Search

Abstract Background The General Data Protection Regulation is a regulation in EU law on data protection and privacy in the European Union. We aimed to provide an overview of the General Data Protection Regulation (GDPR) enablers and barriers to the secondary use of health data in Europe from the research we conducted in the Joint Action InfAct (Information for Action!) WP10 Assessing and piloting interoperability for public health policy, as well as to provide an example of a national-level case study on experiences with secondary use of health data and GDPR on an example of the Austrian COVID-19 data platform. Methods We have identified a number of European initiatives, projects and organizations that have dealt with cross-border health data sharing, linkage and management by desk research and we conducted 17 semi-structured in-depth interviews and analyzed the interview transcripts by framework analysis. Results GDPR was seen as an enabler to the secondary use of health data in Europe when it comes to user rights over their data, pre-existing laws regarding data privacy and data sharing, sharing anonymized statistics, developing new data analysis approaches, patients` trust towards dealing with their health data and transparency. GDPR was seen as a barrier to the secondary use of health data in Europe when it comes to identifiable and individual-level data, data sharing, time needed to complete the process, workload increase, differences with local legal legislations, different (and stricter) interpretations and access to data. Conclusion The results of our analysis show that GDPR acts as both an enabler and a barrier for the secondary use of health data in Europe. More research is needed to better understand the effects of GDPR on the secondary use of health data which can serve as a basis for future changes in the regulation.

Background: In Brazil, secondary data for epidemiology are largely available. However, they are insufficiently prepared for use in research, even when it comes to structured data since they were often designed for other purposes. To date, few publications focus on the process of preparing secondary data. The present findings can help in orienting future research projects that are based on secondary data.Objective: Describe the steps in the process of ensuring the adequacy of a secondary data set for a specific use and to identify the challenges of this process.Methods: The present study is qualitative and reports methodological issues about secondary data use. The study material was comprised of 6,059,454 live births and 73,735 infant death records from 2004 to 2013 of children whose mothers resided in the State of São Paulo - Brazil. The challenges and description of the procedures to ensure data adequacy were undertaken in 6 steps: (1) problem understanding, (2) resource planning, (3) data understanding, (4) data preparation, (5) data validation and (6) data distribution. For each step, procedures, and challenges encountered, and the actions to cope with them and partial results were described. To identify the most labor-intensive tasks in this process, the steps were assessed by adding the number of procedures, challenges, and coping actions. The highest values were assumed to indicate the most critical steps.Results: In total, 22 procedures and 23 actions were needed to deal with the 27 challenges encountered along the process of ensuring the adequacy of the study material for the intended use. The final product was an organized database for a historical cohort study suitable for the intended use. Data understanding and data preparation were identified as the most critical steps, accounting for about 70% of the challenges observed for data using.Conclusion: Significant challenges were encountered in the process of ensuring the adequacy of secondary health data for research use, mainly in the data understanding and data preparation steps. The use of the described steps to approach structured secondary data and the knowledge of the potential challenges along the process may contribute to planning health research.