The Influence of General Data Protection Regulation on Patient Engagement

Abstract

The new European General Data Protection Regulation – also known as GDPR – has raised the awareness among the private business entities regarding the protection of data subjects and the usage of personal data in their trade operations. In the present study, we aim at identifying and assessing the impact the new Regulation mainly on the life science sector, with a particular focus on clinical trials. Besides the subjects of the clinical trials, patients as the data subjects and the protection of their rights, when conducting scientific research in the medical-pharmaceutical field, we seek to define concepts such as sensitive data and data concerning health, data processing in scientific research and roles of all parties involved through the definitions of data subject, controller, processor or recipient given in the GDPR. The scope of the present research is represented by the analysis of the impact of the GDPR provisions on the derogations relating to processing for scientific research purpose on the rights of the clinical trial subjects.