Volume 27, Issue 2 - Public Disclosure
Anonymisation reports from 2016 to 2017: A preliminary analysis
Author: Raquel Billiones
Abstract
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.
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References
- European Medicines Agency. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (EMA Policy 0070). EMA/90915/2016. Version 1.0 (2 March 2016) Version 1.1 (16 December 2016), Version 1.2 (11 April 2017), Version 1.3 (20 September 2017). Available at: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/09/WC500235371.pdf
- Anonymisation Report. Procedure # EMEA/H/C/002345/II/0020. Version 29 August 2017. Published 04 October 2017 at Available from: https://clinicaldata.ema.europa.eu/
- Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Available at Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679&from=EN
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