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SFLC Wants To Avoid Death by Code
foregather writes "The Software Freedom Law Center has released some independent research on the safety of software close to our hearts: that inside of implantable medical devices like pacemakers and insulin pumps. It turns out that nobody is minding the store at the regulatory level and patients and doctors are blocked from examining the source code keeping them alive. From the article: 'The Food and Drug Administration (FDA) is responsible for evaluating the risks of new devices and monitoring the safety and efficacy of those currently on market. However, the agency is unlikely to scrutinize the software operating on devices during any phase of the regulatory process unless a model that has already been surgically implanted repeatedly malfunctions or is recalled. ... Despite the crucial importance of these devices and the absence of comprehensive federal oversight, medical device software is considered the exclusive property of its manufacturers, meaning neither patients nor their doctors are permitted to access their IMD's source code or test its security.'"
the software running your pacemaker is probably patented too!
Does a government agency examine the source code which keeps airliners in the air, cars on the road, nuclear plants from blowing up etc etc? If the government is going to evaluate and approve every important piece of code line by line we will pretty soon run out of programmers. But then, chip designs will have to be evaluated too because they can fail as well. Next, mechanical designs, engines, turbines, reactors, better make sure that the government is stocked with experts in all those fields too.
After all, nothing can possibly be safe until it is certified as such by the government. Just ask hundreds of thousands of people who died while the drugs that could have saved them were waiting for the FDA approval. They are pretty safe now.
Negative moral value of force outweighs the positive value of good intentions.
One of the July 2010 updates bluescreened my 81-year-old dad.
The hospital backed out the update but they had to reboot him in safe mode and go up the back door.
I work for a company does full life-cycle development and verification of safety-critical software, the main areas we work in are aircraft instrumentation, smart munitions, and medical equipment (including pacemakers). The amount of testing and verification that goes into these software categories often exceed the development cost, and at every level it is documented and traced. What on earth do Doctors think they will see in the source code? We do verification, peer review, tracing, etc. what would an MD find that a room full of software, system, and QA engineers wouldn't? About the only thing that they would be able to look at and have a hope in understanding is criteria for taking action, and that is in the requirements and should be reviewed at that level, not at the code level.
Next thing they know Pilots will demand the ability to review the code for their cockpit management system and soldiers the ability to review the code for their Anti-Tank rockets!
DEMETRIUS: Villain, what hast thou done?
AARON: Villain, I have done thy mother.
Shakespeare invents 'your mom'
The devices themselves are rigorously tested in clinical trials. If they pass those tests, what more do you want?
Software errors can (and in fact are most likely to) result in pathological behaviour in unusual circumstances. Example. "The failure only occurred when a particular nonstandard sequence of keystrokes was entered on the VT-100 terminal which controlled the PDP-11 computer: an "X" to (erroneously) select 25MV photon mode followed by "cursor up", "E" to (correctly) select 25 MeV Electron mode, then "Enter", all within eight seconds. This sequence of keystrokes was improbable, and so the problem did not occur very often [i.e. not in any clinical trials] and went unnoticed for a long time." An independent source-code audit could have saved three lives in that case.
I'm sure Therac-25 passed some sort of trials too. That didn't stop it from killing people, of course.
Sent from my PDP-11
// max_int should be enough for anyone
for(i = 0; i < max_int;i++){
sleep(1);
beat_heart();
}
// printf("hi!!!!!\n")
If I have seen further it is by stealing the Intellectual Property of giants.
I'm not trolling or flaming at all here, I'm genuinely surprised.
By my quick-and-dirty calculations:
I tend to feel rough after four or five beers. How is it you're drinking five to ten times that *a night* and still around to talk about it lucidly? I'd expect some serious delerium tremens in short order on that track...
Curious,
"What in the name of Fats Waller is that?"
"A four-foot prune."
An independent source-code audit could have saved three lives in that case.
=Could have= saved 3 lives.
Would have cost 10s of thousands? millions?
Pretty much every time someone on the planet dies of accidental causes there is some procedure or process that "could" have saved them.
Life just isn't that safe. And I'd rather not spend every dime of the gdp trying to make it as safe as possible.
When people die its tragic. If its something simple to fix, we fix it. But lets not lay guilt trip down every time anybody dies. Life is dangerous and it wouldn't be worth living if we made it safe, because the only way it will ever be safe is if we lock everyone up in straight jackets in padded rooms.
Most of these devices don't spend all that long on the market. They keep getting better, having new features and lower power consumption. Proving the code would slow the pace of advancement. Irony of medical advances: an imperfect device that kills a few people may in fact be (from a public-health POV) better than a perfect device that takes an additional two years to develop.
NEVADA GAMING COMMISSION has the code to slots games so why can't the FDA get the code to med systems?