On Hypervigilance Due to Bad Health IT: "Texting While Doctoring: A Patient Safety Hazard"

An Opinion piece "Texting While Doctoring: A Patient Safety Hazard" appeared in the Annals of Internal Medicine of 3 December 2013, authored by Christine A. Sinsky, MD and John W. Beasley, MD.  Dr. Sinsky is known to me to be what some would call a "heatlhcare IT iconoclast" (more accurately represented by the term "healthcare IT gadfly/realist" IMO).

In the piece the authors comment on the distractions caused by the technology, leading to doctors missing important cues in the exam room and to and impaired problem-solving.  This is part of a larger phenomenon that has been called "skill-degrading" or "de-skilling", e.g., see my April 16, 2010 post "Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee" at http://hcrenewal.blogspot.com/2010/04/health-information-technology-basics.html).  

These effects are likely to be further worsened as more and more clerical tasks such as order entry, the authors point out, get shifted to medical professionals.  To new readers: note that computerized order entry is often a complex and convoluted process; the CPOE systems are most decidedly NOT mere "typewriters for orders."  See, for instance, part 6 of my series on "Mission-hostile health IT" at http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html.

Most of the Annals article is available as a free preview at http://annals.org/article.aspx?articleid=1784295 as of this writing and is worth reviewing.

Article preview, click to enlarge

I found one passage in particular striking, though.  In my ongoing discussions with computer scientist/informaticist/polymath Dr. Jon Patrick at U. Sydney (http://www.healthll.com.au/?page_id=440) , the issue of hypervigilance necessitated by bad health IT came up, and we arrived at the definition of same seen at my teaching site at http://cci.drexel.edu/faculty/ssilverstein/cases/:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

Note this passage in Dr. Sinsky and Beasley's opinion piece:

"I am always multitasking ... I am entering orders, checking labs, downloading information while I talk to the patient.  It requires chronic hypervigilance, which is exhausting and demands conscious effort to stay in the 'present' with the patient" (Day S., Personal communication.)  Click to enlarge.

I don't know if Dr. Day had seen my materials, but I suspect the exhausting hypervigilance is all too common, just not much publicized due to the secretive, closed, retaliatory-towards-whistleblowers nature of the healthcare IT sector.

I ask:  is this what we really want, in pursuit of some uncertain cybernetic miracle?

I note that the healthcare IT experiment (and the technology is experimental), long usurped from the Medical Informatics pioneers who trained me and put in the hands of commercial interests and those of a mercantile/manufacturing/management computing background, is increasingly a failure.

-- SS

Today's Bad Health IT Systems: More Dangerous Than Paper?

I believe in 2013 that they are.

(Definition of bad health IT is here:  http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)

I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.

• Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?

• Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch, the following issue needs serious consideration by policymakers.

Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing.

The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information.  It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher  - conservatively, I believe, at least two orders of magnitude.

Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to  reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.

The workarounds also cause users to:

1)  have to deviate from habits of use acquired in training and active use of the systems in question;
2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;
3) keep in mind any other extant workarounds that exist waiting for "fixes"; and
4) be constantly on guard for information storage failures.

In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety.  If these were more conventional medical devices, they'd be recalled.

See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.

Further, with paper records or tangible images, a page or image can be lost, or it can be illegible.  In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly.  Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.

On the other hand, when electronic systems:

1)  lose modified information en masse as in the Siemens examples but keep the old, or
2)  when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or
3)  images are lost (see "Potential Image Loss in GE Centricity PACS" here:  http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html) without warning-

- There are no "flags" that the obsolete, truncated or missing information is erroneous.

What remains is perfectly legible, perfectly convincing and perfectly deceiving.

Electronic healthcare information systems on their face create more risk than paper record systems.  Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation.  Every new upgrade or patch is suspect for introducing new bugs.

Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...

Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper.  Further, hundreds of billions of dollars can certainly buy:

1)  a lot of Health Information Management professionals to perform continuous QA of paper,
2)  a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and
3)  a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html.
4)  a lot of sensible regulation of this industry's product quality.

-- SS

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 2

Part 1 is here.

This is the second a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's.

Frequent reminders are needed by all stakeholders, I believe, to think critically about, and take with a big grain of salt, effusive praise by key opinion leaders, politicians, etc. about health IT, and accompanying attempts to deride those critical of the technology, to counterbalance ongoing HIT hyperenthusiasm.

The following quote comes from a May 2010 post "David Blumenthal on health IT safety: nothing to see here, move along":

Blumenthal, at the time Director of ONC at HHS had reportedly stated that:

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

... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety," he said.

The "nothing" includes 44 injuries voluntarily reported to FDA and 6 reported deaths in an enviroment where few know where to report such things and where no reporting requirements exist, and a statement from the head of CDRH at FDA that due to systematic impediments to accurate knowledge the known figures likely are a small fraction ("tip if the iceberg") of the actual occurrence.

The FDA internal memo on HIT risk brought to the forefront by investigative reporter Fred Schulte and downloadable here spells out the FDA impediments in some detail.  It is not reasonable to believe the head of ONC and an entire ONC committee would have been entirely unaware of the issues.  (Later studies are even more concerning, e.g., by IOM and ECRI, as at this blog.)

Yet an ONC committee under his leadership recommended "full steam ahead" anyway.

In the corporate world that is known as gross negligence:

Gross negligence is a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both. It is conduct that is extreme when compared with ordinary Negligence, which is a mere failure to exercise reasonable care.

There is nothing to discuss, nothing to debate about that.

Claims about HIT beneficence this need to be taken with a big grain of this.

The ongoing "what? me worry?" attitude of the pundits needs to be counterbalanced.  This series is a small effort (the industry has a lot more control of the channel than I) to catalog the words and call out the pundits in a readily-found format.

More to come in this series.

-- SS

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 1

This is the first of a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's.  Frequent reminders are needed by all stakeholders, I believe, to think critically about, and take with a big grain of salt, effusive praise by key opinion leaders, politicians, etc. about health IT, and accompanying attempts to deride those critical of the technology, to counterbalance ongoing HIT hyperenthusiasm (e.g., link).

In face of growing evidence of risk and adverse outcomes of bad health IT from multiple sources and organizations (such as this, as just one example), growing advice on risk remediation from government (such as here), and mass privacy violations (see the multiple posts under this query link), it might also be entitled a series on what health IT hyper-enthusiasts "knew, should have known, or should have made it their business to know."

Let's start out with an extract from a post I wrote on June 29, 2003 entitled "Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?". At the time Leavitt was head of CCHIT, a tester and MU compliance/safety certifier of electronic health records systems: 

... The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat: 

June 19, 2009 - Perspectives 

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

by Mark Leavit  

... Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place, that shady conspiracies are operating -- make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers are easily affected by fear mongering.

"Laugh these stories off?"  That was, and is, simply perverse.

Ironically, this statement was written less than a year before my own mother was seriously and fatally harmed as a result of a health IT-related error.
 

On EHR's:  See No Evil, Hear No Evil, Speak No Evil

While I don't proffer claims of "shady conspiracies" (international health IT expert Dr. Richard Cook explains that in a recent guest post "Dr. Richard Cook on the Health IT Sector's Ills"), I do proffer alternate explanations including arrogance, Radical Solutionism, and this.

More to come in this series.

There are many more statements like this one already on this blog, and elsewhere.

-- SS

Note:  Part 2 is here.

Wisdom from the Medical Journal of Oz: "Good HIT and bad HIT"

The recognition and partitioning of "good health IT" from "bad health IT" is now a mainstream meme.  I have few comments about this new article; it reflects views frequently expressed here at Healthcare Renewal (indeed, one of its references is to this blog and this author):

Good HIT and bad HIT
Jon D Patrick and Susan Ieraci
Medical Journal of Australia 2013; 198 (4): 205.

First and foremost, do no harm. Second, do some good

One of the key issues for high-volume, high-risk workplaces like hospital emergency departments (EDs) is the struggle of conflicting aims. While hospital managers need information systems for data collection and storage, clinicians need efficient clinical documentation, data retrieval and order-entry systems that save time rather than steal it from the patient. The work of clinicians is aided by reliable data but impaired by the delays of real-time input, difficult system navigation, suboptimal presentation of information, and other problems in the user experience of health information technology (HIT).1

Mohan and colleagues’ study of the impact of an electronic medical record information system on ED performance had some limitations.2 It was retrospective and unable to control for all confounders, and therefore could only show a correlation with ED delays, not causation. However, the premise for the study delivers an important message — the work required to use the information system was perceived by the ED staff to directly conflict with time spent with patients.

Another study has shown that the same electronic medical record information system is perceived to have had a negative impact on the care of patients, as well as the productivity and morale of staff, in six EDs in New South Wales.3 The need to be hypervigilant about the accuracy of the information supplied by the electronic health record compounds an already stressful clinical environment, which in turn leads to resentment towards the technology and the people who have imposed it. This makes it “bad” HIT. Unless this is corrected, HIT efforts will overuse precious health care resources, will be unlikely to achieve claimed benefits for many years to come, and may actually cause harm.4,5

The large HIT corporations produce a type of technology that is best categorised as enterprise resource planning (ERP), which has its roots in the manufacturing industry. It is based on the idea that all processes within an organisation can be standardised, and that all processes of the same type should have their information modelled and processed in the same manner. If this high degree of standardisation were considered the best way to process and model information derived from clinical activity, then ERP would be a favoured technology to adopt, as has happened in many places.

However, there is an alternative, almost contradictory, perspective on the nature of clinical work: that it is non-deterministic and performed by a group of diverse staff working in an ecologically stable network of people that has to respond to diverse medical needs and diseases. The ecology model accommodates staff joining and leaving the process, with differing needs emerging at different times, so that the other individuals in the network have to adapt and modify their behaviour and improvise in an unpredictable manner. Amid all this variability is the ever-demanding imperative to improve the processes of care and attention to the patient, while also increasing staff productivity.6

Where the ERP model has been imposed in the clinical setting, staff may be coerced into an approach to their work that is at odds with established best practices. This could only be considered “good” HIT if it brought greater staff productivity with at least no loss (and, preferably, improvement) of patient safety and services and staff morale.

It is not enough just to identify problems: effort must be invested in transforming bad HIT into good HIT. This process must identify and optimise all the operative factors: human behaviour, system design, equipment performance, skills of the IT participants, and the operational policy framework.7 Good HIT should include clinician control of the interface design for content, dataflow and workflow. It includes the ability to change the system in real time, and it incorporates inbuilt data analytical capability, natural language processing, and native interoperability and clinical coding.8 Finally, there must be an appropriate opportunity to test systems for useability, effectiveness and suitability before their release.

There must be a move away from standardised processing models and towards improving the user experience in the clinical setting. Clinicians should not have to shoehorn their activity into predefined, externally imposed work processes that do not reflect actual activity and will not improve efficiency. A true patient-focused system aligns all its components towards the same aim. Like a good clinician, good HIT does no harm — to patients or staff.

American medical / HIT journals are perhaps a bit too beholden to industry to directly commit such health IT heresy.  Thank the stars those Down Under are a bit more bold.

-- SS

Bad Health IT -Yet Another Health IT 'Glitch' - Potential Image Loss in GE Centricity PACS; ECRI Again Reports Health IT a Top Ten Hospital Risk

From my definition of bad health IT (BHIT) at this link:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  

Considering the problem of lost data (lost x-rays) that affects not one, but two versions ("versions 3.x and 4.x and higher") of a common GE PACS (radiology image management) system, as in the attached memo to hospital radiology and IT executives, one might ask:

• How long has this been going on before this 'glitch' was discovered? 

• What validation and safety testing does GE use before releasing its health IT to production? 

• Why was it discovered in several successive versions of PACS systems being used on live patients, instead of in laboratory testing?

• How many delayed diagnoses, injuries and/or deaths might have occurred as a result of this "disappearing image" bug?

• What is the likelihood this "workaround" will be uniformly adopted in short order?  

• What levels of hypervigilance, stress and increased likelihood of error will this temporary "workaround" engender?

• When will it be fixed in all implementations worldwide?

 Beware disappearing x-rays.  Make sure every system user performs this workaround, too (click to enlarge).

Page 2 (click to enlarge)

It's not as if missing x-rays are a trivial matter.  One routine x-ray lost to followup resulted in the needless and rather horrible death of an infant, and a $1.5 million settlement, as at the June 2011 link "Babies' deaths spotlight safety risks linked to computerized systems" (case #2).

Patient safety is being compromised.

Lack of regulation of health IT, and lack of reporting and accountability, needless to say, are major contributors to the prevalence of BHIT.

I also note for several years running, including in the latest report of 2013, the ECRI Institute (an independent tester of healthcare technology) reports health IT-related problems as among the top ten technology problems in hospitals (link to report):

...Five of the top 10 hazards explained in ECRI Institute’s [2013] report are:

    1.  Alarm hazards
    2.  Medication administration errors using infusion pumps
    3.  Unnecessary radiation exposures and radiation burns during diagnostic radiology
         procedures
    4.  Patient/data mismatches in EHRs and other health IT (HIT) systems
    5.  Interoperability failures with medical devices and health IT systems

Three of the ten topics on the 2013 list are directly associated with the still-maturing [i.e., experimental - ed.] health IT field where the interplay between complexity and effectiveness and potential harm is most evident; several of the other topics are peripherally related to HIT issues.

“The inherent complexity of HIT-related medical technologies, their potential to introduce new failure modes, and the possibility that such failures will affect many patients before being noticed—combined with federal incentives to meet Meaningful Use requirements—leads us to encourage healthcare facilities to pay particular attention to health IT when prioritizing their safety initiatives for 2013,” says James P. Keller, Jr., vice president, health technology evaluation and safety, ECRI Institute.

The hazards included in the 2013 list, published in the November 2012 issue of ECRI Institute’s Health Devices journal, met one or all of the following criteria: it has resulted in injury or death; it has occurred frequently; it can affect a large number of individuals; it is difficult to recognize; it’s had high-profile, widespread news coverage.

-- SS

New York Times: "The Ups and Downs of Electronic Medical Records"

The "downs" of health IT have rarely been presented in a prominent public forum.

After a recent Center for Public Integrity series and New York Times story on EHR-related upcoding, the New York times does so again.  This blog is cited:

October 8, 2012
The Ups and Downs of Electronic Medical Records
New York Times
By MILT FREUDENHEIM

The case for electronic medical records is compelling: They can make health care more efficient and less expensive, and improve the quality of care by making patients’ medical history easily accessible to all who treat them.

Small wonder that the idea has been promoted by the Obama administration, with strong bipartisan and industry support. The government has given $6.5 billion in incentives, and hospitals and doctors have spent billions more.

But as health care providers adopt electronic records, the challenges have proved daunting, with a potential for mix-ups and confusion that can be frustrating, costly and even dangerous. 

"Dangerous" is the concept that has been most lacking in public debate.  Through my many years of writing on health IT difficulties and more recently my legal work, I know of injuries and deaths caused or contributed to by bad health IT (e.g., see here and here).  I experienced a tragedy in my own family as well.

The New York Times has done a significant public service in mentioning this critical issue, long hushed by the hyper-enthusiasts to whom computers seem to hold more rights than people, and to whom plans for a "cybernetic healthcare utopia" override long held principles and standards for human subject research protections.

Some doctors complain that the electronic systems are clunky and time-consuming, designed more for bureaucrats than physicians. Last month, for example, the public health system in Contra Costa County in California slowed to a crawl under a new information-technology system. 

Doctors told county supervisors they were able to see only half as many patients as usual as they struggled with the unfamiliar screens and clicks. Nurses had similar concerns. At the county jail, they said, a mistaken order for a high dose of a dangerous heart medicine was caught just in time. 

That scenario, not at all unique (e.g., see New York Times, "Designed for Efficiency, New Computer Software at Health Dept. Misfires", Nov. 2010 and my comments here), is a warning that the technology needs significant work and cannot just be rammed into place.

The first national coordinator for health information technology, Dr. David J. Brailer, was appointed in 2004, by President George W. Bush. Dr. Brailer encouraged the beginnings of the switch from paper charts to computers. But in an interview last month, he said: “The current information tools are still difficult to set up. They are hard to use. They fit only parts of what doctors do, and not the rest.”

Refreshing candor that should be coming from the present ONC leader, not the two-generations-ago former incumbent.

Like all computerized systems, electronic records are vulnerable to crashes. Parts of the system at the University of Pittsburgh Medical Center were down recently for six hours over two days; the hospital had an alternate database that kept patients’ histories available until the problem was fixed. 

Those crashes are also not uncommon.  See for instance my posts on the common refrain when that happens that "patient care has not been compromised" (query link).

Even the internationally respected Mayo Clinic, which treats more than a million patients a year, has serious unresolved problems after working for years to get its three major electronic records systems to talk to one another. Dr. Dawn S. Milliner, the chief medical informatics officer at Mayo, said her people were “working actively on a number of fronts” to make the systems “interoperable” but acknowledged, “We have not solved that yet.”

Perhaps the worst example of that phenomenon is the DoD-VA interface debacle.  See my apparently popular (based on "hits") March 2010 post "VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious About Healthcare IT?"

Still, Dr. Milliner added that even though there a lot of challenges, the benefits of information technology are “enormous” — improved safety and quality of care, convenience for patients and better outcomes in general.

Enormous?  It is quite clear that this has not been proven in the real world with large scale health IT, especially in its present form.  It may be the case that the improvements will be modest at best.  Many if not most healthcare problems may not be related to documentation at all (see my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?" for instance).  Also, as I've written, a good or even fair paper record system is better for patients than BHIT (bad health IT).

In the rare event that a large-scale system goes down at Mayo, backup measures are ready, teams are called in to make rapid repairs, and if necessary “everyone is ready to go on paper,” Dr. Milliner said. 

Paper records do not unexpectedly "go down" en masse.

Reliable data about problems in the electronic systems is hard to come by, hidden by a virtual code of silence enforced by fears of lawsuits and bad publicity. A recent study commissioned by the government sketches the magnitude of the problem, calling for tools to report problems and to prevent them. 

"Omertà" is perhaps the best term of art for this form of silence...

Based on error rates in other industries, the report estimates that if and when electronic health records are fully adopted, they could be linked to at least 60,000 adverse events a year.

My own estimates are much higher if the technology and its industry are not first drastically reformed, as in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

The Obama administration will issue a report on patient safety issues in early November, the current national coordinator, Dr. Farzad Mostashari, said in an interview. That report was requested last year by a panel on health I.T. safety at the Institute of Medicine, a unit of the National Academies of Science.

Considering the available data is limited, as per the FDA and IOM itself (see addendum here), the report should be immediately suspect for underestimation/cheerleading if not whitewashing.

... Elisabeth Belmont, a lawyer for the MaineHealth system, based in Portland, advises hospitals to reject contract language that could leave them responsible for settling claims for patient injuries caused by software problems.

The IT industry is quite mature and no longer merits such special accommodation.  As in other industries, liability should be covered by the industry itself, not by customers (and patient victims).  See "No More Soft Landings for Software: Liability for Defects in an Industry That Has Come of Age", Frances E. Zollers, Andrew McMullin, Sandra N. Hurd, and Peter Shears, Santa Clara Computer & High Technology Law Journal, May 2005.

The institute also recommended that software manufacturers be required to report deaths, serious injuries or unsafe conditions related to information technology. So far, however, neither a new safety agency nor such a reporting system has been adopted.  Some of the largest software companies have opposed any mandatory reporting requirement.

Post market surveillance is standard for other medical device sectors and the pharma industry, as well as other mission critical IT sectors.  The continuing, remarkable special accommodation for health IT is unearned, unjustified and ethically inexplicable.

Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.” 

In other words, while I am an advocate for good health IT, the technology is not yet ready to be pushed nationally.  Bad health IT prevails.  From my Medical Informatics teaching site:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

(I would replace the term "critic" with "realist" and/or "patient rights advocate.")

Another critic, Dr. Scott A. Monteith [who has guest-posted at this blog - ed.], a psychiatrist and health I.T. consultant in Michigan, notes that Medicare and insurance companies generally do not pay for experimental treatments that have not proved their effectiveness ... Dr. Monteith said the electronic systems were “disrupting traditional medical records and, beyond that, how we think” — the process of arriving at a diagnosis. For example, the diagnosing process can include “looking at six pieces of paper,” he said. “We cannot do that on a monitor. It really affects how we think.”

The systems are disruptive due to the paradigm changes, made far worse by their also often being mission hostile in design.

“The problem is each patient is an individual,” said Ms. Burger, who is president of the California Nurses Association. “We need the ability to change that care plan, based on age and sex and other factors.” She acknowledged that the system had one advantage: overcoming the ancient problem of bad handwriting. “It makes it easier for me to read progress notes that physicians have written, and vice versa,” she said.

While this is true, it is also true that the loss of context and structure produces legible gibberish that does not relate the patient narrative well.  Also, the same legibility improvement could be obtained via word processors - or typewriters - that cost far less than the tens of millions of dollars or more per organization that clinical IT commonly costs.

Some experts said they were hopeful that the initial problems with electronic records would be settled over time.

I'm one of them.  Without major health IT industry reforms, however, including strict adherence to evidence-based practices (as that selfsame industry sector demands of medicine and ironically and hypocritically claims its products will enable), I don't expect to see the problems settled in my lifetime.

Dr. Brailer, who now heads Health Evolution Partners, a venture capital firm in San Francisco, said that “most of the clunky first-generation tools” would be replaced in 10 years. “As the industry continues to grind forward, costs will go down,” he said. 

One should ask - why are 'first generation' tools still in abundance, decades into the healthcare information technology industry?  Further, as the industry "grinds forward" without oversight and patient protections, people will be injured.

Mark V. Pauly, professor of health care management at the Wharton School, said the health I.T. industry was moving in the right direction but that it had a long way to go before it would save real money.  “Like so many other things in health care,” Dr. Pauly said, “the amount of accomplishment is well short of the amount of cheerleading.”

That is an understatement.

(Not covered in this article perhaps due to limited space are the issues of information security, privacy and confidentiality that are compromised by current clinical IT.)

In conclusion, it is good that the New York Times has brought the downsides into the public eye.  While the technology's not "ready for prime time", a story like this is ready for prime time, and is in fact long overdue:

-- SS

Ontario must rethink health care ... including costs of health IT

Hat tip to a commenter for the link below to a Toronto newspaper opinion piece on Canadian healthcare rationing and the costs of health IT.

The line:

"While billion-dollar scandals like eHealth make these stories all the more frustrating for Ontarians, because of the appalling waste of scarce health-care dollars, the truth is governments across Canada, not just the Dalton McGuinty government in Ontario, are struggling with the same issues" 

could have been written by me. 

(In fact, I've written exactly such lines about the "National Programme for IT in the HHS" a/k/a the HITECH Act, regarding the waste of precious healthcare resources such as at my Jan. 2010 post "Electronic Medical Records and Going For Broke: Jackson Health System's Financial Future Appears Grim".)

This from the Toronto Sun: 

Ontario must rethink health care
Toronto Sun
Saturday, September 29, 2012, 6:20 PM

The simple truth is Ontario’s health care system is running out of our money to pay for our health care.

That’s why we keep hearing about cases of patients being denied necessary surgery — particularly when it has to be done in the U.S. — and life-prolonging medications.

In the Sun’s news section today, Queen’s Park columnist Christina Blizzard tells the story of Erika Crawford, 17, whose family plans to go ahead with life-saving surgery in the U.S. to prevent her death from Ehlers-Danlos Syndrome, even though OHIP has callously refused to fund the expensive procedure.

Recently, Blizzard wrote about the plight of three-year-old Liam Reid, whose parents went ahead with eye-saving treatment available only in Detroit, with no guarantee OHIP will pay for that.

Over the summer, Blizzard wrote about 67-year-old Percy Bedard, denied OHIP funding for a life-prolonging drug for his prostate cancer because the health ministry doesn’t believe it’s cost effective.

The truth is that as time goes on, there are going to be more and more stories like this.

While billion-dollar scandals like eHealth make these stories all the more frustrating for Ontarians, because of the appalling waste of scarce health-care dollars, the truth is governments across Canada, not just the Dalton McGuinty government in Ontario, are struggling with the same issues.

I presume they're referring to the scandal such as I wrote of in May 2009 at my post "Canadian Health IT Ripoff ... Is Anyone in the U.S. Paying Attention?"

(Addendum Oct. 1, 2012:  per the commenter, also see this July 2012 Toronto Sun story:  eHealth Needs Surgery and this quote:  "Auditor General Jim McCarter, in his clinical dissection of Ontario electronic health records woe in 2009, said $1 billion had been spent by over 10 years by two different governments, without getting full value for those dollars. He’s since been more specific about the numbers, saying “hundreds of millions of dollars” were likely wasted.")

From my aforementioned Jan. 2010 post:

... I have written on numerous occasions that health IT in its present form, often poorly designed and implemented under current IT leadership structures, is often a waste of precious healthcare resources. The resources might be better spent on essentials such as patient care for the poor or improved human staffing, until this experimental technology is perfected.

 
Add "and for the not so poor" to that list. 

Since there isn’t enough money to give everyone the care they need, politicians and health bureaucrats routinely deny medically necessary services and treatments to save money.

This often means choosing between who will live and who will die, and who will suffer and who will lead a normal life.

To be sure, this review process has always been in place, particularly for out-of-province treatments and for funding new medications, since no publicly funded health care system can possibly provide every service to everyone.

But as the health care budget creeps towards eating up half of all spending in Ontario, these decisions are only going to become more frequent, and harder.

 
But in the U.S. let's go merrily ahead and spend a trillion dollars for health IT, even if it's bad health it (BHIT), which there currently is no reason for manufacturers to stop producing (e.g., complete lack of regulation). 

No problem, right?

-- SS  

Good Health IT (GHIT) v. Bad Health IT (BHIT): Paper is Better Than The Latter

An unspoken running assumption of the health IT enthusiast crowd seems to be that any health IT is better than no health IT, because using paper results in mistakes.

I offer a different view.

At the introduction to my Medical Informatics teaching site I've defined good health IT and bad health IT as follows:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. 

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  .    

There are also good paper systems and bad paper systems.

I opine that the elephant in the living room of health IT discussions is that BHIT is infrequently, if ever, made a major issue in healthcare policy discussions.

I also opine that BHIT is far worse, in terms of diluting and decreasing the quality and privacy of healthcare, than a very good or even average paper-based record-keeping and ordering system.  

This is a simple concept, but I believe it needs to be stated explicitly. 

In today's healthcare world, where health IT is dominated by hyper-enthusiasts of one motive or another, such an axiomatic statement will probably be viewed as controversial if not heretical. 

This blog has numerous postings about health IT debacles, e.g., query links here and here, that could not occur with paper systems.  The defects of just one company's products, the only one that publicly reports them to FDA (link) are frightening in terms of potential consequences.

GHIT needs to be promoted and BHIT needs to be eliminated.  That implies a major transformation of the health IT industry and its oversight.

-- SS

Bad health IT and its effects on willingness of patients to share sensitive information

I call your attention to this video from the 2nd International Summit on the Future of Health Privacy where HC Renewal occasional contributor Dr. Scott Monteith, a psychiatrist, presents on how health IT damages the physician-patient relationship, the bedrock of good medicine, in one case via an inexcusable health IT defect.

The defect nearly cost a woman her good reputation - and her child - by "transforming" coffee drinking into solvent sniffing.

The video is here:  http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx

Dr. Monteith on how bad health IT damages trust.  See video at this link starting at 4:40.

Dr. Monteith starts at 4:40 when he is asked

"Do you feel HIT affects the willingness of patients to share sensitive information with providers?"

His answer is a definite "yes", and the video should be seen to understand his reasons, the largest one being the trust that is injured by this technology as currently (mal)implemented, failing to maintain privacy, data integrity, affecting doctor-patient interaction (e.g., due to poor usability), etc.

His two examples where HIT has injured trust, resulting in decreased willingness of patients to share sensitive information:

• A patient feared compromised privacy regarding psychiatric information (a fear that was certainly well-justified in view of ABC's recent expose of health IT breaches as I wrote about at my Sep. 14, 2012 post "A Reason to Refuse Use of EHR's in Your Health Care, and Demand Paper.")

• An error in EHR-generated record affecting a child custody battle, with a husband alleging unfitness of the mother due to substance abuse.  The EHR incorrectly showed a damaging diagnosis due to both a data mapping flaw (lumping multiple diagnoses under the same code) and a user interface flaw (permitting all of the diagnoses lumped under that code to not be seen, only the worst one) that transformed caffeine (i.e., coffee) overuse to "inhalant abuse."  

Stunningly, Dr. Monteith reported the error was not remediated even after several years.

As seen by the voluntary reports submitted by one of many HIT sellers (link), the only one that seems to do so, and some involuntary ones such as at this link, these issues are just the "tip of the iceberg." That exact phrase was uttered by a senior FDA official himself, reflecting known severe impediments to information diffusion on harms, as I reported at this link.

Yet the government (e.g., HHS's Office of the National Coordinator for Health Information Technology, ONC) and IT industry push this technology like candy, emphasizing largely unproven benefits and completely ignoring downsides such as damaged trust, damaged reputations that could have cost a woman custody of her child, and damaged bodies.

A video of an attorney personally affected by these issues is at this link:   http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-137-ec40d08a35f947e487f68a5f534a9e82.aspx

-- SS

EHR sabotage for ransom: Try this with paper!

I have frequently written that health IT, touted as a technology that will deterministically "transform medicine", allows (aside from clinical chaos) new sorts of problems, such as information security abuses en masse, to occur.  See this query link for numerous postings on that topic:  http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy

I am not, of course, advocating a return to paper; I am in fact "pro-good IT" but "anti-bad IT."

"Bad IT" is IT that interferes with quality patient care for any reason, permits evidence spoliation, permits overbilling, exposes confidential medical information to unauthorized parties, etc.

Here is another example of unintended consequences of bad health IT.  Try this trick with paper:

Attackers Demand Ransom After Encrypting Medical Center's Server
John E Dunn, Techworld
August 14, 2012 

Details have emerged of an extraordinary data breach incident in which a U.S. medical practice had thousands patient records and emails encrypted by attackers who then demanded a ransom to unscramble the data.

The incident appears to have come to light after a security blogger 'Dissent Doe' noticed a data breach report made by Illinois-based The Surgeons of Lake County medical centre to the US Department of Health and Human Services.

According to a small newswire that reported events, attackers were able to compromise one of the medical centre's servers, encrypting its contents including 7,067 patient records and a quantity of emails.

The first the centre knew about the attack was on 25 June when a ransom note for an undisclosed sum was posted on the server, at which point it was turned off.

It is not clear whether the data was recovered through backups but the organisations reported the incident to the police and Department of Health.

... What marks the compromise out from almost every data breach attack recorded is that the attackers opted to extort the victim organisation rather than attempting to sell or exploit the data itself.  [Cyber criminals should never be assumed to be uncreative - ed.]

It remains unlikely that the intention was to abuse this data directly; having occurred only days before the extortion note was received, the criminals would normally want a longer period to execute data and identity theft crimes. Most data theft criminals attempt to go undetected for this reason.

The criminals will, nevertheless, had access to sensitive data including names, addresses, social security and credit cards numbers plus medical records, prompting the centre to inform its affected patents of the breach.

"This is a warning bell. Maybe they're the canary in the coal mine that unpredictable things can happen to data once it's digitized," [you think? - ed.] said Santa Clara University law school professor, Dorothy Glancy, quoted by Bloomberg.

This incident is, quite simply, stunning.  In addition to identity theft concerns, a patient whose information was cybernetically 'held hostage' could have suffered clinically as a result.

A warning bell indeed about "bad IT."

-- SS