“Do No Harm” Applies to Medical Software, Says IOM, Medscape, November 11, 2011

Nov 12th, 2011 | By | Category: Media Reports

The Institute of Medicine (IOM) shook the public and the medical establishment in 1999, with its landmark study “To Err Is Human” (summary here) that revealed 98,000 preventable hospital medical errors occur every year in the U.S. 

Fast-forward a dozen years and the IOM is expanding the warning in a new report issued Thursday, November 10, which says medical errors are occurring as a result of computer software, according to an article in Medscape Medical News. (here).

The new report is sponsored by the Department of Health and Human Services (HHS), the IOM urged both government and the private sector to exercise greater oversight over the technology that will manage health information. For example when ordering prescription drugs, a human will input the information into the computer and humans make mistakes.

Humans may also become too reliant on technology and fail to double check whether or not the right medicine was prescribed. The IOM falls short in recommending the FDA regulate medical software apps. According to a report in the Journal of the American Medical Informatics Association, the error rate for electronic prescriptions is about one in ten, the same error rate for humans writing on a prescription pad.

A poorly designed Health IT “can create new hazards in the already complex deliver of care” the report says (here).


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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.