DIA EUROPE 2020

Realising the potential promised by big data poses multiple challenges; this session will explore how we can share data and maintain its utility whilst complying with the GDPR, respecting ethical principles and maintaining trust. The increasing volume, complexity and diversity of data now being captured across multiple settings and devices offers opportunities for medicines regulation in terms of better understanding of diseases, medicines and product performance in the healthcare system. Europe is looking towards the European Data Space in Health, learning health systems and proposed network infrastructure. There is consensus that most benefit will be derived when data are harmonised and linked across care settings, regions, countries and data types. While there are many challenges in data curation and standardisation to allow meaningful linkages perhaps the primary challenge is how can data be shared and linked so as to retain its scientific utility, comply with the General Data Protection Regulation, maintain trust and respect ethical principles. The session will explore, primarily within a panel discussion: • Patient concerns and recommendations regarding data sharing and security based on the output of the results of a related EURORDIS survey. • How the European Commission (EC) is addressing governance and data protection in the European Data Space in Health, in the context of two related EC studies. This will include insights into the data strategy and the European Data Space in Health. • Methodological considerations relating to patients’ concerns about data sharing in a federated network. • Recommendations of the HMA-EMA Joint Task Force Big Data report on how to address concerns associated with data sharing and governance.