this post was submitted on 13 Dec 2023
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Technology
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Sounds like FDA approval requires holding all details of the technology, including all source code, in escrow.
If the company ever stops supporting the product, for any reason at all, all of the details become public property.
Why wait for the company to go under? FDA approval should mandate that the full spec and source code be open source and open to review by anyone, but especially the people in which those things are implanted and all of their medical practitioners. Medicine (and any publicly supported science in general) should never be closed off from public scrutiny.