I'm not sure I agree that it's a critical error on the part of this manufacturer. im not sure they have a duty here.
p much all Class 2 and 3 medical devices. But. The FDA is also pushing interop for MD data.
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So connectivity is encouraged, and honestly, badly needed. But this all boils down to what the right approach is for
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designing for security. Right now IEC 62304 and 60601 say almost nothing. So there is no industry std, really.
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i am optimistic that the industry can establish an encryption standard with at least three xors
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That will never happen. Mfg stds never specify technical details. They move too slowly. Rather, they specify
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the criteria and methodologies for evaluating things that can go wrong, and let mfg decide best current approach.
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The FDA says "this is the level of rigor we expect you to use. Prove that you did." They don't prescribe specifics.
End of conversation
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