To write software for this device you have to: - Maintain a complete design history file - Perform a traceability analysis ...
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Replying to @EmilyGorcenski
- perform a risk analysis such as FMEA - perform a cybersecurity analysis - generate a maintenance plan for updates ...
1 reply 24 retweets 55 likes -
Replying to @EmilyGorcenski
- maintain a device history record, linking serial numbers to versions - establish reporting protocols for failures ...
1 reply 23 retweets 55 likes -
Replying to @EmilyGorcenski
- notify the FDA for any bugs that affect a patient - document every software decision, who made it, and when it was made, in the DMR - etc
1 reply 24 retweets 54 likes -
Replying to @EmilyGorcenski
Now, here is the complete regulatory process for a voting machine:
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Replying to @EmilyGorcenski
That's it. Nothing. No mandatory code reviews. No cybersecurity analysis. No versioning reqs. Absolutely nothing.
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Replying to @EmilyGorcenski
not criticizing, but https://www.eac.gov/testing_and_certification/ … is something that voting system companies go through. It's expensive and
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Replying to @Slestac @EmilyGorcenski
requires adherence to VVSG standards, which include code history, reviews, style guides, etc
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Replying to @Slestac @EmilyGorcenski
and that's just at the federal level. Some states have additional certification requirements that manufacturers must meet.
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And overseen by a congressionally-empowered agency?
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Replying to @EmilyGorcenski
sorry, I didn't get that far into that side of things. VVSG cert is a big driver in this industry.
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Replying to @Slestac
Definitely. It's one of those "free market managing its own standards" things that can sometimes work.
0 replies 3 retweets 12 likes
End of conversation
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