Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT

I am both surprised and pleased to read the new report of an American Medical Informatics Association (AMIA) task force, in the form of an AMIA Board Position Paper released today entitled:

"Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force." Goodman, Berner, Dente, Kaplan, Koppel et al. for the AMIA Board of Directors. J Am Med Inform Assoc (2010). doi:10.1136/jamia.2010.008946.

A free PDF is available at this link.

This report may be part of a trend. As I wrote recently at this link:

I was somewhat taken aback by the appearance of the article by Karsh et al. entitled "Health information technology: fallacies and sober realities" (covered at Healthcare Renewal here) in the Oct. 2010 Journal of the American Medical Informatics Association (JAMIA).

I was taken aback since the article rains heavily on the academic memes of healthcare IT as a benign and deterministic solution to healthcare's ills, and of health IT-related adverse outcomes being mere "anecdotes."

It appears that the views on healthcare IT safety, ethics, management practices, etc. appearing on the Healthcare Renewal blog and on my once-controversial academic health IT website "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" (started in 1999) are now becoming mainstream.

Most of the issues in this new AMIA Position Paper have been written about at this blog since 2004, and at my aforementioned academic HIT website since 1999. I will reproduce the abstract of the paper below, but download and read the entire paper (emphases mine):

ABSTRACT
The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. [The "gag clauses." These are exceptionally unethical, in my view, regarding the use of an experimental technology, healthcare IT, on unsuspecting, unconsented patients unaware of health IT risks - ed.] To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values [I've been writing and saying this for many years now - ed.]; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others’ efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety. [Regulation has been another issue I have focused upon, especially after holding a management role in Big Pharma - ed.]

Also notable was this proclamation:

... “Hold harmless” clauses in contracts between Electronic Health Application vendors and purchasers or clinical users, if and when they absolve the vendors of responsibility for errors or defects in their software, are unethical. [I note that, somewhat remarkably, this is not the more typical hedged academic "may be unethical" statement- ed.] Some of these clauses have stated in the past that HIT vendors are not responsible for errors or defects, even after vendors have been informed of problems.

Unethical, indeed, as per my JAMA letter of July 22, 2009 on that issue entitled "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (link) and per my more detailed essay at my Drexel HIT website (link).

Also remarkable were these statements:

... For-profit manufacturers of healthcare products are bound by values which may at times conflict. For instance, as entities in a marketplace, they are duty-bound to provide a financial return to those investors who have contributed resources in anticipation of their success. Yet, as developers and manufacturers of products that affect the health of people, they are no less obligated to ensure, to the extent possible, that their products are safe and effective, and beneficially support patients [that goes without saying - ed.] and those who treat and care for them. [That is, clinicians, who through their unpaid hard work using oft ill-designed HIT systems are currently used as beta testers and, through 'hold harmless' clauses, as an insurance company and, quite frankly, as cannon fodder - ed.]

... Contracts should require that system defects, software deficiencies, and implementation practices that threaten patient safety should be reported, and information about them be made available to others, as appropriate. Vendors and their customers, including users, should report and make available salient information about threats to patient safety [I've also been writing this for years; it's common sense - ed.] resulting from software deficiencies, implementation errors, and other causes. This should be done in a way easily accessible to customers and to potential customers. This information, when provided to customers, should be coupled with applicable suggested fixes, and should not be used to penalize those making the information available. [There should be as little fear of reporting HIT problems as in reporting medication problems - ed.]

... If appropriate for their size and mission, vendors and client institutions contribute to the growth of biomedical knowledge by conducting HIT research [including research on how to remediate the HIT itself and the IT industry creeds, customs and traditions that cause suboptimal design and implementation in the first place - ed.] … authors of scientific reports should not be prevented from identifying devices, tools, and systems by name in publications.

… There are situations in which HIT vendors pursue joint marketing agreements with institutions that adopt vendors’ products and by which these institutions become a part of the vendors’ marketing program [I believe that hospitals should never allow themselves to become IT marketing and promotion operations - ed.], often in exchange for discounts, payments, stock options, or favorable treatment by the vendor. In at least some cases, these agreements include provisions whereby healthcare institutions that serve as demonstration sites for particular products receive compensation when other institutions adopt products from the same vendor. The Task Force notes that such agreements might place the “referring” institutions in a conflict of interest [a common topic on this blog -ed.], and therefore recommends that:

• Any such conflicts should be eliminated or managed, including disclosure, according to current standards.

• Where such agreements are made, they should include a provision whereby any payment or other compensation contingent on the sale of a system to another party must be disclosed to that other party.

• Payments or gifts to individuals and institutions, including institutional officials, clinicians, etc, should be disclosed. Alternatively, they should be addressed by entities’ internal mechanisms for managing conflicts of interest and commitment, perhaps along the lines of the “rebuttable presumption” standard endorsed by the Association of American Medical Colleges. The goal of the standard is “to ensure that institutions systematically review any financial interest that might give rise to the perception of a conflict of interest, and further, that they limit the conduct of human subjects research by financially interested individuals to those situations in which the circumstances are compelling.

The new AMIA Position Paper and the aforementioned paper on HIT fallacies and realities seem to reflect a welcome transformation or even about-face for AMIA. I am likely considered "radioactive" by some in that organization for espousing similar views dating back to the late 1990's, when expression of such views was uncommon and even frowned upon. Academia has not been highly tolerant of heterodoxy in many domains for quite some time.

One wonders if that stigma will "stick" in view of the increasing realization that such views were not heretical, but forward-thinking along the lines of my early medical mentor, the late Victor P. Satinsky, MD of Hahnemann Medical College and Hospital:

From http://www.upenn.edu/gazette/0298/0298obits.html: Dr. Victor P. Satinsky, C'34, Philadelphia, a cardiovascular surgeon at the old Hahnemann Hospital who helped develop coronary-bypass surgery; September 7 [1997]. He is also credited with 30 major medical innovations and the invention of the Satinsky clamp, now a standard instrument in cardiovascular surgery. He joined Hahnemann (now part of the Allegheny health system [as of 2010 now Drexel College of Medicine - ed.]) in 1946 to do thoracic-surgical research, and from 1961 till his retirement in 1977 he was the research director of its cardiovascular institute. Dr. Satinsky liked to refer to himself on promotional materials as 'the Renaissance Doctor', as he was also a poet, a playwright (some of his plays were produced in London), a painter, a clarinetist, and a fencer; he was known at Hahnemann for practicing his swordsmanship in the halls and classrooms of the hospital. And at the age of 80, he earned a black belt in aikido, and subsequently taught it. Although he had no religious training, during the Second World War he once filled in as a rabbi on a troopship going to Europe when he learned it had chaplains, but no rabbi. He also had taught himself psychiatry and while at Hahnemann developed educational programs for young people; the first, for gifted high-school students, began in 1961. He later added programs for disadvantaged youth, for young people with emotional problems, and one for college dropouts. On retiring, he set up the Satinsky Institute for Human Resource Development to continue this work, which he ran until his death at 84 years.

Dr. Satinsky's short, simple and unyielding credo was:

"Critical thinking always, or your patient's dead."

-- SS

Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT

I am both surprised and pleased to read the new report of an American Medical Informatics Association (AMIA) task force, in the form of an AMIA Board Position Paper released today entitled:

"Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force." Goodman, Berner, Dente, Kaplan, Koppel et al. for the AMIA Board of Directors. J Am Med Inform Assoc (2010). doi:10.1136/jamia.2010.008946.

A free PDF is available at this link.

This report may be part of a trend. As I wrote recently at this link:

I was somewhat taken aback by the appearance of the article by Karsh et al. entitled "Health information technology: fallacies and sober realities" (covered at Healthcare Renewal here) in the Oct. 2010 Journal of the American Medical Informatics Association (JAMIA).

I was taken aback since the article rains heavily on the academic memes of healthcare IT as a benign and deterministic solution to healthcare's ills, and of health IT-related adverse outcomes being mere "anecdotes."

It appears that the views on healthcare IT safety, ethics, management practices, etc. appearing on the Healthcare Renewal blog and on my once-controversial academic health IT website "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" (started in 1999) are now becoming mainstream.

Most of the issues in this new AMIA Position Paper have been written about at this blog since 2004, and at my aforementioned academic HIT website since 1999. I will reproduce the abstract of the paper below, but download and read the entire paper (emphases mine):

ABSTRACT
The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. [The "gag clauses." These are exceptionally unethical, in my view, regarding the use of an experimental technology, healthcare IT, on unsuspecting, unconsented patients unaware of health IT risks - ed.] To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values [I've been writing and saying this for many years now - ed.]; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others’ efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety. [Regulation has been another issue I have focused upon, especially after holding a management role in Big Pharma - ed.]

Also notable was this proclamation:

... “Hold harmless” clauses in contracts between Electronic Health Application vendors and purchasers or clinical users, if and when they absolve the vendors of responsibility for errors or defects in their software, are unethical. [I note that, somewhat remarkably, this is not the more typical hedged academic "may be unethical" statement- ed.] Some of these clauses have stated in the past that HIT vendors are not responsible for errors or defects, even after vendors have been informed of problems.

Unethical, indeed, as per my JAMA letter of July 22, 2009 on that issue entitled "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (link) and per my more detailed essay at my Drexel HIT website (link).

Also remarkable were these statements:

... For-profit manufacturers of healthcare products are bound by values which may at times conflict. For instance, as entities in a marketplace, they are duty-bound to provide a financial return to those investors who have contributed resources in anticipation of their success. Yet, as developers and manufacturers of products that affect the health of people, they are no less obligated to ensure, to the extent possible, that their products are safe and effective, and beneficially support patients [that goes without saying - ed.] and those who treat and care for them. [That is, clinicians, who through their unpaid hard work using oft ill-designed HIT systems are currently used as beta testers and, through 'hold harmless' clauses, as an insurance company and, quite frankly, as cannon fodder - ed.]

... Contracts should require that system defects, software deficiencies, and implementation practices that threaten patient safety should be reported, and information about them be made available to others, as appropriate. Vendors and their customers, including users, should report and make available salient information about threats to patient safety [I've also been writing this for years; it's common sense - ed.] resulting from software deficiencies, implementation errors, and other causes. This should be done in a way easily accessible to customers and to potential customers. This information, when provided to customers, should be coupled with applicable suggested fixes, and should not be used to penalize those making the information available. [There should be as little fear of reporting HIT problems as in reporting medication problems - ed.]

... If appropriate for their size and mission, vendors and client institutions contribute to the growth of biomedical knowledge by conducting HIT research [including research on how to remediate the HIT itself and the IT industry creeds, customs and traditions that cause suboptimal design and implementation in the first place - ed.] … authors of scientific reports should not be prevented from identifying devices, tools, and systems by name in publications.

… There are situations in which HIT vendors pursue joint marketing agreements with institutions that adopt vendors’ products and by which these institutions become a part of the vendors’ marketing program [I believe that hospitals should never allow themselves to become IT marketing and promotion operations - ed.], often in exchange for discounts, payments, stock options, or favorable treatment by the vendor. In at least some cases, these agreements include provisions whereby healthcare institutions that serve as demonstration sites for particular products receive compensation when other institutions adopt products from the same vendor. The Task Force notes that such agreements might place the “referring” institutions in a conflict of interest [a common topic on this blog -ed.], and therefore recommends that:

• Any such conflicts should be eliminated or managed, including disclosure, according to current standards.

• Where such agreements are made, they should include a provision whereby any payment or other compensation contingent on the sale of a system to another party must be disclosed to that other party.

• Payments or gifts to individuals and institutions, including institutional officials, clinicians, etc, should be disclosed. Alternatively, they should be addressed by entities’ internal mechanisms for managing conflicts of interest and commitment, perhaps along the lines of the “rebuttable presumption” standard endorsed by the Association of American Medical Colleges. The goal of the standard is “to ensure that institutions systematically review any financial interest that might give rise to the perception of a conflict of interest, and further, that they limit the conduct of human subjects research by financially interested individuals to those situations in which the circumstances are compelling.

The new AMIA Position Paper and the aforementioned paper on HIT fallacies and realities seem to reflect a welcome transformation or even about-face for AMIA. I am likely considered "radioactive" by some in that organization for espousing similar views dating back to the late 1990's, when expression of such views was uncommon and even frowned upon. Academia has not been highly tolerant of heterodoxy in many domains for quite some time.

One wonders if that stigma will "stick" in view of the increasing realization that such views were not heretical, but forward-thinking along the lines of my early medical mentor, the late Victor P. Satinsky, MD of Hahnemann Medical College and Hospital:

From http://www.upenn.edu/gazette/0298/0298obits.html: Dr. Victor P. Satinsky, C'34, Philadelphia, a cardiovascular surgeon at the old Hahnemann Hospital who helped develop coronary-bypass surgery; September 7 [1997]. He is also credited with 30 major medical innovations and the invention of the Satinsky clamp, now a standard instrument in cardiovascular surgery. He joined Hahnemann (now part of the Allegheny health system [as of 2010 now Drexel College of Medicine - ed.]) in 1946 to do thoracic-surgical research, and from 1961 till his retirement in 1977 he was the research director of its cardiovascular institute. Dr. Satinsky liked to refer to himself on promotional materials as 'the Renaissance Doctor', as he was also a poet, a playwright (some of his plays were produced in London), a painter, a clarinetist, and a fencer; he was known at Hahnemann for practicing his swordsmanship in the halls and classrooms of the hospital. And at the age of 80, he earned a black belt in aikido, and subsequently taught it. Although he had no religious training, during the Second World War he once filled in as a rabbi on a troopship going to Europe when he learned it had chaplains, but no rabbi. He also had taught himself psychiatry and while at Hahnemann developed educational programs for young people; the first, for gifted high-school students, began in 1961. He later added programs for disadvantaged youth, for young people with emotional problems, and one for college dropouts. On retiring, he set up the Satinsky Institute for Human Resource Development to continue this work, which he ran until his death at 84 years.

Dr. Satinsky's short, simple and unyielding credo was:

"Critical thinking always, or your patient's dead."

-- SS

Senator Grassley asks hospitals about experiences with federal health information technology program

At a brief Oct. 24, 2009 posting "Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors" (link) I mentioned an Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices. That letter is here (PDF).

A followup investigation has now begun by Sen. Grassley of hospitals themselves. Here is a link to his Senate website and a copy of the new letter dated Jan. 20, 2010.

This followup letter is being sent to:

Banner Health, Brigham & Women's Hospital Case Western Reserve University Hospital Health System, Catholic Healthcare West, Cedars Sinai Children’s National Medical Center, Geisinger Medical Center, Hackensack Hospital, HCA TriStar, Intermountain Healthcare, Indiana University Hospital, Jefferson Regional Medical Center, Kaiser Permanente System, Marshfield Clinic, Massachusetts General Hospital, Mayo Clinics, Memorial Hermann Healthcare System, Methodist Hospital of Indiana, North Shore-Long Island Jewish Health System, Palo Alto Medical Foundation, Rainbow Babies and Children’s Hospital, Saint Mary Mercy Hospital, Seattle Children’s Hospital, Stony Brook University Medical Center, Trinity Hospital System Tufts Medical Center, University of California San Francisco Medical Center, University of Pennsylvania Health System, University of Pittsburgh Medical Center, University of Virginia Medical Center, and Vanderbilt University Hospital.

According to Huffington Post Investigative Fund reporters Fred Schulte and Emma Schwartz in "Electronic Health Records Probe Expands to Hospitals", these organizations were chosen based on both "positive and negative" press reports, complaints, whistleblowers, and Grassley's own research. The Huffington Post quoted Sen. Grassley's spokesperson Jill Gerber in that regard.

The questions are probing:

1. Please describe in detail your facility’s process for identifying HIT products for purchase and choosing an HIT vendor(s).

a. What is the personnel structure of those involved in the purchase?
b. To what extent do physicians and other health care providers within your facility provide input regarding the specific HIT items to be implemented within your facility?
c. Who or what department within your facility is responsible for making HIT purchase decisions?

I have been writing for years on the strategically unsound practice of hospitals leaving these processes up to business IT (MIS) personnel and other non-clinical management, perhaps only then seeking a qualified physician information technology expert - or more typically, appointing a figurehead physician IT amateur - after the acquisition. That person is tasked with "making it all work" and convincing other doctors to use the technology.

(I use the term "figurehead" in that the incumbent Clinician Director of HIT or Chief Medical Information Officer/CMIO usually is an "internal consultant" with no direct control over resources or personnel, a Director of Nothing or Chief of Nothing if you will. I use the term "amateur" in the same sense that I am a telecommunications amateur, fine for an avocation but not for a lead role in a mission-critical setting.)

2. Three of the companies that I wrote to in October 2009 informed me that they do not manufacture HIT software or hardware, but instead assist their health care clients, such as hospitals, with the implementation and management of HIT systems. To what extent do you contract with such entities to assist with the purchase, implementation and/or management of HIT products in your facility?

I have also written on the huge amount of precious healthcare money wasted on management consulting companies for health IT, when a fraction of that money could pay for in-house, permanent expertise.

3. Please describe the training process implemented in your facility to familiarize employees with new technology systems.

a. How does your facility budget for HIT training?
b. What are the vendors’ roles in helping your facility train in the use of their products?

I sincerely hope these hospitals have not "shorted" training. On the other hand, that these systems require extensive training to use properly is part of the problem. Finally, no manner of training can compensate adequately for mission hostile health IT.

4. Does your facility have any policies or processes governing the reporting of problems or concerns by your health care employees related to the HIT products or systems implemented in your facility? If so, please provide a description of the policies or processes. If not, please explain why not.

I would have added "effective policies or procedures" to that question.

5. When patient care and/or safety problems related to HIT systems arise, how are these problems reported within the facility and what is the process or mechanism for addressing them?

a. Are these problems also reported to the HIT vendor, and if so, what is the process for reporting them?
b. If patient care and/or safety problems related to HIT systems are not routinely reported to the HIT vendors, please explain how your facility decides which problems or issues are reported to a vendor and/or addressed by a vendor and which problems are addressed internally by the facility.

These are questions about fundamental processes of quality control of the IT devices themselves. It would perhaps be a criminal affair if pharmaceutical companies and medical device companies did not have such processes in place regarding their products.

6. Please describe in detail any system your facility has in place to document, track, catalogue, and maintain complaints, concerns or issues related to HIT products that may directly or indirectly involve or impact the delivery of care or patient safety.

One would think there would be a robust database or library of such issues at every hospital deploying HIT. Not having such a resource would in my opinion reflect negligence in both the IT and clinical domains. It will be interesting to see the contents, or if they do not exist, the reasons why.

7. Please provide a list of HIT problems or complaints that have been identified by or reported to your facility since January 2008 that directly or indirectly impacted patient safety or the delivery of care, including any complications or adverse events that have occurred as a result of HIT product design and/or usability. Please describe whether and how each of those problems or complaints was resolved and whether these issues have resulted in a change in policy to prevent the problem in the future.

The answers should prove interesting. Hopefully, "near misses" are accounted for in prior questions.

8. Does your facility have policies regarding the discussion of problems in your HIT systems with other health care facilities or with government officials or any individuals or entities outside your facility? If so, please describe those policies. To what extent are these policies driven by contractual agreements with the HIT vendors, and to what extent do they stem from internal processes? Please provide examples of contracts with HIT vendors that include non-disclosure clauses.

Considering the widespread and uncomfortably similar stories people in my field have been hearing for quite awhile (in my case, for the past fifteen+ years), and as I have written before, there seems to be very little cross-institutional knowledge sharing on HIT pitfalls.

It was, in fact, not easy to get a book about HIT problems published for a wide audience - even in a de-identified form - in 2009. Most accounts of health IT consist of what Greenhalgh calls "sanitized accounts of project success."

These accounts are of little didactic value in helping other organizations avoid known deleterious practices (such as talent mismanagement, internal strife, failure to adapt IT to the environment, over-reliance on vendor promises, contract pitfalls, etc.) leading to HIT failure.

9. Some of the HIT vendors stated specifically in their responses to me that they do not include language that would hold them harmless for failures of their products or for the company’s own negligence or recklessness. However, they may include provisions that spell out the vendor’s and the health care client’s respective legal responsibilities and obligations in the use of the product. For example, one vendor stated that it is accountable for the performance of its product as long as the client uses the product appropriately. Another vendor stated that it is not liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients.

a. Do any of the HIT vendors include language in their contracts with your facility that could be considered “hold harmless” provisions, i.e., the transferring of liability associated with the services or products provided to your facility, or otherwise limit their liability? If so, please provide a copy of sample contracts containing such provisions.

Denial of inclusion of "hold harmless" provisions on the one hand, and statements about being "accountable for the performance of its product as long as the client uses the product appropriately" (whatever that means) and "not [being] liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients" (what are such systems for, playing Pong?) on the other hand, seem to be at odds.

10. What is the relationship between your facility and any HIT vendors?

a. HIT vendors that manufacture software, hardware and/or other products purchased by health care facilities have stated in their responses to me that they do not offer any financial incentives for purchasing their products, such as shares in the company or financial interests in a particular product. At least one vendor stated, however, that it does offer financial incentives in the form of discounts based on purchase size. Another vendor said that health care clients may receive royalty payments when the clients collaborate with the vendor to develop a product. What financial interest, if any, does your facility have in HIT vendors and/or their products?

b. Do the vendors offer your facility and/or any of your health care providers any financial incentives for purchasing the vendors’ products? If so, please describe the types and value of the incentives.

These are clearly questions about conflict of interest. My best advice to these organizations is "be honest."

11. Did your staff, health care providers and/or facility receive any payments, product discounts, or other items of value from any vendor for discussing and/or promoting that vendor’s HIT products? If so, please list the different types of payments and discounts and their value.

This is a question along the lines of the "Key Opinion Leaders" nurtured by pharmas with a green fertilizer that comes from trees, not cows. One vendor did seem to indicate that this occurs in the "10 secrets the EHR companies don't want you to know" essay here.

While that essay must be taken with a grain of salt, it would not surprise me to find out the HIT industry and the pharma industry share practices in common. Today's B-schools and our current dishonest culture produce the leaders and officers of both, after all.

-- SS

Senator Grassley asks hospitals about experiences with federal health information technology program

At a brief Oct. 24, 2009 posting "Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors" (link) I mentioned an Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices. That letter is here (PDF).

A followup investigation has now begun by Sen. Grassley of hospitals themselves. Here is a link to his Senate website and a copy of the new letter dated Jan. 20, 2010.

This followup letter is being sent to:

Banner Health, Brigham & Women's Hospital Case Western Reserve University Hospital Health System, Catholic Healthcare West, Cedars Sinai Children’s National Medical Center, Geisinger Medical Center, Hackensack Hospital, HCA TriStar, Intermountain Healthcare, Indiana University Hospital, Jefferson Regional Medical Center, Kaiser Permanente System, Marshfield Clinic, Massachusetts General Hospital, Mayo Clinics, Memorial Hermann Healthcare System, Methodist Hospital of Indiana, North Shore-Long Island Jewish Health System, Palo Alto Medical Foundation, Rainbow Babies and Children’s Hospital, Saint Mary Mercy Hospital, Seattle Children’s Hospital, Stony Brook University Medical Center, Trinity Hospital System Tufts Medical Center, University of California San Francisco Medical Center, University of Pennsylvania Health System, University of Pittsburgh Medical Center, University of Virginia Medical Center, and Vanderbilt University Hospital.

According to Huffington Post Investigative Fund reporters Fred Schulte and Emma Schwartz in "Electronic Health Records Probe Expands to Hospitals", these organizations were chosen based on both "positive and negative" press reports, complaints, whistleblowers, and Grassley's own research. The Huffington Post quoted Sen. Grassley's spokesperson Jill Gerber in that regard.

The questions are probing:

1. Please describe in detail your facility’s process for identifying HIT products for purchase and choosing an HIT vendor(s).

a. What is the personnel structure of those involved in the purchase?
b. To what extent do physicians and other health care providers within your facility provide input regarding the specific HIT items to be implemented within your facility?
c. Who or what department within your facility is responsible for making HIT purchase decisions?

I have been writing for years on the strategically unsound practice of hospitals leaving these processes up to business IT (MIS) personnel and other non-clinical management, perhaps only then seeking a qualified physician information technology expert - or more typically, appointing a figurehead physician IT amateur - after the acquisition. That person is tasked with "making it all work" and convincing other doctors to use the technology.

(I use the term "figurehead" in that the incumbent Clinician Director of HIT or Chief Medical Information Officer/CMIO usually is an "internal consultant" with no direct control over resources or personnel, a Director of Nothing or Chief of Nothing if you will. I use the term "amateur" in the same sense that I am a telecommunications amateur, fine for an avocation but not for a lead role in a mission-critical setting.)

2. Three of the companies that I wrote to in October 2009 informed me that they do not manufacture HIT software or hardware, but instead assist their health care clients, such as hospitals, with the implementation and management of HIT systems. To what extent do you contract with such entities to assist with the purchase, implementation and/or management of HIT products in your facility?

I have also written on the huge amount of precious healthcare money wasted on management consulting companies for health IT, when a fraction of that money could pay for in-house, permanent expertise.

3. Please describe the training process implemented in your facility to familiarize employees with new technology systems.

a. How does your facility budget for HIT training?
b. What are the vendors’ roles in helping your facility train in the use of their products?

I sincerely hope these hospitals have not "shorted" training. On the other hand, that these systems require extensive training to use properly is part of the problem. Finally, no manner of training can compensate adequately for mission hostile health IT.

4. Does your facility have any policies or processes governing the reporting of problems or concerns by your health care employees related to the HIT products or systems implemented in your facility? If so, please provide a description of the policies or processes. If not, please explain why not.

I would have added "effective policies or procedures" to that question.

5. When patient care and/or safety problems related to HIT systems arise, how are these problems reported within the facility and what is the process or mechanism for addressing them?

a. Are these problems also reported to the HIT vendor, and if so, what is the process for reporting them?
b. If patient care and/or safety problems related to HIT systems are not routinely reported to the HIT vendors, please explain how your facility decides which problems or issues are reported to a vendor and/or addressed by a vendor and which problems are addressed internally by the facility.

These are questions about fundamental processes of quality control of the IT devices themselves. It would perhaps be a criminal affair if pharmaceutical companies and medical device companies did not have such processes in place regarding their products.

6. Please describe in detail any system your facility has in place to document, track, catalogue, and maintain complaints, concerns or issues related to HIT products that may directly or indirectly involve or impact the delivery of care or patient safety.

One would think there would be a robust database or library of such issues at every hospital deploying HIT. Not having such a resource would in my opinion reflect negligence in both the IT and clinical domains. It will be interesting to see the contents, or if they do not exist, the reasons why.

7. Please provide a list of HIT problems or complaints that have been identified by or reported to your facility since January 2008 that directly or indirectly impacted patient safety or the delivery of care, including any complications or adverse events that have occurred as a result of HIT product design and/or usability. Please describe whether and how each of those problems or complaints was resolved and whether these issues have resulted in a change in policy to prevent the problem in the future.

The answers should prove interesting. Hopefully, "near misses" are accounted for in prior questions.

8. Does your facility have policies regarding the discussion of problems in your HIT systems with other health care facilities or with government officials or any individuals or entities outside your facility? If so, please describe those policies. To what extent are these policies driven by contractual agreements with the HIT vendors, and to what extent do they stem from internal processes? Please provide examples of contracts with HIT vendors that include non-disclosure clauses.

Considering the widespread and uncomfortably similar stories people in my field have been hearing for quite awhile (in my case, for the past fifteen+ years), and as I have written before, there seems to be very little cross-institutional knowledge sharing on HIT pitfalls.

It was, in fact, not easy to get a book about HIT problems published for a wide audience - even in a de-identified form - in 2009. Most accounts of health IT consist of what Greenhalgh calls "sanitized accounts of project success."

These accounts are of little didactic value in helping other organizations avoid known deleterious practices (such as talent mismanagement, internal strife, failure to adapt IT to the environment, over-reliance on vendor promises, contract pitfalls, etc.) leading to HIT failure.

9. Some of the HIT vendors stated specifically in their responses to me that they do not include language that would hold them harmless for failures of their products or for the company’s own negligence or recklessness. However, they may include provisions that spell out the vendor’s and the health care client’s respective legal responsibilities and obligations in the use of the product. For example, one vendor stated that it is accountable for the performance of its product as long as the client uses the product appropriately. Another vendor stated that it is not liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients.

a. Do any of the HIT vendors include language in their contracts with your facility that could be considered “hold harmless” provisions, i.e., the transferring of liability associated with the services or products provided to your facility, or otherwise limit their liability? If so, please provide a copy of sample contracts containing such provisions.

Denial of inclusion of "hold harmless" provisions on the one hand, and statements about being "accountable for the performance of its product as long as the client uses the product appropriately" (whatever that means) and "not [being] liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients" (what are such systems for, playing Pong?) on the other hand, seem to be at odds.

10. What is the relationship between your facility and any HIT vendors?

a. HIT vendors that manufacture software, hardware and/or other products purchased by health care facilities have stated in their responses to me that they do not offer any financial incentives for purchasing their products, such as shares in the company or financial interests in a particular product. At least one vendor stated, however, that it does offer financial incentives in the form of discounts based on purchase size. Another vendor said that health care clients may receive royalty payments when the clients collaborate with the vendor to develop a product. What financial interest, if any, does your facility have in HIT vendors and/or their products?

b. Do the vendors offer your facility and/or any of your health care providers any financial incentives for purchasing the vendors’ products? If so, please describe the types and value of the incentives.

These are clearly questions about conflict of interest. My best advice to these organizations is "be honest."

11. Did your staff, health care providers and/or facility receive any payments, product discounts, or other items of value from any vendor for discussing and/or promoting that vendor’s HIT products? If so, please list the different types of payments and discounts and their value.

This is a question along the lines of the "Key Opinion Leaders" nurtured by pharmas with a green fertilizer that comes from trees, not cows. One vendor did seem to indicate that this occurs in the "10 secrets the EHR companies don't want you to know" essay here.

While that essay must be taken with a grain of salt, it would not surprise me to find out the HIT industry and the pharma industry share practices in common. Today's B-schools and our current dishonest culture produce the leaders and officers of both, after all.

-- SS

Cross-occupational invasion of medicine by IT, exemplified

I have written on these pages about a cross-occupational invasion of medicine by IT personnel, wherein the IT personnel seem to forget that they are facilitators of healthcare, not enablers, with a primary purpose of serving the needs of clinicians.

The HISTalk site recently posted an attorney's views on the "hold harmless" and "defects nondisclosure" controversy first reported on by Koppel and Kreda in JAMA, and amplified in my letter to the editor in the same publication. The attorney's views at HISTalk (link below) are quite reasonable regarding such practices.

However, the user comments thread reveals some attitudes exemplifying the "invasion" of which I've written. Both the attorney's post and the responses by a poster under the nom-de-blog "Programmer" to others' concerns can be read at this link.

Read it all. The attitudes of "Programmer" (assuming they are genuine, which is likely) are remarkable.

-- SS

On HIT Vendor Nondisclosure of Nondisclosure Agreements

Seen at the HIStalk blog in News of 8/19/09:

A couple of readers wisely suggested that I not consider running nondisclosure language from vendor contracts. Reasons: (a) it might identify the client since terms are often customized; (b) it might violate vendor privacy requirements and get a client or me in trouble; (c) clients might not want to share anyway since they may like the idea of being prohibited from sharing patient safety information. A couple of vendors e-mailed to say they don’t include such terms. I’d be very surprised if Cerner and Epic don’t based on my limited history with them.

My response to the HISTalk blog owner, Tim, and other interested parties:

Sent: Thursday, August 20, 2009 7:32 AM To: mr_histalk@yahoo.com Cc: david.kreda@gmail.com; rkoppel@sas.upenn.edu; Emilia_DiSanto@finance-rep.senate.gov; MChassin@jointcommission.org; pschyve@jointcommission.org Attachments:

To: HISTalk blog Re: nondisclosure of nondisclosure agreements by HIT vendors Tim, Those who've written advising you *not* to post the language of HIT nondisclosure agreements are in fact correct: As per Koppel and Kreda's March 2009 "Hold Harmless" article in JAMA and my July 21 JAMA letter to the editor commenting on it, nondisclosure and hold harmless agreements stifle HIT innovation, put patients at risk, and cause healthcare executives to violate their Joint Commission and fiduciary responsibilities to protect patients and workers from undue physical or legal jeopardy. You and other bloggers should *not* be the ones to clandestinely obtain and post such language. The HIT vendors themselves, in an atmosphere of transparency and in deference to patients safety and to hospital governance, should gladly and transparently do so if such language exists in their contracts. This assumes, of course, that HIT vendors hold patient safety and practitioners' rights as a high priority. S.S.

I think that says what needs to be said.

-- SS

CCHIT Has Company

It appears CCHIT, an offspring of the large HIT trade association HIMSS, won't get its wish for Health IT Certification hegemony. I think the outcome of a multidisciplinary HIT policy workgroup's deliberations on this issue reasonable:

Aug. 17, 2009

iHealthBeat.org

Policy Committee OKs Plan To Establish Multiple EHR Certifiers

On Friday, the [HHS] Health IT Policy Committee adopted recommendations that called for multiple entities to certify electronic health record systems, Health Data Management reports.

The committee's certification and adoption work group issued the recommendations (Goedert [1], Health Data Management , 8/14).

To receive official certification, EHR systems must meet a minimum set of criteria and achieve the "meaningful use" objectives of the federal economic stimulus package. Under the stimulus law, health care providers who demonstrate meaningful use of EHRs will receive Medicare and Medicaid incentive payments (O'Harrow, Washington Post , 8/15).

Recommendations

The work group recommended that:

* Certification criteria allow for open-source software;
* Certification processes should let health care organizations qualify for EHR subsidies under Stark Law exceptions that allow organizations to subsidize the cost of EHRs for physicians;
* Certification should last for four years;
* Multiple groups perform HHS certification under a single set of criteria;
* The National Institute for Standards and Technology should participate in accreditation and certification decisions;
* The Office of the National Coordinator for Health IT should define certification criteria;
* ONC should create an accreditation process for certification groups;
* Officials develop alternative certification processes for self-developed software; and
* Vendors are required to receive certification from only one group ( Health Data Management , 8/14).

The work group said it envisions the establishment of 10 to 12 different EHR certification groups, in addition to the Certification Commission for Health IT (Manos, Healthcare IT News , 8/14).

The recommendations now go to HHS for consideration ( Health Data Management, 8/14).

The workgroup said CCHIT is too closely aligned with the health IT industry, noted that the industry trade group HIMSS helped found CCHIT, and noted that CCHIT's members includes several people with ties to HIMSS and health IT companies. They were clearly uncomfortable with the potential conflicts of interest, especially if CCHIT gained sole responsibility for HIT "certification." [A term I put in quotes since it really is "features qualification" at this point, not certification such as a physician receives after passing Specialty Boards - ed.]

Having been on the receiving end of CCHIT bullying myself ("Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT"), it's clear most Americans don't like bullies, especially bullying from powerful lobbying organizations such as HIMSS and its progeny. (It's also become clear they don't like 1000+ page healthcare reform plans shoved, unread, down their throats by political bullies.)

By the way, since the July 21, 2009 publication of my JAMA letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" and Koppel and Kreda's reply, pointing out the terrible situation that HIT "defects nondisclosure" and "hold harmless" clauses create for hospital executives, physicians and patients, I have heard from the Joint Commission, but not from HIMSS.

Perhaps HIMSS leadership believes I have nothing worthy to add to the discussion. (Perhaps another 'Open Letter' is called for.)

-- SS

Shareholders Take Notice That Patients Used As Unconsented Guinea Pigs, Physicians as Bank by Health IT Vendors

At my Jan. 2009 post "Waste Feared in Digitizing Patient Records: Wall Street Journal" and others I have written about the illegitimacy of the abuse of patient rights, as well as abuse of clinician trust committed by health IT vendors using patient care settings as an unconsented software development laboratory and beta testing site. I wrote:

The IT industry uses hospitals, doctor offices and patients as alpha and beta test sites and subjects, unregulated by the FDA or other agency. When HIT fails, there is no central agency to report the failures to, only the vendor. Fixes go into a "queue" for remediation, with priority level decided by the vendor.

Clinicians are also used by HIT vendors as a form of bank and insurance company. HIT vendors depend on (free!) physician and nurse ingenuity in finding workarounds to the ill-conceived design and user experience (link to my eight part series on this issue) that their products usually present so that their products can even be salable. This, of course, taxes and tires clinicians at the expense of patients and hampers and complicates EHR diffusion. Clinicians become, in effect, unpaid development consultants to HIT companies (or, perhaps more accurately, since EHR's do become essential to medical practice, indentured servants to the HIT vendors).

Also, under the unethical, Joint Commission-violating and executive fiduciary responsibility-violating "Hold Harmless" and "Defects Nondisclosure" HIT contracting clauses, clinicians pay the price for bad patient outcomes, even if the causative factor was HIT errors. (See Health IT Hold Harmless and Defects Gag Clauses: Have Hospital Executives Violated Their Fiduciary Responsibilities By Signing Such Contracts?, and my July 22, 2009 JAMA letter to the editor on this issue.) Thus, clinicians become an insurance company, bank and risk safety net (a term that might not be inappropriate is "suckers") for the HIT vendors. This is not an optimal way to treat one's ultimate customers.

HIT is a mess, but that doesn't stop HIT vendors from simply lying about their financial status and future projected business to the investor community.

Now, HIT company shareholders are taking note of these industry (mal)practices. These (mal)practices are hitting shareholders where it really hurts - in the pocketbook. My comments in [red italics]:

Allscripts shareholders file class action suit
Healthcare IT News
August 05, 2009 | Bernie Monegain, Editor

CHICAGO – Allscripts shareholders have filed a lawsuit alleging the company broke federal securities laws when it went live with the newest version of its EHR clinical software, Touchworks [i.e., a "version" that had not been thoroughly tested and validated outside hospital walls, a practice HIT vendors get away with due to the near spinelessness of regulators such as the Joint Commission, FDA, and others - ed.] .

Allscripts officers say the suit is without merit.

[As I pointed out at "Do Healthcare Organizations Truly Want Electronic Health Records To Succeed?" regarding the lawsuit my own organization filed against this company and its partner Medicomp Systems (civil complaint PDF here), where incomplete, untested and non-functional software was sold by this company for use by our physicians, I'd say the allegations do deserve further investigation - ed.]

"We are aware of the lawsuit and have reviewed the complaint," Allscripts officials said Wednesday. "While it is our policy not to comment on the substance of pending litigation, we believe the lawsuit is without merit and will vigorously defend the allegations."

The lawsuit, which seeks class action status, has been filed in the United States District Court for the Northern District of Illinois on behalf of those who purchased the common stock of Allscripts-Misys Healthcare Solutions, Inc. (formerly known as Allscripts Healthcare Solutions, Inc.) between May 8, 2007 and Feb. 13, 2008. It names Allscripts-Misys Healthcare Solutions, CEO Glen Tullman and Chief Financial Officer William J. Davis as defendants.

At a user conference in Orlando, Fla., July 30-31, Allscripts CEO Glen Tullman told some of the attendees that Allscripts might have rushed version 11 of Touchworks to market too quickly.

["Might have" rushed it out too quickly? It had, in fact, been delayed several months according to the lawsuit. "Perhaps" the delays needed to be lengthier. In other words, f*** the doctors and patients, we're getting this cr** out the door so as to not further injure our profits with further delays - ed.]

He said the company was caught off guard by providers who found new uses for the product.

["New uses?" (We all know that when companies sell broken HIT, it's always the doctors' fault) ... Likely translation: clinicians tried to practice medicine the way they saw best, not the way the Allscripts software designers saw best or "approved of." (Arrogance, anyone?) The clinician users tried to use the software in a real-world setting while applying the improvisations needed for proper patient care in a poorly bounded, uncertain environment (per Nemeth and Cook) and found the software's support of the uncertainties and realities of the clinical environment, and likely the software's stability itself, poor - ed.]

Tullman and Faisal Mushtaq, the company's senior vice president of product development, said Allscripts has invested roughly $14 million to improve stability and performance [after throwing the doctor and patient test subjects to the wolves after a "might have rushed it out" premature rollout - ed.], and they expect the next version, to be rolled out soon, to work more smoothly.

[I really despise the "version 1.1 will be much better" in healthcare settings, as it goes back to the issue of sick patients as unconsenting subjects in a software testing lab, and physicians as a bank and insurance company for the vendors when things go wrong -ed.]

The complaint alleges that defendants failed to disclose the following adverse facts:

* Allscripts lacked the necessary resources [i.e., smart, a.k.a expensive, people who actually know what they're doing thanks to the appropriate informatics education and expertise. Were the ones they did have tied up in patchwork remediation and crisis management? - ed.] to install V-11 software at customer sites; Allscripts had no historical basis to estimate the completion of V-11 or the impact V-11 sales might have on the company's 2007 revenues and earnings [if they made stuff up, that would not be too uncommon in today's financial environment. Also, the "lack of necessary resources", not unique to Allscripts, portends quite poorly for the planned, manic rush to national EHR by the cavalierly short deadline of 2014 - ed.]

* The complexity of V-11 had materially and adversely lengthened the sales cycle and revenue recognition cycle for the company's V-11 sales contracts [Another instantiation of my belief that business IT sales practices are inappropriate for clinical IT, where there are unconsenting "customers" with special rights - patients. One also wonders: did clinicians balk at a Rube Goldberg contraption but hospital executives purchase it anyway? - ed.];

* Allscripts was currently experiencing adverse and continuing delays in the installation of V-11 software systems [which were perhaps not revealed by clients, thanks to secrecy clauses regarding defects and problems as noted by Penn's Koppel and Kreda in JAMA? - ed];

* Based on the foregoing, defendants had no reasonable basis for their statements concerning Allscripts' current and future financial performance and projections.

The law firm of Izard Nobel LLP, based in West Hartford, Conn. announced the class action lawsuit on Wednesday.

Click here to read the complaint: http://www.izardnobel.com/allscriptsmisyshealthcare/ .

The PDF of this class action complaint is here.

So, it seems entirely possible the defects nondisclosure clauses promulgated by these vendors, and accepted by meek hospital executives and CIO's, may have supported and/or led to a situation of shareholder fraud.

It would be ironic indeed if these cavalier HIT practices end, and the HIT vendors began to adhere to principles of responsibility and resilience engineering, not due to regulatory pressures but due to shareholder lawsuits.

Finally, Allscripts CEO Tullman was a campaign adviser to the President on healthcare. It's perhaps due to advisers like this that national plans for healthcare reform are sinking like the Titanic. As per my Feb. 18, 2009 Wall Street Journal letter:

... it is the government that has been deceived [rather than the public] by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants ... The government has bought the IT magic bullet exuberance hook, line and sinker.

-- SS

addendum:

Perhaps I should self-turn in this post as "fishy" to the healthcare reform snitch line at "flag@whitehouse.gov"?

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

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

JAMA letter: "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards"

My letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA yesterday. A preview of the letter can be seen here, or a full version here if you subscribe to JAMA.

The letter was in response to Koppel and Kreda's groundbreaking March 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians."

The 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 such 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. In the Drexel website essay I also noted that:

... these stipulations [hold harmless and gag clauses in contracts] further instantiate my observation that health IT lacks the rigor of medical science itself, its major Achilles heel.

Koppel and Kreda note in their JAMA reply to my JAMA letter that:

Dr Silverstein's letter adds context to our Commentary on HIT vendors' self-protective "hold harmless" clauses while introducing an important discussion about hospitals' and vendors' possible violations of Joint Commission standards. We agree with Silverstein about the misapplication of the standard business software contracting model.

Of interest, the American Medical Informatics Association (AMIA) had authored a reply to Koppel and Kreda quite different than mine, which for a time appeared on their national website (www.jamia.org) but was later withdrawn apparently due to concerns that such a letter might be viewed as an official organizational position. It was entitled "Response to Commentary in JAMA -- Ross Koppel, David Kreda" and can be read in its entirety here.

The AMIA response piece concluded:

"While we support increased transparency around error disclosure, the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced. Such an approach would stifle innovation and not achieve the desired goals. At a minimum equal attention needs to be given to the role that provider organizations bring to configuration, management and oversight of the software and related processes."

In fact, Koppel and Kreda addressed the provider side issues extensively in their article.

Of interest, JAMA did not publish the AMIA response but instead published mine. Perhaps it's because JAMA felt I had something important to say, as opposed to simply making excuses for HIT vendors and valuing prevention of "stifling of innovation" over hospital leadership's safety and fiduciary obligations to patients and staff.

"The belief that the best approach to improving HIT safety is via regulation is misplaced?" (Misplaced how, exactly?) Tell that to the airline or public transit or pharma or the medical device industries. Or to the public whose care is increasingly dependent upon these HIT systems.

It is my firm opinion that "innovation" done recklessly, in secrecy, without accountability, and via exploitation is not innovation at all.

-- SS

July 23 addendum:

Dr. Koppel has forwarded to me a letter he and Mr. Kreda submitted to AMIA in response to AMIA's aforementioned critique of his March 2009 JAMA "Hold Harmless Clause" article. Koppel and Kreda's letter, "On the AMIA Response to Commentary in JAMA by Ross Koppel and David Kreda" can be read here (MS Word .doc format).

Highlights:

... Where the AMIA authors disagree with us is the emphasis placed on errors produced in the coupling. [The coupling of healthcare organization and software, i.e., alterations and customizations beyond the control of the software vendor - ed.] We say a vast number or errors are generated in the marriage. But they say we have essentially ignored how many errors are created by doctors and hospitals seeking to consummate their relationship with HIT systems in situ ...

... A brief recap of our JAMA commentary seems in order. We wrote about: (1) the HIT vendor “non-disclosure” clauses that prevent clinicians from sharing information about errors generated from faulty software; (2) the clauses that remove all vendor responsibility for errors in their systems – and place all responsibility on clinicians and hospitals (the “hold harmless/learned intermediary” clauses); (3) the need to protect vendors from responsibilities for errors introduced when hospitals implement HIT or when untrained or incompetent clinicians use the HIT; and (4) the need for more balanced contracts that are fair to clinicians and hospitals ...

... Given that we addressed the non-software issues we are said to have ignored, we are not sure why our JAMA commentary earned the response it received on official AMIA letterhead. We hope, therefore that this letter can further a longer conversation about the many ways to make clinical IT software and its implementation better. Nonetheless, we stand by our statement that the imbalance in incentives we described in our JAMA Commentary is a structural obstacle that on balance hurts improving the clinical part of clinical IT.

Read the whole thing at the link above. (I placed Koppel and Kreda's response to AMIA on my faculty server. The response, to the best of my knowledge, was not published by AMIA itself.)

-- SS