At an interview of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group HIMSS and chief medical officer of Imprivata, a company specializing in healthcare IT security, Chaiken pleads for the following special accommodations for Health IT relative to other medical sectors:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better.

[Why are the health IT applications bad to begin with, I ask? - ed.]

I note the following.

• If 'we're' still learning (and I don't include people with genuine clinical computing expertise in that subgroup, but it does include the plethora of amateurs in the commercial health IT industry), then the technology is experimental.
• Worse, it's unregulated - a major special accommodation in and of itself.
  
• These sentiments about "being patient" would be appropriate - if the subjects of this experimental technology that vendors need to be "given a chance" to make better were experimental lab rats.

Instead, the subjects of the experimental technology are unwitting, unconsenting human beings, who are being used as experimental test subjects for software development, and being put at risk, injured and indeed killed by the disruptions these experimental technologies cause.

Under these realities, the position presented by Chaiken is, in my opinion, ethically perverse.

That such sentiments come from someone who holds the MD degree and who I assume took the Hippocratic oath in some form is stunning.

In the health IT industry, "Primum non nocere" seems to have been replaced with "Kybernetik über alle."

Further, the commercial health IT vendors have had the good part of five decades to "get it right." How long is long enough?

Their software is unavailable for detailed evaluation and open critique of the user experience by impartial experts, unlike open source EHR's like VistA CPRS, demo version available at this link where anyone can:

• Download the latest version of CPRS today and get access to new features including graphing functionality
• Use the software as if you were a provider by entering orders, entering documentation, retrieving reports (and graphs) and viewing alerts and notifications that help with decision support
• Learn first hand how VA’s electronic health record system works

Personally, I've had to use stealth simply to obtain and post graphical representations of some simply inexcusable commercial HIT interface sins (link). Why should a secretive industry be given additional special accommodation?

Dr. Chaiken goes on to state:

Let’s hold them accountable if they don’t [make the applications better]. Absolutely, hold them accountable if they don’t; and the marketplace, I hope, will be able to make those choices and hold them accountable when they don’t. But, we’re still learning.

Again, I'm not sure who the "we're" refers to, but "holding companies accountable" will not really help victims of the experiments who are seriously injured or killed.

A better solution, as I have written on this blog (such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and at other sites as well:

Protect patients. Constrain the health IT experiment temporally and geographically, and apply the laws, customs and regulations of medical experimentation until this industry "has learned" whatever lessons Chaiken thinks they need to learn, e.g., from decades of Medical Informatics, Social Informatics, Computer Science, HCI and other research. None of these fields - last time I looked - are classified or protected intellectual property. Share information on patient adverse outcomes and near misses, instead of concealing them and contractually gagging users from openly speaking about problems.

That would be the ethical approach.

Further, how many more decades should we wait for the health IT industry to figure out how to look for better leaders beyond the "school of hard knocks" bias that's existed for at least the past decade? How many substandard health IT leaders were placed in hospitals the past few decades as a result of outrageous attitudes like these below from the major recrutiers, centered on spreading the wealth?

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman. Healthcare Informatics, "Who's Growing CIO's."

[No, that line about 'being consumed with patient care issues' as a strike against health IT leadership didn't come from a Scott Adams business-idiot parody cartoon - ed.]

As in clinical medicine itself, if you're going to be anywhere near patient care and making decisions affecting its delivery, a degree damn well "gets you something."

At about the same time the above appeared in Healthcare Informatics, a generalist IT recruiter wrote me this:

... What is happening to MDs trying to change careers is providing a window into broader issues about professionals in society today - narrow training, pigeonholing in the marketplace, difficulty making lateral and cross-industry transition, what a handicap it is to be creative, entrepreneurial, or cross-disciplinary in the current marketplace, and the wasted intellectual capital represented by the high caliber of individuals who can't find ways to fruitfully plug themselves into the marketplace.

I continue to be amazed at this general phenomenon...the remarkable quality of a number of candidates I've met, and the lack of recruiters' ability to get them in the door of good companies. The interesting part of the story is that when I am able to get access to high level execs in some of these companies (not just IT, but devices, pharmaceuticals, etc. also) they are dismayed at the quality of those that they hire. They know that something is wrong in how the recruitment process is working. (eg, one of the major device cos. just devoted the time of 1 FTE in Human Resources to 'finding innovative ways of identifying and recruiting good talent into the company.')

Whose fault were the outrageous, deleterious hiring practices prevalent in this industry that contributed materially to its production of substandard products, hiring practices that persist to this day? (See example here.)

Why should we be "patient", and "give them [yet more chances] to figure out the right way to do this", and why should patients permit themselves to continue to be guinea pigs to such a sloppy, cavalier industry?

I note that Chaiken's credentials appear to fit the template, as colleague Roy Poses describes at various posts including here, of an "executive isolated from the real world of health care" and member of the superclass. From the interview linked above:

... According to your LinkedIn profile, you’re CMO for Imprivata, CMIO for Symphony Corporation, and CMO of DocsNetwork. You’re on a couple of advisory boards, you own a vineyard, and you just finished your term as chair of the HIMSS board.

Perhaps that helps explain the mantra of "computers [and profit] first, patients second."

Finally, in answer to my own question above "Why are the health IT applications bad to begin with", I suggest complacency, incompetence, willful ignorance, and negligence (including criminal negligence) as possible answers.

-- SS

Addendum:

The following in today's WSJ caught my eye ("What we've learned from the Gulf spill", Michio Kaku, July 20, 2010):

The nagging question is: Why did it take so long? Why couldn't they have capped the leak months ago? For three agonizing months, BP's engineers and executives were essentially making things up as they went along, conducting a billion dollar science project with the American people as guinea pigs. The basic science of stopping oil leaks at 5,000 feet below sea level should have been done years ago.

Concepts are similar. With just a few edits, we have this:

The nagging question is: Why is it taking so long? Why couldn't they have learned to create useful health IT decades ago? For at least thirty agonizing years, Health IT vendors' engineers and executives were essentially making things up as they went along, conducting a multibillion dollar science project with the American people as guinea pigs. The basic science of producing safe, effective, usable health IT should have been done years ago.

AI recently had the chance to observe my mother's care in a small community hospital.

This was a hospital that, in her last several days there before going back to a nursing home for rehab, went live with a major vendor CPOE. The CPOE was brought in from a parent large hospital where the CPOE had been in use several years.

Just by passing the nursing station/doctor's charting room on my mother's floor and opening my eyes and ears, I saw doctors and nurses struggling to take care of patients while "getting the bugs out of the system."

They had had received some classroom "training" in a static environment, but it was clear they were learning about a lot of "gotcha's" and unanticipated glitches in vivo.

The fact of problems were predictable. In fact, I predicted unexpected difficulties to several of my mother's clinicians before go-live.

There was some skepticism (maybe in my nearly being in tears about my mother, I came off as a bit melodramatic). However, several later told me they "now knew what I was talking about" upon my mother's discharge, just several days into the go-live.

One story I overheard during go-live especially sticks out in my mind.

A newly-admitted patient who needed urgent heparinization did not receive the medication promptly. The patient's physician could not order it, and could not enter the required weight needed to order it, due to some type of 'glitch' or system malfunction. Physicians found no way to override, despite calls to the help desk, attempts by on site IT people and users from the parent hospital, etc.

In the end, the pharmacist simply provided the med using a weight estimate despite no "official" order having been entered into CPOE. I heard that the delay was on the order of "several hours."

Clearly, both technology and people issues were involved ... but I assure the reader, injured or dead patients really don't care exactly how their injury occurred, after the fact (other than in litigation, which doesn't fix the damage or remediate the suffering).

Here, then, is my question:

Where does the moral authority come from to subject live, unsuspecting, uninformed patients to the type of risks the patient whose heparin was delayed was subject to?

What right did the hospital have to NOT inform this patient before admission that a new critical CPOE system was going "live" that day, and that the patient could consider going to another hospital a few miles down the road instead that had no such potential problems?

From the Belmont Report (also see http://ohsr.od.nih.gov/guidelines/belmont.html ), the six fundamental ethical principles for using any human subjects for research are:

• (1) Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent;
• (2) Beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and
• (3) Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits to potential research participants.)
• (4) Fidelity: fairness and equality.
• (5) Non-maleficence: Do no harm.
• (6) Veracity: Be truthful, no deception.

I would like a straight, unspun answer to this simple question:

On the basis of Belmont Report and other medical ethics regulations, where does the moral authority come from for hospitals to put patients through such risks without informing them ahead of time and offering them an opt-out, even if only the continued use of paper in their care?

I have passed this question on to major American Medical Informatics Association mailing lists and await replies.

The National Institute of Standards and Technology (NIST) has begun to address deficient clinical IT usability. A PDF with presentations on the topic from the recent NIST conference on HIT usability is here (warning: very large, 26 MB).

There is a critical "meta-issue" that's being ignored regarding usability, though, yet it is the elephant in the living room.

First, I will detail the elephant, then ask the simple, logical question that arises (the "inconvenient" question that nobody seems to be able to give a straight, non-marketing-spin answer to).

Here are the details of the elephant.

First, poor usability ---> increased risk to patients.

This is a first principle; it is not open to debate.

Now:

If NIST is just now getting involved in "improving HIT usability" (the improvement of which should have occurred at least two decades ago);

While HIMSS's former Chairman of the Board admits the technology remains experimental:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better;

While HIMSS itself admits in this 2009 PDF that

"Electronic medical record (EMR)!adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available";

While the National Research Council (the highest scientific authority in the U.S.) last year reported that :

"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt);

While it's not just the user experience that's the problem, either...

Insurers are starting to recognize this, e.g., "NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" ;

While hospitals and vendors cannot yet manage the technology reliably - how many medical mistakes have/will occur as a result of screw ups like this one, now confirmed to have occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.?

This patient won't get a second chance, either.

The above issues are the elephant in the living room. Or, shall I say, in the Boardrooms and meeting rooms where health IT is planned and discussed?

Health IT is great stuff, guys; it might actually work well one day!

Let's roll it out nationally and penalize those Luddite doctors

who refuse to "use it meaningfully" because it's not very usable.

Oh, just ignore that strange creature over there in the corner ...

Considering the size and weight of the elephant, here is my question:

Why are we rolling out this technology nationally under penalty of Medicare garnishment?

I cannot get a straight, unspun answer to that question.

Perhaps we need Bill O'Reilly to ask these questions of health IT officials on his FOX News program, The O'Reilly Factor, where spin is attacked relentlessly (the "No Spin Zone.")

In the Battle of Britain in WW2, the Royal Air Force (RAF) heroically repelled a foreign invasion of the UK.

The Supermarine Spitfire, key defense tool in the Battle of Britain. (Worked without major glitches.)

Now, the invasion is American, and the battlefield is healthcare...

I have often said health IT remains an experimental technology. However, the technology is being inexplicably force-fed with a vengeance to hospitals by IT companies and governments, force-fed with respect to the actual evidence of benefit.

In the case of the NPfIT in the UK, we have items such as those below from a 2009 government report "The National Programme for IT in the NHS: Progress since 2006 - Public Accounts Committee." Emphases in italics mine:

The termination of Fujitsu's contract has caused uncertainty among Trusts in the South and new deployments have stopped. One option being considered for new deployments is for Trusts to have a choice of either Lorenzo provided through CSC or the [Cerner, an American company - ed.] Millennium system provided through BT. There are, however, considerable problems with existing deployments of Millennium and serious concerns about the prospects for future deployments of Lorenzo. Before the new arrangements for the South are finalised, the Department should assess whether it would be wise for Trusts in the South to adopt these systems. Should either of the Local Service Providers take on additional commitments relating to the South, the Department should take particular care to assess the implications of the extra workload for the quality of services to Trusts in the Local Service Providers' existing areas of responsibility.

The Programme is not providing value for money at present because there have been few successful deployments of the [Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively. Unless the position on care records system deployments improves appreciably in the very near future (i.e. within the next six months), the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme.

In 2010 Londoners continue to be used as cannon fodder for the health IT experiment, which continues to rain IT bombs down upon them. The result?

Mayhem:

St George’s suffers Cerner teething pain
E-Health Insider
Jon Hoeksma
26 Aug 2010

St George’s Healthcare NHS Trust is facing teething problems with its installation of a Cerner Millennium hospital information system.

"Teething" problems? As if to imply problems with health IT are as minor as an infant's dental discomfort? That's some spin:

Health IT problems? Just baby issues; nothing a good cry can't solve ...

(The health IT baby must have serious endocrinological problems. Even after decades, it never seems to grow up, and is forever teething.)

The spin and excuses surrounding the health IT industry are simply nauseating, considering it's people's lives that are being screwed with.

Let's translate to everyday language: the project has been a disaster.

... The trust went live with the Millennium in March, under a new local delivery model from local service provider BT.

Five months later, the trust, which is one of the largest in London, has had to second additional senior management expertise into the project team and institute an additional programme of workflow changes and training.

The trust says the new system is creating difficulties in tracking patient notes in some areas and in managing outpatient appointments; creating backlogs of work that have required extra staff to deal with.

Health IT is touted as improving clinician-clinician communication. Allow me to translate "difficulties in tracking patient notes." In King's English (as opposed to health IT political-ese and other mumbo-jumbo), this translates to "patient notes are getting lost."

That means that health IT is obstructing patient care. I'm sure the patients didn't consent to the use of unproven technology that could get them killed.

Health IT is also the supposed cure to healthcare's financial and staffing woes:

They have also had a knock-on effect on the trust’s ability to meet and report on activity. Sources familiar with the implementation say the trust was fortunate that the coalition government dropped the national requirement to meet 18-week referral to treatment time targets in the revised NHS operating framework.

The problems are understood to mainly relate to staff finding it difficult to adjust to new processes and to using the unfamiliar Cerner system.

...“Since the programme deployed some staff have found it challenging to follow the new workflows. Therefore, where appropriate, we are simplifying processes by modifying workflows and administrative procedures.”

Translation: staff are finding it difficult to perform clinical-related work according to the capricious diktats of non-clinician health IT developers. In other words, they have difficulty being coerced to work for the computer, instead of the computer working for them.

The south London trust told E-Health Insider this week that the implementation was just the beginning of a major change programme; a project it calls iCLIP.

Only the beginning? God save the King....

“Although we successfully avoided some of the major pitfalls of other deployments, the new systems have presented some challenges to staff, particularly in relation to outpatient clinics and the tracking of case notes,” said chief operating officer Patrick Mitchell in a statement.

How major could those "major pitfalls" have been? Perhaps he means, the software actually runs and no longer crashes?

He added: “We have allocated additional temporary support while the new system and processes fully embed in these areas. A further programme of training and workflow changes are also underway as we continue to support staff and prepare for the next stages of the programme.”

"Temporary?" We'll see about that. Per the recent article "Electronic Medical Records, Nurse Staffing, and Nurse-Sensitive Patient Outcomes: Evidence from California Hospitals, 1998–2007" (Health Services Research, 9 APR 2010, DOI: 10.1111/j.1475-6773.2010.01110.x), on a longitudinal analysis of 326 short-term, general acute care hospitals in California:

... Our results suggest that advanced EMR applications may increase hospital costs and nurse staffing levels, as well as increase complications and decrease mortality for some conditions. Contrary to expectation [I'm not sure whose expectation, and on what basis - ed.], we found no support for the proposition that EMR reduced length of stay or decreased the demand for nurses.

On to the issues of skills:

Julia Crawshaw, the general manager for maternity services, has now been seconded into the project team “to lead on the work looking at optimisation of workflows, operational procedures and further training.”

Will this GM for maternity be looking at workflows in, for example, neurosurgery?

The problems now being addressed occurred despite 1,600 staff being comprehensively trained prior to go-live.

"Comprehensively?" What does that mean, exactly? The results seem to belie that assertion. Or are these systems and their user experience so ill conceived, tedious, cryptic and complex that no amount of "training" is adequate? (I believe the latter.)

However, Mitchell stressed that thanks to the hard work of staff, the new information system is delivering benefits, including “real-time reporting in the A&E department and more complete monitoring of bed occupancy.”

How many millions of pounds and person-years were spent to achieve these startling results, I wonder?

Mitchell said: “Reporting in real-time requires that staff report more promptly and accurately so additional training needs are also being identified to help individual staff become more comfortable with the system.”

Perhaps the system - and its designers - should be "trained" to be more comfortable with the users?

A spokesperson for BT told EHI: “Obviously these are operational issues the trust is dealing with. It is not for BT to comment. But you would expect that on a major deployment programme of this scale there would be issues.”

This is a classic appeal to common practice. Such "issues" might be tolerable for inventory systems of widgets (perhaps Cadbury Schweppes products?), but no, in mission critical areas I would not "expect" problems such as lost clinical notes.

In the most recent trust newsletter, the chief executive said: “I do fully appreciate that iCLIP has been far from smooth sailing. However, all major projects have their ups and downs and I know that many colleagues are focused on the long-term success of this important project.”

More spin and appeal to common practice.

This voyage was smooth sailing, until a little glitch was encountered...

"Far from smooth sailing?" Why does the HMS Titanic come to mind?

... The next trust due to go live with Millennium in London is meant to be Imperial, scheduled to take the system in 2011, under Cerner’s Method M delivery model.

"Method M delivery model"? How many "models" does it take to implement information systems in mission critical healthcare environments?

In summary, the NPfIT, already by the government's admission a multi-billion pound debacle, continues to drag on. Patients and hospital workers are the fodder for this experiment, spearheaded this time by an American invasion.

The Blitz is on.

Unfortunately, this time there's no RAF in sight to repel the foreign invasion.

The upside down world of commercial health IT. Is healthcare in St. George's Trust being incernerated?

As I have written at Healthcare Renewal before, computerized physician order entry systems (CPOE's) are known to present risks to patients through induction of medical errors.

This technology is held out to be ready for national diffusion, right up to the POTUS. Per ONC director Blumenthal in the July 13, 2010 NEJM:

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

Vendors deny major problems with their CPOE and other health IT products.

The true story is a bit more complex.

Fortunately, there are some medical centers who are open and honest about HIT problems. These medical centers seem a rarity. However, those that do share are actually conducting themselves in an honorable and mission-true manner, per Joint Commission Safety Standards, the ethics of the medical profession, and the expectations of the public. They should be commended.

One such example is Munson Medical Center in Michigan.

From the October 2010 "News for Physicians affiliated with Munson Medical Center" newsletter, a large medical center in Northern Michigan, about more than six thousand"issues" with their Cerner CPOE:

POE Program Continues to be Improved, Enhanced

The Provider Order Entry (POE) program continues to be improved. Since implementation in June [four months ago - ed.], more than 6,000 issues have been reported. Issues are defined as an aspect of the program not working as intended [does that include medication and treatment errors and 'near-misses'? - ed.], process issues [can these 'issues' kill? - ed.], education needs, or PowerPlan [Cerner - ed.] change requests.

About 600 of these remain open. Issues are prioritized by the POE Team and addressed according to existing standards.

One wonders how many of those 6,000, and how many of the 600 remaining "issues" fall into categories of "likely to cause patient harm in short term if uncorrected" or "may cause in patient harm in medium or long term."

I note that Cerner CPOE is not a new product, nor are similar products from other vendors also afflicted with long lists of "issues." That there could be more than 6,000 "issues" at a new site suggests deep rooted, severe problems with CPOE specifically and health IT design and implementation processes in general.

Did patient harm result here or at other CPOE sites (using products of any vendor, not just this one) that had hundreds or thousands of "issues"? We may never know.

That national rollout is mandated as if this technology were proven, safe, and plug and play is a scandal of UK NPfIT-like proportions.