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If you had a medical implant would you rather it be closed or open source?

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Deozaan:
This is a really interesting ~15 minute audio clip from Open Source Conference.

Some time ago, Karen Sandler was diagnosed with hypertrophic cardiomyopathy, a medical condition in which the heart muscle thickens, greatly increasing the chances of sudden death. A defibrillator implant was recommended. Of rightful curiosity, Karen asked what software ran the implant, and if she could have a look at its source code before entrusting her life to a gamble on its quality. After many a confused look, much finger pointing and buck passing, the buck landed back on her, and the cat was let out of the bag.
-http://itc.conversationsnetwork.org/shows/detail5091.html
--- End quote ---

Read/listen to the rest of the story here.

40hz:
Hmm...

From the above link (emphasis added):

Medical devices are approved by the Food and Drug Administration (FDA), which never reviews source code unless the administration has a sense that there might be a problem with the device. Instead, it relies on the self-appraised reports published by the device manufacturer or the software vendor. Beside a general guideline as to format, there are no specific requirements mandated by the FDA about what these reports must contain.

The rationale behind this approach is that, each device being different, the FDA worries that if they mandate specific requirements, they might miss something important. And because they do not understand the intricacies of each device as well as the manufacturer does, it makes more sense for the manufacture to determine what tests to perform to validate the quality, correctness and accuracy of the device.
--- End quote ---



I wonder if this is the reason why the initials of so many government agencies end up having three letters.

Renegade:
Oh god... You MUST watch "The Third Letter":

http://www.vodo.net/otherworlds

That has a bunch of films in it, but watch "The Third Letter".

Answer... OPEN SOURCE GNU GPL ONLY.

Remember, open source can still have strings attached. Open source does NOT mean free. There are free licenses, like BSD and GNU GPL, and they are also open source, but...

cranioscopical:
This is a really interesting ~15 minute audio clip...
-Deozaan (December 29, 2011, 07:03 PM)
--- End quote ---
I'd rather it be closed. I don't like open sores.  :o
 

mwb1100:
I haven't followed any of the links in this thread so far, but I do want to say that I used to work for a medical device manufacturer (our site made defibrillators and ECG monitors) and I do want to say a few things:

  - I can understand that patients might like to have the firmware source made available
  - keep in mind that there are in fact trade secrets used in the firmware that could be damaging to the manufacturer if made easily available to competitors
  - the outfit that I worked for took safety *very seriously*.  I have no qualms saying that safety was the primary concern. Reliability was held to a high standard as well.
  - while the FDA didn't directly inspect the code (as far as I know - I imagine that they could request it, and maybe even did), they did hold testing to a high standards. And the FDA could and would perform intensive audits - unannounced - that sometimes took more than a month to complete.
 
I'm not trying to say that the current system is perfect or that it cannot be improved, but I do want to say that there are valid, reasonable arguments for why device software can't necessarily be easily open sourced and that the regulatory environment isn't useless.

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