Dr. Richard Cook on the Health IT Sector's Ills

This explanation of the health IT sector's ills comes from Dr. Richard Cook, a physician, educator, researcher, and patient safety expert formerly at the University of Chicago and now Professor of Healthcare System Safety at the Royal Institute of Technology, Stockholm, Sweden.

Dr. Cook was also a member of the U.S. Institute of Medicine panel that studied health IT safety, leading to the 2012 IOM report ("Health IT and Patient Safety: Building Safer Systems for Better Care").

He was also co-author of an article I consider a must-read for anyone in the health IT sector, Hiding in plain sight: What Koppel et al. Tell Us About Healthcare IT, Journal of Biomedical Informatics. 38 (4): 262-3.

Reproduced with his permission:

My views are already on record. [This links to his IOM report dissent where he made the case that health IT is a Class 3 medical device and should be regulated - ed.]

Politically important activities (cynically, things that cost >10B$) are never neutral. HIT techno-fantasies are common and easily commandeered. Claims about the present and future efficacy of HIT have been altered in bewildering patterns to fit the circumstances of the moment.  This is not uncommon for expensive technologies with a few dominant producers and strong government ties (cf. Mackenzie's Inventing Accuracy, MIT Press, 1993). 

The recent history of HIT is dominated by the social construction of several myths.  Although there are technical threads in the history, they are exceptionally frail. There have been myths of safety, of productivity, of economic efficiency, of clarity, of precision, of reliability.  

The truth is that the Obama administration depended, in part, on savings to be obtained from HIT for claims it made prior to the election of 2008 about the savings to be derived from the plan to "reform" healthcare. These interests aligned with those of the industry and a faction from academic medicine and the result was the usual sausage.

A central problem with techno-fantasies is that they are impossible to disprove. They are claims about the future. HIT's cornucopia has been promised repeatedly since the 1960's. Nothing like the promises has materialized.  Indeed, the IOM committee that was commissioned to evaluate the best evidence on this subject found no persuasive evidence that HIT improved patient safety. I know because I was there.

But this is not the point and never has been. Privileged entities marshall arguments in favor of their purposes. The devil can cite scripture to his purpose. The result is what matters to them and the goal here was to get the government to fund private HIT installation in private healthcare facilities by offering first a carrot and then a stick. They steamrollered the opposition -- which was much more nuanced and thoughtful than the attacks on you [Scot Silverstein] make it appear -- and made it happen.

To be clear, there was no conspiracy here. This is not deal done in back rooms by a few executives and cigar smoking pols. Instead it is the entirely predictable result of a confluence of interest among powerful stakeholders to advance their agendas. There is nothing shocking about an inferior, ill-conceived product getting government support, viz. Solyndra. Ultimately, the technical issues serve to the socio-political ones.

It's no better over here.  [That is, in Sweden - ed.] We face the same problems in Sweden that you do in the U.S. We have the advantage of paying about 1/3 of what you do for healthcare and getting, objectively, better medical care and a better life than you do in the U.S.  But we have the same fractionated approach that you do and the same age bulge looming in the next 2 decades and there are plenty of problems with safety and humaneness, just like in your country. 

I present this without any changes that might have occurred when unpleasant truths or opinions undergo peer review in a specialized, non-transparent and highly profitable sector.

-- SS

New York Times: "A Digital Shift on Health Data Swells Profits in an Industry"

The New York Times has published an article today by Julie Creswell entitled "A Digital Shift on Health Data Swells Profits in an Industry."  It is available at this link.

... While proponents say new record-keeping technologies will one day reduce costs and improve care [only when today's bad health IT is abolished - see here - ed.], profits and sales are soaring now across the records industry. At Allscripts, annual sales have more than doubled from $548 million in 2009 to an estimated $1.44 billion last year, partly reflecting daring acquisitions made on the bet that the legislation would be a boon for the industry. At the Cerner Corporation of Kansas City, Mo., sales rose 60 percent during that period. With money pouring in, top executives are enjoying Wall Street-style paydays.

None of that would have happened without the health records legislation that was included in the 2009 economic stimulus bill — and the lobbying that helped produce it. Along the way, the records industry made hundreds of thousands of dollars of political contributions to both Democrats and Republicans. In some cases, the ties went deeper. Glen E. Tullman, until recently the chief executive of Allscripts, was health technology adviser to the 2008 Obama campaign. As C.E.O. of Allscripts, he visited the White House no fewer than seven times after President Obama took office in 2009, according to White House records.

The article does not reveal anything that readers of this blog did not know already.

The push for the financial incentives and profits were also written about at the The Huffington Post Investigative Fund by investigative reporter Fred Schulte, now at the Center for Public Integrity ("Stimulus Fuels Gold Rush For Electronic Health Systems"), and in the Washington Post by Robert O'Harrow Jr. (which I wrote about at this post:  The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians).

Rather than re-hash the issues, I wanted to focus on some of the current NYT reader comments:

... After a visit to a Florida hospital for suspicion of heart attack, I asked for a copy of my records to give my home (IL) physician. I was shocked to read that I had had "anal surgery." When I reviewed these records with my doctor, she told me that I had probably told the admitting ER nurse I had recently had a colonoscopy, so the closest coding information their electronic system allowed was anal surgery. So, how can these inaccuracies which will live on forever electronically be helpful toward patient care? The old acronym GIGO certainly applies here--garbage in; garbage out.

... This article highlights only one aspect of the "Failed Promise of Electronic Health Records". Through lobbying but also supported by a study from the RAND organization, the three final 2008 presidential candidates, Hillary Clinton, John McCain, and Barack Obama outbid each other with promises to spend billions to entice doctors to use electronic record systems. Unfortunately, because of unsolved documentation problems, such systems are often disliked and slow the process. Instead of creating interoperability, electronic medical record systems (EMRs) with limited functionality and benefits were created. In particular, true interoperability has been neglected and attempts to create it through networks in the form of CHINs, RHIOs, and HIEs have failed.

... Mr. Tullman's comment is priceless. “I think it’s very common with every administration that when they want to talk about the automotive industry, they convene automotive executives, and when they want to talk about the Internet, they convene Internet executives." Of course, when "they" want to radically alter the way doctors do their jobs, "they" talk to academics, lawyers, publicly traded insurance CEOs and internet executives. Today's diatribe about quality care being more important than quantity care is laugh out loud funny. Unless you're a physician. Only in America does getting paid less and less, with more clerical data entry record-keeping at every step just to get paid and protect against lawsuit, translate into an incentive to provide quality care. Somebody prescribe a dose of common sense. Oops. Too late.

... Every person needs a national health ID with up to date health information. To say that the current EMR systems are problematic would be an understatement. They take away face time with patients, the M.D.'s talents and time are wasted doing data entry and worst of all ,they are potentially dangerously flawed. An example is a recent patient I saw who was treated by a number of physicians. His medications had required significant changes which were done by 2 different M.D.'s from his main doctor. Both gave him computer generated lists from the same system. Both had a mixture of unmatching generic and proprietary names, the patient's actual medicines from the pharmacy had a mixture and different doses from the Dr.'s orders. He was trying to set up his week's supply. But didn't know which proprietary name went with which medicine. These systems should have been tried out on a small scale and approved by M.D.'s before this became law. The VA system which is time tested, physician friendly and free only the VA is using. These other systems are set up to maximize profits for the IT companies, cost the physicians huge amounts to install, cost the hospitals huge amounts esp when they are changing from one system to another due to problems when they were advertised to maximize hospital billing. This another example of our distorted legislative process where profits and politics take precedence over people.

... I am a dermatologist in private practice who teaches at a local medical school part time. Electronic records are problematic. Every doctor I know feels they take time away from being a doctor. I literally don't know a single colleague who feels their benefits are worth the extra time involved. In medical school, we learned how to record notes in medical records so that patient care is improved from visit to visit. In short, we use notes from the previous visits to assist in our decisions in subsequent examinations. In today's digital world, most doctors I know are forced to change their notation style to justify payments from insurance companies. The more detailed the note in the medical record, the lower the chance that an insurance company downgrades the fee charged to the patient. Thus, notes are now longer and more detailed than they were ten years ago. The problem with such notes is that they are filled with detritus geared to prevent payment reduction rather than aimed at improving continuity of patient care from visit to visit. The impact of this adoption of electronic medical records is that insurance company computer systems can easily sift through notes to reduce compensation to doctors who spend more time with patients and who write cleaner, more efficient notes.

... I still use pen and paper.  One requirement would fix this mess: interoperability No, NOT the "industry supported" standard. Thats a joke. Industry wants NO inter-operability because they want to lock us in to a an individual product, The government has a great EMR (the VA system). All commercial ones should be forced to be able to export data in a way that is 100% compatible with that. As such, they would then be 100% compatible with each other. Some of my colleagues are now on their third EMR product in 7 years. Why? Big company buys company B and then stops supporting it. The doctor is forced to switch to Big Company's new product. Of course the data does not transfer over so the doctor has to go through the crude data-entry mess all over.

... The folly of relying only on digital records. Without constant and costly software and hardware upgrades, your digital medical records will be rendered obsolete. Could be a matter of years or decades, but it will happen. Not only that, digital proprietary systems are at huge risk if the private for-profit company goes bankrupt. Paper records can last 1000 years.

... Another scam. Very expensive and involved for end user:ie doctor. Have had to hire an IT company to assist, have to pay annually for service contract, upgrades and what the article didn't mention was the "meaningful use" criteria that all doctors have to comply with in order to pass government inspection for a rebate. The software vendors, labs, and others are charging doctors extra for software upgrades and abilities to comply with each "meaningful use" component . This is already costing more money and aggravation than the worth of the government rebate. Who will subsidize this? Doctors are starting to lose interest. We know this is another corrupt government sponsored ploy and only the tip of the iceberg. If the government were to have spent the 19 billion with a consortium of vendors such as google apple and microsoft, the goal of free software provision capable of interexchangeable data would likely have been completed with all providers on board.

... Common sense can tell you that the real value of these systems is marginal. Much of medical treatment is "incident specific" where history is not necessary. Most PCP's already have a system that works. In larger systems and for complex diseases, perhaps EMR are beneficial but not for routine care. As has been noted, all sorts of problems arise with EMR's: destruction of MD-pt relationship, incorrect data being entered and never removed, cumbersome and expensive requirements of instituting and maintaining the system, etc. It is awful that physicians and patients are "used" in the service of politicians and EMR execs.

... As a practicing physician I have to struggle everyday with the Citrix and Quickbase electronic records. The Electronics Medical Records industry has been getting the gold promised by the government in exchange of a very poor and deficient product. The EMR industry has been selling to the healthcare providers, in need of electronic records, the equivalent of the Formaldehyde-contaminated trailer homes sold to FEMA for the Katrina homeless.

These are just from the first page of comments.  Read the article and the comments at the link above.

My observation is that it seems that as transparency increases, the public "gets it" that these systems are not the panacea the industry wants us to believe, and may impede the clinicians trying to treat them.

Now, when will the government "get it" that they've been had?

-- SS

Addendum:  another "anecdote" just caught my eye because it sings an unfortunate familiar tune to me:

So much data, so little knowledge. My best friend's father just died because none of his who-knows-how-many physicians took the time to actually read and anaylze the reams of info they were dutifully inputting. They killed him with an overdose of one drug and not enough of another.  Useful data collection and analysis is one thing, but what we seem to have now is just institutionalized hoarding. More data doesn't make anyone safer (except the data companies), just like stacks of old magazines or cans of beans makes one safer. More is NOT better; it is just more. More time and more expense wasted on stuff and less spent on actual health care. You've got to USE anything or it is just more useless and potentially dangerous stuff.

-- SS

Dr. Extormity's Testimony at Healthcare IT Hearing

At "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith" I reproduced a physician's testimony on "Meaningful Use" of Health IT.

I thought his testimony illustrated the issues quite well.

However, Dr. Monteith's been outdone, this time by Dr. Extormity. Click to play:

Dr. Extormity's Testimony at Healthcare IT Hearing - click to play.

Also see my May 2008 post "SEEDIE, the Society for Exorbitantly Expensive and Difficult to Implement EHR’s" for more on Dr. Extormity's fine work.

Note: this was a "medical humor break" of the kind Residents need to stay sane on the battlefield.

(Hat tip to ducknetweb.blogspot.com).

-- SS

Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight

(Note: also see my followup post "More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight")

The Huffington Post Investigative Fund has published a remarkable expose of health IT difficulties and the Big Politics that surround them regarding safety and efficacy:

FDA, Obama Digital Medical Records Team at Odds over Safety Oversight
Aug. 3, 2010
By Fred Schulte and Emma Schwartz

Computers at a major Midwest hospital chain went awry on June 29 [after an 'upgrade' - ed.], posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]

Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

... Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.

Yet despite the high [actually, potentially catastrophic - ed.] political and financial [and clinical -ed.] stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.

I began to document some of the problems and the resistance of what Washington Post reporter Robert O'Harrow Jr. in May 2009 called the "Healthcare IT lobby" a decade ago in a website. That website, now hosted at Drexel University, is entitled "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties."

Few in government and industry were apparently listening, despite ongoing worldwide interest in the topic (PPT).

Read the Huffington Post report in its entirety. It includes a slide-show timeline of the health IT industry's sidestepping of government oversight and safety concerns.

As I am currently busy helping out my ill mother, I will offer more commentary later.

However, one quote really stuck out. Is the Chairman of the Office of the National Coordinator for Health IT (ONC) Dr. David Blumenthal lying, or simply misinformed?

Judging by the quality of academic discourse these days, I'd hope the latter (an alarming situation in and of itself), but the former is also possible.

He is quoted as stating:

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

As at my July 14, 2010 post Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records" , however, I pointed out some examples that contradict this meme.

This list is just for starters:

(Hyperlinks to these and others can be found at my Medical Informatics teaching site here and here:)

1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA.

2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks

3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203

4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.”

5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand)

6. Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient."

8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program.

9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act).

10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I wrote here, is slated for abandonment. I cannot imagine it was greatly improving outcomes).

11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care.

12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs."

13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London.

14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al.

15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF here)

My healthcare informatics graduate students are well aware of studies such as these.

[Feb. 2011 addendum: see a much longer list at this link - An Updated Reading List on Health IT - ed.]

Why isn't ONC Chairman Dr. Blumenthal?

Perhaps equally as remarkable is this from Trinity Health, the healthcare system whose health IT crashed:

We are not aware of any patient safety or quality of care issues caused by this event,” he said.

Many of the "safety and quality" issues due to erroneous data in charts can come out weeks, months or even years later. The issue that the health IT cheerleaders seem to ignore is risk.

Has the erroneous data been identified and corrected, I wonder?

Probably not. According to the Huffington Post Investigative Fund article, they don't even know what caused the problem:

... While doctors were concerned about the problems, ...

[well, yes, I'd be quite frightened myself, especially considering who holds the liabilities for health IT defects - ed.]

... Shivinsky said that most are happy with the system and would “never go back to paper.”

[That sounds very nice. Is it true? - ed.]

Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said.

Eventually, I would hope, since the kludged "correction" I heard about is that clinicians can now only open one electronic patient chart at a time, potentially slowing and impairing their work.

I've emailed Mr. Shrivinsky asking if they'd truly identified and remediated the problem yet.

-- SS

HIMSS: Hospital CIO's Should Not Only Manage Healthcare IT, But Also Biomedical Engineering

I have written in the past about the territoriality of the IT department in hospitals, observing that the departments I was exposed to seemed more political than the clinical departments themselves. This territoriality came at the expense of clinicians' and patients' best interests.

This phenomenon seems to go beyond the confines of the hospital IT shop, perhaps as a manifestation of the IT culture. For example:

Other have observed - unapprovingly so - how the health IT trade group HIMSS, via a massive lobbying effort and via its offspring, the CCHIT, has sought to gain hegemony over health IT through a "certification" process, a service for which CCHIT desires to be the sole provider.

It's become worse. Now control over biomedical instrumentation (which includes such safety critical devices as ventilators, cardiac and other physiologic monitors, heart-lung machines, radiological devices, etc.) is sought.

In the June 2009 HIMSS analytics report "Devices in Hospitals" (link to PDF):

Page 7:

... It appears that the IS department [a.k.a. IT department, or Management Information Systems department - ed.] is becoming the key support department for interfaced intelligent medical devices. This is a natural extension as IS departments build and support a cadre of interfaces to improve the collection and use of data within the hospital.

Then at the end of the report, in the Conclusion, a leap of logic of gargantuan proportions:

What is less clear at this time is whether the biomedical operations will be placed under the IS department for management. We believe that it should be , ala the movement of responsibility for telecommunications to the CIO when telecommunications and information technologies merged in the last 15 years .

Au contraire ... it is very clear to those who know what they're doing that this is a very bad analogy and suggests HIMSS does not understand the vast differences between the discipline and functions of biomedical engineering, versus the IT department role of management of computer and other ICT's (information and communications technologies). I find this astonishing.

Having done a clerkship in biomedical engineering in medical school, and being somewhat knowledgeable about electronics as an FCC-licensed radio amateur at the Extra class (highest certification attainable by a series of FCC examinations), I find the HIMSS Analytics position risible and dangerous. It suggests a desire to expand territory even further into an area for which CIO's and hospital IT personnel are even less qualified - indeed, far less qualified - than clinical IT.

Apparently, CCHIT wants to have hegemony over "certification" of clinical IT, and the parent organization HIMSS through its research arm opines IT should also take over "medical devices" (while still excluding clinical IT from that categorization to avoid regulation, of course).

As I first asked over ten years ago after observing IT personnel in hospitals :

Who, exactly, are the IT personnel in hospitals, and what, exactly, in their backgrounds qualifies them for major involvement in clinical affairs, let alone leadership roles regarding safety-critical clinical devices?

Perhaps the Joint Commission, FDA, and other regulators need to start asking the same question.

-- SS

Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?

Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include:

• Resorting to ad hominem attacks when questioned or criticized.
• Deficient familiarity with the current literature.
• Opining that others' concerns expressed in that literature could be "laughed off."
  
• Years-behind view of the situation on the ground.

The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat (emphases and comments in red italic mine):

June 19, 2009 - Perspectives

Health IT Under ARRA: It's Not the Money, It's the Message

by Mark Leavitt

... Estimates by the Congressional Budget Office suggest the total incentive payout could reach $34 billion, although with expected savings the net cost is half that. Add to that another $2 billion that the Office of the National Coordinator for Health IT can use on various initiatives in support of the goal of having an EHR for every American by 2014.

[Note the catchy marketing slogan, which carries the implicit message "what manner of people would oppose Mother and Apple Pie?" - ed.]

But more important than the money itself is the message implicitly conveyed along with it. Will incentives be perceived as an intrusive, carrot-and-stick manipulation of health care providers' business decisions? Or will health care providers interpret ARRA as the correction of a reimbursement anomaly, welcoming the opportunity to modernize their information management and transform the care they deliver.

[Cybernetic Miracle™ Alert - note the grandiose term "transform", as opposed to "facilitate" or "improve" - ed.]

Some of the early signs have been worrisome. Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place,

[As an information scientist, I'm almost embarrassed to post this link and this link, the results of just a few minutes' work with public resources. Thorough, robust searches in Dialog's suite of databases, Current Contents, Lexis Nexis, SciFinder etc. would show far more - ed.]

that shady conspiracies are operating --

[i.e., HIT industry lobbies - ed.]

make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers

[i.e., those who take due diligence and fiduciary responsibilities seriously - ed.]

are easily affected by fear mongering.

That is, Bah! to the apostates' narratives --

-- even though many of these narratives are in the peer-reviewed biomedical science and biomedical informatics literature ...

Bah!

I'm really tired of amateurish political rhetoric and marketing puffery masquerading as substantive debate on critical issues as above. However, being experienced with EHRs, their design, implementation and lifecycle, and concerned with widespread irrational exuberance over health IT (a facilitative tool that carries risk to patients and medical organizations if not done well) I am not at all "laughing these stories off", and will critique the above in a quite serious manner.

Indeed, "laughing off" stories from credible sources and personnel (e.g., many AMIA members) about potential harm from an experimental technology affecting patients seems the height of hubris, or blindness of a kind mediated by incomplete knowledge or conflicts of interest.

First, binary thinking. It seems those who critique health IT's drawbacks are "individuals with a deeper-seated anti-EHR bent." That is, they don't buy into the consensus of the industry "experts" and must therefore be biased and wrong.

I, in fact, am a health IT proponent, but simply abhor poor HIT such as at my series here, or HIT sold to my organization in an unusable (but "Certified") state as in the Civil Complaint here (PDF). I believe the rush to national EHR by 2014 is premature, will waste massive amounts of money, and will cause disruption to an already strained healthcare system with resultant adverse effects. I believe far more research remains to be done before our social and technical understanding of "how to do clinical IT well" justifies mass government-mandated cybernetic re-engineering in healthcare. (See literature list below.)

On the issue of ad hominem attacks against questions and critique, I documented those at Healthcare Renewal at "Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT" at this link. Both I and another physician, David Kibbe, MD, MBA, Health IT Consultant at American Academy of Family Physicians, were subjected to "nonlinear" commentary.

It also seems Dr. Leavitt is unfamiliar with or deliberately downplaying a growing body of literature on health IT risks and failures. [Health IT failure never, ever puts patients at risk, as I wrote here, of course - ed.]

Examples of this growing body of "unknown" or "ignored" or "downplayed" literature include:

1. The article "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop", Bonnie Kaplan and Kimberly D. Harris-Salamone, Journal of the American Medical Informatics Association 2009;16:291-299. DOI 10.1197/jamia.M2997 - and the references cited.

There are more than 70 references at the end of this article (See fulltext at link above), and my comments on the findings and recommendations of the multi-working group informatics workshop that created it are in the post "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop" at this link.

2. This corpus of literature below. These are just examples and not a comprehensive listing:

Joint Commission: Sentinel Events Alert on HIT, Dec. 2008.

National Research Council report. Current Approaches to U.S. Healthcare Information Technology are Insufficient. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions, Jan. 2009

The National Programme for IT in the NHS: Progress since 2006, Public Accounts Committee, January 2009. Summary points here.

Common Examples of Healthcare IT Difficulties (my own 10-year-old website). S. Silverstein, MD, Drexel University College of Information Science and Technology.

Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278

Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1

Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies, Ball et al., Methods Inf Med 2008; 47: 4–7,

IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers, JAMA Mar. 4, 2009, p. 919-920.

Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, Han et al., Pediatrics Vol. 116 No. 6 December 2005, pp. 1506-1512

Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203

Hiding in Plain SIght: What Koppel et al. tell us about healthcare IT. Christopher Nemeth, Richard Cook. Journal of Biomedical Informatics. 38 (4): 262-3.

Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423

The Computer Will See You Now, New York Times, Armstrong-Coben, March 5, 2009,

Bad Health Informatics Can Kill. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405

Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless? Ford et al., J Am Med Inform Assoc. 2006;13:106-112

Resistance Is Futile: But It Is Slowing the Pace of EHR Adoption Nonetheless, Ford et al., J Am Med Inform Assoc. 2009;16:274-281

High Rates of Adverse Drug Events in a Highly Computerized Hospital, Nebeker at al., Arch Intern Med. 2005;165:1111-1116.

"Dutch nationwide EHR postponed: Are they in good company?", ICMCC.org, Jan. 24, 2009

“Avoiding EMR meltdown.” About a third of practices that buy electronic medical records systems stop using them within a year, AMA News, Dec. 2006.

"The failure rates of EMR implementations are also consistently high at close to 50%", from Proceedings of the 11th International Symposium on Health Information Management Research – iSHIMR 2006

"Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from A Commonsense Approach to EMRs, July 2006

Adverse Effects of Information Technology in Healthcare. This knowledge center presents a collection of information on the adverse effects of information technology in its application to healthcare. It also references sources of information on information security, and related media reports.

Pessimism, Computer Failure, and Information Systems Development in the Public Sector. Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007

The literature at my HIT website's "Other Resources" page (link)

The teachings of the field of Social Informatics about new Information and Communications Technologies (ICT's) and the unanticipated negative consequences they cause. An introductory essay entitled “Learning from Social Informatics” by R. Kling at the University of Indiana can be found at this link (MS-Word file). The book “Understanding And Communicating Social Informatics” by Kling, Rosenbaum & Sawyer, Information Today, 2005 (Amazon.com link here) was based on this essay.

3. The warnings of HIT dangers from the U.S. Joint Commission, the EFMI, as linked above, and others; doubts about cost savings from Wharton and Stanford professors (surely no amateurs).

In the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:

... 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.

There are also reports of problems from FDA-like agencies of other countries such as Sweden's, whose report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" (available in English translation at this link in PDF) stated:

It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.

Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents [including deaths - ed.] that has been reported to the Swedish National Board of Health and Welfare.

On wonders if Dr. Leavitt would include the Swedish Medical Products Agency, who incidentally have a cooperation agreement with our own FDA, under the category of "fearmongers."

Finally, stories of HIT mayhem of which Dr. Leavitt seems blissfully unaware are making their way to appropriate political circles. The whistleblowers are afraid to speak out publicly due to fear of job loss or retaliation. However, when the case examples do come out, it may be Dr. Leavitt who will be found to be "fear mongering" about those who care more about patients and their rights than about information technology.

Health IT Under ARRA: It's Not the Money, It's the Message. Indeed.

And Dr. Leavitt's message about those who think critically about health IT seems quite ill informed and mean spirited.

Finally, to get past the ad hominem and other logical fallacy nonsense I believe will be coming my way, I'll just admit to any and all of it. I'm an SOB, I'm a disgruntled curmudgeon, I'm an HIT dilettante, my uncle was in the mafia, I kick little cygnet swans in the park to be mean to Chucky, the cob (father) , and Princess, the pen (mother). /sarc

:-)

The Mute Swan family of Towamencin Twp., PA. Click to enlarge. The cygnets have really grown this past month (major cuteness warning if you click this picture from June 1!)

Now that we're hopefully past the expected ad hominem, perhaps the real issues can be addressed.

As a final piece of advice to Dr. Leavitt, I can add that dismissing concerns of others, Dogbert-style, is not a way to win friends and influence people.

Humor and a little humility work much better.

-- SS

Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices. And, Can We Drop the "Massive Cost Savings" Fable?

Here is some sense on healthcare IT from the European Union, echoing a number of themes I've written about at Healthcare Renewal and my academic site on HIT difficulties and failures.

These themes revolve around the consideration of healthcare information systems (increasingly used to mediate many aspects of medical care delivery) as medical devices requiring regulation by transparent and impartial authorities - i.e., without conflicts of interest; the importance of regulation due to the adverse consequences caused by ill designed and/or poorly implemented HIT; the need for validation and postmarketing surveillance of the performance of these systems; and vendor accountability.

From the Swedish Medical Products Agency:

Improving patient safety in the EU: Many Medical Information Systems should be classified as Medical Devices

Thursday, June 18, 2009

Correctly functioning Information Technology (IT) systems for health care is a prerequisite for ensuring patient safety. However, applicable regulation is rarely applied, mainly due to the lack of useful guidelines on how to classify the IT-systems [guidelines whose formulation has been resisted for many years by the HIT industry, I might add - ed.] A national working group in Sweden has prepared a guidance report that will help increase compliance with the Medical Device regulation in the EU, thus improving patient safety.

An increasing number of serious incidents, with IT-systems involved, have been reported from the health care sector in recent years [but largely covered up in part due to contractual gag clauses on HIT sales and resultant violations of healthcare leadership fiduciary responsibilities - see this link - ed.] In most of these cases, existing regulatory regimes have not been applied, either by manufacturers or by health care providers. As a result, the assessment of safety issues has become unclear because the manufacturer’s responsibility is vague. [It's not vague; it's contractually absent - ed.]

For this reason, in 2008 the Swedish Medical Products Agency (MPA) initiated a national working group with the aim of providing guidelines for the classification of IT-systems intended to be used in health care. The working group has now prepared a report, intended to serve as guidance for both manufacturers and end-users. At present, there are no guidelines of this kind in Sweden, or the rest of Europe.

“Many parties, including the European Commission, have expressed interest in our work. We believe that it will improve the quality and safety of medical information systems. [Finally -ed.] A common approach to product classification is key” says Lennart Philipson, Scientific Director.

One important conclusion from the working group is that the Medical Device Directives is the most suitable regulation to be applied.

“Our market surveillance of medical information systems will be based on the conclusions in the report from now on. If a system falls within the definition of a medical device, the requirements for CE-marking [Conformité Européene, a branding mark - ed.] shall be applied” says Mats Ohlson, Chairman of the working group.

Manufacturers need to adapt to applicable standards when it comes to quality systems, risk management and usability. They will also need to establish post-market surveillance routines to regularly assess products on the market.

The working group consisted of members from the Swedish Medical Products Agency, the National Board of Health and Welfare, the Swedish Association of Local Authorities and Regions, Swedish Medtech, the Swedish Standards Institute, Swedish Electrical Standardization and notified bodies through Intertek Semko.

A report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" is available in English translation at this link (PDF).

Download and read the entire report.

Highlights:

A general opinion of the health care providers represented in this Working group is that from a patient safety point of view, it is desirable that stand alone software and systems intended to, directly or indirectly, affect diagnosis, health care and treatment of an individual patient [what I have referred to a "mediating aspects of care" - ed.] shall be regulated under a Product Safety Regulation.

The Working group has not been able to define any other appropriate regulation than the Medical Device Directive when it comes to the definition of such systems. Adherence to the Medical Device Directive is important so that manufacturers and clients can work with the same intentions. [I would add that the intentions are not exactly the same; the manufacturers' intentions are, by necessity, to maximize profits - ed.] This project report serves as one step towards the clarification regarding which conditions that shall apply.

The Working group believes that software intended for a medical purpose must be regarded as a "device" [indeed - ed.] and expressions such as "project", "service" and similar must be avoided describing a Medical Information System. This approach has advantages since a product safety regulation, such as the Medical Device Directive, can be applied and the product will have:

• a defined intended use
• defined and documented specifications
• a manufacturer with a clear responsibility until the delivery is accepted
• a controlled ”Post Market” surveillance

Furthermore, the Working group believes:

• that the Medical Device Directive shall be applicable for software and systems that fulfills the definition of a medical device
• that the manufacturer of the intended systems shall follow the appropriate validation method [e.g., as in the pharma industry's IT - ed.] in the Medical Device Directive
• that the level of risk shall be assessed, motivated and control the classification and verification method
• that applicable standards shall be followed for design, verification and validation regarding software and information systems that are medical devices
• that there is no legal requirement that manufacturers of devices in the lowest device classes must have certification for their operational processes to fulfill the Medical Device Directive. The Medical Products Agency has in these cases no mandate to formally demand certification, such as for instance ISO 13485. However, in reality it is still necessary to have some form of a functional quality management system to manage a proper design process for software systems [due to the fact that patients, ethical issues, and human rights issues are involved - ed.] as well as the necessity to fulfill the Post Market Requirements including Vigilance reporting.
• that the prerequisite for a successful and fair application of the regulation assumes that health care providers demands that such systems shall be CE‐marked and be regarded as medical devices
• that a controlled and standardised verification method when performing installation work in a user’s network, supported by the manufacturer, is an essential supplement to the manufacturer’s CE‐marking and a prerequisite for an acceptable safety level when using the device.

This section gets to the heart of the matter regarding electronic medical records:

8.2.3 Electronic patient records

Electronic patient record systems are more than an archive for just documents, they also have features for compiling and transferring information to be used for decision making. Patient records are the basis for documentation and planning of diagnosis, therapy and follow‐up, especially when it comes to drug prescriptions and recommendations. [These caveats include CPOE systems as well - ed.]

It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.

Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents that has been reported to the Swedish National Board of Health and Welfare. [It would be interesting to know more about this "series of incidents" - ed.]

Finally, in the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:

... 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.

HIT can be a facilitator (not a replacement or revolutionary tool) to physicians, if done well, and not overdone to the point of costing far more than entire new hospitals or hospital wings. There is no replacement for a physician with a strong background in the preclinical and clinical sciences, ethics, critical thinking, and the scientific method. Computers are not a miracle. They can help provide facts, but cannot fundamentally turn a poor physician into a Marcus Welby. Verghese on that issue:

To come back to my favorite painting: a computer cannot take the place of the doctor in Fildes’s painting ["The Doctor", 1891, see below - ed.]; an electronic medical record (EMR) may or may not save money (it won’t be anywhere as much as is projected) but what it will do is ensure that we doctors, nurses, therapists, particularly in hospitals will be spending more and more time focused on the computer, communicating with each other, ordering and getting tests, buffing and caring for our virtual patient—the iPatient is my term for this phenomenon—while the patient in the bed wonders where everybody is. Having worked exclusively for the last seven years or so in hospitals that have electronic medical records (EMR), I have felt for some time that the patient in the bed has become an icon for the real focus of our attention, the iPatient. Yes, electronic medical records help prevent medication errors [only when done well, see Koppel - ed.] and are a blessing in so many ways, but they won’t hold the patient’s hand for you, they won’t explain to the family what is going on.

"The Doctor", 1891 (Sir Luke Fildes, 1843-1927)

I will go a step further. It is now clear that the promises of massive savings from electronic medical records, usually originating from vendors based on hearsay or cherry-picked, favorable but flawed studies that dismiss a growing body of other literature (such as in Cerner CEO Neil Patterson's hyper-ebullient piece here), have been deliberately manufactured by a lobby of industry pundits.

It is only now that I more fully comprehend the origins of and motivations behind the "we will revolutionize medicine" fervor exhibited by HIT company CEO's, such as I experienced and wrote about starting back in the 1990's. From my 1999 essay "What is Medical Informatics, and Why is it an Important Specialty":

... A letter I had written [in Feb. 1999 - ed.], "Broken Chord" published in the journal Healthcare Informatics, further amplifies the skills and experience issue. The letter addressed issues of skills, insights, and roles of MIS personnel in healthcare settings. I described a Microsoft Healthcare Users Group conference attended predominantly by healthcare MIS staff and vendors, where I observed a panel discussion moderated by the CEO of HBOC [before he was found to be cooking the books - ed.] and composed of several other industry CEO's. The panel was discussing how they would revolutionize healthcare through their leadership in information technology.

During the Q&A period I asked the audience how many really felt they would revolutionize medicine through their leadership in IT. Several hundred--almost all in the audience--raised their hands. I then asked how many had ever taken care of patients or examined any textbook of medicine, such as Harrison's Textbook of Internal Medicine or the Merck Manual. A minority of hands went up. This suggested, in my view, a striking deficiency of knowledge, experience and insight on the part of the de facto clinical information technology leadership, complicated by rather cavalier attitudes regarding the essential role of clinical expertise.

I believed what I was hearing to be irrational exuberance, not manufactured exuberance.

Quality improvements are possible under the most controlled of environments, such as here (such projects are not easily portable, unfortunately). Massive cost savings? When organizations are spending upwards of $100 million just for system implementation, not including ongoing lifecycle costs, massive savings projections from HIT are risible.

One would think that after Madoff, Stanford and other recent financial confidence scandals, that bright people would be more skeptical of "massive returns, always and forever" promises, but that does not appear to be the case. With regard to mass savings, I make the prediction that in 2014, as in the UK today, our government, healthcare management, and medical professionals will realize, Madoff style, that they've been had.

So, Health IT Industry executives, pundits, and consultants, can we drop the grandiose "we will revolutionize medicine!" and "massive savings" myths, and focus on facilitating clinicians and on quality improvement, please?

-- SS

6/22/09 Addendum

The U.S. Food and Drug Administration (FDA) and Sweden's Medical Products Agency are no strangers.

Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

A remarkable Bill (ASSEMBLY, No. 3934, STATE OF NEW JERSEY, 213th LEGISLATURE) has appeared in NJ that would prohibit the sale or use of healthcare IT not "certified" (i.e., feature-qualified) by the industry-founded and connected group "Certification Commission for Healthcare Information Technology" (CCHIT). The Bill calls for monetary civil penalties for such sale or use:

A civil penalty or civil fine is a term used to describe when a state entity or a governmental agency seeks monetary relief against an individual as restitution for wrongdoing by the individual.

I previously wrote about CCHIT in a series of linked posts that start here: A very troubling post about the CCHIT (Certification Commission for Healthcare Information Technology).

I have now written the following open letter to Mark Leavitt, MD, PhD, Chairman, Certification Commission for Healthcare Information Technology.

To: "Mark Leavitt"
Date: Sunday, June 07, 2009 02:10PM
Cc: Robert O'Harrow, Jr., Washington Post, and various AMIA working group mailing lists (CIS - clinical info systems, POI - people & organizational issues, OS - Open Source, and ELSI - Ethics, Legal & Social Issues)

June 7, 2009

Mark Leavitt, MD, PhD
Chairman, Certification Commission for Healthcare Information Technology
www.cchit.org
[6/8/09 - contact info from www.markleavitt.com removed per critique in response below -ed.]

Re: NJ HIT Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17

Dear Mark,

The NJ Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17, calls for making it a violation of law to sell HIT not "certified" by CCHIT . Penalties are called for. The bill states:

... No person or entity, either directly or indirectly, shall sell, offer for sale, give, furnish, or otherwise distribute to any person or entity in this State a health information technology product that has not been certified by the Certification Commission for Healthcare Information Technology.

As used in this section, "health information technology product" means a system, program, application, or other product that is based upon technology which is used to electronically collect, store, retrieve, and transfer clinical, administrative, and financial health information.

b. A person or entity that violates the provisions of subsection a. of this section shall be liable to a civil penalty of not less than $1,000 for the first violation, not less than $2,500 for the second violation, and $5,000 for the third and each subsequent violation, to be collected pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).

I and others find this bill remarkable. It really calls into focus the HIT community's concerns about CCHIT and its political connections, especially pursuant to the article " The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records " of May 16, 2009 in the Washington Post by Robert O'Harrow Jr.

I therefore seek answers to the following questions:

1. Do you approve of the proposals in the bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM ?

2. Did you, or anyone in a governance or leadership position at CCHIT, play a role in sponsorhip of this bill, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?

3. Did anyone with governance or leadership roles in CCHIT's founding or affiliated organizations (e.g,, HIMSS, CITL, and others) or business associates of such people, play a role in the bill's sponsorhip, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?

4. Did anyone (person or company) in the HIT industry, broadly speaking, who could directly profit from such a bill becoming law play a role in sponsorhip of, or advocacy for this bill?

I believe candid and transparent answers to these questions are important in giving the HIT community confidence that CCHIT primarily serves the public interest, not interests of an HIT lobby.

-- SS

6/8/09

Dr. Leavitt has candidly responded. I take his word on these issues at face value, having done business with him a bit over a decade ago (supporting the purchase of his company's EHR, Logician, for Christiana Care over the opposition of the IT department which preferred another vendor):

From: "Mark Leavitt"
Date: 06/08/2009 02:51AM
cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org
Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems

Scot,

Here are the answers to your questions:

1. No, I do not approve of this legislation -- which I'm reading for the first time in your email. Our goal, stated in almost every presentation I've given, and to which I've adhered in my leadership of the Commission, has always been to unlock positive incentives for health IT adoption. The bill does not fit that model at all, and it is a bad idea.

2. Neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill. We were unaware of it until it started showing up on listserves Friday. The bill has never been mentioned in any of our Trustee, Commission, or staff meetings.

3. Trustees, Commissioners, and Work Group members serve in a volunteer capacity at CCHIT. We require disclosure of conflicts of interest, but we do not monitor all activities in their 'day jobs' or other volunteer roles. "HIMSS, CITL, etc" are not affiliated with CCHIT, and we don't know about all their advocacy activities. I'm not privy to the information you seek.

4. This question presumes that I would know everything that "anyone in the HIT industry, broadly speaking" has done regarding the bill. Naturally I do not have that knowledge either.

Now that I've responded, the AMIA listserve members can stop reading here, while I go on to chat with Scot.

Scot, in 15 years of medical training and practice followed by 25 years of healthcare informatics, I've encountered very few people -- and certainly no university professors -- who acted so disrespectfully toward me. Being a veteran of health IT, it's easy to find people who have worked with me or know me well, and to ask them about my integrity. Or to talk to some of the other 50 or so Commissioners who've served or the hundreds of work group volunteers. Shouldn't an informatics scientist do a modicum of research before undertaking a potentially harmful procedure such as attacking a person's or organization's reputation? Reading a news article by Mr O'Harrow does not qualify as due diligence. Would you let your informatics students get away with that before recommending a major, potentially disruptive or destructive IT project?

From your own blogging I see that your "early medical mentor, cardiothoracic surgery pioneer Victor P Satinsky, MD, believed in public embarrassment as a tool to fight bureaucracy and discrimination ." Well, that helps me understand. And your blogging about your frustration when you sought employment with a commercial EHR vendor http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html explains even more. Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists. I would be pleased to engage in a civil, rational debate with you along the lines of "EHRs -- do the benefits outweigh the risks?" C'mon out to the farm here sometime -- you know the address, and the dog's friendly -- or we could do it on the web.

Finally, my apologies to everyone on the mailing lists that Dr. Silverstein chose to include in his investigative journalism broadcast. If you object to his use of AMIA mailing lists for this kind of activity, you could let him know.

Mark Leavitt, MD, PhD
Chairman, CCHIT

My response was simple:

To: "Mark Leavitt"
Date: 06/08/2009 05:24PM
cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org
Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems

Mark,

I thank you for the answers to my questions.

> Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists.

Mark, that information came from your page at http://www.markleavitt.com/ which I found on a google seach for "Mark Leavitt." Image attached. I believed that to be your professional contact info.

As to the rest of your response, you appear to attempt to discredit my arguments through ad hominem. I refer you to this page:

http://www.nizkor.org/features/fallacies/ad-hominem.html

Translated from Latin to English , "Ad Hominem" means "against the man " or "against the person."

An Ad Hominem is a general category of fallacies in which a claim or argument is rejected on the basis of some irrelevant fact about the author of or the person presenting the claim or argument. Typically, this fallacy involves two steps. First, an attack against the character of person making the claim , her circumstances, or her actions is made (or the character, circumstances, or actions of the person reporting the claim ). Second, this attack is taken to be evidence against the claim or argument the person in question is making (or presenting). This type of "argument" has the following form:

1. Person A makes claim X.
2. Person B makes an attack on person A.
3. Therefore A's claim is false.

The reason why an Ad Hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not (in most cases) have a bearing on the truth or falsity of the claim being made (or the quality of the argument being made).

Ad hominem, sadly, is not debate.

Neither is appeal to authority .

Scot

Truth be told, I actually offered no arguments in my email message. I was asking very probing questions with concern they would be ignored, or responded to with "spin" as here, and their tone offended him. Fair enough.

I was a bit disappointed, however, by the "The lady doth protest too much, methinks" ad hominem embellishments to an otherwise candid and convincing response.

Such are the risks of directness and disruptive innovation, however.

-- SS

6/9 Addendum:

Additional views on the NJ Bill are at ePatients.net at "David Kibbe & Mark Leavitt:Openness vs. Opacity" and "Dossia, Microsoft HealthVault & Google Health: Illegal in NJ?". There are some now-familiar themes regarding CCHIT civility in those posts.

6/10 Addendum:

As a result of a link sent by a commenter, I am adding the post "The Kibbe/Leavitt Rumble in the High Tech Jungle!" to the list of interesting views in the 6/9 addendum above.