The Software Freedom Law Center's latest white-paper, "Killed by Code: Software Transparency in Implantable Medical Devices," examines the strange circumstances around pacemakers and other implanted medical devices. Regulators like the FDA inspect the hardware designs for these devices in great detail, but the crucial software that runs the devices is a closed book — a proprietary secret that's only ever called in for examination when the devices start to crash, with disastrous circumstances.
In 2008, the Supreme Court of the United States' ruling in Riegel v. Medtronic, Inc. made people with IMDs even more vulnerable to negligence on the part of device manufacturers.4 Following a wave of high-profile recalls of defective IMDs in 2005, the Court's decision prohibited patients harmed by defects in FDA-approved devices from seeking damages against manufacturers in state court and eliminated the only consumer safeguard protecting patients from potentially fatal IMD malfunctions: product liability lawsuits. Prevented from recovering compensation from IMD-manufacturers for injuries, lost wages, or health expenses in the wake of device failures, people with chronic medical conditions are now faced with a stark choice: trust manufacturers entirely or risk their lives by opting against life-saving treatment.
We at the Software Freedom Law Center (SFLC) propose an unexplored solution to the software liability issues that are increasingly pressing as the population of IMD-users grows–requiring medical device manufacturers to make IMD source-code publicly auditable. As a non-profit legal services organization for Free and Open Source (FOSS) software developers, part of the SFLC's mission is to promote the use of open, auditable source code5 in all computerized technology. This paper demonstrates why increased transparency in the field of medical device software is in the public's interest. It unifies various research into the privacy and security risks of medical device software and the benefits of published systems over closed, proprietary alternatives. Our intention is to demonstrate that auditable medical device software would mitigate the privacy and security risks in IMDs by reducing the occurrence of source code bugs and the potential for malicious device hacking in the long-term. Although there is no way to eliminate software vulnerabilities entirely, this paper demonstrates that free and open source medical device software would improve the safety of patients with IMDs, increase the accountability of device manufacturers, and address some of the legal and regulatory constraints of the current regime.
(Image: Medtronic EnRhythm Pacing System, a Creative Commons Attribution (2.0) image from winton's photostream)