Scientific Research and the Biomedical Sector: Requirements and Methods for Planning and Managing a “Data Protection by Design” Project: ‘How Can a Scientific Research Project Be Planned and Managed to Comply “By Design” with GDPR?’

Scientific research in the biomedical sector is characterised by a high level of complexity, and a correct balance between the rights and interests involved should be achieved. Data sharing and collaborative research have become imperative in contemporary science: the development of such research depends inextricably on opportunities for accessing and using data, on practices and methods, and on the cross-checking of information in different disciplinary sectors. Unlike traditional collections of biological samples, biobanks have some distinctive features in both quantitative and qualitative terms. The data collected may be considered to be personal data and even data concerning health, and thus natural persons have individual interests in the safeguarding of the data. This chapter investigates the requirements and methods for planning and managing a “data protection by design” scientific project. After a description of the data protection framework applicable to scientific research in the biomedical sector in the European Union, the essay analyses the data protection by design obligation established by the General Data Protection Regulation, and aims to provide brief guidance on the technical and organisational measures that should be implemented to ensure proactive compliance with the applicable data protection law.