UK: Another Example of IT Malpractice With Bad Health IT (BHIT) Affecting Thousands of Patients, But, As Always, Patient Care Was "Not Compromised"

At my Dec. 2011 post "IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised" and others, I noted:

... claims [in stories regarding health IT failure] that "no patients were harmed" ... are both misleading and irrelevant:

Such claims of 'massive EHR outage benevolence' are misleading, in that medical errors due to electronic outages might not appear for days or weeks after the outage ... Claims of 'massive EHR outage benevolence' are also irrelevant in that, even if there was no catastrophe directly coincident with the outage, their was greatly elevated risk. Sooner or later, such outages will maim and kill.

Here is a prime example of why I've opined at my Sept. 2012 post "Good Health IT (GHIT) v. Bad Health IT (BHIT): Paper is Better Than The Latter" that a good or even average paper-based medical record keeping system can facilitate safer and better provision of care than a system based on bad health IT (BHIT).

Try this with paper:

NHS 'cover-up' over lost cancer patient records

Thousands awaiting treatment were kept in the dark for five months when data disappeared

Sanchez Manning
The Independent
Sunday 30 September 2012

Britain's largest NHS trust took five months to tell patients it had mislaid medical records for thousands of people waiting for cancer tests and other urgent treatments. Imperial College Healthcare NHS Trust discovered in January that a serious computer problem and staff mistakes had played havoc with patient waiting lists.

It's quite likely the "serious computer problem" far outweighed the impact of "staff mistakes", as disappearing computer data does so in a "silent" manner.  One does not realize it's missing as there's not generally a trail of evidence that it's gone.

About 2,500 patients were forced to wait longer on the waiting lists than the NHS's targets, and the trust had no idea whether another 3,000 suspected cancer patients on the waiting list had been given potentially life-saving tests. Despite the fact that the trust discovered discrepancies in January and was forced to launch an internal review into the mess, including 74 cases where patients died, it did not tell GPs about the lost records until May.

That is, quite frankly, outrageous if true and (at least in the U.S.) might be considered criminally negligent (failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner).

Revelations about the delay prompted a furious response yesterday from GPs, local authorities and patients' groups. Dr Tony Grewal, one of the GPs who had made referrals to Imperial, said doctors should have been told sooner to allow them to trace patients whose records were missing. "The trust should have contacted us as soon as it was recognised that patients with potentially serious illnesses had been failed by a system," he said. "GPs hold the ultimate responsibility for their patient care."

That is axiomatic.

The chief executive of the Patients Association, Katherine Murphy, added: "This is unacceptable for any patient who has had any investigation, but especially patients awaiting cancer results, where every day counts. The trust has a duty to contact GPs who referred the patients. It's unfair on the patients to have this stress and worry, and the trust should not have tried to hide the fact that they had lost these records. They should have let the GPs know at the outset."

Unfair to the patients is an understatement,  However, if one's attitude is that computers have more rights than patients, as many on the health IT sector seem to with their ignoring of patient rights such as informed consent, lack of safety regulation, and lack of accountability, then it's quite acceptable.

The trust defended the delay in alerting GPs, arguing that it needed to check accurately how much data it had lost before making the matter public. It said a clinical review had now concluded that no one died as a result of patients waiting longer for tests or care.

That would be perhaps OK if the subjects whose "data had been lost" through IT malpractice were lab rats.

Despite this, three London councils – Westminster, Kensington and Chelsea, and Hammersmith and Fulham – are deeply critical of the way the trust handled the data loss. Sarah Richardson, a Westminster councillor who heads the council's health scrutiny committee, said that trust bosses had attempted to "cover up" the extent of the debacle. "Yes, they've done what they can but, in doing so, [they] put the reputation of the trust first," she said. "Rather than share it with the GPs, patients and us, they thought how can we manage this information internally. They chose to consider their reputation over patient care."

As at my Oct. 2011 post "Cybernetik Über Alles: Computers Have More Rights Than Patients?", to be more specific, they may have put the reputation of the Trust's computers first. 

Last week, it was revealed that Imperial has been fined £1m by NHS North West London for the failures that led to patient data going missing. On Wednesday, an external review into the lost records said a "serious management failure" was to blame for the blunder.

Management of what, one might ask?

Imperial's chief financial officer, Bill Shields, admitted at a meeting with the councils that the letter could have been produced more quickly. He said that, at the time, the trust had operated with "antiquated computer systems" and had a "light-touch regime" on elective waiting times.

Version 2.0A will, as again is a typical refrain, fix all the problems.

Terry Hanafin, the leading management consultant who wrote the report, said the data problems went back to 2008 and had built up over almost four years until mid-2011. Mr Hanafin said the priorities of senior managers at that time were the casualty department and finance.

Clinical computing is not business computing, I state for the thousandth time.  When medical data is discovered "lost", the only response should be ... find it, or inform patients and clinicians - immediately.

He further concluded that while the delays in care turned out to be non-life threatening, they had the potential to cause pain, distress and, in the case of cancer patients, "more serious consequences" ... The trust said it had found no evidence of clinical harm and stressed that new systems have now been implemented to record patient data. It denied trying to cover up its mistakes or put its reputation before concerns for patients. "Patient safety is always our top priority," said a spokesman.

"More serious consequences" is a euphemism for horrible metastatic cancer and death, I might add.  The leaders simply cannot claim they "found no evidence of clinical harm" regarding delays in cancer diagnosis and treatment until time has passed, and followup studies performed on this group of patients.

This refrain is evidence these folks are either lying, CYA-style, or have no understanding of clinical medicine whatsoever - in which case their responsibilities over the clinic need to be ended in my opinion.

I, for one, would like to know the exact nature of the "computer problem", who was responsible, and if it was a software bug, how such software was validated and how it got into production.

-- SS

Oct. 1, 2012 Addendum:

What was behind the problems, according to another source?   

Bad Health IT (BHIT):

Poor IT behind Imperial cancer problems
e-Health Insider
28 September 2012
Rebecca Todd

An independent review of data quality issues affecting cancer patient referrals to Imperial College Healthcare NHS Trust has identified “poor computer systems” as a key cause of the problem.

The review’s report highlights the trust’s use of up to 17 different IT systems as causing problems for patient tracking.

However, it says the trust should be aware of the risks of [replacing the BHIT and] moving to a single system, Cerner Millennium, because of reported problems in providing performance data after similar moves at other London trusts.

In January 2012, the report says the NHS Intensive Support Team was reviewing the way reports on cancer waiting times were created from Imperial’s cancer IT system, Excelicare.

The team discovered that almost 3,000 patients were still on open pathways who should have been seen within two weeks. In May, letters were sent to GPs to try and ascertain the clinical status of around 1,000 patients.

BHIT must be forbidden from real-world deployments, and fixed rapidly or dismantled (as Imperial College Healthcare NHS Trust appears to be doing), although the "solution" might be just as bad, or worse, than the disease.

-- SS

Hype, Spin and Health Care: the Case of an Apparently Failed Hospital Purchase by Steward Health Care

Health care is drowning in a sea of hype and spin.  We have frequently posted about deceptive marketing used to sell drugs, devices, and health care services.  We have also posted about deceptive public relations and lobbying used to sell policy positions and strategies favorable to health care organizations, and usually most favorable to their leaders.

Nevertheless, there rarely is much public skepticism about or criticism of such marketing and public relations messages when they appear.  Rather, often the media and other public voices, including those of politicians with power over the relevant public policy issues, seem to accept the messages at face value.

The Case of Steward Health Care and Landmark Medical Center

The Buy-Out Falls Apart

Therefore, it is instructive to look at examples of how such messages in retrospect appear to be fallacious, to use a polite term.  A local example that just popped into view was documented in two short news items by Felice Freyer in our own Providence Journal.  (Web access to a longer version story that appeared in the print version of the journal is here.)  The first item included,

The deal to sell Landmark Medical Center to Steward Health Care System may be falling apart. In a court filing this week, Jonathan N. Savage, the special master in charge of the hospital, made reference to the possibility that Steward would withdraw. The Boston hospital group faces a Sept. 30 deadline to complete the sale.

The Message Promoted by Steward Health Care 

We have blogged about the rapid expansion of Steward Health Care, despite the name, a for-profit company owned by private equity/ leveraged buyout firm Cerberus Capital Management. Steward has hyped its supposedly world class "new health care" model in its advertising (look here). In promoting its bid for Landmark, Steward's well-paid CEO (look here), displayed his vision for promoting the medical center through "economies of scale," "right-siting," and emphasizing ties with the community: "it's not a community hospital system. It's really a health care system," as reported by Felice Freyer in April, 2012 (Freyer F. Landmark Medical Center. A Leap into the unknown. Providence Journal, April 22, 2012.)

 In a dispute over payment rates with Rhode Island Blue Cross Blue Shield, Steward ran full-page newspaper advertisements claiming that insurance companies leaders issued an order to "terminate Landmark Medical Center," because they did not care if "residents would lose their only hospital, ... employees ... would lose their jobs, or the elderly ... would have to travel for care." (Look here.) That implied, of course, that Steward, which did not mention that it is a for-profit corporation owned by a private equity firm in the ads, cared deeply about the health care of residents of Woonsocket.

Some Skepticism, but More Acceptance

The article by Felice Freyer above did feature journalistic skepticism and include interviews with some local physicians who questioned whether Steward could possibly fulfill all its promises to simultaneously increase the quality of care and reduce costs.

However, the article showed that there was lots of positivity about Steward's track record in neighboring Massachusetts. Predictably, the President of Steward owned Quincy Medical Center boasted, "Not one person has been laid off. We have not reduced any service lines. Our focus is on enhancing." However, some people who were apparently independent of Steward also had favorable views.  A Massachusetts consumer advocate said "as far as we know, it's going fine." A Brandeis University Professor said, "it's impressive how successful they've been."

The Politicians' Buy In

Elsewhere, there were plenty of statements of support for Steward by local politicians.  The Mayor of Woonsocket supported Landmark (and implicitly Steward) it its dispute with RI BCBS, as reported by the Providence Journal, saying that the proposed buyout by Steward "is far too critical for our city, and I must take every step possible to ensure that the interests of the city and those who rely upon Landmark (Medical Center) for healthcare are being protected [by taking Steward's side in the dispute.]" Also, as reported by the Woonsocket Call, RI Congressman David Cicilline said, "I look forward to working with Landmark's new administration [that is, Steward] to ensure that it continues to deliver affordable, quality health care and well-paying jobs for hardworking Rhode Islanders." To fulfill Steward's wishes, The Rhode Island state legislature rushed to make its laws about for-profit conversion of non-profit hospitals more lenient (see the Providence Business News).

The Attorney General Later Says it was All About the "Bottom Line"

However, now Steward has apparently pulled out of the deal with nary a public mention of the reason why, much less demonstration of its concern for the poor people of Woonsocket. As reported in a second small item in the Providence Journal,

Steward Health Care System, which is apparently backing out of its deal to buy Landmark Medical Center, 'has left the hospital, its patients and its employees in a worse position,'

Attorney General Peter F. Kilmartin said in a statement today. 'It has become very clear that Steward's only interest was the bottom line, not, as the Company claimed, the patients, the employees or the Woonsocket community,' Kilmartin said.

Summary

This is just one local kerfuffle about a small hospital system. However, looking at it in granular detail says a lot about how big health care organizations, like the one that here attempted to buy the local hospital system, push misleading messages to secure their private interests. These misleading messages often promote these organizations' commitments to the traditional health care mission, often in the modern argot of quality, access, and affordability), when their leaders may really care more about short term revenue. This case also shows how at least some local policy makers may be drawn in by such messages, and how the few skeptics get lost in the shuffle.

An important feature of the modern, commercialized, laissez faire health care system in the US is the role of opinion manipulation through modern, sophisticated marketing and public relations in promoting the short-term financial interests of health care organizations and their leaders at the expense of patient's and the public's health. This role seems rarely to be discussed, particularly in health care research and policy circles. It may be that some members of the public, health care professionals, and health policy makers are naturally skeptical of marketing and public relations hype, spin, and deception. However, we have seen too many examples of health care leaders promoted as "visionaries" who are anything but.

Health care professionals, patients, policy makers, and the public at large ought to be extremely skeptical of the self-serving messages packaged by marketing and public relations. Academics ought to be dissecting these messages more often. Skeptics need to make their voices heard.

Meanwhile, look out for the next "visionary," or the next "new health care" promotion. They may not turn out to be what is advertised.

HIMSS Senior Vice President on Medical Ethics: Ignore Health IT Downsides for the Greater Good

The Health Information Management Systems Society (HIMSS) is the large health IT vendor trade group in the U.S.  At a Sept. 21, 2012 HIMSS blog post, John Casillas, Senior Vice President of HIMSS Financial-Centered Systems and HIMSS Medical Banking Project dismisses concerns about health IT with the refrain:

... To argue that the existence of something good for healthcare in many other ways, such as having the right information at the point of care when it’s needed, is actually bad because outliers use it to misrepresent claims activity is deeply flawed.

Through the best use of health IT and management systems, we have the opportunity to improve the quality of care, reduce medical errors and increase patient safety. Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records.

Surely, no one can argue paper records are the path forward. Name one other industry where this is the case. I can’t.

Let’s not let the errors of a few become the enemy of good.

The ethics of these statements from a non-clinician are particularly perverse.

The statement "Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records" is particularly troubling.

When those "some" include organizations such as FDA (see FDA Internal 2010 memo on HIT risks, link) and IOM's Committee on Patient Safety and Health Information Technology (see 2012 report on health IT safety, link) both stating that harms are definite but magnitude unknown due to systematic impediments to collecting the data, and the ECRI Institute having had health IT in its "top ten healthcare technology risks" for several years running, link, the dismissal of "clouds" is unethical on its face.

These reports indicate that nobody knows if today's EHRs improve or worsen outcomes over good paper record systems or not.  The evidence is certainly conflicting (see here).

It also means that the current hyper-enthusiasm to roll out this software nationwide in its present state could very likely be at the expense of the unfortunate patients who find themselves as roadkill on the way to the unregulated health IT utopia.

That's not medicine, that's perverse human subjects experimentation without safeguards or consent.

As a HC Renewal reader noted:

Astounding hubris, although it does seem to be effective.  Such is PC hubris.  Who could ever call for reducing the budget of the NIH that is intended to improve health.  Has health improved?  No.

So why does a group with spotty successes if not outright failure never get cut?  It’s not the results, it’s the mission that deserves the funding.  So it’s not the reality of HIT, it’s the promise, the mission, that gets the support.  Never mind the outcome, it’s bound to improve with the continued support of the mission.

Is this HIMSS VP aware of these reports?  Does he even care?

Does he believe patients harmed or killed as a result of bad health IT (and I know of a number of cases personally through my advocacy work, including, horribly, infants and the elderly) are gladly sacrificing themselves for the greater good of IT progress?

It's difficult to draw any other conclusion from health IT excuses such as proffered, other than he and HIMSS simply don't care about unintended consequences of health IT.

Regarding "Surely, no one can argue paper records are the path forward" - well, yes, I can.  (Not the path 'forward', but the path for now, at least, until health IT is debugged and its adoption and effects better understood).  And I did so argue, at my recent posts "Good Health IT v. Bad Health IT: Paper is Better Than The Latter" and "A Good Reason to Refuse Use of Today's EHR's in Your Health Care, and Demand Paper".  I wrote:

I opine that the elephant in the living room of health IT discussions is that bad health IT is infrequently, if ever, made a major issue in healthcare policy discussions.

I also opine that bad health IT is far worse, in terms of diluting and decreasing the quality and privacy of healthcare, than a very good or even average paper-based record-keeping and ordering system.  

This is a simple concept, but I believe it needs to be stated explicitly. 

A "path forward" that does not take into account these issues is the path forward of the hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.

If today's health IT is not ready for national rollout, e.g., causes harms of unknown magnitude (e.g., see this query link), results in massive breaches of security as the "Good Reason" post above, and mayhem such as at this link, then:

The best - and most ethical - option is to slow down HIT implementation and allow paper-based organizations and clinicians to continue to resort to paper until these issues are resolved.  Resolution needs to occur in lab or experimental clinical settings without putting patients at risk - and with their informed consent.

Anything else is akin to the medical experimentation abuses of the past that led to current research subjects protections such as the "Ethical Guidelines & Regulations" used by NIH.

-- SS

Good Health IT (GHIT) v. Bad Health IT (BHIT): Paper is Better Than The Latter

An unspoken running assumption of the health IT enthusiast crowd seems to be that any health IT is better than no health IT, because using paper results in mistakes.

I offer a different view.

At the introduction to my Medical Informatics teaching site I've defined good health IT and bad health IT as follows:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. 

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  .    

There are also good paper systems and bad paper systems.

I opine that the elephant in the living room of health IT discussions is that BHIT is infrequently, if ever, made a major issue in healthcare policy discussions.

I also opine that BHIT is far worse, in terms of diluting and decreasing the quality and privacy of healthcare, than a very good or even average paper-based record-keeping and ordering system.  

This is a simple concept, but I believe it needs to be stated explicitly. 

In today's healthcare world, where health IT is dominated by hyper-enthusiasts of one motive or another, such an axiomatic statement will probably be viewed as controversial if not heretical. 

This blog has numerous postings about health IT debacles, e.g., query links here and here, that could not occur with paper systems.  The defects of just one company's products, the only one that publicly reports them to FDA (link) are frightening in terms of potential consequences.

GHIT needs to be promoted and BHIT needs to be eliminated.  That implies a major transformation of the health IT industry and its oversight.

-- SS

No Skin in the Game - A Private Health System for the Very Rich

We have noted occasional hints that the very rich may have a separate health care system which may shield them from the vicissitudes of our dysfunctional health care system. A broader hint came in an interview in the Wall Street Journal.

The Company

 The subject of the interview was Leslie Michelson, the CEO of Private Health Management.  The activities of the company were defined somewhat vaguely,

an ultra high-end company that borrows from concierge medicine, managed care, applied-sciences research and information technology while fitting into no neat category. The best analogue might be the investment and tax specialists that the affluent employ to run their finances; Mr. Michelson does the same for their health care. 'Like private wealth management, just far more important,' he quips in his modern Beverly Hills offices, all green glass and steel, white walls, white floors.

The Clientele

The company manages health care for a select clientele:

Private Health caters to 'high net worth individuals' and to businesses that retain its services for their executives as a benefit. Mr. Michelson says he serves between 12,000 and 15,000 clients, 'principally in private equity, hedge funds, professional and financial services firms.'

Note that the clientele seem to come mainly from the ranks of top executives of financial firms, probably some of the richest of the rich in the US.

Rapid Response Team for Acute Illness

Private Health Management's most distinctive service is the rapid response team it can "parachute in" to provide care for an acute illness,

whenever one of its patients has a medical emergency or complex condition, say, a traumatic brain injury or newly diagnosed cancer. A personal-care team parachutes in, led by a clinician employed by the company, and compiles a brief on the patient. They centralize and digitize the patient's medical records, usually dog-eared paper piles that can run to thousands of pages. Research scientists immerse themselves in the latest findings and treatment regimens for the particular condition involved.

Tests are double-checked—biopsy tissues are sent to an outside pathologist, MRIs to another radiologist. For an era of targeted therapies, Private Health runs a full battery of molecular diagnostics 'to sequence the entire three billion base pairs of somebody's DNA in a couple of hours,' Mr. Michelson marvels.

The goal is to ensure an accurate diagnosis and lay out all the treatment options. Private Health functions as a kind of running, independent second opinion.

Physician Network

In addition, Private Health Management provides access to a network of ostensibly the very best physicians,

Mr. Michelson built a series of proprietary algorithms to distinguish 'the few who are the very best' from 'the many who are very good,' based on 'the factors that predict excellence.' For example, the premier caregivers for metastatic cancer are usually academic researchers on the cutting edge, not general oncologists. The best orthopedic surgeons perform many procedures as they master the clinical learning curve, ideally for a single injury.

His referral database includes 2,200 specialists across 160 medical fields, 'reified into far finer groupings of disease than is standard practice.' He says that 'the world becomes so much clearer when you are able to identify the physician with the deepest and narrowest expertise in exactly what you need.'

Mr. Michelson says doctors like to belong to his informal network because they're 'interested in excellence and what we stand for.'

However, next,

 He adds, with more than a little euphemism, 'In a world in which 98% of the conversations are about cost containment, it's a joy for them to have somebody who's focused on enhancing quality only.' No doubt true, though it probably doesn't hurt that providers also like to have a relationship with his client base, the sort of people who become university patrons or donate a hospital wing.

This raises the question of whether doctors in his network may exhibit some greed along with their putative excellence.

Questions Begged About How it Works

The article actually devoted more space to Mr Michelson rationalizing his business as part of his overall interest in reforming health care than to discussion of how it works and what its implications are.  The short description of the processes above actually raised more questions about how the Private Health System works than it answered.  Some examples are: how could an optimal rapid response team be quickly mobilized given that the nature of acute illnesses may not be immediately apparent?  How would such a team interact within a hospital setting, or does the company have its own parallel hospital system?  What about the rest of medicine and health care outside of acute and intensive care, particularly primary care and management of chronic disease?  How does the referral data base function, and how would a classification that seems focused on the "narrowest expertise" cope with patients with multiple common illnesses or patients with undefined or undiagnosed problems?  These begged questions suggest there may actually be much more to the Private Health Management system than was discussed in the article.

Perhaps instead the care provided by Private Health Management might not actually result in better outcomes for its patients.  Consider some other questions: given how hard it is to assess physician performance and measure quality of care, how can Private Health Management be assured that its physicians are really the best of the best?  Given the apparent financial incentives for participating in the system, would the doctors who most appreciate these incentives be likely to provide the best care?  Would the apparent bias of the system toward high technology and super specialized care, would the system over-treat most of its patients? 


Summary and Implications

Nonetheless, the article provides more evidence that the US has a secretive parallel health care system for the very rich.  The most important implication is that such a system could protect the very rich from the access problems and bureaucratic annoyances that plague ordinary patients in larger dysfunctional health care system.  By thus having "no skin in the game," those among the very rich who are not themselves directly involved with health care would have little reason to care or want to do anything about the problems besetting the larger health care system.  Since the very rich have become increasingly politically powerful, the absence of such interest or motivation for change among them would make true health care reform much more difficult. 

If there is a parallel health care system for the very rich, its real effects on health and health care are unknown.  As best as I can tell, the very concept is almost entirely anechoic except for our very limited discussions on Health Care Renewal.  The subject cries out for investigative reporting, and consideration by health care policy, research, and ethics experts. 

Just the Latest Legal Settlement for HCA

Last month, we posted about investigative reports that suggesting that for-profit hospital chain HCAwas pushed by its private equity owners to put short-term revenue ahead of good patient care.  A legal settlement announced this week corroborates these concerns. 

As reported by television station WRCB in Chattanooga, TN,

HCA Inc., one of the nation's largest private hospital chains, has agreed to pay $16.5 million to settle alleged violations of the Ethics in Patient Referrals Act (also known as the Stark law), the False Claims Act, and other federal and state laws and regulations in connection with the operation of its subsidiary, Parkridge Medical Center, Inc., in Chattanooga.
In addition, Parkridge Medical Center has entered into a comprehensive five-year Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services (HHS-OIG) to ensure its continued compliance with federal health care benefit program requirements.
As alleged in the settlement agreement, during 2007, HCA, through its subsidiaries Parkridge and HCA Physician Services (HCAPS), entered into a series of financial transactions with a physician group, Diagnostic Associates of Chattanooga, through which it provided financial benefits intended to induce the physician members of Diagnostic to refer patients to HCA facilities.
The financial benefits included lease of office space from Diagnostic at a rental rate well in excess of fair market value to meet the mortgage obligations of the Diagnostic members and release of Diagnostic members from a separate lease obligation. These financial arrangements violated the Ethics in Patient Referrals Act and the Anti-Kickback Statute – laws designed to protect patients as well as the integrity of government-funded health care benefit programs such as Medicare, Medicaid, TRICARE, and TennCare.

The issue here were allegations that HCA and its subsidiaries were paying physicians extra so that they would refer patients to an HCA hospital. Obviously, physicians are supposed to put each patient's interests ahead of extraneous considerations, and hence should make referral decisions based on the patients needs, and the likely benefits and harms of the referral, not the amounts the physicians might make from such payments.

Referrals for particular services can be very lucrative for hospitals.  So this settlement seems to provide more evidence that to get profitable referrals, HCA was willing to subvert physicians' values by paying physicians to induce to make what might have been the wrong decisions for individual patients.  Of course, in this situation some physicians were hardly blameless, since they were also willing to set aside their values to receive the payments that generated those referrals.

This fits with the thesis we advanced last month.  While hospitals are supposed to have a mission to put care of the sick ahead of all else, it appears that for-profit hospitals, and especially those owned by private equity are more likely to put short-term revenue ahead of patient care.

As an aside, while this settlement provides useful information, do not think of it as a solution to the immediate problem. 

As we have frequently asserted, it is doubtful that the relatively small payment and the relatively unlikely to be enforced corporate integrity agreement imposed in this settlement will change the company's behavior, in the absence of any negative consequences for the people who authorized, directed or implemented the bad behavior.  HCA once made a $1.7 billion fraud settlement, at the time the biggest such settlement ever made (see this post).  However, the company's CEO at the time, Rick Scott, left the firm with a golden parachute and no negative consequences, and is now Governor of Florida.  If that previous huge settlement did not deter the more recent bad behavior in the absence of any penalties for company executives, why should we expect that the current comparatively tiny settlement also in the absence of such penalties will have any effect?

As we have now said many, many times, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Furthermore, as I wrote last month, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. Before market fundamentalism became so prominent, many stated prohibited the corporate practice of medicine, and the American Medical Association forbade the commercialization of medicine. It is time to heed that wisdom. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.

Another unsolicited email from a physician describing EHR-caused chaos in the clinic

I periodically receive unsolicited stories of EHR difficulties (mayhem, really) as a result of clinicians or others locating my materials online, via web searches, social networking sites, or word of mouth.

Another unsolicited email from a physician describing EHR-caused chaos in the clinic, reposted with permission, is at my Health IT academic site at this link.

-- SS

At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professionals

I am revisiting the issue of HITECH in light of recent reports on health IT drawbacks and/or failure to achieve long-claimed advantages.

The HITECH Act, a multi-billion dollar EHR incentive/penalty measure inserted into the 2009 American Recovery and Reinvestment Act legislation (ARRA or 'economic recovery' act), is proving to be an example of what should be called "Social Policy Malpractice."

The HITECH Act was largely a consequence of intense industry lobbying on behalf of the IT industry (as in the Washington Post at "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records", May 16, 2009).

It is in fact not based on science or reliable evidence, and has led to increased patient endangerment and a worsening national debt picture.

The recent revelations of reports from diverse sources including but not by any means limited to the following indicate that HITECH and its expenditures of billions of dollars on experimental, unregulated, unproven technology represents social policy malpractice:
 

• ABC News (Your Medical Records May Not Be Private: ABC News Investigation" - privacy of electronic health data is very poor, in ways that paper would and could never have permitted);

• The Center for Public Integrity "Growth of electronic medical records eases path to inflated bills", on how EHRs lead to increased, not decreased healthcare costs;

• Experts at Penn and Harvard -"A Major Glitch for Digitized Health-Care Records" - savings from EHRs are illusory;

• Budget reports - in view of the deficit spending reported by OMB and others that is causing national debt to spiral out of control, jeopardizing the economic well being of the United States, and with upcoding as a side-effect and no cost savings, HITECH is an unaffordable extravagance. 

• Recent revelations of outright EHR-induced mass chaos largely due to outspoken clinicians who've had enough - "Contra Costa County health doctors air complaints about county's new $45 million computer system", "Lake County (IL) Health Department - Depression era soup lines at the clinic";

• Abuses of NPRM Public Comment periods on followup health IT incentive regulations via industry ghostwriting (stealth lobbying), reducing EHR effectiveness while further enriching the industry - "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?";

Of course, I'd already cited these reports in past posts but they bear repeating:

• The IOM report on HIT safety ("There's risk, but we don't even know the magnitude because there are major systemic impediments to diffusion of that information"), http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html;

• FDA (known injuries and deaths are likely the "tip of the iceberg" because of the impediments, and EHRs are medical devices that should fall under the FD&C Act, but FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices because they're a political hot potato - Jeff Shuren MD JD, CDRH), http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html;

• NIST (health IT usability is poor, major remediation is needed) - http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html

I'd called for a moratorium on ambitious EHR plans for similar reasons as far back as 2008, at posts here and here.

 

The path that ethical medical centers and clinicians should take is to delay computerization in 2012 and push for slowdown or retraction of HITECH and its penalties for non-adopters. 

Yet instead, what is usually seen is excuses and cheerleading by healthcare organization leaders, and passive physician and nurse acceptance of deficient information technology.  

This stunning passivity and acceptance by physicians and nurses of a deeply flawed technology of unknown risk seems largely due to physician learned helplessness and the Stockholm Syndrome.  See the posts on "physician learned helplessness" at http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html (commenting on observations in MedScape written by a lawyer), as well as on the "Stckholm Syndrome"  at http://en.wikipedia.org/wiki/Stockholm_syndrome. 

Per a psychiatrist/informatics specialist Dr. Scott Monteith who has commented on this blog, the compliance of clinicians may also be a manifestation of the inherent human psychopathology reflected in the Milgram Experiment (and elsewhere):

The Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that conflicted with their personal conscience. Milgram first described his research in 1963 in an article published in the Journal of Abnormal and Social Psychology, and later discussed his findings in greater depth in his 1974 book, Obedience to Authority: An Experimental View.

As to the consequences of physician "acceptance" of this technology in 2012 in its present condition, physicians are:

• Acting, in effect, 'in loco parentis' for their patients, not in the latter's best interests, who are not even afforded opportunity for informed consent.  This is in violation of long-accepted norms of human subjects experimentation and research such as the Belmont Report, Nuremberg Code and HHS human subject protection regulations at 45 CFR part 46 themselves;

• Giving free provision of their expertise and labor at improvisation and workarounds, in effect providing free alpha and beta testing to an entirely unregulated IT sector;

• Engaging in passive acceptance of the entire liability and their hospital executives' breach of fiduciary responsibility to protect them from same due to Hold Harmless clauses, and breach of Joint Commission safety standards through signing "gag" clauses on defects and harms (see http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda).

National health IT leaders have proven to be hyperenthusiasts about health IT benefits as well:

... This from Robert Kolodner, former head of the Office of the National Coordinator for Health IT (ONC) at HHS:

Dr. Robert Kolodner, a physician who headed the federal push for electronic medical records in 2007, acknowledged that billing abuse took a backseat to steps likely to entice the medical community to embrace the new technology.

Kolodner said officials were certain the savings achieved by computerizing medicine would be so great that billing abuse, “while needing to be monitored, was not something that should be put as the primary issue at that time.”

In other words, sideline (ignore) health IT-based billing abuse (and safety risks to the live patients subjected to this experimental technology without informed consent) because "we believe" the savings will be greater based on "our faith in the technology."

 

Such individuals contributed materially to the social policy malpractice represented by the HITECH ACT.

Considering all of the above, I call once again for a moratorium on further economic incentives for EHR adoption, and investment in the very measures recommended by the National Research Council in its Jan. 2009 report "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" that:

In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.

This research must be conducted, of course, with full human subjects protections in place.

-- SS

In addition to nurses, doctors now air their alarm: Contra Costa County health doctors air complaints about county's new $45 million computer system

At my Aug. 2012 post "Contra Costa's $45 million computer health care system endangering lives, nurses say", I described how an experimental EHR being forced on clinicians in Contra Costa county, California, was endangering patients who had not consented to its use, and how nurses were reported to be raising hell about it.  I also noted:

... The[se] scenarios [of EHR-created mayhem] are also usually accompanied by amoral misdirection from these personnel away from patient risks...

Herein is the problem:  the attitude that a clinic full of non-consenting patients is an appropriate testbed for alpha and beta clinical software that puts them at risk is medically unethical, based on the guidelines developed from medical abuses of the past.  There is nothing to argue or debate about this. 

Now the affected physicians have their say.

These physicians are apparently represented by a union; therefore they likely fear retaliation less than non-union physicians, and thus can be candid:

Contra Costa County health doctors air complaints about county's new $45 million computer system
By Matthias Gafni
Contra Costa Times
Posted:   09/18/2012, Updated:  09/19/2012

MARTINEZ -- One of every 10 emergency room patients at the county's public hospitals in September left without ever being seen by a doctor or nurse because of long waits -- a number rising since implementation of Contra Costa's $45 million computer system July 1.

One patient waited 40 hours to get a bed.

Dr. Brenda Reilly delivered the troubling news Tuesday afternoon to county supervisors. She was one of three dozen doctors in the supervisors' chamber complaining about EPIC, new computer software aimed at integrating all of the county's health departments to create a federally mandated electronic medical record for patients.

The response, as seen later, were characterized by the typical amoral excuses, mistaken beliefs in technological determinism, (a/k/a quasi-religious computer fanaticism) and misdirection I described above.

To allow for the major computer program installation and conversion, administrators cut doctors' patient loads in half, in turn cutting the number of available appointments in half.

In a letter to the supervisors, Dr. Ori Tzvieli -- medical staff president whose union has been negotiating a new contract with the county -- along with 14 doctor co-signers pleaded for administrators to continue scaling back physician workloads because doctors are over-stressed. Six doctors have left this year, said Dr. Keith White, a 22-year pediatrician.

I point out that such stress from interacting woth a mission hostile EHR (really, a clinician workflow-control system), and the needed state of hypervigilance to avoid IT-related mistakes that harm patients, lead to burnout and ultimately, a lower quality of patient care. 

Patient workloads were reduced by 50%, which is bad enough (and indicative of gross project mismanagement, as I wrote about in another example in my Sept. 2012 post "Lake County (IL) Health Department: The extremes to which faith-based informatics beliefs can drive healthcare facilities - Depression era soup lines at the clinic?").

Yet the 50% reduction, according to the principal end users, was still not enough.  Usability and fitness of the software is surely in question.

"We were not ready for EPIC and EPIC was not ready for us," White told supervisors. "As a result, the providers are struggling to provide safe and effective care for 100,000 citizens of the county, many of whom are very ill. We often feel that we are failing. We are very tired ... many doctors have left and all are considering leaving."

It is impossible for people, especially medical professionals, to be "ready" for a system that "is not ready for them", i.e., "bad IT" as defined at my teaching site intro at this link:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.
   
Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

The two phrases "We were not ready for EPIC" and "EPIC was not ready for us" do not belong together in the same sentence.

A claim that physicians (and nurses) are "struggling" to provide safe let alone effective care for 100,000 should RAISE ALARM BELLS, not produce a paternalistic, patronizing response from medical and governmental officials as it did, seen below.

Both doctors and administrators agreed Tuesday that creating an integrated electronic health record is important, but a series of white coats stepped to the podium in what they jokingly termed "Doccupy" to share their nightmarish last few months.

I disagree with the assessment that "creating an integrated electronic health record is important", in that the technology and know-how to do so without endangering the very patients the technology is supposed to protect does not yet seem to exist in the commercial sector.

In that sense, regulating EHR technology and subjecting it to controlled clinical trials and refinement (as with any other medical device or drug, and many other types of healthcare-related IT such as MDDS - medical device data systems) with consenting subjects is what's important.

On MDDS, from the FDA link above:

Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring. Examples of MDDS include:

• software that stores patient data such as blood pressure readings for review at a later time;
• software that converts digital data generated by a pulse oximeter into a format that can be printed; and
• software that displays a previously stored electrocardiogram for a particular patient.

The quality and continued reliable performance of MDDS are essential for the safety and effectiveness of health care delivery. Inadequate quality and design, unreliable performance, or incorrect functioning of MDDS can have a critical impact on public health.

That health IT used on live patients receives special regulatory accommodation in the form of non-regulation, when clearly the quality and continued reliable performance of EHR systems are essential for the safety and effectiveness of health care delivery, is inexcusable in 2012.  

(Of course, stunningly, FDA won't touch the latter, although admitting they are medical devices that should fall under the FD&C Act, because EHRs are a "political hot potato."  See this post for the relevant citations.)

... "This has been excruciatingly painful to do what is needed for those people who need it most," said Dr. Rachel Steinhart, an emergency room doctor who worked a graveyard shift ending Tuesday morning, hours before the board meeting. She said she still had to document paperwork for 16 of her patients. "It's going to implode. It can't go on like this."

Patients are surely going to be injured or killed in this setting.  There is likely a "hold harmless" clause with the vendor, so, doctors, I'm sorry to say, despite your complaints, you will very likely be held legally liable.

The head of the county's health care system sympathizes, and hopes to work with medical staff to ease the transition for what is a monumental moment in medical history.

"We're in an era of massive change right now, not only in our system, but in the system nationwide," said Dr. William Walker, Contra Costa's health services director. "Coming with the rapidity is its throwing people off balance."

Dr. Walker has just painted a big red "name me as a defendant for gross negligence and breach of fiduciary responsibilities to patients and clinicians" target on his back for glossing over known health IT risks and what appear to be rather profound complaints coming from his constituents.  Instead, he supplies platitudes, not action to remediate or withdraw the bad IT.

Name me as a defendant for gross negligence and breach of fiduciary responsibilities to patients and clinicians

The response is stunning:

To ease the burden, Walker hopes to have teams of medical care providers formed to ease the doctors' paperwork burden, enabling them to return to treating patients.

It takes teams of physicians to properly see a patient due to the interference of EHRs?  That is remarkable.

The ccLink program has its benefits, some doctors said. Dr. Chris Farnitano, an ambulatory care medical director, described how he retrieved a patient's biopsy results from a different hospital on the spot, whereas in the past it would have taken weeks.

However, other doctors called ccLink clunky and time-consuming, designed more for bureaucrats than physicians. Even with doctors cutting their patient load in half -- meaning half as many appointments are available for patients -- doctors complained that they spend more time on their computers than treating patients.

This is misdirection by the Medical Director.  It's unarguable that the risks far outweigh the benefits.  Further, retrieving a biopsy or other result result instantaneously could easily be done from an innocuous, non-disruptive document imaging system (e.g., Documentum).  The latter would also be many millions of dollars less expensive than an EHR.

"It's a truncation of patient care. The individual patient doesn't get the care they used to get," said David MacDonald, a 22-year family medicine doctor.

Again, Dr. MacDonald, the liability for adverse outcomes is on you.

You are now, in effectm an indentured servant of an IT company, providing free alpha and beta testing at your expense and peril, using the patients as an even lower level of indentured servant/guinea pig.

There's also significant patient-endangering collateral damage from this mayhem:

The lack of appointments has overburdened emergency rooms, which already exceeded emergency room wait benchmarks in a facility built to see 80 patients a day, but often sees more than 200 patients a day. Since ccLink started, the average patient spends four hours in the ER, up an hour from before the computer system transition, which was already over national benchmarks, said Reilly.

The scenario could not be worse.  The ED's are themselves burdened by EHR's.

The supervisors asked for continued updates, and for patience.

"Continuous improvement means you need continuous change," said supervisor Federal Glover. "Eventually, it's going to become second nature as it was with cell phones. We'll wonder how we ever did without it."

Supervisor Glover has also painted a "defendant" target on his back.  This is the misdirection I was speaking of earlier, consisting of platitudes, logical fallacy and falsehoods:

• "Continuous improvement" is not what's going on here; 
• Such improvement does not mean creating chaos as a precondition; 
• Whether this software will become "second nature" is anyone's guess.  That is a hysterical and logically fallacious statement (e.g., an appeal to belief) of an almost quasi-religious fanaticism regarding computing.  This technology could ultimately be scrapped in favor of, say, simpler document imaging systems due to increasing clinician complaints, inherent usability issues in fast-paced medical settings, litigation, costs, harms etc.;
• What of the patients placed at risk, and/or injured/killed as a result of this experimentation?  What of them, and their medical and human rights?

In effect, a response like this is medically unethical.  The correct response would be a halt in the rollout until problems are substantially remediated in a controlled, risk free setting - not the clinic.

If that is not possible, the system needs to indeed be scrapped or replaced.

Continuation of patient endangerment is inexcusable medically, ethically and legally.

-- SS

Majority of the Public Wants Politicians Who Will Root Out Corporate Corruption

Here is a story that makes me unusually optimistic, at least about the wisdom of the people at large. Reuters reported on a new poll,  

With less than two months to go before the U.S. presidential election, a new survey found 61 percent of Americans say a candidate's commitment to rooting out corporate wrongdoing will be key in deciding who gets their vote.

Along with keen interest in knowing each candidate's plans to fix the struggling economy, voters want government to do more to fight corporate misconduct - which they say helped cause the financial crisis.

'In these difficult economic times, Americans are mad as hell about corporate wrongdoing and are going to do something about it in the November elections and beyond,' said Jordan Thomas, a partner at law firm Labaton Sucharow, which commissioned the survey and which represents corporate whistleblowers.

A telephone poll of 1,015 people conducted from August 16-19 found that 64 percent of Americans said corporate misconduct helped bring about the current economic crisis.

And 81 percent of respondents said the government has not done enough to stop corporate wrongdoing.

Furthermore,

77 percent of respondents saying they believe politicians favor corporate interests over constituent interests.

Some 63 percent of Americans believe government should make more money available to regulators and law enforcement to eliminate corporate wrongdoing.

This is really amazing in its contrast to the usual received wisdom in all its cynicism.

We on Health Care Renewal have been railing about misbehavior and outright criminal behavior by major health care organizations and their leaders for a long time.  In 2008, the global financial collapse shocked us into awareness that the problems in health care actually parallel perhaps worse problems in finance.  Yet while numerous legal settlements documented the continuing epidemic of bad behavior in health care, the relatively small penalties they entailed, generally limited to corporate fines that could be viewed as costs of doing business, and to toothless corporate integrity agreements seemed to do little to deter future bad behavior.  Again, since 2008 there were parallels in the world of finance.   As Oscar winning producer of Inside Job Charles Ferguson complained, no one went to jail for financial misbehavior either.

In health care, the anechoic effect dampened public discussion of bad leadership, including criminally bad leadership as a major cause of health care dysfunction.  While we have been calling for more serious efforts to deter bad behavior at least since 2008 (look here), our position seemed very lonely.  It took until last week for arguably the most prestigious US medical journal to run an article suggesting that leaders of health care corporations that commit fraud ought to go to jail (look here).

Yet it may be that the general public has been paying attention to this issue even if policy makers and political leaders have not.  The brief Rueters article did not make it clear whether these poll results only apply to wrongdoing by financial corporations and their leaders, or to all corporations and their leaders. Even if it were the former, the results were certainly striking, suggesting a majority of Americans now identify corporate corruption, and its influence on politics as a major, maybe the major problem for this country. That might lead to some interesting election outcomes, especially since very few US politicians seem to have taken any sort of stand against corporate corruption, at least to my knowledge.

If there is so much public awareness of the problem of bad corporate leadership, corporate misdeeds, and corporate corruption of politics, I can only hope that it will translate into awareness of these problems as they affect health care. As I wrote in 2009, not long after Pfizer's mere $2.3 billion settlement,...   "Until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations."  We can start realistically anticipating real health care reform once we get some politicians in office who are committed to "rooting out corporate wrongdoing." 

"The Syndrome of Useless Information" Revisited

At a time when the press seems to be starting to "get it" regarding health IT myths, and expecting significant pushback, I thought it useful to repost a link to a post I authored in Jan. 2010 entitled "The Syndrome of Useless Information."

The post is here:  http://hcrenewal.blogspot.com/2010/01/syndrome-of-useless-information.html

The IT culture of late stinks to high heaven of that phenomenon.

-- SS

BLOGSCAN - Why Not Just Pay Physicians By the Hour?

We have frequently discussed how perverse incentives are spread around health care.  In the US, the physicians are paid according to a system that provides strong incentives for doing procedures, (see our posts about how the RUC has encouraged this bias towards procedures.)   Since physicians are the most influential "deciders" about the care of individual patients, these incentives encourage overtesting and overtreatment with the highest technology, driving up costs and subjecting patients to increased risks of adverse events.  The recent health care reform law, however, essentially encouraged a version of capitated payment, which might very well provide incentives for undertreatment and undertesting.  For years, Dr Robert Centor has argued logically and forcefully for paying physicians for the time they spend on behalf of payments, very analogous to how lawyers and many other professionals are paid.  This might provide much more neutral, less perverse incentives than would existing or other proposed physician payment schemes.  Dr Centor argued again for this seemingly reasonable and logical idea on his DB's Medical Rants blog.  The big question is why this idea has been so anechoic?

WSJ, Koppel and Soumerai: A Major Glitch for Digitized Health-Care Records - Cost Savings Illusory

Two EHR experts from Ivy-league institutions (which are typically hyperenthusiast-oriented) doubt cost savings from EHR technology.

Wall Street Journal
Opinion
September 17, 2012

A Major Glitch for Digitized Health-Care Records

Savings promised by the government and vendors of information technology are little more than hype.

By STEPHEN SOUMERAI And ROSS KOPPEL

In two years, hundreds of thousands of American physicians and thousands of hospitals that fail to buy and install costly health-care information technologies—such as digital records for prescriptions and patient histories—will face penalties through reduced Medicare and Medicaid payments. At the same time, the government expects to pay out tens of billions of dollars in subsidies and incentives to providers who install these technology programs.

Which, of course, means printing more money for luxuries we cannot afford in the midst of the worst economic downturn since 1929...

The mandate, part of the 2009 stimulus legislation [I think it would be more accurate to say "sneaked into the 2009 stimulus legislation for IT industry benefit" - ed.], was a major goal of health-care information technology lobbyists and their allies in Congress and the White House. The lobbyists promised that these technologies would make medical administration more efficient and lower medical costs by up to $100 billion annually. 

By up to $100 billion annually?   (Perhaps these lobbyists need lie detector tests - and/or drug tests to see what they may have been smoking?)  I note the lobbying was covered in the Washington Post in "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records" by Robert O'Harrow Jr., May 16, 2009.

Many doctors and health-care administrators are wary of such claims—a wariness based on their own experience. An extensive new study indicates that the caution is justified: The savings turn out to be chimerical.

Some still have empirical observational skills and common sense, fortunately.  In my early days of health IT involvement two decades ago as an NIH-sponsored Medical Informatics post doctoral fellow, I believed there was some cost savings possible, but certainly not in the tens or hundreds of billions per year.  The technology was not solving problems that could lead to such savings (see for instance my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?").  My experiences since my fellowship have only confirmed my own early opinions.

Since 2009, almost a third of health providers, a group that ranges from small private practices to huge hospitals—have installed at least some "health IT" technology. It wasn't cheap. For a major hospital, a full suite of technology products can cost $150 million to $200 million. Implementation—linking and integrating systems, training, data entry and the like—can raise the total bill to $1 billion.

That's countless billions that could have been spent on actual healthcare delivery itself, especially for underserved populations and the poor.  Instead, that money was funnelled to the IT industry for an experimental, unregulated, unvetted technology to be applied on live patients (and without patient consent, I add).

But the software—sold by hundreds of health IT firms—is generally clunky, frustrating, user-unfriendly and inefficient. For instance, a doctor looking for a patient's current medications might have to click and scroll through many different screens to find that essential information. Depending on where and when information on a patient's prescriptions were entered, the complete list of medications may only be found across five different screens.

Examples of that from actual systems (sketched to avoid IP problems) is at my ten part series on mission-hostile health IT at this blog, shortened link http://www.tinyurl.com/hostileuserexper.

Now, a comprehensive evaluation of the scientific literature has confirmed what many researchers suspected: The savings claimed by government agencies and vendors of health IT are little more than hype.

To conduct the study, faculty at McMaster University in Hamilton, Ontario, and its programs for assessment of technology in health—and other research centers, including in the U.S.—sifted through almost 36,000 studies of health IT. The studies included information about highly valued computerized alerts—when drugs are prescribed, for instance—to prevent drug interactions and dosage errors. From among those studies the researchers identified 31 that specifically examined the outcomes in light of the technology's cost-savings claims.

With a few isolated exceptions, the preponderance of evidence shows that the systems had not improved health or saved money.

One must understand this in the context of what these systems really are, what they do, and the problems they can actually address as in my post on 'solution to the wrong problem' mentioned supra.

The authors of "The Economics of Health Information Technology in Medication Management: A Systematic Review of Economic Evaluations" found no evidence from four to five decades of studies that health IT reduces overall health costs. Three studies examined in that McMaster review incorporated the gold standard of evidence: large randomized, controlled trials. They provide the best measure of the effects of health IT systems on total medical costs.

I point out that randomized controlled trials (RCT's) are notably rare in health IT studies.  Most "confirmatory" studies on health IT benefits are less powerful retrospective/observational studies in specialized settings, with many biases, poor science, etc.  In that sense, such studies can be considered non-generalizable and anecdotal at best (more on the "anecdotes" issue is below).

Of course, the pundits and Ddulites ("Luddite" with first four letters reversed; meaning ardent hyperenthusiasts) will likely say "it will all be fixed in version 2.0" despite decades of opportunity to get health IT "right" and demonstrate generalized improved outcomes and cost savings:

... At "Health IT: Ddulites and Irrational Exuberance" and related posts (query link) I've described the phenomenon of the: 'Hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.'

From Regenstrief Institute, one of the premier and pioneering centers for Medical Informatics research and teaching:

A study from Regenstrief, a leading health IT research center associated with the Indiana University School of Medicine, found that there were no savings, and another from the same center found a significant increase in costs of $2,200 per doctor per year. The third study measured a small and statistically questionable savings of $22 per patient each year.

That's probably not taking into account increased medical malpractice costs as exemplified here and here and by other settlements I know of but cannot mention due to my consulting role in those cases.

A primer on health IT risks, containing a number of key articles and links, is downloadable at http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip. 

In short, the most rigorous studies to date contradict the widely broadcast claims that the national investment in health IT—some $1 trillion will be spent, by our estimate—will pay off in reducing medical costs. Those studies that do claim savings rarely include the full cost of installation, training and maintenance—a large chunk of that trillion dollars—for the nation's nearly 6,000 hospitals and more than 600,000 physicians.

$1 trillion would pay for a tremendous amount of actual healthcare delivery, I note.

These system lifecycle costs, known as "total cost of ownership", are due to upgrades and necessary changes as medicine itself, including the science, business and legal components change over time.   The costs are generally underestimated ahead of time.  A good source on these issues is the article "Pessimism, Computer Failure, and Information Systems Development in the Public Sector"  (Public Administration Review 67;5:917-929, Sept/Oct. 2007).  This is a cautionary article on IT that recommends much more critical attitudes towards major IT initiatives in all sectors. 

But by the time these health-care providers find out that the promised cost savings are an illusion, it will be too late. Having spent hundreds of millions on the technology, they won't be able to afford to throw it out like a defective toaster.

There, I disagree.  We may have to "throw it out" as the disruptions to good medical care by bad health IT (BHIT) increase, unless the industry reforms itself very rapidly.  As I state in the introduction to my teaching website "Contemporary Issues in Medical Informatics: Good IT, Bad IT, and Common Examples of Healthcare Information Technology Difficulties" (started in late 1998 due, in fact, to my observations of inappropriate leadership and poor quality of health IT):

The site takes a view consistent with medicine’s core values and with patients’ rights that health IT, as a medical apparatus that increasingly forms an enterprise clinical resource management and clinician workflow control mechanism, remains experimental and should be subject to the same ethical considerations, validation processes and regulatory oversight to which almost all other medical technologies and pharmaceuticals are subjected. The site is pro-health IT, but only when the health IT is “good IT” - as opposed to “bad IT."

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

This site challenges medically and ethically controversial views that health IT merits special accommodations in terms of freedom from scientific rigor and evidence-based practices, freedom from regulation, and freedom from accountability. 

I  hold little hope of these issues being seriously addressed - let alone solved - any time in the near future due to:

1)  the irrational exuberance about this technology, cf: Twitter feeds on hashtags #EHR, #EMR, #HCIT and similar;
2)  the industry-promoted myths and fabrications over decades;
3)  the FDA-admitted impediments to information diffusion about defects and harms (link);
4)  IOM-admitted impediments to same (link);and
5)  the latter's industry-favoring, Milquetoast 2012 recommendations on monitoring, remediation and regulation.

These are indicative of an industry that has neatly avoided any meaningful regulation and is, in plain terms, out of control.

Why are we pushing ahead to digitize even more of the health-care system, when the technology record so far is so disappointing? So strong is the belief in health IT that skeptics and their science are not always welcome. Studies published several years ago in the Journal of the American Medical Association and the Annals of Internal Medicine reported that health IT systems evaluated by their own developers were far more likely to be judged "successful" than those assessed by independent evaluators.

"Not welcome" is an understatement. 

ONC itself is guilty of bad science, as in its grossly deficient March 2011 Health Affairs paper on health IT benefits. (See my Oct. 2011 post "ONC: The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results".  Also see my Aug. 2012 post "ONC and Misdirection Regarding Mass Healthcare IT Failure".)

So bad is the "Health IT critique not welcome" phenomemon that, for example, Medical Informatics leaders such as Bill Hersh of Oregon Health Sciences University (OHSU) openly attack those who are candid on health IT risks (and make fools of themselves via the open attacks), such as the attack I wrote of at my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture".

Also common in the "Health IT Critique Not Welcome Here" club, and probably deliberately so, is mistaking risk management activities for research observations and calling the former, even when reported by credible witnesses, "anecdotal" while calling at-best weak HIT-positive studies "definitive science."  See "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" for the definitive rebuttal of that type of patient-endangering intellectual blindness or dishonesty.

Government agencies like the Office of the National Coordinator of Healthcare Information Technology (an agency of the Department of Health and Human Services) serve as health IT industry boosters. ONC routinely touts stories of the technology's alleged benefits.

But almost never the opposite, which is equally if not more important.  Further, they tout "certification" as a means of HIT safety evaluation and assurance, or do not deny that misconception, despite statements by the very certification bodies or ATCB's they appoint to the contrary.  Yet they need to come clean on this. (I've seen the claim of 'certification equals safety' in actual legal briefs in defense of health IT.)  See my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified."

ONC also seems to turn a blind eye to industry-ghostwriting abuses in the public comments period of Notices of Proposed Rulemaking for "meaningful use" (itself an Orwellian term) rules.  See for instance my Sept. 2012 posts "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" and "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?"

We fully share the hope that health IT will achieve the promised cost and quality benefits. As applied researchers and evaluators, we actively work to realize both goals. But this will require an accurate appraisal of the technology's successes and failures, not a mixture of cheerleading and financial pressure by government agencies based on unsubstantiated promises.

I share the same sentiments.  As I've often written, the Achilles heel of the health IT sector is its ignoring the very science and evidence-based approaches of the field - medicine - that health IT is supposed to somehow "revolutionize" and "transform."

It is, quite frankly, the utmost in hypocrisy for an industry that demands evidence-based medicine - and touts its expensive products as leading to that change - to itself not practice what I've called "evidence-based computing."

Mr (sic) Soumerai is professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. Mr. Koppel is a professor of sociology and medicine at the University of Pennsylvania and principal investigator of its Study of Hospital Workplace Culture.

Dr. Soumerai also co-authored "Don't Repeat the UK's Electronic Health Records Failure" with Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK, Huffington Post, Dec. 5, 2010.

I also expect to hear an "Ivy tower academics - what do they know?" refrain from the industry.  However, this will not hold water, as the Ivory tower inhabitants, as I previously stated, are almost uniformly of the Ddulite-hyperenthusist persuasion and touted when they speak or write in uncritical favor of health IT.

-- SS

Addendum:

Penn Wharton professors had a similar opinion on cost-savings in 2009:

Information Technology: Not a Cure for the High Cost of Health Care: Knowledge@Wharton, Wharton School of Business, University of Pennsylvania, June 10, 2009. (PDF version available at this link)

As I observed in my June 20, 2009 post "Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices. And, Can We Drop the "Massive Cost Savings" Fable?", in a WSJ article that same day entitled "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford echoed the Wharton professors' doubts about the cost savings and ultimate value of electronic medical records:

... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.

I also had related observations published in a Letter to the Editor in the WSJ in February of that year:

Digitizing Medical Records May Help, but It's Complex, Feb. 18, 2009

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

Next time you hear from some pundit about enormous "cost savings" from clinical IT, remember this post.

Let's implement health IT - and do it well, i.e., good health IT (GHIT) instead of bad health IT (BHIT)- to facilitate clinicians, not to work financial miracles or "revolutionize" anything.

A slide from my Aug. 1, 2012 presentation to the Health Informatics Society of Australia at HIC2012.  Click to enlarge.

-- SS