The use of personal data is critical to ensure quality and reliability in scientific research. The new Regulation [European Union (EU)] 2016/679 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 [general data protection regulation (GDPR)], repealing Directive 95/46/EC, strengthens and harmonises the rules for protecting individuals' privacy rights and freedoms within and, under certain conditions, outside the EU territory. This new and historic legal milestone both prolongs and updates the EU acquis of the previous Data Protection Directive 95/46/EC. The GDPR fixes both general rules applying to any kind of personal data processing and specific rules applying to the processing of special categories of personal data such as health data taking place in the context of scientific research, this including clinical and translational research areas. This article aims to provide an overview of the new rules to consider where scientific projects include the processing of personal health data, genetic data or biometric data and other kinds of sensitive information whose use is strictly regulated by the GDPR in order to give the main key facts to researchers to adapt their practices and ensure compliance to the EU law to be enforced in May 2018.
Keywords: European Union (EU); biomedical research; computer security; humans; privacy; translational medical research.