Universal Health Care

Universal Health CareUniversal health care seems to be a fiercely discussed topic whenever health care change in the United States is actually reviewed.

People that maintain that will health is surely an individual responsibility are afraid a process that requires these phones contribute levy dollars to aid guy individuals who don't work responsibly within defending as well as selling their own health. They reason that they want the freedom to decide on their very own physicians along with treatments, and suggest that authorities cannot know very well what is the best for these. These individuals debate that protecting the actual program together with enhancements to provide far better insurance coverage regarding people which continue to be not insured as well as under covered with insurance for his or her health care bills requires may be the merely change that's needed.

Those that think health care is surely an particular person appropriate assist a new common health care system with the disagreement that many resident deserves to have the proper care at the right time understanding that a united state's duty is to safeguard it's individuals, frequently even via by themselves.

Two other arguments as a result of two opposing ideologies. Both are perfect arguments nevertheless not could possibly be the helping disagreement for working with or doubt universal health care. The issue have to be resolved via an honorable platform.

Examination of the particular moral issues inside health care change would require consideration of very different reasons than those already introduced. Moral troubles might target the particular meaningful proper. Discussion would certainly start out with certainly not "What is perfect for me personally?" but "How run out as being a modern society be acting to ensure our measures are generally fairly appropriate?"

Integrity refers to determining proper and also completely wrong within precisely how human beings connect with one another. Ethical making decisions with regard to health care reform then would likely demand individuals some thing inside thought on our interactions to each other not really our personal person hobbies.

Contra Costa's $45 million computer health care system endangering lives, nurses say

I am reproducing this story almost without comments - few are needed - merely highlighting familiar themes I have written about at this blog:

Contra Costa's $45 million computer health care system endangering lives, nurses say

Updated:   08/14/2012 08:55:52 PM PDT

MARTINEZ -- A new medical computer system used at Contra Costa correctional facilities recommended what could have been a fatal dose of a West County Jail inmate's heart medication last week, an incident that a detention nurse characterized Tuesday as one of many recent close calls with the month-old program.

However, the inmate's nurse was familiar with his medical history, recognized the discrepancy and administered the correct amount of Digoxin.

It's just one of a number of computer errors that medical staffers say have been endangering inmates, medical staff and sheriff's deputies at the county's five jail facilities since Contra Costa switched on July 1 to EPIC, a computer system that links the correctional facilities to the Contra Costa Regional Medical Center and other county health care operations, two nurses and their union representative told the Contra Costa County Board of Supervisors on Tuesday.

"It's dangerous. It's very dangerous," said an emotional Lee Ann Fagan in a phone interview. The registered nurse works at West County Detention Facility in Richmond. "It's hard to work in an environment that's so frustrating.  [Staff frustration increases risk of error and decreases morale, which increases risk of error further - ed.]
"What nurses want is for the EPIC program to go away until it's fixed," she said.

The $45 million EPIC system integrates detention medical records with the other arms of the county health system. The system led to 142 nursing complaints in July, said California Nurses Association labor representative Jerry Fillingim, who told supervisors the system does not mesh well with detention health care.

"I have never in all the time working with the California Nurses Association seen that many (complaints) be filled out," he said. "Each day, these nurses are fearful that they will kill somebody [requiring hypervigilance, which is emotionally and intellectually tiring, increasing risk of error further - ed.] ... I think the county tried to rush it, making it comprehensive for everything."

EPIC has never included corrections in its software and is treating Contra Costa as a "guinea pig," Fillingim said.  [Subjects of this experiment don't get the opportunity for informed consent, I add - ed.]

Guinea pigs to experiments don't give consent

'Just a tool'

The county wanted to create a uniform electronic health record (EHR), and executives said the tool is important, but not the be-all, end-all.

"The EHR is just a tool," said David Runt, chief information officer for the county health services department and who helped phase the system in over 18 months. "It's just one piece of the health care system. The people are the most important part of this process. We can't rely just on a computerized system."  [That's certainly a much more temperate position than the usual seller and pundit line that "health IT will transform medicine." It is also an especially good observation when the tool is unreliable! - ed.]

In addition to ongoing training, staff has trained "superusers," safety alerts, diagnostic testing, patient safety daily briefings and other help available. Still, "we are working on resolving many different issues," said Anna Roth, CEO of Contra Costa Regional Medical Center and health centers.

"It's the beginning of a long journey that occurs over time," [i.e., an experiment - ed.] she said. "I think we can do a better job ... at how we communicate everything we're doing to respond to concerns." [The health IT industry has had several decades to "get it right."  When will the experiment end? - ed.]

Management warned

Staff superusers have warned management of EPIC issues, and two training sessions in May and June were inadequate, Fagan said.

"They were next to useless because the program wasn't in place well enough to practice," she said. "Everyone in the classes could see the gross loopholes in information."

Although nurses across the county's health care system have complained [but impediments to diffusion per FDA, IOM etc. prevented the complaints from becoming more widely known - ed.], the problems have been acute in detention, Fagan and Fillingim said.

On Monday, one inmate told a nurse she was supposed to be seen by mental health specialists because she was hearing voices, but the follow-up appointment was not registered in the system. The same patient had a Pap smear scheduled for two weeks ago to test for sexually transmitted diseases, but the appointment disappeared from the system, Fagan said.

Nurses cannot access tuberculosis history for inmates, so when some are transferred to Immigration and Customs Enforcement, staff cannot provide a full medical summary.
"We don't exactly know how that happened; we can't tell," she said.
The kinks will be worked out, and patient safety issues rise to the top of the list, Runt said.

"When we go live is just a point in time, and now it becomes a period of stabilization and optimization," he said.

I think the line "We don't exactly know how that happened; we can't tell" sums up the dangers of today's EHR's, a.k.a. clinical resource and clinician workflow control systems, very well.

I note that nurses is California may be a bit better prepared to recognize and call out the dangers of ill-designed and ill-implemented health IT than those in other states.  See my post "Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee."

Regulation, anyone, or shall the experiment continue as-is?

-- SS

When Does Lavish Executive Compensation Become "Embezzlement?"

A single article in the Miami Herald raises the question of when is excessive executive compensation in health care too excessive.  To set up the question, I will be quoting from the story in an order quite differently from how the story was presented.


The story is about the executives of the Miami Beach Community Health Center, described thus:
Headquartered on Biscayne Boulevard in North Miami, the Miami Beach Community Health Center is one of the oldest and most well-respected public health clinics in Florida. It opened more than three decades ago, and now includes four locations, three on the Beach, including two sites that care for people with mental illness. The center employs more than 280 people, with a monthly payroll of around $1.2 million.

The health center’s annual budget is about $36 million — about one-third of which comes from private insurance, Medicaid, the state and federal health insurance for needy people, Medicare, the federal insurer for elders, and private payments.

The CEO's Compensation

Previous stories, and public records suggested that the Center's CEO, Kathryn Abbate, was very well compensated. First,
an October 2010 Miami Herald business story ..., relying on federal tax documents, reported Abbate’s compensation package as $824,000 in 2008. In the article, Abbate said the compensation package was inflated by cashed-out sick time, vacation time and a retirement account.

She did even better in subsequent years,
The Miami Beach Community Health Center’s federal tax report for 2010 indicates Abbate’s base salary was $261,165 — but includes an additional $956,584 in 'bonus and incentive' dollars that pushed her total compensation to more than $1.2 million. The center’s IRS disclosure for the prior year reported Abbate’s base salary as $970,532, and total compensation of $987,902. In 2008, Abbate’s total reported compensation was $824,686, records show.

The CEO got very generous compensation given the size of her organization.  This compensation was documented on forms the organization submitted to the IRS that were in the public domain.

However, as we have discussed many times before (look here), many leaders of health care organizations, including non-profit organizations, have been collecting very generous compensation.

The Role of the Board of Trustees

As we have discussed before, e.g., here, exceptional compensation for top hired managers is often justified by the governing boards, that is, boards of trustees or directors, to whom the hired managers nominally report.  These governing board members often seem to be working off a common set of "talking points." 

In this case, there was a difference. The Herald reported that the Centers board of trustees "never agreed to pay Abbate more than $300,000, [Center Chief Medical Officer Dr Mark] Rabinowitz said."

The board seemed totally unaware of what their organization was paying its CEO.
Rabinowitz and a health center spokeswoman, Alia Faraj-Johnson, said that board members they spoke to had not seen the [2010] newspaper story [about the CEO's 2008 compensation]until just recently, and acknowledged its content would have raised significant red flags.

'That would have tripped everybody’s light,' Rabinowitz said.
Why the board had never thought to look at the organization's own reports (990 forms) to the US Internal Revenue Service which detailed the executives' compensation, reports that were in the public domain, and are easily available online (look here), is unknown.

The article implied that the board was somehow not up to this task even though it has fiduciary responsibilities to oversee the top hired managers, oversee the overall budget, and try to maintain both the organization's mission and fiscal stability did not seem up to the task. The article noted,
board members remained unaware until last spring. Under federal law, at least half of the board members of federally subsidized health centers such as Miami Beach’s must be consumers of the clinic, and some of the clinic’s board members were simply ill-equipped to detect what the center calls a sophisticated financial crime.

The board members seemed to think that it was the job of the CEO's subordinates to keep tabs on her compensation,
'One of the sad things about this, regrettably, is that if the gatekeeper in this case, the chief financial officer, had done his job, a large portion of this would have been discovered a long time ago,' said Bill Dillon, a Tallahassee-based healthcare lawyer who is advising the center.

The Chief Financial Officer contended that he would not have been able to successfully blow the whistle:
[CFO Stanley] DeHart, who lives in Coral Springs, said he was aware of many of Abbate’s activities, but declined to alert the board of directors. 'The board of directors was very close to her, and I really thought they would not believe me,' DeHart said. 'They held her in very high esteem.'

DeHart and members of his staff 'discussed whistle-blowing,' he said, but they all agreed taking such an action was more likely to result in their firing than Abbate’s. 'I felt at the time, and I still feel, that I had no proof that the board of directors would accept.'

And, DeHart added, blame for the scandal should include outside auditors, who failed to raise any objections when Abbate wrote dozens of checks to herself for 'community development' — a department that regularly generated an enormous amount of 'abnormal activity.' DeHart said he told auditors he suspected something was amiss in the community development department.

'The external auditors had to have known about this,' DeHart said, 'because I laid it out to them in plain view. I did not hide anything.'

In fact, the CEO's total compensation, plus a variety of other payments she seemed to direct to herself, were not made clear until
May, after a routine audit required by federal funders turned up irregularities, said Mark Rabinowitz, an obstetrician and gynecologist who is the center’s chief medical officer. Abbate had written a check for $5,000 to herself, and cashed it, labeling the expenditure a 'community development' expense....

Only after that,
Calling the actions of their former administrator an 'outrageous betrayal of trust,' authorities with the Miami Beach Community Health Center are investigating what they call the theft of almost $7 million in taxpayer money by the center’s longtime chief executive.

Members of the health center’s board of directors fired Chief Executive Officer Kathryn Abbate, saying she diverted the nearly $7 million in money intended to provide healthcare for the needy to her personal use beginning in 2008.


So let me backtrack a bit. The board of a moderately big, non-profit community health center seemed to make no attempt to monitor the organization's finances, did not even review the organization's own filings with the US government, and therefore had no idea what they were paying their CEO. Nonetheless, they seemed to assume that the organization's finances would be kept in order by an executive who reported to that same CEO. When an audit ordered externally ordered revealed that the CEO was being paid much more than the board had assumed, they charged "embezzlement," again even though a good chunk of such payments were in the form of compensation reported to the US government.

The real distinction between this case and many other cases of huge executive compensation we have discussed is that in this one the board seemed to be trying to maintain "plausible deniability" of any knowledge of the CEO's compensation, even though supervising that compensation was its direct responsibility. In other cases, board seem fully aware of enormous compensation, but blithely dismissive of any concerns about it. 

So does this case could represent "embezzlement, " why were all the other cases of hired managers lavishly compensated not so regarded, even when their compensation was completely out of proportion to their known accomplishments, their organizations' financial performance, much less their organizations' fulfillment of their missions and positive impact on patients' and the public's health?  In many of those cases, the money paid out in executive compensation was also partially derived from taxpayers, and also was partially meant to "provide healthcare for the needy."

As I have said many times before,...  Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Old Mystery Solved? Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

At my Dec. 2005 post "Report: Life Science Manufacturers Adapt to Industry Transition" I wrote:

... The recognition of a gap in formally-trained medical informatics-trained personnel in the pharmaceutical industry [by Gartner Group] is welcome. For example, from my own experience:

I recall an interview I had last year with the head of the Drug Surveillance & Adverse Events department at Merck Research Labs in a rehire situation [after a 2003 layoff]. I came highly recommended by an Executive Director in the department, to whom I had shown my prior work. This included well-accepted, novel human-computer interaction designs I'd developed for use by busy biomedical researchers for a large clinical study in the Middle East, as well as my work modeling invasive cardiology and leading the development and implementation of a comprehensive information system to detect new device and treatment modality risks in a regional center performing more than 6,000 procedures/year. In addition, I'd worked with the wife of the Executive Director in years prior, when she ran the E.R. of the hospital where I was director of occupational medicine.

Despite all this in my favor, the Executive Director's boss, himself a former FDA adverse events official [a former deputy director of CDER’s office of drug safety, who'd recently moved to the pharma industry he once regulated - ed.], dismissed me in five minutes as I was showing him the cardiology project, saying flatly "we don't need a medical informatics person here." I had driven 80 miles to Rahway for this interview to save the executive a trip to Pennsylvania, where I was originally scheduled to come for the interview, since the executive's father was ill in the hospital. In an instance of profound social ineptness, my effort was not even acknowledged. Perhaps he was in a bad frame of mind, but the dismissal under the circumstances was all the more disappointing.

I recall this was one of the most puzzling hiring debacles I'd ever experienced, as all the senior people in his dept. had recommended he hire me - I was really only there for his approval and signoff - and the work I'd shown him had improved care, saved lives, and saved money.

I may not need to be puzzled any longer.  This story just appeared:

Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety
By Martha Rosenberg, Truthout
July 29, 2012

The Food and Drug Administration (FDA) is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports this week of an institutionalized FDA spying program on its own scientists, lawmakers, reporters and academics that included an enemies list of "actors" and collaborators

... Ronald Kavanagh [FDA drug reviewer from 1998 to 2008]:  ... In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee. There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drug ... While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs.

Read the entire story at the link.  I won't cover it more here, except to say it's certainly possible to believe certain FDA officials don't want serious people around -- who in addition to being MD's can write serious software to detect drug and device problems -- whose work can get in the way of drug approvals.

-- SS

A Bonus for Bankruptcy? - KV Pharmaceutical Reveals CEO's Bonus, then Declares Bankruptcy

The latest example of the disconnect between compensation for leaders of health care organizations and their and their organizations' performance comes from a report in the St Louis Business Journal. 

Executive Compensation and KV Pharmaceutical

Its essence was:
KV Pharmaceutical Co. President and CEO Gregory Divis Jr. earned $976,270 in the fiscal year ended March 31, more than double the $385,102 he was paid in fiscal 2011, according to a proxy statement the company filed Thursday with the Securities and Exchange Commission.

His 2012 earnings were comprised of a $638,750 salary, a $130,000 bonus, $204,189 in option awards and $3,331 in other compensation, which includes a $2,909 car allowance, a 401(k) match and group term life insurance.

The total pay for other top executives was as follows:

Treasurer and Chief Financial Officer Thomas McHugh earned $506,615 in fiscal 2012, including a $65,000 bonus. Hit total comp in fiscal 2011 was $320,950.
Vice President, General Counsel and Secretary Patrick Christmas earned $530,604 in fiscal 2012. He joined the company in June 2011.

Admittedly, compensation of just under $1 million a year does not seem that high for the CEO of a pharmaceutical company in this day and age. Furthermore, as noted in Forbes, Mr Divis' compensation is less than that of his predecessor:
who was interim ceo and president, received $1.25 million before Divis succeeded him, and so the ceo is now being compensated at a lower amount.

The Troubled History of the Company

However, first consider that the company was not exactly in the best financial health at the time Mr Divis was getting his pay, as per the St Louis Business Journal:
KV Pharmaceutical Co. officials said July 20 that the company has been notified by the New York Stock Exchange that it is below listing standard criteria due to the company’s average market capitalization being less than $50 million over a 30-day trading period and its stockholder’s equity being less than $50 million.

After years of missteps, mismanagement and mounting losses, KV Pharmaceutical’s ability to survive is in question. The company itself raised doubts as to its ability to continue as a going concern in its quarterly filing Feb. 9 with the Securities and Exchange Commission. [Note that this filing occurred during the same fiscal year in which the CEO received the compensation noted above - Ed.]

In fact, as we discussed here in 2010, a former KV Pharmaceutical CEO and Chairman is one of the very few for-profit health care corporate leaders who actually received personal punishment due to a US government prosecution. Former CEO and Chairman Marc Harmelin was banned from doing business with the US government for 20 years after a fraud prosecution that lead to "a KV subsidiary's conviction on criminal charges earlier this year for shipping oversize morphine tablets" per the St Louis Post-Dispatch.

The Failed Strategy to Get a License for a Previously Generic Drug, and Increase its Price by Ten Thousand Percent (10,000%)

Then consider the direction company leadership took after that setback.  As described in an August, 2012, St Louis Post-Dispatch article, the company's main strategy was based on a license to sell Makena, an injectable form of hydroxyprogesterone. Hydroxyprogesterone had first been approved in the 1950s. In 2003, a National Institute of Health funded study showed that injecting it reduced the risk of premature birth [Meis PJ, Klebanoff M, Thom E et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003; 348: 2379. Link here.]. Somehow, with funding from KV Pharmaceutical, "the FDA granted the approval to Hologic, which presented the application and argued for the drug based on medical research sponsored by the National Institutes of Health." After that, while "KV neither invented nor patented Makena, but agreed to pay Hologic nearly $200 million for 'orphan drug' status – and seven years of market exclusivity – for the rights to sell the branded drug." I cannot figure out why either company should have been granted an exclusive right to sell this drug under these circumstances. Nonetheless, once KV Pharmaceutical obtained the rights,
Makena sparked a national controversy over its sky-high price – a 100-fold increase over the average cost – about $15for an already widely available non-branded version of the drug produced by compounding pharmacies.

Leading national medical organizations and advocacy groups, including the March of Dimes and two U.S. senators, publicly blasted the pricing.

On March 30, 2011, the FDA announced that it would not enforce KV’s market exclusivity because of concerns that the drug would be unaffordable to many women. Hours later, the federal Centers for Medicare and Medicaid Services indicated that states could purchase the compounded version, called 17P, from specialty pharmacies.

The resistance prompted KV executives to dramatically lower Makena’s cost, but the move failed to forestall the backlash. As a result, KV’s ambitious sales projections for its latest drug failed to materialize.


That sealed the company's fate, and the same article reported,
KV Pharmaceutical Co., once among the St. Louis region’s strongest public companies, now faces yet another survival struggle after filing for bankruptcy.

Summary: A Bonus for Bankruptcy

So a company that suffered a criminal conviction for selling morphine tables whose dose was twice what was on their label, whose former CEO was banned from the pharmaceutical industry, which based its survival on a scheme to game the regulations to allow it to sell a previous $15 drug for $1500, then paid its CEO nearly $1 million, including over $330,000 in cash bonus and stock options just before it filed for bankruptcy.  Note that the CEO "earned" that compensation over a time period during which the company revealed doubts that it could survive as a "going concern."

This is a simple, relatively small, but especially graphic example of how leaders of health care organizations are not simply overpaid, but seem to personally profit from their organizations' mismanagement, poor financial results, and last but not least, exploitation of patients. Describing these incentives as perverse seems euphemistic.

Economists seem to like to justify outsized executive compensation by citing shareholder value they create, realistically defined as short-term stock price (look here).  One could argue that companies that sell health care products or provide health care directly should measure performance in terms of effects on patients' and the public's health.  Putting this aside, however, in this case, the executives seemed to be receiving bonuses not based on shareholder value, or stock price, but for continuing a course that resulted in the complete destruction of shareholder value.  (Stock shares lose essentially all their value when a company goes bankrupt.) 

In this case, and in others we have discussed, executive compensation seems to be based on the ability of executives to control their own pay, which seems more like what economists like to call "rent-seeking," as defined by Wikipedia, gaining from "manipulating the social or political environment in which economic activities occur, rather than by creating new wealth." 

Clearly, as long as health care leaders can personally profit however bad their performance is, or even due to their poor performance, we can expect nothing other than worsening performance.  Health care will become continually more dysfunctional until true reform makes health care leaders accountable for their actions, and all their effects, on stockholders, but also on patients' and the public's health.

My Presentation to the Health Informatics Society Of Australia: "Critical Thinking on Building Trusted, Transformative Medical Information: Improving Health IT as the First Step"

In early 2011 I was invited to present at the annual convention of the Health Informatics Society of Australia (HISA) by its CEO, Louise Schaper, PhD.  HISA was aware of my writings and thought a presentation at their conference would be of interest to the Australian informatics and healthcare governance community.

Dr. Schaper wrote:

From: Louise Schaper
Sent: Thursday, March 24, 2011 10:50 AM
To: Scot Silverstein
Subject: HIC invitation to deliver a keynote presentation

Hi Scot,

I trust this email finds you well and I hope spring is bringing you some warmer weather and cheer.

I wanted to let you know that the Health Informatics Conference committee met recently and expressed a high level of interest in having you deliver a keynote address at HIC and also to form part of a panel presentation. 

I know you may not be able to make a commitment to come to Australia in August, but I wanted to let you know what we would love to have you, if circumstances permit you being here.  I’m confident we could have your trip sponsored (providing you don’t mind spending some face-time with the sponsoring organisation) and generate some media coverage around your visit.

The preliminary program will be advertised in the next few weeks and at the moment I’m leaving a ‘spot’ for you in the hope that you may be able to join us.  I know you are in difficult and upsetting circumstances so please know that I’m not intending to add to any pressure – I just wanted to let you know that we would be honoured if you are able to deliver an address at HIC this year and I will keep a speaking spot reserved for you if you think you may be able to accept our invitation.

Thanks for your time Scot.  I look forward to hearing from you.

Kindest regards,


Sadly, the "difficult and upsetting circumstances" she mentioned were my involvement in caring for my mother, seriously injured in May 2010 in a healthcare information technology-related medical misadventure and, by this time, dying.

I was thus unable to attend.

My mother passed away June 6, 2011 of her injuries.

In January 2012, Dr. Schaper was gracious enough to re-invite me to the annual 2012 conference in Sydney.  I accepted.

I attended HIC 2012, held in the Darling Harbour Convention Centre in Sydney 30 July - 2 August 2012.

I enjoyed taking pictures like this with my trusty (and portable) Canon SX110 IS.  Click to enlarge.  More photos here.

My powerpoint slides for the presentation entitled "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step" are at this link.

Darling Harbour Convention Centre, Sydney, Australia. Click to enlarge.

Australia has embarked on a national Personally Controlled Electronic Health Record (PCEHR) project under the auspices of Nehta, the National E-Health Transition Authority.  I find this an interesting approach to national health IT; unlike the U.S., whose project is top-down (centrally controlled records), Australia seems to have learned from our mistakes and is initiating health IT as a bottom-up (patient-controlled) initiative.

At the conference last week, I delivered a keynote address on the theme of improving health IT as an essential step in leveraging the capabilities of the technology.

Being that I am anti-"bad IT" and pro-"good IT", implicit in my address was the issue of the technology's untrustworthiness in 2012, largely due to the unregulated free-for-all its market represents and the poor engineering that is the result.

I also participated in a Panel Discussion led by Australian investigative journalist and popular political TV program host Tony Jones.  Mr. Jones hosts the Australian Broadcasting Corporation's "Q&A - Adventures in Democracy."

Panel discussion moderated by Australian political commentator Tony Jones, who hosts the show "Q&A" on the Australian Broadcasting Corporation.  Click to enlarge.

I will highlight several key points I made in my keynote and on the panel:

  • Critical thinking is essential at all times in healthcare ... or your patient's dead.
  • Critical thinking is not mindless criticism; on the contrary, it is reflective, inquisitive, logical thinking that is focused on deciding what to believe or do.
  • Health IT must be trusted by users and patients [and be free of major downsides] - as a primary step before HIT can optimally benefit healthcare 
  • I pointed out I am not suggesting anything new and that, in fact, I am suggesting something old:  "First, do no harm."
  • I pointed out the "revolutions" usually have downsides, and IT always produces winners...and losers (per the empirical research of Social Informatics). 

Me presenting my keynote, driving home the point that IT on its own won't "revolutionize" healthcare; it is a tool to facilitate the true enablers of healthcare - clinicians - a point that should never be forgotten.  Click to enlarge. From the excellent multimedia piece on the conference at this link.

I then posed a series of questions of great relevance to understanding health IT realities.  Click to enlarge:


I left it to the audience to answer these questions.

I then posed the question "Is health IT being done well?"

I provided links to various evidence that it was not, such as the National Research Council 2009 report on health IT; AMIA's report on its workshop on healthcare IT failure, the 2012 U.S. IOM report on safety, the 2012 U.S. NIST report on usability, work by Australian Professor Jon Patrick of U. Sydney on health IT defects, and other sources as aggregated at this link.

Again, I did not impose views on the audience.  I didn't need to, as that corpus speaks for itself.

I also clarified terminology that reduces essential caution, such as the terms "electronic medical record" (EMR) and "electronic health record" (EHR) - a source of endless, wasted contention on definitions of which is which - being anachronisms from an earlier age of IT.  I pointed out that in 2012 what these innocuous terms somewhat deceptively and disarmingly represent are in reality complex enterprise clinical resource management and clinician workflow control systems – where many, many things can go wrong.

"EHR":  an innocuous "file cabinet" for records, or something else entirely?  Click to enlarge.

I asked if case reports of health IT unintended consequences (UC’s) were “anecdotal” and to be played down, while studies of health IT benefits to date solid science.  I then asked if the reality might be that studies of health IT benefits to date were mostly anecdotal (e.g., in specialized settings; weak observational studies vs. randomized clinical trials) while reports of UC’s are risk management-relevant incident report “red flags” pointing to possible systemic problems.

I pointed out the common seller marketing memes of beneficence and deterministic efficacy, and asked if these were realistic.  I also pointed out the need for transparency about HIT risks, and the impediments to this transparency.

Finally, I indicated what was the likely problem affecting all countries involved in EHR projects: that the rigor, ethics and skepticism of medical science itself not applied in the domain of health IT.

I suggested a simple solution:  a paradigm shift in thinking about health IT as another medical device, that needed to be subject to the same methodologies and ethical considerations applicable for decades (or more) in the healthcare delivery sector such as medical devices, pharmaceuticals, and research (and other risk-prone industries e.g., aviation and automotive).

My goal was to provoke thinking about these issues, to circumvent blank, uncritical acceptance of industry and industry-supporter memes.

I believe I succeeded.  Feedback I received was that the audience, including government officials, found many new things to consider as they embark on their national health IT projects.

I also heard that some HIT seller representatives were squirming a bit.  That was not unexpected.  I was taking "control of their message" away from them.

University of Sydney Professor Jon Patrick presenting on computational linguistics.   Jon is the author of a treatise on health IT defects (at this link), mentioned numerous times on this blog.  Click to enlarge.

Finally, I had a question from the audience, from fellow blogger Matthew Holt of the Health Care Blog.  Matthew asked me a somewhat hostile question that I was well prepared for, expecting a question along these lines from the seller community, actually.  The question was preceded by a bit of a soliloquy of the "You're trying to stop innovation through regulation" type, with a tad of Merck/VIOXX ad hominem thrown in (I ran Merck Research Labs' Biomedical libraries and IT group in 2000-2003).

His question was along the lines of - you were at Merck; VIOXX was bad; health IT allowed discovery of the VIOXX problem by Kaiser several years before anyone else; you're trying to halt IT innovation via demanding regulation of the technology thus harming such capabilities and other innovations.

The audience was visibly unsettled.  Someone even hollered out their disapproval of the question.

My response was along the lines that:

  • VIOXX was certainly not Merck at its best, but regulation didn't stop Merck from "revolutionizing" asthma and osteoporosis via Singulair and Fosamax;
  • That I'm certainly not against innovation; I'm highly pro-innovation;
  • That our definitions of "innovation" in medicine might differ, in that innovation without adherence to medical ethics is not really innovation. 

(I forgot to mention that I gave an invited presentation to Merck's Drug Surveillance department in 2006, PPT here, long after I was their employee, on the potential use of EHR data to detect drug adverse events sooner than traditional phase IV studies or ad-hoc reporting allowed.)

When I spoke of medical innovation requiring ethics, nearly the full audience at my keynote address - hundreds of people - broke out in applause.

I knew at that point that my talk was a success.

This author with HISA CEO Louise Schaper , PhD. Click to enlarge.

More photos of my trip are here.

-- SS

Addendum:  Another added pleasure in my visit Down Under. As Australia and the U.S. respect each other's amateur radio licenses, I was able to operate my handheld radio as "KU3E portable Victor-Kilo." VK is the international radio prefix for Oz.  Contacting Australia from the U.S. is considered a "holy grail" of ham radio.  It was interesting to hear amateur radio "from the other end."

Yaesu VX-3 Multiband Transceiver

-- SS

Aug. 11, 2012 Addendum:

An excellent multimedia video of HIC 2012 produced as the conference proceeded has been posted on YouTube at http://www.youtube.com/watch?v=DZg_46wY0E0.  It was finished and shown immediately after the conference's conclusion.

-- SS

Defense Attorney Lies Under Oath In Sworn Filing to Protect Hospital's Health IT

At my Aug. 7. 2012 post "Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?" I wrote:

 ... I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons.   The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago:

(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act

... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software [see addendum below - ed.], such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.

Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id.

The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts any state law that conflicts with the exercise of federal power. Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).

In this case, to impose common law liability upon [name redacted] Hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR 

I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but here it is again in a new set of objections.  I find its reappearance remarkable.  I also wonder if the industry is behind it.

What I didn't post is the reply to this nonsense that was presented to the court by Plaintiff (me), via Plaintiff's counsel after my analysis of this passage, in a Memorandum of Law to the court Dec. 5, 2011:

... HHS does not regulate the design, manufacture, specification, certification, and sale of EMRs or any other clinical information technology. The HITECH Act itself does not establish standards and certification criteria for health information technology, but instead establishes the HIT Standards Committee to implement such specifications and standards for certification. HITECH Act § 3003, 42 U.S.C. § 300jj-13.

The initial set of standards specifications and certification criteria were not published until July 28, 2010, approximately 2 months after Mrs. Silverstein entered [name redacted] Hospital. Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 75 Fed. Reg. 44589 (July 28, 2010). Therefore, it would have been impossible for [name redacted] Hospital’s EMR system “to be in compliance with federal law and regulations for Health Information Technology” during the time of Mrs. Silverstein’s admission.

These facts were filed with the Court and delivered to the defense on Dec. 5, 2011 regarding health IT certification.  An Affidavit/Certificate of Service to the defendants was also filed with the Response and Memorandum of Law as is customary, and are noted on the Prothontary website.  No "I didn't receive it" excuse is possible...

The facts about health IT "certification" are trivial to verify. 

As the hospital admission where my mother was injured, and the injury itself, were in May 2010, "using certified EHR technology in compliance with federal law and regulations for Health Information Technology" was not possible at that time.  (Not to mention the facilities' EHR's were not actually "certified" until December 2010 via the ONC database of certified systems.)

Thus, the defense attorney by re-issuing this claim in August 2012 (to the new judge overseeing the case re-filing) is now knowingly lying to the Court in sworn filings, in order to harass, cause unnecessary delays in litigation, and needlessly increase the cost of litigation while collecting hourly fees for production of frivolous and untrue assertions.

The attorney is also making a mockery of the court system in the locality where the case is being heard, and also insulting the judges' intelligence.

These are the lengths to which hospitals and defense attorneys seem to be willing to go in defense of health IT.  I find this remarkable (but not surprising).

It will be interesting to see how the judge responds to an attorney knowingly trying to blow smoke up his behind.

-- SS

Addendum:  Also pointed out in earlier filings was the fact that use of EMR's is not "required."   It seems the defense attorney, besides being a liar, has a thick skull.

-- SS

Needed: A Webcast on Disruptive and Criminal Hospital Executives

I received this, unsolicited, via email:

Webcast:  Managing Disruptive Docs in a New Era of Hospital-Physician Relations

If you haven't already purchased this live Webcast, don't miss out! Left unchecked, disruptive physicians do more than just create a negative work environment; they endanger patient care and can lead to million-dollar lawsuits and bad publicity.  Our top experts will show you early intervention techniques and a range of effective resources that can help you reduce behavioral problems, retain star physicians, create a healthier workplace and save millions in potential lawsuits.

The agenda includes:

    Defining and identifying causes of disruptive behavior
    Economic consequences of disruptive behavior
    Overcoming disruptive physician problems

This program will be guided by your questions, so register now and ask away!
Your instructors:

Alan Rosenstein, MD, MBA
Medical Director of Physician Wellness Services

David Danielson, JD, CPA
Senior Vice President, Clinical Risk Management, Sanford Health

Scott Hurst
Former Director of Physician Alignment and Recruitment, CHRISTUS Spohn Health System

Managing Disruptive Docs in a New Era of Hospital-Physician Relations is designed to help CEOs, COOs, CMOs, group practice administrators, HR leaders, and physicians learn strategies and tactics to prevent, reduce, and limit the severity of disruptive physician incidents.

"Disruptive physician" is a vague term subject to enormous abuse, leading to sham peer review among other totalitarian tactics.   It reminds me of the old Soviet Union's politics.

You have been deemed a Disruptive Physician, Comrade.  You will be given a fair trial, then shot

In particular, this label can be used to suppress clinician concerns about care quality in an era of cost cutting and care manipulation through electronic workflow control systems (e.g., EHR's CPOE, CDS etc.)

The potential of being labelled as "disruptive" may be one reason why physician outcry against the very low quality of healthcare IT systems and dangers posed by them is relatively uncommon.

Patients - you - ultimately suffer when your physicians fear being your outspoken advocates.

As the many stories of healthcare executive malfeasance and profiteering at the expense of patients on this blog indicate, what is really needed for true healthcare reform are webcasts on:


-- SS

Addendum:  here are additional resources on the “Disruptive Physician”:

Abuse of the “Disruptive Physician” Clause, http://www.jpands.org/vol9no3/huntoon.pdf

The Insulting Physician “Code of Conduct”
, http://www.jpands.org/vol13no1/huntoon.pdf

In the latter article, Lawrence Huntoon MD PhD, and expert on abuses of this label, notes:

... The typical physician code of conduct is initiated by a hospital administration. Its wording is curiously similar from one hospital to the next, suggesting that a template is being circulated.

... The physician code of conduct is intentionally insulting, demeaning, and degrading to physicians, and reduces physicians to being treated like juvenile delinquents at a reform school. It assumes that all physicians, like juvenile delinquents, need to be subjected to a long list of prohibited behaviors because, in the hospital administration’s view, physicians are predisposed to such things as theft, destruction of property, and physical and sexual assault. Conspicuous by its absence is any mention of “disruptive” or “abusive” hospital administrators, or any similar code of conduct applicable to a hospital administration.

Dr. Huntoon then goes on to make a recommendation, a "hospital administration’s code of conduct":

... The term “disruptive hospital administrator” and/or “abusive hospital administrator” should be incorporated into the hospital administration’s code of conduct and should be defined as anyone in the hospital administration who, in the view of the medical staff (as determined by majority vote), interferes with the ability of physicians to provide safe and high-quality care to patients in the hospital.

His detailed criteria for “disruptive hospital administrator” in the latter article are worth reading in their entirety.

-- SS

ONC and Misdirection Regarding Mass Healthcare IT Failure

In my keynote address to the Health Informatics Society of Australia in Sydney recently, I cautioned attendees including those in government to be wary of healthcare IT hyper-enthusiast misdirection and logical fallacy (a.k.a. public relations).

In the LA Times story "Patient data outage exposes risks of electronic medical records" on the Cerner EHR outage I wrote of in my post "Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised" (the title, of course, being satirical), Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology is quoted.  He said:

"These types of outages are quite rare and there's no way to completely eliminate human error."

This is precisely the type of political spin and hyper-enthusiast misdirection I cautioned the Australian health authorities to evaluate critically.

As comedian Scott Adams humorously noted regarding irrelevancy, a hundred dollars is a good price for a toaster, compared to buying a Ferrari.

Further, when you're the patient harmed or killed, or the victim is a family member, you really don't care how "rare" the outages are.

Airline crashes are "rare", too.   So, shall they just be tolerated as a "cost of doing business" and spun away?

(As I once wrote, the asteroid colliding with Earth that caused the extinction of the dinosaurs was a truly "rare" event.)

It seems absurd for me to have to point out that paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, do not go blank en masse across multiple states and countries for any length of time, raising risk across multiple hospitals greatly, acutely and simultaneously.   Yet, I have to point out this obvious fact in the face of misdirection.

Locally hosted health IT, of course, can only cause "local" chart disappearances.  "Local" is a relative term, however, depending on HC organization size, as in the example of a Dec. 2011 regional University of Pittsburgh Medical Center (UPMC) 14-hour outage affecting thousands here.

Further, EHR's and other clinical IT, whether hosted locally or afar, had better offer truly major advantages, without major risks and disadvantages, over older medical records technologies before exposing large numbers of patients to an invasive IT industry and the largest unconsented human subjects experiment in history.

Unfortunately, those basic criteria are not yet apparent with today's systems (see for instance this reading list).

EHR's and other clinical IT, forming in reality an enterprise clinical resource management and clinician workflow control apparatus, have introduced new risk modes including mass chart theft (sometimes tens of thousands in the blink of an eye); also, mass chart disappearances as in this case - all not possible with paper.

At the very least, if hospitals want enterprise clinical resource management and clinician workflow control systems, these should not be relegated to a distant third party.  Patients are not guinea pigs upon whom to test the ASP software model ("software as a service") that, upon failure for any reason, threatens their lives.

Finally, these complications are a further example why this industry cannot go on without meaningful oversight.  The unprecedented special medical device regulatory accommodations must end.

-- SS

Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"

At my recent post "Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised" over a massive, outrageous Cerner outage to hospitals contracting their clinical IT via an ASP model (that is, 'software as a service'), I observed:

... The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages.

From the JC's page "About the Joint Commission":

An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

It's time to up the ante regarding this accreditation body, fully aware of health IT risks (e.g., the Dec 2008 Sentinel Events Alert on Health IT) but to date having done little about them.  Through my legal work and my speaking to Plaintiff's attorneys, I am becoming increasingly aware of medical malpractice cases that  involve an EHR or related clinical IT systems at JC-accredited organizations.

In effect, the JC has accredited hospitals whose entire clinical command-and-control structure (the term EHR is an anachronism; these systems are in reality enterprise clinical resource management and clinician workflow control devices) can disappear in the blink of an eye, without warning, raising risk to patients greatly.

If I discover that a patient was harmed or killed as a result of, or related to, this massive recent outage of outsourced medical records/workflow control  infrastructure, I will be recommending that the Joint Commission, including its leadership, which likely certified the hospital(s) involved for safe operations in areas such as Information Management, be named as defendants.

I have informed the JC leadership by email.
-- SS

Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised

Having been 'Down Under' in Sydney addressing the Health Informatics Society of Australia on the need to slow down their national health IT program - and on the need to think critically about HIT seller public relations exaggerations and hubris - and being very busy, I missed this quite stunning story of a major health IT outage.

Just a typical "glitch":

Some lessons from a major outage
Posted on July 31, 2012
By Tony Collins

Last week Cerner had a major outage across the US. Its international customers might also have been affected.

InformationWeek Healthcare reported that Cerner’s remote hosting service went down for about six hours on Monday, 23 July. It hit “hospital and physician practice clients all over the country”. Information Week said the unusual outage “reportedly took down the vendor’s entire network” and raised “new questions about the reliability of cloud-based hosting services”.

A Cerner spokesperson Kelli Christman told Information Week,

“Cerner’s remote-hosted clients experienced unscheduled downtime this week. Our clients all have downtime procedures in place to ensure patient safety.  [Meaning, for the most part, blank paper - ed.] The issue has been resolved and clients are back up and running. A human error caused the outage.  [I don't think they mean human error as in poor disaster recovery and business continuity engineering - ed.]  As a result, we are reviewing our training protocol and documented work instructions for any improvements that can be made.”

Christman did not respond to a question about how many Cerner clients were affected. HIStalk, a popular health IT blog, reported that hospital staff resorted to paper [if that was true, that paper was OK in an unplanned workflow disruption of major proportions, then why do we need to spend billions on health IT, one might ask? - ed.] but it is unclear whether they would have had access to the most recent information on patients.

One Tweet by @UhVeeNesh said “Thank you Cerner for being down all day. Just how I like to start my week…with the computer system crashing for all of NorCal [Northern California].”

Tony Collins is a commentator for ComputerWorldUK.com.  He's quoted me, as I wrote in my May 2011 post Key lesson from the NPfIT - The Tony Collins Blog.

This incident brings to life longstanding concerns about hospitals outsourcing their crucial functions to IT companies.  

Quite simply, I think it's insane, at least in the foreseeable future, as this example shows.

It also brings to mind the concerns that health IT, as an unregulated technology, causes dangers in hospitals with inadequate internal disaster and business continuity functions aside from fresh sheets of paper.  Such capabilities would likely be mandatory if health IT were meaningfully regulated.

The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages.

There's this in the article:

... “Issue appears to have something to do with DNS entries being deleted across RHO network and possible Active Directory corruption. Outage was across all North America clients as well as some international clients.”

Of course, patient safety was not compromised.


Imagine being a patient, perhaps with a complex history, in extremis at the time of this outage.  

I, for one, do not want my own medical care nor that of my relatives and friends subject to cybernetic recordkeeping unreliability and incompetence like this, and the risk it creates.

-- SS

Aug. 8, 2012 addendum:

The Los Angeles Times covered this outage in a story aptly entitled "Patient data outage exposes risks of electronic medical records."

They write:

Dozens of hospitals across the country lost access to crucial electronic medical records for about five hours during a major computer outage last week, raising fresh concerns about whether poorly designed technology can compromise patient care.

My only comment is that the answer to this question is rather axiomatic.

They also quote Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology, who said:

"These types of outages are quite rare and there's no way to completely eliminate human error"

This is precisely the type of political spin and misdirection I cautioned the Australian health authorities to evaluate critically.

Paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, do not go blank en masse across multiple states and countries for any length of time, raising risk across multiple hospitals greatly, acutely and simultaneously.  (Locally hosted IT outages only cause "local" mayhem; see my further thoughts on this issue here).

-- SS

Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?

I am jet-lagged after returning from Sydney, Australia, where I delivered one of the keynote addresses at the Health Informatics Society of Australia annual conference, HIC 2012 (http://www.hisa.org.au/page/hic2012/).

My theme in a talk entitled "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step" was health IT trust and safety.  I was actually invited in 2011 but could not attend; I was helping care for my mother, who was severely injured due to a HIT-related mishap in 2010.  Her death in 2011 allowed me to attend now on re-invitation.

More on my presentation later.

A beautiful view of the Sydney Harbour Bridge and Opera House, taken with a mere Canon SX110IS.  Click to enlarge.

In the meantime, I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons.   The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago:

(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act

... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.

Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id.

The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts any state law that conflicts with the exercise of federal power. Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).

In this case, to impose common law liability upon [name redacted] Hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR 

I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but here it is again in a new set of objections.  I find its reappearance remarkable.  I also wonder if the industry is behind it.

As per numerous posts in this blog, such assertions are false - and likely knowingly so in this situation.  (In that case, this would be an even more serious matter.)

For example as I pointed out at my Feb. 2012 post Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified", ONC-Authorized Testing and Certification Bodies (ATCB's) answered my questions about safety, legal indemnification etc.  Their work has nothing to do with certifying HIT as safe by their own admission.

Also, as in my April 2011 post FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs and my Nov. 2011 post IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care, the HIT industry is unregulated.

On the HIT regulation issue, IOM has itself stated in no uncertain terms that HIT is non-regulated (not "a highly regulated industry") in their report to HHS.  For instance, in the aforementioned 2012 report they state (as one example):

... If the Secretary [of HHS] deems it necessary for the FDA to regulate EHRs and other currently nonregulated health IT products, clear determinations will need to be made about whether all health IT products classify as medical devices for the purposes of regulation. If FDA regulation is deemed necessary, the FDA will need to commit sufficient resources and add capacity and expertise to be effective.

I won't even address the claim that the HITECH Act represents or intended to represent Federal pre-emption of state common law rights.   It's without merit, and actually absurd.

Worst of all, statements in legal dockets that "HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH Act" (in reality, private non-governmental ONC-Authorized Testing and Certification Bodies or ATCB's are appointed by ONC to "certify" HIT features and functionality to be compliant with "Meaningful Use" guidelines and do not test for safety or efficacy) potentially puts those private ATCB's at risk for being named defendants in lawsuits where HIT was found unsafe and/or ineffective if upheld.

I am sure the ATCB's and ONC would not be happy about that.

-- SS

Private Equity, Obfuscatory Advertising, and Making Health Care a Commodity: Lessons from Cerberus Capital Management

The use of advertising by Steward Health Care, currently a regional hospital system here in New England, continues to provide lessons about how public relations and marketing may be used to shape the health care policy debate.  Stand by because the story is convoluted.

Steward Promotes "New Health Care," Whatever That May Be

This week, Commonwealth reported on Steward's latest high profile advertising campaign in the Boston area,
Steward Health Care is using the Olympics to hone its image. The Boston-based chain of 10 community hospitals, many of which were on the verge of going under when Steward acquired them, is running a series of ads on WHDH-TV (Channel 7) during Olympics coverage that cast the company as a delivery system for a new type of world-class health care.

While visible, the advertisements are notably vague. One features
a Steward employee who says she believes 'world class health care is here.' Another of the initial ads features individual doctors and technicians pledging to be stewards of 'the new health care,' which is the tagline for all of the Steward ads.

What the 'new health care' means is never fully explained in the ads

One local health care expert
Paul Levy, the former CEO of Beth Israel Deaconness Medical Center, said he thinks the ads are part of a campaign by [Steward Health Care owner] Cerberus [Capital Management] to make Steward more attractive to would-be buyers. 'This has very little to do with anything other than establishing the image and the brand of the Steward hospitals so when the day comes when Cerberus sells the company it will be better received in the public markets,' Levy said.

The article had noted that
Cerberus Capital Management, a New York private equity firm, owns Steward,...

So it is possible that no one at Steward really has any idea what sort of "new health care" the organization is promoting

Steward's CEO Promotes Health Care as a Commodity

However, there is reason to think that the top leadership of Steward, and probably of Cerberus Capital Management, the private equity group that owns it, actually does have a clear idea what new health care they are promoting.

Almost simultaneous with the Commonwealth article and the Olympic advertising campaign an interview appeared with Steward's CEO in Fortune. CEO Dr Ralph de la Torre first pitched medicine as science,
A lot of us physicians went into medicine because we loved the art aspect of it. There wasn't a lot of real hard-core science when many of today's doctors went into medicine. It was your intuition, your abilities, the gestalt of what was going on. But something happened in medicine along the way. It started becoming a real science, and a lot of studies have come out that guide what we do and how we do it. We as a society need to understand that science has to guide our practice of medicine. Not everyone with a headache needs a CAT scan; not everybody with a sprained ankle needs an MRI.

This sounds like it could be an affirmation of evidence-based medicine, the approach that attempts to base medicine on systematic search for and critical review of the best clinical research, among other things. However, De la Torre takes it a big step further, citing:
In deference to those who love the individual hospital, you have to look back at America and the trends in industries that have gone from being art to science, to being commodities. Health care is becoming a commodity. The car industry started off as an art, people hand-shaping the bodies, hand-building the engines. As it became a commodity and was all about making cars accessible to everybody, it became more about standardization. It's not different from the banking industry and other industries as they've matured. Health care is finally maturing as an industry, and part of that maturation process is consolidation. It's getting economies of scale and in many ways making it a commodity.

Apparently Dr De la Torre does not see a distinction any longer between health care, or to use an old-fashioned word, medicine, traditionally considered an art or practice of caring for individual patients, and making automobiles on an assembly line. Dr De la Torre may be deeply misinterpreting evidence-based medicine, which is about evidence from clinical research, but also much more. Consider how the Cochrane Collaboration discusses it:
Evidence-based health care

Evidence-based health care is the conscientious use of current best evidence in making decisions about the care of individual patients or the delivery of health services. Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of health care, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors [1].

Evidence-based clinical practice is an approach to decision-making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits that patient best [2].

Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research [3].

[1] Cochrane AL. Effectiveness and Efficiency : Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972. Reprinted in 1989 in association with the BMJ. Reprinted in 1999 for Nuffield Trust by the Royal Society of Medicine Press, London, ISBN 1-85315-394-X.[2] Gray JAM. 1997. Evidence-based healthcare: how to make health policy and management decisions. London: Churchill Livingstone.
[3] Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. 1996. Evidence based medicine: what it is and what it isn't. BMJ 312: 71–2 [3] [Full text]

Note the emphasis on making decisions for individuals based on what is best for each, and the integration of evidence from clinical research with clinical expertise. This is far from commoditization.

Nonetheless, Dr De la Torre seems to envision "new health care" like a 1930s automobile assembly line, with the physicians and other health professionals cast as assembly line workers, and the patients cast as automobiles.

Our next example may provide some explanations for this point of view.

Steward's Advertising Raises Questions of Whose Hands Should be on Health Care

As we discussed earlier, Steward Health Care has been working on acquiring a struggling local Rhode Island hospital system, and in doing so is in a dispute with the statewide non-profit Blue Cross health insurance company. Steward had been putting daily full-page advertisements in the local paper. A recent version (27 July, 2012), had this text:

With 80% of the market under its control, Blue Cross & Blue Shield of Rhode Island thinks it can decide which hospitals survive or fail. The people of Rhode Island beg to differ.

For the past decade, they've watched Blue Cross starve Landmark Medical Center of its funding. And this year, when Blue Cross issued an ultimatum to terminate the hospital, Rhode Islanders heard enough.

In a poll conducted this week by John Marttila, a nationally recognized leader on public attitudes concerning health care, 76% of respondents said that Blue Cross shouldn't be allowed to use their monopoly to dictate the fate of Rhode Island hospitals. They also felt, by a 2-1 margin, that if Landmark did indeed close, Blue Cross would be to blame.

However, soon after, investigative reporting by the Providence Journal's Ms Felice Freyer revealed that maybe the poll should have been interpreted differently. Not unexpectedly, Ms Freyer revealed the poll to have been "commissioned by Steward." Its basic results were really:
Just over half the respondents knew that Landmark was being sold to Steward, and of those, 58 percent did not have an opinion, 29 percent supported the sale, and 13 percent opposed it. However, among those who knew about the sale and also live in northern Rhode Island, the approval rating was higher –– 37 percent support the sale, with 15 percent disapproving and 48 percent having no opinion.

The pollster than provided prompting, perhaps in an attempt to get results more favorable to its client:
One of the questions starts with this statement: 'Blue Cross Blue Shield provides health insurance to 80 percent of Rhode Island. By refusing to negotiate on reimbursement rates, Blue Cross can essentially determine if hospitals in the state stay open or if hospitals close.' Based on that statement, 76 percent of respondents agreed that 'Blue Cross should not be allowed to use its monopoly to dictate which hospitals stay open and which close their doors.'

Unfortunately, it appears that the prompting statement was perhaps not fully accurate:
In 2011, Blue Cross covered 66 percent of Rhode Islanders with private health insurance, not 80 percent, according to a report by the Office of the Health Insurance Commissioner.

Blue Cross denies that it has refused to negotiate.

'We have negotiated in good faith and have offered a fair contract to Landmark Hospital that is consistent with our reimbursement arrangements for other independent hospitals,' Blue Cross said in a statement. 'Unfortunately, Steward has been unwilling to enter into a contract under those conditions.'

While they touted probably methodologically biased survey results, Steward's local advertising campaign's headline might prompt some people to think about whose hands should really be on their health care. The advertising tries to limit this question to Blue Cross' influence. However, one might also ask whose hands control Steward Health Care?

Whose Hands are on Steward Health Care?

As the Commonwealth article above pointed out, Steward Health Care is a wholly owned subsidiary of Cerberus Capital Management, a New York based private equity firm.

Cerberus' top leadership includes
- CEO Steven A Feinberg, who, as we noted previously, was listed as number 21 on a list of the 25 most powerful businessmen in 2007 by Fortune, at that time running through Cerberus 50 companies with total revenues of $120 billion.  On Wikipedia, his net worth was estimated as $2 billion in 2008.
- Chairman John W Snow, who, as we noted previously, resigned as Treasury Secretary in the administration of President George W Bush "in 2006 only because it was revealed that he had not paid any taxes on $24 million in income from CSX, which had forgiven Snow's repayment of a gigantic loan that the company had made to him," according to Chareles Ferguson in Predator Nation.
- Chairman, Cereberus Global Investments J Danforth Quayle, the controversial former US Vice President during the George H W Bush administration.

Furthermore, Cerberus Capital Management, which wholly owns Steward Health Care, owns several other businesses.  As we noted here, these include, DynCorp (see their web-site), which has been called one of the "leading mercenary firms," by an article in the Nation.  As reported by Bloomberg, DynCorp, and hence indirectly about Cerberus, and Steward Health Care, in 2011 settled accusations that it overbilled the US government for construction work in Iraq.   Furthermore, as we noted here, Cerberus also owns the biggest manufacturer of firearms and ammunition in the US. As reported by BusinessWeek in 2010, Cerberus owns 13 brands of fire-arms and munitions under the umbrella Freedom Group.

So while Cerberus Capital Management would like us to believe that Rhode Island residents question the hands of Blue Cross Blue Shield of Rhode Island on a struggling local hospital system, it seems to be trying to avoid questions about whose hands would be on the hospital system were Cerberus Capital Management's subsidiary Steward Health Care to acquire it. 


So, to recapitulate this winding story....   A regional hospital system has been pushing its "new health care" idea.  However, its former surgeon CEO promotes new health care as commoditized health care, assembly line health care, in which doctors become assembly line workers and patients become widgets.  This seems bizarre until one realizes that the CEO actually works for a huge private equity firm whose goal is to make a lot of money in the short-term.  Standardized, commoditized health care is likely to be cheaper to provide than individualized health care.  Private equity firms thrive by cutting their subsidiaries' costs, and then selling them quickly, sometimes before the long-term consequences of these cuts become apparent.  (Look here.)

So there are two lessons.

To repeat the lesson from our earlier post, everybody, doctors, other health care professionals, health policy makers, patients, and the public ought to be extremely skeptical of the marketing and public relations efforts of big health care organizations.  Based on the examples above, they ought to be particularly skeptical of organizations that are overtly for profit, and/or have a clear focus on short-term revenue generation.  As a society we need to think about how to best counter these biased, incomplete, sometimes grossly deceptive efforts to manipulate public psychology and opinions through our rights to free speech and a free press.

To add a lesson, everybody, doctors, other health professionals, health policy makers, patients and the public ought to be extremely wary of the ongoing corporatization of medicine and health care.  Corporate leaders who often get large incentives for maximizing short term revenue are likely to be enthused about turning our health care into a commodity.  Doctors and health care professionals should not want to be assembly line workers, and patients surely should not want to be widgets.