Closed Source Can you audit the software that goes in your body?

This was interesting:
http://www.boingboing.net/2010/07/22/can-you-audit-the-so.html

Original paper here:
http://www.softwarefreedom.org/resources/2010/transparent-medical-devices.html

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-Sebastien, RepRap.org library gnome.

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Remember, you're all RepRap developers (once you've joined the super-secret developer mailing list), and the wiki, RepRap.org, [reprap.org] is for everyone and everything!

Very interesting article, Thanks!

I certainly like the idea of opening up source code for auditing when it comes to life saving devices, however, it seems this would only further protect a rogue company from lawsuits (We made our source open for auditing. We can not be at fault for the software bugs that killed your father/mother/husband/wife -- they had full capability of examining the source before it was installed to determine whether it was suitable for their use or not.)

I think ultimately, manufacturing and distribution companies must be held liable, and reasonable court cases against them allowed to move forward. There must be some pressure to ensure safety guards, quality assurance, and testing exist. To rely only on third party auditing companies seem a bit hopeful and unlikely to prevent or fix problems. Also, it should be noted that auditing code cannot substitute for rigorous Q&A testing -- it is great for ensuring maintainability and understandability (if you allow audits/reviews to come full circle.. not sure how this would occur under such an open system either..)

At the very least, the article seems to point out lack of oversight within the FDA for medical devices; this in and of itself would seem a good target to correct for, including reinstating the ability for lawsuits by consumers who are negligently hurt or killed by faulty software in the medical devices they've used.

But our personal context is people who build machines to build stuff like this.

For herbal medicine, no one will sponsor an FDA study to see if it works. (Note: some of it does, some of it doesn't - those details are beyond the scope of this discussion.)

Similarly, Big Pharma and Big Medicine aren't going to touch open-source hardware with a 10 ft, jewel-encrusted platinum pole. And to be blunt, we do need to test stuff like this a bit before implanting it. But, at the same time, opensource medical hardware in the developing world can save and improve millions of lives.

Now, if you'll excuse me, I've got to go overclock my pacemaker.

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-Sebastien, RepRap.org library gnome.

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Remember, you're all RepRap developers (once you've joined the super-secret developer mailing list), and the wiki, RepRap.org, [reprap.org] is for everyone and everything!