Bug in MetaVision ICU system potentially catastrophic - American bad health IT goes Down Under

I have often written in this blog about healthcare IT defects and the lack of quality control regulation and safety testing.   I have indicated that patients have become guinea pigs for software development and testing, and healthcare facilities a software beta testing "proving ground" and defects remediation site.

This should all be occurring in the lab, not on live patients who've never given their consent to the use of these experimental cybernetic "command and control" systems that, in fact, regulate and govern their care in many ways.

Now there's this from Down Under in the journal Pulse*IT:

http://www.pulseitmagazine.com.au/index.php?option=com_content&view=article&id=2127:bug-in-metavision-icu-system-potentially-catastrophic 

Bug in MetaVision ICU system potentially catastrophic
Written by Kate McDonald on 27 October 2014.

A bug in the MetaVision intensive care software package being rolled out in several Brisbane hospitals has been identified as having the potential to seriously harm or even kill patients, several media outlets are reporting.

Fairfax's The Brisbane Times reported that a risk assessment by the Metro North Hospital and Health Service - which covers Brisbane's Prince Charles and Royal Brisbane and Women's (RBWH) hospitals - had found potentially catastrophic problems with prescription errors caused by the system that had a 60 to 90 per cent likelihood of causing a patient death.

MetaVision, from US vendor iMDsoft, is one of the few specialist critical care software packages on the market. It is able to capture information from medical devices and contains a full medical record specific to ICU patients.

This is U.S. software being foisted onto the very sick ICU patients of another country, Australia.

I should note that the author of the article, Kate McDonald, did an article about me in July 2012 and about my - at the time - upcoming presentation to the Health Informatics Society of Australia in health IT trust (article at http://issuu.com/pulseitmagazine/docs/pulseit_july2012/56, writeup of my presentation and link to slides at http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html).

A 60 to 90 percent likelihood of causing a patient death is of great concern, especially in an ICU.  The likelihood of injury is probably in the same ballpark.

Who detected the problems?  The true experts - those with clinical expertise:

... It also contains medications management and decision support, and is able to interface with the complex IV infusion pumps used to administer medications to patients in intensive care.

The ABC [Australian Broadcasting Company] reported that according to the risk assessment report, “monitoring of patient records by pharmacists has revealed several potentially serious prescription errors specifically caused by the system”.

"Large volume prescriptions and high acuity of patients overlayed [sic] with functional risks of the system increases the likelihood of a SAC 1 (serious harm or death) event.

(Where have I seen computer-caused prescription errors with harm potential caused by bad health IT before?  Here, for one:   "Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands", http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html.)

According to the ABC, the testing of this software was about par for the course in this unregulated health IT industry:

"There is no record of robust regression or functional testing at vendor, Queensland Health corporate or facility level."

Yet the software has been, and is, being rolled out by eager beavers seemingly just jolly at subjecting non-consenting ICU patients to an American experiment:

MetaVision has been rolled out in the ICUs at the Canberra and Calvary hospitals in the ACT, and at the Gold Coast, Prince Charles, Townsville, Rockhampton, Cairns and Logan hospitals in Queensland, where it has been installed for over a year.

It went live at Brisbane's Royal Children's in June, RBWH in September and at Princess Alexandra Hospital (PAH) just last week.

It is live at the Sydney Adventist Hospital and has also been chosen for a statewide roll-out in all ICUs in NSW.

The software company responds:

MDsoft issued a statement late on Monday saying that the problem was unique to the version implemented at Queensland Heath and does not affect any other installations in Australia.

"Late last week, certain clinicians from Queensland Heath highlighted potential risks as a result of prescribing with the MetaVision clinical information system," iMDsoft's director of marketing, Anne Belkin, said.

"iMDsoft is aware of this issue, and has already provided a solution to Queensland Heath. The software fix has been in testing at the site for several weeks and will be implemented in the near future.

First, one wonders why software being rolled out at hospitals in the Australian state of Queensland would be uniquely affected by such a severe bug, while at other sites it has not.  I question if some "new" features are being alpha- or beta-tested there - using Queensland Health ICU patients as unwitting laboratory rats.

Unless that "fix in testing" is being tested completely offline, this suggests patients are being used as literal software debugging test subjects regarding a flaw that could kill them.  The very best interpretation is that clinicians are asked to work around a potentially fatal "bug" in an ICU setting with the very sickest patients while the "fix" for a bug that should not exist in the first place is being remediated.   

"The risks highlighted by the report were originally identified during testing and, with close cooperation between iMDsoft and the clinicians at the Hospital and Health Service sites, a mitigation plan was immediately put into effect.  ... [The Brisbane Times] said the system has been manually over-ridden with medical charts [presumably the electronic charts - ed.] being reviewed daily by ICU specialists.

This suggests workarounds, which can be dangerous themselves ("one should not have to work around that which is not in their way", as I've written.)

A better and more ethical solution, in my opinion, to a potentially fatal bug's "mitigation plan" would be to turn the system off in the interim and revert to paper - as if the system had crashed - until the "bug" is fixed.

The company is then quoted as making this statement:

"The underlying risk is unique to the version implemented at Queensland Heath, and does not exist in any prior or subsequent releases for Australia. MetaVision is used at more than three hundred sites worldwide and is regulated by stringent international standards to ensure patient safety."

"Three hundred sites worldwide" is a very small number.  This suggests this is a very recent - or perhaps unpopular - offering.

The company site offers this:

iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements.

iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements. - See more at: http://www.imd-soft.us/about-us#sthash.RZMu32FN.dpuf

iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements. - See more at: http://www.imd-soft.us/about-us#sthash.RZMu32FN.dpuf

It would be interesting to know what "stringent international standards" are being followed to "ensure patient safety" (ISO 13485, http://www.iso.org/iso/catalogue_detail?csnumber=36786 for medical devices is likely the one being cited), and what testing the FDA performed specifically.

I don't know of such standards for ICU health IT in the U.S., the country of origin of this software, where regulation of health IT is in the discussion stages by the government and FDA, and very unsatisfactorily I might add (see "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).

Nor do I know of rigorous ICU clinical EHR software evaluation and testing regulations and procedures anywhere else, for that matter, although would be glad to be informed of some that could be adopted in the U.S.

The expected excuses also appear:

Brent Richards, director of intensive care at the Gold Coast Hospital and then chairman of Queensland's Statewide Intensive Care Clinical Network, told Pulse+IT last year that the system delivered improvements in workflow and safety.

“ICU is incredibly complex and can be quite hard to computerise, because we have a lot of data flow,” Dr Richards said. “You want to capture all of that data including the data from the equipment interfaces, which is transferred minutely in MetaVision.

“Giving drugs is a lot more complex because ICU patients frequently have numerous infusions, and there is frequent real-time management of infusions – titrating medication infusions is normal in ICU – and the system has got to be able to capture it.”

In response, I penned this letter to Kate McDonald.  It speaks for itself:

From: Silverstein,Scot
Sent: Friday, November 07, 2014 9:58 AM
To: Kate McDonald
Subject: Re: Bug in MetaVision ICU system potentially catastrophic

Re:  http://www.pulseitmagazine.com.au/index.php?option=com_content&view=article&id=2127:bug-in-metavision-icu-system-potentially-catastrophic

Dear Kate,

I hope you are well.  My Australian colleagues alerted me to your article on the Metavision ICU flaws.

The excuse that:

... “ICU is incredibly complex and can be quite hard to computerise, because we have a lot of data flow,” Dr Richards said.

rings incredibly hollow.

If an ICU is so complex, the most stringent IT testing is indicated BEFORE go-live on actual patients.  If this were an aircraft or nuclear energy facility, one might now have a smoldering ruin or a Chernobyl (or Three Mile Island in the U.S., http://en.wikipedia.org/wiki/Three_Mile_Island_accident) radiation cloud.

Live patient environments, especially with the sickest in an ICU, are not proper software beta testing and debugging environments.

This is why in the U.S. I call for mandatory and strict quality and safety regulation of healthcare IT that will be employed on patients, much as software is regulated in other mission-critical and life-critical industries.

The health IT industry has for decades been given an extraordinary regulatory accommodation - that is, little to no regulation - and this can, and has, harmed and killed patients.

Please consider this letter suitable for publication.  I addressed some of these issues in my keynote at HISA 2012 in Sydney.

Sincerely,

Scot Silverstein

I, for one, certainly do not want buggy software deployed in ICU's anywhere near my residence.  Hospitals have a legal and ethical obligation to maintain safe environments for care.

Australian as well as American hospital management seem to have been cavalier about that when it comes to healthcare information technology.

-- SS

9:15 AM

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

3:43 PM

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

3:35 AM

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  

6:16 AM

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

4:33 PM

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

10:36 AM

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

3:20 PM