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Comment by gentleman11 | Hacker News Reader

As a member of that group, I honestly wonder what use our work will be due to regulations. Most hospitals cannot use uncertified equipment or software. I think however that there might be a large policy shift where these projects may become acceptable for use after some new or temporary legislation in 1-2 months. At that time, the projects may be extremely valuable

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...also, if China and Italy are any example, you might be taking care of mom/dad at home because the hospitals cannot accept any more patients.

...and at home, the FDA isn't there to tell you not to use your home-made respirator.

In italy its so bad they are triaging to the point of not even treating the worst/most elderly cases. In extreme circumstances projects like this could save lives, regulations be damned.

If things get bad enough they might use the state of emergency to relax that regulation.

U.K. has already indicated they will change the rules for this.

“Uncertified ventilated vs dead” is not decision.

Do note the vaccine testing skipped the normal animal testing phase and went straight to human trials.

I'm pretty sure the regulator is willing to work with you. Also you should contact them now. It is actually possible you can tap into a lot of incidental industry experience if they point you toward someone who has spent a lot of time doing medical equipment certs or ventilator certs before.

If its this, or triage, a bloody thump up should be sufficient. If the regulators dont like it, let them come down and out to review procedure.

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