Legal requirement clusters as means to build legally interoperable data bridges between research infrastructures

The EU project BioMedBridges has built an infrastructure to allow interoperability between data and services in the biological, medical, translational and clinical research domains. Most databases in research infrastructures employ some form of data curation and data protection or are in the process of developing one. However, by enabling interoperability between infrastructures and by linking and merging different databases, data protection is lifted to a new and higher level. Openly accessible bio-molecular and structural data may become linked to data that is and has to remain protected, such as patient data. To address this challenge, using a novel approach, concepts from computer science were employed to create legal requirements clusters for data sharing. First, legal interoperability is defined as a specification of the general interoperability concept; second, data bridges are interpreted as interfaces; third, requirements engineering were used to create requirement clusters for data protection/ privacy, data security, Intellectual Property (IP) and licenses and security of biosamples. The requirement clusters were applied to a usage scenario of a cross-species phenotypic data bridge employing data amendments, phenotypic metadata and data linkage. All combined requirement clusters represent a knowledge base that can be added to workflow applications, software tools or databases to inform researchers about legally compliant data sharing.