistant professor of psychiatry at the Sleep Research and Treatment Center. "Weight loss predicted who was going to stop experiencing daytime sleepiness, reinforcing the causal relationship."

Body mass index and sleepiness association was independent of sleep duration, so obese people might be sleepy during the day regardless of how much sleep they get. Obesity is also associated with sleep apnea. The chief reason heavy people are more tired is that fat cells create immune compounds called cytokines that make one sleepy.

According to the study, depressed people have daytime drowsiness because they have trouble falling asleep and often wake up during the night. "The mechanism that we believe is playing a role here is hyperarousal, which is simply going to bed and being to alert; in other words, people with depression feel fatigued but do not necessarily fall asleep during the day, Fernandez-Mendoza said.

The study showed that a one-size-fits-all method for treating daytime drowsiness will not be effective. Daytime sleepiness doesn't always mean a person doesn't get enough sleep, Fernandez-Mendoza said. "The main causes of a sleepy society are an obese society, a depressed society and, to some extent, people who have a physiological disorder. By looking at our patients more closely, we can start personalizing sleep medicine."
Princess Health and How do diet and exercise influence risk of diabetes? Diet seems more important.Princessiccia

Princess Health and How do diet and exercise influence risk of diabetes? Diet seems more important.Princessiccia

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Many people think exercising and eating properly are interchangeable, but a paper by Edwards Weiss, associate professor of nutrition and dietetics at Saint Louis University, asserts that exercising and restricting diet results in specific and cumulative benefits in reducing the risk of Type 2 diabetes. According to the 2013 Kentucky Diabetes Report, 6.9 percent of Kentucky adults have diabetes.

Participants in the study were sedentary, overweight middle-aged men and women who reduced their weight 6 to 8 percent through calorie restriction, exercise or both. Researchers measured their insulin sensitivity levels, which determines risk of diabetes. "Your blood sugar may be perfectly normal, but if your insulin sensitivity is low, you are on the way to blood sugar issues and, potentially, Type 2 diabetes," Weiss said.

The researchers measured twice the improvement of insulin sensitivity in the group of participants who both exercised and restricted their diets than in the other two groups. Weiss notes that exercise helps regulate glucose, even if a person isn't losing weight as a result. The researchers also found that exercised-induced weight loss didn't regulate glucoregulation more effectively than calorie restriction. "What we found is that calorie restriction, like exercise, may be providing benefits beyond those associated with weight loss alone," Weiss said.

Weiss said that though it might seem obvious that a combination of diet and exercise would engender the best results, "there are a lot of people who believe that if they maintain a healthy weight, it doesn't matter what they eat. And others have an appropriate food intake but don't exercise."
Princess Health and Lahey Health: hospital jobs lost, but computer vendors prosper. Princessiccia

Princess Health and Lahey Health: hospital jobs lost, but computer vendors prosper. Princessiccia

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At numerous posts on this blog I link to stories of health IT expense putting hospital financial stability at risk, e.g., "Monetary losses and layoffs from EHR expenses and EHR mismanagement" (http://hcrenewal.blogspot.com/2013/06/monetary-losses-and-layoffs-from-ehr.html),  "Financial woes at Maine Medical Center: Reading this blog might have saved them millions of dollars, and prevented massive 'cost saving initiatives'" (http://hcrenewal.blogspot.com/2013/05/financial-woes-at-maine-medical-center.html), "In Fixing Those 9,553 EHR "Issues", Southern Arizona�s Largest Health Network is $28.5 Million In The Red" (http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html) and others.

Here's another, with human layoffs as a result:

Boston Globe
May 20, 2015
Lahey Health to lay off 130 workers at three hospitals
https://www.bostonglobe.com/business/2015/05/20/lahey-health-lay-off-workers/uXbvA2UcBpBLa8PLfRy5tJ/story.html

Lahey Health, the Burlington-based hospital network, is laying off 130 people at three hospitals and cutting the pay of top executives as it moves to close a budget gap.

Lahey said Wednesday that it lost $21 million during the six months that ended March 31 because it spent more than anticipated on the rollout of a new software system and lost business during the harsh winter as patients canceled appointments. It also blamed what it called low reimbursements from public and private insurers that did not cover the full cost of delivering care to patients.

... The job cuts represent about 1 percent of Lahey�s workforce of about 14,000 and include managers, clinicians, and administrative staff.

They include 95 people at Lahey�s flagship hospital in Burlington, 30 at Winchester Hospital, and five at Beverly Hospital.

In health IT, "spending more than anticipated" is an activity that might be more accurately called "fixing bad software at customer expense."

Perhaps hospitals need to abandon the dream that health IT is going to save money, and consider it a serious money sink for which exceptional due diligence needs to be performed - before purchase.

At least management is taking some of the hits in this case.

-- SS

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