"Hold harmless" clauses in health information technology contracts that absolve vendors of errors or defects in their software are unethical, according to a position paper of the American Medical Informatics Association.

The association ends the paper with a belief that government regulation of health I.T. applications may be necessary, although it does not yet call for regulation.

“Task force members are mindful of the well-motivated controversy surrounding the idea of (increased) government regulation of medical and health-related software. A majority of members, however, are of the view that (1) given the patient safety concerns at the table, (2) in light of noteworthy cases involving adverse events, and (3) because of the need to foster public trust in a rapidly expanding use of electronic health records with embedded decision-support functionality, personal health records, and research tools, some system of government oversight or regulation of health information technology needs to be given serious consideration. Although the form of any such oversight was left for further discussion, we hope that a useful framework will emerge from the additional studies recommended here.”

The paper has a series of recommendations to increase transparency, veracity and accountability in the vendor-customer relationship. It includes specific contract language to protect patient safety and detail the responsibilities that vendors and clients have for a successful implementation. AMIA also calls for health I.T. ethics education and standards for corporate conduct.

"With as much interest and investment in HIT as there is today, AMIA--an unbiased third party--wanted to take a fresh look at gray areas that currently exist between vendors and their customers to see where new practices could be implemented to better support patient outcomes and protect patients, who these systems ultimately serve," says Nancy Lorenzi, AMIA board chair and professor of biomedical informatics at Vanderbilt University in Nashville, Tenn. "We think these recommendations do an excellent job of addressing fairness and balancing accountability in the HIT marketplace and in the health sector."

The position paper is available at http://jamia.org.

--Joseph Goedert


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