WP5 - Secure access

Data sharing between the biomedical sciences research infrastructures will lift ethical, legal and security concerns to a new level of complexity. A preliminary analysis of data security requirements of ECRIN, EATRIS, BBMRI, ELIXIR, Euro-BioImaging, INSTRUCT and INFRAFRONTIER showed that EATRIS, ECRIN, BBMRI, Euro-BioImaging and ELIXIR store or process patient-related data (or biosamples), while INSTRUCT is interested in secure sample transport and in intellectual property rights, and INFRAFRONTIER stores high-throughput data from mice. BBMRI, with its focus on the availability of biomaterials, is currently emphasizing aspects like k-anonymity and metadata management for its data. Sharing of imaging data by Euro-BioImaging poses challenges with respect to anonymisation and intellectual property. An ethical, regulatory and security framework for international data sharing that covers these diverse areas and different types of data (e.g. clinical trials data, mouse data, and human genotype and DNA sequence data) is of crucial importance for BioMedBridges.

The WP will address regulations, requirements and design aspects as well as security implementation. It will analyse the legal and ethical situation concerning sharing and transfer of data and access to data in a trans-European context for all e-Infrastructures. The legal implications and corresponding data exchange strategies will be analysed on the European, national, regional (e.g. data protection law in Scotland) and local (e.g. hospital law) level. Legal implications for different types of data and linking of data have to be considered, including biobank data, genetic data, stem cell research data, data originating from children and vulnerable populations, and the special situation of clinical trials data (Directive 2001/20/EC and GCP). Specific attention will be paid to personal data (Directive 95/46/EC) and the roles of data controller and data processor for the data bridges.