That's not how the FDA works. If they approve AI for diagnosing anything, it will be for one disease or closely related family of diseases. (Even that will take multiple years.) Then they'll do another disease or family of diseases. Each one will have its own multi year clinical trials.

"AI is primary method for diagnosing diseases", as in, most or all diseases, will not happen for at least 10y, even assuming every AI trial goes amazingly well.

The title and the resolution criteria are way off, having one hospital (and one clinic, and one healthcare provider if that's what you meant) use AI for diagnosis would not mean it's the "primary method for diagnosing diseases in healthcare".

@LuisCostigan My reading was that either hospitals, clinics, other healthcare providers, or some combination thereof must adopt the technology broadly. I agree the wording is unclear though.