[schiffern]

  > 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?

[patmcc]

>>>should be illegal if uncertified.

I think this is the key part of the comment - yes, uncertified changes by anyone could feasibly be illegal. The FDA or similar should probably do code reviews.

[Kim_Bruning]

Looking at corner cases for this:

What if you fix a bug in your own pacemaker? Would it be ok to:

a) Fine you?

b) Jail you?

c) Force you to revert the change? (plausibly leading to death in an extreme case)

[edit: I do agree that there's a chance that making a 'fix' to your own pacemaker might also make it worse. In which case, who do we trust more? The person on the ground with a stake in the matter (however misinformed), or $government_official with no stake in the matter (however well informed).

I think it's tricky! ]

[Xymist]

I don't think that scenario is particularly tricky. If you modify someone else's pacemaker, it's a tricky question, even with their consent. If you modify your own, absolutely nothing should stand in your way beyond a nice big notice saying "danger of death,on your head be it". That is, you should have the same freedom to screw with your own personal medical devices that you have to climb out of your own fourth floor window.

People have a right, albeit not enshrined in law, to do stupid things that might kill them - at least as long as they don't then ask someone else to save them.

[ketzo]

This is a huge straw man/whataboutism that contributes nothing to the discussion.

Yes, bad software modifications are bad and should be punished wherever they arise.

Homebrew modifications make it way easier for bad stuff to happen, and make it harder to punish.

[worik]

> bad software modifications are bad and should be punished wherever they arise.

That almost never happens. Software sux.

[schiffern]

  >  This is a huge straw man/whataboutism that contributes nothing to the discussion.

It's a countervailing concern, not a strawman.

  > bad software modifications... should be punished wherever they arise

Corporations are currently unpunished (per TFA) when they alter software in a way that risks patient safety, and they have already caused documented harm to patients. This is a shocking failure of federal oversight, but the captured FDA will (by design) never fix it. Oops.

In light of the real harm caused by this neverending policy failure, the Library of Congress is morally and ethically obligated to permit fair use exemption. Individuals and homebrew communities must be unshackled to protect patients from the real (not hypothetical!), documented, and widespread harm caused by corporate-sponsored attacks on US medical infrastructure.

No, that's not an exaggeration.

Given the current anti-patient landscape, the protections of open source far outweigh any risk.