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Showing posts with label healthcare IT lobby. Show all posts
Showing posts with label healthcare IT lobby. Show all posts
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

5:09 PM
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
9:51 PM
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.
8:39 AM
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.
11:11 AM
The publication "The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records" on May 16 2009 in the Washington Post (my comments here) exposes a massive lobby that has grossly over-represented the benefits of healthcare IT, committed a cross-disciplinary invasion of medicine, and created a myth about HIT's supposed transformative powers in curing healthcare's ills.

Since its publication in the Post I have become concerned that the research literature that exists extolling healthcare IT may be tainted by corporate influence. The phenomenon of tainted biomedical literature is certainly familiar to readers of Healthcare Renewal and other medical blogs regarding pharmaceuticals and medical devices.

Electronic health records systems can facilitate, not revolutionize, medicine when led by competent experts cross-trained to a meaningful extent (i.e., graduate level or beyond) in both clinical medicine and information science and technology, e.g., biomedical informatics professionals. Even these professionals must often expend much effort in "managing the mismanagement" by incompetent and/or conflicted IT and hospital leadership. (An example of a tightly run and highly specialized project in a high risk medical subspecialty that did have tangible clinical and some financial returns, via identification of poorly performing medical devices -- not something the medical device industry cares for -- is here. This type of project is not easily portable.)

Making yet another case for how the concept of national electronic health records is probably a bad idea at this point in time with respect to our understanding of health IT and its social-technical interactions and challenges, it appears the military's EHR system AHLTA is simply a disaster. [Note: this is not to denigrate the military, and I am very thankful to all who serve and defend our country and freedoms. HIT problems seem unfortunately universal - ed.] All of the preventable elements I've written about are present: unreliability to due inadequate attention to resilience engineering, a mission hostile user experience, time-wasting, demoralization of clinicians, and a cornucopia of other predictable (to informatics experts) consequences when health IT is managed by anyone other than experts.

Just as our economy and culture are now falling apart at the seams as a result of decades of mismanagement and corruption, from micro to macro levels, in most domains (borrowing a phrase from Rev. Jeremiah Wright, "the chickens are coming home to roost"), so the wages of incompetence and corruption in healthcare and healthcare IT are rearing their ugly head. This is the situation in the setting of a relatively constrained patient population (primarily active military personnel and families):

U.S. Medicine - the Voice of Federal Medicine

May 2009

Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress - By Sandra Basu

WASHINGTON—AHLTA, the Department of Defense’s $4 million [sic - that should be $4 billion - ed.] electronic medical record system, continues to be difficult for military physicians to use, according to top military health leaders who spoke at a House Armed Services subcommittee hearing at the end of March.

At a Congressional hearing titled “AHLTA is ‘Intolerable,’ Where do we go from here?” top Department of Defense and service leaders told members that medical personnel are hampered by an electronic medical record system that, among other issues, is slow, difficult to use, unreliable and frequently crashes.“Being the first service to vigorously support the fielding of AHLTA five years ago, we faced a near mutiny of our healthcare providers, our doctors, our nurse practitioners, physician assistants and others last summer,” Army Surgeon General Lt. Gen. Eric Schoomaker, MC, USA, told committee members at a joint hearing held by the Military Personnel Subcommittee and the Terrorism, Unconventional Threats and Capabilities Subcommittee.

Committee members also voiced concern about how the system was impacting provider morale and patient care. “The committee has heard from military doctors and nurses who use AHLTA that it is unreliable, difficult to use and has decreased the number of patients they can see each day. We have also heard that medical professionals leave the military because of their frustration with AHLTA,” said Rep. Joe Wilson, R.-S.C., ranking member of the Military Personnel Subcommittee of the House Armed Services Committee.

Difficult for physicians to use. Intolerable. Slow. Unreliable. Frequently crashes. Near mutiny. Morale. Affecting patient care, decreasing patient load. Can it get worse?

Yes:

A Troubled System

AHLTA is currently deployed worldwide to 70 hospitals, 410 clinics and 6 dental clinics. In addition, the system is used in 14 theater hospitals and 208 forward resuscitative sites.

While Army, Navy and Air Forcer medical leaders who testified all stressed the importance of an electronic medical record [perhaps due to lobby influence and myth-making? - ed.], they all expressed frustrations with AHLTA. Dr. Schoomaker told committee members that medical personnel, particularly specialists, often “spend as much or more time working around the system as they do with the system.” He said that the services are still not effectively able to seamlessly access complete data of patients from the battlefield between the military treatment facilities and the Department of Defense and the Veteran’s Administration.

Last year he said he knew he had a problem when he asked a physician who is a self-described “super user” of the system whether she was a “super fan” of the system and she responded that she was not. “When our best and most faithful users of AHLTA could not admit to being fans of the system, I knew we were really having serious problems,” Dr. Schoomaker said.

When the Army's Surgeon General observes that clinicians "spend as much or more time working around the system as they do with the system", and that the superusers are not enthusiastic about the system, and a Congressional hearing is held entitled "where do we go from here?" (it's clear to this author that they have no clue), one should start to very critically question basic assumptions about health IT. Who said it's a powerful tool to improve healthcare and reduce costs? Who said it's ready for national dissemination? What conflicts do such individuals have with the health IT industry?

He blamed the system’s failures on a lack of a clear-cut strategy for implementing AHLTA—a problem he believes still exists. “In my opinion, the failures of AHLTA can be attributed to the overall lack of a clear, actionable strategy and poor execution from its genesis. As a result of the MHS’s lack of an information management/information technology strategy up to this point, theArmy Medical Department has been largely frustrated by a number of obstacles that continue to impede the system’s capabilities and functionality,” he said.

He also said that the services should have a greater input in decision making regarding AHLTA. “Military health system information technology investments and solutions should be transparent to the services sitting here at the table and should be jointly governed, meaning that we with service input are treated as principal customer clients of the system and that we are heard and acted upon promptly,” he said.

As a faculty member in a College of Information Science and Technology where undergraduates and graduate students are taught the importance of information science and consideration of the needs of end users as a primary enabler of IT success, how can there be a "lack of an information management/information technology" strategy in this national health IT project? How can there have been a lack of input into decision making by the services in the development and deployment of AHLTA?

Leaders from the Navy and Air Force detailed the challenges that their personnel face in using AHLTA. “Almost all of the providers I spoke to relate to the system going down unexpectedly, recently at least once a week,” Navy Deputy Surgeon General Rear. Adm. Thomas R. Cullison, MC, USN, told committee members. He added that while no one would like to return to paper records, providers are “largely dissatisfied” with the system and that the system slows down their clinic time. “Most of our providers say they have to stay later in the afternoon to finish up notes simply because it slows down clinic time,” he said.

Air Force Deputy Surgeon General Maj. Gen. Charles Bruce Green, USAF, MC, told the committee that Air Force primary care physicians spend about 40 percent of their time working with AHLTA versus 60 percent of their time with patients. On the other hand, specialists are “working around the system trying to find new solutions,” since the system does not address the needs unique to their practices. In his written testimony, Dr. Green said that the problems associated with AHLTA have resulted in “low productivity and provider morale.”

Forty percent of clinician time spent tinkering with balky computers? This should be astonishing to any reader unfamiliar with these issues, and an eye opener to our governmental representatives not just regarding the military, but regarding the entire lobby-promoted scheme to force clinicians to adopt HIT by 2014 or suffer financial penalties.

Specialists "working around" the system (thus risking the dangers of workarounds of HIT deficiencies observed by Koppel and others) because it does not meet the needs of their subspecialties? No surprises here. After reading about issues in development of domain specific healthcare information systems for high risk subspecialties (such as here), it should be obvious that the business IT-dominated health IT industry as it currently exists cannot fill such needs.

More importantly, I feel the AHLTA project is an illustration of what will be reproduced, thousands or tens of thousands of times over, in hospitals and physician practices all over this country as we proceed in a national EHR initiative based on false premises borne of the health IT lobby.

The Problem

Then-Assistant Secretary of Defense for Health Affairs S. Ward Casscells, M.D., told committee members that many of the problems that AHLTA has suffered have been “self-inflicted wounds,” due to software contracts with vendors that were “poorly written.” “We have had, over the past decade, contracts that were poorly written from the standpoint of performance, they have loopholes in them that permitted delays. We have, in some instances, lax oversight of some of these contracts,” he said.

Unbelievable. Hospitals sign HIT contracts putting all liability for system defects on clinicians, and that gag them from disclosing defects outside their organizations. The military's HIT contracts apparently had additional flaws that are probably pervasive in the commercial sector as well.

... In moving forward to rectify AHLTA problems, DoD has adopted a Unified Strategy Regional Distribtion Approach, a three-phased plan for reshaping the electronic health system. In written testimony, Dr. Casscells explained this strategy seeks to “improve provider satisfaction, improve reliability and strengthen data sharing throughout DoD and Department of Veterans Affairs healthcare delivery continuum and with private healthcare providers.” The first phase of the approach will focus on “stabilizing performance, reliability and the core infrastructure,” of the system according to Casscell’s written testimony.

"I want to be wary of overpromising. We have done that in the past [indeed, the entire HIT industry has massively overpromised for decades - ed.], but I am excited about this. I think there is a chance here that we can once again be leaders for the nation in electronic health records, as was the case several decades ago. I would like to think that a year or two from now, you will agree with me that AHLTA has gone from intolerable to indispensible,” Dr. Casscells told committee members.

Tommy J. Morris, acting director in DoD’s office of the Deputy Assistant Secretary of Defense for Force Health Protection and Readiness Programs, said that the only service that nonconcurred with their proposed blueprint to overhaul AHLTA was the Army [not exactly an unimportant stakeholder - ed.]

Dr. Schoomaker, on his part, challenged the notion that there was actually a “strategy” in place for rectifying AHLTA. “Mr. Morris has got a plan, he does not have a strategy. We asked for a strategy. A plan is just one element of a larger strategy. We asked for a strategy and our involvement in that strategy, so with respect, that is what we in a sense partially nonconcurred with,” Dr. Schoomaker said.

"I've got a plan." How familiar a refrain that is in a time of mass societal mismanagement.

If I were a politician examining health IT, I'd really start looking into how our government became convinced health IT was not only a worthwhile investment, but an "economic stimulus." As with our friends up north, it seems to be primarily a stimulus for poseurs and dyscompetents to come out of the woodwork, disrupt healthcare providers, and then collect massive fees for the "favor."

In consideration of the above, I ask:

If the military, with its internal discipline and ability to take over entire modern countries with just a few thousand soldiers lost, and its constrained patient population (active military personnel and families generally free of complex and chronic illnesses) can't get electronic health records right, why would anyone think inept and sometimes corrupt EHR companies, dyscompetent hospital IT departments, and reckless and cavalier hospital executives can?

I reiterate my concerns that the "AHLTA experience" will become all too familiar to hospitals and physician practices throughout this country, unless sanity and rationality is restored to our thinking about health IT.

-- SS
4:40 AM
(To those who linked here from "The Health Care Blog", see my footnote at the end of this post. Also, I suggest readers at least peek at each and every hyperlink I've placed in this essay. It takes time, but it's illuminating - ed.)

In many past posts on Healthcare Renewal I have commented on a bewildering healthcare and IT industry blindness to a growing body of literature and experiences of those "in the trenches" that throw doubts upon Utopian views of health IT as a panacea for healthcare's problems. Those responsible for this literature advise caution and the highest levels of scientific rigor in the large scale adoption of clinical information technology if that technology is to actually improve healthcare, myself included. We know the difficulties and risks. Bad healthcare informatics wastes money and distracts clinicians. Bad healthcare informatics can kill. "Primum non nocerum" is a critical ideology in health IT.

I first wrote about these observations a decade ago and was merely standing on the shoulders of those who preceded me with their own critical thoughts and observations regarding cybernetic miracles in medicine.

I've also been puzzled about the sudden lurch by the current administration to commit tens of billions of dollars to national HIT, along with eventual penalties for resistance, within the ridiculously short time frame of 2014 and with little public discussion. The provisions seemed to simply "appear" in H.R. 1 EH, a.k.a. the Economic Recovery Act of 2009. I wrote about this here.

Finally, I was curious about the timing of a remarkable set of reports from highly respected U.S. organizations on HIT issues, such as a Dec. 2008 Sentinel Events Alert from the Joint Commission and a Jan. 2009 report from the U.S. National Research Council. What motivated their release?

The answers to these questions have become bit clearer via a remarkable article from the Washington Post. It reveals an administration heavily influenced by - no surprise - powerful industry lobbyists. (I thought this administration had pledged a different mode of government conduct, but as has been said, campaigning is done with poetry, and governing is done with prose.)

Here is an interesting explanation of how medicine has been cross-occupationally invaded by the IT industry, probably ten or more years before that industry really has the depth of understanding, depth of talent and capabilities to make useful, usable, safe, and cost effective national health IT a reality:

The Machinery Behind Health-Care Reform
How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records

By Robert O'Harrow Jr.
Washington Post Staff Writer
Saturday, May 16, 2009
When President Obama won approval for his $787 billion stimulus package in February, large sections of the 407-page bill focused on a push for new technology that would not stimulate the economy for years.

The inclusion of as much as $36.5 billion in spending to create a nationwide network of electronic health records fulfilled one of Obama's key campaign promises -- to launch the reform of America's costly health-care system.

But it was more than a political victory for the new administration. It also represented a triumph for an influential trade group whose members now stand to gain billions in taxpayer dollars.

A Washington Post review found that the trade group, the Healthcare Information and Management Systems Society (HIMSS), had worked closely with technology vendors, researchers and other allies in a sophisticated, decade-long [lobbying] campaign to shape public opinion and win over Washington's political machinery ... At the center of those efforts is the Healthcare Information and Management Systems Society. Started a half-century ago, it represents 350 companies and about 20,000 members. Corporate members include government contractors such as Lockheed Martin and Northrop Grumman, health-care technology giants such as McKesson, Ingenix and GE Healthcare, and drug industry leaders, including the Pharmaceutical Research and Manufacturers of America.

With financial backing from the industry, they started advocacy groups, generated research to show the potential for massive savings and met routinely with lawmakers and other government officials.

A lot of voices were left out of that trade group's lobbying, including the open source EHR proponents following the traditions of the VistA effort, as one can learn about in the book "Medical Informatics 20/20" by VA pioneers Goldstein, Groen et al. These traditions are largely alien to the commercial IT sector as evidenced by the mission hostile clinical IT products they put out (see my series on that issue starting here) and even known grossly defective software for use on live patients.

The HIMSS trade group's massive conflicts of interest also seem to have blinded it to the longstanding concerns of many experts in medical informatics, social science and related fields that current approaches to health IT are insufficient and may impair healthcare quality initiatives (let's be frank about what that really means - it means patient harm).

The creation of advocacy groups backed by industry financing also seems eerily similar to many stories on HC Renewal and other blogs about the pharmaceutical industry, as does "generated research." That "research" may also have been industry funded, and it is my belief the impartiality and soundness of such research needs to be critically and impartially re-examined.

Their proposals made little headway in Congress, in part because of the complexity of the issues and questions about whether the technology and federal subsidies would work as billed.

In other words, Congress was doing its job regarding lobbying by proponents of an experimental technology in which they had a major financial stake. Until...

As the downturn worsened last year, advocates helped persuade Obama's advisers to dust off [i.e., uncritically accept lock, stock and barrel - ed.] electronic records legislation that had stalled in Congress -- legislation that the advocates had a hand in writing, the Post review found.
Their sudden success shows how the economic crisis created a remarkable opening for a political and financial windfall: the enactment of a sweeping new policy with no bureaucratic delays and virtually no public debate about an initiative aimed at transforming a sector that accounts for more than a sixth of the American economy.

Let me add that while the advocates "had a hand" in writing the legislation [i.e., they wrote the legislation - ed.], researchers and critical thinkers regarding the downsides of health IT industry in its present state seem to have had little voice in this legislation.

"It was perhaps a once-in-a-generation opportunity to make something happen," said H. Stephen Lieber, the trade group's president. Obama "identified the vehicle that he could use to move his policy agenda forward without the crippling policy debate."

I find this simply outrageous. The reason for policy debates in healthcare and especially healthcare IT is to avoid crippling or killing patients.
Lieber is not a clinician. Who is he to cheer (and perhaps to have spearheaded) the short circuiting of "policy debate" on health IT? According to his bio, he holds an MA from the School of Social Service Administration at the University of Chicago, a BA in Psychology from the University of Arkansas, and has completed additional course work at the graduate schools of business at both universities and at the Keller Graduate School of Management.

... Many technology advocates, including health policy specialists, say that networked electronic patient records that can be transmitted instantly would make health care more efficient and provide valuable insights about costs and care.... Some advocates also say the savings could amount to tens of billions of dollars each year from reduced paperwork, faster communication and the prevention of harmful drug interactions. An equally important benefit, they say, could be to enable researchers to determine the most effective procedures for an ailment. Such an approach would rely on unprecedented data-mining into medical records and the practices of doctors, a kind of surveillance that also would enable insurers to cut costs by controlling more precisely the care that patients receive [Leading to rationing to increase profits? - ed.]

These assertions have never been proven in a scientifically robust manner. Further, there is a growing body of literature expressing significant doubts about these predictions of cybernetic miracles from health IT (see short partial lists of examples here and here) that has largely been ignored - in the worst traditions of pseudoscience and scientific fraud - by the industry and its lobbyists. In fact, the latter assertion - comparative effectiveness research based on EHR data - may have moved from scientific possibility (e.g., better detection of major adverse drug and therapy events) to anti-scientific pipe dream, as in my essay "Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?" I am not even considering massive potential for abuses created by online national health records.

"Finally, we're going to have access to millions and millions of patient records online," said Blackford Middleton, a physician, Harvard professor and chairman of the Center for Information Technology Leadership, whose studies have concluded the health-care system could save $77.8 billion each year through the universal use of information technology networks. "This is the biggest step for health-care information technology in this country's history."
But others said the case was far from being so clear. Some observers said the projected savings are overly optimistic and that launching such vast computer networks under tight deadlines is risky, a lesson learned by the Bush administration when it botched a variety of homeland security systems rushed into place after the Sept. 11 terrorist attacks.

While I respect Blackford Middleton as a former leader of the EHR company from which I selected the EHR for Christiana Care Health System in the late 1990's, I also respect those "others" who say the case is far from clear. It is through science and an open political process that such debates need to be resolved, not through lobbying and utopianism. The potential for adverse, unexpected consequences in such a major social re-engineering effort are simply too great for cavalier attitudes or utopianism. We are already seeing adverse consequences - just the most recent examples are here and here.

Industry "roll out HIT no matter what, patient and clinician informed consent be damned" attitudes also teeter on the precipice of human rights violation. In fact, the corporatization of health IT and the treatment of health IT as if it were any other IT not involving third parties with special rights (i.e., patients) may have already resulted in serious breaches of hospital executive fiduciary responsibilities towards safety and (in the U.S.) of their Joint Commission safety standards obligations as well; see my essay here.

Some proponents said they worry that an over-reliance on technology as a solution could distract the health-care system from difficult questions about quality of care. They said efforts to find a quick technological fix will likely run up against complex cultural challenges.

The latter quote sounds like me, stating the obvious. Allow me to translate the applied, real world meaning of "cultural challenges." It means increased political infighting between stakeholders, power grabs, distractions and chaos on the medical floor and in the medical office, and other social and political upheavals within medicine that will likely distract from the ability of already harried clinicians to provide care.

"I would like to believe that the effective use of technology to augment health care will lead to substantial savings and improvements in the quality of care," said Mark Frisse, a physician and professor of biomedical informatics at Vanderbilt University, who leads an electronic health record program in Nashville. "But the evidence does not consistently bear this out."

Dr. Frisse is quite correct, although I would add that the evidence that does not bear out these beliefs is many, many times stronger than that which, say, caused VIOXX to be pulled off the market.

"HIMSS has a very effective grass roots advocacy program that reaches all levels of government," Dave Roberts, a senior executive, said in the group's literature... HIMSS has a "strategic alliance" with the Center for Information Technology Leadership, a nonprofit that produces research reports -- which HIMSS prints and distributes to Congress and elsewhere.

I agree with that description. Missing from the description, and one I would not add, is a "scientific organization."

After volunteering on John Kerry's presidential campaign in 2004, [now-chairman of the board of HIMSS and their ally, the Center for Information Technology Leadership] Middleton said he was recruited as an Obama volunteer last year and provided information about electronic records to the candidate's health-care policy group. Middleton said he worked with several campaign officials, including David Blumenthal, a colleague at Partners HealthCare and a Harvard professor, who was Obama's health-care adviser and is now the administration's national coordinator for health technology.

"We didn't have to go very far to get our information," said one senior Obama adviser, who was not authorized to speak publicly and discussed the campaign on the condition of anonymity. Blumenthal "taught all the rest of us everything we know."

He may have taught them "everything they know", but he apparently did not teach them everything that is important to know. Obama's team has seemingly thrown a significant body of literature on HIT drawbacks and risks under the bus. This is the essence of scientific naïveté and quackery.

Middleton said he provided many of those details.
"I sent them a LOT of stuff, many papers and most of the reports. I probably spoke or communicated with David Blumenthal, David Cutler (the health economist on the team), or Dora Hughes about every other week during the heat of the campaign," Middleton said in an e-mail.

While Blumenthal goes on in the article to minimize Middleton's influence, I can only wonder if any of the HIT industry lobbyists sent "this stuff" to the campaign.

The stimulus bill suggests that the government will recoup about a third of the spending allocated for electronic health records over the next decade, an assumption that some health-care observers question, in part because of a critical analysis by the Congressional Budget Office last year.

The CBO, then led by Orszag, examined the industry-funded study behind the $77.8 billion assertion, among other things, and concluded that it relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology.

I can add that not only is there much unknown about the potential, but there is much unknown about the true difficulties of making it all actually work as promised. See this seminal short article on why this is so.

This is a spectacularly poor way to run major national initiatives costing tens of billions of dollars and upon which patient wellbeing rides. Blindly.

Joseph Antos, a health-care policy specialist who has examined the legislation, said the risks of the technology plan are high because of the haste with which it is being implemented and the special interests seeking to profit from it.

"This is the real way things get done [and the "real" way true disasters such as our recent world wide financial chaos get initiated - ed.]," said Antos, of the American Enterprise Institute, a Washington think tank. "The stimulus bill looked like a bonanza to an awful lot of people." [I tend to take "awful lot of people" quite literally in this case.]

Haste is an understatement. A more reasonable timeframe might have been 2024, not 2014.

I can add that if this initiative blows up as it has in the UK, then the only triumph will be the financial triumph of the trade group and its apparatchiks. The losers will be the administration, patients, clinicians, and everyone else in the healthcare system. [6/29/09 addendum: it's worse than I thought. The UK's NPfIT in the NHS was suspected to have been doomed from the start, but proceeded anyway; see "16 key points in Gateway Reviews on NHS IT scheme" and the Gateway Reviews themselves, released under a UK FOI request - ed.]

In all seriousness, and with recognition of the harshness of this observation, I add that the patients who might die as a result of hastily and poorly designed and implemented health IT under this rushed "real way" initiative, will have in effect been murdered by this lobby.

-- SS

Footnote:

It is interesting to watch the "circling of the wagons" that is starting over the WaPO story. It is in fact predictable that ad hominem, distortion of views, etc. will follow. For example, Matthew Holt of The Health Care Blog, who writes (emphases mine):

I draw your attention to a troika of articles, all of which show how things can be slightly misinterpreted.

First, who knew that Blackford Middleton was either the most influential health policy wonk out there, or single-handedly responsible for the Haliburtonization of health IT? If you read the WaPo article about it, it looks as though there was some kind of terrible conspiracy to impose an evil fraud in terms of unnecessary health IT spending on the taxpayer. And for example MedinfomaticsMD over at Health Care Renewal (who appears to have jumped from the position that some health IT installations have real problems to the less tenable one that all EMRs kill) is just one going loopy about it.

"Loopy?"

Merriam-Webster:
Loopy:

1 : having or characterized by loops
2
: crazy, bizarre

loop·i·ly           Listen to the pronunciation of loopily \-pə-lē\ adverb
loop·i·ness           Listen to the pronunciation of loopiness \-pē-nəs\ noun

Ad hominem (link) is no substitute for a logical argument, in fact it is a logical fallacy. Further, an over the top statement that I've "jumped to a less tenable position that all EMR's kill" is quite disappointing from someone who clearly has the intellect to know how amateurishly political an attack that is on a physician-informaticist in this field for almost two decades. One who is trying to take a strong pro-patient, ethical stance while balancing the need to develop safe and effective health IT along more reasonable timelines, and without the behind-the-scenes corporate influence we write about at Healthcare Renewal.

-- SS

2012 Addendum:  see the end of my post regarding my keynote presentation to the Health Informatics Society of Australia at this link for more on Matthew Holt's apparent disdain for my positions regarding HIT ethcs.
4:06 PM