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If you had a medical implant would you rather it be closed or open source?
Renegade:
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.
-mwb1100 (December 30, 2011, 12:01 AM)
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I'm rather skeptical of modern medicine. I would feel MUCH better with GPL'd software, and specifically GPL, not BSD.
Some FDA official/officer just got charged with fraud (or something like that). Fluorine is an important component of sarin nerve gas, but we put it in our water/toothpaste/etc. Discussions about putting psychotropics in fast food... Vaccines against breast cancer (or whatever) that cripple women... Industrial grade silicon for breast implants... The list goes on. A quick search reveals a near infinite series of horror stories.
Modern medicine simply scares the b'jeezus out of me.
I just can't get behind corporate interests over health concerns.
zircle:
The way I see it, the source code not open source can actually be a good thing because people might try to fiddle with the code or repair/modify it because they don't want to pay for maintainence from the manufacturer.
This might be a bad analogy, but consider the "black box". It makes maintenance easier because if it is broken, you replace it and if it isn't, you keep it. (You don't try to fix it.)
"a black box refers to a piece of equipment provided by a vendor, for the purpose of using that vendor's product. It is often the case that the vendor maintains and supports this equipment, and the company receiving the black box typically are hands-off."
http://en.wikipedia.org/wiki/Black_box
Renegade:
The way I see it, the source code not open source can actually be a good thing because people might try to fiddle with the code or repair/modify it because they don't want to pay for maintainence from the manufacturer.
This might be a bad analogy, but consider the "black box". It makes maintenance easier because if it is broken, you replace it and if it isn't, you keep it. (You don't try to fix it.)
"a black box refers to a piece of equipment provided by a vendor, for the purpose of using that vendor's product. It is often the case that the vendor maintains and supports this equipment, and the company receiving the black box typically are hands-off."
http://en.wikipedia.org/wiki/Black_box
-zircle (December 30, 2011, 02:49 AM)
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Watch "The Third Letter" I mentioned above. It's a prediction for exactly this situation.
We're currently seeing "Brave New World" and "1984" slowly come to fruition. "Fahrenheit 451" is here as well in the form of SOPA (burn a site rather than a book). I rather doubt that "The Third Letter" won't happen.
Deozaan:
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.-mwb1100 (December 30, 2011, 12:01 AM)
--- End quote ---
Karen, the woman who gave the talk, says she offered to sign NDAs. She just wanted to learn as much as possible about the technology she relied on to save her life if she should go into "sudden death."
Closed source doesn't necessarily mean it is bad or buggy. But due to it's nature, nobody can really say for sure whether it is or not.
Ath:
nobody can really say for sure whether it is or not
-Deozaan (December 30, 2011, 12:02 PM)
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Hm, but who can assure that any outsider can tell from a piece of sourcecode, applicable to hardware they don't know, if there are bugs or 'undesirable features'?
Guess the comment by mwb1100 is closest to reality: The producers of these hard/software combos have high standards to live up to, are checked scrutinized at irregular, unannounced, intervals, and the end-product is thoroughly tested before it's put into an actual patient. If it's FDA-, or other health-related agency, approved, I'll take it any time I need it, without any hesitation.
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