A report from the Software Freedom Law Center says that source code defects in implantable medical devices could be result in a life-or-death situation for its users. In the report, "Killed by Code: Software Transparency in Implantable Medical Devices," SFLC advocates free and open-source software as a the standard approach. The center says that despite evidence that links critical device failures to source code defects, FDA rarely preemptively reviews software.
"The findings of the paper are important to anyone who has a friend or loved one with a pacemaker or insulin pump," says the paper's author and SFLC General Counsel, Karen Sandler. "Clearly, we need mandatory, public, and broad safety review of code that runs these devices. At the very least, the U.S. Food and Drug Administration must require device manufacturers to submit software to the agency for review and safe keeping."