General Data Protection Regulation: The Impact On Clinical Trials And Data Subjects

Richard Dickinson, Jackie Mulryne and Zoe Walkinshaw, Arnold & Porter Kaye Scholer LLP, consider how the GDPR will impact clinical trials

The EU rules on data protection seek to protect individuals by placing restrictions on the processing (collecting, storing or using) of their personal data. Under the new General Data Protection Regulation 2016/679/EU ("GDPR"), which will apply throughout the EU from May 25, 2018, these rules have been strengthened: data subjects have new rights to help ensure their data are processed securely and with adequate protections, and clearer responsibilities and obligations are placed on companies using such data.

However, these strengthened rights do not necessarily fit neatly with other sector specific legislation where large quantities of data are collected and processed. In particular, the GDPR raises some important questions for clinical trials, one of the fundamental aspects of which is the collection and analysis of sensitive