Showing posts with label Joint Commission. Show all posts
Showing posts with label Joint Commission. Show all posts

Wednesday, March 17, 2010

A Simple Lesson for the Health IT Industry

From an Op Ed "Living with the Electronic Car" in today's Wall Street Journal:

"A Toyota executive recently explained to a Congressional committee investigating claims of uncontrolled acceleration: "We need to reduce the number of things we ask our customers to do correctly." In fact, the exec was describing the essence of responsible engineering - though perhaps the balance in auto design has gotten out of whack."

Considering the feedback from physicians on the needless complexity of electronic medical records and other computerized medical devices for example at "An Honest Physician Survey on EHR's", it seems the healthcare IT industry has yet to learn this simple lesson.

I'm frankly not convinced there's "anyone home" in this complexity-loving industry who could fathom such advice as a good business practice.

It also seems that industry may not give a damn about such lessons, even in the most safety critical of environments, the intensive care unit, as long as profits are maintained.

See for example "A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare." Also see "Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation" on political maneuvering by this industry to avoid the federal regulation other healthcare drug and device sectors have been subject to for decades (largely as a result of public health disasters such as this and this, I might add).

The interesting aspect of these issues is that the executives and officials behind these decisions and machinations are setting themselves up as near-indefensible defendants in future litigation by patients (and their estates) harmed or killed by healthcare IT-related problems.

For instance, I had communications with the Joint Commission leadership over issues I raised in my July 22, 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards." Namely, on how hospital executives were violating their fiduciary and Joint Commission safety standards obligations, and jeapardizing patient safety, in signing the traditional health IT contract calling for confidentiality about health IT malfunctions and defects. The JC Leadership is quite well aware of this letter and my more thorough essay here.

Nothing has been heard from the Joint Commission on these issues since.

Perhaps never before have the malpractice lawyers been provided a better scenario for taking the houses and personal property from irresponsible and/or conflicted healthcare and health IT regulators and other officials via lawsuits as health IT diffusion increases, with its "tip of the iceberg" injury and death occurrences now firmly established.

-- SS

Friday, December 18, 2009

Arguments for Maintaining the Health IT Status Quo on Defects Nondisclosure Clauses

As I wrote at Healthcare Renewal here, I recently posted a web petition "Transparency and Openness in Electronic Patient Records and Other Healthcare Information Technology Systems" at http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454 , calling for an end to Nondisclosure Clauses [of defects, problems, EHR-related adverse events, etc.] in HIT contracts. The petition reads:

We, the undersigned, believe in transparency, accuracy, and accountability in scientific research, especially in matters related to healthcare.

We believe contractual nondisclosure clauses [1] that prohibit or restrain unfettered disclosure and dissemination of information about healthcare information technology problems related to bugs, design defects, suboptimal user interfaces, other factors that can adversely affect care, and the adverse events and near accidents these problems cause, are unethical.

We believe that patients and clinicians have a right to knowledge of healthcare information technology problems and defects that can distract clinicians and/or reduce clinician effectiveness and productivity. We also believe that hospital governance personnel have the fiduciary responsibility as well as obligation under Joint Commission safety standards to protect patients, clinicians and others working within and for their organizations from the potential consequences of healthcare information technology problems [2].

We believe that only through transparency about healthcare information technology can medical ethics be maintained, the rights of patients to the best possible care be protected and medical science advanced.

Therefore, we call for such clauses to be refused by governance bodies, vendors of healthcare information technology to refrain from including such clauses in their contracts, and the U.S. Congress to prohibit nondisclosure clauses related to medical devices and healthcare information technology.

Furthermore, retaliatory actions against those who in good faith report such matters or incidents should be prohibited.

[1] Koppel R, Kreda D. Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians, JAMA. 2009;301(12):1276-1278.

[2] Silverstein S. "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards." Letter to the Editor, JAMA. 2009; 302: 382.

As I had spelled out many months ago at "Health Care Information Technology Vendors' Hold Harmless and Keep Defects Secret Clauses" here, and in a July 22, 2009 letter to the editor in JAMA entitled "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", I believe these clauses:

  • Are responsible for stagnation in health IT industry thinking that requires an unrelenting focus on the needs of clinicians and patients;
  • Cause hospital executives to violate their fiduciary and Joint Commission safety obligations to patients and staff;
  • Perhaps even put clinicians themselves in a conflict of interest with their own professional ethics (that call for widely sharing information about potential risks to patients).

The Joint Commission nor any other healthcare regulatory body has done anything about such contract clauses since that time, to the best of my knowledge despite being made aware of these issues by direct email to JC leadership.

I've noted few signatures to the petition so far, but have received some feedback and noted other justifications for maintenance of the status quo. The arguments fall into several categories that defend the status quo of HIT defect/problem nondisclosure clauses. The categories of argument include:

  • Legal arguments (or perhaps I should say 'legalistic'): e.g., HIT is not a "medical device", is not regulated, therefore such clauses are nobody's business but the seller and buyer.
  • Semantic arguments (arguing about words): e.g., the Joint Commission safety standards calling for "the organization to communicate information related to safety and quality to those who need it, including staff, licensed independent practitioners, patients, families, and external interested parties" really do not mean communication to other healthcare organizations, regulatory bodies, the press, etc.
  • Corporatist arguments: the clauses are needed to protect the industry and protect "innovation" - however, innovation without adherence to patient's rights and medical ethics is not innovation at all in my mind (cf. the Tuskegee Study of Syphilis).
  • Statist arguments: e.g., we know what's best for medicine, and even if HIT today does have problems and hurt people, it's for the greater future good that their diffusion should be unimpeded by free dissemination of information on downsides.
  • Logically fallacious or irrational arguments: e.g., the circular argument that there's no reason to prohibit nondisclosure clauses about HIT defects and patient incidents, since these problems do not occur in the first place -- or if they occur patient harm is "always" averted by clinicians.

While these type of arguments are interesting and may make for excellent debate, (and medical ethicist George Annas at BU taught his medical students, myself included, well on such issues): none of these arguments are aligned to the ethics, customs and traditions of medicine and the oaths taken by its practitioners.

The oaths taken by healthcare IT companies (i.e., to the speculators investing in this technology) leave much to be desired in that regard.

On the other hand, here is a sentinel reason for supporting their quick abolishment, a strong informatics-based reason to abolish nondisclosure clauses:

As admissions such as "We are unable to share documents [relating to likely problematic EHR's - ed.] as our contract with XXXX includes a confidentiality clause" at http://www.computerweekly.com/blogs/tony_collins/2009/11/claim-of-censorship-over-cerne.html indicate, to the point of rejecting a FOI request for information, there are unknowns in health IT (as Tim the proprietor at Histalk wryly noted, the refusal probably is not on the grounds of having glowing praise to report).

How many other data points have not made it to the literature, either peer reviewed or press? Does anyone know definitively?

Do we really know that Medical Informatics research therefore represents a valid sampling of the events that transpire when HIT is designed and implemented?

A parallel and currently controversial issue in pharma is the deliberate suppression of negative or neutral clinincal trials results, with an emphasis on the positive, to protect a drug candidate or an actual drug in postmarketing surveillance. Does this not potentially taint the science?


-- SS

Tuesday, December 15, 2009

Web Petition: Transparency and Openness in Electronic Patient Records and Other Healthcare Information Technology Systems

I have created a new Web petition "Transparency and Openness in Electronic Patient Records and Other Healthcare Information Technology Systems."

It is at WEBPETITIONS.COM at this link: http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454

Aimed at clinicians, hospital governance personnel and other healthcare stakeholders including patients, the petition states:

We, the undersigned, believe in transparency, accuracy, and accountability in scientific research, especially in matters related to healthcare.

We believe contractual nondisclosure clauses [1] that prohibit or restrain unfettered disclosure and dissemination of information about healthcare information technology problems related to bugs, design defects, suboptimal user interfaces, other factors that can adversely affect care, and the adverse events and near accidents these problems cause, are unethical.

We believe that patients and clinicians have a right to knowledge of healthcare information technology problems and defects that can distract clinicians and/or reduce clinician effectiveness and productivity. We also believe that hospital governance personnel have the fiduciary responsibility as well as obligation under Joint Commission safety standards to protect patients, clinicians and others working within and for their organizations from the potential consequences of healthcare information technology problems [2].

We believe that only through transparency about healthcare information technology can medical ethics be maintained, the rights of patients to the best possible care be protected and medical science advanced.

Therefore, we call for such clauses to be refused by governance bodies, vendors of healthcare information technology to refrain from including such clauses in their contracts, and the U.S. Congress to prohibit nondisclosure clauses related to medical devices and healthcare information technology.

Furthermore, retaliatory actions against those who in good faith report such matters or incidents should be prohibited.

[1] Koppel R, Kreda D. Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians, JAMA. 2009;301(12):1276-1278.

[2] Silverstein S. "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards." Letter to the Editor, JAMA. 2009; 302: 382.

The signed petition will be sent to the U.S. Senate Finance Committee (currently investigating healthcare IT), the Secretary of HHS, the Director of AHRQ, the Director of the Office of the National Coordinator for Health IT, and the President of the Joint Commission.

Please sign at the WEBPETITIONS.COM link http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454, and spread the word.

-- SS

Addendum: as an example of the problems these nondisclosure clauses can create, see my post "We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause."

Monday, August 3, 2009

Making Hospitals Safer by Making Healthcare IT Safer

At my July 24, 2009 HC Renewal post "Inquiry to Joint Commission on points raised in my July 22, 2009 JAMA letter on HIT", I reproduced a letter I sent to the Joint Commission seeking their opinions on the issue of Health IT "hold harmless" and "defects nondisclosure" contractual terms. (See "Health Care Information Technology Vendors' Hold Harmless Clause - Implications for Patients and Clinicians", JAMA 2009;301(12):1276-1278 and my HIT difficulties website essay here.)

Those contractual terms cause hospital executives to violate Joint Commission safety standards and their own fiduciary responsibilities to people both providing and seeking care in hospitals. My inquiry was acknowledged, and I await a reply.

In Making Hospitals Safer for Patients, New York Times, Aug. 2, 2009 , Mark R. Chassin, president of The Joint Commission, wrote:

To the Editor:

Jim Hall makes an important point about the costs and preventability of harm caused by medical errors, but his suggestion for a National Medical Safety Board is not the answer. It is not sufficient to investigate health care “crashes” one at a time and hope to transform the health care system into one that performs more reliably.

Too often, the lessons learned are not easily transferable to other hospitals or even to other problems within the same organization.

The key to transforming our health care system into a safer one is to use proven quality improvement methods — already in use in high-risk fields like aviation and nuclear power — as part of everyday work ...


In a followup email to the Joint Commission, I pointed out to Dr. Chassin that this is the same key to improving the quality and safety of EHR, CPOE and other information technology-based medical devices.

I also pointed out that "Hold harmless" and "Defects nondisclosure" -- a.k.a. "gag clause" -- contractual methods (unless I'm mistaken, in which case we're all in jeopardy) are not used in building and deploying safety-critical devices found in the aviation and nuclear energy industries.

-- SS

Friday, July 24, 2009

Inquiry to Joint Commission on points I raised in my July 22, 2009 JAMA letter on HIT

As I posted here, my letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA on July 22, 2009. A preview of the letter can be seen here, or a full version here if you subscribe to JAMA.

This JAMA letter covered some of the same points I addressed extensively at my Drexel HIT website essay "Hold Harmless and Keep Defects Secret Clauses", including the major point that hospital executives signing HIT "Hold Harmless" and "Defects Nondisclosure" contracts are in violation of Joint Commission standards for conduct related to safety, and in violation of their fiduciary responsibilities towards patient and employee safety and freedom from undue liability.

I've sent the following inquiry to Paul M. Schyve, M.D., Senior Vice President, The Joint Commission:

July 24, 2009

Paul M. Schyve, M.D.
Senior Vice President
The Joint Commission
schyve@jointcommission.org

Cc: MChassin@jointcommission.org, otrippi@jointcommission.org

Dear Dr. Schyve,

In testimony to the House Committee on Veterans' Affairs on July 22, 2009 at this link , you state:

... The Joint Commission has established standards that require the hospital to:

  • Create a culture in which adverse events are reported and evaluated for underlying ("root") causes, and preventative actions are taken.
  • Identify high-risk processes and prospectively determine their possible modes of failure, the effects of those failures, and the actions that will prevent the failures or mitigate their effects.
  • Establish a culture of safety throughout the hospital. This accreditation standard became effective January 1, 2009, although its purpose and expectations were publicized for over a year in advance.

In my JAMA letter to the editor of July 22, 2009 entitled " Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" ( link ), I point out that the Hold Harmless and Defects Nondisclosure clauses signed by hospital executives in contracting for healthcare information technology (such as CPOE and EHR systems) are in violation of Joint Commission safety standards, as well as hospital executive fiduciary responsibilities to patients and clinicians. These clinical IT systems can and do cause medical errors and patient harm.

My letter was in response to Koppel and Kreda's March 25, 2009 article " Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians ", JAMA. 2009;301(12):1276-1278.

I am interested in the Joint Commission's response to the issues I raise.

I await a response.

-- SS

Thursday, March 26, 2009

Health IT "Hold Harmless" and Defects Gag Clauses: Have Hospital Executives Violated Their Fiduciary Responsibilities By Signing Such Contracts?

July 2009 - Note: also see my letter to the editor in JAMA on this same topic, "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", published July 22, 2009, available online at this link.

Regarding healthcare IT "Hold Harmless" and Defects Gag Clauses as revealed by the JAMA article
Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians by Koppel and Kreda:

Have hospital executives violated their fiduciary responsibilities by signing such contracts, and violated Joint Commission standards of hospital leadership conduct as well?

Fiduciary
(fidOO'shÄ“e"rÄ“), in law, a person who is obliged to discharge faithfully a responsibility of trust toward another. Among the common fiduciary relationships are guardian to ward, parent to child, lawyer to client, corporate director to corporation, trustee to trust, and business partner to business partner. In discharging a trust, the fiduciary must be absolutely open and fair. Certain business methods that would be acceptable between independent parties dealing with one another “at arm's length” may expose a fiduciary to liability for having abused a position of trust.

Hospital management conduct is not bound by traditional business law only, just as physicians and other clinicians hold additional obligations. In both cases, obligations go beyond that of, say, a manager or worker at a McDonald's or a Wal-Mart. In healthcare there are "special" third parties involved with critical rights and responsibilities, namely, patients and clinicians.

At Health Care Information Technology Vendors' "Hold Harmless" Clause I expressed great concern about the remarkable revelations in Koppel and Kreda's expose of arguably unethical and clearly inexcusable contracting practices by healthcare IT producers and vendors.

The vendors have declared themselves off limits from liability even if patients die as a result of software defects and malfunctions, pushing that liability onto clinicians. Vendors have simultaneously declared themselves the Ministry of Information, Soviet style, on such defects.

I also expressed my concern that the contractual suppression of information dissemination on health IT problems and defects may be one reason websites on health IT difficulties, such as the site I started in 1998 (in fact cited by Koppel and Kreda) remain uncommon on the Web. This is despite my documentation of continued, ongoing, world wide interest in this topic (see my 2006 AMIA abstract on this issue here, PDF, and poster here, PPT).

It is not just the vendors who may be acting against the best interests of medical science and patient safety, however.

It also seems to me that hospital executives, boards and counsel have fiduciary responsibilities, as well as obligations under principles of due diligence, Joint Commission and other regulatory guidelines, etc. to protect not just patients from defective technologies but also to protect their staffs from unfair risks and legal liabilities. I note that these health IT contracts have apparently been signed willingly by hospital executives, against the best interests of patients and medical staffs. Nobody is holding a gun to their heads, and nobody is forbidding negotiation of terms.

As a former CMIO/Director of Informatics I would never have signed such a contract. Period. (Of course, CMIO's and Directors of Informatics don't generally sign or even see health IT contracts, as they are Chiefs and Directors of Nothing.)

Have hospital executives, boards of directors and counsel been violating their responsibilities and obligations every time they've signed a healthcare IT "hold vendors harmless, it's all on your docs" and "shhhh! keep the defects secret" contract? Have they abused their positions of trust?

NIH research leaders and grant reviewers, as an example, consider seriously any problems with research that might place not just research subjects but also investigators at risk, medically, legally and otherwise. I perform this function on NIH study section panels.

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.

I urge physicians and concerned others reading this to read the Univ. of PA press release "Why Are Healthcare Information Manufacturers Free of All Liability When Their Products Can Result in Medical Errors?" here, obtain the JAMA article by Koppel and Kreda, and call their congressional and other representatives to have these self-serving industry practices that ignore protection of patients and practitioners from undue jeopardy stopped.

I also believe any clinician under lawsuit related to hospital HIT malfunction, and/or patients harmed, should consider suit against the management that signed the contracts allowing the defective IT's entry into the hospital and mandated clinicians to use the HIT.

I, for one, already have begun discussing these issues with my representatives in Washington, and they've expressed great surprise at these revelations.

-- SS

Thursday, January 15, 2009

I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?

In Nov. 2008 I wrote a post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?"

The question was raised based on reports of serious difficulty experienced by the UK in their national program for electronic health records, Connecting for Health.

I commented on how the world financial crisis of 2008-09, combined with chronic project difficulties and mismanagement and profound clinician resistance 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 actual cancellation.

From the British press:

Bank bailout puts £12.7bn NHS computer project in jeopardy

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.

It is simply stunning that the UK might be "locked in" to a potential disaster by IT vendors. (How is this allowed to happen?)

I'd also commented on how the lack of true Medical Informatics education and expertise in the new UK CfH "head of informatics" (and predecessors, for that matter) was a symptom of a much larger disease in healthcare IT.

The disease is a paradoxical (especially for medicine) and turned-on-its-head leadership structure where "amateurs" reign. Amateurs, in the sense that my significant telecommunications experience and even licensure as a radio amateur (ham) extra class, a hobby, would not qualify me to, say, lead a national telecommunications projects for the British Armed Forces due to lack of professional telecommunications training and credentials.


Read my Nov. 2008
"Moratorium" post for details on the UK problems.

Since that time, there have been two remarkable events in the United States (when I wrote the above posting, I had no idea whatsoever that the following would occur):

In Dec. 2008, the Joint Commission (the organization that accredits healthcare organizations here) issued a Sentinel Event Alert on HIT recommending that significantly more caution be taken in its design and implementation due to risks posed by the technology. In "Joint Commission Sentinel Event Alert On Healthcare IT" I commended the JC for taking such a step, likely to be viewed with disdain by the business sector and those infatuated with HIT as a "magic bullet" panacea for healthcare.

Then, in Jan. 2009, the highest scientific authority in the U.S., the National Research Council (NRC) of the National Academies issued their report after a several-year study of HIT entitled "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions," a rather innocuous sounding title for a potentially explosive report.

The National Academies perform an unparalleled public service by bringing together committees of experts in all areas of scientific and technological endeavor. These experts serve pro bono to address critical national issues and give advice to the federal government and the public.

Four organizations comprise the Academies: the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine and the National Research Council.


I believe the title of the Press Release about the NRC report summarizes the report more accurately than its native title. The Press Release title is: "National Research Council: Current Approaches to Health IT Insufficient."

I presented the release at the post "Current Approaches to Health IT Insufficient ... and Other Master of the Obvious News."

While I do not know if my work had any influence on this report, its conclusions parallel those of myself and a relatively small number of colleagues who've stuck to unpopular (with the industry, that is) contrarian views on the unquestioned goodness of HIT. It is likely a number of the authors of this report were aware of my work over the years, as a frequent poster in the American Medical Informatics Association listservs and frequent writer and speaker on these issues, including some outspoken comments made at AMIA when some of the authors were in attendance. I believe the report can be better summarized by the following quote:

"Healthcare IT, dominated by non-medical IT personnel who views these tools as IT systems that happen to involve clinicians, rather than clinical tools that happen to involve computers, have mismanaged HIT through their false assumptions, lack of knowledge and lack of insight for at least several decades." - Silverstein

The NRC report found that current efforts aimed at the nationwide deployment of health care IT are not sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause. This conclusion was reached based partially upon site visits to eight U.S. medical centers considered leaders in the field of health care IT.

It concluded that greater emphasis should be placed on information technology that provides health care workers and patients with cognitive support, such as assistance in decision-making and problem-solving , as opposed to its current "medicine as a business" paradigm providing clinicians with, essentially, an inventory system based on 19th century accounting theorem (the major critique of IT, in fact, by Peter Drucker in his latter years). As I observed in 1999:

Management expert Peter F. Drucker, one of the most respected names in modern management thinking, offers some highly relevant insights about information issues in his book "Management Challenges for the 21st Century" (HarperBusiness, 1999). These insights amplify the importance of medical information specialists (medical informaticists) taking leadership roles in healthcare organizations, and the problems with allowing MIS to predominate on medical information issues and clinical information tool development and evaluation.

Drucker writes that "the information revolution...is not happening in IT or MIS, and is not led by CIO's...what has triggered the [real] information revolutions and is driving them is the failure of the 'information industry' - the IT people, the MIS people, the CIO's - to provide information. For 50 years, information technology has centered on data...and technology [not useful information]."

He continues, "The data available in business enterprises are still largely based on early 19th century accounting theorem. MIS has taken the data based on this theorem and computerized it. They are the data of the traditional accounting system. IT...collected the [accounting system's] data, manipulated them, analyzed them and presented them. On this rested, in large measure, the tremendous impact the new technology had on what cost accounting data were designed for: operations. But it also explains IT's near-zero impact on the management of business itself."

I'd also observed at that time that Medical Informatics and its teachings can thus be seen as a means to an end: the creation and dissemination of useful information that advances the practice, science and management of healthcare, not just facets of its operations.

In 2008 I wrote that:

... I believe the unimaginative, process over results, tightfisted control, bureacratic "data-processing" culture of the business IT (management information systems) world to be the lineal descendant of IBM's patchcord plug-panel programmed, card tabulating machines from which IBM made a large portion of their profit in the days before the electronic computer. You perhaps required such a culture when you were running huge businesses from stacks of tens of thousands of punched cards. However, such a model does not work well in meeting the information needs of clinical medicine.

... Medical informatics, a pioneering field, in many ways saw the electronic computer not as a card-based data processing machine but as a canvas for development of creative works to serve the needs of clinical medicine and its practitioners.

The National Research Council report in fact incarnates my contention that HIT is not a subspecies of MIS or management information system (i.e., business IT). I maintain that only the assumption that it is, combined with leadership by non clinicians, could result in outcomes such as this:

The report describes difficulties with data sharing and integration, deployment of new IT capabilities, and large-scale data management. Most importantly, current health care IT systems offer little cognitive support; clinicians spend a great deal of time sifting through large amounts of raw data (such as lab and other test results) and integrating it with their medical knowledge to form a whole picture of the patient. Many care providers told the committee that data entered into their IT systems was used mainly to comply with regulations or to defend against lawsuits, rather than to improve care. As a result, valuable time and energy is spent managing data as opposed to understanding the patient.

Provision of cognitive support for clinicians is perhaps an alien concept to those mired in data processing paradigms.

It seems critical that the National Research Council's recommendations for

"interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering"

occur, in order to change current thinking and practices in HIT design, implementation and lifecycle. Further, this research must occur, and in a manner unbiased by industry interests, before more tens or hundreds of billions of dollars are sunk into yet more HIT systems that miss the mark.

Even the vaunted VistA system of the Veterans Administration has some problems:

Software hiccups cause drug, treatment errors at VA
Associated Press
Posted: January 14, 2009 - 5:59 am EDT

Patients at Veterans Affairs health centers around the country were given incorrect doses of drugs, had needed treatments delayed and may have been exposed to other medical errors because of software glitches that showed faulty displays of their electronic health records.

The glitches, which began in August 2008 and lingered until last month, were not disclosed by the Veterans Affairs Department to patients even though they sometimes involved prolonged infusions of drugs such as heparin, which in excessive doses can be life-threatening, according to internal documents obtained by the Associated Press under the Freedom of Information Act.

There is no evidence that any patients were harmed, even as the VA says it continues to review the situation. But the issue is more pressing as the federal government begins promoting universal use of EHRs. President-elect Barack Obama has made it a part of an additional $50 billion a year in spending for health IT programs that he has proposed.

The VA's recent glitches involved medical data—vital signs, laboratory results and active medications—that sometimes popped up under another patient's name on the computer screen. Records also failed to clearly display a doctor's stop order for a treatment, leading to reported cases of unnecessary doses of intravenous drugs such as blood-thinning heparin.

In a statement, the VA said there were nine reported cases where patients at the VA medical centers in Milwaukee, Durham, N.C., and Marion, Ind., were given incorrect doses—six of them involving heparin drips that were given for up to 11 hours longer than necessary. The other cases involved infusions of either sodium chloride or dextrose mixtures that were prolonged for up to 15 hours past the doctor's prescribed deadline.

This is a rather major "glitch", even more unnerving in that it was sporadic and geographically dispersed.

With these issues in mind, I again ask the question, backed up not just by my own relatively unknown and trivial work but by the national accrediting agency for healthcare in the U.S., and the highest scientific body here as well:

Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?

$50 billion a year is big money that might be better spent elsewhere - such as providing care for the poor and for disadvantaged children - until we know how to get HIT right.

I suggest it may be best not to go all-out for HIT under the current paradigm. It is my belief, in fact, based on the above issues plus a chronic influx of HIT difficulty and mismanagement stories I hear from colleagues, ex-colleagues, recruiters, etc., that healthcare organizations not contractually obligated should consider a postponement of plans to purchase clinical IT (i.e., systems for direct use by clinicians such as EHR's).

This postponement should last at least until the issues that lead to ineffective and counterproductive HIT can be better understood and corrections initiated in the industry.

-- SS