As almost all translational medicine data are personal data of high sensitivity, the application of and compliance with the General Data Protection Regulation (GDPR) is a central topic in ELIXIR-LU.

ELIXIR Luxembourg is engaged in training activities around the GDPR and develops solutions for the various requirements. In this context, ELIXIR Luxembourg is developing the open source software DAISY for a research data registry and is working on a generic data agreement wizard. Contract templates for our data hosting services and the corresponding data use agreement are already available here:

• data hosting services agreement [v2.3, updated April 2023]
• data use agreement [v1.5, updated May 2023] For an introduction into the GDPR and its implication for sharing of research data, have a look at the ELIXIR Webinar on the topic: Requirements in data protection law and the upcoming General Data Protection Regulation (GDPR) implementation. The slides are available here.

For a quick overview on GDPR and its impact on biomedical research, have a look at the article entitled “Biomedical research: achieving transparency under the General Data Protection Regulation”, published in the September 2018 issue of Semper, a monthly magazine distributed in Luxembourg and targeting doctors, pharmacists and healthcare professionals. The full text can be found in the online version of the magazine (p. 26 - 28).

Other presentations regarding the GDPR:

• FAIR Human Data under GDPR
• The BEACON use case under the GDPR
• The Galaxy use case under the GDPR
• Obligations of a controller - A walk through the GDPR
• Responsibility and Accountability

Open source software for a research data registry Within life-science research, the EU General Data Protection Regulation has a significant operational impact on organisations that use and exchange controlled-access Human Data. One key principle of the GDPR is accountability, where institutions are required to keep a record of their “data processings". The Data Information System (DAISY) is designed to help institutions, projects or data hubs to record personal data used in biomedical research.

DAISY source code is available on GitHub.

For more information:

• DAISY: A Data Information System for accountability under the General Data Protection Regulation GigaScience, Volume 8, Issue 12, December 2019.
• Provenance-enabled stewardship of human data in the GDPR era (F1000 poster)
• Alper P. et al. (2018) Provenance-Enabled Stewardship of Human Data in the GDPR Era. In: Belhajjame K., Gehani A., Alper P. (eds) Provenance and Annotation of Data and Processes. IPAW 2018. Springer Lecture Notes in Computer Science, vol 11017.