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Author Topic: If you had a medical implant would you rather it be closed or open source?  (Read 6105 times)
Deozaan
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« on: December 29, 2011, 07:03:24 PM »

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.

Read/listen to the rest of the story here.
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40hz
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« Reply #1 on: December 29, 2011, 07:35:29 PM »

Hmm...

From the above link (emphasis added):

Quote
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.



I wonder if this is the reason why the initials of so many government agencies end up having three letters.
« Last Edit: December 29, 2011, 09:07:57 PM by 40hz » Logged

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Renegade
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« Reply #2 on: December 29, 2011, 08:28:29 PM »

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...

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cranioscopical
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« Reply #3 on: December 29, 2011, 08:38:42 PM »

This is a really interesting ~15 minute audio clip...
I'd rather it be closed. I don't like open sores.  ohmy
 
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Chris
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« Reply #4 on: December 30, 2011, 12:01:32 AM »

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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Renegade
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« Reply #5 on: December 30, 2011, 02:20:54 AM »

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.


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.

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« Reply #6 on: December 30, 2011, 02:49:01 AM »

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
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Renegade
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« Reply #7 on: December 30, 2011, 02:56:16 AM »

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

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.




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Deozaan
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« Reply #8 on: December 30, 2011, 12:02:05 PM »

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.

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.
« Last Edit: December 30, 2011, 02:51:53 PM by Deozaan » Logged

Ath
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« Reply #9 on: December 30, 2011, 12:22:30 PM »

nobody can really say for sure whether it is or not
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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f0dder
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« Reply #10 on: January 05, 2012, 08:11:23 AM »

Fluorine is an important component of sarin nerve gas, but we put it in our water/toothpaste/etc.
Hydrogen is an important component of Hydrogen bombs, but we put it is in our water.
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- carpe noctem
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« Reply #11 on: January 05, 2012, 09:28:10 AM »

Fluorine is an important component of sarin nerve gas, but we put it in our water/toothpaste/etc.
Hydrogen is an important component of Hydrogen bombs, but we put it is in our water.


Check up on sodium fluoride and hydrogen fluoride. There are tons of articles, documents, documentaries on the topic. They are pure toxins. Anyone that doesn't believe it is more than welcome to chomp on a teaspoon of it. Just make certain to write your last will and testament first.

The hydrogen in hydrogen bombs is tritium/deuterium, which are only found in extremely small trace amounts in normal water. If you have a glass of tritium or deuterium, sell it. It's worth quite a bit. Wink (If you have lots, sell it to Iran as they won't be able to buy much of anything in the near future.)

It's funny that you bring this up. I just finished a blog post...

http://cynic.me/2012/01/0...-call-them-what-they-are/

If I were to add to my comment in that previous post, I'd add in that GMOs are biological weapons - bio-warfare.

You can check up on them and find out just how toxic they are. There is a lot of information available on the topic.

I just can't get on the band wagon. When all the evidence shows that corporate interests come first before health, and that health concerns are largely ignored... Nah... Trust levels are below zero.




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JavaJones
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« Reply #12 on: January 05, 2012, 04:21:35 PM »

Getting rather off-topic now I guess, but in regards to fluoride in the water, let's consider not what harm it may be causing (which is debated but documented), rather what *good* is it doing, if any. The evidence for any positive benefit from fluoride at concentrations as low as in our water supply is... scant. In other words we're ingesting fluoride for no good reason. There are a variety of theories, ranging on the "conspiracy spectrum" from "We had good reason to believe it was beneficial when the policy was implemented" to "We needed a good way to get rid of excess fluoride from other manufacturing processes" (the latter of which seems rather far-fetched but quite scary if even remotely true).

Regardless of the reason it's there, the only useful question in my view is whether it actually does any *good*. Continuing something simply because it does not/may not do any harm is not reason enough to continue.

- Oshyan
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Renegade
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« Reply #13 on: January 05, 2012, 07:03:13 PM »

Getting rather off-topic now I guess, but in regards to fluoride in the water, let's consider not what harm it may be causing (which is debated but documented), rather what *good* is it doing, if any. The evidence for any positive benefit from fluoride at concentrations as low as in our water supply is... scant. In other words we're ingesting fluoride for no good reason. There are a variety of theories, ranging on the "conspiracy spectrum" from "We had good reason to believe it was beneficial when the policy was implemented" to "We needed a good way to get rid of excess fluoride from other manufacturing processes" (the latter of which seems rather far-fetched but quite scary if even remotely true).

Regardless of the reason it's there, the only useful question in my view is whether it actually does any *good*. Continuing something simply because it does not/may not do any harm is not reason enough to continue.

- Oshyan

+1

As far as I can discover, there is zero benefit to it. The *only* evidence where it is less toxic is in topical application, and even then, there's no evidence that it is beneficial.

If this is the kind of science that modern medicine is offering, then back to the original topic, I see significant reason for serious concern and think that GPL'd software is the only truly sane solution to the problem.

Did anyone watch "The Third Letter" that I posted above? It is EXACTLY bang on this topic.


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« Reply #14 on: January 05, 2012, 07:50:44 PM »

As far as I can discover, there is zero benefit to it. The *only* evidence where it is less toxic is in topical application, and even then, there's no evidence that it is beneficial.

IIRC they started putting fluoride in the water back when to (allegedly) help prevent tooth decay/cavities/etc. The local city water plant was included in this fiasco. However... We had our own well, so I just got plain ol' natural ground water throughout my youth. I've never had a cavity in my life...And most of my fluoride drinking peers have had most of their heads replaced.

So I'll vote yes to it being completely pointless also.
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JavaJones
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« Reply #15 on: January 05, 2012, 09:37:20 PM »

It's not science though, it's politics. The science is what tells us fluoride is unnecessary. It's politicians in various forms that keep fluoride living on in our water supply. And Stoic, I agree, I grew up drinking water out of a spring, now that I live in a city I try to only drink filtered tap water (takes out the fluoride and chlorine). Hardly any cavities, especially compared to my friends. But that's all anecdotal and not really necessary given there is "hard science" showing essentially no benefit, not to mention potential risks from ingesting it. As Renegade said, the only potentially beneficial effects shown were with *topical* application, and even then then are apparently better options for preventing tooth decay.

- Oshyan
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f0dder
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« Reply #16 on: January 06, 2012, 10:40:34 AM »

Anyway, trolling aside, it seems a bit weird to put fluoride in the water supply - wouldn't it be more appropriate to put it in toothpaste?
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« Reply #17 on: January 06, 2012, 11:21:01 AM »

Anyway, trolling aside, it seems a bit weird to put fluoride in the water supply - wouldn't it be more appropriate to put it in toothpaste?

That assumes people will actually use it. Water is a bit more of a necessity (can't go more than 3 days without it they say). Hell they'll probably start putting Chantix in the water next to eliminate smokers.
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« Reply #18 on: January 06, 2012, 11:24:17 AM »

Anyway, trolling aside, it seems a bit weird to put fluoride in the water supply - wouldn't it be more appropriate to put it in toothpaste?

That assumes people will actually use it. Water is a bit more of a necessity (can't go more than 3 days without it they say). Hell they'll probably start putting Chantix in the water next to eliminate smokers.
Well, I guess the reason for putting it in the water supply is THEY need it in your bloodstream to boost the effectiveness of the psychotropic drugs they add to your cereals - confining it to toothpaste would only help against cavities :-)
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« Reply #19 on: January 06, 2012, 02:51:10 PM »

Anyway, trolling aside, it seems a bit weird to put fluoride in the water supply - wouldn't it be more appropriate to put it in toothpaste?

That assumes people will actually use it. Water is a bit more of a necessity (can't go more than 3 days without it they say). Hell they'll probably start putting Chantix in the water next to eliminate smokers.


You joke about that now... (I'm not kidding... see below...)


Anyway, trolling aside, it seems a bit weird to put fluoride in the water supply - wouldn't it be more appropriate to put it in toothpaste?

That assumes people will actually use it. Water is a bit more of a necessity (can't go more than 3 days without it they say). Hell they'll probably start putting Chantix in the water next to eliminate smokers.
Well, I guess the reason for putting it in the water supply is THEY need it in your bloodstream to boost the effectiveness of the psychotropic drugs they add to your cereals - confining it to toothpaste would only help against cavities :-)


(I'm getting a hint of sarcasm, flavoured with moderate overtones of cynicism... Wink )

Yeah, yeah, yeah... I suppose WE should take off our tinfoil hats for a moment... Well...

http://www.thedaily.com/p.../052211-news-lithium-1-5/

(Graphic there - can't quote here.)

http://www.dailymail.co.u...-lower-suicide-rates.html


Quote
Should we drug the drinking water? Adding lithium to the taps 'could lower suicide rates'

Lithium has been heralded by some experts as the next potential flouride, after scientists found suicide rates were lower in areas where the drinking water had higher concentrations of the element.

Researchers from the Medical University of Vienna compared the suicide rates in different regions of Austria with the natural lithium concentrations in the drinking water.


Laugh it up. That's just the start.

http://www.guardian.co.uk...d-we-put-lithium-in-water

Quote
Should we put lithium in the water?

A psychiatrist in Ireland has suggested that putting psychiatric medicine in drinking water could cut the suicide rate

It sounds like science fiction: a consultant psychiatrist in Ireland proposed last week that mass medication could be used to make us all happier. Aldous Huxley had his soma; Dr Moosajee Bhamjee, former Labour party politician (he accidentally won a seat while campaigning for "the protest vote" in Clare in 1992), says his government should add lithium to the water supply.


http://ag.arizona.edu/azw...r/awr/july00/feature1.htm

Quote
Developed to promote human health and well being, certain pharmaceuticals are now attracting attention as a potentially new class of water pollutants. Such drugs as antibiotics, anti-depressants, birth control pills, seizure medication, cancer treatments, pain killers, tranquilizers and cholesterol-lowering compounds have been detected in varied water sources.


http://www.msnbc.msn.com/...urking-us-drinking-water/

Quote
A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows.

To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe.


Ah, yeah... Constant, continual exposure to small amounts of dangerous drugs is safe...

There is a very good reason why some of these drugs have extreme warnings. They are DANGEROUS!


There are other calls in the medical community to start putting other psychotropics in the water supply. (I forget the reference at the moment -- it was out of a university in the UK.)

You can't make this stuff up.

It's all there in plain sight. No "conspiracy theory" needed. If anything, this is "conspiracy history/fact".




Putting lithium in the water supply is forced medication. It's utterly insane for many reasons. And yet, there are a half-dozen or do references right out of the mainstream media right above.

You don't need a tinfoil hat to read what's right in front of you.


And THIS is what modern medicine is? Forced medication? Putting psychotropic drugs in the water supply? For real?


--- Just to put a tiny bit of this in perspective -- the above stuff is just the tip of the iceberg. I could go on at length about other things, however, some would probably be too inflammatory for some people. It's probably inflammatory enough to point out that there is serious consideration being given to the thought that "putting lithium in the water is a good thing", even when it's got numerous mainstream sources to back it up.


Back to the original post --- I firmly believe that software in medicine like that should be open source, GPL'd software.





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« Reply #20 on: January 06, 2012, 03:00:25 PM »

Shades of Miranda!

(In Serenity, the government put a pacifying agent in the water of a colony to calm them.  It was an unmitigated failure- it either pacified them to death, or turned them into a raving monster)
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« Reply #21 on: January 06, 2012, 03:07:35 PM »

Shades of Miranda!

(In Serenity, the government put a pacifying agent in the water of a colony to calm them.  It was an unmitigated failure- it either pacified them to death, or turned them into a raving monster)

That was such a cool show! Damn shame it got canned. Sad

The shameful thing here is that this sort of insanity is great and fantastic and fun and interesting and entertaining WHEN it is part of a fictional story. When it's reality, it's a much different case...

"Brave New World" should never have been a manual. It should have remained a story... Sad



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« Reply #22 on: January 06, 2012, 05:45:33 PM »

Back to the original post --- I firmly believe that software in medicine like that should be open source, GPL'd software.

So what happened to uncle Dave??

Well he was trying to jailbreak his pacemaker and bricked himself.
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« Reply #23 on: January 06, 2012, 05:49:37 PM »


So what happened to uncle Dave??

Well he was trying to jailbreak his pacemaker and bricked himself.

Great one!
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« Reply #24 on: January 06, 2012, 06:13:52 PM »


So what happened to uncle Dave??

Well he was trying to jailbreak his pacemaker and bricked himself.

Great one!

+1

That was a fantastic illustration of exactly the kind of thing that could go wrong.

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