All good points, except for one major flaw: medical devices are woefully insecure. Tons of process doesn't help.https://twitter.com/EmilyGorcenski/status/801464391174590465 …
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so most devices in-the-field didn't have to go through them. The requirements have little bite, but they are denying 510(k)s now.
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my guess is that even that guidance won’t make for secure products.
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my sense is that the heavy process for updating code likely makes the devices *less* secure, since you can’t address holes.
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So, I could say a lot on this, and it's a common industry perception that's not strictly true. But that's another discussion :)
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hopefully one day we can chat about it at > twitter length!
End of conversation
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