Healthcare IT Delirium

The delirium surrounding healthcare IT seems to be worsening.

In an Aug. 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing" I wrote that health IT company Epic, one of the largest, seemed to not care about healthcare or IT education or experience in its recommendations to hospitals on staffing of safety critical projects (i.e., the implementation of safety critical clinical cybernetic devices):

Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say.

The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores.

Based on a presentation by the company at my university, they apparently they mean it:

Career Presentation: Epic Systems Corporation - TONIGHT

The Drexel Women in Computing Society (WiCS) will organize a career presentation by Epic Systems Corporation tonight, January 19, 2011, from 6 to 7 p.m. at University Crossings, room 149 (32nd and Market Streets).

Epic Systems Corporation, located in Madison, Wisc., creates software for the healthcare industry and is hiring for many positions. They are recognized nationally as a leader in moving healthcare organizations from paper medical records to completely electronic ones. Epic hires from all majors, all degrees and all experience levels, and requires no software experience. [Or, as is obvious from this solicitation, healthcare experience - ed.] The presentation will include an overview of Epic's industry work, corporate philosophy and role-specific expectations.

This presentation is open to all graduate and undergraduate students at Drexel University. Pizza will be provided and resumes will be accepted after the presentation.

Other health IT merchants will probably soon follow suit.

As I also wrote at the aforementioned post:

Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be, and these practices as described, in my view, represent faulty and dangerous advice.

The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

This talent management ideology is also alien to medicine (at least since the Flexner Report of 1910), and at odds with critical thinking and common sense.

Then there's this, an attempt by Medical Informatics researchers of the American Medical Informatics Association (AMIA) to ex post facto put a scientific veneer on the troublesome and extremely costly "Meaningful Use of health IT" criteria mandated by the US Government. Those criteria were largely arrived at through "off-the-top-of-their heads" committee meetings (see "Meaningful Use and the Devil in the Details: A Reader's View" on this blog and "The MU Hearings: DrLyle Goes to Washington 1/18/11" at the HIStalk site):

On behalf of the CISWG Leadership Team [AMIA Clinical Information Systems work group - ed.]

In light of the HITECH Act and subsequent Meaningful Use objectives, it is imperative for the informatics community to consider the current science behind clinical information systems and to identify areas requiring further research. In keeping with this, the CISWG leadership is interested in developing a white paper, “The Science Behind the Meaningful Use Criteria”.

The purpose of this paper will be to synthesize the existing literature regarding each of the meaningful use criteria and develop recommendations for future research. We are requesting your assistance in this work.

We ask you, as experts in the field, to help identify current literature and subject matter experts for EACH of the meaningful use criteria. In addition, please state if you (1) believe there is evidence for the objective, and (2) if the evidence is supporting of the objective. Please do not delete other’s input but rather add your comments directly to the document (even if in conflict with others).

The document should result in a great asynchronous discussion. Please provide your input by the 7th of February. We appreciate any input you are able to provide. Thank you for your assistance and we look forward to sharing the results of this work in the future

My contribution will probably be that it's probably better to examine the science in a domain before putting it into national policy, not after ...

I'd also observed at "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" and at the followup post "Cart before the horse, again: IOM to study HIT patient safety for ONC" that a focus on "meaningful use" before a focus on health IT "meaningful usability" and health IT safety was putting the cart before the horse.

Recklessly so, in fact.

How not to do health IT: by putting the cart before the horse on usability and safety

Finally, in light of the recent experiences of a medical informatics-skilled hospitalist as I posted at "An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem" ...

[The NY Times article on information overload in the military causing deaths] was eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU.

Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.)

Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem...

PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.

... and the injury of my relative in 2010 due to interference of healthcare IT in clinician-clinician communications (including, but not limited to, me communicating with those caring for my relative, and them communicating among themselves and with the technology itself), all I can say is:

The field of health IT has become delirious.

On top of an irrational exuberance (see this blog query) largely unsupported by the literature (e.g. here), the technology is experimental, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient informed consent, nobody is in control, and nobody is taking responsibility for regulating the domain despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.

This is crazy stuff.

Running off the rails. We seem to be going out of our way looking for this with HIT, sending it out full speed ahead on far too short a track ...

There's very little else I can do about it at this point, having tried writing, speaking, and political venues.

This will affect your healthcare, not just mine (at least I know what to look out for).

I suggest litigators stay closely attuned to hospital morbidity and mortality incidence (and incidents).

-- SS

Post Title → Healthcare IT Delirium

Meaningful Use and the Devil in the Details: A Reader's View

A reader, Dr. Scott Monteith, a psychiatrist, shared his thoughts on government-mandated 'Meaningful Use' of Electronic Medical Records ('MU') with me after reading a number of my EHR posts, and asked if he could share his thoughts via Healthcare Renewal.

Dr Monteith is a graduate of the University of Michigan and Michigan State University where he was chief resident. He is a board certified psychiatrist, clinical assistant professor in the departments of psychiatry and family medicine at Michigan State University, and has worked in the same community health center for 20 years serving people suffering from severe and persistent mental illness. His interest in Health Information Technology goes back over 20 years. He has served as a CCHIT Juror, was appointed by Michigan’s Governor Granholm to the Controlled Substances Advisory Commission which has an oversight role for the Michigan Automated Prescription System, and was a member of the Business Operations group of the Michigan Health Information Network.

Dr. Monteith writes:

From Medical Economics:

“While 85% of physicians were aware of the financial incentives for implementing an electronic health record (EHR) system, more than 35% did not know that they face government-assessed financial penalties for not complying, according to a survey of more than 500 physicians by Physicians' Reciprocal Insurers, a New York-based medical liability insurance company. The penalties are equal to a 1% reduction of the physician's annual Medicare payments per year up to 5%. However, those penalties do not seem to be having the intended effect, as more than 65% of physicians who were unaware of the financial penalties said this would not cause them to implement system."

The above Medical Economics article reflects a reality that is consistent with what we are seeing in the clinical ‘trenches.’

Eligible Providers (EPs) are realizing that Meaningful Use (MU) incentives are not as simple as…using a certified EHR + being part of Medicare and/or Medicaid + applying for MU + attesting to MU.

Receiving $44k (or $64k) in incentives seems not only increasingly elusive, but of questionable benefit even if some or all of the incentives are realized.

The ‘carrot & stick’ of Meaningful Use (MU) seems to increasingly be viewed as ‘meaningless and useless’ by at least some clinicians. Some are asking if ‘MU’ will stand for ‘meaningless and useless’ in the future.

There seems to be a long list of reasons why MU is so challenging. From what I have gleaned, there appear to be two main issues:

1. the cost to meet MU may be too high (and, said another way, the ROI might be too low); and

2. there are too many uncertainties associated with MU (largely stemming from the risk of burdensome bureaucratic entanglement – an unknown and potentially huge “cost”).

As we know, MU reimbursement flows through two streams: Medicare and Medicaid.

And one’s incentive dollars and/or penalties are based on Medicare/Medicaid volume.

So small Medicare/Medicaid volume means small incentives/penalties. With the perception of inevitable Medicare and Medicaid cuts, these two funding streams become increasingly irrelevant for more and more providers.

Another issue stems from the fact that MU and the associated EHR “certification” are losing credibility because they do not address “usability.” My users simply want EHRs that “work,” and “work” well (like their iPhones).

Users ultimately want and expect usability. They hoped that certification would help guide them in this important respect, but they are finding that is not the case.

To the extent that certification is not meaningfully addressing ‘usability,’ therefore, MU is viewed as ‘useless’ in guiding purchasing decisions.

Further, many are simply not confident that they will meet MU.

Other challenges I’ve encountered include:

• One big problem with MU is that many people believe that wedding one’s self to MU (ARRA) will open a can of bureaucratic worms (and they might be correct)

• MU is 864 pages of details. How many users will read all 864 pages of the government’s final rule for MU? (And of those few who do, how many will understand it?). If one doesn’t know the MU rules, how will one prepare for MU? Hire consultants and IT experts? How much will this cost?

• How will one establish that one is MU-certified? In year one there will be self-attestation. But who/what will certify users as to whether or not users are meeting MU in the other years? How much will it cost (direct costs to pay above certification organization/entity)?

• How much will it cost users to become certified (indirect costs to prepare for your certification)?
• Currently it appears that one must recertify every year for incentives. But how often will one have to recertify to avoid penalties? What will be the ongoing cost in terms money, time, energy, business flow? Will the ROI be positive or negative (and how positive or negative)?

• To what future governmental audits might one be subjected if one gets incentive dollars and/or wants to avoid penalties (especially after the inevitable celebrated cases of abuse)? It is not hard to imagine receiving a letter from the government that says, in essence: “You self attested that you met MU in year one. You are now being audited to substantiate your attestation.”

• How many people will be audited after receiving ARRA dollars? How much time will the audit take? For how long will you need to keep records? What records?
• What will Congress (and the FBI) do when someone gets ARRA dollars through the “incentives” (or avoids “penalties” in the penalty phase), but they haven’t properly completed the MU certification process, or properly/fully documented it (perhaps no fault of their own)?

• What liability does one incur by claiming to meet MU, but then later discovering that someone in the government says that you have not met MU?

• Given that one needs to do things for MU that establish X percent of a given function (e.g., Rxs) are accomplished through an EHR, one needs both a numerator and denominator to establish the percentage. But how does one capture the data to establish MU percentages for Rxs (and other tasks) that are done on paper?

• Are incentive dollars taxable? The answer appears to be “yes.” But many doctors are already “signing over” their dollars to institutions. Unfortunately, neither the doctors nor the institutions are making accommodations for the tax implications. That is, what happens when institutions get the dollars, but because the dollars flow through the clinician, the clinician gets the tax bill?

• What happens if you change EHRs, for example, due to moving to new practice? Will you have to start all over again? Will you have to reimburse the government?
• Today there are over 400 EHR vendors. In five years, it is expected that at least 350 will ‘go under’ (no longer exist). What then? Recertify? Give back ARRA dollars?
• Will the goal line (either in terms of criteria or time) for MU be moved? (It might move; some say it definitely will move.) How often will this occur? What are the implications for your MU and any ARRA dollars that you have received?
• The Republican “Pledge” is calling for no incentives be spent (including related to HIT).

Of course, my own opinion is that setting standards for "meaningful use" implies that use of EHR's can be meaningful to the doctor & patient (rather than to the government and to payors); the literature is conflicting on this point.

Further, doing do at a time when HIT is widely acknowledged to be of poor usability (even by HIMSS itself) is putting the cart before the horse, as I wrote at my post "Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?"

We report; you decide.

-- SS

Post Title → Meaningful Use and the Devil in the Details: A Reader's View

Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

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

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced.

I note the lack of footnotes showing the source(s) of these statements.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. I can think of more than a few examples of the latter just off the top of my head [ref. 1-15 below, certainly not a comprehensive list but merely skimming the surface].

In politics, however, no such sourcing is necessary. It's easy for a politician to say "Free markets will not give us the healthcare system we want" or, conversely, "I never heard about the DOJ's selective dismissal of charges against people intimidating voters at a voting site in Philadelphia."

So, did the NEJM publish fact, or political platitude?

Can someone provide a list of peer reviewed, rigorous studies that back the assertions of certainty in 10.1056/NEJMp1006114, and override the body of literature that could cast doubt on these assertions of certainty?

Since it's people's lives at stake, not an inventory of widgets, I've promoted the idea of holding off on national roll outs until we:

• learn sufficiently from failures such as the UK's NPfIT (National Programme for IT) in the NHS and our own military's AHLTA debacle on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;

• improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;

• end the contractual "hold vendor harmless clauses" (see Koppel and Kreda's 2009 JAMA article here), and fear-based censorship of information on health IT problems, patient injuries and deaths related to the devices; and

• meaningfully regulate these devices that have increasingly become governors of care delivery.
  

I have written extensively on these topics at this blog, at my academic website on health IT failure, and other sources (see list at end of my bio).

When there are significant doubts about a medication or medical device, we ought not push for national rollout.

Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with.

-- SS

References: (hyperlinks to these and others can be found at my medical informatics teaching sites 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)

Addendum 7/14:

I think this statement at "The Road to Hellth" blog in a post entitled "Meaningful Ruse" that cites my posts is apropos:

... Meaningful use entered our vocabulary in early 2009 as part of a $20+ billion gift from doctors, hospitals and the taxpayers to the needy folks at Cerner, GE, Siemens, Allscripts, Epic and other purveyors of complex, expensive and difficult-to-use and potentially even dangerous medical software products.

-- SS

Post Title → Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain

Despite a massive push in our (yet-unnamed) U.S. national program for health IT in the past year (which I shall christen as the NPfIT in the HHS), nagging questions about healthcare IT remain.

The first regards the Public Comment period on the "Meaningful Use" criteria for HIT, part of the Medicare and Medicaid Programs; Electronic Health Record Incentive Program Proposed Rule:

This proposed rule would implement the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible professionals (EPs) and eligible hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified electronic health record (EHR) technology. The proposed rule would specify the initial criteria an EP and eligible hospital must meet in order to qualify for the incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs and eligible hospitals failing to meaningfully use certified EHR technology; and other program participation requirements.

Perhaps submitting comments in the public forum of a blog will spread the message further than through the method above...

As I wrote in Oct. 2009 at "Washington Post Article: Electronic medical records not seen as a cure-all", there is a major problem with the term "meaningful use" itself:

This [term "meaningful use"] is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term."

I go further. Use of a term that a priori assumes some outcome reflects the antithesis of science. The term "meaningful use" in the domain of technology implies that those following the recipe for use of some technology, as well as their subjects, will experience meaningful outcomes. A parallel is in the logical fallacy of begging the question or circular argument, where the conclusion of an argument is among its premises.

'A priori knowledge' is knowledge known independently of experience, i.e., from reason alone; 'a posteriori knowledge' is knowledge proven through experience.

To say we as a society have a priori knowledge of the benefits of health IT would unarguably be an absurdity; to say we have uncontested a posteriori knowledge of same is, quite simply, a lie. Evidence of the portable, healthcare-improving qualities of health IT in its current form has been weak, and the literature challenging this often technologically-deterministic position is growing.

In scientific research, an experiment (Latin: ex- periri, "to try out") is a method of investigating causal relationships among variables, or to test a hypothesis. An experiment is a cornerstone of the empirical approach to acquiring data about the world and is used in both natural sciences and social sciences.

The truth is that healthcare IT remains an experiment, using virtual medical IT devices that are entirely unregulated. The "meaningful use" criteria, basically arrived at by opinions and committee consensus, must be viewed in that framework. (I note that some NPfIT experiments in other lands have not been very successful).

When the criteria are viewed in, say, the framework of a NIH grant proposal for testing some new technology, the correct term is not "meaningful use", it is "experimental protocol" or "research protocol." The government is paying for physicians to follow an experimental protocol, reimbursing them for part of the expense and labor, in the hope that the experiment will have beneficial effects and no major adverse side effects on the practice and financing of medicine.

If one accepts the premise that HIT -- and our collective understanding of how to design and implement it -- is fully proven and ready for societal rollout (which is the operative assumption of our government - witness the duress of penalties), then one is not following the methodologies of science. If, on the other hand, one accepts that it *is* an experimental technology, then one should also accept that the current rollout plans are nonscientific in the extreme. This is simply not how ethical biomedical research is conducted, e.g, without the consent of the subjects (patients) -- indeed, with actual coercion of the healthcare professionals -- and without regulation of the experimental technologies.

I therefore ask the following nagging but important question: why is the term "meaningful use" even in the lexicon of the U.S. NPfIT in the HHS? Why should physicians buy into this program?

Why should they not instead refuse to participate in an experiment that could waste their time or cause adverse consequences for which they are liable? Why should those who do participate not calculate the person-hours required to perform the experimental tasks as specified by the experimental protocol, and charge for their time and labor accordingly?

(See some related points at the vendor post "Readers Respond: The Exorbitant Cost of Meaningful Use" at the EMR Straight Talk site. Note: I have no relationships with, or connections to, this vendor.)

Further, what is missing in the experiment of unregulated IT medical devices is robust risk assessment, adverse events reporting, and perhaps most importantly, patient informed consent. It is also unclear if the "hold harmless" and "defects nondisclosure" clauses traditional in IT contracting, and that likely violate healthcare leadership fiduciary responsibilities and joint commission safety standards, will be forbidden in this grand experiment.

A second nagging question arises regarding a somewhat perplexing announcement: a HIT vendor's product that provides data interchange (i.e., an interface apparatus) between EMRs and other medical devices has received FDA pre-marketing clearance, making it available for sale.

On an Interface to Nowhere:

Thousands of medical devices are used in hospitals, physician offices and homes to help clinicians provide better care to patients. Medical devices are used to monitor patient vital signs, infuse medication and even help patients breathe. These devices capture important information about patient health, but oftentimes that information resides in disparate systems outside of the patient's electronic health record (EHR). To solve this problem, [vendor] created the CareAware device connectivity architecture to connect medical devices to the EHR, enabling bi-directional data sharing between medical devices and the patient record. The[vendor] CareAware iBus, a solution that connects medical devices to the EHR to support the entire care process, recently received 510(k) pre-market clearance from the U.S. Food and Drug Administration and is now available in the United States and all U.S. territories.

Here is the question:

How is it possible that an intermediary apparatus to interface medical devices to an EHR can be subject to FDA approval, but the EHRs themselves that this intermediary apparatus interfaces the devices to can be entirely unregulated? EHRs are not subject to FDA approval or any other regulatory agency's evaluation and approval whatsover.

Further, why is the FDA marginalized to the point where the only component of HIT they evaluate and approve are interfaces?

This is a somewhat jarring violation of common sense and first principles of systems thinking: that systems should be evaluated in their entirety, as unexpected adverse consequences are often the result of system-related failures exacerbated by the "weak links" in the system. This probably also violates the principles of resilience engineering, a term I first learned after presenting on IT difficulties to the IEEE Medical Technology Policy Committee a few years ago.

With regard to these nagging questions, I'm just asking. Let the reader decide if these are reasonable questions regarding their medical care.

I doubt I will receive official answers to my lèse majesté.

-- SS

Post Title → Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain

Washington Post Article: Electronic medical records not seen as a cure-all

Regarding the very well done Sunday Oct. 25, 2009 story in the Washington Post "Electronic medical records not seen as a cure-all" by staff writer Alexi Mostrous - signup may be required for access - I have several observations.

(Not including the observation that Mr. Mostrous probably deserves an award for being the first major newspaper reporter to broach this topic in a serious and balanced manner.)

First, I believe healthcare IT can live up to all the predictions made about its benefits - but only if done well. There is massive complexity behind those two words "done well", and that is HIT's key stumbling block in 2009. I believe we are only in the adolescent stage of knowing how to "do health IT well."

Second, I should point out that the intended consequences of health IT include, among many other things, the following "hiding in plain sight" (i.e., not often verbalized) intended consequences:

• The improvement of medicine ... in the context of protection of patient rights established over centuries of development of modern medicine.

• The improvement of IT itself through cross disciplinary collaboration between IT and medicine, of the science of IT (computer science), the social aspects of computerization ("sociotechnical issues"), and improvement of the our understanding of the intersection of medicine and computers.

Instead, we largely have the opposite. Patients' rights are trampled, and hostility and territoriality has arisen between clinicians (including medical informaticists) and IT, groups that rarely if ever interacted in hospitals ten or twenty years ago.

Of concern, when scientific study sections evaluate NIH grant proposals calling for testing of new IT that involves patients, patient protections and informed consent processes are a paramount concern since such activities are considered research. Yet, in implementing large clinical IT system in a hospital with new features, there are no formal regulations, and I'm not sure there's even IRB involvement in most cases. Patients do not get the chance to give informed consent to the use of these IT devices mediating their care. Why the difference?

The unintended results of computerization efforts have also included suppression of research on sociotechnical issues and on informatics, which must include study of the downsides of HIT, and of the failures in addition to the study of the successes. That is scientific fact - there is no room for debate, no room for spin on the need for careful study of the downsides of any mission critical domain. One would think there to be a vibrant literature on these issues, Yet searches on massive biomedical databases such as PubMed on, say, "cerner electronic health record" (or other vendors as well) are disappointing to say the least. Further, my own website on HIT difficulties remains nearly unique (PPT) after ten years online. That is not bragging; it is a disturbing finding to me - symptomatic of an industry that somehow has managed to avoid serious scrutiny.

In a field with downsides, there are:

1) those who know about the problems but fail to speak,
2) those who see the problems but fail to act, and
3) those who see, know and speak/write/research the problems.

That said, now on to the Washington Post article:

... bipartisan enthusiasm has obscured questions about the effectiveness of health information technology products, critics say. Interviews with more than two dozen doctors, academics, patients and computer programmers suggest that computer systems can increase errors, add hours to doctors' workloads and compromise patient care.

I would include the bipartisan enthusiasm under the subject header of "irrational exuberance", which itself falls under the header of "lack of domain knowledge." That itself is a consequence of both failure to study the issues, and suppression of those issues by those with an interest in doing so.

health IT's effectiveness is unclear.

The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now.

The Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.

Being the ranking member of that committee, Sen. Grassley has a fiduciary responsibility to protect Medicare and Medicaid patients (and one might argue, to protect all patients since those programs often serve as models for private insurers). In that regard, the investigation he has initiated is part of his responsibility as a ranking member of Congress. Politics aside (and there are those who will resort to ad hominem "political witch hunt" arguments), he would have been negligent if he had not initiated an inquiry.

Sen. Grassley has taken on the pharma industry and the government's Food and Drug Administration itself, such as in this recent article "FDA fails to follow up on unproven drugs" where he concluded from a GAO study he ordered that "FDA has fallen far short of where it should be for patient safety." He seems quite serious about medical safety.

If only others in Congress had done their job similarly regarding national finance, we might now not be in the worst economic crisis since '29 with many major industries failing.

David Blumenthal, the head of health technology at the Department of Health and Human Services, acknowledged that the systems had flaws. "But the critical question is whether, on balance, care is better than before," he said. "I think the answer is yes."

This sounds uncomfortably like how a pharmaceutical company might respond to doubts about drug effectiveness and safety. In reality it's really irrelevant what he "thinks." Where's the data? Is this a political statement, a personal belief, or a statement backed up by scientific fact that is not cast into doubt by other research results? Our own National Research Council, Joint Commission, and other international organizations have written about their doubts and concerns about HIT [as that IT is designed and implemented in 2009]. If there is rigorous, systematic research weighing pro's and con's to back this assertion, I wish it would be published.

For his statement is really saying "we don't really know how many systems have flaws, we know some do, and we don't really know the full extent of the impact of those flaws, but because there can be some benefits, let's spend $50+ billion before we know the extent of the problems and fix them." I point out research from Harvard forty years ago, when Harvard informatics pioneer Dr. Octo Barnett published the "Ten Commandments of HIT." Two of those commandments were:

... 8. Thou shall be concerned with realities of the cost and projected benefit of the computer system [i.e., ROI - ed.]

10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

The full set is in this post. Somewhere in the past 40 years, the rigorous ROI evaluations (which also must include systematic evaluations of risk, as any businessperson knows) and the fundamental skepticism seem to have gotten lost.

Over the next two months, Blumenthal will finalize the definition of "meaningful use," the standard that hospitals and physicians will have to reach before qualifying for health IT stimulus funds.

This is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term."

"If you look at other high-risk industries, like drug regulation or aviation, there's a requirement to report problems," said David C. Classen, an associate professor of medicine at the University of Utah who recently completed a study on health IT installations.

This is obvious, the reasons for it are obvious, and the reasons why health IT needs a requirement for problems reporting (one aspect of post-marketing surveillance, the "Phase IV" study as it is known in pharma) is obvious. Yet in 2009, no such requirement exists (see my post "Our Policy Is To Always Have Unabashed Faith In The Computer" for more on why we need reporting requirements.) Why do these requirements simply not exist in HIT?

"It's been a complete nightmare," said Steve Chabala, an emergency room physician at St. Mary Mercy Hospital in Livonia, Mich., which switched to electronic records three years ago. "I can't see my patients because I'm at a screen entering data." Last year, his department found that physicians spent nearly five of every 10 hours on a computer, he said. "I sit down and log on to a computer 60 times every shift. Physician productivity and satisfaction have fallen off a cliff."

The industry in the past has called such physicians "luddites", "resistant to change", "stubborn" etc. However, argumentum ad hominem is a fallacious mode of argument that has no place in a scientific field such as biomedicine. There also seems to be quite a lot of such concerns expressed by a large number of physicians, nurses, etc., and dismissing their concerns with a wave of the hand is cavalier in the extreme - again, these are first principles, without room for argument or debate. Let's study the issues rigorously and scientifically before resorting to ad hominem.

Other doctors spoke of cluttered screens, unresponsive vendors and illogical displays. "It's a huge safety issue," said Christine Sinsky, an internist in Dubuque, Iowa, whose practice implemented electronic records six years ago.

See my eight part series on mission hostile clinical IT here for examples of what Dr. Sinsky is referring to.

She emphasized that electronic records have improved her practice. "We wouldn't want to go back," she said. "But EHRs are still in need of significant improvement."

Yes, not cancellation, but improvement. And, quite importantly, before tens of billions of dollars are spent. Hospitals and physician offices are not an IT development laboratory, since the users of these facilities (patients) have very special rights and the clinicians, very special obligations and responsibilities.

Legal experts say it is impossible to know how often health IT mishaps occur. Electronic medical records are not classified as medical devices, so hospitals are not required to report problems.

That after decades of HIT development, sales and implementation we cannot know with certainty how often mishaps occur is, quite simply, a scandal of major proportions. Quoting an old House of God law, #10: "if you don't take a temperature, you can't find a fever." Another applicable aphorism seen on another discussion board: "you can only be so negligent or craven before the only remaining rationale is that you intended the result."

"Doctors who report problems can lose their jobs," Hoffman said.

I've taken risks with my own career in criticizing health IT, as have my colleagues. Hoffman is not exaggerating.

"Hospitals don't have any incentive to do so [speak out about problems with HIT] and may be in breach of contract if they do."

Imagine the outcry if the same prevailed regarding drugs or medical devices. The cemeteries would be lined with people whose epitaph could read "we bury our mistakes."

While orange-shirted vendor employees "ran around with no idea how to work their own equipment," the internist said, doctors struggled to keep chronically ill patients alive. "I didn't go through all my training to have my ability to take care of patients destroyed by devices that are an impediment to medical care."

This gets to issues I first raised in my website on HIT difficulties: who are these IT personnel, and what are their qualifications, exactly, to be working in mission critical medical environments? How is their competence evaluated?

I think these are questions that need to be answered.

-- SS

Post Title → Washington Post Article: Electronic medical records not seen as a cure-all

HHS to promote low-cost electronic health record software packages including the VA's VistA

If I were a proprietary health IT vendor, the following bolded passage in the new Healthcare Bill (PDF here) would make me a bit nervous:

SEC. 1102. ENCOURAGING MEANINGFUL USE OF ELECTRONIC HEALTH RECORDS.

(a) STUDY.—The Secretary of Health and Human Services shall conduct a study of methods that can be employed by qualified health benefits plans offered through an exchange to encourage increased meaningful use of electronic health records by health care providers, including—

(1) payment systems established by qualified health benefit plans that provide higher rates of reimbursement for health care providers that engage in meaningful use of electronic health records; and
(2) promotion of low-cost electronic health record software packages that are available for use by health care providers, including software packages that are available to health care providers through the Veterans Administration.

The VA system, VistA/CPRS ("computerized patient record system"), was developed with taxpayer money and is freely available. A free working demo is downloadable here (Windows only).

This represents a needed "public option" for healthcare IT, the estimates of cost of adoption of proprietary systems now at somewhere between $20 and $50 billion dollars, give or take. (I believe the actual figure to be far higher due to IT sector dyscompetence in HIT as I wrote at my post "Fuzzy Math Indeed.") To put that figure in context, $50 billion is enough to build approximately five hundred shiny new 100-bed hospitals, or one hundred 500-bed hospitals, at ~$1 million per bed.

Entrepreneurial companies have sprung up to adopt it for the private healthcare sector such as WorldVista. They probably won't be charging the multimillion dollar rates that the private HIT sector does, and the quality will likely be higher.

-- SS

Post Title → HHS to promote low-cost electronic health record software packages including the VA's VistA