Karen M. Sandler General Counsel July 23, 2010 OSCON Free Software on Medical Devices: Unchain My Heart!

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Presentation transcript:

Karen M. Sandler General Counsel July 23, 2010 OSCON Free Software on Medical Devices: Unchain My Heart!

Our software must be safe ● Cars ● Voting machines ● Financial markets ● Medical devices – Yesterday! 34,000 malfunctioning Boston Scientific ICDs

I am a lawyer. My story:

I am an activist.

I am a patient.

I am a cyborg?

Pacemakers can be maliciously hacked

I am an author.

Software has bugs. ≈

● In 2008, ≈ 350,000 pacemakers and 140,000 ICDs were implanted in the United States ● SEI estimates one defect for every 100 lines of code ● One study showed 98% of software failures analyzed in recalls would have been detected with all pairs testing.

Security through obscurity just doesn't work. ≈

Free and open source code – gives users the ability to independently assess the system and its risks – enables bugs to be patched more easily and quickly – removes dependence on a single party

The FDA – does not typically review source code – does not have a clear set of mandatory requirements for software – does not keep a repository of source code – preempts patients from suing under state product liability laws

I am a citizen.

I am a daughter.

Killed by Code: Software Transparency in Implantable Medical Devices

SFLC is a 501(c)(3) charity in the USA and accepts donations on its website at This talk and the slides are: Copyright © 2010, Karen M. Sandler These slides, this talk, and audio/video recordings thereof are licensed under the Creative Commons Attribution-No Derivative Works 3.0 United States License!