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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”

#23
post #8

Sure this is about pacemakers, but cant we say something similar about the rest of our body?

Unfortunately, it's a black box made from nature that we have to reverse engineer.

It's also self-modifying code that bootstraps its own compiler.

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

#24

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?

The code to the Jeep Grand Cherokee is closed source, yet security researchers (and now thieves) have been able to take complete control over the vehicle via simple protocol sniffing and reverse engineering. Closed source is no safer than open source.

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

#25

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 as I knowingly own many such devices myself. I can certainly see, however, how I may want more control over a pacemaker than, say, my phone.

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

#27
post #18

Earlier quoted context omitted.

Even if we assume that these arguments are sound (which they aren't), they do not appear to provide a proper justification for letting a human being die . Put another way: If you had to explain Marie Moe's death to one of her relatives, which of your three points would make the relative understand your position?

These are sound arguments. Medical devices have to be certified in all applicable jurisdictions and companies want to protect their competitive advantage. This is no different from, say, new drugs, which are similarly proprietary and the maker retains exclusivity for several years. Further, medications too are risky black-boxes towards end-users.

They are not sound in the context of human welfare.

We do not allow food companies to hide the ingredients of their products, because we know that companies (in the interest of profit) will fail to inform consumers about the dangers of eating unhealthily. Similarly, we do not allow meat producers to leave their meat ungraded because it endangers their "competitive advantage" - we understand (empirically) that doing so leads to food contamination and otherwise preventable disease.

Your choice of proprietary medicine as a counterexample is an interesting one. The pharmaceutical industry in the United States has a long history of "protecting its competitive advantage" at the cost of individual welfare - consider how frequently "reformulations" of the same base chemical are patented to continue milking a lucrative product that could improve the lives of thousands if genericized.

Perhaps even more pointedly, consider the fact that we deem it acceptable (and necessary) that the FDA step in and regulate the release of new drugs. Is there a valuable distinction to be drawn between the sort of regulation and evaluation that the FDA does and the sort that would be possible if programmers could openly evaluate medical devices?

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

#28

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.

With or without a warrant...?

EDIT: Not sure what's up w/ the downvotes. There are well-established ways for regulatory agencies (whether FDA, FCC, etc) to obtain firmware for devices -- and it almost always involves a warrant under extraneous circumstances -vs- proactively receiving proprietary code.

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

#29

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?

1) The software in a pacemaker is not a competitive advantage. The hardware and rights to distribute to hospitals are.

2) Open and closed are equally vulnerable. Closed may be even more vulnerable, since security researches have to attack a black box and can't run ordinary code linting tools.

3) Liability after update is a good question, but one which can be (and is) solved with traditional contract agreements. See cpap machines.

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

#30

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 necessarily make it safer. However, it should, at worst, be no less safe - the requirements on the manufacturer (testing etc.) should be the same regardless

> 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.

You can open the code but, for example, required a signed binary before a device can be updated. The openness of the code and the openness of the device itself are linked but separate issues.

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