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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

to derive medication doses based on a patient's weight, and software that erroneously remove warnings about fatal drug allergies. In both cases "learned intermediary" clauses hold that clinicians are responsible for noticing the mistake before prescribing.

Equally unfortunate and unacceptable are the provisions in most HIT contracts that prohibit healthcare organizations from openly disclosing any problems caused by vendor software, even to the other HIT licensees using the same products, e.g., clinicians, hospitals. Such stipulations defeat patient safety efforts and are contrary to the principles of evidence- based medicine, says Koppel.

The authors also identify circumstances where HIT vendors should not be held accountable for patient safety failures arising from their products' misbehavior, e.g., user misuse and medical circumstances not knowable in advance. "Legal and contractual changes must not reduce incentives to vendor innovation," said Koppel. "We must achieve a better balance among patient safety concerns, fairness to clinicians, vendor responsiveness, and vendor marketing." The authors suggest moving the HIT industry toward this balance may require several changes to the status quo, including:

  • State and national organizations with responsibility for inspecting hospitals would have additional power to set rules affecting HIT contract terms.
  • Professional medical organizations taking a stand that HIT contracts containing blanket "hold harmless/learned intermediary" clauses are inconsistent with professional practice. Vendors would then have to focus more strongly on patient safety concerns.
  • Healthcare professionals and their associations lobbying Congress for changes in federal law that would recognize a range of HIT vendors' safety responsibilities--much as with auto manufacturers and seatbelt laws.
  • Altering legal standards to facilitate rather
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SOURCE University of Pennsylvania School of Medicine
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