In the light of big data applications in modern medicine, the various forms of registries becoming increasingly more important. To meet the changing requirements in the field of digital healthcare, the European Commission proposed a comprehensive reform of data protection rules in the European Union (EU). After a transition phase the novel regulations will come into force from 25 May 2018 and then replace the existing Federal Data Protection Act. To conscientiously deal with this subject is of utmost importance before implementing registry-based projects in medical research or quality improvement. To protect patient rights in times of technical progress and increasing amounts of data, appropriate data protection strategies are needed. This article gives an overview on the background and developments in European data privacy law. It further aims to illustrate solutions to overcome new challenges associated with medical register projects.
Keywords: Anonymity; Data protection; Health services research; Innovation fond; Register-based research.