> it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary
Do companies redact patient data before submitting it to the FDA? Are they even allowed to? That sounds like the sort of information that the FDA should have access to.
> FDA may inspect study records, for example, to assess investigator compliance with the study protocol and the validity of the data reported by the sponsor
PII is not just name and SSN. Using all the demographic information recorded for each participant and open-source intelligence, you should be able to uniquely identify them.
Do companies redact patient data before submitting it to the FDA? Are they even allowed to? That sounds like the sort of information that the FDA should have access to.