It is not often that the Healthcare Renewal blog offers praise to large healthcare organizations, but this is one such case.

In late 1998, ten years ago almost to the day, I initiated a web site entitled “Medical Informatics and Leadership of Clinical Computing.” (That site has evolved into its present form here and is now subtitled “Medical Informatics, Information Technology Leadership, and Clinical IT Success.”)

In that 1998 site I explicitly called, perhaps for the first time, for actual leadership of clinical IT initiatives by Medical Informatics professionals, who were formally educated and experienced in that domain, as opposed to the traditional leadership model by business IT personnel. The latter most often had backgrounds only in management information systems and lacked biomedical credentials and experience.

I created the web site, in fact, after a number of years as Chief Medical Informatics Officer at a large healthcare system and as faculty at an academic medical center, where I was exposed to alarming healthcare IT mismanagement. The first two stories at the current site chronicle several of my experiences. Further, my attempts to improve the situations and protect multi-million dollar IT investments from rejection and failure - and protect patient lives - were often met with opposition in the form of active or passive aggression by powerful CIO’s and other IT staff, with (at best) passive and unsupportive responses by senior management. I realized there was almost no literature to turn to regarding this phenomenon and thus started the site.

I’ve experienced a degree of ostracism even within my own professional community for “airing the dirty laundry” and speaking my mind, and even today the website remains nearly unique. A google search on “healthcare IT failure” or similar expressions demonstrates that. (One could - hyperbolically speaking, of course - argue that only the National Security Agency does a better job of keeping information out of the public eye…)

Yet despite these efforts and that of others in writing about health IT difficulties, informaticists in similar roles experience the same issues, a decade later.

I therefore view with great interest a major Ivy academic healthcare system that has apparently decided to “do healthcare IT the right way”, as evidenced by the following position solicitation seen at the Association of American Medical Colleges website AAMC.org (link). Note bolded passages in this excerpt:

Founding Director, Penn Institute for Biomedical Informatics and Associate Dean, Information Technology

The University of Pennsylvania School of Medicine invites applications for the position of Founding Director of a new Penn institute focused on biomedical informatics. This new institute is intended to span from clinical informatics, to translational informatics, to public health informatics, and bridge as well to library sciences, computational biology, and bioinformatics. This new leader will establish the institute, bring together current informatics-related faculty from several School of Medicine departments, hire new School of Medicine faculty, and reach out to informatics faculty in other Penn schools.

The successful applicant will have a distinguished international record in biomedical informatics, with experience in leadership appropriate for a center director. Applicants must have an M.D. and/or Ph.D. and have demonstrated outstanding expertise in education, research, and leadership …

… As Associate Dean for Information Technology, the candidate will oversee Penn Medicine’s Chief Information Officer, jointly with the Chief Administrative Officer of the University of Pennsylvania Health System. In this role, the candidate will have a leadership role in formulating and implementing an enterprise-wide vision for research and administrative IT in the School of Medicine, and for clinical IT for the health system.

A leader with a distinguished academic record in biomedical informatics overseeing a healthcare system CIO (who most often have a traditional business IT background) is a bit of a precedent. While there may be other examples, this is exactly the type of organizational arrangement I have been calling for now for a decade. Clinicians will no longer be answering to business computing personnel.

I applaud the University of Pennsylvania for taking the initiative and creating this role in this manner. I can only hope the role will be supported by senior health system management and university administration when the inevitable sociotechnologic issues arise between clinical practitioners and researchers, and IT personnel.

Finally, while my aforementioned web site and this June ‘08 Healthcare Renewal post probably played no role in Penn’s formulation of the new role, I can imagine that someone there read them (there have been hits from U. Penn from time to time) and at least might then have had a greater inclination to support such a position formulation.

That’s how the introduction of new ideas that challenge the dominant paradigm (a.k.a. “subversion”) works, I suppose.

I also hope other healthcare organizations will begin to follow Penn’s lead.

– SS

[Source : Health Care Renewal]

We are now engaged in a worldwide economic crisis, the likes of which have probably not been seen since the 1920’s.

In “Bank Bailout Puts £12.7bn NHS Electronic Medical Record Project In Jeopardy” I commented on how the world financial crisis of 2008 combined with chronic project difficulties and mismanagement was creating such high levels of doubt about the UK’s Connecting for Health (CfH) national program for electronic health records (EHR’s), that the program was under consideration for cancellation.

From that post:

Christine Connelly, the Department of Health’s recently appointed head of informatics, is understood to be reviewing whether the programme is a cost-effective way of improving the quality and safety of patient care.

She will have to find compelling arguments to stop the Treasury earmarking health service IT as a candidate for cuts to compensate for the billions spent on the bailout of the banks. However, the high cost of cancelling contracts with IT suppliers may be a factor saving the programme from cancellation.

More on Connelly, the “recently appointed head of informatics” later.

In the United States, we need to consider the implications of this towards our own ambitious plans for national health records.

Either we get it right, or we should not pursue it at all under the current economic downturn. There are millions of uninsured and underserved people in this country who would benefit far more tangibly from funding of healthcare services rather than funding of ambitious health records projects that transfer scarce capital from the healthcare to the IT sector. These are initiatives that are demonstrably fraught with peril (as in the UK), that healthcare organizations and clinicians may not truly want to succeed, and with unproven ROI and unclear quality improvement benefits (see “Do Healthcare Organizations Truly Want Electronic Health Records To Succeed?“).

If we are going to stay on our present course and commit money better spent on healthcare provision to ambitious IT projects, we damn well better learn something from the UK experience. I am unfortunately doubtful of this.

However, one lesson of the highest importance is on leadership of HIT and towards that end I provide additional material on the UK’s national EMR difficulties.

At Healthcare Renewal, Roy Poses and I have often noted the lack of biomedical or healthcare credentials in the “C” level and board leadership of healthcare delivery and healthcare supporting organizations such as pharmaceuticals and medical devices and technology companies.

Here is more on the UK CfH problems, followed by an interesting (and predictable!) finding on its new leadership.

From The Telegraph:

NHS IT system ‘at a standstill’

By Kate Devlin, Medical Correspondent Last Updated: 6:24PM GMT 28 Oct 2008

The roll-out of a flagship £12billion NHS IT system has come to a standstill in many parts of the country because of problems with the system, the NHS has admitted. Ministers want the computer programme, one of the largest in the world, to eventually contain the medical records of every patient in the country. But NHS bosses in London have decided to halt the roll-out of the electronic care records to hospitals indefinitely, to sort out technical problems.

From E-Health Insider:

Political row over NPfIT: London on hold
28 Oct 2008

Opposition politicians have renewed their condemnation of the National Programme for IT in the NHS following press reports that the programme is “grinding to a halt.”

Conservative shadow health spokesman Stephen O’Brien said the reports confirmed that, with the “hugely expensive” programme “desperately behind schedule” suppliers were “deserting in droves” and “frontline professionals” were “voting with their feet and insisting on local solutions.”

Meanwhile, Liberal Democrat health spokesman Norman Lamb issued a statement saying that the “centralised project” had been “a shambles from the start” and it was “time for a re-think on how to proceed.”

The latest round of political attacks on the national programme follow the publication of an article in the Financial Times, arguing that progress on one aspect of the £12 billion project, the deployment of “strategic” care records systems, has stalled.

The article reviewed a number of recent stories that suggest this and questioned whether the programme would ever be completed.

… It noted that hospitals that have taken the London Release 1 version of Cerner’s Millennium care record service are experiencing problems with it and that further deployments that were scheduled for this year are showing no sign of going ahead.
And it noted that although health ministers promised that the much-delayed first installation of iSoft’s Lorenzo care record system would take place in Morecambe Bay this summer, the system has not gone live and neither the trust nor NHS Connecting for Health can give a date for go-live.

Jon Hoeksma, editor of E-Health Insider, was quoted as saying that while other parts of the programme continue to make progress, “this key part seems to be simply stuck. It has ground to a halt.”

Other national papers picked up the story, prompting an apparent admission that in London at least further deployments have been put on hold indefinitely.

This from Financial Times:

NHS records project grinds to halt
By Nicholas Timmins, Public Policy Editor
Monday Oct 27 2008 18:30

Progress on the £12bn computer programme designed to give doctors instant access to patients’ records across the country has virtually ground to a halt, raising questions about whether the world’s biggest civil information technology project will ever be finished.

Since [its launch in 2002], however, just one of the scores of acute care hospitals due to install the underlying administration system required in order for the patient record to work has done so. The hospital, Royal Free NHS Trust in London, continues to have difficulties getting it to operate properly.

… Health ministers originally promised the long-delayed first installation of patient record software in the north of England would finally take place in June at Morecambe Bay on the Lancashire/Cumbria border. But four months on, the system has still not gone live and neither Morecambe Bay nor Connecting for Health can give a date when it might.

CfH’s most recent published plans for the next three months do not include a single installation of a patient administration system into any acute hospital trust.

… Hospital chief executives, he said, did not want to take a new system “until they have seen it put in pretty flawlessly elsewhere”.

And this from the Evening Standard (UK):

£12bn NHS computer system crashes at the first attempt
Anna Davis
Oct. 30, 2008

THE roll-out of a new computer system to every London hospital has been frozen after being installed in just one organisation.

IT experts have stopped setting up the software across the capital and have rushed to sort out problems caused by the system at the Royal Free Hampstead NHS trust the only acute hospital to have installed it so far.

It is the latest blow for the £12billion national programme, designed to give doctors access to patients’ records wherever they are in the country.

The system has been beset with software glitches and design faults. One internal health service document said it could put seriously ill patients at risk of being inaccurately diagnosed.

According to the document, it is routinely crashing, intermittently losing patient information, and some staff are reverting to pen and paper.

It seems this UK program, which has already resulted in the expenditure of billions of dollars, is not at all meeting expectations. In fact, it may die.

This raises a few questions:

• Could this CfH debacle have been prevented?

• Could this scenario find itself repeated here in the United States?

I offer the opinion that the answer to both of these questions is a resounding “yes.”

On the first question, the answer is related directly to the issue of leadership expertise as I explain in some detail at my academic teaching site “Sociotechnologic Issues in Clinical Computing: Common Examples of Healthcare IT Difficulties.” At that site I wrote:

… diffusion of clinical information technology (IT specifically intended for use by clinicians in clinical care settings) after 30-plus years of effort and billions of dollars spent remains limited.

… This website is concerned with the reasons for this apparent paradox … While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition: the benefits will be realized only if clinical IT is done well. For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources.

Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity. This website is about the meaning of “done well” in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.

Of note regarding leadership changes in the UK CfH electronic medical records program and its IT leadership:

Two senior management appointments for NHS National Programme for IT announced
12 August 2008

The Department of Health has announced the two long-awaited senior management appointments for the National Programme for IT … The Department announced in February that it was recruiting the two positions as part of a revised governance structure for handling informatics in the Department of Health.

Christine Connelly will be the first Chief Information Officer for Health and will focus on developing and delivering the Department’s overall information strategy and integrating leadership across the NHS and associated bodies including NHS Connecting for Health and the NHS Information Centre for Health and Social Care.

Christine Connelly was previously Chief Information Officer at Cadbury Schweppes with direct control of all IT operations and projects. She also spent over 20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business.

Martin Bellamy will be the Director of Programme and System Delivery. He will lead NHS Connecting for Health and focus on enhancing partnerships with and within the NHS. Martin Bellamy has worked for the Department for Work and Pensions since 2003. His main role has been as CIO of the Pension Service. He has also held the positions of Group Applications Director in Corporate IT, and as Senior Responsible Officer for Information Management in the DWP Change Programme. He was previously a partner with KPMG Consulting in London, and has also worked in Reuters where his roles included Head of Real Time Technology and Director of News Products Development.

Cadbury Schweppes? The candy and Dr. Pepper/Snapple company? Gas and Power? Pension services? To lead a national health IT initiative?

The absence of biomedical, healthcare and medical informatics expertise in this “revised governance for handling informatics” is quite remarkable.

Can government really be the sponsor of ambitious health IT projects, I wonder? Should they?

On the second question, could the UK scenario find itself repeated in the United States, the answer is most definitely ‘yes.’

While there are informatics professionals at high levels within the HHS/ONC-led national initiative (not yet a formal program), the clinical IT initiatives of rank and file healthcare organization are still largely under the model of leadership by non-medical IT personnel.

Amateurs in health IT are running heath IT.

By analogy, in the field of Amateur (“ham”) Radio, I am among an uncommon group of physicians who hold high-level radio telecommunications licenses from the FCC, the Extra class, obtained after a series of examinations. I have built, operated and repaired sophisticated and powerful radio transmitters, receivers and other equipment. I can set up an emergency station with local, regional and international coverage in a very short time and communicate readily with others if needed.

Even with this background, I would not for a moment believe I should be telling commercial broadcasters, emergency services, and the military how they should be implementing and operating their wireless technologies, or managing those functions. I do not have the level of training and experience necessary. In radio, I am an amateur, not a professional.

In Electronic Health Records (EHR’s) and related clinical IT, however, a wide variety of “amateurs”, including technologists, clinicians and politicians, are telling medicine - as a field - how to implement and operate this modern and increasingly important tool of the profession.

Those IT professionals with success in the business computing field, or clinicians with some knowledge (often self taught) about information technology, are not best equipped to manage the issues in health IT. These personnel are, consistent with my amateur radio analogy above, “amateurs” in such settings, if one is truly honest about it.

As in radio, this label is not meant in a pejorative way. It is simply reality. However, the results of such a leadership model are predictable.

In effect, every HIT delay, failure, or difficulty is simply a transfer of wealth from the healthcare sector to the technology sector with one root cause being an unlikely leadership model.

Considering the uncertain ROI and QI data, the current financial turmoil, the local clinical IT problems paralleling the more widespread problems in the UK CfH program, and the many uninsured and medically underserved communities in the U.S., I wonder if national EMR’s may be an unwise pursuit in the U.S. at this time and if a moratorium on healthcare IT in the U.S. is warranted.

Billions of dollars that might be spent on IT misadventure in a time of unprecedented financial challenges and hardships might be better spent for the time being on provision of direct medical care.

– SS

[Source : Health Care Renewal]

There has been a lawsuit in the news about a very unfortunate adverse drug reaction that may have major implications towards future pharmaceutical company liabilities and the role of the federal government, especially the FDA, in adverse events issues. The case, in fact, has gone to the Supreme Court.

The case involves a woman, Diana Levine, a musician who suffered from migraines and who lost an arm as a result of a devastating side effect from an apparently bungled IV injection of phenergan. In an editorial entitled “The Court Confronts a Grievous Injury“, New York Times, Nov. 7, 2008, the case is summarized:

Ms. Levine went to a clinic seeking relief for a migraine headache. She received Demerol for her headache and Wyeth’s Phenergan to combat nausea, both administered by injections into the muscle, which is the preferred route of administration. When the headaches persisted, she returned for more treatment.

This time, the same medicines were administered by an intravenous “push” technique that is known to be risky — using a needle inserted into a vein. A physician’s assistant mistakenly hit an artery, with catastrophic results. Ms. Levine quickly developed gangrene; her hand and lower arm had to be amputated.

She sued the physician’s assistant, the supervising physician and the clinic for malpractice and won an out-of-court settlement … Then she sued Wyeth for failing to warn the clinicians to use the much safer “IV drip” technique, in which the drug is injected into a stream of liquid flowing from a hanging bag that already has been safely connected to a vein, making it highly unlikely that the drug will reach an artery.

A trial court awarded $6.7 million, and the Vermont Supreme Court upheld the verdict. Now Wyeth has asked the U.S. Supreme Court to reverse the verdict on the grounds that Wyeth complied with federal regulatory requirements [e.g., the product labeling that was approved by FDA]. The federal government at high levels apparently supports this position.

In other words, Wyeth and its governmental and other supporters are arguing that the FDA is the “gold standard”, the emperor of drug adverse events warnings and labeling, and that the decisions made by the emperor override state laws and pharmaceutical industry’s own judgment and warning efforts (or lack thereof).

If the FDA approved it, then the matter is settled. The emperor has spoken. The gold standard pre-empts lowly silver and copper wannabees.

In an ideal world, this might be a reasonable position.

In this real world, however, I find this position risible, objectively unsupportable, and dangerous.

The overarching assumption is that, like James Bond (apologies to Carly Simon), “nobody does it better, makes me feel sad for the rest” than the FDA. That is a very bad assumption.

First, a prerequisite for being the “ultimate authority” in an information intensive endeavor such as pharmaceutical safety requires one be unmatched in the management of information and of information systems. Is there evidence that FDA is lacking in that regard?

At HCRenewal post “Computer debacle: a Broken down process at the agency - or beyond?” I commented on a WSJ article on familiar (to medical informaticists, that is) clinical IT mayhem at FDA:

Report on FDA Blasts New Effort To Track Drugs; Four-Year Delay Is Said To Hinder Safety Work; Agency Disputes Claims

Anna Wilde Mathews. Wall Street Journal. Mar 3, 2007. pg. A.1

The Food and Drug Administration has bungled its effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself.

As a result, the agency must continue to rely on its existing “dysfunctional” computer system as a primary tool for tracking the safety of medications sold in the U.S., according to the November 2006 report, which hasn’t been made public.

A dysfunctional computer system? Computer systems do exactly what they’re designed to do. Perhaps its designers and implementers were the ones who were “dysfunctional?”

The situation is “frustrating and undermining . . . the post- marketing drug safety work” of its staff “because they lack some of the basic tools they need to perform their jobs, e.g. a computing system that meets their requirements,” says the report. It was prepared by the Breckenridge Institute, a research and consulting firm in Breckenridge, Colo.

You’d think designing such a computer system were magic.

The FDA’s drug-tracking system, called the Adverse Event Reporting System, consists of a database and other software and hardware that amass and help sift reports of potential side effects that have been filed by drug makers, doctors and others. The data are the FDA’s main way to detect drug-related hazards, and can lead to changes in label warnings or even withdrawals of drugs from the market.

But, the report says, FDA safety experts waste time — an average of 45 minutes per day — dealing with the inefficiencies and snags caused by the current software. The Adverse Event Reporting System is overwhelmed by the growing volume of adverse-event reports, which exceeds 400,000 a year, the report says.

This report does not surprise me. It’s hard enough to build effective HIT in a hospital due to the politics of IT and the bureaucracy. Performing that task in a huge, highly political burea-crazy such as a federal agency makes hospital IT look like child’s play.

However, as a former big pharma middle manager (in the Research IT division of Merck Research Labs), I have seen reasonably effective efforts at the level of the pharmas, who are both better motivated to do so (profits and such) and better equipped (attractive salaries) than a federal agency. That speaks to the need to keep significant responsibility — and liability — for drug labeling within the pharmas themselves, and not allow preemption by a clumsy Big Brother.

Pharmas are closer to the data, even though they have their own problems (examples that cross both pharma and FDA follow) and a marketing-based reluctance to share adverse drug data freely and promptly. However, pushing the responsibility from pharma and the states to a federal agency that bungles the very technology needed to achieve credible results is akin to putting ultimate decision making of FedEx in the hands of the U.S. Postal Service.

Is there more evidence that making FDA the “ultimate authority” on adverse events issues might be insane in the real world in which we live?

Here is more from a paper I authored entitled “A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance.” The PDF is downloadable at this link. (Note: some of the links below may require updating or a search of archive.org):

In 2004 the U.S. government announced support for development and implementation of a nationwide, interoperable health information technology infrastructure to improve the quality and efficiency of health care. In the same year, several high-profile drug safety cases raised concerns about the ability of the Food and Drug Administration (FDA) to manage issues raised by adverse drug events [3].

[3] United States Government Accountability Office, Washington, D.C. Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process. March 2006, p. 5.

Concerns about FDA’s ability to manage issues raised by adverse drug events? Is this a sign of an organization that should be considered a gold standard?

More on this from the paper:

Outspoken critics on drug safety issues such as Dr. David Graham, a senior official in the FDA’s Office of Drug Safety often come under fire for their views: “A Food and Drug Administration official [Graham] who sought to estimate the harm done to patients by side effects of the painkiller Vioxx said yesterday that his supervisors tried to suppress his conclusions, according to Sen. Charles Grassley (R-Iowa).” Since 1988, Graham has called for the removal of 12 drugs from pharmacy shelves, leading to 10 actual recalls of harmful drugs. Graham told Congress that FDA’s problems with ensuring drug safety were “immense in scope” and left the nation “virtually defenseless” against the chance that unsafe drugs will reach consumers [18].

[18] International Biopharmaceutical Association. Drug Recall: Effects on consumer confidence.

Still more confidence-inspiring material:

The [FDA’s first annual Federal Register (FR) report on [drug] postmarketing studies] defines the status of 1,339 open manufacturers and 223 open postmarketing study commitments for biological products by 44 manufacturers. Of the open postmarketing drug studies, 820 (61%) are yet to be initiated; 285 (21%) are ongoing; 25 (2%) are delayed; 8 (1%) have been terminated before completion but the manufacturers have not submitted a final study report; and 201 (15%) have been either completed or terminated, and the FDA has received the final study report. Also in the drug area, annual reports for 289 (22%) of the open postmarketing commitments are overdue [32].

[32] 32. U.S. Food and Drug Administration. Federal Register Report and FDA Web Site on Postmarketing Studies, May 22, 2003.

So, the FDA is ineffectual at ensuring basic postmarket studies are conducted. Gold standard?

And more:

FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues. The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management, and data constraints … There are weaknesses in the different types of data available to FDA, and FDA lacks authority to require certain studies and has resource limitations for obtaining data. Some of FDA’s initiatives, such as the establishment of a Drug Safety Oversight Board, a draft policy on major postmarket decision making, and the identification of new data sources, may improve the postmarket safety decision-making process, but will not address all gaps … FDA is taking steps to identify additional data sources, but data constraints remain [40].

[40] United States Government Accountability Office, Washington, D.C. Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process, March 2006, Highlights

On attempts at corrective action:

FDA itself has a history since the 1950’s of founding committees and establishing and disestablishing multiple new research organizations (centers, bureaus and least one institute) to make major changes in the organization and management of its scientific endeavors. Most of these repetitive efforts failed [42].

[42] Baciu A, Stratton K, Burke S, Editors. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice (BPH), Institute of Medicine, 2006, p. 104.

Now, on to another issue with FDA. Is staring idiocy directly in the face a “teachable moment” that can be used to extrapolate the existence of more severe problems?

I believe it is.

My personal interaction with a senior FDA official is documented at “FDA’s hefty bonuses seek to retain workers.” I reported my experience at a late 2004 Merck interview with the FDA’s former Deputy Director of the Office of Drug Safety at CDER, Dr. Martin Himmel, who had come to Merck from FDA and taken the position of Executive Director in Clinical Risk Management & Safety Surveillance, Merck Research Labs.

Unemployed since Merck’s mass layoffs of 4,400 souls in late 2003, I had interviewed with Himmel’s underlings in Clinical Risk Management & Safety Surveillance, and had shown them my prior work in building innovative tools and techniques to allow scientists much more fluid and dynamic access to large biomedical datasets, and to perform ad hoc analytics upon that data firsthand. The scientists and clinicians in the department viewed my work highly favorably, and informed me about significant problems with data access they were experiencing.

Those problems included a somewhat unwieldy structure to their adverse events database, and a dependence on overworked IT personnel to run queries and abstract data from the large database, often providing the scientists with paper results which were next to useless for advanced work.

I came to Dr. Himmel with the highest of recommendations from his staff. I proceeded to show him my work, including an invasive cardiology information system of my design, in use for adverse events detection and analysis, PI, QA, benchmarking, etc., at one of the largest centers in the region (performing more than 6000 procedures annually) along with acclaim the system had received from experts at the national organization for Cardiac Angiography and Interventions:

“We believe your efforts in [cardiac laboratory database development] are exceptional compared with the current norm in most laboratories and we strongly support the continued efforts to develop this system within Christiana Care.”

Report of Consultation Visit, Laboratory Survey Committee of the Society of Cardiac Angiography and Interventions, Gregory Dehmer, MD, Patrick Scanlon, MD, Oct. 1999).

I also brought with a demo of the Saudi Arabia-Yale Clinical Birth Defects information system (SAYGR) I built in an international collaboration with the King Faisal Specialist Hospital & Research Centre in Riyadh. SAYGR employed novel techniques I invented at Yale to allow capture and ad hoc analytics of clinical, genetic, genealogical, drug and chemical exposure (e.g., chem warfare) data, and other data types by non-computer expert scientists and clinicians.

The work I’d done in building these systems was directly and immediately relevant towards building of drug adverse events databases and analytical tools, but Dr. Himmel simply didn’t see it.

He cut me off after only about ten minutes and dryly observed that “we don’t need Medical Informatics here.”

At that, I realized I was staring idiocy in the face. Since it’s pointless to argue with idiocy, I got up, said goodbye and left. This from a former top official in drug safety at CDER, I thought? Unbelievable.

It should be noted that the Institute of Medicine of the National Academies, as I observed at “IOM gets it regarding Medical Informatics“, recommends:

… that CDER [FDA’s Center for Drug Evaluation and Research] build internal epidemiologic and informatics capacity in order to improve the postmarket assessment of drugs. In recognition of the limitations in human resources in the current employment market to meet this role, a combination of advancing professional skills through continuing education and support for academic training programs is needed.

and that

Informatics experts should track progress on the national health-information infrastructure, look for opportunities to gather information about drug safety and efficacy after approval, coordinate partnerships with external groups to study the use of electronic health records for [drug] adverse event surveillance, participate in FDA’s already strong role in setting national standards and track the development of tools for data analysis in industry and academe, and encourage the incorporation of the tools into FDA practice where appropriate.

I had been told by a former top leader at CDER that he, in effect, disagreed with this assessment.

This very same person was a leader at FDA in the time frame of Ms. Levine’s travails.

Again, the industry wants the FDA to be considered the “ultimate authority” on drug adverse events?

We have evidence for IT disarray, noted defects in management of drug adverse events responsibilities, and reactionary leadership in the Office of Drug Safety at CDER itself.

As noted in the NYT editorial:

… And that is the greater point. When Congress revised the federal law governing the F.D.A. in 2007, drug companies wanted, but did not get, a provision shielding them from this sort of lawsuit. The drug industry and its administration allies now want the court to ignore the absence of express legal language and grant drug companies immunity based on a phony assertion that state lawsuits improperly usurp federal regulatory authority.

I would state the true “greater point” a little differently. The federal regulator in this case is an emperor that stands naked and tin-plated. Considering the FDA as “a gold standard” that negates the jurisdiction of the states not only reduces the responsibility and liability of pharmaceutical companies, but also is cavalier on its face considering the FDA’s troubles.

As is noted by the NYT:

Far from usurping the F.D.A.’s power, litigation aimed at holding drug companies liable for problems like those in this case complement the agency’s efforts to protect the public. For many years the F.D.A. welcomed state failure-to-warn suits as reinforcing those efforts; two former commissioners, David Kessler and Donald Kennedy, made that point in a brief in the case.

These commissioners apparently understood the limitations of the FDA and that FDA efforts needed to be complimented in that manner to protect the public.

Finally, a commenter to the NYT editorial, Arthur Taub, MD PhD, New Haven, CT, wrote that:

“It is essential that the authority of the FDA be maintained, and that license is not given in 50 separate jurisdictions for uncontrolled litigation and supplementary “deep pocket” awards against industry.”

Irrespective of Dr. Taub’s role as expert witness for hire (I have not researched if he has represented pharmas), I would say instead that it’s essential the authority of the FDA be challenged relentlessly, until the agency can be relied upon to stop screwing up fundamentals like clinical IT and adverse events data management. Until then the states should hold their ground against a federal intrusion by the Keystone Kops.

It is my hope the Supreme Court will examine the evidence critically and agree with this assessment.

– SS

[Source : Health Care Renewal]

What health IT mismanagement could not accomplish, perhaps international financial mismanagement will. Could this happen here?

This story reflects a veritable cornucopia of the issues I write about at Healthcare Renewal and at my site on HIT failure, with the added spice of the World Financial Debacle That Keeps On Giving, er, Taking.

Bank bailout puts £12.7bn NHS computer project in jeopardy

John Carvel, social affairs editor
The Guardian, Wednesday October 29 2008

The future of the NHS’s £12.7bn computer programme was in doubt last night after its managers acknowledged further delays in introducing a system for the electronic storage and transmission of patients’ records.

Connecting for Health, the NHS agency responsible for the world’s biggest civil IT project, said it was no longer possible to give a date when hospitals in England will start using the sophisticated software that is required to keep track of patients’ medical files.

Christine Connelly, the Department of Health’s recently appointed head of informatics, is understood to be reviewing whether the programme is a cost-effective way of improving the quality and safety of patient care.

She will have to find compelling arguments to stop the Treasury earmarking health service IT as a candidate for cuts to compensate for the billions spent on the bailout of the banks. However, the high cost of cancelling contracts with IT suppliers may be a factor saving the programme from cancellation.

In May the National Audit Office said the project was running at least four years late, but still appeared to be feasible. It has since been beset by a series of further setbacks.

The agency fired Fujitsu, the contractor responsible for building the patient record system in the south of England. It asked BT to take over the work, but has not yet agreed a price.

In London, attempts to install the system at the Royal Free hospital and Barts caused weeks of confusion and disruption. Other trusts that were next in line were so alarmed that they pleaded for postponement.

In the north, the first installation of the Lorenzo version of the software at Morecambe Bay was repeatedly delayed.

A Connecting for Health spokesman said parts of the programme are working well, with doctors and patients already noticing the benefits.

But he added: “The programme is one of the largest IT change programmes in the world and it is inevitable that such transformation will present challenges.”

“Challenges.”

You don’t say?

One wonders if some of those “challenges” might have been minimized or avoided through some simple measures. Such as a google search by project leaders and politicians.

Jon Hoeksma, editor of E-Health Insider, a website that has specialised in tracking Connecting for Health, said: “Contracts [for the patient care record] were let in 2003 and they were supposed to be completed by 2010. But the best estimates now are that the software will not be ready until well into the next decade.

I believe the estimate of widespread U.S. electronic health records by 2014 are just a little overoptimistic …

On the world financial mess, that’s another matter entirely. Unfortunately, Medical Informaticists don’t have the technology yet to perform Brain Transplants.

– SS

[Source : Health Care Renewal]

In 2006 I’d commented on Healthcare Renewal about the Wall Street Journal story “Spread of Records Stirs Patient Fears of Privacy Erosion“, by Theo Francis, published Dec. 26, 2006.

As I wrote at “Another Electronic Medical Record Horror Story” here, a patient, Patricia Galvin, was betrayed after medical information she thought was confidential about her psychotherapy was divulged to an insurance company.

I also penned a Letter to the Editor at the WSJ, published on Dec. 30, 2006 (viewable here as published, second letter from top; and as submitted, in the blog post above). I had noted that:

The issues of 2008 U.S. politics aside, I believe another blow to patient confidence in EHR has just occurred, I’m afraid:

Apparently a statement was made by Ohio officials that this type of checking was done on anyone who “comes into public attention” or words to that effect.

Ohio Senate President Bill M. Harris sought answers on why state officials checked out Wurzelbacher. Harris called the multiple records checks “questionable” and said he awaits more answers. “It’s kind of like Big Brother is looking in your pocket,” he said.

I would agree with that assessment.

I believe nearly every U.S. citizen who’s awake and conscious has heard of this by now, and very many people abroad are aware of this as well.

This raises several key questions.

• How will this event and others that come to light affect confidence in EHR privacy and confidentiality by the “average Joe” who might fear intimate details might be divulged about them if they are shown on the evening news regarding something controversial or in the newspaper? (For example, did someone check my background after my WSJ editorial above was published?)

• Of what use are “guarantees of medical records privacy” if government officials themselves decide that they are justified for whatever reason and “well meaning” in peeking at a person’s records - especially for reasons as dubious as in the Wurzelbacher example?

• Were medical records breached in Mr. Wurzelbacher’s case? Although I am unaware of any evidence of this, I would place the likelihood at “very concerning” considering what is already known.

I believe this incident may have serious repercussions upon patient confidence in electronic record privacy, with a resultant harder time in diffusing this technology for clinical care and research.

I, for one, already feel less confident in my assertions that EHR data, especially data in governmental systems, is “safe.”

– SS

[Source : Health Care Renewal]