Yeah, I agree. At best, I think it's people trying to help, but I doubt they'll get anywhere. I worked on an ML project for a hospital as late as last year.

Yeah, I agree. At best, I think it's people trying to help, but I doubt they'll get anywhere. I worked on an ML project for a hospital as late as last year. The FDA was clear - we could develop it in house and use it as a clinician tool, but productizing it outside the hospital it was nearly forbidden. One generic model for all patients and that model had to have FDA approval. Any changes at all required FDA approval. This was what our legal team and a partner vendor interpreted. "The FDA doesn't want someone in a basement with no medical knowledge marketing a medical device," said one person. These amateur ventilators seem like the kind of stuff the FDA wants to prevent.