Navigation Links
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 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 than frustrate disclosure of HIT product shortcomings that have patient safety implications.

Dr. Koppel's research on HIT came to national attention in 2005 with a JAMA article on medication errors associated with computerized physician order entry (CPOE) systems. More recently, his work on errors in bar-coded medication administration and on the interactions between HIT and the organizations implementing it has received international focus. Dr. Koppel has also published widely on the many benefits of HIT.


'/>"/>
SOURCE University of Pennsylvania School of Medicine
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. AtriCure to Present at Thomas Weisel Partners 2007 Healthcare Conference
2. BD to Present at the Bear Stearns 20th Annual Healthcare Conference
3. ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference
4. Dr. Paul Bandt Celebrates 35th Anniversary With Desert Radiologists and a History of Healthcare in Las Vegas
5. Omnicell to Present at Thomas Weisel Healthcare Conference 2007
6. MDS to Present at Thomas Weisel Partners Healthcare Conference
7. Hospira to Present at the Bear Stearns 20th Annual Healthcare Conference on September 11
8. AMICAS to Present at Thomas Weisel Partners Healthcare Conference 2007
9. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
10. Kingfisher Healthcare (KFH) Achieves World Class Quality Platform
11. Omnicom Acquires Leading Healthcare Marketing Communications Firm in China
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2017)... ... 2017 , ... Christie Medical Holdings, Inc. , with its market-leading ... Medical Inc. , a leader in infusion therapy and pain management. , Intravenous ... percent of hospital patients receiving a peripheral IV catheter as part of their treatment ...
(Date:4/27/2017)... ... April 27, 2017 , ... Thinksport, the ... heels of Thinksport’s award-winning sunscreen they’ve used the same scientific approach to solving ... Countless deodorants flood the aisles that contain harmful chemicals that should be put ...
(Date:4/27/2017)... ... , ... Goodcents Deli Fresh Subs announced a franchise expansion agreement today including ... , The first new location will open at the corner of 27th and Randolph ... Lights Drive this fall. And the third location is in the process of being ...
(Date:4/26/2017)... ... 2017 , ... Jump Technologies, Inc., an innovative software company ... a round of funding to accelerate its growth strategies. The $3.5 million investment ... a growth equity firm focused on investments in healthcare and technology companies. This ...
(Date:4/26/2017)... ... April 26, 2017 , ... ... the adoption of e-prescribing as measured in Part D Medicare data. The dataset, ... to pharmacies, either using e-prescribing, faxes or paper. The PaPR (pronounced "paper") ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... -- Vivify Health, the pioneer and market leader of remote ... significant patent for the advancement of healthcare delivery from ... health.  This landmark patent provides the company with broad ... position as the leader in remote care.  ... to apply consumer mobile devices, wireless biometrics, EMR integration ...
(Date:4/20/2017)... , April 20, 2017 ... "Global Biosimilar Pipeline and Market Prospects: Addressing Production ... report to their offering. ... "Global Biosimilar Pipeline and Market Prospects: ... Design" provides an in-depth assessment of the current trends ...
(Date:4/20/2017)... DUBLIN , April 20, 2017 Research ... Delivery Technologies - Innovation Driven by Rapidly Expanding Injectables Market and ... to their offering. ... market for drug delivery technologies will rise from USD 20 Billion ... Global Drug Delivery Technologies - Innovation Driven by Rapidly ...
Breaking Medicine Technology: