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EmilyGorcenski's profile
Emily G
Emily G
Emily G
Verified account
@EmilyGorcenski

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Emily GVerified account

@EmilyGorcenski

Lead Data Scientist, activist, survivor. Was actually assaulted by an actual right-wing terrorist. Opinions belong only to me, especially the bad ones. she/they

Deep Space Nine
emilygorcenski.com
Joined June 2013

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    1. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016

      So I want to compare the regulatory process it takes to write software for a medical device compared to a voting machine. A thread:

      10 replies 625 retweets 560 likes
    2. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      Replying to @EmilyGorcenski

      Consider a pulse oximeter, one of those clippy things they put on your finger at the hospital to measure your pulse.

      3 replies 26 retweets 51 likes
    3. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      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
    4. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      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
    5. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      Replying to @EmilyGorcenski

      - maintain a device history record, linking serial numbers to versions - establish reporting protocols for failures ...

      1 reply 23 retweets 55 likes
    6. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      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
    7. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      Replying to @EmilyGorcenski

      Now, here is the complete regulatory process for a voting machine:

      2 replies 147 retweets 178 likes
    8. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      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
    9. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      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
    10. Rich E‏ @kaspe_r11 23 Nov 2016
      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
      Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
      Replying to @kaspe_r11

      at the bottom of the thread I link a document which contains all relevant state regulations.

      3:18 PM - 23 Nov 2016
      • 2 Likes
      • Robin Kauffman Altytwo Altryness, BS
      1 reply 0 retweets 2 likes
        1. Emily G‏Verified account @EmilyGorcenski 23 Nov 2016
          Replying to @EmilyGorcenski @kaspe_r11

          Note that mandating certification is an order of magnitude or more less potent than having codified regulations.

          0 replies 2 retweets 2 likes
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