The CommCare platform is widely used by global health research teams for their data collection or mHealth intervention needs.
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#4 Is CommCare HIPAA compliant? Can it store PHI and Confidential Information?
Yes, CommCare is HIPAA compliant. However, we sign HIPAA BAAs with partners using the CommCare Advanced software plan or above.
#5 Is CommCare 21 CFR Part 11 compliant?
CommCare is 21 CFR Part 11-ready, meaning that if implemented in conjunction with appropriate procedures, documentation, and qualification, then your study may meet part 11 requirements. However, compliance depends on the setting, which includes both the technical aspects of the installation and maintenance, quality requirements [Implementation Quality (IQ) – Operational Quality (OQ) – Production Quality (PQ)], as well as the essential processes put in place by users.
CommCare has the technical features necessary to serve as the data collection and management component of a 21 CFR Part 11 compliant study. However, a study using CommCare must have policies, procedures, training, validation and documentation meeting the requirements of Part 11 and the predicate rules for the underlying legislation. An FDA auditor will review all project documentation to determine at the study level if a study is compliant.
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