1. Introduction



Data privacy, protection and security are more important than ever. In an environment of heightened community awareness around data collection, new data sources, methods, and technologies, digital health systems must support safe storage and sharing of data to meet legislative requirements and encourage public trust. The data protection framework [1] adopted in May 2016 aims at making Europe fit for the digital age.

The General Data Protection Regulation (GDPR) [2], which applies since 25 May 2018, is at the centre of the EU framework guaranteeing the fundamental right of EU citizens to protection of their personal data, as laid down in the Charter of Fundamental Rights of the European Union (Article 8) and in the Treaties (Article 16 of the Treaty on the Functioning of the European Union, ‘TFEU’).


[1] Data protection in the EU. https://ec.europa.eu/info/law/law-topic/data-protection/data-protection-eu_en
[2] Regulation (EU) 2016/679 of the European Parliament and of the Council. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02016R0679-20160504&from=EN