Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?

Meaningful use before meaningful usability?

The Dept. of HHS today has released the final version of "Meaningful Use" rules on HIT, which can be seen here: Meaningful Use – Final Version Full Text.

By what category of diligence were the rules for "meaningful use" finalized on the same date that a NIST conference is being held on health IT "usability" ("Usability in Health IT: Technical Strategy, Research, and Implementation", http://www.nist.gov/itl/usability_hit.cfm), implying there's a problem with usability of these experimental devices physicians are supposed to "meaningfully use?"

Don't take my word on the issue of usability problems...

The National Research Council of the National Academies (considered the highest scientific authority in the U.S.) issued a 2009 report on HIT. In that report, presided over by noted HIT pioneers G. Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt), were findings that current HIT does not support clinicians' cognitive needs as here:

CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT

WASHINGTON -- Current efforts aimed at the nationwide deployment of health care information technology (IT) will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause, says a new report from the National Research Council. The report, based partially on site visits to eight U.S. medical centers considered leaders in the field of health care IT, concludes that greater emphasis should be placed on information technology that provides health care workers and patients with cognitive support, such as assistance in decision-making and problem-solving.

How about HIT industry trade/"educational" group HIMSS itself? I think reasonable people might conclude the technology is not ready for "meaningful use" on a national scale from their mid 2009 report:

Defining and Testing EMR Usability: Principles and Proposed Methods of EMR Usability Evaluation and Rating (PDF)
HIMSS EHR Usability Task Force
June 2009

EXECUTIVE SUMMARY
Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available. Achieving the healthcare reform goals of broad EMR adoption and “meaningful use” will require that efficiency and usability be effectively addressed at a fundamental level.

These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.

Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the risks entailed.

For crying out loud, talk about putting the cart before the horse...

Something's very wrong here...

However, this situation is anything but humorous.

How more "cart before the horse" can government get?

Poor usability promotes medical error. Medical error puts patients at risk of iatrogenic injury and death.

Are we are entering an era of cybernetic medical assault on our patients (and perhaps criminal negligence and manslaughter, a term I do not use lightly) through irrational exuberance in computing -- and through exuberance about the profits to be made by the HIT industry?

Unless we slow down in our exuberance and recklessness on HIT diffusion, my fear is that we very well might be.

-- SS

Addendum:

Also see my followup July 14, 2010 post "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records."

-- SS

NSW Nightmare and Overuse of Computers: Do We Really Need Full EHR's in ED's?

At "From Down Under: The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" I posted excerpts from a paper of the same name by an Australian medical informatics specialist, Professor Jon Patrick from the Health Information Technologies Research Laboratory (HITRL), University of Sydney, about what appears to be an Emergency Department (ED) nightmare. The paper is here. [10/24 note: not available at present at this link or from its author in Australia; I pulled it from the Drexel U. server in the U.S. at the author's request while his right to post it on his department's server in Australia is being discussed Down Under - ed.]

[2010 update: the paper is now at the following link (PDF): A Critical Essay on the Deployment of an ED Clinical Information System - Systemic Failure or Bad Luck, version 6. Prof. Jon Patrick, Health Information Technologies Research Laboratory, University of Sydney, Australia, Dec. 2009.]

Those excerpts should be frightening to anyone who ever gets ill and might need to visit an ED (meaning, all of us).

An ED electronic health record system (EHR) is being installed in an entire Australian state, New South Wales (NSW), with 200+ hospitals that apparently presents a mission hostile user experience and is causing great opposition by critical care physicians in a setting where death can occur - suddenly and irreversibly - in the flash of an eye.

His essay about the problems with complex EHR's (of American design and manufacture, no less) being installed in Australian ED's -- without doubt a highly expensive undertaking -- raises several questions about both the EHR industry and hospitals themselves.

When I was a CMIO at a 1400+ bed hospital system a decade ago, a regional center in a state with very few hospitals at all (Medical Center of Delaware, now Christiana Care Health System), I counseled that the best solution in my opinion for the very, very busy ED was document imaging of paper, supplemented by a nurse/intake triage system to rapidly record and/or confirm basics (e.g., meds/major problems/allergies/vitals) that was interfaced to the main EHR system.

I based this on the assessment that in the ED, a localized and "closed" environment, the incidence of charts getting lost or writing being illegible resulting in adverse outcomes was minimal. ED charts also did not get lost when patients moved to the floors and the information passed along on paper was adequate for quick transfer and acceptance. Therefore we felt images of past ED charts (of paper) would be satisfactory for assisting care in the ED, where time constraints and hectic pace made the type of EHR system and primary data entry described in the Australian paper disadvantageous (and for exactly the reasons described in the above linked essay from Down Under).

Document imaging is a proven technology that works well even in high volume settings. For example I managed a pharma departmental budget of $13 million, as did an entire pharma company, using an enterprise document imaging system.

I've also been startled by the ED EHR installed at the hospital where I take my mother, who unfortunately has needed far too many admissions in recent years than I care to see. Some of the ED staff were my former medical colleagues and even high school classmates. They've told me, in no uncertain terms, that they felt the system was terrible, again for many of the reasons cited in the Australian essay. My own views of it (albeit brief) showed what appeared to be a mission hostile user environment, including multiple very tiny pulldowns, cornucopia-like picklists, and screens.

Most recently that system did not prevent busy ED docs from almost giving my mother Levaquin after her telling the triage nurse it had caused tendon rupture in the past - and the data being entered. They actually brought in a bag of it to hang, and if I'd not been there as medical advocate for my mother they might have given it. Then when she got to the floor, the next day they almost gave it to her again, except by this time mom was her own medical advocate. I trained in that hospital, and as Admitting Officer for the ED held the record for the most number of admissions, ever, in one night (New Year's Eve 1986), when it was beyond crazy, starting out with one of our own physicians being brought in, shot in the chest, and dying after open heart massage just to set the mood.

The surgeons did the cutting. The heart massage was relegated to the physician present who didn't cut - the internal medicine representative - me.

We managed to treat hundreds and admit several dozens of sick patients using paper, and despite our gloomy emotional state not a single error occurred, to my knowledge.

With all this in mind, I raise these questions:

• Can the EHR industry actually produce a competent ED EHR that can be used by ED physicians to enter detailed data in real time?

• Do we really need full EHR's in the ED?

• A related question: is the extent of ED adverse events related to lost or illegible ED charts (that could not be remediated with non-technology-based solutions far less expensive and troublesome than EHR's) known to a significant degree of confidence?

• Is there trustworthy literature that shows that the time, expense, and resources for a full ED EHR are worth it in terms of clinical outcomes, ROI etc.? (By trustworthy, I mean scientific peer reviewed literature without author conflict of interest - common in biomedicine as readers of this and other healthcare blogs know, e.g., see this link - not glossy pseudo-P.R. health IT throwaway journals.)

• Considering that the literature on benefits of EHR's in general is equivocal, I should also ask, is there literature that refutes the value of full ED EHR's, or shows it as possibly having a negative return?
  

Or:

• Are we over-computerizing healthcare, even specialties and subspecialties where doing so might actually be deleterious due to the nature of their specific medical environments, just because "we can" (and because there is money to be made by some)?

• Are we doing so based on irrational exuberance, leap of faith, hope, and/or an uncritical belief that if health IT provides benefits to medical domain "A0", it therefore must benefit medical domains and subdomains B1 to B99 through Z1 to Z99 as well?
  

I am concerned about the probability that the latter is the case.

I think it not unreasonable to ask these questions before we in the United States spend billions of dollars on our own ED's.

-- SS

Wharton on Healthcare IT: Can I Go Home Now?

Professors at the Wharton School of the University of Pennsylvania (one of the most prestigious business colleges in the world) had some very interesting observations about healthcare IT yesterday in an article entitled:

"Information Technology: Not a Cure for the High Cost of Health Care."

I have been writing on these same themes - irrational exuberance, HIT not being a panacea or cybernetic miracle, HIT as a facilitating tool in medicine, not a revolutionary one (but only if "done right"), inadequate research to back up the often grandiose claims, and so forth for over a decade ("Contemporary Issues in Medical Informatics: Common Examples of Healthcare IT Failure", link). I penned such sacrilege, often at risk to my career due the unpopularity of these ideas, itself due to the irrational exuberance of the HIT community (these attitudes were perhaps in part manufactured by a healthcare IT lobby).

Here are excerpts of what Wharton professors observed. Do read the entire article at the link above:

President Obama made information technology a linchpin in his plan to reform health care when he included $19 billion in computerized medical record funding in the $787 billion American Recovery and Reinvestment Act of 2009. The goal: Use technology to reduce costs and improve the quality of care. The reality: Technology could increase health care costs without markedly improving quality, according to experts at Wharton [except perhaps in very highly specialized projects, not easily portable, such as here - and not without its own set of problems - ed.]

... "No one has done the careful research to indicate that if one health care system has information technology and the other doesn't, then the care is different. There are no controlled trials," says Mark Pauly, a health care management professor at Wharton. All that technology is no panacea, he warns. In fact, he believes IT could actually raise costs because of culture clashes, training, the implementation of the systems [I would say "the mayhem that often goes on during the implementation" - ed.] and the labor required to maintain the new technology.

"The best-case scenario is that information technology will improve quality but not lower costs. The worst case is that there's no difference at all." [I believe if HIT is "done well", we can achieve best case, and lower costs as well to an extent, but there is enormous complexity behind the two simple words "done well" that I'm not sure we've fully mastered as a society yet - ed.]

... That opinion is echoed by other experts at Wharton and the University of Pennsylvania. "The focus on IT in health care is a good thing, but there's way too much hype about it [an understatement - ed.] and misunderstanding about what the benefits will be and how quickly they will come," says Peter Gabriel, medical director of clinical information systems at the University of Pennsylvania Health System.

[Kevin Volpp, professor of medicine and health care management] agrees that tracking real cost savings from health care IT is a difficult task, but he expects there to be some benefits from spotting and eliminating redundant care. [Agree - ed.] But those benefits aren't likely to add up to big savings, says Lawton R. Burns, director of the Wharton Center for Health Management and Economics. "I agree that information technology is important, but it's not the slam dunk it's portrayed to be," he says. The chase to reduce costs, improve quality and expand coverage is deemed the "iron triangle of health care. A lot of us wince [at that goal]," Burns notes. "It's arguable that we can't do any of those things well."

David A. Asch, a Wharton health care management and economics professor, agrees that technology is a big part of reform. "No one is arguing against it, but that doesn't mean that it's not oversold," he says. Gabriel likens the fascination over IT in health care to a shiny new object that's easier to focus on relative to more daunting issues.

... In addition, it's unclear what cultural issues [a big theme in my writings - ed.] will emerge as information technology is adopted. These cultural issues are in the forefront of primary care physician relationships. Experts at Wharton and Penn say physicians are generally skeptical of the technology movement. How much will a technology overhaul add to operating costs? How much will it cost to retrain workers? What's the electronic record learning curve? And what happens when a doctor has a laptop between him and the patient?

"Individual physicians just don't know where the money is going to come from," says Pauly. "If IT is tied to reimbursements it could work, but [many] are skeptical." Burns adds that the physician-patient relationship can also be altered. "Technology adoption changes the way you practice. What happens when your primary care physician is looking at his screen instead of you?"

All themes obvious to me after an informatics fellowship and term as CMIO at a major hospital, and to a number of my like minded colleagues as well. However, these themes were as hard to get published and recognized (i.e., turned into "memes") as a book against Global Warming ...

The Wharton article concludes with this pithy wisdom:

Experts say these projects are worth the effort, but the industry should keep its expectations in check [i.e., ditch the irrational exuberance - ed.] and closely scrutinize investments. "To the extent [that] these technologies improve the quality of care and get the patient more involved, I'm all for them," says [Richard Neill, residency director and vice chair at the University of Pennsylvania's Department of Family Medicine and Community Health]. "But the technology is not a sea change -- just a chance to change."

Anyone in Washington listening?

Finally, after a decade of writing on these same observations to a public apparently inclined to believe the myths and promised cybernetic miracles nourished by the IT industry, and getting nowhere until some very serious organizations caught on this year and joined in (the Joint Commission, the National Research Council, UK House of Commons, JAMA, AMIA, Wharton, etc.) I ask: can I go home now?

-- SS

Harvard's EMR Justification: We Just Have To Do Something?

I think what I termed "irrational exuberance" over health IT is now devolving into just simple irrationality.

I am unfamiliar with the reasoning employed below (in boldface) by the Harvard researcher, Ashish Jha, MD, MPH (who authored the April 2009 EHR usage survey "Use of Electronic Health Records in U.S. Hospitals" in the NEJM).

From "Cash for Computers", HealthLeaders Media, May 11, 2009. First, my opinions:

... "This forced timeline [by 2014] is a very bad thing. I'm concerned it is going to take an experimental technology and turn it into a train wreck," Silverstein [me - ed.] says. "We need a more gradual process where we can learn from mistakes on a small scale to avoid reproducing them on a large scale ... So now, Silverstein says, healthcare providers are caught between their mission to provide quality care and the financial pressure to install an unproven technology that may threaten the mission.

"Health IT, when it's done correctly, can improve healthcare and reduce costs. But health IT when it is not done well has the exact reverse potential," Silverstein says. "It can impair healthcare, decrease quality, and create other adverse effects for patients. That is the missing element in this discussion."

Then, Jha's:

A need to act

Others aren't so pessimistic. Jha [Ashish Jha, MD, MPH, the lead author of the survey, and an associate professor of health policy and management at Harvard] says hospitals will have five years to establish EHR before federal penalties kick in. And because it involves the federal government, Jha says it's more than likely that those deadlines will get pushed back even further [not according to ONC chair and fellow Harvard professor David Blumenthal, who as I noted in this post said HIT timelines were "cemented in law" - ed.]

Jha says critics are "missing the point."

"I'm not suggesting EHR is going to be a panacea, but the one thing that is absolutely true is there is nothing else out there now that has any more political appeal," Jha says. "Everybody agrees, whether you are a conservative, moderate, or liberal, that we have to do something about healthcare. So the one place where we can all come to agreement is we have to do something about electronic records."

$20+ billion and penalties upon already squeezed practitioners and hospitals for non-adoption of expensive, experimental technology is a lot of "doing something.", especially at a time when many are medically uninsured or underserved.

I am also not sure about what point critics are "missing." (Note: I am not a critic, but am a gadfly of healthcare IT mis-design, mismanagement and fraud.)

It appears that reasoning at Harvard has dropped to the level of "we should do it, because we have to do something." Good intentions trump outcomes. Not to make a comparison between HIT and other types of medical experimentation, but it's likely the PI's of the Tuskegee Experiment felt the same way.

Ironically, Harvard is home to Medical Informatics pioneers such as Dr. Octo Barnett, coauthor of the National Research Council report warning that approaches to today's HIT are inadequate.

-- SS

Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?

We are now engaged in a worldwide economic crisis, the likes of which have probably not been seen since the 1920's.

In "Bank Bailout Puts £12.7bn NHS Electronic Medical Record Project In Jeopardy" I commented on how the world financial crisis of 2008 combined with chronic project difficulties and mismanagement was creating such high levels of doubt about the UK's Connecting for Health (CfH) national program for electronic health records (EHR's), that the program was under consideration for cancellation.

From that post:

Christine Connelly, the Department of Health's recently appointed head of informatics, is understood to be reviewing whether the programme is a cost-effective way of improving the quality and safety of patient care.

She will have to find compelling arguments to stop the Treasury earmarking health service IT as a candidate for cuts to compensate for the billions spent on the bailout of the banks. However, the high cost of cancelling contracts with IT suppliers may be a factor saving the programme from cancellation.

More on Connelly, the "recently appointed head of informatics" later.

In the United States, we need to consider the implications of this towards our own ambitious plans for national health records.

Either we get it right, or we should not pursue it at all under the current economic downturn. There are millions of uninsured and underserved people in this country who would benefit far more tangibly from funding of healthcare services rather than funding of ambitious health records projects that transfer scarce capital from the healthcare to the IT sector. These are initiatives that are demonstrably fraught with peril (as in the UK), that healthcare organizations and clinicians may not truly want to succeed, and with unproven ROI and unclear quality improvement benefits (see "Do Healthcare Organizations Truly Want Electronic Health Records To Succeed?").

If we are going to stay on our present course and commit billions of dollars to ambitious IT projects that might be better spent on healthcare provision, we damn well better learn something from the UK experience. I am unfortunately doubtful of this.

As I state at my academic site on HIT difficulties (link), learning from others' mistakes - learning what not to do, aside from "best practices" - is important. However, one fundamental lesson to be learned of the highest importance is on leadership of HIT. Towards that end I provide additional material on the UK's national EMR difficulties.

At Healthcare Renewal, Roy Poses and I have often noted the lack of biomedical or healthcare credentials in the "C" level and board leadership of healthcare delivery and healthcare supporting organizations such as pharmaceuticals and medical devices and technology companies.

Here is more on the stunning UK CfH problems, followed by an interesting (and predictable!) finding on its new leadership.

From The Telegraph:

NHS IT system 'at a standstill'

By Kate Devlin, Medical Correspondent Last Updated: 6:24PM GMT 28 Oct 2008

The roll-out of a flagship £12billion NHS IT system has come to a standstill in many parts of the country because of problems with the system, the NHS has admitted. Ministers want the computer programme, one of the largest in the world, to eventually contain the medical records of every patient in the country. But NHS bosses in London have decided to halt the roll-out of the electronic care records to hospitals indefinitely, to sort out technical problems.

From E-Health Insider:

Political row over NPfIT: London on hold
28 Oct 2008

Opposition politicians have renewed their condemnation of the National Programme for IT in the NHS following press reports that the programme is “grinding to a halt.”

Conservative shadow health spokesman Stephen O’Brien said the reports confirmed that, with the “hugely expensive” programme “desperately behind schedule” suppliers were “deserting in droves” and “frontline professionals” were “voting with their feet and insisting on local solutions.”

Meanwhile, Liberal Democrat health spokesman Norman Lamb issued a statement saying that the “centralised project” had been “a shambles from the start” and it was “time for a re-think on how to proceed.”

The latest round of political attacks on the national programme follow the publication of an article in the Financial Times, arguing that progress on one aspect of the £12 billion project, the deployment of “strategic” care records systems, has stalled.

The article reviewed a number of recent stories that suggest this and questioned whether the programme would ever be completed.

... It noted that hospitals that have taken the London Release 1 version of Cerner’s Millennium care record service are experiencing problems with it and that further deployments that were scheduled for this year are showing no sign of going ahead.

And it noted that although health ministers promised that the much-delayed first installation of iSoft’s Lorenzo care record system would take place in Morecambe Bay this summer, the system has not gone live and neither the trust nor NHS Connecting for Health can give a date for go-live.

Jon Hoeksma, editor of E-Health Insider, was quoted as saying that while other parts of the programme continue to make progress, “this key part seems to be simply stuck. It has ground to a halt.”

Other national papers picked up the story, prompting an apparent admission that in London at least further deployments have been put on hold indefinitely.

This from Financial Times:

NHS records project grinds to halt
By Nicholas Timmins, Public Policy Editor
Monday Oct 27 2008 18:30

Progress on the £12bn computer programme designed to give doctors instant access to patients' records across the country has virtually ground to a halt, raising questions about whether the world's biggest civil information technology project will ever be finished.

Since [its launch in 2002], however, just one of the scores of acute care hospitals due to install the underlying administration system required in order for the patient record to work has done so. The hospital, Royal Free NHS Trust in London, continues to have difficulties getting it to operate properly.

... Health ministers originally promised the long-delayed first installation of patient record software in the north of England would finally take place in June at Morecambe Bay on the Lancashire/Cumbria border. But four months on, the system has still not gone live and neither Morecambe Bay nor Connecting for Health can give a date when it might.

CfH's most recent published plans for the next three months do not include a single installation of a patient administration system into any acute hospital trust.... Hospital chief executives, he said, did not want to take a new system "until they have seen it put in pretty flawlessly elsewhere".

And this from the Evening Standard (UK):

£12bn NHS computer system crashes at the first attempt
Anna Davis
Oct. 30, 2008

THE roll-out of a new computer system to every London hospital has been frozen after being installed in just one organisation.

IT experts have stopped setting up the software across the capital and have rushed to sort out problems caused by the system at the Royal Free Hampstead NHS trust the only acute hospital to have installed it so far.

It is the latest blow for the £12billion national programme, designed to give doctors access to patients' records wherever they are in the country.

The system has been beset with software glitches and design faults. One internal health service document said it could put seriously ill patients at risk of being inaccurately diagnosed.

According to the document, it is routinely crashing, intermittently losing patient information, and some staff are reverting to pen and paper.

It seems this UK program, which has already resulted in the expenditure of billions of dollars, is not at all meeting expectations. In fact, it may die.

This raises a few questions:

• Could this CfH debacle have been prevented?

• Could this scenario find itself repeated here in the United States?

I offer the opinion that the answer to both of these questions is a resounding "yes."

On the first question, the answer is related directly to the issue of leadership expertise as I explain in some detail at my academic teaching site "Sociotechnologic Issues in Clinical Computing: Common Examples of Healthcare IT Difficulties." At that site I wrote:

... diffusion of clinical information technology (IT specifically intended for use by clinicians in clinical care settings) after 30-plus years of effort and billions of dollars spent remains limited.

... This website is concerned with the reasons for this apparent paradox ... While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition: the benefits will be realized only if clinical IT is done well. For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources.

Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity. This website is about the meaning of "done well" in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.

Of note regarding leadership changes in the UK CfH electronic medical records program and its IT leadership:

Two senior management appointments for NHS National Programme for IT announced
12 August 2008

The Department of Health has announced the two long-awaited senior management appointments for the National Programme for IT ... The Department announced in February that it was recruiting the two positions as part of a revised governance structure for handling informatics in the Department of Health.

Christine Connelly will be the first Chief Information Officer for Health and will focus on developing and delivering the Department's overall information strategy and integrating leadership across the NHS and associated bodies including NHS Connecting for Health and the NHS Information Centre for Health and Social Care.

Christine Connelly was previously Chief Information Officer at Cadbury Schweppes with direct control of all IT operations and projects. She also spent over 20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business.

Martin Bellamy will be the Director of Programme and System Delivery. He will lead NHS Connecting for Health and focus on enhancing partnerships with and within the NHS. Martin Bellamy has worked for the Department for Work and Pensions since 2003. His main role has been as CIO of the Pension Service. He has also held the positions of Group Applications Director in Corporate IT, and as Senior Responsible Officer for Information Management in the DWP Change Programme. He was previously a partner with KPMG Consulting in London, and has also worked in Reuters where his roles included Head of Real Time Technology and Director of News Products Development.

Cadbury Schweppes? The candy and Dr. Pepper/Snapple company? Gas and Power? Pension services? To lead a national health IT initiative?

The absence of biomedical, healthcare and medical informatics expertise in this "revised governance for handling informatics" is quite remarkable.

Can government really be the sponsor of ambitious health IT projects, I wonder? Should they?

On the second question, could the UK scenario find itself repeated in the United States, the answer is most definitely 'yes.'

While there are informatics professionals at high levels within the HHS/ONC-led national initiative (not yet a formal program), the clinical IT initiatives of rank and file healthcare organization are still largely under the model of leadership by non-medical IT personnel.

Amateurs in health IT are running heath IT. One impact is a high failure rate for EHR implementations [1]. By analogy, in the field of Amateur (“ham”) Radio, I am among an uncommon group of physicians who hold high-level radio telecommunications licenses from the FCC, the Extra class, obtained after a series of examinations. I have built, operated and repaired sophisticated and powerful radio transmitters, receivers and other equipment. I can set up an emergency station with local, regional and international coverage in a very short time and communicate readily with others if needed.

Even with this background, I would not for a moment believe I should be telling commercial broadcasters, emergency services, and the military how they should be implementing and operating their wireless technologies, or managing those functions. I do not have the level of training and experience necessary. In radio, I am an amateur, not a professional.

In Electronic Health Records (EHR’s) and related clinical IT, however, a wide variety of “amateurs”, including technologists, clinicians and politicians, are telling medicine - as a field - how to implement and operate this modern and increasingly important tool of the profession.

Those IT professionals with success in the business computing field, or clinicians with some knowledge (often self taught) about information technology, are not best equipped to manage the issues in health IT. These personnel are, consistent with my amateur radio analogy above, “amateurs” in such settings, if one is truly honest about it.

As in radio, this label is not meant in a pejorative way. It is simply reality. However, the results of such a leadership model are predictable.

In effect, every HIT delay, failure, or difficulty is simply a transfer of wealth from the healthcare sector to the technology sector with one root cause being an unlikely leadership model.

"Irrational exuberance" for any technology or innovation can create - as we have learned - massive unexpected problems. This is certainly the case in IT.

Considering the uncertain ROI and QI data about healthcare IT, questionable leadership models, current financial turmoil, local clinical IT problems paralleling the more widespread problems in the UK CfH program, and the many uninsured and medically underserved communities in the U.S., I wonder if national EMR's may be an unwise pursuit in the U.S. at this time. Perhaps a moratorium on large scale healthcare IT efforts in the U.S. is warranted.

Such a move might also allow time to objectively and scientifically resolve some of the above issues.

This will certainly be an issue for the new U.S. administration.

Billions of dollars that might be spent on IT misadventure in a time of unprecedented national financial challenges and hardships might perhaps be better spent for the time being on delivery of needed medical services, health insurance and other "safety net" interventions.

-- SS

Note:

[1] Market Barriers and Challenges to Widespread Adoption of Health Information Technology. U.S. Office of the National Coordinator for Health Information Technology (accessed Nov. 13, 2008).

On the Pitfalls of Going Electronic: Should Physicians Reject Hospital EMRs?

Yes, I believe they should, and with a spine, especially when they're lousy and their design and implementation have been led by people with superficial "certification" and/or no clinical credentials whatsoever. And sometimes no discernible IT credentials, either, unless you consider the "school of hard knocks" a credential.

(More on the credentials issue below. Also see my website "Common Examples of Healthcare IT Difficulties" for more on these issues.)

A viewpoint article was just published in the NEJM by Harvard physicians Pamela Hartzband, M.D. and Jerome Groopman, M.D. entitled "Off the Record — Avoiding the Pitfalls of Going Electronic" (NEJM 358:1656-1658, April 17, 2008).

The authors note:

... The ultimate goal of the electronic medical record — a technological solution being championed by the Bush administration, the presidential candidates, and New York Mayor Michael Bloomberg, as well as Google, Microsoft, and many insurance companies — is to make all patient information immediately accessible and easily transferable and to allow its essential elements to be held by both physician and patient. The history, physical exam findings, medications, laboratory
results, and all physicians' opinions will be collected in one place and available at a single keystroke. And there is no doubt that these records offer many benefits. We worry, however, that they are being touted as a panacea for nearly all the ills of modern medicine. Before blindly embracing electronic records, we should consider their current limitations and potential downsides.

As we have increasingly used electronic medical records in our hospital and received them from other institutions, we've noticed several serious problems with the way in which notes and letters are crafted. Many times, physicians have clearly cut and pasted large blocks of text, or even complete notes, from other physicians; we have seen portions of our own notes inserted verbatim into another doctor's note. This is, in essence, a form of clinical plagiarism with potentially deleterious consequences for the patient.

Residents, rushing to complete numerous tasks for large numbers of patients, have sometimes pasted in the medical history and the history of the present illness from someone else's note even before the patient arrives at the clinic. Efficient? Yes. Useful? No. This capacity to manipulate the electronic record makes it far too easy for trainees to avoid taking their own histories and coming to their own conclusions about what might be wrong. Senior physicians also cut and paste from their own notes, filling each note with the identical medical history, family history, social history, and review of systems. Though it may be appropriate to repeat certain information, often the primary motivation for such blanket copying is to pass scrutiny for billing. Unfortunately, these kinds of repetitive notes dull the reader, hiding the important new data.

Writing in a personal and independent way forces us to think and formulate our ideas. Notes that are meant to be focused and selective have become voluminous and templated, distracting from the key cognitive work of providing care. Such charts may satisfy the demands of third-party payers, but they are the product of a word processor, not of physicians' thoughtful review and analysis. They may be "efficient" for the purpose of documentation but not for creative clinical thinking.

In effect, the doctors have keenly observed that not only do EMR's impair documentation and thinking by seasoned professionals, especially those pressed for time, but the use of these technologies impairs the training of the next generation of physicians. I benefited much through learning how to properly document medical observations, findings, differential diagnoses, treatment plans, and other high level cognitive processes. IT designed by non clinicians with the maintenance of payor profit as a principal motivator may be, in effect, causing a further dilution in the quality of medical training. Social informatics predicts such unexpected adverse outcomes of any new information and communications technology (ICT).

However, the current environment of irrational exuberance over Health IT, as well as the potential for capital transfer from the healthcare to the IT and payer sectors and the motivators and conflicts this generates among hospital management, consultants, regulators and others, has had a marked blinding effect.

The NEJM authors also note:

Similarly, electronic medical records can reproduce all of a patient's laboratory results, often dropping them in automatically. There is no selectivity, because it takes human effort to wade through all the data and isolate the information that is pertinent to the patient's current problems. Although the intent may be to ensure thoroughness, in the new electronic sea of results, it becomes difficult to find those that are truly relevant.

A colleague at a major cancer center that recently switched to electronic medical records said that chart review during rounds has become nearly worthless. He bemoaned the vain search through meaningless repetition in multiple notes for the single line that represented a new development. "It's like `Where's Waldo?'" he said bitterly. Ironically, he has started to handwrite a list of new developments on index cards so that he can refer to them at the bedside.

...The worst kind of electronic medical record requires filling in boxes with little room for free text. Although completing such templates may help physicians survive a report-card review, it directs them to ask restrictive questions rather than engaging in a narrative-based, open-ended dialogue. Such dialogue can be key to making the correct diagnosis and to understanding which treatment best fits a patient's beliefs and needs.

... These problems, we believe, will only worsen, for even as we are pressed to see more patients per hour and to work with greater "efficiency," we must respond to demands for detailed documentation to justify our billing and protect ourselves from lawsuits. Though the electronic medical record serves these exigencies, it simultaneously risks compromising care by fostering a generic approach to diagnosis and treatment.

I agree with these assessments, especially for hospital based enterprise EMR's forced on doctors by management.

Physician leadership of HIT projects would be of great benefit. However, here's what typical healthcare organizational leaders have to say about physician leadership of HIT initiatives, in this case Denis Baker, the CIO of Sarasota Memorial Hospital, a major medical center on the Gulf Coast of Florida in an interview here:

I think that physicians bring a certain aspect to the job, but I don’t think they necessarily know how a hospital works. I think they know how their practice works and how they interact with the hospital, but I don’t think they absolutely know what nursing does, or any of the ancillary departments, and what they do.

Worse, as far as I can tell, the CIO making that statement appears to lack formal education in medicine, information systems, information technology and biomedical information science i.e., informatics. (I was unable to find any such credentials but will correct this if mistaken.)

Stereotypes of physicians do not come any more patronizing than that.

Oh, wait ... yes they do.

His statement is little different than a decade ago when I wrote this essay about stereotypes and observed others in influential positions holding marginalizing views of physicians - and indeed of professional education of any kind:

Several healthcare MIS Recruitment firms have published interesting views on healthcare MIS leadership, views that most clinicians will not identify with. " I don't think a degree gets you anything ," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers.

Healthcare MIS recruiter Betsy Hersher of Hersher Associates , Northbrook, Illinois, agreed, stating " There's nothing like the school of Hard Knocks ." (Who's Growing CIO's, Healthcare Informatics, Nov. 1998, p. 88).

In seeking out CIO talent, recruiter Lion Goodman " doesn't think clinical experience yields [hospital] IT people who have broad enough perspective . Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues ," according to Goodman.

It appears there's been little change in ten years.

Oh, wait ... yes there has been "change."

"Specialists" and "managers" in HIT projects now undergo certification by vendor-centric groups such as the Health Information Management Systems Society HIMSS.

Here's a description of the value of certication as a HIMSS Certified Professional in Healthcare Information and Management Systems (CPHIMS):

CPHIMS status provides both internal and external rewards. As a Certified Professional in Healthcare Information and Management Systems, you:

• Distinguish yourself from your peers as certified in healthcare information and management systems;
• Expand your career opportunities;
• Signal that you have mastered proven, broad-based concepts through successful completion of the Certified Professional in Healthcare Information and Management Systems Examination;
• Provide yourself with skills and tools to help you make a difference in your career, your organization, and your community;
• Enjoy the pride of recognition of knowing that you are among the elite in a critical field of healthcare; and
• Have a premier credential based on a sound assessment to distinguish yourself in an increasingly competitive marketplace.

Wow! "You are among the elite" after taking this exam!

Here are the eligibility standards:

Baccalaureate degree plus five (5) years of associated information and management systems experience*, three (3) of those years in healthcare.

Graduate degree plus three (3) years of associated information and management systems experience*, two (2) of those years in healthcare.

*Associated information and management systems experience includes experience in the following functional areas: administration/management, clinical information systems, e-health, information systems, or management engineering.

And now, the certification instrument:

The CPHIMS credential is awarded to individuals who demonstrate eligibility for the Certification Program and who successfully complete a qualifying examination. The examination consists of 115 multiple-choice test items, presented during a 2-hour session. Scoring is based on 100 items pre-selected for desirable psychometric characteristics. The additional 15 test items are included as pretest items. Performance on pretest items does not affect a candidate’s score.

That is the certification that will be used to hire more "experts" in HIT.

This is pathetic. My exams to become a licensed ham radio operator were more challenging. I consider such a credential unmeritorious at best, fraudulent at worst. (I haven't even inquired as to costs.)

However, medical credentialing exams are just a bit more thorough.

By several orders of magnitude, that is.

In conclusion, medicine is in very sad shape when in an era of out of control technology costs ($100 million for an EMR?), unclear benefit and irrational exuberance over HIT it's demanded of physicians that they use tools designed by business IT personnel, processes and methodologies best known for failure, produced by an industry rife with conflicts, whose leaders often lack substantive credentials, patronize those who do, produce ill-conceived and/or shoddy products whose use is mandated by non-clinician hospital managers and that as the NEJM writers note, impair medical practice and education.

-- SS

Blue Cross of California - Wellpoint to Use EMR's to Deny Women Prenatal Care and Encourage Abortions, it follows...

I commented on the "irrational exuberance" over healthcare IT here. Health IT is a double-edged sword. It can be used, and it can be misused. In the hands of the wrong people, it will "revolutionize healthcare" all right ... but not in the direction health informaticists and clinicians would desire.

The title of this post seems the logical outcome based on the self-initiated debacle of Blue Cross of California, as posted at Wellpoint Halts Attempts to Have Doctors "Rat Out Patients":

Blue Cross of California is sending physicians copies of health insurance applications filled out by new patients, along with a letter advising them that the company has a right to drop members who fail to disclose 'material medical history,' including 'pre-existing pregnancies.''Any condition not listed on the application that is discovered to be pre-existing should be reported to Blue Cross immediately,' the letters say.

The full extent of the "medical derangement syndrome" represented by this incident calls for elucidation that seems absent in the main stream media.

First, a plan seeking to deny coverage that specifically singles out a "condition" of "pre-existing pregnancy" is heartless beyond hope:

• Is pregnancy now considered by Wellpoint to be merely a "pre-existing condition?"
• What about women who might not have known they were pregnant at the time of application? With the history of Wellpoint's cancellation of policies, how would such situations be adjudicated, and how rapidly considering the clinical time windows involved?
• Why would such patients be subject to cancellation instead of rate adjustments? Who was to make that determination? What was it to be based on?
  

It seems to me that the intent was to deny coverage to pregnant women who did not for whatever reason disclose their pregnancy, thus pushing them towards inadequate prenatal care and/or abortions.

I would like to know the answers to the following:

• Who conceived this policy and the announcement? What committee and executives approved it?
• Did they have any idea of the all too predictable physician reaction? If yes, did they care?
• If they knew the likely reaction and did not care, why are these people in a position of authority in healthcare?
• If they did not know the predictable reaction, what are people so utterly divorced from medical culture and ethics doing in a position of authority in healthcare?
• Who hired these people?

Finally, being denied access to physicians "ratting out" their patients, it's likely Blue Cross of California will resort to using Health Information Technology and Electronic Medical Records data from physicians to provide the same information.

In effect, it seems Blue Cross of California - Wellpoint will use EMR's and other healthcare IT to deny people coverage, including denying women prenatal care and probably pushing them to have abortions.

Is this the "revolution" health informaticists had in mind when we began advancing the field of computing in medicine?

With regard to their statement "As a result, we are discontinuing the dissemination of this letter going forward", the business-speak spin term "going forward" is best translated as:

We got caught doing some seriously bad sh*t, but let's just sanitize it and brush it under the carpet.

Finally, I find it pathetically ironic that this organization expects potentially hostile-to-self-interest honesty out of its subscribers about their medical histories, when as Roy Poses pointed out, their own corporate history includes:

• Settling a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see post here).
• Being fined for cancelling individual insurance policies (again in California) after their holders filed claims (see post here)
• Being found to have mis-handled at least half of its revocations of individual policies (see post here)

Perhaps honesty best begins at home.

-- SS