Centre for the Fourth Industrial Revolution Network 2023-2024

19 Action: To support implementation of the recently adopted legislation, the centre worked to develop bylaws to support the establishment of the initiatives. Next steps: The Ministry of Health and the Ministry of Science, Technological Development and Innovation need to jointly adopt the proposed bylaws. The Centre for the Fourth Industrial Revolution Serbia will coordinate with the ministries and the Office for IT and eGovernment to build the information system for the Genetic and Biomedical Data Registry. Result: The bylaws thus drafted regulate the detailed conditions and manner of establishing and maintaining a Genetic and Biomedical Data Registry, as well as other data relevant for research and development in the fields of biotechnology, bioinformatics, bioeconomy, genetics and medicine. Serbia Context: Genetic and health data present a tremendous opportunity for advancing healthcare outcomes, medical research and public health initiatives. Recognizing the significance of data sharing, Serbia has adopted legislation on medical documentation and registries in healthcare. The Centre for the Fourth Industrial Revolution Serbia contributed to the legislation with regard to a genomic registry, secondary use of biomedical data and digitalization of the healthcare system in Serbia. One of the Law’s key innovations is the Genetic and Biomedical Data Registry, advancing modern diagnostics, early detection of genetic predispositions, and personalized medicine. It ensures high level data security, supporting biomedical science and software to enable faster diagnostics and identification of rare diseases. Jelena Bjović Director, Centre for the Fourth Industrial Revolution Serbia Case study 6: Legislation for digital health