Re:An exoskeleton let a paralyzed man walk, then its maker r...
by numpad0 on Saturday October 12, 2024 @02:12AM
(#41816861)
^ this sounds like a long-term good plan to me. Submit all code to qualify, or not. That should be the standard for all authority-approved things globally.
Re:An exoskeleton let a paralyzed man walk, then its maker r...
by notjulianjaynes on Saturday October 12, 2024 @03:14AM
(#41817082)
There already exists some limitations from the FDA regarding software. For example if you receive clearance (NB this is different than approval) for a device which uses AI, it cannot modify its own source code and any changes need to go through the clearance process again. (Or something like that it's been a while since I looked this up.)
I don't know that this is how things are currently structured, but if a company was required to submit a device's source code as a condition of receiving a 510(k) clearance perhaps there should also be a condition that the FDA can release this code in instances where the public interest in doing so would outweigh the IP interests of some piece of abandonware.
Yeah who am I kidding that won't happen.
- create a medical product
- apply for FDA approval and put code in escrow
- get approval
In case of bankruptcy or other types of failure to maintain product, release code from escrow.
Although I wonder what would happen in this scheme if you use someone else's IP while creating a product, or parts of your stack are also obsolete.
with respect to similar sorts of things, I think the library of congress used to get copies of copyrighted works. And patents have enough drawings and descriptions to (re)create what is being patented.