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An extension of the FHIR Patient Reported Outcomes (PRO) Implementation Guide (IG) for 21 CFR 11 Compliance

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FHIR Support for 21 CFR Part 11-compliant Patient Reported Outcomes

This is the repository for the FHIR 12 CFR 11 Patient Reported Outcomes Initiative (PRO) initiative supported by an FDA U24 grant.

Implementation Guide Location

The current draft site is available here: https://chb.github.io/21cfr11pro-ig/

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An extension of the FHIR Patient Reported Outcomes (PRO) Implementation Guide (IG) for 21 CFR 11 Compliance

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