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

A Message for Xerox: Americans Not 'Resistant to Change'; They Are Resistant to Reckless Change That Endangers Them

A press release from Xerox Healthcare Provider Solutions:

Jul 31, 2012
Only 26 Percent of Americans Want Electronic Medical Records, Says Xerox Survey

The subtitle is a rhetorical question:

When it comes to healthcare, are Americans resistant to change?

This is analogous to the refrain of calling physicians and nurses "Luddites" regarding their not happily and passively accepting today's clinical IT.  I addressed that issue at my post on pragmatist clinicians v. health IT hyper-enthusiasts at this link.

Jul 31, 2012

ROCHESTER, N.Y. – Americans routinely use electronic files to manage their finances, communicate with friends and family and even take college courses – but when it comes to medical records – only 26 percent want them digital. The findings come from the third annual Electronic Health Records (EHR) online survey of 2,147 U.S. adults, conducted for Xerox (NYSE: XRX) by Harris Interactive in May 2012. 

According to the survey, only 40 percent of respondents believe digital records will deliver better, more efficient care. That response fell two percent from last year’s survey, and matches the response reported in 2010. Overall, 85 percent of respondents this year expressed concern about digital medical records.

Americans have a healthy skepticism of putting their private information online to be hacked, of the disruptive effects of today's commercial health IT on their clinicians, and the costs of doing so.  This likely comes from common sense, reading and observation.

As one reader of this blog wrote:

Xerox kindly shared all three years of their annual Electronic Health Records (EHR) online surveys by Harris Interactive. The media, industry and government unrelentingly promote health technology as the latest, greatest best stuff. But the public ain’t buying it. They want smart phones, but they don’t want EHRs.

The Xerox article paternalistically continues:

“We continue to see a resistance to change from consumers – meaning providers need to continue to educate Americans on the value of EHRs,” said Chad Harris, group president, Xerox Healthcare Provider Solutions.

(Note the use of the 'EHR' acronym.  As I've written, the acronyms 'EHR' and 'EMR' are anachronisms used to describe what are no longer innocuous filing systems, but greatly intrusive enterprise clinical resource and workflow control systems.  I think the public increasingly understands that.)

This patriarchal statement by Chad Harris about "resistance to change" by "healthcare consumers" needing re-education is, in a word, depraved, because I think the person uttering the sentence knows better.  Let's define depraved:

Depraved (adj.):  morally bad or debased; corrupt; perverted

This statement implies is that health IT is a perfected technology without significant flaws, whose benefits are well-proven and whose drawbacks and risks are well understood.

Unfortunately, none of those are true.  From my May 2012 post on ONC's embarrassing "Health Data Palooza", worth repeating here, with hyperlinks:

• There is a markedly unscientific "irrational exuberance" pushing clinical IT into wide use at a dangerously rapid pace. This exuberance is contradicted by a growing body of literature that shows the benefits are likely far less than stated, e.g., by way of example, the ad-hoc set at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist;
• The technology remains experimental, its rollout is a human subjects experiment on a massive scale lacking nearly all the protections of other human subjects experimentation and for IT in mission critical settings (e.g., informed consent, formal quality control/validation/regulation, formal postmarket surveillance and reporting) due to extraordinary legal and regulatory special accommodations afforded the technology and its purveyors;
• Defects of in-use systems are rampant, inappropriately turning patients and clinicians into software alpha and beta testers (e.g., as in the voluntary FDA MAUDE database, http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html which contains information for just one HIT vendor, Cerner, who voluntarily reports such issues);
• The technology is unsupportive of clinician cognitive needs (2009 National Research Council study, which also stated that accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering will be essential to perfect this technology);
• The roles of scientific discovery and anecdote have been turned on their heads. RCT's of clinical IT are nearly non-existent and lower-level evidence (e.g., weak observational, pre-post, qualitative, and other study types) are cited as "scientific proof" of efficacy and safety justifying hundreds of billions of dollars of taxpayer (or is it Chinese loan?) expenditures.  Yet, risk management-relevant case reports of harmful events and near misses, crucial to help organizations and regulatory agencies understand risks are dismissed as "anecdotal" (e.g., Blumenthal: "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said, while ONC issued an article based on questionable research methods entitled "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" extolling the virtues of HIT, written about at http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html).
• Risks are definite, with known patient injury and death, but the magnitude is admittedly unknown as admitted by JC (2008 Sentinel Event Alert), FDA (2010 Internal memo on HIT risks and statements of Jeffrey Shuren MD JD about known harms likely being "the tip of the iceberg"), IOM (2011 report on HIT risk), ECRI Institute (Top ten healthcare technology hazards for 2011 and 2012), NORCAL Mutual Insurance Company 2009 report on EHR risks, others;
• Existence of severe impediments to information diffusion about risks explicitly admitted by FDA (2010 memo), IOM (2011 report), others;
• Usability of commercial products in real world settings is often poor (e.g., NIST 2011 study on usability), promoting "use error" (user interface designs that engender users to make errors of commission or omission, where many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc.)
• These systems promote capture and display of clinically irrelevant information in the interest of charge capture, and result in reams of "legible gibberish" with many negative characteristics that make it difficult for other clinicians and reviewers to establish a cohesive, definitive narrative of clinical events and timelines.

The article continues:

Despite consumers’ misgivings of the value of EHRs, caregivers [largely hospitals and healthcare systems who force it on their staffs and owned physician practices - ed.] are quick to adopt digital technology.  [Thanks to incentives and looming penalties - ed.] When asked how their healthcare provider recorded medical information during their last visit to a doctor or hospital, 60 percent of respondents – who have visited a doctor or hospital – reported that the information was entered directly into a tablet, laptop or in-room computer station versus 28 percent who reported the information was taken via handwritten notes. 

As the numbers don't justify the practice, even if the numbers as stated are valid, my response is:

So what?

To help caregivers do more with this patient information, Xerox is working with researchers at PARC, A Xerox Company, to explore EHRs as a gateway to a variety of healthcare innovation possibilities. The resulting technology tools will simplify back-office and front-line processes, reduce errors, and free up caregivers to spend more time and attention on day-to-day patient care.

The "possibilities" will accomplish all these things?  

Not only does that not follow logically, but where's the data, or is this simply wishful thinking? 

The latter "possibility that will come true" - "free up caregivers to spend more time and attention on day-to-day patient care" - is the most laughable.   These systems do anything but, as for example here regarding the the time costs of data acquisition and the time costs of data input.  I have yet to see serious studies that consistently demonstrate any time savings at all for clinicians.  Quite the reverse, actually.

Of course, the mandatory marketing puffery:

“A big part of PARC’s healthcare work for Xerox is using ethnography and other social science methods to observe and analyze actual work practices – not just what people say they do,” said Steve Hoover, CEO, PARC, A Xerox Company. “If there’s one thing that this survey tells us, coupled with our own experiences, it’s that you should never develop or deploy technology outside of the human context.”

Precisely what is being done now, and on a national scale in the 'National Program for IT in the HHS.'

Xerox, either you're part of the solution or part of the problem.

Which is it?

-- SS

Health IT difficulties and controversial excuses from health IT hyperenthusiasts and extremists

As I observed at my Aug. 15, 2012 post "Contra Costa's $45 million computer health care system endangering lives, nurses say" and other posts, common in case reports of health IT difficulties is the refrain (usually from a seller, healthcare executive or health IT pundit) that:

• It's a rare event, it's just a 'glitch',  it's teething problems, it's a learning experience, we have to work the 'kinks' out, it's growing pains, etc.

Or perhaps worse:

• Patient safety was not compromised (stated long before the speaker or writer could possibly know that).

What these statements translate to:  any patient harm that may have resulted is for the "greater good" in perfecting the technology.

Here is the problem with that:

These statements, while seemingly banal, are actually highly controversial and amoral. and reflect what can be called "faith-based informatics beliefs" (i.e., enthusiasm not driven by evidence).

They are amoral because they significantly deviate from accepted medical ethics and patient rights, especially regarding experimentation or research such as the plain language of the Nuremberg code, the Belmont Report, World Medical Association Declaration of Helsinki, Guidelines for Conduct of Research Involving Human Subjects at NIH, and other documents that originated out of medical abuses of the past.

Semantic or legal arguments on the term "research", "experimentation" etc. are, at best, misdirection away the substantive issues.  Indeed, for all practical purposes the use of unfinished software (or software with newly-minted modifications) that has not been extensively tested and validated and that is suspected to or known to cause harm, without explicit informed consent, is contrary to the spirit of the aforementioned patients' rights documents.

They are excuses from health IT hyper-enthusiasts ("Ddulites"), who in fact have become so hyper-enthusiastic as to ignore the ethical issues and downsides.  The attitude gives more rights to the cybernetic device and its creators than to the patients who are subject to the device's effects.

These excuses are, in effect, from people who it would not be unreasonable to refer to as technophile extremists.

-- SS

Addendum:

The Belmont Report of the mid to late 1970's, long before health IT became at all common, actually starts out with a section discussing "BOUNDARIES BETWEEN PRACTICE AND RESEARCH."  I have updated one of the observations in that section to modern times:

 ... It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research.

... When a clinician [or entire healthcare delivery system - ed.] departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research.

Radically new procedures of this description [such as use of cybernetic intermediaries to regulate and govern care - ed.] should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation [such as health IT - ed.] be incorporated into a formal research project.

Health IT appears to have been "graduated" from experimental to tried-and-true without the formal safety research called for in the Belmont report.

The Belmont report continues:

Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.

Instead, what we have for the most part are excuses and special accommodations for health IT, on which the literature is conflicting regarding safety and efficacy, all the way up to the Institute of Medicine.

-- SS

ONC's "Health Data Palooza" - A Title of Exceptionally Bad Taste, For a "See No Evil" Meeting

The Office of the National Coordinator of Health IT has sent out this announcement:

Subject: HEALTH DATA PALOOZA III: Unleashing the Power of Data to Improve Health
From:    ONC Health IT
Date:    Thu, May 10, 2012 10:36 am

HEALTH DATA PALOOZA III: Unleashing the Power of Data to Improve Health

June 5-6th, Washington DC
Health Data and Innovation Week
www.hdiforum.org | #healthdata

CONFIRMED SPEAKERS
Kathleen Sebelius, Secretary of Health and Human Services
Marc Bertolini, CEO Aetna
Thomas Goetz, Execuitve Editor of WIRED
Atul Gawande, surgeon and author
Bill Frist, former Republican Majority Leader
Dominique Dawes, two time gold medal winner
Todd Park, US Chief Technology Officer


Hear from Farzad Mostashari, National Coordinator for Health IT on data liberation
ONC will host breakout sessions on Consumer e-Health, HealthData.gov,
and Uses of Data by ACOs
ONC will release nine challenges during this year’s event! 

This title for a government-sponsored meeting is bizarre and tasteless in my opinion.  What is deemed by ONC to be the major source of this data?  Health IT.

"Palooza?"

From Urban Dictionary:

Palooza - http://www.urbandictionary.com/define.php?term=palooza

An all-out crazy party; partying at one place with a ton of people like there's no tomorrow; The art of throwing a very drunken extravagant party with a plethora of friends

"Data Liberation?"    

What about "patient liberation" -- from risk?

Considering it unlikely that issues in the bulleted points below, commented on in detail in past posts on this blog, will be discussed at this meeting, the title of the meeting is especially tasteless:

• There is a markedly unscientific "irrational exuberance" pushing clinical IT into wide use at a dangerously rapid pace. This exuberance is contradicted by a growing body of literature that shows the benefits are likely far less than stated, e.g., by way of example, the ad-hoc set at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist 
• The technology remains experimental, its rollout is a human subjects experiment on a massive scale lacking nearly all the protections of other human subjects experimentation and for IT in mission critical settings (e.g., informed consent, formal quality control/validation/regulation, formal postmarket surveillance and reporting) due to extraordinary legal and regulatory special accommodations afforded the technology and its purveyors;
• Defects of in-use systems are rampant, inappropriately turning patients and clinicians into software alpha and beta testers (e.g., as in the voluntary FDA MAUDE database, http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html which contains information for just one HIT vendor, Cerner, who voluntarily reports such issues);
• The technology is unsupportive of clinician cognitive needs (2009 National Research Council study, which also stated that accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering will be essential to perfect this technology);
• The roles of scientific discovery and anecdote have been turned on their heads. RCT's of clinical IT are nearly non-existent and lower-level evidence (e.g., weak observational, pre-post, qualitative, and other study types) are cited as "scientific proof" of efficacy and safety justifying hundreds of billions of dollars of taxpayer (or is it Chinese loan?) expenditures.  Yet, risk management-relevant case reports of harmful events and near misses, crucial to help organizations and regulatory agencies understand risks are dismissed as "anecdotal" (e.g., Blumenthal: "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said, while ONC issued an article based on questionable research methods entitled "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" extolling the virtues of HIT, written about at http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html).
• Risks are definite, with known patient injury and death, but the magnitude is admittedly unknown by JC (2008 Sentinel Event Alert), FDA (2010 Internal memo on HIT risks and statements of Jeffrey Shuren MD JD about known harms likely being "the tip of the iceberg"), IOM (2011 report on HIT risk), ECRI Institute (Top ten healthcare technology hazards for 2011 and 2012), NORCAL Mutual Insurance Company 2009 report on EHR risks, others;
• Existence of severe impediments to information diffusion about risks explicitly admitted by FDA (2010 memo), IOM (2011 report), others;
• Usability of commercial products in real world settings is often poor (e.g., NIST 2011 study on usability), promoting "use error" (user interface designs that engender users to make errors of commission or omission, where many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc.)
• These systems promote capture and display of clinically irrelevant information in the interest of charge capture, and result in reams of "legible gibberish" with many negative characteristics that make it difficult for other clinicians and reviewers to establish a cohesive, definitive narrative of clinical events and timelines.

Health IT and health data issues are not 'partying' affairs. An un-seriousness about anything related to health IT seems in vogue of late.

Finally, I ask:  does this "Health Data Palooza" bring my Ddulite term to life?

Ddulite: Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

A Ddulite Palooza.  How charming.

Like the recent extravagances of other government agencies such as GSA in Las Vegas and the Secret Service in Colombia, let's hope this Data Palooza is a Palooza in name only.

In light of those recent scandals, calling a government sponsored meeting a "Palooza" seems inappropriate on that basis as well.

-- SS

5/13/12  Addendum:

A commenter pointed this flyer out:

(click to enlarge)

I post it here with no additional comments.

-- SS

Forbes: Obamacare Billionaire: What One Entrepreneur's Rise Says About The Future Of Medicine

An article in Forbes appeared today (4/18/12) entitled "Obamacare Billionaire: What One Entrepreneur's Rise Says About The Future Of Medicine" by Matthew Herper.

The article is largely a hagiography of Cerner founder Neal Patterson:

North Kansas City is an unlikely place to launch a revolution in American health care. Yet here, amid the dilapidated grain elevators, fast food joints and vast green plains, the dream of using computers to keep you alive at a reasonable cost is battling onward. In a bunkerlike building built to withstand a direct hit by a category five tornado, 22,000 servers handle 150 million health care transactions a day, roughly one-third of the patient data for the entire U.S. Records of your blood pressure, cholesterol, lab test results, that gallbladder surgery last year—and how much you paid for it—may sit there right now. Armed guards stand watch.

This is a data center at the headquarters of Cerner, the world’s largest stand-alone maker of health IT systems—and company number 1,621 on FORBES’ Global 2000 list—where the blood-and-guts realities of medicine meet the ­sterile speed and exactitude of the computer revolution.

Omitted are some pertinent negative accounts, such as Cerner's role in the failed £12.7bn ($20bn U.S.) National Programme for IT in the NHS (NPfIT), as described here and here.

Patterson is quoted with the standard industry bellicose grandiosity and hysterics about computers "revolutionizing" (as opposed to facilitating) medicine:

... In 1999 a report from the prestigious Institute of Medicine gave Patterson hope that the rest of medicine was ready to follow in Mayo’s footsteps. Titled “To Err Is Human,” the report detailed how between 44,000 and 98,000 people die every year in hospitals from preventable mistakes, like getting the wrong medicine or the wrong dose of the right one. The ­report specifically prescribed better computer systems as a way to prevent these deadly mistakes. Patterson cites that study as the moment when health IT entered the mainstream. But it was still slow going, and that drove him nuts. His customers at that time were more worried about the Y2K bug than they were about revolutionizing health care.

I first heard him and other HIT CEO's uttering the "revolution" line at a Microsoft Healthcare Users Group meeting ca. 1997 and attended largely by IT technicians. I was probably the only Medical Informatics-trained professional in attendance, and perhaps the only physician there.

When I then asked those in the room how many had healthcare experience or had even read the Merck Manual, few hands went up. The CEO's could not then satisfactorily explain how medicine would be "revolutionized" by such a crowd. (One of those CEO's, of erstwhile HIT vendor HBOC, was later found to be seriously cooking the books after acquisition by McKesson. See "Former McKesson HBOC Chairman Convicted of Securities Fraud; Defrauded Investors Lost in Excess of $8 Billion" at FBI.gov. Some revolution...)

Unfortunately, most medical errors have little to do with documentation, either paper or electronic, as I wrote in Dec. 2010 at "Is Healthcare IT a Solution to the Wrong Problem?". The latter, however, has introduced many new errors modes and other social-technical problems, permitted massive security breaches (it's very hard to haul away 10,000 paper charts without being noticed) and opportunities for medical records evidence spoliation simply not possible with paper.

There are a few Ddulite-ish quotes from Eric Topol and David Bates in an article with a clear tone of exalting health IT.

I am quoted in the Forbes article in about the only comment critical of health IT, and the only comment concerning the ethics of human subjects experimentation conducted with this technology, as it exists in 2012:

... the Hippocratic oath says nothing about breaking eggs to make omelets. “We’re kind of headed in the wrong direction,” says Scot Silverstein, a health IT expert at Drexel University who believes that the current systems are too prone to randomly losing data [I had cited this study - ed.] and complicating doctors’ lives.

While the "breaking eggs to make omelets" metaphor was not mine, it reminded me that I just carried out my final earthly duty for my mother, injured in mid 2010 by a health IT-related error and deceased since June 2011. I filed her final IRS tax return yesterday, the due date.

I just hope my mother is enjoying her omelet in the Pearly Gates Diner. Scrambled eggs were about all she could eat well after the health IT accident.

As a result of that experience, my new business card (phone # redacted):

(Click to enlarge)

I no longer merely write about health IT risks. I find past involvement with attorneys early in my medical career, as Manager of Medical Programs and Medical Review Officer (drug testing officer) for one of the largest public transit authorities in the United States, quite helpful in this new role.

The "eggs that get broken", as in a well known old nursery rhyme from the early 1800's, cannot be reassembled. Those injured or killed in the unregulated, thoughtless, cavalier journey to some mystical medical cybernetic utopia deserve justice, and the eggheads responsible for their harms have earned the privilege of explaining themselves in the courtroom and being properly penalized where appropriate.

The future of medicine - if it is to not become a nightmare ignoring the lessons of history, repeating the mistakes of the past - belongs to those willing to take an ethical stand in defense of medicine's core values, and in defense of patients.

-- SS

University of Arizona Medical Center, $10 million in the red in operations, to spend $100M on new EHR system

In my Oct. 2006 post "$70 million for an Electronic Medical Records system?" I wrote:

... healthcare doesn’t have the capital for clinical IT misadventures, and I believe when the issues become more public in this industry sector and information flows about mismanagement and abuses (as is happening in the UK ’s Connecting for Health project) [now abandoned as described here - ed.], the fallout won’t be pretty.

Here's an example of an organization in profound ardent technophile-driven Ddulite mode:

UA Medical Center to spend $100M on new records system

Tucson's largest health-care organization expects to spend upward of $100 million on getting its two hospitals talking to each other.

Right now, the inpatient medical record systems at the University of Arizona Medical Center's two campuses aren't speaking to each other.

The lack of communication is resulting in more work for healthcare providers in the University of Arizona Health Network.

[How much more work, exactly, and how much would a non-cybernetic solution cost? These issues seem never to be mentioned - ed.]

The $1.2 billion, nonprofit company employs nearly 7,000 people.

The network is installing a new, uniform electronic medical records system for all patients at its two hospitals - UA Medical Center - University Campus and UA Medical Center - South Campus - and at outpatient centers as well.

... Project leaders predict it will result in a more efficient organization with fewer medication errors and better patient care.

... The new system's benefits will certainly trickle down to patients, said Clint Hinman, an experienced pharmacy director within the network who is directing the computer upgrade program.

[Note once again the absolutist statements of deterministic benefit and beneficence, based on scant supportive evidence and increasing contradictory evidence, that I bolded above - ed.]

I note that $100 million+ is probably enough to pay for AN ENTIRE NEW HOSPITAL or hospital wing ... or a lot of human medical records professionals.

Executives and project leaders have probably never read any of the literature at the reading list here or at my academic site here, or if they have, choose to be blind to it and trusting of literature such as ONC's sloppy-science "should not have been published in its present form" health IT cheerleading here.

Most important of all:

It's not advisable to gamble with $100 million in that fashion, especially under these conditions:

... BUDGET ISSUES

Spending $100-million-plus on electronic medical records is a lot of money for a network that as of mid-January was at $10 million in the red in operations, BUT network spokeswoman Katie Riley said the electronic medical records are not to blame.

[Capitalization and emphasis of the "but" mine - ed.]

This statement is both representative of a healthcare system gone overboard - you don't spend on luxuries when you're $10 million in the red - and is a non-sequitur.

Who cares if the EHR's are not to blame for the system being $10 million in the red? That does not seem like a good reason to go ahead and spend $100 million (which will probably balloon to several times that figure, hence I will use $100 million++) on a very risky gamble.

Further, all it will take is a few of these mishaps to put the system further in the red.

I should also ask: will medical and other staff be laid off to afford the new systems, in effect trading people for computers?

To spend $100 million++ on HIT when you're already $10 million in the red on operations is, in my view, financially reckless.

-- SS

Nancy Finn, author of "e-Patients Live Longer", openly calls for unethical medical experimentation without consent

My construct of the "Ddulite" orientation largely driving health IT is not merely a theoretical construct. Ddulites (derived from the term "Luddite" with first four characters reversed) are:

Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

Here is an example of this disposition on display:

In a March 14, 2012 Pittsburgh Post Gazette article "Digital ease may complicate health care" by Bill Toland about the recent controversy caused by a Harvard study showing EHR's may actually increase test ordering thus raising, not lowering, medical costs, Nancy Finn, a medical consultant and author of "e-Patients Live Longer" is quoted as saying:

... In an ideal world, management would know if a software suite is going to improve health outcomes before it's rolled out, said Nancy Finn, a medical consultant and author of "e-Patients Live Longer." Unfortunately, though, uncertainty is built into the process.

"The only way to know [the systems] are inefficient and flawed is to deploy them, then correct them as we go," she said. [That is, they are experimental - ed.]

"That is the way that all of the new innovative technologies have worked over the years. We have to take the risk, and then improvements get made."

This statement in highly alien to medical ethics.

She is explicitly stating that this technology is experimental - "The only way to know [the systems] are inefficient and flawed is to deploy them" - and then states "We have to take the risk" where the "we" are unconsenting patients, i.e., not afforded the opportunity for true informed consent, and 'investigators' also often coerced to use these systems, i.e., clinicians themselves.

Never mentioned are the downsides of experimental technology such as health IT: patient injury, death, litigation against physicians and other clinicians entrapped into "use error" (errors promoted by the common mission hostility of today's health IT), or led into errors by poor software quality causing data corruption, misidentification or outright loss, and additional issues described by FDA (link) and others. Nor are ethical issues considered.

NO, Ms. Finn: "We" do NOT have to "take the risk."

There are scientific methods for improving experimental technologies such as "controlled clinical trials" with informed consent, opt-out provisions and built-in protections for patients and investigators.

The "trial and error", "learn-as-we-go", "computers' rights supercede patients' rights" approach you suggest, while perhaps appropriate for mercantile computing, is highly inappropriate for healthcare.

Such issues, I had believed, had been settled after WW2.

There is nothing to argue, and nothing to discuss.

-- SS

Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality

One manner by which Healthcare's core values are usurped is via distortions and slander about physicians and other clinicians.

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.'

I have called this personality type the "Ddulite", which is "Luddite" with the first four letter reversed. I have also pointed out that the two are not exact opposites, as the Luddites did not endanger anyone in trying to preserve their textile jobs, whereas the Ddulites in healthcare IT do endanger patients.

Yet, in the 20 years I've been professionally involved in health IT, I have frequently heard the refrain, usually from IT personnel and their management, that "Doctors resists EHRs because they are [backwards, technophobic, reactionary, dinosaurs, unable/unwilling to change, think they are Gods, ..... insert other slanderous/libelous comment].

I've heard this at Informatics meetings, at medical meetings, at commercial health IT meetings (e.g., Microsoft's Health Users Group, and at HIMSS), at government meetings (e.g., GS1 healthcare), and others.

The summary catchphrase I've heard and seen (even in the comments on this blog) is that doctors are "Luddites" while IT personnel are forward-thinking, know better than doctors, and are "Modernists."

This slander and libel of physicians and other clinicians needs to stop, and the entire issue needs to be reframed.

Doctors are pragmatists. When a new technology is rigorously shown to be beneficial to patients, and (perhaps more importantly) rigorously shown not to be of little benefit or worse, significantly harmful, doctors will embrace it. There are countless examples of this that I need not go into. They also have responsibilities, obligations, ethical considerations, liabilities, and other factors to consider in their decisions:

Pragmatism (Merriam-Webster):

: a practical approach to problems and affairs

The reality is not:

Luddite doctors <---- are in tension with ----> Modernist IT personnel

but is:

Pragmatist doctors <---- are in tension with ----> Ardent technophiles (Ddulites)

The technophiles' views may be due, on the one hand, to ignorance of medicine's true complexities and "innocent" overconfidence in technology. Unfortunately, it is a gargantuan leap of logic to go from "well, computers work in tracking FedEx packages and allowing me to withdraw money from my U.S. bank when I'm abroad, to "therefore with just a little work they will transform medicine."

Anyone familiar with even the most fundamental issues in Medical Informatics is aware of this. (This is the problem with "generic management" of healthcare IT - healthcare amateurs are unfamiliar with these issues.) Due to the complex, messy social, scientific, informational, ethical, cultural, emotional and other issues relatively unique to medicine, that leap from banking/widget tracking/mercantile computing --> medicine is probably more naive than the leap in logic, for instance, that would have a person believe since a hot air balloon can go high in the sky, it can take a person to the moon, as I observed here.

On the other hand the technophile's expressed views can also be a territorial ploy with full awareness of, and reckless disregard for, the consequences of technology's downsides.

(The CIO where I was a CMIO was well-known to be an aficionado of Sun Tzu's "Art of War" in his corporate politics - the polar opposite of a 'team player.' I might add that the doctors were fully expected to be 'team players'.)

Part of the struggle between the health IT industry and medical professionals has also been control of information flow about HIT.

This has been brought to the fore by my observation of the almost uniformly negative comments on today's HIT at the physician-only site Sermo.com. Sermo is populated, I might add, not by computerphobes but by physicians in a wide variety of specialties using computers for social networking. These comments will hopefully soon be published.

(They are not dissimilar to the many comments I reported in my Jan. 2010 post "An Honest Physician Survey on EHR's", although some might call the sponsor of the latter survey, AAPS, biased. I do not think the same can be said of Sermo.com, an open site for all physicians.)

I have mentioned on this blog the numerous impediments to flow of information about health IT's downsides, and these impediments are well described, for example, in the Joint Commission Sentinel Events Alert on Health IT (link), the FDA Internal Memorandum on H-IT Safety (link) and elsewhere (such as at link, link).

The Institute of Medicine of the National Academies noted this in their late 2011 study on EHR safety:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”

I note that the 'impediments to generating evidence' effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians", JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398.

Pragmatist physicians are quite rightly very wary of the technology as it now exists.

Ultimately, even when information on HIT risks or defects does surface, it is highly inappropriately labeled as "anecdotal" (see this post on anecdotes for why this behavior is inappropriate).

This "anecdotalist" phenomenon occurs right up to the HHS Office of the National Coordinator for Health IT (ONC), as I described in my post "Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector" and elsewhere.

Therefore, another part of reframing the pragmatism vs. technophilia issue is for clinicians to put an end to censorship of HIT adverse experiences.

I have the following practical suggestions, used myself, to start to accomplish the latter goal.

These suggestions are in the interest of protecting public health and safety:

When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

• Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).

• Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)

• Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at http://www.jointcommission.org/report_a_complaint.aspx . Also consider writing the JC senior officers (link to officer's list), whose awareness of HIT issues I can personally attest to via our correspondences.

• Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. An example of such an adverse event report I filed myself (when the involved hospital refused) is at this link in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.

• Inform the State Medical Society and local Medical Society of your locale.

• Inform the appropriate Board of Health for your locale.

• If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."

• Inform a personal attorney.

• Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.

• As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:

"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."

• If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.

• As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe.

-- SS

Increased Lab Ordering with EHR's?

ONC has once more proffered typical politically-motivated spin with regard to the Harvard study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that I wrote about at "Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access."

That study had the rather tame, reasonable conclusion:

... These findings raise the possibility that, as currently implemented, electronic access does not decrease test ordering in the office setting and may even increase it, possibly because of system features that are enticements to ordering. We conclude that use of these health information technologies, whatever their other benefits, remains unproven as an effective cost-control strategy with respect to reducing the ordering of unnecessary tests.

The ONC response (posted here at present) to such a mild conclusion about an experimental technology seemed very splenetic.

As I mentioned at the aforementioned post, ONC has thrown good science under the bus before, for political purposes in my view:

... On the other hand, coming from a political office that clearly does not understand how to conduct qualitative research and creates political promotion pieces masquerading as "research", such a statement is not surprising. See "ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" at this link, where essential research methodologies were thrown under the bus for publication in Health Affairs.
At least the deviations from rigorous research methodologies were admitted:

“... Our findings must be qualified by two important limitations: the question of publication bias [e.g., bias in evidence selection - ed.], and the fact that we implicitly gave equal weight to all studies regardless of study design or sample size.”

Unfortunately, the media, politicians, financial decisionmakers and others are likely not to really comprehend, in-depth, the full significance of that sentence.

I am in the unfortunate situation of again having to stuff ONC's - um, stuff - back into the bull.

First, hat tip to Histalk where I found the link below:

National Coordinator for HIT Farzad Mostashari, MD takes issue with the recently published report that found doctors with online access to patients’ charts ordered more tests. Mostashari disputes the study, which raised questions as to whether or not EHRs cut costs. Mostashari’s contends that the study was based on 2008 data and before the start of the Meaningful Use program and thus does not address certified EHRs’ capabilities for data exchange and clinical data support.

The fatal passage in the linked ONC piece at http://www.healthit.gov/buzz-blog/meaningful-use/study-facts/ is this:

"Also, the study data were from 2008, before the passage of the HITECH Act and the linking of payment incentives to the meaningful use of EHRs."

This seems a variation of the typical excuse-making in IT - "they were using v. 1.0; it's all fixed in the later version."

The outcomes of (Orwellian-named) "Meaningful Use" (MU) have not been studied, to my knowledge. Futher, the criteria chosen for "Meaningful Use" were primarily best guesses as to what could be beneficial. ("Meaningful Use" should have been more accurately termed "good faith use.")

Claiming that 2008 data on EHR-related test ordering is invalid because "Meaningful Use" was not in effect at the time is, in fact, jumping to an unsupported conclusion that "Meaningful Use" will counter whatever multiple medical/social factors caused the increased ordering in the first place -- because, of course, MU is "Meaningful" and deterministically guaranteed to work out, nationally, as planned, among all outpatient and inpatient settings.

This seems a form of "begging the question":

Begging the Question is a fallacy in which the premises include the claim that the conclusion is true or (directly or indirectly) assume that the conclusion is true. This sort of "reasoning" typically has the following form.

- Premises in which the truth of the conclusion is claimed or the truth of the conclusion is assumed (either directly or indirectly).
- Claim C (the conclusion) is true.

This sort of "reasoning" is fallacious because simply assuming that the conclusion is true (directly or indirectly) in the premises does not constitute evidence for that conclusion. Obviously, simply assuming a claim is true does not serve as evidence for that claim. This is especially clear in particularly blatant cases: "X is true. The evidence for this claim is that X is true."

I note that the MU criteria are themselves evolving and not finalized. Making predictions about the future is the domain of fortune tellers with crystal balls, not scientists:

Health IT WILL reduce costs and improve caregivers’ decisions and patients’ outcomes. It is written in the stars!

ONC seems to think it is capable of such certainty, as I wrote in mid-2010 at "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records":

... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

In its current piece, ONC goes on to state:

Reducing Test Orders Is Not the Way that Health IT Is Meant to Reduce Costs

The ultimate impact of EHRs on reducing cost will be through improvements in the coordination and quality of care, and the prevention of unnecessary and costly complications and hospitalizations. [Note the mysterious disappearance of the word "tests" - ed.] Providers who are embracing new delivery and payment models such as Accountable Care Organizations and Patient-Centered Medical Homes know that meaningful use of EHRs is a critical foundation for being able to improve quality while reducing cost.

That is, simply, a lie. Reducing test utilization has long been claimed as a benefit of EHR's.

For example, from http://www.healthit.gov/patients-families/benefits-health-it:

EHRs reduce unnecessary tests and procedures. Have you ever had to repeat medical tests ordered by one doctor because the results weren’t readily available to another doctor? Those tests may have been uncomfortable and inconvenient or have posed some risk, and they also cost money. Repeating tests—whether a $20 blood test or a $2,000 MRI--results in higher costs to you in the form of bigger bills and increased insurance premiums. With EHRs, all of your care providers can have access to all your test results and records at once, reducing the potential for unnecessary repeat tests.

It is also another example of "moving the goalposts", a defense often used by those without a sound argument; by politicians; and sometimes by - scoundrels.

(I observed another "moving of the goalposts" at my aforementioned post "Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access." In that post I observed Michael Furukawa, a health economist in the ONC office, stating that the researchers’ focus was not "deep enough" to support the study’s conclusions. He wrote: “The data are sound, the methods are appropriate, but the focus is limited,” he said. “They only looked at one piece of health IT.”)

Well, yes, and the piece they looked at should set off red flags that the assumptions about health IT and savings might be erroneous - not generate excuses that the goalposts were too close, and need to be moved further away.

This is not to mention that it appears most healthcare errors have little to do with documentation, as I outlined in my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?"

I particularly take issue with the ONC statement that:

... this was not a randomized trial, but an observational study (the National Ambulatory Medical Survey) that was not designed to answer the question of cost, or associations between EHRs and quality. As a result, many other variables that could affect physician behavior could not be examined in this study

Yet in the aforementioned ONC "predominantly positive results" literature survey described at this link, ONC "implicitly gave equal weight to all studies regardless of study design or sample size." Their review thus included qualitative studies that were probably not meant to be evaluative, and observational studies subject to severe methodological bias, yet all were weighted equally. Further, studies contradicting the 'narrative' of health IT efficacy and beneficence such as in this list appear to have been excluded.

This appears a prime example of, at best, "the pot calling the teakettle black", and raises doubts as to ONC's objectivity and perhaps even intellectual honesty. Of course, they are a political office with a mission, so perhaps this can be understood. (Not excused, but understood.)

ONC also views risk management-critical reports of health IT-caused harm as "anecdotal", a scientific and ethical faux pas (or is it willful blindness?) of major proportions.

As I wrote at my April 2001 post "Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector":

... This view [of negative HIT reports being 'anecdotes'] extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight that FDA's own reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:

Internal FDA memorandum on HIT risks (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010.

(My description/summary of the memorandum is at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?")

The definitive take-down of the "anecdote" canard is at this link.

One could wonder if a criteria for work at ONC is a Ddulite disposition ('Luddite' with first four characters reversed):

Ddulites: Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

Instead of logical fallacy and "spin", perhaps the ONC would be better served by sponsoring some (independent, objective) researchers to actually conduct research supporting their claims about the effects of the "Meaningful Use" program.

Finally, perhaps ONC should ask my mother what she thinks about EHRs. She has specially-acquired firsthand expertise. They can find her here.

-- SS

Addendum 3/9/12:

At my Feb. 2011 post "Does EHR-Incited Upcoding (Also Known as "Fraud") Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance " is another side effect on costs of EHR's in inpatient settings, specifically, the ED.

-- SS

Addendum 3/11/12:

Another article in 2010 by Himmelstein, Woolhandler & Wright had reached related conclusions:

Hospital Computing and the Costs and Quality of Care: A National Study

David U. Himmelstein, MD, Adam Wright, PhD,Steffie Woolhandler, MD, MPH

The American Journal of Medicine Volume 123, Issue 1 , Pages 40-46, January 2010

Background

Many believe that computerization will improve health care quality, reduce costs, and increase administrative efficiency. However, no previous studies have examined computerization's cost and quality impacts at a diverse national sample of hospitals.

Methods

We linked data from an annual survey of computerization at approximately 4000 hospitals for the period from 2003 to 2007 with administrative cost data from Medicare Cost Reports and cost and quality data from the 2008 Dartmouth Health Atlas. We calculated an overall computerization score and 3 subscores based on 24 individual computer applications, including the use of computerized practitioner order entry and electronic medical records. We analyzed whether more computerized hospitals had lower costs of care or administration, or better quality. We also compared hospitals included on a list of the “100 Most Wired” with others.

Results

More computerized hospitals had higher total costs in bivariate analyses (r=0.06, P=.001) but not multivariate analyses (P=.69). Neither overall computerization scores nor subscores were consistently related to administrative costs, but hospitals that increased computerization faster had more rapid administrative cost increases (P=.0001). Higher overall computerization scores correlated weakly with better quality scores for acute myocardial infarction (r=0.07, P=.003), but not for heart failure, pneumonia, or the 3 conditions combined. In multivariate analyses, more computerized hospitals had slightly better quality. Hospitals on the “Most Wired” list performed no better than others on quality, costs, or administrative costs.

Conclusion

As currently implemented, hospital computing might modestly improve process measures of quality but does not reduce administrative or overall costs.

-- SS