3 ms·

Doesn't the FDA already regulate medical software?

• nradov 1y ago
  To an extent, but only if the software meets the criteria for being legally classified as a "medical device". And at the lower classification levels the regulations are very light. You don't necessarily have to prove any level of reliability or usability. https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device https://www.fda.gov/medical-devices/classify-your-medical-de...
  • Neywiny 1y ago
    Ex employee of the division of imagine devices and software reliability here. I have nothing to add, and I'm not qualified to confirm or deny your comment. Just interesting to see a mention of my past life
• codeulike 1y ago
  But thats part of the problem, as well as part of the solution. The FDA regulations say the software must do this and must do that, and you end up with thousands of pop up alerts. I think the regulations are well meaning but they way they translate into software is not realistic. In the article an FDA-regulated pop-up is part of the story.
  • nradov 1y ago
    There are no FDA regulations that require EHR software to display pop-up alerts for possible sepsis.
    • deleted 1y ago
      [deleted]