Consider a pulse oximeter, one of those clippy things they put on your finger at the hospital to measure your pulse.
-
-
Replying to @EmilyGorcenski
To write software for this device you have to: - Maintain a complete design history file - Perform a traceability analysis ...
1 reply 24 retweets 62 likes -
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:
2 replies 147 retweets 178 likes -
Replying to @EmilyGorcenski
That's it. Nothing. No mandatory code reviews. No cybersecurity analysis. No versioning reqs. Absolutely nothing.
8 replies 104 retweets 235 likes -
Replying to @EmilyGorcenski
Everything that's done is done at the discretion of the manufacturer. Maybe there's some state regulations out there, but I don't know any.
6 replies 36 retweets 84 likes -
Replying to @EmilyGorcenski
Ostensibly, purchasers for voting machines are gov'ts, so they can demand rigorous testing before buying. Do they? Doubt it
1 reply 1 retweet 0 likes -
Replying to @kaspe_r11
at the bottom of the thread I link a document which contains all relevant state regulations.
1 reply 0 retweets 2 likes
Note that mandating certification is an order of magnitude or more less potent than having codified regulations.
Loading seems to be taking a while.
Twitter may be over capacity or experiencing a momentary hiccup. Try again or visit Twitter Status for more information.