Basic legal prerequisites for secondary use of genomic data for scientific purposes

The aim of genomic data sharing is to enable secure access to this data, primarily for research, personalized healthcare and health policy-making. Data sharing has the potential to accelerate research and bring about significant advances in the understanding of health and disease, but it faces legal and ethical issues related to the protection of privacy and confidentiality of information. In addition to the often counterintuitive European legislation leading to different legal interpretations, there are other national rules in individual European Union countries that can further specify the handling of genomic data. This diversity complicates international cooperation and data sharing, not only in genetics but also in other areas of biomedical research. This thesis analyzes the basic legal framework and its application enabling the sharing of genomic data and clarifies the concepts of further processing, secondary use and purpose of data processing. Furthermore, it stresses the importance of data subjects' consent and specific exceptions to the general ban on processing sensitive data. For effective sharing of genomic data, it is essential to comply with European and national legislation, including a clear definition of the purpose and legal basis of processing. International cooperation requires regulatory harmonization and robust data management. This paper analyzes the fundamental dynamics and legality of data sharing in the field of genomic research.