Research Cites Safety Benefits of Free and Open Source Software in Critical
Technology

New York, NY, July 21, 2010//Software vulnerabilities in life-sustaining
medical devices such as pacemakers and infusion pumps pose a growing threat
to public health, warns a new report published by the Software Freedom Law
Center (SFLC).

*Killed by Code: Software Transparency in Implantable Medical Devices* will
be presented at OSCON 2010 on July 23. It addresses the potentially fatal
risk of source code defects in implantable medical devices and explores why
patients, doctors and the public should insist that free and open source
software be the standard approach.

"The findings of the paper are important to anyone who has a friend or loved
one with a pacemaker or insulin pump," said 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."

*The Software Liability Nightmare*

Millions of people with chronic heart conditions, epilepsy, diabetes,
obesity, and even depression depend on Implantable Medical Devices (IMDs)
for their lives but the software that enables the delivery of crucial
treatment remains hidden from patients and their doctors. 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 preemptively by the regulators responsible for ensuring its
safety.

In 2008, the Supreme Court of the United States eliminated the only consumer
safeguard protecting patients from negligence on the part of device
manufacturers by prohibiting people from seeking damages in product
liability lawsuits. Today, people with chronic conditions that require IMD
treatment are now faced with a stark choice: trust manufacturers entirely or
risk their lives by opting against life-saving treatment.

*Why Free and Open Source Software is Safer*

The SFLC's paper proposes a new solution to the software liability nightmare
confronting the medical device field: requiring manufacturers of IMDs to
make source code auditable. Research indicates that software transparency
would make the devices less vulnerable to malicious hackers and security
breaches and the public less vulnerable to negligence by the corporations
that sell them.

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 code in all computerized technology. Though the paper
focuses specifically on the security and privacy risks of implantable
medical devices, they are a microcosm of the wider software liability issues
discussed in the paper. The argument for public access to source code of
IMDs advanced in the paper can, and should be, extended to all the software
people interact with everyday. The well-documented recent incidents of
software malfunctions in voting booths, cars, commercial airlines, and
financial markets are just the beginning of a problem that can only be
solved through software transparency.

To view the paper, click
here<http://www.softwarefreedom.org/resources/2010/transparent-medical-devices.pdf>

To view the Software Freedom Law Show episode about Software Freedom in
Medical Devices, click
here<http://www.softwarefreedom.org/podcast/2010/feb/16/0x21/>

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