Skip to content

Feature Articles

Anonymisation reports from 2016 to 2017: A preliminary analysis

Authors: Raquel Billiones

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 infor -  mation 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 assess -  ment, data utility assessment, and use of  software is presented.    

Medical Writing. 2018;27(2):22–26

Back To Top
Your Cart

Your cart is empty.