Defining AI liability: What past device lawsuits can teach physicians

David Simon, J.D., Ph.D., L.L.M., associate professor of law at Northeastern University, draws on decades of medical device litigation to explain how courts may approach artificial intelligence (AI) in malpractice and product liability cases.

Simon says physicians can expect early AI cases to mirror traditional device lawsuits, where injured patients target manufacturers under product defect or negligence claims. But as AI becomes more embedded in care — from surgical robots to diagnostic software — physicians may face liability when deviating from device specifications or applying untested uses.

“The cases where doctors are involved,” Simon explains, “will be those where the device functions properly, but the physician uses it in a way that differs from the standard of care.”