Manufacturers of health care information technology (HIT) currently benefit from wide contractual and legal protections that render them virtually “liability-free” when their products are implicated in harm to patients, according to commentary in the March 25 issue of the Journal of the American Medical Association.
The lead author of the commentary, Ross Koppel, PhD, of the University of Pennsylvania School of Medicine, writes that the system needs to be changed so that all liability does not rest entirely on physicians, nurses, hospitals, and clinics when the users are following vendor instructions
Currently, to avoid vendor liability, the HIT industry relies on a legal doctrine known as “learned intermediaries,” which holds physicians, nurses, pharmacists, and health care technicians accountable for HIT errors, even when the HIT is faulty.
“HIT vendors claim that, because they cannot practice medicine, clinicians should be accountable for identifying errors resulting from faulty software or hardware,” says Koppel. “But errors or lack of clarity in HIT software can create serious, even deadly, risks to patients that clinicians cannot foresee.”
Additionally, Koppel points out the provisions in most HIT contracts that prohibit health care organizations from openly disclosing any problems caused by vendor software, even to other HIT licensees using the same products, defeating patient safety efforts and contradicting principles of evidence-based medicine.
Koppel and co-author David Kreda, a software designer, provide a list of suggestions to move the HIT industry toward greater balance, including granting additional power to set rules affecting HIT contract terms to state and national organizations with responsibility for inspecting hospitals.