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I'm curious how this architecture (or any "AI" medical tool) handles regulatory compliance issues. In this case I would think you'd want to display when the ru
by garysieling 10y ago
I'm curious how this architecture (or any "AI" medical tool) handles regulatory compliance issues.
In this case I would think you'd want to display when the rules/facts used for recommendations were last updated, which would add extra fields to track. There are also some interesting QA problems to work through.
- ska 10y agoI'm curious how this architecture (or any "AI" medical tool) handles regulatory compliance issues. So is the FDA. Currently the typical answer from a medical device company is a combination of "carefully" and "with clinical oversight". The typical answer from a non-medical startup seems to be "poorly", for the most part.
- garysieling 10y agoI did a little research and it seems IBM is claiming that the Watson tools are publications, not a medical devices, although I can't see that applying to the OP. https://www.quora.com/Medical-Devices-Is-IBM-Watson-FDA-regulated https://www.quora.com/Medical-Devices-Is-IBM-Watson-FDA-regu...
- ska 10y agoPeople have been applying ML techniques clinically in medical devices since at least the 90's. With the right approach and indications it is quite doable. You have to do the work, mind you.