On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts.

Note: the reports to which this post refers are available as a set of PDF's from the University of Sydney, NSW, Australia at this link (12 Mb, .zip folder).

March 6, 2011 addendum. Also see my new post "What to do about the state of the ED EHR in NSW?"

Over ten years ago now, 1999 in fact, I started my healthcare IT difficulties website.

That site, "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" now resides on a Drexel University server in Philadelphia, Pennsylvania USA at this link, and used as a teaching resource.

I started the site after observing, for lack of a better description, "crazy stuff" in the commercial healthcare information technology sector.

Crazy stuff such as EMR systems for ICU's that crashed regularly and spread pathogens around, EMR's for invasive cardiology cath labs that were an informational jumble and abyss and that also issued regular General Protection Faults and died, lack of Medical Informatics expertise (and actual disdain for it) in healthcare IT projects, grossly incompetent IT leaders, and hospitals uncritically and enthusiastically buying these products as if they were a plug and play, proven technology.

To make matters worse, I also observed executives expressing a hostile indifference to glaring deficiencies.

My observations about health IT and about responses to my counsel brought to mind the biblical passage:

"Give not that which is holy unto the dogs, neither cast ye your pearls before swine, lest they trample them under their feet, and turn again and rend you." - Matthew 7:6

I was never afforded the opportunity to perform a forensic analysis of the internals of these systems, being that I was not allowed to obtain the software or "schematics" of the data structures. In fact, to make the cardiology system usable, I ordered the IT staff to simply discard the internal data dictionary, relational data structures, input screens, and analytic routines, and rebuild them - from scratch - using a proper Medical Informatics-based, cardiology domain expert-driven, iterative and incremental (agile) approach.

The result was a resounding success, and was described in a written report as "exceptional" by national specialty association reviewers invited to evaluate the effort.

(A success for which, I might add, I and my enlightened executive sponsor were paradoxically demonized by the IT department and hospital executives; cf. Matthew 7:6.)

Now, an Australian researcher of considerable computer and database expertise, Professor Jon Patrick at the University of Sydney, has put considerable ink to a forensic evaluation of the internals and external reactions to an EMR system "built in America", Cerner Firstnet.

Professor Patrick holds a Ph.D. from Monash University. He came to the University of Sydney from Massey University, New Zealand, where he held the foundation Chair of Information Systems. Professor Patrick won Australia's national Eureka science prize in 2005 for developing a natural language processing system that detected financial scams in web pages at the behest of the Australian Government.

FirstNet is an ED EHR that government officials decided must be installed in ED's of public hospitals throughout the Australian state of New South Wales. Promo material below, click to enlarge:

FirstNet promo material, page 1. Click to enlarge. (Hmm ... Is there a subliminal message in the picture of the doctor and nurse?)

FirstNet Promo material, page 2. Click to enlarge.

The initiative's been underway for several years, and the result is a group of apparently very unhappy Wal-Mart shoppers. (I guess the correct line would be "unhappy Big W shoppers" for those Down Under.)

Prof. Patrick had written a preliminary essay on the issue entitled, in rhetorical question-style, "The Story of the Deployment of an ED Clinical Information System: Systemic Failure or Bad Luck?" back in 2009. He apparently found himself in considerable hot water for doing so due to 'pushback' as I described at "Academic Freedom and ED EHR's Down Under: An Update". However, his university stood by him in defense of academic freedom (and of the sanctity of those in the healing arts, I might add).

He's spent the intervening time expanding the analysis of the ED clinical system and its deployment considerably, right down to the fine nuances of relational database design in complex domains (such as biomedicine).

As I wrote in an initial post "A Study of an Enterprise Health information System - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner", the TOC of his new analysis are these (the files are available as a .zip archive at this link):

3.0 Part 0 - Executive Summary
3.1 Part 1 - A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck? First published here in Oct 2009, revised Dec 2009.
3.2 Part 2 - Discussions with ED Directors: Are we on the right track?
3.3 Part 3 - Discussions with Software Performance Experts.
3.4 Part 4 - Conceptual Data Modelling.
3.5 Part 5 - Database Relational Schema and Data Tables.
3.6 Part 6 - Coalescing the Analyses of the ER Diagrams, Relational Schemata and Data Tables.
3.7 Part 7 - The Integrated Assessment.
3.8 Part 8 - Future HIT Regulation Proposals.
3.9 Part 9 - Ockham's Razor of Design. Published at the IHI conference, Nov 2010 Washington.

I have been reading these sections, and have found the technical sections (parts 4-6) highly informative about a major suspicion I've held for many years.

I suspected chaos in the health care IT software engineering process, with inadequate attention to quality, rigor, fine detail, resilience engineering, talent management and other practices essential in development of mission critical products of any type.

Prof. Patrick's forensic analysis, while not proof of my concerns, certainly supports them. If Boeing produced aircraft with malfunctioning engines, broken seats, defective flaps, tires that blew on landing, and rust right out of the factory (like the Chevy Vega of old?), one might suspect the development and manufacturing environment could be substantially problematic.

The theme of apparent violations of fundamental precepts of relational database design run consistently through his analysis of the FirstNet product.

Without getting too technical (which I can, having written successful relational database-based clinical information systems of considerable complexity for challenging environments, with novel user interaction design besides), I see evidence of developmental chaos.

Examples: primary key-foreign key inconsistencies and problematic usages ("keys" are flags used to link sets of information about some object or entity, such as a patient to their diagnoses or meds), internal field nomenclature faux pas (there are best practices on how to do this to enhance software quality and maintenance), cryptic documentation , "stale bits" (old code and data) from past iterations remaining to create "glitches", unreliabilities and new problems, and other technical sins apparently abound.

These can be read about in sections 4-6 of Prof. Patrick's analysis. The issues can be summarized as he did in the part 6 Abstract:

Consistent weaknesses in sections of the Millenium clinical information System (CIS) are revealed in the combined study of the ERD (entity-relationship diagram), logical schema and the data tables. PK (primary key, i.e., unique identifier) values are not always defined unambiguously at the design level and data tables reveal inconsistencies in declarations and data validation. There is evidence that keys are managed by software within the application rather than by the in-built functions available in the database management system leading to less confidence in data integrity.

He goes on to relate:

The [technical design] weaknesses in terms of clinical work practices, that have been identified are only likely to show up in occasional circumstances with a combination of processing and data values separated in time. [In other words, the resulting errors are unpredictable, and depend on variable factors about the patient's data and user's attempted actions that cannot be predicted ahead of time - ed.] Staff are not likely to associate one instance of missing or mis-processed data with another. This spasmodic nature tends to lull staff into a false sense of security that the mis-processing is either inconsequential or an accident of their own making. We recommend that each and every mis-processing experience be recorded as accurately as possible so that appropriate computational forensic analysis can correctly identify if weaknesses in the underlying technology have been the source.

These are dead-serious matters, literally. One's well being in an ED should not depend on random chance. If you are the "lucky patient" who Wins the Lottery or Hits the Jackpot on health IT mis-processing, or whose clinicians are distracted by user experience flaws, "workarounds", demoralization or other issues, you might end up maimed - or in the grave.

The ED EHR Slot Machine. Click to enlarge. You've hit the ED EHR mis-processing jackpot! Perhaps today is a good day to die...

I do not believe mission critical software for, say, avionics, or for implantable medical devices, suffers such sloppiness. (In part due to regulation, which health IT lacks entirely in the U.S.).

The UK, having their own HIT issues (see my Aug. 2010 "Battle of Britain" post at this link), apparently learned something, as evidenced in:

Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E).

and

Health Informatics — Application of clinical risk management to the manufacture of health software. UK National Health Service, DSCN14 (2009), formerly ISO/TS 29321:2008(E).

That said, I will now comment in more detail on a part of the analysis readily understandable by 'database laypeople': part 2, "Discussions with ED Directors: Are we on the right track?" (again, probably a rhetorical question).

In this section, candid discussions were held with the Directors of seven Emergency Departments in New South Wales public hospitals assessing the impact of the introduction of the FirstNet information system into their ED's. The effort has been ongoing for approximately the last 5 years.

Numerous themes remind me of my own observations as in my aforementioned Drexel health IT difficulties site:

The implementation processes of the HSS [governmental Health IT support, a.k.a. Health Support Services - ed.] were criticised for refusing to acknowledge the validity of complaints, failing to fulfil promises, creating an ineffective change process, refusing to consult clinicians, using strategies to disenfranchise participation by clinical staff, and introducing a technology that doesnʼt fit their needs.

All of these themes are familiar to me, and are representative of the phenomena of non-clinician, IT-centric arrogant ignorance, paternalism, leadership-pyramid inversion (i.e., the facilitators thinking and acting as if they are the enablers of healthcare), playing nasty politics with clinicians to avoid work, and minimizing job and results-evaluation discomfort for those lucky enough to secure cushy IT jobs in health IT support.

In determining the clinical documentation needs of staff, the Directors claim that the HSS ignores the needs of staff. Directors report over-supply of irrelevant information and under-supply of needed information in the clinical interfaces. ["Legible gibberish" - ed.] The environment consists of counter-intuitive interfaces where data is entered by one person in one part of the system so that it is not discoverable by another person.

The interfaces have inappropriate sizing of objects, confusing functions, redundant steps, unused functions and cluttered interfaces. These difficulties have resulted in increased time usage on the system resulting in decreased time with patients for no gain in administrative or clinical outcomes. Staff minimise their use of the system to as little as possible with work arounds being constantly developed and improved. Staff morale has been clearly degraded with accompanying loss of respect for the HSS and more generally NSWHealth’s authority.

These concepts are described and illustrated in my multi-part essay on the healthcare IT mission hostile user experience at this link. They represent major deviations from good information science, information presentation and human-computer interaction (HCI) precepts.

... Workarounds in using the system are the most obvious tangible response of staff to the functions of the system they consider unsatisfactory. The key aspect of workarounds is that they constitute a subversion of the policy processes created by the software that the staff are not prepared to collaborate with. Some of these strategies may even compromise the legal status of the records in the system: such as not signing documents, unrecorded alterations to documents, and test results not attached to patient records.

... Another form of staff protest workaround is the strategy by staff to avoid using the system by either having other people [presumably underlings - ed.] do the work on the system, inserting minimal amounts of information thereby reducing the value of the information and passing information to other staff verbally.

Workarounds to IT obstacle courses and booby traps, as noted by Koppel, Wetterneck, Telles & Karsh in "Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety", J Am Med Inform Assoc. 2008 Jul-Aug;15(4):408-23, increase, not reduce, the risk of EHR-mediated medical errors. I wrote about their findings at "Business v. clinical computing: Workarounds to Barcode Medication Administration Systems" at this link.

It should be kept in mind that these are mission-critical systems for use in a fast-paced ED, not tracking systems for widgets - or for lab rats.

The lack of appropriate reporting functionality of the system has had a serious impact on the critical work of the Directors on process improvement ... It was evident in talking to the Directors that they have antennae highly tuned to the processes happening in their departments and the public health issues that emerge from their patients.

On a daily, weekly and monthly basis they review single cases, collections of common cases, and variations in established disease profiles to understand the success of their work and to detect emerging new trends or potential new disease outbreaks. At an administrative level they are asked to review cases either because of the return of new test results or due to complaints or reviews from other bodies.

The FirstNet installation has removed all the reporting functionality the directors had in their previous system EDIS while destroying their information sources for process improvement, and their mechanisms for creating and collaborating in research projects. This, in turn, has led to a loss of motivation to enter data further degrading the value of the data held within the system.

Reducing the value of a tool to people, and decreasing their ability to perform their jobs (especially when they take great professional responsibility and pride in those jobs) predictably leads to demoralization, demotivation and a cascading path down a whirlpool of failure.

The disadvantages of the system for day to day operations is well demonstrated by the issues around the ordering system. It is stated to be overly complex and requires a large deal of repetitive information to be input for multiple orders on one sample, plus specialist data entry knowledge that requires every joint order to have exactly the same timestamp. Ordering was the first accession where staff recognised that information is sometimes sent to the wrong staff, both arriving where it shouldn’t and not arriving where it should.

... Further mis-processing is seen with the cancellation of orders when a patient is transferred to a hospital ward from the ED. The results of orders, particularly radiology, often need to be checked by senior staff, but the system has no functionality to enable efficient processing of orders that have normal results, and thereby require no further attention.

I do recall another EHR system, by the same vendor I believe, where an "upgrade" in the recent past led to orders ending up in the wrong places (link):

... Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]

Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

Not to pick on this vendor; these "glitches" seem to be occurring in many HIT vendor's products.

All this, dear readers, is simply madness.

... Patient record retrieval is an important aspect of the staff work with patients, therefore its efficiency and accuracy is of vital importance to the activities of the ED. Staff were particularly pointed about the deterioration of this functionality in FirstNet compared to the previous system EDIS. [ED information system - ed.] There were cases where records could not be found, confusion about where data was stored in the patient record with different staff writing the same information into different parts of the record, and the [manual] rewriting of records [requiring a large amount of additional labor and time, not exactly a commodity in an ED -ed.] due to insertion of content into the wrong record.

These are critical issues. If you can't get information out of a computer in a timely fashion, what you have is a very expensive doorstop. I also note that a document imaging system that images hand written charts would not have these problems...

Prof. Patrick addresses the oft-heard canard that such complaints are the complaints of "Luddite doctors", old dogs who simply don't want to learn new tricks:

The staff in the ED are now generally experienced at using some form of clinical information system, many for over 10 years. This experience gives them a keen sense of what is possible with technology as well as the deficiencies in the existing systems. Combining this experience and knowledge with a sense of professional responsibility for process improvement enables them to judge quite acutely when a system is well designed or not. Hence their observations about elements of systems that are not parsimonious enough for optimal clinical efficiency deserve to be respected.

That it even needs to be written that the opinions of experienced medical professionals on the tools they are coerced to use by non-medical outsiders "deserve to be respected" gives testimony to my observation of a cross-disciplinary invasion of healthcare by the IT profession (among others).

Workflow and dataflow and the continuity of these processes are vital to the smooth running of a complex socio-technical process. ED staff have shaped these flows over a period of years and socialised all staff into the streaming. The directors have found that with the workflow of staff needing to use both clinical and nursing notes at the same time, their separation in FirstNet is deleterious. One department considered that the many nursing and medical notes accumulated over a day had to be kept in a single continuous sequence in the clinical record. Their workaround was to keep the one note page open for 24 hours to maintain the needed continuity in the patient record and avoid staff using a significant amount of time at the computer searching for needed information.

Nemeth and Cook explain how an ED EHR can be developed and marketed that interferes with, not supports, the workflows common in ED"s worldwide, in "Hiding in plain sight: What Koppel et al. tell us about healthcare IT", J Biomed Inform. 2005 Aug;38(4):262-3:

... On the surface, healthcare work seems to flow smoothly. That is because the clinicians who provide healthcare service make it so. Just beneath the apparently smooth-running operations is a complex, poorly bounded, conflicted, highly variable, uncertain, and high-tempo work domain. The technical work that clinicians perform resolves these complex and conflicting elements into a productive work domain. Occasional visitors to this setting [i.e., IT personnel, non-medical bureaucrats, etc. - ed.] see the smooth surface that clinicians have created and remain unaware of the conflicts that lie beneath it.

The technical work that clinicians perform is hiding in plain sight. [Hiding from the uninformed, that is - ed.] Those who know how to do research in this domain can see through the smooth surface and understand its complex and challenging reality. Occasional visitors cannot fathom this demanding work, much less create IT systems to support it. Progress in healthcare IT systems relies on scientific data on the actual, not the perceived, nature of day-today operations.

It increasingly seems the only place the faux-expert, healthcare-facilitor, cybernetic snake oil salespeople are going ot learn this simple lesson is in the courtroom...

A recent article in the press has presented evidence that access block times in EDs across the state of NSW are worsening.

As regards causality, it perhaps takes being an IS dept. director in a hospital - or holding elected office - to be unable to recognize the nose at the front of one's face.

Prof. Patrick wraps up this section of his forensic analysis as follows:

A number of conclusions can be drawn from the study:

1. Staff are entirely dissatisfied with the SBB and they feel that the deliverables have significantly failed to match the promises.

2. The Directors see that the HSS have failed in their support of the frontline of emergency care across the Sydney basin and their practices are decidedly lacking in proper engagement with the user community which should be their primary concern.

3. Some of the consequences of the HSS decision not to provide the reports needed by the Directors have lead to them being seriously hampered in being able to monitor the quality of their own department’s practices and wider changes and trends in community health.

4. The inefficiencies introduced by this technology have lead to a litany of complaints about its behaviour that have gone unheeded over the past three years.

5. It has lead to major strategies to work around the system by staff at all levels, to the point of complete avoidance by some staff.

The major consequences of these failings in the eyes of the ED directors are:

• Lost productivity and inefficiencies,
• Increased risks to patients,
• Disillusionment of staff and loss of morale.

Considering my own relative's injuries originating in an ED EHR mishap, I think I can safely add to Prof. Patrick's final tally an additional item:

• Patients have been harmed.
  

This is not a pretty picture.

I'm confident the Australian legal system abhors negligence as much as our own here in the U.S. If patients are injured and/or die as a result, considering that the Programme leadership and IT vendors knew - or should have known - of these deficits, it would not surprise me if criminal negligence charges begin to appear.

These issues are not exactly rocket science, and an expanding literature base has been appearing in recent years. See, for example, my recent post "An Updated Reading List on Health IT" at this link.

I can only add that my own relative was nearly killed as a result of a number of the phenomena described in Prof. Patrick's analysis.

More on other sections of his report at another time.

-- SS

March 6, 2011 addendum:

Also see my new post "What to do about the state of the ED EHR in NSW?"

-- SS

Mar. 8, 2011 addendum:

Prof. Patrick has added a new section to his report, entitled "The Future Pathways for e-Health in NSW." It is available at this link (PDF).

It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, magical thinking about the technology, and lack of accountability):

More on the Pathways at my post here.

The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation.

--SS

Post Title → On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts.

"A Study of an Enterprise Health information System" - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner

Australian professor Jon Patrick, who I wrote about at this blog in the past such as at my Nov. 2009 post "Academic Freedom and ED EHR's Down Under: An Update", has written what I consider the first truly serious, rigorous evaluation of a commercial EHR system.

He has evaluated the Cerner FirstNet ED EHR, being 'forced' on hospitals in the Australian state of New South Wales by their government.

His evaluation is entitled "A study of an Enterprise Health information System" and was released on March 4, 2011.

In my view, all current EHR's should undergo this level of scrutiny and critique.

His multi-part analysis, down the the level of the data schema, speaks for itself.

The report is at: http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

or download directly from: http://www.it.usyd.edu.au/~hitru/essays/Study%20of%20Enterprise%20Health%20IS%20-%20Parts%200-9%20PDF-ARCHIVE.zip [Note: this is a 12 Mb .zip file].

Summary:

This is a study into the roll-out of Cerner FirstNet into EDs in NSW. The original study was issued in Dec 2009 (Part 3.1). This has been added to with a new study in 2010 consisting of discussions with 7 ED Directors (Part 3.2), discussions with software experts who do performance evaluations on Cerner sites (Part 3.3), and reviews of Entity-Relationship Diagrams (Part 3.4), Schema descriptions and data tables from customer installations (Part 3.5 & 3.6). All this information is coalesced to establish a much more detailed picture of a Cerner installation (Part 3.7). A number of weaknesses are identified in the design and implementation and risk assessments are recommended for organisations using this software or intending to use it. Regulations that might minimise the risks to users of health software are recommended (Part 3.8). An alternative architecture and method for constructing clinical information systems is presented (Part 3.9).

The .zip file contains the following files:

3.0 Part 0 - Executive Summary
3.1 Part 1 - A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck? First published here in Oct 2009, revised Dec 2009.
3.2 Part 2 - Discussions with ED Directors: Are we on the right track?
3.3 Part 3 - Discussions with Software Performance Experts.
3.4 Part 4 - Conceptual Data Modelling.
3.5 Part 5 - Database Relational Schema and Data Tables.
3.6 Part 6 - Coalescing the Analyses of the ER Diagrams, Relational Schemata and Data Tables.
3.7 Part 7 - The Integrated Assessment.
3.8 Part 8 - Future HIT Regulation Proposals.
3.9 Part 9 - Ockham's Razor of Design. Published at the IHI conference, Nov 2010 Washington.

A non-technical but revealing summary from Part 2:

Discussions were held with the Directors of 7 Emergency Departments in New South Wales (NSW) public hospitals assessing the impact of the introduction of the FirstNet information system into their Departments. All but one of the Directors has found that the system has had a deleterious impact on their department’s clinical work. The range of problems reported indicate that whilst the software is not fit-for-purpose, many of the problems are created or exacerbated by attitudes of the NSW Health IT support, Health Support Services (HSS). In most departments it was reported that staff have developed significant strategies for minimising and circumventing the use of the system. The Directors are frustrated by the lack of a reporting functionality that disables their ability to monitor their own department’s performance. Most Directors report an increase in the time required to deal with patients and therefore a deterioration in access block times. This has been masked by changes in the way this time has been redefined by NSW Health. Overall, most perceive that in moving from their previous information system EDIS to FirstNet they and their patients have suffered. Most Directors are resigned to the fact that no improvements will be made to the current performance of the system due to its inherent inadequacies and the attitude of HSS. A consequence of the ED Directors critique leads inevitably to the debate on the merits of enterprise wide systems versus best-of-breed systems. Emerging from these issues are criteria for a new technology for creating clinical information systems.

I will have more to say on this study later. I have to take an injured relative to the doctor. (Note - the culpable system was not by this vendor).

-- SS

Post Title → "A Study of an Enterprise Health information System" - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner

Cerner's Blitzkrieg on London: Where's the RAF?

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 tampered with and put at risk.

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?

-- SS

Post Title → Cerner's Blitzkrieg on London: Where's the RAF?

Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear

On April 16 at "Healthcare IT Corporate Ethics 101: A Strategy for Cerner Corporation to Address the HIT Stimulus Plan" I wrote about a Duke Fuqua School of Business paper (apparently authored by a Cerner official) promoting a business strategy of regulatory manipulation to restrain the free market for HIT products.

The paper, and the Fuqua School of Business web page "Past Papers" on which the paper was promoted, have both disappeared as of this April 18 writing.

I have posted an image of the "Past Papers" page and updated my link to an archived copy of the paper, but the scrubbing of the Fuqua site and removal of the paper is interesting.

-- SS

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

Post Title → Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear

Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'

Combination in restraint of trade: An illegal compact between two or more persons to unjustly restrict competition and monopolize commerce in goods or services by controlling their production, distribution, and price or through other unlawful means. Such combinations are prohibited by the provisions of the Sherman Anti-Trust Act and other antitrust acts.

I have written on these blog pages that the IT industry has staged an invasion of the healthcare professions.

One of these invasions has to do with the ethics of the IT industry, ethics at odds with medical ethics and the Hippocratic oath. The HIT industry is characterized by an overarching interest in profits and cavalier attitudes towards HIT-related adverse clinical events through sales of inferior products (domestically as well as abroad) based on archaic technologies, exaggerated claims of benefits, ultra-aggressive marketing, and legalized suppression of adverse events information about unproven, non-secure, largely experimental health IT medical devices.

I find it truly remarkable, more than 20 years into consumer availability of the GUI, that in the 2009 publication "Principles and Proposed Methods of EMR Usability Evaluation and Rating" (PDF) the major HIT trade group HIMSS admits 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.

Unbelievable. What has this industry been doing for the past few decades?

Worse, the health IT industry is entirely unregulated and has pushed to maintain that status quo. Now the HIT industry may be clamoring for industry regulation as a means of restraint of trade as described below.

The public is beginning to wake up to the vendor and HIT trade group puffery, at least with regard to security hazards and exaggeration of the benefits:

Electronic health records prompt security, costs concerns
Richmond Times-Dispatch
By Tammie Smith
Published: April 5, 2010

The thought of one's personal medical information being just a computer click away does not sit well with many consumers. In a March 2009 survey of 1,238 randomly selected adults by the Kaiser Family Foundation, the Harvard School of Public Health and National Public Radio, 59 percent of respondents didn't think confidentiality of electronic medical records could be assured ... 76 percent thought it was likely that an unauthorized person would get access to medical records online.

... While there are anecdotal stories of electronic health records improving outcomes, the data are mixed on whether they save money. A Harvard Medical School study published in the American Journal of Medicine last year linked 2003-2007 cost and quality data for 4,000 hospitals, including the 100 "most wired" hospitals. The researchers concluded that the electronic health records systems in place so far "might modestly improve" quality quality but produced no savings on administrative or overall costs.

'Anecdotal'? 'might'? 'modestly'? Is that worth spending hundreds of billions of dollars on, at a time when the healthcare system is struggling to make ends meet, I ask?

Unfortunately, the public and healthcare regulators need a further awakening about the Healthare IT industry's ethics.

A profoundly disappointing lesson in the ethics of the healthcare IT sector (and the B-schools as well) can be gleaned from the following, a paper written by a Cerner employee and two health industry colleagues for a Duke Fuqua School of Business course.

The course is "Health Economics & Strategy (HLTHMGMT 326), Distance Executive MBA" (syllabus here in PDF). The course's stated purpose:

We will apply the tools of economics and strategy to address the challenges and opportunities of today's health care managers and policy makers. We will begin most classes with analysis of recent news, then discuss a case, and conclude with additional insight on the application of economics and strategy.

The paper is entitled -

"A STRATEGY FOR CERNER CORPORATION TO ADDRESS THE HIT STIMULUS PLAN" (PDF).

*** April 18 NOTE: the paper apparently has been scrubbed and is no longer available from the above link as it was on April 16. A copy is here (PDF).

It is actually highlighted at Duke professor David Ridley's page "Duke University Fuqua School of Business: Past Papers."

*** April 18 NOTE: the "Past Papers" page has also seemingly been scrubbed. This is how it looked two days ago:

(click to enlarge)

This appears to be a Final Paper for an online MBA program course for executives. These are therefore not just students in the academic sense; as in my own healthcare informatics courses, I've had 'students' who concurrently were executives and managers in healthcare companies and organizations.

All three authors are listed at business networking site LinkedIn.com:

• Dan Aycock - appears as Business Strategist at Cerner
• Aparna Prasad - MBA Candidate at The Fuqua School of Business, Duke University
• Barri Stiber - Administrative Fellow at Legacy Health - formerly Senior Analyst at The Advisory Board Company

The paper is emblazoned with the Cerner corporate logo on its cover page and could be mistaken for an official document:

Paper's cover page. Click to enlarge

From the paper, an example of HIT corporate ethics (and business school ethics as well):

Electronic health records (EHRs) have the potential to improve the healthcare system through several means including reduced medical errors, better coordination of care, and reduced costs. However, adoption of EHR systems in the U.S. has been slow; only 1.5% of acute care hospitals have comprehensive EHR systems.

While the Bush administration made efforts to spur adoption of these systems, the Obama administration’s American Recovery and Reinvestment Act of 2009 (ARRA) has pushed EHR adoption to the fore with over $20 billion dollars in incentives. With such a large infusion into a relatively small market the effects of the stimulus package have enormous strategic implications for EHR vendors.

This paper seeks to clarify these implications, understand the strengths and weaknesses of various players in the industry and recommend a strategy for Cerner Corporation to maximize its profit from the stimulus package and thereby secure a dominant position in the HIT industry.

... We recommend that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry. Other strategic recommendations to capture market share, facilitate EHR adoption, and improve Cerner’s operational readiness are detailed and framed within an implementation plan.

I am going to highlight one key sentence for emphasis:

We - recommend - Cerner - collaborate - with - other - incumbent - vendors - to - establish - high - regulatory - standards, effectively - creating - a - barrier - to - new - firm - entry.

Did I read that correctly?

The paper goes on to explain:

... With the introduction of stimulus funding, this industry is ripe for disruptive innovation, which could significantly change the competitive landscape. Examining Christensen’s work on disruptive innovation outlined in Figure 6, the primary factor that will influence the entry of new HIT vendors is regulation.

Therefore, the technology standards and definitions of “meaningful use” which are under development have the potential to raise or reduce barriers to entry, limiting or enhancing the ability for disruptive innovations to enter at a lower performance point. When asked about which competitors the organization is most concerned about, a Siemens Executive indicated “it is these new guys who could come in and undercut prices with substandard products.”

["New guys" ="substandard"? This from a company that apparently fired an informatics physician for raising concerns that a substandard ICU system was going to kill patients - ed.]

Therefore, incumbent firms, like Cerner, have strong incentives to influence regulation in their favor, keeping barriers to entry high.

[Influence in their favor, not in the favor of patients, to maintain the industry oligarchy? - ed]

In other words, to stifle disruptive innovation and prevent newcomers from entry into the HIT business, large HIT vendors should influence regulation towards high standards impossible for newcomers to meet.

NOT that they should influence regulation for the sake of patient safety!

This student is apparently a Cerner strategist seeking an MBA. His colleague Barri Stiber was a Senior Analyst at The Advisory Board Company, a company that serves "nearly 3,000 progressive organizations worldwide—health care, health benefits, and educational organizations alike—providing innovative solutions to their most pressing challenges such that they can “hardwire” best-practice performance."

This paper raises a number of questions:

• Does this paper reflect a strategy that would amount to illegal restraint of trade and/or fall under the federal RICO act, through knowingly and willfully advancing a lobbying strategy to strangle fair competition?

• Were any of these authors on Cerner's payroll when this was written?

• Are Mr. Aycock or other authors giving such advice to Cerner management presently?

• Did or does Cerner use this paper or derivatives thereof internally?

• Does this paper reflect on the business ethics of Cerner or other large HIT vendors? Will they openly condemn its ideas as both wrong minded and monopolistic, using their influence to create a market adverse to smaller competitors - not to mention the paper's seeming lack of concern for what really matters - the "customer" (patients)?

• Did or does this paper reflect a more widespread healthcare IT large player collusion on restraint of trade?
  

• Is this how the Advisory Board company conducts its business in advising healthcare organizations?

• What type of professor would exalt a paper via posting it as an example for other students to emulate, a paper whose basic premise is unethical, or at the very least on the precipice of unethicality?

• Does this professor teach such ethics?

• Why was this paper not returned to its authors with a big, red "F" on it? That's what I would have done.

• What other papers are accepted by this professor that demonstrate similar business "strategies" in other sectors?

Finally, and perhaps most importantly:

• Does this paper reflect, or did it influence, current Cerner or other large HIT vendor business strategy?
  

Recent developments are consistent with that, i.e., Cerner starting to acknowledge need for regulation, per the Feb. 2010 story "FDA Considers Regulating Safety of Electronic Health Systems" by the Huffington Post Investigate Fund, http://huffpostfund.org/stories/2010/02/fda-considers-regulating-safety-electronic-health-systems).

From that article:

.... Yet some inside the industry favor stepped-up scrutiny. One major vendor, Cerner Corporation, which has voluntarily reported safety incidents to the FDA in recent years, signaled its support for a rule that would make those reports mandatory. Cerner has reported potential safety concerns because it is the “right thing to do,” a company official said.

I was puzzled by that turnaround.

Perhaps now I know from where it arose.

It certainly is the "right thing to do." It's the right thing to do to enhance profits and enforce restriction of market entry by "disruptively innovative" newcomers.

Those newcomers might actually hold the answers to improving healthcare IT and reducing costs through fair, free market competition, saving lives and money the healthcare system dearly needs. (For example, see my post "Hospitals Under the Knife: Sacrificing Hospital Jobs for the Extravagance of Healthcare IT".)

-- SS

Addendum Apr. 16 -

A commenter speculates that:

... When I did my MBA, back in the day, we were one of the first programs to have a working business background as a requirement for admission. From that base I would make the following guesses:

• The people were not only on the company payroll, but also were having their tuition paid for by the company.
• This document was widely circulated within the company,
• The document was highlighted as a means for the university to curry favor with the company thus increasing recruits or for financial gain.

... The modern remote MBA program is in many instances simply a way to check a box for employees on the fast track to senior management. Often papers are written with the support of the company and access to department heads who contribute to material turned in.

From my experience this is not some theoretical exercise, but a document that, even retiled, will be used internally to drive policy.

While that is speculation, it is certainly plausible; nothing would surprise me in the health IT industry.

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

-- SS

Post Title → Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'

"We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause ..."

In my post "Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development" I reported on the Univ. of Sydney's somewhat belated support for academic freedom, and the reappearance of an essay on ED electronic health records problems in NSW by one of its informatics faculty, Prof. Jon Patrick, after an apparently government-initiated attempt at censorship.

A new update of the paper "A Critical Essay on the Deployment of an ED Clinical Information System - Systemic Failure or Bad Luck" version 6, has now been posted by Dr. Patrick at this link on his department's web pages (a direct link at this time to the PDF is here).

The press has started to take notice. A piece in the Sydney Morning Herald entitled "Health department accused of censorship" appeared on Nov. 28 here.

That piece was noted by Computer Weekly in the U.K. in a piece entitled "Claim of censorship over Cerner system" here. The U.K. suffers a severe EHR epidemic (the UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.)

[12/3/09 update: the piece has disappeared, then reappeared, at Computer Weekly. In case it disappears again, a copy of the article from Google's cache is here.]

From the U.K. Computer Weekly article:

The Sydney Morning Herald and ZDNet in Australia report that the University of Sydney removed from its website - temporarily - a negative essay about a Cerner system which had been installed at hospitals in New South Wales.

The author of the essay is a medical IT professor, Jon Patrick, who is reported to have claimed that NSW Health, which is part of the government of New South Wales, put pressure on the university to take down the paper.

If true, it would tie in with what's been happening in England where mentions of Cerner in a negative context are being officially discouraged.

Cerner is due to be installed at hospitals across London as part of the National Programme for IT [NPfIT] but several trusts that have already gone live - including the Royal Free and Hampstead, Barnet and Chase Farm, and Barts and The London - have run into serious problems, including the losing of patient appointments and patients not being treated.

A showcase Cerner site at Homerton ceased mentioning Cerner in its public board papers after doing a deal with NHS Connecting for Health and the Department of Health. Homerton also rejects FOI requests related to its discussions on Cerner.

Homerton told me: "We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence."

I am repeating that last sentence for effect:

We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence.

This is solid evidence of such confidentiality clauses in HIT contracts and the chilling effect they have, along with dangers of "hold harmless" clauses. This style of EHR contracting is a practice now under investigation by the U.S. Senate Committee on Finance, as in their Oct. 16, 2009 letter to major healthcare IT vendors and management consultants from Senator Charles E. Grassley (ranking member). A copy of that letter is here (PDF).

I have written on the dangers of such clauses before as in my July 22, 2009 letter in the Journal of the American Medical Association "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (http://jama.ama-assn.org/cgi/content/extract/302/4/382), as well as my much more thorough posting on these issues in the essay at my Drexel University website here.

In that essay I observed:

Regarding healthcare IT "Hold Harmless" and Defects Gag Clauses, I also question whether hospital executives violated their fiduciary responsibilities by signing such contracts, and violated Joint Commission standards of hospital leadership conduct as well ...

Let's look at the Joint Commission Hospital Accreditation Program Leadership Chapter, and its standards for hospital leadership (link, PDF):

Leadership
LD.01.03.01

Standard LD.01.03.01
The governing body is ultimately accountable for the safety and quality of care, treatment, and services.

Rationale for LD.01.03.01
The governing body’s ultimate responsibility for safety and quality derives from their legal responsibility and operational authority for [organization] performance. In this context, the governing body provides for internal structures and resources, including staff, that support safety and quality.

The governing body has a legal responsibility for safety and quality, not just a moral obligation. One of the "internal structures" is healthcare IT that is safe and effective and that does not expose patients or staff to undue risks.

How does signing "hold harmless" and "defects gag order" clauses with an HIT vendor serve such a purpose, exactly?

Hospital executives know, should know, or should have known that such provisions would remove incentives for health IT vendors to produce the best products and to correct deficiencies rapidly, thus increasing risk to patients and clinicians.

Elements of Performance for LD.01.03.01
5. The governing body provides for the resources needed to maintain safe, quality care, treatment, and services.

One of those resources is health IT.

Standard LD.02.01.01
The mission, vision, and goals of the [organization] support the safety and quality of care, treatment, and services.

Rationale for LD.02.01.01
The primary responsibility of leaders is to provide for the safety and quality of care, treatment, and services. The purpose of the [organization]’s mission, vision, and goals, is to define how the [organization] will achieve safety and quality. The leaders are more likely to be aligned with the mission, vision, and goals when they create them together. The common purpose of the [organization] is most likely achieved when it is understood by all who work in or are served by the [organization].

How is a contract with an HIT vendor that calls for hiding defects in health IT and exposing staff to liability for defects in same serving the above purposes?

Standard LD.02.03.01
The governing body, senior managers and leaders of the organized medical staff regularly communicate with each other on issues of safety and quality.

Does that include communication on health IT defects? Can a medical staff member ask to see a database of such defects when the hospital has signed a nondisclosure of defects agreement with an HIT vendor?

Rationale for LD.02.03.01
Leaders, who provide for safety and quality, must communicate with each other on matters affecting the [organization] and those it serves.

I ask the same question as above.

Standard LD.03.01.01
Leaders create and maintain a culture of safety and quality throughout the [organization].

Safety for whom, exactly? Patients, or patients and staff?

How is exposing professional staff to undeserved liability from defective health IT serving the creation of a culture of safety and quality for them? How is suppressing information on health IT defects and problems helping patient safety and care quality?

How is lack of seeking informed consent on health IT use from patients whose care is mediated by health IT devices with known but undisclosable defects creating a culture of quality?

How is hiding such defects creating a culture of quality in the community's other hospitals, that may be considering purchase of the very same health IT?

Standard LD.03.04.01
The [organization] communicates information related to safety and quality to those who need it, including staff, licensed independent practitioners, [patient]s, families, and external interested parties.

Rationale for LD.03.04.01
Effective communication is essential among individuals and groups within the [organization], and between the [organization] and external parties. Poor communication often contributes to adverse events and can compromise safety and quality of care, treatment, and services. Effective communication is timely, accurate, and usable by the audience.

Are physicians and nurses explicitly informed by administration that clinicians are liable for bad outcomes due to software problems? Are they informed of the gag clause? Are patients informed of unremediated health IT defects existing at time of service?

This standard seems a veritable smoking gun regarding breach of fiduciary responsibility and Joint Commission obligations when hospital leadership signs agreements specifically excluding the sharing information about health IT defects and complaints. It is already known that hospitals maintain lists of health IT defects, some in the thousands of items. A number of the defects rise to the level of creating considerable risk to patients, and nobody is in a hurry to remediate them. (See my proposed although somewhat tongue in cheek "HIT Informed Consent" that describes some of these known defect categories here).

Standard LD.04.04.03
New or modified services or processes are well-designed.

... 3. The hospital's design of new or modified services or processes incorporates: Information about potential risks to patients.

4. The hospital's design of new or modified services or processes incorporates: Evidence-based information in the decision-making process. Note: For example, evidence-based information could include practice guidelines, successful practices, information from current literature, and clinical standards.

How does the contractual inability to communicate about health IT defects, which its executives willingly sign, serve this purpose?

Standard LD.04.04.05
The [organization] has an organization-wide, integrated [patient] safety program.

... 12. The hospital disseminates lessons learned from root cause analyses, system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation.

Disseminates lessons learned, except when the HIT contract they've signed with a vendor forbids it, that is.

The practices of the health IT industry, and the dealings of the hospital leadership with that industry, may in fact be a scandal of national (or international) proportions.

International scandal, indeed.

I predict these EHR confidentiality clauses will end up causing great loss of money in failed systems, and/or harming patients, due to the chilling effect they have on revelation of defects and problems by clinicians and executives alike.

Those who signed them will very likely be held liable, at least in the U.S., as the clauses breach the safety standards of the accrediting agency for hospitals here, the Joint Commission. I wish the signers of such contracts good luck in the courtroom.

In Australia and the U.K., I cannot comment, but also wish good luck to those who signed these clauses when lawyers go full court press on EHR-mediated debacles.

-- SS

Post Title → "We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause ..."

Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development

In "Academic Freedom and ED EHR's Down Under: An Update" I wrote about the disputed essay on electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney.

The essay was entitled "A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck?"

I am happy to report that an updated version of the essay, version 5, is now available from Dr. Patrick's university web site at http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146 . It can be downloaded from the icon at Item 6.

This is a welcome development.

The essay is now labeled as an Op-Ed (Opinion Editorial).

-- SS

Post Title → Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development

Health IT Vendors Trafficking in Patient Data?

Of all of the risks regarding electronic health records, the largest is perhaps to privacy and confidentiality, and other civil liberties through the ability of information technology to rapidly duplicate and disseminate massive amounts of data.

This duplication and dissemination can be performed in a controlled manner for the betterment of patient and public health, but it can also occur in a harmful manner that serves the interests of others, often without meaningful informed consent by the patients (legal jargon on typical disclosure forms that almost nobody reads or understands does not fall into what I consider "meaningful").

This can occur in, for example, the stealing of computers and computer backup disks, tape etc., which seems to be a common occurrence in the news in recent years, or through corporate processes that carry inherent risk of abuse. Here is just one recent example of both data mismanagement and theft involving not patients (by chance) but physicians themselves:

Blue Cross: Thousands of doctors' computer data stolen

Wednesday, October 07, 2009

By Bill Toland, Pittsburgh Post-Gazette

Tens of thousands of doctors under contract with Pittsburgh's Highmark Inc. are being notified that their personal information, including Social Security numbers or tax ID numbers, may have been compromised when a laptop containing sensitive data was stolen from a Blue Cross-Blue Shield Association employee.

Physicians and specialists in western and central Pennsylvania are being notified of the breach this week, according to a Highmark spokesman. Across the country, the number of affected doctors is expected to reach the hundreds of thousands once a review of the theft is complete, said national Blue Cross-Blue Shield Association spokesman Jeff Smokler. The stolen computer did not contain patient information. [Simply due to luck -ed.]

The letter sent to Highmark providers said "a BCBSA employee [transferred] provider data information onto a personal laptop, in violation of BCBSA's established data security policies.

I have recently become aware of an example of purposeful corporate healthcare data trafficking that gives me pause.

Cerner’s LifeSciences traffics in patient data taken from the EMRs its company sells to healthcare organizations. See the document below. They advertise:

Cerner LifeSciences’ data warehouses and consulting services help you manage your R&D opportunity through Cerner’s analytical solutions. Through our data mining of our vast warehouse of electronic health records (EHRs), you can accelerate development processes and reduce business risks. Each year, new compounds debut new abilities or first-in-class molecules. Far more common are new compounds that target the same receptors as compounds already in the market ... This is when Cerner LifeSciences makes it possible to analyze anonymous, HIPAA-compliant, EHR-derived data for efficacy and safety.

Cerner apparently includes contract language with their HIT customers that allows them to traffic in "de-identified" patient data for sale to drug companies and others, getting the data essentially as a "value add" (to the HIT vendor, that is) from its healthcare IT customers. (The flyer below does not indicate pricing of healthcare data, but it's likely substantial.)

A major HIT vendor selling patient data to anyone who wants it. Click to enlarge. (Full copy is at this link in PDF format).

This practice raises numerous questions:

• Meaningful informed consent issues: as an example, of 1000 patients at one of the facilities using this vendor's HIT products, what percentage would be able to tell me they know their data is being trafficked to pharmaceutical companies and other organizations for profit?

• Healthcare data ownership and stewardship issues: who, exactly, extracts the data for aggregation and sale? Hospital employees properly trained and bonded (i.e., Healthcare Information Management professionals) regarding privacy of patient data? IT personnel lacking such credentials and experience? HIT vendor employees?

• De-identification issues: what processes are being used to de-identify data? Who is performing it? At some point before the data is de-identified, it is protected information in identifiable form. Is access to the data during de-identification audited in any way, and if so, by whom? If not, why not? (Also see article on re-identification below.)
  

• Legal issues: who is, by contract, liable for data breaches that occur in the transfer process?

• Fiduciary issues: as I expressed in my July 22, 2009 JAMA letter to the editor regarding "vendor hold harmless" and IT defects gag clauses, are hospital executives further violating their fiduciary responsibilities by signing HIT contracts that surrender ownership of patient data to third parties? (see my posts "JAMA letter: Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" and "Inquiry to Joint Commission on points I raised in my JAMA letter on HIT" for more on those issues.

• Pharma integrity issues: with the many stories on this blog and others about ethically questionable pharma practices such as ghostwriting, manipulation of clinical research, suppression of research, pushing drugs on physicians and patients for unapproved off-label uses, etc., what are these organizations going to do with the data? Who will have access to it, and will their access be audited? Are they going to resell it? Might they try to re-identify data to locate individuals of interest? And so forth.
  

Serious consideration of these issues in vendor-led healthcare data trafficking becomes more imperative in the face of just how easy it is to "re-identify" data:

Ohm, Paul: "Broken Promises of Privacy: Responding to the Surprising Failure of Anonymization" (August 13, 2009). University of Colorado Law Legal Studies Research Paper No. 09-12. Available at SSRN: http://ssrn.com/abstract=1450006

Abstract:

Computer scientists have recently undermined our faith in the privacy-protecting power of anonymization, the name for techniques for protecting the privacy of individuals in large databases by deleting information like names and social security numbers. These scientists have demonstrated they can often 'reidentify' or 'deanonymize' individuals hidden in anonymized data with astonishing ease. By understanding this research, we will realize we have made a mistake, labored beneath a fundamental misunderstanding, which has assured us much less privacy than we have assumed. This mistake pervades nearly every information privacy law, regulation, and debate, yet regulators and legal scholars have paid it scant attention. We must respond to the surprising failure of anonymization, and this Article provides the tools to do so.

Further, Cerner is digging deeper into the life sciences, licensing its "Discovere" system to clinical trials vendor such as Quintiles Transnational (link to story in Bizjournals.com):

Quintiles will use Cerner’s Web-based Discovere product, whose features include the ability to integrate data from study participants and site researchers and increase data quality by reducing transcription errors, the companies said in a release. A Cerner spokeswoman said the company isn’t disclosing financial terms of the deal.

According to an entry at HISTalk, part of "Discovere" is the former First Genetic Trust technology that Cerner bought some time ago. Quintiles signed an agreement with Cerner back in 2001 and took an equity position in it. The Discovere modules include biobanking, research registries, public health investigator workflow, clinical trials management, and adverse event reporting.

Is Cerner also selling HIT-gleaned patient data to Quintiles and other CRO's (clinical research organizations)?

Other HIT vendors are sure to follow in Cerner's footsteps for competitive reasons, if not already doing so.

Another major issue:

HIT vendors like this are devoting resources to profit from medical data, diverting resources from their core business. Might health IT vendors make better use of their resources, such as improving the core products they sell to hospitals and clinicians, avoiding the "mission hostile user experience" I wrote about in this eight part series?

Might they devote resources to solving problems that are affecting entire national health IT programs, instead of peddling data from the systems they have managed to implement to third parties?

From the UK's experiences as recorded in 2007 by the former head of their National Program for HIT in the NHS (NPfIT):

Richard Granger has said he was “ashamed of the quality of some of the systems put into the NHS by Connecting for Health suppliers”, singling Cerner out for criticism (link). Going further than he before in acknowledging the extent of failings of systems provided to some parts of the NHS - such as Milton Keynes – the Connecting for Health boss, said "Sometimes we put in stuff that I'm just ashamed of. Some of the stuff that Cerner has put in recently is appalling."

As recorded in Jan. 2009 by the UK House of Commons - Public Accounts Committee :

... Termination of Fujitsu's contract has caused uncertainty among Trusts in the South and new deployments have stopped. One option: have a choice of either Lorenzo or [Cerner] Millennium. There are, however, considerable problems with existing deployments of [Cerner] Millennium and serious concerns about the prospects for future deployments of Lorenzo.

... Programme 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 … 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.

Most recently, in the UK Cerner's Millennium product is blamed for the jump from 1,700 to 23,000 patients whose referrals don’t meet the 18-week target from referral to treatment at Barts and the London NHS trust.

Should HIT vendors be devoting resources to data peddling, instead of focusing on their core mission to produce usable HIT that can facilitate healthcare professionals in providing care?

Finally, as an added item of interest, our current healthcare "czar", Nancy-Ann DeParle was on the board of Cerner just prior to appointment in the current administration.

All of these issues considered, while I am not implying improprieties current or future, the possible permutations of problems in the resale of clinical data by HIT vendors potentially created by careless data stewardship, profit motive, conflict of interest, malevolent motives, etc. is endless.

If there ever were a scenario for civil liberties groups to explore, it's this one.

-- SS

addendum on HIT quality and COI issues: found this at HISTalk as well:

IT outsourcing puts MU Health at risk

An associate professor of pathology at University of Missouri criticizes his employer’s decision to outsource to Cerner … A simple Internet search turns up a plethora of complaints and reports of lawsuits regarding the effectiveness of Cerner’s software and, more important, its failure to provide requested support. The pattern of receiving untested software has been a recurring problem at this institution ...

... University Hospital’s success depends largely on the effectiveness of the people in information technology. In the past on two occasions, the billing was so flawed the hospital faced serious fiscal problems. The most recent one was in 2002, when the hospital’s viability was threatened. The major issue was the inability to produce accurate and timely billings, which cost the system millions of dollars. [where have I seen that before? How about: here (Yale) and here - ed.]

... The medical school’s administrative residency program is on probation and is undergoing critical review; a major factor is that the Cerner system is so cumbersome that resident training is compromised … Three years ago, the radiology department dropped a Cerner software program because it was seriously flawed.”

... [UM President] Forsee has several business and personal ties to the company (Cerner). Forsee and Cerner CEO Neal Patterson serve together on at least two boards of trustees, and online records indicate Forsee’s son-in-law, Brandon Bell, works for Cerner.”

If this all is true, I believe the problems with HIT in general are no better now, and probably worse, than when I started writing about such issues a decade ago.

I rest my case on whether the HIT vendors should focus on solving basic quality, usability and efficacy issues before peddling data ...

-- SS

Post Title → Health IT Vendors Trafficking in Patient Data?