Ethical approach to the genetic, biometric and health data protection and processing in the new EU General Data Protection Regulation (2018).

PURPOSE: The main purpose of the present paper is to analyze the rules for processing of special categories of personal data (genetic data, including biological samples, biometric and health data) in the light of the new General Data Protection Regulation (GDPR), thus contributing to overview the health status and the biomedical state of the data subject. BACKGROUND: Over the last two decades, debating the European Union's (EU) major legislation with regard to personal data and patients' rights became relevant for the scientific research. The paper assesses the basic legal provisions with regard to the genetic, biometric and data concerning health considered as "sensitive data", while safeguarding the ethical standards of the scientific research. The present article investigates the ethical and legal approaches to processing personal data in the understanding of the new regulatory guidelines regarding the data protection, here including the health status and the rights of a data subject. CONCLUSIONS: The protection of natural persons with regard to the processing of genetic, biometric and health data and the free movement of such data are reinforced in the new GDPR entered into force in May 2016 and applied from 25 May 2018. The new legal context elucidates: the special categories of personal data ("sensitive data"), the "consent" and the research exemption by explicitly recognizing the "pseudonymised" data. Although the new guidelines revisit the EU data protection reform, it also grants the EU Member States the right to maintain or introduce further limitations to the processing of such data.