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Software that supports your body should always respect your freedom

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Re: Software that supports your body should always respect your freedom

#21

Post by schiffern »

7e wrote: post #10
mbakke wrote: post #4

Great article. Real life horror stories of life-critical software gore, with some good news at the end. It should be illegal to sell software that someones life depends upon without giving the user the right to inspect and modify the code.

Quality of life critical software should be ensured by FDA certification. Homebrew modifications of that software, even in the name of “freedom”, risks the patient’s life and health and should be illegal if uncertified.

  > Homebrew modifications of that software, even in the name of “freedom”, risks the patient’s life and health and should be illegal if uncertified.
The official modifications of that software — in the name of "profit" — are currently risking the patient’s life and health, and therefore should also be illegal by your logic.

Surely you must also support effective (ie harsh/deterrent) prosecution and punishment for these crimes as well, correct?

Re: Software that supports your body should always respect your freedom

#22

Post by leghifla »

7e wrote: post #10
mbakke wrote: post #4

Great article. Real life horror stories of life-critical software gore, with some good news at the end. It should be illegal to sell software that someones life depends upon without giving the user the right to inspect and modify the code.

Quality of life critical software should be ensured by FDA certification. Homebrew modifications of that software, even in the name of “freedom”, risks the patient’s life and health and should be illegal if uncertified.

In EU (and probably elsewhere), there are strict rules for the stability of power wheelchair. One such rule is "On a incline of x% (x chosen by the manufacturer), pushing for max speed from stop should not lift the front wheels"

To achieve that, the max acceleration must be quite low (software controlled), and the whole experience is sluggish, like trying to steer a car by pulling on rubber bands attached to the wheel.

From the moment I found a way to overcome this, I never went back. I know that I can hurt myself if I do something stupid, but I prefer this hypothetical risk instead of cursing 100 times a day because I cannot move how I want. It has been 10 years and I never got hurt.

I understand that such "high" risk device cannot be sold, but forbidding someone to change this is like inflicting a second handicap on him.

Re: Software that supports your body should always respect your freedom

#23

Post by dheera »

mbakke wrote: post #4

Great article. Real life horror stories of life-critical software gore, with some good news at the end. It should be illegal to sell software that someones life depends upon without giving the user the right to inspect and modify the code.

I have an ICD (implanted cardioverter-defibrillator) to save my life if my heart stops.

I was also given a proprietary box that sits at home, reads data from it and sends it to my cardiologist over a cellular network, on demand. As part of periodic remote checkups I'm supposed to sit next to it, press the button, which causes it to read data and send any abnormal heart rhythms it detected (via cellular network), whether it treated it (via a shock, in which case I would have known anyway) or whether the abnormal rhythm resolved itself with no treatment (in which case it's worth it that they check out what it picked up). I have to do this about 2-4 times a year.

Every time I hit the button I'm charged $200. Even if there are ZERO events. 90%+ of the time there are zero events.

There is NO interface provided to me where I can read the data directly. There is no way for me to read the device on my own, see zero events, and inform my cardiologist that there are no events and that there is nothing new to diagnose.

I hate this medical system. The device is great for saving my life but I want access to read its data without being charged.

Re: Software that supports your body should always respect your freedom

#25

Post by subw00f »

dheera wrote: post #23
mbakke wrote: post #4

Great article. Real life horror stories of life-critical software gore, with some good news at the end. It should be illegal to sell software that someones life depends upon without giving the user the right to inspect and modify the code.

I have an ICD (implanted cardioverter-defibrillator) to save my life if my heart stops. I was also given a proprietary box that sits at home, reads data from it and sends it to my cardiologist over a cellular network, on demand. As part of periodic remote checkups I'm supposed to sit next to it, press the button, which causes it to read data and send any abnormal heart rhythms it detected (via cellular network), whet…

This is nuts. Who charges you? Is it the company that makes these devices? What if you want a different “provider”?

Re: Software that supports your body should always respect your freedom

#26

Post by dheera »

subw00f wrote: post #25
dheera wrote: post #23

Earlier quoted context omitted.

I have an ICD (implanted cardioverter-defibrillator) to save my life if my heart stops. I was also given a proprietary box that sits at home, reads data from it and sends it to my cardiologist over a cellular network, on demand. As part of periodic remote checkups I'm supposed to sit next to it, press the button, which causes it to read data and send any abnormal heart rhythms it detected (via cellular network), whet…

This is nuts. Who charges you? Is it the company that makes these devices? What if you want a different “provider”?

Stanford Healthcare charges me for "general classification" just for a nurse to open up their computer and see that there are zero events.

Boston Scientific, the device maker, does not have an interface for patients, they only send data to hospitals directly.

I'm not currently willing to switch to a different ICD because Boston Scientific's ICD has successfully saved my life 3/3 times in out-of-hospital situations and 2/2 times during in-hospital testing where they induced ventricular vibrillation in controlled testing and I'd rather not risk trying something different. Insurance wouldn't pay for an extra surgery deemed unnecessary, anyway.

I could switch healthcare providers, but I'm not sure if the others in my area are better at cardiology.

Re: Software that supports your body should always respect your freedom

#28

Post by hn_acker »

alistairSH wrote: post #20
zarzavat wrote: post #16

Earlier quoted context omitted.

Serious question, what does the FDA know about software quality?

Surely not less than the average consumer. And surely they could hire experts to do the job.

1. Compared to the average person in the FDA's population of people who are in charge of evaluating the medical devices, the average person in the population of people who would make fixes and helpful modifications might have more expertise in determining the quality of the device's normal software.

2. It's not as if the people who depend on the medical devices have to take the word of the community of people who will mod the devices over the word of the FDA.

Re: Software that supports your body should always respect your freedom

#29

Post by bowsamic »

dheera wrote: post #23
mbakke wrote: post #4

Great article. Real life horror stories of life-critical software gore, with some good news at the end. It should be illegal to sell software that someones life depends upon without giving the user the right to inspect and modify the code.

I have an ICD (implanted cardioverter-defibrillator) to save my life if my heart stops. I was also given a proprietary box that sits at home, reads data from it and sends it to my cardiologist over a cellular network, on demand. As part of periodic remote checkups I'm supposed to sit next to it, press the button, which causes it to read data and send any abnormal heart rhythms it detected (via cellular network), whet…

That is genuinely insane
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