New EU-level actions required to improve sharing of health data

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New research from the Netherlands Institute for Health Services Research (Nivel) and RCSI University of Medicine and Health Sciences has identified potential future EU-level actions to enable more efficient sharing of healthcare data across the EU. The research was commissioned by the European Commission’s Directorate-General for Health and Food Safety.

The proposed actions include the development of a code of conduct for data collection and sharing. The actions would support the establishment of a European Health Data Space to ensure a consistent approach to healthcare data exchange, as well as improving healthcare provision, research and policy-making in the region.

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 reveals significant variation in how member states implement GDPR in the area of health. This fragmentation hinders the creation of an efficient joint infrastructure and blocks a more co-ordinated European approach to healthcare and research into the spread and treatment of diseases.

The researchers recommend the implementation of additional legislation and guidelines on the use of health data to regulate data use more consistently across EU member states.

Co-author of the study, Mary Kirwan, 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 the regulations governing the processing of health data in individual EU member states. The study consisted of a review of best practice, 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, and engaging key stakeholders through surveys and workshops.

Reports were compiled to identify differences between member states and elements that might affect the cross-border exchange of health data in the EU, and to examine the potential for EU-level action to support health data use and re-use.

The research finds that several legal and operational issues need to be addressed to ensure that EU healthcare systems can make best possible use of health data to support the safe and efficient functioning of healthcare systems, and to drive health research and innovation.

The study recognises that, while GDPR is a valuable piece of legislation, variation in interpretation of the law and national-level legislation linked to its implementation have meant that cross-border co-operation for care provision, healthcare system administration and research is more difficult.

The study identifies the need for a fully harmonised approach to 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 recommend a range of non-legislative and legislative actions to develop an infrastructure that would ensure a consistent approach to health data exchange while supporting the processes of different member states. The study also notes that patients should be 'active agents' in their own health and care, with full capacity to exercise their rights relating to their health data.

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.