Showing posts with label healthcare IT unintended consequences. Show all posts
Showing posts with label healthcare IT unintended consequences. Show all posts

Wednesday, October 29, 2014

"The tragedy of electronic medical records"

The Indianapolis Business Journal has published this article, citing former head of Indiana University's Regenstrief Institute, a world leader in EHR research, Dr. Clem McDonald:

The tragedy of electronic medical records
October 23, 2014
J.K. Wall
http://www.ibj.com/blogs/12-the-dose/post/50131-the-tragedy-of-electronic-medical-records

It wasn’t supposed to work out this way.

Digitizing medical records was supposed to transform health care—improving the quality of care and the service provided to patients while helping cut out unnecessary costs. Just like IT revolutionized all other industries.

Perhaps they still will. But lately, electronic medical record systems are getting nothing but votes of no-confidence from physicians, hospitals, insurers and IT experts.

Dr. Clem McDonald, who did more than anyone to advance electronic medical records during his 35 years at the Indianapolis-based Regenstrief Institute, called the 5-year, $27 billion push to roll out electronic medical records “disappointing” and even a “tragedy” last month during a talk with health care reporters (including me) at the National Institutes of Health in Bethesda, Maryland.

I agree with those sentiments.  The botched industry approach to clinical information technology has set back the cause of good health IT severely, largely through clinician disenfranchisement.  That dissatisfaction and disappointment will not be easy to reverse - and never should have needed to have been reversed.

... “It’s sort of a tragedy because everybody’s well-intentioned,” said McDonald, who spearheaded one of the nation’s first electronic medical record systems at Regenstrief and what is now Eskenazi Health. McDonald’s work in Indianapolis on the electronic exchange of medical records put patients here at least a decade ahead of those in most of the country in benefiting from the technology.

I'm not so sure that perverse behaviors such as willful blindness to the risks, profiteering, and indifference to harms caused by these systems, as I've documented at this blog and elsewhere count as "well-intentioned" (e.g., "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

... McDonald now has a nationally influential post to promote electronic medical records, as the director of the Lister Hill Center for Biomedical Communications, a part of the National Library of Medicine, which is one of the National Institutes of Health.

During his talk, McDonald released his latest research survey, which found that electronic medical records “steal” 48 minutes per day in free time from primary care physicians.

That may be true regarding data entry time.  I'd say the amount is likely more when accounting for confusion and communications difficulties that bad health IT causes.

... One-third of physicians surveyed said it took longer to find and review medical record data. One-third also said it was slower to read other clinicians’ notes.

Some docs don’t even read reports any more. This is a perverse side effect,” McDonald said, noting that the electronic reports have so much information in them, that they become “endless and mindless.”

I have used the term "perverse" in the past regarding commercial health IT; this is the first time I recall seeing the term from one of the EHR pioneers.

... More bad news about electronic health records came out this week in a new research study. It found that physicians using electronic medical records spend an extra 16 minutes per day, on average, doing administrative tasks than their peers who still use only paper.

The study relied on data from 2008—which when compared with McDonald’s study suggests EMRs are now consuming more of doctors’ time than they were before the federal push to expand their use.

“Although proponents of electronic medical records have long promised a reduction in doctors’ paperwork, we found the reverse is true,” wrote study authors Steffie Woolhandler and David Himmelstein.
  
Yet we still hear promises about "increased efficiency" and reduction of clinicians' administrative tasks and paperwork due to health IT.  When will that canard be put to rest, one might wonder?

In my view, the experiment of making clinicians perform EHR clerical work has been a failure.

And it was, in fact, an experiment in the full sense of the word.  It was done with little clue as to the true effects on patient care.

From the article:

... So with so many so upset with electronic health records, why is McDonald still optimistic?

He thinks the problems folks are having aren’t inherent to the technology itself, but are instead caused by overly restrictive rules coming both from the federal government and from hospital systems.

Hospital systems, knowing that more information can be recorded now that it’s electronic, have insisted that doctors do more documenting. McDonald cited one research study that found that documentation requirements have doubled in the past decade.

“I think they’ve got to ask less,” McDonald said of hospital administrators. “Nobody has any idea of the time-cost of one more data entry.”

I don't share that optimism or a belief physicians will be asked to "do less" with EHRs, since physicians have essentially abrogated their professional independence and autonomy, and are increasingly becoming servants of their business-degree masters - and of bad technology.

At least nurses are fighting back, e.g., per National Nurses United (see query link http://hcrenewal.blogspot.com/search/label/National%20Nurses%20United).

-- SS

Wednesday, May 28, 2014

"Texas VA Run Like a ‘Crime Syndicate,’ Whistleblower Says" - Can Reports About the Benefits of EHRs at the VA Healthcare System Be Trusted?

More and more is leaking out about alleged executive malfeasance at the Veteran's Administration healthcare system in the U.S.

This article just appeared:

Texas VA Run Like a ‘Crime Syndicate,’ Whistleblower Says
May 27, 2014

http://www.thedailybeast.com/articles/2014/05/27/exclusive-texas-va-run-like-a-crime-syndicate-whistleblower-says.html

For years, employees at a Texas VA complained that their bosses were cooking the books. For years, the VA insisted there was no widespread wrongdoing.

New whistleblower testimony and internal documents implicate an award-winning VA hospital in Texas in widespread wrongdoing—and what appears to be systemic fraud.

Emails and VA memos obtained exclusively by The Daily Beast provide what is among the most comprehensive accounts yet of how high-level VA hospital employees conspired to game the system. It shows not only how they manipulated hospital wait lists but why—to cover up the weeks and months veterans spent waiting for needed medical care. If those lag times had been revealed, it would have threatened the executives’ bonus pay.

What’s worse, the documents show the wrongdoing going unpunished for years, even after it was repeatedly reported to local and national VA authorities. That indicates a new troubling angle to the VA scandal: that the much touted investigations may be incapable of finding violations that are hiding in plain sight. 

“For lack of a better term, you’ve got an organized crime syndicate,” a whistleblower who works in the Texas VA told The Daily Beast. “People up on top are suddenly afraid they may actually be prosecuted and they’re pressuring the little guys down below to cover it all up.”

Read the linked article in its entirety.  It contains document images of altered electronic orders, the EHR system apparently being used for "creative storytelling" to allow for "good metrics", and an employee "performance plan" evaluation submitted by a whistleblower containing perverse incentives:

... The VA’s 2012 performance plan, provided to The Daily Beast by the whistleblower, contains five critical elements to evaluate success, each one containing multiple sub-criteria. But critical element No. 5, the “Results Driven” component that contains the “wait time” criteria, is worth 50% of the overall score. That’s as much as all the other elements combined.

I won't delve into the gory details of the article further...read it yourself...but I do raise the following issues:

1.  The VA EHR system VistA CPRS has been touted as among the best EHR's in the world, based on reports that come out of the VA.

  • Can these reports on the benefits and safety of VistA CPRS be trusted, considering what may be going on systemically regarding altered data related to "making the numbers" and getting bonuses?
  • It is well known that EHRs slow clinicians down, through annoying alerts and reminders and other decision support, cryptic and complex order-entry processes, and the general need to navigate multiples screens and templates to perform what used to take seconds on pen and paper.   Is it also possible that the inability of the VA system to meet its care obligations in a timely manner is related to adverse effects on productivity of the EHR system itself?

2.  EHR audit trails are an automatically-generated log of user activities, such as viewing, printing, altering or deleting an electronic document or other data.  They are the only way to authenticate an electronic record as complete and unaltered, since all paper/handwriting cues are gone in the computer world.

  • It may be of interest to investigate the electronic audit trails generated by the VA electronic health records (EHRs)... or the lack thereof, for as I understand it those audit trails are often only active for VIPs ("very important persons") in the VA VistA CPRS EHR system.
  • Even worse, in the commercial sector hospitals admit they can alter or delete the EHR system audit trails - see my post at http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html.  It's likely the same applies in the VA, and it would be of concern that any audit trails of test and visit scheduling or other activities could be undergoing a "disappearing act" in the wake of this scandal, in addition to the actual test/scheduling data itself.

It is unfortunate that this scandal sheds doubt on claims made about activities, including EHR use, at the VA hospitals.  I myself have taught my students that the VA model has been a model for others to emulate, at least as far as EHRs are concerned.

-------------

As an important aside:

I am personally familiar with very odd events at the VA, namely in 1995.  At http://hcrenewal.blogspot.com/2009/06/computer-and-other-mysteries-at.html regarding the computer-related radiation brachytherapy debacle at the Philadelphia VA Hospital I wrote [and I am adding some additional comments now in brackets]:

... I have some familiarity with odd events at the Philadelphia VA Hospital. (Not including the fact that I spent a few months there as a medical intern in the early 1980's). In the mid 1990's I took my father there for evaluation for increased service-related disability. He had been treated for skin lesions in the Army in WW2 and after by the VA with Fowler's solution (an arsenical) and as a consequence of this (even then-outdated and dangerous) treatment, had developed widespread basal cell carcinomatosis over a major portion of his body, with chronic bleeding and discomfort.

I accompanied my father to the exam but did not identify myself as an MD, only as his son. [I was on vacation and was rather casually dressed.  I looked like any other schlep bringing his elderly veteran father in for care.]

My father was seen in an evaluation by several physicians and students (arsenic-caused basal cell carcinomatosis is quite rare now) in my presence, and he was then handed his (paper) chart to take with him back to the main desk.  [As we were walking] I told my dad I wanted to look at the note. The note by a physician who'd seen him stated (paraphrasing):

"Mr. Silverstein said he'd taken more than the prescribed dose of arsenic for years, and even shared it with his wife."

My father and I were shocked and dumbfounded. He'd said no such thing, and being a retired pharmacist of 40+ years, thought anyone making such a statement would have had to have been insane. (My mother had even harsher words when she heard about this.) [Along the lines of, "ARE THEY CRAZY???"]

Needless to say, I was upset. I [identified myself and] confronted the physician who wrote the note, but that physician [a relatively young woman] would not change it, bizarrely claiming that they "remembered my father telling that story in a visit several years prior." Needless to say, such a claim violated all the precepts of medical information integrity of which I was familiar.  [I wondered to myself, "what type of utter imbecile would even say such a thing to a Yale physician/medical informatics faculty member?"]

In an initial attempt to counteract this disability exam sabotage, I actually crossed out the statement in the chart, writing "this is untrue" or words to that effect and signed my own name.

The head of the Philadelphia VA Hospital would not return my calls on this matter.

That is, until Jesse Brown, then Secretary of the Department of Veterans' Affairs, inquired directly a few days later.

Unknown to the VA examiners, my father had been sent for the disability exam after reporting problems to Sen. Jay Rockefeller's office about prolonged delays in having his case heard.  Sen. Rockefeller's staff [specifically, Ms. Charlotte Moreland, http://votesmart.org/public-statement/25153/retirement-of-charlotte-moreland, who my mother had befriended through many telephone conversations] had set up the exam!

Sen. Rockefeller's staff was rather upset at the story I reported upon my return to New Haven about the bizarre chart fabrication at my father's VA disability exam, and apparently relayed the story up the chain of command, as it were.

After that, the head of the Philadelphia VA Hospital really, really wanted to speak to me and called me at Yale several times. He wanted to set up a phone conference between me, himself, and the doctors who'd seen my father. I told his administrative assistant that there was "nothing to talk about", and that the false statement in my father's chart would be removed. Period.

I think it was. My father's increased disability was granted in the end, but what was going on here with disability exams was never fully investigated to my knowledge (having done disability exams myself years prior for the regional transit authority, police, fire etc. in Philadelphia, I suspected an "incentive" program to deny vets a disability determination). If I had not examined my father's chart, we might have never known a reason for his being turned down.

A culture of honesty and accountability seemed lacking then, and seems lacking now.

In retrospect, it seems there may indeed have been an "incentive program" for, in essence, limiting positive disability determinations by sabotage, thus causing negative determinations on benefits.

Ironically, among other experiences, it was the impoverished experiences at the Phila. VA as an intern in 1981, with a decade of computer experience under my belt at that time, that led me to pursue a career in Medical Informatics.

With inadequate staff and resources, especially at night when a medical student and I and a minimum of nurses covered something like 50 patients - and at that early stage of my career I am honestly admitting that I did not know what I was doing, really - and large amounts of time wasted on paperwork, I thought there had to be a better way via computing.

I never expected that computers in medicine could become a tool for "creative data alteration" for executive enrichment, an impediment to good care, and a risk in and of itself, as was outed by a whistleblower recently in Athens, Georgia as at http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html.

-- SS

May 28, 2014 Addendum:  

Also see "How VA Clinics Falsified Appointment Records" at http://www.huffingtonpost.com/2014/05/28/va-clinics-falsified-records_n_5402547.html

-- SS

Tuesday, December 10, 2013

44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like?

Modern Healthcare published an article "Feds eye crackdown on cut-and-paste EHR fraud" on Dec. 10, 2013 by Joe Carlson.

The article is about federal efforts to reduce the amount of clinician cut-and-paste from prior notes of a patient - which can even be done between charts of different patients.  This practice can result in overbilling for work not actually performed.  The practice can also result in no-longer-accurate data being carried forward; I have been consultant to cases where that phenomenon, in my opinion, contributed to grave patient injury in cases that have settled out of court.

It is at this link:  http://www.modernhealthcare.com/article/20131210/NEWS/312109965/feds-eye-crackdown-on-cut-and-paste-ehr-fraud?utm_source=articlelink&utm_medium=website&utm_campaign=TodaysHeadlines#

Subscription required, but googling the article title may allow reading it in its entirety.

The article begins:


Federal officials say the cut-and-paste features common to electronic health records invite fraudulent use of duplicated clinical notes and that there is a need to clamp down on the emerging threat. That concern is enhanced by the fact that it's too easy to turn off features of EHR systems that allow tracking of sloppy or fraudulent records.

In an audit report released Tuesday morning (PDF), [HHS Office of Inspector General, "NOT ALL RECOMMENDED FRAUD SAFEGUARDS HAVE BEEN IMPLEMENTED IN HOSPITAL EHR TECHNOLOGY"], HHS agencies confirmed that they are developing comprehensive plans to deter fraud and abuse involving EHRs, including guidelines for cut-and-paste features. The issue arises at a time when critics say federally subsidized digital patient record systems are sometimes being used inappropriately by providers to drive up reimbursement.

“Certain EHR documentation features, if poorly designed or used inappropriately, can result in poor data quality or fraud,” according a report from HHS' Office of the Inspector General.

None of this is a surprise to me, and to readers of this blog.

However, the real "money quote" in the article, I believe, is this:


"In addition, only 44% of hospitals' “audit log” systems could record whether cut-and-paste was used to enter data, and an identical percentage of hospitals reported [to OIG] that they can delete the contents of their internal audit logs whenever they'd like."


From page 11 of the HHS OIG Report linked above (http://www.modernhealthcare.com/assets/pdf/CH92135129.PDF):

[In 2006, ONC contracted with RTI International (RTI) to develop recommendations to enhance data protection; increase data validity, accuracy, and integrity; and strengthen fraud protection in EHR technology.]

... Hospitals' control over audit logs may be at odds with their RTI- recommended use as fraud safeguards:

RTI recommends that EHR users not be allowed to delete the contents of their audit log so that data are always available for fraud detection, yet nearly half of hospitals (44 percent) reported that they can delete their audit logs. Although these hospitals reported that they limit the ability to delete the audit log to certain EHR users, such as system administrators, one EHR vendor noted that any software programmer could delete the audit log.

RTI recommends that the ability to disable the audit log be limited to certain individuals, such as system administrators, and that EHR users, such as doctors and nurses, be prevented from editing the contents of the audit log because these actions can compromise the audit log's effectiveness. Hospitals reported they have the ability to disable (33 percent) and edit (11 percent) their audit logs, although they reported restricting those abilities to certain EHR users, such as system administrators or EHR vendors. All four EHR vendors we spoke with reported that the audit logs cannot be disabled in their products, but one vendor again noted that a programmer could disable the audit log.

I further note that, being voluntarily provided, i.e., not part of a formal investigation of any specific organization, those numbers are likely low, perhaps very low considering this issue.

An audit log or audit trail is an automatically-generated dataset, invisible to most users, containing items such as who viewed records, the date/time/location of viewing, and indication of actions they may have performed on the records such as editing/changes/additions/deletions, etc.

As an EHR itself is a collection of magnetized or optically encoded bits on some computer storage medium, it cannot be authenticated as complete and free from alteration by humans.

The audit trail is the only way to authenticate an EHR printout, however (as well as EHR screenshots or any other electronic data turned into a tangible form from those bits) as complete and free from alteration.

If an EHR printout cannot be authenticated as complete and free from alteration, its trustworthiness and perhaps even court admissibility as a business record under an exception to the hearsay rules regarding evidence may be damaged or invalidated.

My concern is that, if true, and considering the conflict of interest a hospital has regarding hiding potential fraud or malpractice that could cost them millions of dollars, a capability to "delete the contents of their internal audit logs whenever they'd like" and to edit audit trails (which based on the capabilities of relational databases also implies an ability to delete sections of audit logs selectively and/or to substitute false data) is simply alarming.

I don't think the EHR pioneers intended EHRs to be used for purposes of allowing evidence spoliation without traceability ...

-- SS

Dec. 13, 2013 Addendum:

I received the following reply from EHR compliance expert Dr. Reed D. Gelzer.  Re-posted with permission:

Good morning Dr Silverstein,

Thank you yet again for the illumination that you bring to matters of truth in Healthcare Information Technology.

Regarding the OIG report’s source document, the 2007 report to the ONC, I was the Fraud Prevention Workgroup Chair for that project, working under Principal Investigators Dr. Don Simborg and Susan Hanson, former Chair of AHIMA. 

For anyone who is interested in this subject matter, I would recommend that you go to the source document and, among other things, review the list of contributors.  These were all individuals who volunteered time to attempt to mitigate harms of defective HIT, in their capacities of records management systems, nearly 8 years ago now.   Many have gone on into leadership roles in related organizations and domains, some still working towards trustworthy health information technology systems.

I believe that I can say that none of those working on the report then would have believed that it was conceivable that even our most basic recommendations regarding the fitness of audit functions would remain "novel" in the industry in 2013.  One cannot be surprised at the low level of authenticity supports in hospitals’ EHRs systems given that fitness as record management systems for patient care has, to date, been either neglected or presumed, not tested or attested.   I am gratified that our 2007 work was utilized for the OIG report to illuminate the deplorable state of integrity supports in these patient care information systems.  This will undoubtedly spur interest in supportive resources such as the HL7 EHR System Functional Model Standard and the HL7 Records Management and Evidentiary Support Profile Standard.

All of us who worked on that ONC report are, I hope, as gratified as I am that the OIG removed our work product from its designated obscurity.   We developed the guidelines via methods that were more qualitative than quantitative, entirely intended to guide initial implementation backed by more methodical research.   We represented the most informed at that time, including those like myself and my ADIC associate Patricia Trites who had performed compliance testing on over 30 among the leading EHRs at the time and found extraordinary ranges of deficiencies, including audit functions that could be disabled at will.   Standards and tools existed then to support mitigation of risks and those Standards and tools have expanded since.  Now that the events and ONC decisions that led to inactions on the report are now in the past, we can more rapidly achieve the potentials nascent in HIT by rendering it more trustworthy, usable, and safe.

Thank you again for your ongoing vigilance.

Sincerely,

Reed D. Gelzer, MD, MPH, CHCC
Trustworthy EHR, LLC
Co-Facilitator, HL7 Records Management and Evidentiary Support Workgroup

To this I add that I also would not have found it conceivable that my concerns about bad health IT and the risks of patient harm it poses, as well as common healthcare IT project mismanagement, of which I started writing about in 1998 (http://cci.drexel.edu/faculty/ssilverstein/cases/) would remain "novel" ideas in the industry in 2013.

The Obamacare healthcare exchange website debacle has made the latter issue mainstream.  The former issues still need more sunlight.

-- SS

2/4/14 addendum:

HHS is apparently starting to pay attention to the importance of robust and secure EHR audit trails.

I note in the HHS document "Meaningful Use Stage 2, 2014 Edition EHR CERTIFICATION CRITERIA 45 CFR 170.314", page 7, regarding audit trails, available at this writing at http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf:

§170.314(d)(2) Auditable events and tamper-resistance.

(i) Record actions. EHR technology must be able to:
(A) Record actions related to electronic health information in accordance with the standard specified in § 170.210(e)(1);
(B) Record the audit log status (enabled or disabled) in accordance with the standard specified in § 170.210(e)(2) unless it cannot be disabled by any user; and
(C) Record the encryption status (enabled or disabled) of electronic health information locally stored on end-user devices by EHR technology in accordance with the standard specified in § 170.210(e)(3) unless the EHR technology prevents electronic health information from being locally stored on end-user devices (see 170.314(d)(7) of this section).

(ii) Default setting. EHR technology must be set by default to perform the capabilities specified in paragraph (d)(2)(i)(A) of this section and, where applicable, paragraphs (d)(2)(i)(B) or (d)(2)(i)(C), or both paragraphs (d)(2)(i)(B) and (C).

(iii) When disabling the audit log is permitted. For each capability specified in paragraphs (d)(2)(i)(A), (B), and (C) of this section that EHR technology permits to be disabled, the ability to do so must be restricted to a limited set of identified users.

(iv) Audit log protection. Actions and statuses recorded in accordance with paragraph (d)(2)(i) must not be capable of being changed, overwritten, or deleted by the EHR technology.

(v) Detection. EHR technology must be able to detect whether the audit log has been altered. 

From a posting at http://healthcaresecprivacy.blogspot.com/2012/09/meaningful-use-stage-2-audit-logging.html:

... The Information that needs to be recorded: § 170.210(e)(1)(i):  These rules [in a column I did not show here - ed.] identify “sections 7.2 through 7.4, 7.6, and 7.7 of the standard specified”. This is simply the list of attributes that an audit log entry should contain that ASTM E2147 says are mandatory, and excludes the values it outlines as important but not mandatory. Below is about 90% of what is in section 7, I didn't want to copy all of it out of respect for the copyright. But, the part missing is just a one-line definition of each item, nothing more than that.
7. Audit Log Content
7.1 Audit log content is determined by regulatory initiatives, accreditation standards, and principles and organizational needs. Information is needed to adequately understand and oversee access to patient identifiable data in health information systems in order to perform security oversight tasks responsibly.
Logs must contain the following minimum data elements:
7.2 Date and Time of Event
7.3 Patient Identification
7.4 User Identification
7.5 Access Device (optional)
7.6 Type of Action (additions, deletions, changes, queries, print, copy)
7.7 Identification of the Patient Data that is Accessed(optional)
7.8 Source of Access (optional unless the log is combined from multiple systems or can be indisputably inferred)
7.9 Reason for Access (optional)
7.10 If capability exists, there should be recognition that both an electronic “copy” operation and a paper “print” operation are qualitatively different from other actions.

I am not sanguine about the "optional" components, especially 7.7 - the actual data that was accessed and acted upon.

I also note it is stunning that these audit trail 'rules' have only been promulgated recently.  It will be interesting to see how rigorous the EHR "certification" process will be regarding audit trails.

-- SS

Wednesday, April 24, 2013

Johns Hopkins: Thanks to EHRs, time with patients seems “squeezed out” of medical training, investigator says

Question:  Who would have thought it?  That there is yet another potentially deadly unintended consequence of bad health IT and health IT hyper-enthusiasm?

Suggested answer:  anyone who truly understands the issues at the intersection of medicine, information science, information technology, and Social Informatics - which probably excludes 95% of the health IT "experts", pundits and opportunists.

Which only goes to show how dense such people can be - as the medical trainees of today will be treating them, their families, and their children in the future:

Johns Hopkins Medicine
Release Date: 04/23/2013

Medical interns spend just 12 percent of their time examining and talking with patients, and more than 40 percent of their time behind a computer, according to a new Johns Hopkins study that closely followed first-year residents at Baltimore’s two large academic medical centers. Indeed, the study found, interns spent nearly as much time walking (7 percent) as they did caring for patients at the bedside.

I can honestly say much if not most of my time in training, several decades ago, was spent at the bedside.

Compared with similar time-tracking studies done before 2003, when hospitals were first required to limit the number of consecutive working hours for trainees, the researchers found that interns since then spend significantly less time in direct contact with patients. Changes to the 2003 rules limited interns to no more than 30 consecutive hours on duty, and further restrictions in 2011 allow them to work only 16 hours in a row.

“One of the most important learning opportunities in residency is direct interaction with patients,” says Lauren Block, M.D., M.P.H., a clinical fellow in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine and leader of the study published online in the Journal of General Internal Medicine. “Spending an average of eight minutes a day with each patient just doesn’t seem like enough time to me.”

An understatement, as most critical information comes from the H&P and ongoing patient interaction - not from cybernetics.  Further, that's probably all the time a butcher spends processing a slab of meat...

“Most of us went into medicine because we love spending time with the patients. Our systems have squeezed this out of medical training,” says Leonard Feldman, M.D., the study’s senior author and a hospitalist at The Johns Hopkins Hospital (JHH).

For the study, trained observers followed 29 internal medicine interns — doctors in their first year out of medical school — at JHH and the University of Maryland Medical Center for three weeks during January 2012, for a total of 873 hours. The observers used an iPod Touch app to mark down what the interns were doing at every minute of their shifts. If they were multi-tasking, the observers were told to count the activity most closely related to direct patient care.

The researchers found that interns spent 12 percent of their time talking with and examining patients; 64 percent on indirect patient care, such as placing orders, researching patient history and filling out electronic paperwork; 15 percent on educational activities, such as medical rounds; and 9 percent on miscellaneous activities. 

Researching the history is made more complex by today's low-usability EHR systems, so much so that I personally know of cases (through my legal work) where trainees and even attendings did not know the patient's history.  In the past, this would have been considered a severe medical faux pas.

The researchers acknowledge that it’s unclear what proportion of time spent at the bedside is ideal, or whether the interns they studied in the first year of a three-year internal medicine training program make up the time lost with patients later in residency. But 12 percent, Feldman says, “seems shockingly low at face value. Interns spend almost four more times as long reviewing charts than directly engaging patients.”

Not to be critical of the Hopkins piece, it is excellent - but academics often use disclaimers and softeners in their conclusions as a custom and tradition.  At a blog I can be more direct:  12% is shockingly low.  No "seems" is actually necessary.

Feldman says questions raised by his study aren’t just about whether the patients are getting enough time with their doctors, but whether the time spent with patients is enough to give interns the experience they need to practice excellent medicine. 

Personally, I would really be nervous under the care of graduates who'd only spent a tenth of their clinical hours actually seeing, speaking to and examining patients, and a majority of their time frittering around with computers.

With fewer hours spent in the hospital, protocols need to be put in place to ensure that vital parts of training aren’t lost, the researchers say.

“As residency changes, we need to find ways to preserve the patient-doctor relationship,” Block says. “Getting to know patients better can improve diagnoses and care and reduce medical errors.” 

As opposed to getting to know the (needlessly complex and confusing) EHR better, which adds little.

The researchers say better electronic medical records may help reduce time spent combing through patient histories on the computer.

After several decades of the health IT industry being in business,  it's sad that an organization of the (deserved) stature of Johns Hopkins has to provide remedial education 101 to that industry in 2013.

Perhaps that's the most important finding of all in this study.


There's some wisdom in this comic strip.  Click to enlarge.


-- SS
 

Tuesday, January 29, 2013

How the HIT zealots and profiteers have harmed physicians and nurses, not to mention patients, taxpayers, and the government

Any new technology introduced into a complex system, especially when introduced recklessly, has the potential to produce unexpected consequences, and the problems introduced can be worse than the problems the technology was attempting to solve.  This is a fundamental precept and empirical observation in the field of social informatics, a domain that studies information and communication tools in their cultural or institutional contexts.

Idealism combined with zealotry (excess of zeal; fanatical devotion) and/or hyper-enthusiasm that ignores the downsides of an intervention, and silences credible critique,  has also proven to be a dangerous combination.

Characteristic of the health IT hyper-enthusiasts been zealotry, silencing of credible critics, and spreading of illusory memes and technologies not yet fit for purpose; the characteristics of HIT profiteers is similar but for a different motive.  The end result in either case is harm to the interests and well-being of patients, physicians and nurses and other clinicians, taxpayers, and the government.

(Doctors and nurses ... after reading the findings below, be prepared to countersue the health system officers who mandated your use of EHR's for breach of fiduciary responsibilities, including due diligence, if you are sued for EHR-caused medical malpractice.)

---

Medscape 
Business of Medicine
Malpractice 'Discovery' Dangers in Your EHR
Leslie Kane, MA
Jul 16, 2012

Introduction

Picture this: You've been sued, and now the plaintiff attorney has the right to send in an expert to sit at your computer and examine information in your electronic health record (EHR). Besides any mistakes you might have made, system-wide bugs or design flaws that lead to data inconsistencies could be found and held against you in the discovery phase of a malpractice lawsuit.

Doctors are becoming increasingly aware that EHRs can create certain malpractice risks. However, an expert in EHR and liability says there is a new category of malpractice risks in EHRs that most doctors have never considered. These include EHR system issues that you were never aware of and didn't cause.

You may have been coerced into using the EHR system via threat of Medicare cuts -- embedded without a public comment period in the HITECH section of ARRA thanks to the zealots and profiteers -- or via draconian hospital policies set by senior executives that threaten adverse personnel actions or other retaliation for those who refuse to use or are unable to learn to "effectively" use the corporate-chosen EHR (I have seen such policies in print).

These executives have simply taken the word of the sellers that the technologies are harmless, and have likely negligently signed hold-harmless agreements with the sellers as a symbol of their confidence in the assessment.

"Every aspect of EHR selection, implementation, and use may be examined in the course of medical malpractice discovery to uncover the source of the incident, or undermine the records that are being presented in defense of the malpractice claim," says Ronald B. Sterling, CPA, MBA, national EHR expert, Silver Spring, Maryland, and author of Keys to EMR Success (Greenbranch Publishing; Phoenix, Maryland; second edition, 2010). "Anything could be a malpractice issue, from the product itself, the way it was set up, or how you've been using it."

The same applies, I add, to any technology a clinician or healthcare facility might introduce into practice.

For example, authorized software upgrades can unknowingly cause liability problems. Upgrades to the software can change the historical data presentation you've already worked with. "An EHR upgrade can go back and affect data being stored for a patient," says Sterling. "The upgrade can affect the presentation and the reporting and usage of that information. I'm aware of upgrades in which a large amount of data was lost."

I'm aware of numerous "upgrades" that nearly caused catastrophes - in fact they may have caused catastrophes that were not publicized- such as here.

"Even if the practice does everything perfectly, there could be design flaws in the electronic health record or the way the practices uses it or sets it up. This gets exposed in the light of discovery during a malpractice suit. If the plaintiff attorney spots errors in the record -- even if the system, not the physician, creates them -- it calls into question every record you produce and every statement you make."

Considering the evidence spoliation that can and does occur thanks to electronic systems, of which I am becoming aware of an increasing number of incidents, discrepancies ("errors" in the record) should arouse suspicions.   Those "hold harmless" agreements should look less and less appealing....

... "There are all kinds of issues I can now delve into, more than I'd find in the paper world. In the paper world, there is not a lot of supporting information," he says. "However, with an EHR, you can see what time each event or note happened, whether it was before or after another event. These could become critical points in a trial."

Thank the zealots for this, docs.

Sterling described several types of problems that could create difficulties for a doctor in a malpractice liability case.

... System or product bugs (defects). One doctor was using an EHR that had inherent errors in it. It wasn't documenting information correctly. The information being entered was not being stored in the right location, and the patient's medical note was ultimately incorrect. "This now calls into question anything in the note, even if you did the right thing," says Sterling.

Caveat emptor.

Transferring paper records to EHR. What happens to the patient's history that was stored in the paper medical chart? The new EHR form may not specifically account for or match up with every notation you have in the old medical chart. If some information doesn't get transferred in, the plaintiff attorney may ask, "Did the doctor have the full picture of the patient's condition?" The discovery process may include comparing the patient's old paper record (if you still have it) with the history now in the EHR.

Signing notes. Some doctors don't sign their notes. This creates a problem with billing, but it also could prompt the question of whether the doctor actually provided those services to the patient.

The zealots never considered these issues, or didn't care.   "You're going to use EHR's whether you like it or not, because they WILL transform medicine.  So say we all."

... One physician was inadvertently distributing clinical notes that included inappropriate findings (such as results of tests that would not have been given to that patient). When the note was challenged during a malpractice trial, it called the patient's entire record into question.

"Unfortunately, the physician had been using software that contained the test setups from the vendor," explained Sterling. "He was recording information on the screen and printing it, and the printed copy was appropriate when he gave it to the patient, but the electronic record contained inappropriate findings and events. Because the doctor was using the forms that contained the original test data (even though the data were not quite visible), the EHR incorporated these old findings."

Just a "glitch", of course.  

One template affects other screens. When you use templates and you're charting by exception, you're viewing 1 screen. But when you check off items in the box, it sends those data to 5 or 6 other screens, and you may not be aware that the information is now contained on those screens. A doctor may decide to remove the information on 1 screen, but that deleted information has already populated 6 other areas and is still in the patient's medical record.

Why would one expect that using tools of grossly inappropriate provenance would not create problems?

Usage issues. The vendor stored it one way, but the doctor stored information another way, which changed the location in which information was stored. The historical record actually changed.

"What happened when the doctor could not produce the record he gave to the patient because it no longer existed?" asked Sterling. "The attorney would look at it and say, 'This is not the piece of paper you provided.' "Any of these could be the killer issue that ends your chance of successfully defending yourself in a malpractice trial," he says.

Sure, EHRs will 'revolutionize' medicine, once the EHRs actually don't introduce booby-traps to the practice of medicine exposing clinicians to the revolutionary guillotine.

Vendor Says, "Not My Fault!"

One might think that a product defect or design flaw should be the responsibility of the vendor, and the doctor should be held harmless for those types of errors. But it doesn't work that way.

"The doctor can be held liable because most vendors' contracts (signed by the physician) essentially say, 'We do not practice medicine; it is up to the physician to make sure this EHR is being used correctly.' The practices have to understand what they're using and verify that the system is appropriately set up to document the care they provide."

I note that doctors forced to use hospital EHR's never see nor sign those contracts.

In a trial, the doctor would be held responsible for product problems.

But just as scary, doctors could be held responsible for following vendor instructions. "I've seen situations in which the vendor tells doctors to do something, and doctors are relying on vendor and not doing their own proper analysis and design of the EHR that's tailored for their own practice," says Sterling. "The vendor is not the one responsible for maintaining the patient's medical record."

More than $20 billion of taxpayer "incentive" money has already gone to the accountability-free sellers of this technology, I might add. 

Bad News: You Need to Delve Into Technicalities

Most doctors are unprepared to explore the technical elements of working with an EHR. "Doctors have to understand what happens when you push the buttons," says Sterling. That means they have to take the time to work with the EHR and explore various screens and scenarios before they ever use it with a patient.

It would help to have people who actually know what they're doing around, a lesson hospitals have not yet fully learned when they depend on grossly inappropriate personnel of a business-computing background to lead HIT projects and make critical decisions on vendor contracts.

In summary, the HIT hyper-enthusiasts and profiteers have successfully conned the government and healthcare sector into using, or coercing clinicians to use, technologies unproven to provide the fantastical levels of clinical and financial benefit claimed (as in many other posts), that introduce booby-traps to users' legal safety, that can be injurious to patient safety, and that suck money from healthcare that could be better used in, say, care of the underserved.

What an enviable arrangement for the enthusiasts.

-- SS

Wednesday, January 09, 2013

Some Real-World Lessons for the Health IT Hyper-Enthusiasts

An article was published in Health Leaders Media yesterday by Scott Mace, senior technology editor entitled "Scot Silverstein's Good Health IT and Bad Health IT" at this link.

(Actually, the terms "good health IT" and "bad health IT" themselves came from Prof. Jon Patrick as a result of my discussions with him in Australia about my conviction, presented to the Health Informatics Society of Australia in my Aug. 2012 talk "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step", that to be trusted and do no harm, health IT must be “done well".)

Scott Mace observes:

Inevitably, when the subject turns to the pitfalls of bad health IT, you will find Scot Silverstein, MD, ready to comment. He has been writing about health IT difficulties since 1998.

Silverstein is an adjunct professor at Drexel University who I recently interviewed for an upcoming HealthLeaders magazine story on physician resistance to health IT.

A recent Silverstein blog post caught my eye for the following statement: "It is impossible for people, especially medical professionals, to be 'ready' for a system that 'is not ready for them.'"

I wanted to learn about the good doctor's thinking and so I gave him a call. We spoke for two hours and it felt like scratching the surface of issues that healthcare will be facing for a good while to come.

Indeed, the issues we discussed were just scratching the surface.  The real world is ever so complex.

Also noted was my observation that:

... Silverstein says it is wrong to think of the tension in healthcare as being IT modernists versus Luddites ... [he says] "I believe the proper framing of this tension between technologists and physicians is that of technology hyper-enthusiasts, who either are unaware of or deliberately ignore the downsides and ethical issues of healthcare information technology in its present state, versus pragmatist physicians who just want to get a job done."

The hyper-enthusiasts largely ignore the real world. 

Two recent "real world" posts on other blogs by practicing physicians caught my eye, that help illustrate the concepts of health IT's disruption of clinicians and of clinical care.  These disruptions increase risk of error (even under normal circumstances; in an emergency scenario, I fear the disruptions will become far more destructive).

These disruptions need to be thrust in the face of the hyper-enthusiasts as characteristic of a very flawed approach to healthcare improvement.

The real-world observations, courtesy KevinMD blog (who reposted them from the source bloggers), with my comments are in [red italics]:

Information overload for doctors increases malpractice risk
Wes Fisher, MD
January 1, 2013

I have used the electronic medical record (specifically EPIC) since 2004.  I have grown accustomed to its nuances, benefits and quirks.  There are parts about it I really like.  There are parts of it I’d like to do without but accept that they are necessary evils in our current health care climate.  I know that there will always be parts of any modified computer system that will suffer growing pains.  For any new and adapting technology this is understandable.

But there is a little-appreciated issue that I see brewing: doctors (and maybe even patients) are quietly being buried by electronic information overload.  As a result, I believe doctors are being placed at an increased liability risk. [Not just doctors, but all clinicians, and the acquirers and implementers of the technology, and those who force the use of it on the clinicians - ed.]

Let me explain.

In the past era of medicine, nothing happened without a doctor’s order.  Nothing.  If you wanted a medication, lab test, invasive procedure, opportunity to participate in rehab classes – anything – you needed a doctor’s order.   For the years of paper records and independent doctors offices, this work flow assured that doctors (1) knew what was happening with their patients, (2) saw their patients, (3) prescribed the proper therapy, and (4) assumed the risk for the intervention or treatment prescribed.  Information proceeded in a logical linear fashion and the doctor was always at the head of the information line.

But we are no longer in the old days in medicine.  We are in the era of near-instantaneous information flow, multi-directional electronic communication, and geographically disparate order entry by “caregivers,” (think nurses, nurse practitioners, advanced practice nurses, clinic operators, registrars, etc.) who help us take messages, continue care, and order things.  In this electronic process, messages are no longer passed from just one individual to another, but rather are passed to two, three, four, or more individuals simultaneously from any one of several different clinical locations – some of which might be many miles apart.  There is an incredible amplifying effect of all of these messages, orders, and notifications — so much so that even the most tech-savvy doctors are struggling to keep up. [This observation about an "amplifying effect" gives life to my own observation that the terms "EHR" and "EMR" are anachronistic and suggest to the layperson an innocuous file cabinet, when in reality today's "EHR" is an enterprise healthcare resource and clinician control system, with all that implies in terms of potential adverse unintended consequences - ed.]

In fact, it is not uncommon for a doctor these days to work for two hours on a procedure and return to the computer to find twenty or thirty new notifications, e-mails, or orders have been deposited there.  Head back in for the next case and then another thirty items appear.  Pretty soon, it’s an avalanche of items.  Worse: doctors must click on each one of these notifications individually to “verify” he or she has looked at each and every single one.  [Looking at the computer has likely become a source of dread to many clinicians; I used to get the same feeling when facing up to a day's emails in Pharma, sometimes more than a hundred - ed.]

Doctors understand that the reason we have to click on all these orders is because (a) no one gets paid in our system unless a doctor orders whatever-it-is [not the best motivation - ed.] and (b) someone has to be the fall guy if there’s a problem with a nurse, medical assistant, or lab technician that “orders” something on behalf of the physician.  [Ditto; the "social issues" of health IT include factors like these  - ed.]  There is even a trend to auto-order things (like a pneumovax vaccine, for instance) that assure the hospital maintains excellent public reporting metrics whether the doctor ordered them or not with the order later appearing in our inbox to be clicked.  [This observation gives life to my own that the computer is increasingly becoming the intermediary between doctor and patient - ed.]

But worst of all are the silent notifications sent from fellow physician colleagues buried amongst the other notifications. They tell of an important story, one that needs fairly urgent attention, but because people no longer pick up the phone, are not immediately noticed or highlighted. It’s like a landmine sitting in a doctor’s inbox waiting to be stumbled upon.

* Click* *Click* *Click* * Click* *Click* *Boom*  [The "silent silo" syndrome, as I called it, also affects lab results reporting.  It should be clear that health IT does not "automagically" improve communications over Alexander Graham Bell's invention - ed.]

With all these people and devices ordering and sending, the limited number of doctors out there are being bombarded from multiple directions.   It is getting harder to keep up these days.  Orders and notices come to us on names we don’t recognize or have been long forgotten.  (Computers don’t forget that you saw the patient eight years ago).  [These observations should put an end, once and for all, to the oversimplifications of comparing health IT to, say, mercantile or banking IT - ed.] And once an order is placed and acted upon without our knowledge these days, we click on the order to clear our notices and thereby assume all the legal risk for the care. The legal buck still ultimately stops with us.

Doctors need to speak up about this problem.  [I could not agree more - ed.] We are not in the old days any longer.  We are in the fast-paced, electronic medical record era where things happen (literally) at the speed of light.  We need the electronic medical record companies, payors, hospitals and legal community to come together to help us find a solution to this current information overload crisis that maintains patient safety and improves efficiencies while limiting legal risks to the doctors who are doing their very best just to keep up.

Wes Fisher is a cardiologist who blogs at Dr. Wes.

The above "anecdote" (I use that term somewhat satirically, see here) is likely characteristic of the lives now lived by most clinicians using today's health IT.  Hyperenthusiasts, take note.

The second real-world illustration of the naivete of the hyper-enthusiasts is as below.  I'd observed most of the points made in my own writings after my CMIO period in the late 1990's, which I highlight.   It is quite interesting to see these same points come from others without Informatics expertise, directly from the clinic:

Explaining the epic failure of EMRs
Kiran Raj Pandey, MD
December 19, 2012

It is no news a lot of doctors like to stick up a rather snotty nose to EMR. The defenders of the EMR tend to label such doctors as archetypal Luddites, sticking to their archaic ways and unbecoming of change and the new times. [In reality, the tension is between the hyper-enthusiasts or 'Ddulites' vs. pragmatist clinicians with real-world patient care responsibilities and obligations - ed.] But as is usually the case with any two heated but opposite arguments, the truth likely lies somewhere between the two extremes.

On an objective basis, there is no denying that automatisation of medical record keeping is the new way forward. In theory, if the machine could keep records for you and give it back to you when and where you want it, thus freeing up valuable time for the patient encounter, that should be winsome for everyone. That alas, is a vision of the EMR utopia [the path to Utopia usually has very bad unintended consequences, and Utopia never reached - ed.], and let alone being anywhere close to such utopia, it is difficult to ascertain if we are even set in the road leading us there. [As I've opined, we're on a speeding bullet train on a quarter-mile track - ed.]

Sometime ago, exasperated at the sheer waste of time that the clunky new discharge module was causing because it would not work the way it is supposed to (my hospital is means challenged, so they are building a patchwork of cheapskate EMR suite on top of their legacy system from the 90s, just to placate the gods of CMS [and the Lords of Kobol - ed.]), I complained to the IT guy that the thing barely works! The guy was sympathetic and said, “look I know the discharge module sucks, just bear with it until the end of the year when we should be able to weed out the bugs.” [Hospitals and clinics, as I've written, are NOT the proper place for software alpha and beta-testing - ed.]

But that’s not all, I said, even if it were working just the way it is supposed to, the discharge still takes me longer than what it used to with paper. “That’s something you will have to learn to live with,” he retorted. “Computer records do take a longer time than paper, and there is nothing I can do to change that.” [This reflects healthcare IT culture's of arrogant acceptance of bad health IT, largely ignoring ways to ease human-computer interaction - ed.]

Right there, I think is where EMR loses a lot of ground against paper records. At any practice, time is the most valuable resource, and anything that doesn’t offer a straight off benefit to save time will have a hard time being adapted. [The reverse is also true - ed.] Add to that the inertia people have about their old ways and you have a deal breaker right there.

That’s not all. Driven by the constant government whip to adopt EMR, and an EMR industry that is hell bent upon imposing itself on healthcare [long ago I began writing of a territorial invasion of healthcare by the IT industry - ed.], a lot of makeshift EMR adoption has taken place. So you have hospitals where one part is using one system while the other is using a completely different one. At one clinic I recently worked at, we had to switch between 3 different EMR systems, just to get the patients records. And there still was the paper records not to mention the dictation.The constant juggling not only made the patient encounters time consuming and cumbersome [and surely tiring - ed.], it literally made us curse at the computers and ruin an otherwise perfectly normal day at work. [And increase risk of cognitive overload and error substantially - ed.] Patient volumes have gone down from 15-16 patients per day to a half of that after EMR adoption.

What’s wrong with the current adoption of EMR? Why are even the converted like me questioning EMR? [Converted to what? - ed.]

I think there are two reasons for such seemingly epic failure. First, how we interface with an EMR. Second how the EMR tries to impose its will on to us instead of the other way around. [I've written that HIT should work like the clinicians work, not the other way around.  Again, the IT has become the cybernetic 'governor' or 'regulator' of care, and is not just an innocuous records system - ed.]  A keyboard and a point and click device may well have worked for many other interactions with the computer, but with an EMR it doesn’t always appear to be nifty.

... On the same note, no EMR is going to be see a faster adoption if something like writing a prescription takes a minute when in paper it barely takes 10 seconds. Right now doing something as simple as writing a prescription feels like running through a bunch of fire breathing hoops. Someone may argue, you can at least read it better [when bugs and 'glitches' due to sloppy industry practices don't cause faulty output such as occurred here - ed.] , but don’t get me started on how the EMR can come up with its own ludicrous set of errors, something that would never be possible with paper. ["not possible with paper" is a theme I've written about as well - ed.]

Trying to impose a ready made architecture on to health care will not work. “It works for retail and banking,” some people seem to offer cluelessly [Business/mercantile computing and clinical computing are two different subspecialties of computing, I've long observed - ed.]. But a patient encounter is no visit to your bank cashier. And human body is not your bank account, it is way more complicated and it is bound to generate way more complex information that is difficult to straight jacket into the rigid and rudimentary pipeline of set information pathways. An ideal EMR is supposed to be a seamless body-glove; today they feel like the hangman’s cloak, not only are they cumbersome, dark and dreary and suffocating, under their apparition, they force things you to do things you wouldn’t otherwise do. [Hyper-enthusiasts don't really seem to care; if it's a computer, it must be better - ed.]

Such forced behavior modification may make the administrator, the insurance company, and the government happy [it does - ed.] but I can’t understand how selecting a dozen pesky radio buttons while doing the discharge makes the patient lead a healthy life or make his doctor particularly enamored with the EMR, just because the government said so, or that it made the IT companies a few million dollars richer. [Doctors are just supposed to obediently accept this technology by the hyper-enthusiasts and profiteers - ed.]

Kiran Raj Pandey is an internal medicine resident who blogs at page59.

I feel "anecdote" #2 is also quite common, and the sentiments shared by a large number of clinicians forced into using this technology in its present state.

Hyper-enthusiasts and other health IT promoters and grandstanders need to read the above accounts well.  They need to understand that the real-world effects of the technology, recklessly pushed, can be toxic, and not result in the utopia of better care and cost-savings they naively believe will deterministically occur. 

-- SS

Monday, March 22, 2010

Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT

A paper I recently wrote on a critical issue in healthcare IT was rejected on first pass by the Medical Informatics academic community.

The paper concerns the profound lack of publicly available data on unintended adverse consequences of healthcare IT and proposed steps that could be taken by ethical clinicians and others to remediate this gap.

I have decided not to make "revisions", feeling the "problems" with the paper were likely more about its topic than its substance or format, making the topic unpublishable in the medical informatics literature. I am therefore making the paper available publicly.

It is entitled "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT." The full paper is available via Scribd at this link:

http://www.scribd.com/doc/28747771/
(MS Word .doc format).


Only this month has the FDA even acknowledged patient injury and deaths due to health IT problems, and admits their numbers are likely the "tip of the iceberg" (in a future essay I will explain my reasoning as to why I believe their numbers may be three orders of magnitude or more off the mark and perhaps four orders of magnitude off when HIT goes national).

About the paper:

Abstract:

Case reports, systematic statistical data and other information on unintended consequences (UC’s) of healthcare information technology (HIT) is relatively scarce despite ample literature on potential HIT benefits. This impedes optimal efforts at computerization of healthcare, and can and should be remediated.

Objectives: To illustrate the relative scarcity of information on HIT UC’s, suggest contributing factors, and recommend tactical measures for improvement such as better user reporting of HIT UC’s and better diffusion of existing literature on the phenomenon.

Methods: A number of recent indicators for scarcity of UC information were compiled and possible reasons described. Examples of suboptimal adverse results disclosures in related domains (e.g., the pharmaceutical industry) that may hold lessons for HIT were included.

Results: UC information on HIT is relatively scarce likely due to a variety of influences and complex interactions among and between medicine, informatics, government and industry that, left unaddressed, may lead to delays or other harm to good faith efforts to computerize informational aspects of healthcare delivery and research.

Conclusions: The relative scarcity of definitive information on the extent of HIT UC’s should be addressed in a responsible and ethical manner by clinicians, regulators and other stakeholders if this technology is to be successfully rolled out nationally.

While some reviewers commented on paper organization and formatting issues, which is fair, the most striking review comments received were these:

This paper addresses a potentially important issue but adds little that is new or that goes beyond what a reader might find in a major city newspaper.
and
Proposing a classification of sources of UC [unintended consequences - ed.] and analysis of reasons for undereporting of each type in the resulting classification could be a useful addition to the field.

I do not recall reading many, if any, articles about the covering up of healthcare IT dangers in major city newspapers. Further, it's hard to "classify UC's" when there is scant data available about them in the first place. I feel it's more important, as I did in the paper, to propose reasons for underreporting of unintended consequences in a global fashion and propose remediation steps, not perform a useless exercise of classifying that which is tightly suppressed.

I have the experience of being one of a very few medical informatics professionals to publicly challenge the HIT hysteria beginning over a decade ago at a website at this link and observing the reactions of the informatics community to that site. In addition to that experience, here are a few more points on why I think the paper unpublishable by the informatics community due to its controversial, HIT business-unfriendly topic:

One reviewer opined they'd recognized the writing style and:

... may have seen the paper prepublished on a blog somewhere.

Coming from supposed information experts who must be aware of search engines and their indexing of blogs (this blog's stories uniformly coming up very high in Google searches, for instance), this comment was remarkable.

It would seem the smart thing to have done would have been to prove their hypothesis false in a five-minute effort rather than slandering me to the editor. Further, if they'd recognized my writing, they'd surely have known I once ran a scientific library and was well aware of such publication issues, and write for this blog as well on the ethical issues concerning scientific publication. I propose the reason behind that comment was hostility.

Finally, a reviewer offered this gem:

Out of curiosity, I also wonder why all the web sites cited were accessed on the same date [the date of paper submission - ed.], if the date was noted at all.

Coming from a community of supposed computing and information experts regarding the stated dates when cited websites were "last accessed", I could only shake my head.

Peer review being somewhat of an echo chamber regarding controversial social issues in healthcare informatics (i.e., against the flow of the HIT business) , I turn the paper over to the court of public opinion.

Fortunately, the paper will likely get far more exposure where it matters - i.e., outside the academic informatics orthodoxy - via web based dissemination than via publication in rarified informatics journals.

-- SS