Browsing by Subject "Findata"

Finland has long traditions on the use and development of digital healthcare systems. This infrastructure, covering the entire population, has enabled the utilization of electronic healthcare records (EHR) collected in various registers for secondary purposes, such as research, development, and innovation (RDI) activities. Following the emergence of this activity, an operational environment supporting the reuse of data developed between these registers and data users, enabling diverse research activities. The Secondary Use Act, prepared on the basis of the General Data Protection Regulation (GDPR) and which came into force in May 2019, triggered many reforms for this operating environment. According to experts from various stakeholder groups, the reforms were seen as both beneficial and challenging, as observed in a small number of related studies already conducted. The purpose of this study was to investigate the current state of the impacts brought by the Secondary Use Act by mapping the views and opinions of representatives from different expert groups on key changes in the operating environment from their perspective and identifying potential areas for development. The study was conducted in early 2024 as a semi-structured interview study. The interviewees consisted of experts (n=8) from various stakeholder groups familiar with the operating environment for the secondary use of real-world data. The interviewees had extensive and significant experience with either the Secondary Use Act or its operating environment. Six distinct themes emerged from the material: data management in national registers, data utilization in research, the national process and guidance, the preparation process and culture of the Secondary Use Act, internationality, and actors and their equality. To identify new and significant observations, a comparison with previous research findings was conducted, ultimately identifying key factors that still challenge stakeholders. These factors related to inequalities among stakeholders, restrictions due to data protection requirements, lack of guidelines, and data harmonization. The results confirm the previous studies’ observations and highlight the particularly challenging areas for stakeholder groups in the current time. Overall, opinions about the data permit authority were mostly positive, while there was relatively more distrust towards register holders and legislators. Based on the study, there are clear grounds for developing the Secondary Use Act, but its timing is influenced by the progress of international projects, such as the EHDS model. Future research should increasingly focus on joint European projects to integrate Finland into the international operating environment.