De-Identification and Anonymization of Patient Data
De-identification involves removing or recording health information that could identify an individual such as patient identifiers, free text verbatim terms or references to dates. Subsequently, data anonymization involves destroying all links between the de-identified datasets and the original datasets.
As of 2016, any Sponsor selling products in the European Union must comply with the European Medicines Agency (EMA) guidance on the anonymization of clinical trial data. Within 60 days of a marketing authorization decision, the Clinical Study Report must be made available in a form that removes any risk of a subject’s identity being breached. The Food & Drug Administration (FDA) similarly requires transparency through the use of de-identified and masked data.
Clinical trial Sponsors must also adhere to the General Data Protection Regulation (GDPR) which looks to harmonize data privacy laws across the European Union.