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July 23, 2010
Killed by Code?
Slashdot and Boingboing both pointed this week to a publication by the Software Freedom Law Center titled "Killed by Code: Software Transparency in Implantable Medical Devices"
. The page at that URL has the full text and you can download PDF and Postscript versions if you want.
The SFLC, chaired by Eben Moglen, is an advocacy organization for free/open software. In this case they're arguing that the closed proprietary software of IMD - implanted medical devices - is another instance of IP can kill. They have a raft of scary statistics on product recalls of IMDs and note that although the hardware parts of these devices are regulated and tested by the FDA the brains - the software that controls the device - is not only not tested, it's not testable. It's an opaque black box that exists and is distributed, revised, and updated (or not) at the manufacturer's whim. If the manufacturer goes bankrupt or leaves the medical device field the code goes with it.
This puts patients in a place where they either have to trust these manufacturers literally with their lives, or turn down potentially life-saving treatments. SFLC argue that this is not an acceptable position and that the code as well as the hardware should be subject to review, to recall, and ideally to replacement with open source that could be inspected, debugged, and maintained by those who care the most about it.
Which is, you know, an admirable idea. And also approximately as likely as my suddenly sprouting a prehensile tail. What's far more likely is that there will be a bug, and someone - or many someones will die. There will be lengthy court proceedings - made more difficult because in 2008 the US Supreme Court (in a case known as Riegel v. Medtronic, Inc.) prohibited patients harmed by defects in FDA-approved devices from seeking damages against manufacturers in state court and also eliminated product liability lawsuits against manufacturers of approved devices. However, state suits are not the only possible avenue.
As usually happens with these things if the outcry gets big enough then Congress will feel compelled to act, but neither the courts nor Congress are big fans of open source software. The solution will probably be more FDA oversight or something along those lines. In this sense the SFLC paper does a good job of highlighting a potential danger but a poor job of sketching out how we might address such dangers.
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