Regulatory agencies around the world have established or are piloting policies and regulations for the public sharing of clinical trial documents. Given that clinical trial documents contain personally identifying health information about trial participants, it is necessary to anonymize these documents. While there are efforts among the agencies to harmonize their anonymization guidance and practices, they are governed by different privacy laws and, especially in the case of the U.S. Federal Drug Administration, are implementing quite a different anonymization methodology. This raises the question of what the risks would be to the users of these public clinical trial documents if the anonymization performed for a public data release was not adequate and the public documents still have a high risk of re-identification. In this piece for The Privacy Advisor, Khaled El Emam and Mike Hintze, CIPP/C, CIPP/E, CIPP/G, CIPP/US, CIPM, CIPT, FIP, explore the risks of using public clinical trial data under the EU General Data Protection Regulation.
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