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.
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 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.
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! ]