The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room

The National Institute of Standards and Technology (NIST) has begun to address deficient clinical IT usability. A PDF with presentations on the topic from the recent NIST conference on HIT usability is here (warning: very large, 26 MB).

There is a critical "meta-issue" that's being ignored regarding usability, though, yet it is the elephant in the living room.

First, I will detail the elephant, then ask the simple, logical question that arises (the "inconvenient" question that nobody seems to be able to give a straight, non-marketing-spin answer to).

Here are the details of the elephant.

First, poor usability ---> increased risk to patients.

This is a first principle; it is not open to debate.

Now:

If NIST is just now getting involved in "improving HIT usability" (the improvement of which should have occurred at least two decades ago);

While HIMSS's former Chairman of the Board admits the technology remains experimental:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better;

While HIMSS itself admits in this 2009 PDF that

"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";

While the National Research Council (the highest scientific authority in the U.S.) last year reported that :

"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt);

While it's not just the user experience that's the problem, either...

Insurers are starting to recognize this, e.g., "NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" ;

While hospitals and vendors cannot yet manage the technology reliably - how many medical mistakes have/will occur as a result of screw ups like this one, now confirmed to have occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.?

This patient won't get a second chance, either.

The above issues are the elephant in the living room. Or, shall I say, in the Boardrooms and meeting rooms where health IT is planned and discussed?

Health IT is great stuff, guys; it might actually work well one day!
Let's roll it out nationally and penalize those Luddite doctors
who refuse to "use it meaningfully" because it's not very usable.
Oh, just ignore that strange creature over there in the corner ...

Considering the size and weight of the elephant, here is my question:

Why are we rolling out this technology nationally under penalty of Medicare garnishment?

I cannot get a straight, unspun answer to that question.

Perhaps we need Bill O'Reilly to ask these questions of health IT officials on his FOX News program, The O'Reilly Factor, where spin is attacked relentlessly (the "No Spin Zone.")

-- SS

Barry Chaiken, MD, MPH: "Let's be patient" with experimental devices that harm patients

At an interview of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group HIMSS and chief medical officer of Imprivata, a company specializing in healthcare IT security, Chaiken pleads for the following special accommodations for Health IT relative to other medical sectors:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better.

[Why are the health IT applications bad to begin with, I ask? - ed.]

I note the following.

• If 'we're' still learning (and I don't include people with genuine clinical computing expertise in that subgroup, but it does include the plethora of amateurs in the commercial health IT industry), then the technology is experimental.
• Worse, it's unregulated - a major special accommodation in and of itself.
  
• These sentiments about "being patient" would be appropriate - if the subjects of this experimental technology that vendors need to be "given a chance" to make better were experimental lab rats.

Instead, the subjects of the experimental technology are unwitting, unconsenting human beings, who are being used as experimental test subjects for software development, and being put at risk, injured and indeed killed by the disruptions these experimental technologies cause.

Under these realities, the position presented by Chaiken is, in my opinion, ethically perverse.

That such sentiments come from someone who holds the MD degree and who I assume took the Hippocratic oath in some form is stunning.

In the health IT industry, "Primum non nocere" seems to have been replaced with "Kybernetik über alle."

Further, the commercial health IT vendors have had the good part of five decades to "get it right." How long is long enough?

Their software is unavailable for detailed evaluation and open critique of the user experience by impartial experts, unlike open source EHR's like VistA CPRS, demo version available at this link where anyone can:

• Download the latest version of CPRS today and get access to new features including graphing functionality
• Use the software as if you were a provider by entering orders, entering documentation, retrieving reports (and graphs) and viewing alerts and notifications that help with decision support
• Learn first hand how VA’s electronic health record system works

Personally, I've had to use stealth simply to obtain and post graphical representations of some simply inexcusable commercial HIT interface sins (link). Why should a secretive industry be given additional special accommodation?

Dr. Chaiken goes on to state:

Let’s hold them accountable if they don’t [make the applications better]. Absolutely, hold them accountable if they don’t; and the marketplace, I hope, will be able to make those choices and hold them accountable when they don’t. But, we’re still learning.

Again, I'm not sure who the "we're" refers to, but "holding companies accountable" will not really help victims of the experiments who are seriously injured or killed.

A better solution, as I have written on this blog (such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and at other sites as well:

Protect patients. Constrain the health IT experiment temporally and geographically, and apply the laws, customs and regulations of medical experimentation until this industry "has learned" whatever lessons Chaiken thinks they need to learn, e.g., from decades of Medical Informatics, Social Informatics, Computer Science, HCI and other research. None of these fields - last time I looked - are classified or protected intellectual property. Share information on patient adverse outcomes and near misses, instead of concealing them and contractually gagging users from openly speaking about problems.

That would be the ethical approach.

Further, how many more decades should we wait for the health IT industry to figure out how to look for better leaders beyond the "school of hard knocks" bias that's existed for at least the past decade? How many substandard health IT leaders were placed in hospitals the past few decades as a result of outrageous attitudes like these below from the major recrutiers, centered on spreading the wealth?

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." 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. Healthcare Informatics, "Who's Growing CIO's."

[No, that line about 'being consumed with patient care issues' as a strike against health IT leadership didn't come from a Scott Adams business-idiot parody cartoon - ed.]

As in clinical medicine itself, if you're going to be anywhere near patient care and making decisions affecting its delivery, a degree damn well "gets you something."

At about the same time the above appeared in Healthcare Informatics, a generalist IT recruiter wrote me this:

... What is happening to MDs trying to change careers is providing a window into broader issues about professionals in society today - narrow training, pigeonholing in the marketplace, difficulty making lateral and cross-industry transition, what a handicap it is to be creative, entrepreneurial, or cross-disciplinary in the current marketplace, and the wasted intellectual capital represented by the high caliber of individuals who can't find ways to fruitfully plug themselves into the marketplace.

I continue to be amazed at this general phenomenon...the remarkable quality of a number of candidates I've met, and the lack of recruiters' ability to get them in the door of good companies. The interesting part of the story is that when I am able to get access to high level execs in some of these companies (not just IT, but devices, pharmaceuticals, etc. also) they are dismayed at the quality of those that they hire. They know that something is wrong in how the recruitment process is working. (eg, one of the major device cos. just devoted the time of 1 FTE in Human Resources to 'finding innovative ways of identifying and recruiting good talent into the company.')

Whose fault were the outrageous, deleterious hiring practices prevalent in this industry that contributed materially to its production of substandard products, hiring practices that persist to this day? (See example here.)

Why should we be "patient", and "give them [yet more chances] to figure out the right way to do this", and why should patients permit themselves to continue to be guinea pigs to such a sloppy, cavalier industry?

I note that Chaiken's credentials appear to fit the template, as colleague Roy Poses describes at various posts including here, of an "executive isolated from the real world of health care" and member of the superclass. From the interview linked above:

... According to your LinkedIn profile, you’re CMO for Imprivata, CMIO for Symphony Corporation, and CMO of DocsNetwork. You’re on a couple of advisory boards, you own a vineyard, and you just finished your term as chair of the HIMSS board.

Perhaps that helps explain the mantra of "computers [and profit] first, patients second."

Finally, in answer to my own question above "Why are the health IT applications bad to begin with", I suggest complacency, incompetence, willful ignorance, and negligence (including criminal negligence) as possible answers.

-- SS

Addendum:

The following in today's WSJ caught my eye ("What we've learned from the Gulf spill", Michio Kaku, July 20, 2010):

The nagging question is: Why did it take so long? Why couldn't they have capped the leak months ago? For three agonizing months, BP's engineers and executives were essentially making things up as they went along, conducting a billion dollar science project with the American people as guinea pigs. The basic science of stopping oil leaks at 5,000 feet below sea level should have been done years ago.

Concepts are similar. With just a few edits, we have this:

The nagging question is: Why is it taking so long? Why couldn't they have learned to create useful health IT decades ago? For at least thirty agonizing years, Health IT vendors' engineers and executives were essentially making things up as they went along, conducting a multibillion dollar science project with the American people as guinea pigs. The basic science of producing safe, effective, usable health IT should have been done years ago.

-- SS

FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary MAUDE (Manufacturer and User Facility Device Experience) database below.

From FDA's description of MAUDE:

• MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
• The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
• MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.

I somehow missed the following case when I wrote the Oct. 2009 post 'Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault' but I have added it there as well:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460
CERNER MILLENIUM POWERCHART CPOE
Event Date 11/19/2006
Event Type: Death
Patient Outcome: Death

The medication review screen of the subject device does not specify the exact dose in milligrams of combination medications. For example, narcotics are combined with tylenol in at least two strengths. Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The exact dose of tylenol is not specified and requires knowledge of the combination medication dose in the volume specified.

Certain fields of the grid do not specify the volume, but rather state "date/time" requiring another click or pop up screen. The immediate knowledge of tylenol dosage in mg is directly related to understanding and preventing excessive doses. In the subject, 10 ml of acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours. That means that 1950 mg of tylenol was administered in 4 hours while the patient was in a state of starvation and receiving other medication that increase the effects of tylenol.

This dose would equate to 11,700 mg of tylenol over 24 hours, nearly 3 times the maximum daily dose in otherwise health people. In the ensuing days, the patient developed acute renal failure, presumably acute tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology ante-mortem. The counterintuitive screen impaired the professionals. The pharmacist did not recognize and stop the medication, the nurses administered it, and the excessive dose, clinically meaninglessly listed as a volume of 10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone, was missed by the physicians. Adverse events have been ascribed to "user error" by vendors.

The device offers a potent propensity to life endangering oversights. There are other screens on this device which present information that interfere with clinically useful visualization of data. [Who designed these screens, I ask? Clinicians, or business IT personnel used to designing inventory systems for widget control? - ed.] The data does not flow to the professionals. It is not represented in a meaningfully useful manner.

The professionals need to hunt for it. As such, the user unfriendly screens [see this link on mission hostile HIT - ed.] impair safe medical care consistent with the impediment to expedient professional understanding of what, exactly, is the dose of medication and how much was administered to the patient. This sentinel case of death is directly attributed to user unfriendly screens on this device.

How many cases like this, as well as "near misses" related to health IT go unreported, nationwide and worldwide?

As in my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT", nobody really knows; these devices are unregulated with no requirements for reporting.

However, let's roll it out nationally anyway, because HIT will deterministically "revolutionize" medicine. Just ignore those spoil-the-party, man-behind-the-curtain prattle from writers like these.

We can safely ignore all contrarian research and literature, of course, as we all know HIT will revolutionize medicine from the definitive certainty of HHS in "The 'Meaningful Use' Regulation for Electronic Health Records", NEJM, Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010):

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.

[Except for those who haven't - ed.]

And our government's called BP Energy Company cavalier?

I offer no additional comments.

-- SS

Meaningful Use Final Rule: Have the Administration and ONC Gone Insane 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 insane can government get?

Poor usability promotes medical error. Medical error puts patients at risk of iatrogenic injury and death - such as the one suffered in May 2010 by my own mother.

My mother, in ICU on ventilator after iatrogenic cerebral hemorrhage, May 2010, after receiving the 'rewards' of electronic medical record beneficence that caused a critical cardiac medication to 'disappear' from her current meds list. Still in hospital as of this writing in mid July.

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

David Blumenthal on health IT safety: nothing to see here, move along

At "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just Tip of Iceberg" I wrote about a meeting of the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010. The topic was "HIT safety." The agenda, presenters and presentations are available at this link.

At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking.

He wrote:

... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

Well, there's absolutely nothing to worry about, according to the Office of the National Coordinator and Dr. David Blumenthal. Nothing to see here. Move on.

Blumenthal has just reportedly stated that:

http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented

... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "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.

I ask a simple question:

• Are these the words to be reasonably expected from an academic physician/scientist?

Perhaps I'm a bit behind these postmodern times, but I once believed the perhaps now old-fashioned and obsolete view that a scientist would not base a conclusion of medical safety in national dissemination of drug, device, or whatever on some analysis of anecdotal data, whether 'preliminary' or final.

Due to reasons such as the lack of knowledge of FDA as a place to report HIT problems, as well as fear by clinicians in reporting HIT problems at all, the cited FDA data (260 HIT-related adverse events over two years, including 44 reported injuries and six deaths) is most certainly anecdotal and incomplete, and potentially (per FDA's Jeff Shuren, MD, JD) the "tip of the iceberg."

I would not take the FDA data to be anything but a possible red flag, not a source of truth, one way or the other.

For example, the scant reports of health IT bugs and defects -- many of which admittedly could cause medical error -- in another database, MAUDE, voluntarily submitted by just a tiny fraction of the HIT vendors, should give a scientist pause. They are a sentinel. (See my Oct. 2009 post "Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault" for several MAUDE database examples).

Obviously, the unreported, unrecognized (and therefore uncorrected) bugs and defects have the same potential. Those MAUDE reports alone should provide an impetus to call for full, rigorous, scientific, uncensored investigations on HIT safety, not make pronouncements on safety to a national audience.

Proof by lack of evidence is not what I was taught in medical school.

Blumenthal appears to be speaking not as a scientist, but as a marketer and (of course) politician.

This is quite disappointing.

However, as the man said, nothing to see here, move along.

By the way, I am assuming the "analysis" will be open to public scrutiny.

-- SS

A Short, Pithy, Open Letter to the National Coordinator for Health IT Dr. David Blumenthal

Sent: Wednesday, April 21, 2010 7:17 AM
To: David.Blumenthal@hhs.gov
Cc: fschulte@huffpostfund.org; 'Ross Koppel'; 'Justin Starren'
Subject: Re: "As Doctors Shift to Electronic Health Systems, Signs of Harm Emerge"

Dear Dr. Blumenthal,

In the Apr. 20, 2010 article "As Doctors Shift to Electronic Health Systems, Signs of Harm Emerge" at http://huffpostfund.org/stories/2010/04/doctors-shift-electronic-health-systems-signs-harm-emerge#ixzz0ljMzNOzD you are quoted as saying that:

"... CPOE alert and decision support features make doctors better ... CPOE is critical to the success of the electronic health records initiative. We need to support it and make sure it happens. How fast and in what form remains to be seen."

I have written that our approaches to IT in medicine lack the scientific approach we use in medicine itself. The foundation of that approach is the use of evidence.

Yet the evidence base is increasingly shedding doubt on statements such as yours, including studies and articles I've been compiling at http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009 . This growing corpus of literature suggests these statements may be premature regarding the health IT experiment.

I also share a belief that HIT potentially holds great promise towards improving healthcare quality, safety and costs. However, my beliefs are based on my experiences developing such technology for highly specialized clinical settings, but specifically not based on my experiences with commercial HIT upon which your office is leading a multi-billion dollar spending frenzy. My experiences with that sector have been disappointing as I have repeatedly documented at the Healthcare Renewal blog of the Foundation for Integrity and Responsibility in Medicine.

As we enter the second decade of the 21st century this potential has been largely unrealized. Significant factors impeding HIT achievement have been false assumptions concerning the challenges presented by this still-experimental technology, underestimations of the expertise essential to achieve the potential benefits of HIT, and the current orthodoxies around leadership for this grand social reengineering experiment.

The enabler and driver of these factors has been a lack of critical thinking about the technology, about social informatics and its implications, and a marketing and HIMSS driven 'irrational exuberance.'

We really need to return to critical thinking and to a scientific approach to our evaluations and prognostications about HIT.

With that in mind, please show us the hard evidence, now, that would support such statements, or please stop making statements to an unwitting medical audience and public that "CPOE is critical to the success of the electronic health records initiative."

Such statements sound more and more like marketing, not the measured statements on experimental technology I would expect to hear from a Harvard physician-scientist.

-- SS

If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers

In 2005 the RAND corporation ‘guesstimated’ figures for healthcare IT benefits based on existing, limited data sets (http://www.rand.org/pubs/research_briefs/RB9136/index1.html).

Their methods and results were contested, such as by the Heartland Institute (as here). Recent studies also put the RAND assumptions including those about flawless implementation and acceptance in serious doubt (as here).

Similarly, the often-quoted 2000 Institute of Medicine (IOM) report "To Err is Human" used several small studies to extrapolate a death rate due to medical mistakes at 98,000 per year. That report was challenged by medical informatics pioneer Clement McDonald, MD in a 2000 JAMA article "Deaths Due to Medical Errors Are Exaggerated in Institute of Medicine Report" here, PDF.

However, the refutation didn't stop anyone who could benefit from quoting such numbers from touting them, including those pushing healthcare IT. In fact figures such as these have been used as a bludgeon to affect national policy on healthcare IT.

If the benefits of HIT can be guesstimated, so can and should the dangers.

The true incidence of health IT-related medical errors, injuries and deaths from IT error, poor design, cognitive overload, clinical disruption, etc. is unknown. The Joint Commission in its 2008 Sentinel Events Alert advised that "There is a dearth of data on the incidence of adverse events directly caused by HIT overall" (as here).

As a thought experiment, presented here are some estimated corrective factors that might shed some light on the actual figures for HIT-related injuries and deaths "on the ground" when national, universal HIT deployment is achieved.

The thought experiment:

Jeffrey Shuren, MD, JD of FDA mentioned reports of 44 injuries and 6 deaths over 2 years that are likely the "tip of the iceberg" at the Feb. 25, 2010 HIT Policy Committee Adoption/Certification Workgroup on IT safety (http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html).

Ross Koppel, PhD at the same Feb. 25 IT safety conference opined that "We don't know 99 percent of the medication ordering errors that are made [due to difficulty in recognition, lack of proper studies and other factors - ed.]. If 100 percent of the known errors were reported, that would be 1 percent of the [true] total. But the data suggests that the maximum on voluntary reporting is about 5 percent. So 5 percent of 1 percent that is what we know is reported...."

Now, some estimated corrective factors:

• Due to a severe lack of awareness by physicians and healthcare organizations of FDA as a "go-to" organization to whom to report HIT-related medical errors and harm, let us assume FDA is privy to only 1/100 of the known injuries and deaths due to HIT (mostly reported locally). That's probably a conservative figure. Corrective factor = 100x

• Based upon figures from "Electronic Health Records in Ambulatory Care — A National Survey of Physicians", NEJM 359:50-60, July 3, 2008, let us roughly estimate that 10% of doctors/organizations are using HIT "meaningfully" (or better term, "in good faith") in 2010. Corrective factor for HIT-related errors that cause harm = 10x for universal use nationwide.

• Per Koppel, only a maximum of 5% of medication errors are voluntarily reported at all. Assuming similar figures for [medication and other] HIT-related errors that cause harm, corrective factor = 20x

• In approximating the actual number of HIT-related medication errors based on reported numbers, we would need to multiply reported figures by 100x per Koppel (since only 1% of HIT-related medication errors are recognized as HIT-related). However, from the JC Sentinel events alert figures from the United States Pharmacopeia MEDMARX database from 2006, only 1.25% (i.e., approximately 1%) of medication errors actually cause harm, so reported figures on medication errors require no corrective factor regarding patient harm (corrective factor for HIT-related medication errors that cause harm = unity = 1x).

• Although the learning curve never becomes flat in part due to clinician unfriendliness of the software, newcomers to HIT will for a number of years be more error-prone and experience more HIT-related adverse outcomes than experienced users and organizations. Conservatively assume a corrective factor = 2x.

Overall, that creates a corrective factor of 100 x 10 x 20 x 2 = 40,000

Multiply the FDA figures per year (22 injuries and 3 deaths) by this factor = 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved.

Merely multiply by 4,000 for a guesstimate of current figures at ~10% diffusion.

This assumes no major changes occur with regard to the technology's risks, such as via the accelerated interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering recommended by the National Research Council in their Jan. 2009 report on HIT (http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572), and via other studies and improvements that might be made.

The way this industry operates, however, e.g., as in my post "Healthcare IT Corporate Ethics 101", the National Research Council-recommended changes are unlikely in the near future.

While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events.

In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.

-- SS