Anonymisation reports from 2016 to 2017: A preliminary analysis.

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of anonymisation in each package and the rationale for these methods. As of December 31, 2017, 64 ARs have been published on the clinical data website of the European Medicines Agency. A preliminary high-level analysis of these reports was performed, with the aim of gaining information on the current industry practices in anonymisation and AR preparation. After excluding 12 ARs from packages that did not contain protected personal data, 52 ARs were analysed. Information on anonymisation methodology, re-identification risk assessment, data utility assessment, and use of software is presented. [ABSTRACT FROM AUTHOR]