Wednesday, July 22, 2009

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to Koppel and Kreda quite different than mine, which for a time appeared on their national website ( but was later withdrawn apparently due to concerns that such a letter might be viewed as an official organizational position.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).


... 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

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