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:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica ... Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs ... Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/25/2016)... ... 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the ... to iHire in recognition of their exemplary accomplishments in worksite health promotion. , The ... Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... Conference and Scientific Sessions in Dallas that it will receive two significant new ... the grants came as PHA marked its 25th anniversary by recognizing patients, medical ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Research and Markets has announced the ... to 2022" report to their offering. ... patients with kidney failure, it replaces the function of kidneys ... blood and thus the treatment helps to keep the patient ... Increasing number of ESRD patients & substantial ...
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... BRAHMS PCT (procalcitonin) assay as a dedicated testing solution ... this clearance, Roche is the first IVD company in ... sepsis risk assessment and management. PCT is ... levels in blood can aid clinicians in assessing the ...
(Date:6/23/2016)... Bracket , a leading clinical trial technology and specialty ... Bracket eCOA (SM) 6.0, at the 52 nd ... in Philadelphia , Pennsylvania.  A demonstration of ... its kind to fully integrate with RTSM, will be held ... a flexible platform for electronic clinical outcomes assessments that is ...
Breaking Medicine Technology: