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Why Are Healthcare Information Manufacturers Free of All Liability When Their Products Can Result in Medical Errors?
Date:3/24/2009

Commentary in JAMA: Penn Author Urges Changes that Hold Health Care Providers Responsible when Healthcare Technology Errs

PHILADELPHIA, March 24 /PRNewswire-USNewswire/ -- Even when their products are implicated in harm to patients, manufacturers of healthcare information technology (HIT) currently enjoy wide contractual and legal protection that renders them virtually "liability-free," writes Ross Koppel, Ph.D., of the University of Pennsylvania School of Medicine, in the March 25th issue of the Journal of the American Medical Association.

The current system needs to be changed so that all liability does not rest entirely with physicians, nurses, hospitals, and clinics, even when these users of faulty HIT scrupulously follow vendor instructions. Dr. Koppel's piece is co-authored with David Kreda, a software designer.

The HIT industry avoids liability by relying on a legal doctrine known as "learned intermediaries" that holds physicians, nurses, pharmacists, and healthcare technicians responsible for HIT errors because are presumed to be able to identify--and correct-- medical mistakes generated by software faults.

"HIT vendors claim that, because they cannot practice medicine, clinicians should be accountable for identifying errors resulting from faulty software or hardware," said Koppel. "But errors or lack of clarity in HIT software can create serious, even deadly, risks to patients that clinicians cannot foresee."

In one example, a trauma team did manage to catch an error in a piece of faulty vendor software that miscalculated intracranial pressures. Had they not, patients would have been severely threatened and the hospital would have been responsible for the resulting harm. "From an equity standpoint," says Dr. Ross Koppel, "This is unacceptable."

Other examples of internal software mistakes include confusing kilograms and pounds used
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SOURCE University of Pennsylvania School of Medicine
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