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“I Want to Know What Code Is Running Inside My Body”

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Re: “I Want to Know What Code Is Running Inside My Body”

#41

By extension should every device I own require me to have access to the source code and output data? Not a rhetorical question.

Do you want to control the device, or do you want someone else to control your devices? If you're OK with someone else (who probably doesn't have your well-being anywhere in their list of priorities) controlling all of your devices, then the answer is no, you are not required to have access to the source code and output data. EDIT: I didn't realize this was such a controversial statement. I stand by it, though; even…

There's another whole level to this question of control, which is do you want someone else's algorithm, written in the past, to control your device, or do you want them to have realtime access to change your device's behaviour whenever they want? The latter is becoming more and more common and, I think, is far more disturbing than the former.

(As an aside, the suggestion that a software developer writing firmware for pacemakers "probably doesn't have your well-being anywhere in their list of priorities" seems unfair. You wouldn't believe the amount of effort that goes into ensuring that critical systems behave properly.)

Re: “I Want to Know What Code Is Running Inside My Body”

#43
post #14

Earlier quoted context omitted.

> If your company takes ~2 years to develop a pacemaker's software, it's not to your advantage to let your competitors catch up. Why should the patient who has the pacemaker implanted care? This seems like a clear situation in which the patient's interests trump everybody else's. Pacemaker manufacturers should be competing in how well their devices meet patient needs. Closed source doesn't meet a key patient need.

Medical device software is subject to a level of rigor in development process that little else is. Exactly what patient need do you believe open source would meet that is not being met by the current closed-source development process?

What happens in closed source development model if pacemaker company ceases to develop one or goes belly up?

Re: “I Want to Know What Code Is Running Inside My Body”

#44
post #32

Earlier quoted context omitted.

except code running your heart was built over millions of years and code she mentions - created by company in years - see the difference? :)

Which is funny because, nonetheless, she had to replace the code built over millions of years by code created in a few years.

Well, if the code built over millions of years is error prone, then surely the code created in the last few years is packed with errors.

She found out what happens when one of them gets triggered.

Re: “I Want to Know What Code Is Running Inside My Body”

#45
post #35

Earlier quoted context omitted.

As heartless as this sounds: the patient isn't the only person in the equation. There are investors that fund the medical research, a company has employees to pay, the hospital wants the best pacemaker available, etc.

Sure - why not ask patient for paid subscription for privilege of using pacemaker? Somebody please think of the investors...

And in the same vein, why not ask investors to if they'll fund a pacemaker company in a purely philanthropic fashion? Isn't it better to get pacemakers in a limited fashion than not at all?

Re: “I Want to Know What Code Is Running Inside My Body”

#46
post #43

Earlier quoted context omitted.

Medical device software is subject to a level of rigor in development process that little else is. Exactly what patient need do you believe open source would meet that is not being met by the current closed-source development process?

What happens in closed source development model if pacemaker company ceases to develop one or goes belly up?

Well now, this isn't quite the same thing as your normal IoT device. You would need to be Really Damn Sure any updates are bug-free before you could push them, which would take actual financial resources. Open source would help here, but not quite as much as it normally would.

Re: “I Want to Know What Code Is Running Inside My Body”

#47

Reasons to NOT open up the code: 1> Loss of competitive advantage 2> Open source is not necessarily any safer (heartbleed bug ... ) 3> If software for the pacemaker is allowed to be updated like that on a computer, someone will update it with buggy software that can cause adverse side effects. Who owns the liability in that case?

None of these are particularly compelling reasons IMO. > 1> Loss of competitive advantage Patient safety trumps business considerations. Skipping clinical trials would be a major competitive advantage (lower costs, quicker to market etc.), but we don't allow that for the same reason > 2> Open source is not necessarily any safer (heartbleed bug ... ) I'll agree, in so far as saying making it open source doesn't necess…

>Skipping clinical trials would be a major competitive advantage (lower costs, quicker to market etc.), but we don't allow that for the same reason

About that ...

Have you seen http://www.fdareview.org/05_harm.php and http://www.fdareview.org/07_market_failure.php?

Re: “I Want to Know What Code Is Running Inside My Body”

#48
post #9

Earlier quoted context omitted.

3> has nothing to do with the code being OS, wherether or not a device is locked down is independent of that.

Maybe in a complete vacuum, but in reality, having access to source certainly makes it easier to look for vulnerabilities, and if the same software is in many devices, the cost of finding vulnerabilities is amortized. Security by obscurity obviously doesn't stop a determined attacker, but it does raise the barrier to entry for script kiddies.

No.

Tell me, how many vulnerabilities are running wild on Linux, the software that powers... well, pretty much anything (including the servers through which you read this content)? Even if you find a vulnerability, it gets patched within hours and it may take a day or two for it to be distributed to everyone.

> Security by obscurity [...] does raise the barrier to entry for script kiddies.

Which script can help you find a vulnerability inside of the source code? You'll need a script that can understand the code it's looking at. I'm not aware of any such script.

Re: “I Want to Know What Code Is Running Inside My Body”

#49
post #9

Earlier quoted context omitted.

3> has nothing to do with the code being OS, wherether or not a device is locked down is independent of that.

Maybe in a complete vacuum, but in reality, having access to source certainly makes it easier to look for vulnerabilities, and if the same software is in many devices, the cost of finding vulnerabilities is amortized. Security by obscurity obviously doesn't stop a determined attacker, but it does raise the barrier to entry for script kiddies.

Anyone you're likely to classify as a "script kiddy" is not going to be able to read the kind of code going into embedded devices like a pacemaker to a deep enough level to find any problems. And if they can the software is really problematic, most likely.

Security by obscurity is never a good idea, but especially not when it might prevent a white hat from finding a bug that would allow a malicious actor to remotely STOP MY HEART.

Re: “I Want to Know What Code Is Running Inside My Body”

#50

Does anyone know if at least the FDA is allowed to review the source code for pacemakers? Or is it a complete blackbox? Personally I would be appalled if even the FDA is not allowed to.

Does the FDA have the knowledge and experts to really understand if the firmware is good or bad though?
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