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

Healthcare IT Transparency Could Stand Some Improvement

Transparency in the health IT sector is akin to the transparency of Pb (lead).

The following report comes from the FDA Maude (Manufacturer and User Facility Device Experience) voluntary-reporting database, reported by a (likely unhappy) biomedical engineer a month after the "incident" - the nature of which is deliberately kept hidden.  This is regarding the PICIS "Pulsecheck" EHR for emergency departments:

Report Date     05/14/2010

PICIS INC. CARESUITE ED PULSECHECK S/W, TRANSMISSION & STORAGE PATIENT DATA
Event Type:  Other
Patient Outcome:  Required Intervention

Event Description

The customer has reported a patient incident that has prompted a review of their internal process and possible issues surrounding the incident. The customer report alleges the involvement of picis' ed (emergency dept. ) electronic health record application, whereby, duplicate results were received by the picis ehr application from an enterprise info system, which, when displayed in their entirety may have contributed to some degree of confusion for the treating physician - the context of which the customer has declined to clarify any further.  [What in the world? -ed.] At this time, we have been informed by the customer that they are restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support picis' investigation.

"Restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support Picis' investigation?"

That is perverse on its face, and probably in violation of Joint Commission safety standards on reporting of incidents that could affect other organizations.


Manufacturer Narrative

Picis' investigation into the reported incident is based on a limited exchange of info with the customer, as well as our internal review of the application design and current configuration in use at the reporting site. Review of configuration files, existing system build at the client site, interface specification documents and previous customer communications demonstrate that the customer implemented and accepted the picis edis in 2008. During this process, the picis edis system was configured to display all results sent from the customer's enterprise system rather than configuring the results display in 'overwrite' mode. Prior to acceptance, an investigation by picis and the client revealed that it was the sending system, sending multiple duplicate results messages [great quality - ed.] and a request was made by the customer of that enterprise vendor [I can only wonder who that was - ed.] to investigate. However, due to the enterprise system's protocol for 'add on' tests, it was not possible to utilize the 'overwrite' configuration due to the risk of filtering out unique results and subsequently not presenting the clinicians with important info. Therefore, the customer elected to have all results displayed.

A workaround that apparently, from the limited information provided, led to physician confusion..."the context of which the customer had", not very helpfully, "declined to clarify any further."

Hospitals also are required to have add'l safeguards in place for the handling of critical results including expedited reporting of critical results with a licensed responsible caregiver rather than relying solely on standard results reporting processes (joint commission national patient safety goal 02. 03. 01).

This is not a resounding statement of confidence in health IT...

The customer is currently working with a 3rd party integration consultant to improve the handling of results sent to picis' electronic health record application. We are providing support as it is requested. At this time, no corrective action is needed. 

The "senior leadership" that withheld details was protecting what, exactly?  Money and contracts, perhaps; conflicts of interest, possibly ... but not patients.

All I can say is:

Imagine if this was a report on a new drug suspected of harming people. 

What in heaven's name was going on here?

As I've written many times, and as illustrated by this MAUDE report, the health IT industry must first be transformed into one of evidence-driven IT practices and transparency before anyone touting its products has any business even speaking about the technology "transforming medicine."

-- SS

Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"

At my recent post "Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised" over a massive, outrageous Cerner outage to hospitals contracting their clinical IT via an ASP model (that is, 'software as a service'), I observed:

... The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages.

From the JC's page "About the Joint Commission":

An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

It's time to up the ante regarding this accreditation body, fully aware of health IT risks (e.g., the Dec 2008 Sentinel Events Alert on Health IT) but to date having done little about them.  Through my legal work and my speaking to Plaintiff's attorneys, I am becoming increasingly aware of medical malpractice cases that  involve an EHR or related clinical IT systems at JC-accredited organizations.

In effect, the JC has accredited hospitals whose entire clinical command-and-control structure (the term EHR is an anachronism; these systems are in reality enterprise clinical resource management and clinician workflow control devices) can disappear in the blink of an eye, without warning, raising risk to patients greatly.

If I discover that a patient was harmed or killed as a result of, or related to, this massive recent outage of outsourced medical records/workflow control  infrastructure, I will be recommending that the Joint Commission, including its leadership, which likely certified the hospital(s) involved for safe operations in areas such as Information Management, be named as defendants.

I have informed the JC leadership by email.
 
-- SS

Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality

One manner by which Healthcare's core values are usurped is via distortions and slander about physicians and other clinicians.

At "Health IT: Ddulites and Irrational Exuberance" and related posts (query link) I've described the phenomenon of the:

'Hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.'

I have called this personality type the "Ddulite", which is "Luddite" with the first four letter reversed. I have also pointed out that the two are not exact opposites, as the Luddites did not endanger anyone in trying to preserve their textile jobs, whereas the Ddulites in healthcare IT do endanger patients.

Yet, in the 20 years I've been professionally involved in health IT, I have frequently heard the refrain, usually from IT personnel and their management, that "Doctors resists EHRs because they are [backwards, technophobic, reactionary, dinosaurs, unable/unwilling to change, think they are Gods, ..... insert other slanderous/libelous comment].

I've heard this at Informatics meetings, at medical meetings, at commercial health IT meetings (e.g., Microsoft's Health Users Group, and at HIMSS), at government meetings (e.g., GS1 healthcare), and others.

The summary catchphrase I've heard and seen (even in the comments on this blog) is that doctors are "Luddites" while IT personnel are forward-thinking, know better than doctors, and are "Modernists."

This slander and libel of physicians and other clinicians needs to stop, and the entire issue needs to be reframed.

Doctors are pragmatists. When a new technology is rigorously shown to be beneficial to patients, and (perhaps more importantly) rigorously shown not to be of little benefit or worse, significantly harmful, doctors will embrace it. There are countless examples of this that I need not go into. They also have responsibilities, obligations, ethical considerations, liabilities, and other factors to consider in their decisions:

Pragmatism (Merriam-Webster):

: a practical approach to problems and affairs

The reality is not:


Luddite doctors <---- are in tension with ----> Modernist IT personnel

but is:


Pragmatist doctors <---- are in tension with ----> Ardent technophiles (Ddulites)


The technophiles' views may be due, on the one hand, to ignorance of medicine's true complexities and "innocent" overconfidence in technology. Unfortunately, it is a gargantuan leap of logic to go from "well, computers work in tracking FedEx packages and allowing me to withdraw money from my U.S. bank when I'm abroad, to "therefore with just a little work they will transform medicine."

Anyone familiar with even the most fundamental issues in Medical Informatics is aware of this. (This is the problem with "generic management" of healthcare IT - healthcare amateurs are unfamiliar with these issues.) Due to the complex, messy social, scientific, informational, ethical, cultural, emotional and other issues relatively unique to medicine, that leap from banking/widget tracking/mercantile computing --> medicine is probably more naive than the leap in logic, for instance, that would have a person believe since a hot air balloon can go high in the sky, it can take a person to the moon, as I observed here.

On the other hand the technophile's expressed views can also be a territorial ploy with full awareness of, and reckless disregard for, the consequences of technology's downsides.

(The CIO where I was a CMIO was well-known to be an aficionado of Sun Tzu's "Art of War" in his corporate politics - the polar opposite of a 'team player.' I might add that the doctors were fully expected to be 'team players'.)

Part of the struggle between the health IT industry and medical professionals has also been control of information flow about HIT.

This has been brought to the fore by my observation of the almost uniformly negative comments on today's HIT at the physician-only site Sermo.com. Sermo is populated, I might add, not by computerphobes but by physicians in a wide variety of specialties using computers for social networking. These comments will hopefully soon be published.

(They are not dissimilar to the many comments I reported in my Jan. 2010 post "An Honest Physician Survey on EHR's", although some might call the sponsor of the latter survey, AAPS, biased. I do not think the same can be said of Sermo.com, an open site for all physicians.)

I have mentioned on this blog the numerous impediments to flow of information about health IT's downsides, and these impediments are well described, for example, in the Joint Commission Sentinel Events Alert on Health IT (link), the FDA Internal Memorandum on H-IT Safety (link) and elsewhere (such as at link, link).

The Institute of Medicine of the National Academies noted this in their late 2011 study on EHR safety:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”


I note that the 'impediments to generating evidence' effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians", JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398.

Pragmatist physicians are quite rightly very wary of the technology as it now exists.

Ultimately, even when information on HIT risks or defects does surface, it is highly inappropriately labeled as "anecdotal" (see this post on anecdotes for why this behavior is inappropriate).

This "anecdotalist" phenomenon occurs right up to the HHS Office of the National Coordinator for Health IT (ONC), as I described in my post "Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector" and elsewhere.

Therefore, another part of reframing the pragmatism vs. technophilia issue is for clinicians to put an end to censorship of HIT adverse experiences.

I have the following practical suggestions, used myself, to start to accomplish the latter goal.

These suggestions are in the interest of protecting public health and safety:

When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

  • Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).
  • Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)
  • Inform the State Medical Society and local Medical Society of your locale.
  • Inform the appropriate Board of Health for your locale.
  • If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."
  • Inform a personal attorney.
  • Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.
  • As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:
"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."
  • If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.
  • As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe.

-- SS

Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style

At my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" I wrote:

... It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").

For "anecdotes" of patient harm due to medical devices even from the most reliable of sources to be counted as "evidence" of device risk, apparently, the stories need to be blessed with Statistical Holy Water. The Holy Water must also be of a brand approved by the academic pundits.

For me, this is no longer merely a professional debate. My elderly relative became one of those "anecdotes" in May last year.

I address the casual, Dogbert-style, waving-of-the-hand "Bah!" dismissal of health IT harm "anecdotes" at numerous other posts as well, such as "
EHR Problems? No, They're Merely Anecdotal" and "Health IT: On Anecdotalism and Totalitarianism".

Bah! Your Health IT adverse events reports are anecdotes, and anecdotes don't make data!

In those posts I also mention how Australian informatics professor Dr. Jon Patrick had essentially hit the flaws of this argument out of the Southern hemisphere with a short editorial in the journal "Applied Clinical Informatics" entitled "
The Validity of Personal Experiences in Evaluating HIT." That essay is free at the link and is worth reading.

Interestingly and thankfully, the "anecdotes are meaningless" crowd have now lost, and lost big - Supreme Court style. In fact, the U.S. Supreme Court has shown far more common sense than many esteemed academics and industry pundits.

As noted in this post at Derek Lowe's pharmaceutical industry "In the Pipeline" blog, the company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court.

The Supreme Court would have none of that argument:

"Matrixx’s [Zicam's manufacturer - ed.] premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence.

The full court decision is at this link: http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf (PDF file), but a passage I consider key to this issue is as follows:

... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.

This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.

In essence, it is saying that adverse events reports, especially repeated ones, from trustworthy sources are not to be lightly dismissed, but should serve at the very least as red flags that there may be a systemic problem requiring further investigation.

One wonders how and if public healthcare IT vendors will begin disclosing "anecdotal" reports of their products causing patient harm to their own stockholders.

One also wonders if the academic anecdotalists (up to the level of the chair of the Office of the National Coordinator for Health Information Technology at HHS) will cease their unfettered dismissal of health IT AE reports as mere "anecdotes" and therefore let's roll out this 100% beneficent technology nationwide ASAP:

"Nothing [ONC has] found would give them any pause that a policy of introducing EMR's could impede patient safety." - David Blumenthal

That sounds a bit like the refrain of the makers of Zicam.

One might also wonder if the anecdotalists merely lack common sense, or are using this form of
epistemological dementia to obscure conflict of interest.

On a final note, my favorite comment at the aforementioned "In the Pipeline" blog story is this by anonymous commenter "Still Scared of Dinosaurs":

One of the most important ideas real statisticians must get into their heads is "Thou shalt not worship the 0.05 threshold". The whole concept of "statistical significance" for AEs is idiotic and the fact that Matrixx based any part of their defense on it indicates that their stupidity did not end when they named the company.

Perhaps this Dilbert cartoon is apropos to the Supreme Court decision:


-SS

Addendum:

I thought it appropriate to share these thoughts with the leadership of the Joint Commission, the organization that accredits healthcare organizations in the United States:

From: Scot Silverstein
Sent: Sunday, March 27, 2011 10:41 AM
To: MGiuntoli, Anita; Chassin, Mark; Schyve, Paul; Legaspi, Shirley
Cc: Ross Koppel; 'David Kreda'
Subject: Re: MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL.

Not a complaint this time [about health IT failure - ed.], but an observation.

The JC has noted health IT risks in the Sentinel Events Alert "Safely implementing health information and converging technologies" of 2008.

The company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court.

The Supreme Court would have none of that argument:

"Matrixx’s [Zicam's manufacturer] premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence.

The full court decision is at this link: http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf (PDF file), but a passage I consider key to this issue is as follows:

... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.

This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.

I believe JC should start to pay serious attention to "anecdotal reports" of health IT-caused patient injury, and consider reliable reporting of these events as an Accreditation standard.

As I noted in my July 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" in response to Koppel and Kreda's JAMA article on HIT industry practices, "hold harmless" and "gag" clauses must go, and be replaced with proactive reporting of healthcare IT-related "events."

Scot Silverstein

-- SS

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

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

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."
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