Software defects in life-sustaining medical devices such as pacemakers and infusion pumps could be risking public health, a report by the Software Freedom Law Center (SFLC) has warned.
According to their report, patients, doctors and the public should insist that free and open source software should be the standard approach.
Despite strong evidence linking critical device failures to source code defects, software is considered the exclusive property of its manufacturers and is almost never reviewed by regulators.
The authors are also concerned that a Supreme Court ruling in 2008 has prohibited people from seeking damages in product liability lawsuits by eliminating the only consumer safeguard protecting patients from negligence on the part of device manufacturers.
SFLC general counsel and report author Karen Sandler said that the US Food and Drug Administration needed to require device manufacturers to submit software to the agency for review and safe keeping.
