Thursday, November 11, 2010

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):

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 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


Anonymous said...

"should not be used to penalize those making the information available" -- No one will believe that this is possible. We all know that we will be flatlined, whacked or ruined if we speak up. Happens all the time and no one cares.

Anonymous said...

Why now, AMIA? Why not before this experiment was funded by the taxpayers?

AMIA, after years of deceit and conjoined enrichment with vendors and sleeping in the same bed feathered with greenbacks, is coming clean.

Hospitals too are sleeping with vendors on greenbacks. This would not be that big of a deal for other scenarios, but we are talking about the lives of our family and patients.

These suppurative arrangements evolve create septic care. For one, they evolve to identifying physicians to be champions to preach the HIT gospel to the more skeptical congregants who if they do not become obedient users, become under threat of disruptive behavior by those sleeping in the bed of greenbacks.

And what does AMIA have to say about the years of sham certification that gave the illusion to Congress that the devices are safe?

All the while, patients suffer injuries and deaths because these vapour ware driven devices have been sold on hype and deception.

There is indeed reason to believe that Congress was deceived when it voted to spend $ billions on these experimental devices that create innumerable impediments to safe and efficacious medical care, not having been subject to the Federal Food Drug and Cosmetic Act.