New EU-level actions required to enable more efficient sharing of health data across the European Union

New research commissioned by the European Commission, DG Sante, from the institute for health services research, NIVEL in collaboration with RCSI University of Medicine and Health Sciences, has identified potential future EU-level actions to enable the more efficient sharing of healthcare data across the EU.

The actions, which include the development of a Code of Conduct for data collection and sharing along with other non-legislative and legislative actions, would support the establishment of a European Health Data Space to regulate and ensure a consistent approach to healthcare data exchange and improve healthcare provision, research and policy-making across Europe.

The study, entitled ‘Assessment of the EU Member States’ Rules on Health Data in Light of GDPR’, was conducted over the first months of the COVID-19 pandemic in 2020, as part of preparatory work to provide a framework for the use of health data for healthcare delivery, research and policy making in the EU Member States.

The research revealed that there is too much variation between member states in implementing GDPR in the area of health, in order to create an efficient and effective joint infrastructure. This fragmentation precludes a more co-ordinated European approach to health care and health research into the spread and treatment of diseases. The researchers recommended the implementation of additional legislation and guidelines on the use of health data to regulate data use in a more uniform way across EU Member States.

Mary Kirwan, co-author of the study and Department of General Practice, RCSI said: ‘Efficient collection and a rights based approach to the sharing of data is critical to the future of healthcare worldwide. The COVID-19 pandemic has highlighted how important it is that we have access to research and data on a large scale that can enable healthcare policy makers to make informed evidence-based decisions that impact directly on healthcare provision and outcomes for patients. The pandemic has done much already to increase willingness for such co-operation and provides us with many new models for rapid, responsive and impactful action. This is essential to the provision of efficient health care across the EU into the future.’

The objective of the research was to examine and present the General Data Protection Regulations (GDPR) that govern the processing of health data in individual EU Member States. The study used consisted of a review of best practices, analysis of legal and technical aspects of health data usage at a national level, in-depth case studies of national governance models of data sharing, a survey of stakeholders and workshops with representatives from Ministries of Health, experts and stakeholders in the healthcare sector. Reports were compiled and analysed to identify possible differences between Member States and elements that might affect the cross-border exchange of health data in the EU for healthcare provision, research, innovation and policy-making, and examine the potential for EU-level action to support health data use and re-use.

The study found that a number of legal and operational issues need to be addressed to ensure that European healthcare systems can make best possible use of health data for the purposes of primary use and secondary use to support the safe and efficient functioning of healthcare systems and to drive health research and innovation. The study found that while the GDPR is a much appreciated piece of legislation, variation in interpretation of the law and national level legislation linked to its implementation have led to a fragmented approach that makes cross-border co-operation for care provision, healthcare system administration or research, difficult.

The study identifies the need for a fully harmonised approach to the rules on processing healthcare data and guidelines on the implementation of GDPR to ensure data interoperability and to build trust in data governance amongst EU citizens. The researchers recommended the development of a Code of Conduct and other non-legislative and legislative actions to develop an infrastructure that would ensure a consistent approach to health data exchange while supporting the systems and processes of different Member States. In addition, the study specifies that patients should be supported as ‘active agents’ in their own health and care, with full capacity to exercise their health data related rights.

The project was a joint effort of NIVEL, the Dutch Institute for Health and the Environment (RIVM), RCSI University of Medicine and Health Sciences, the MLC Foundation and Health Connect Partners.

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