A joint European Health Data Space would result in better care for patients, better opportunities for health research as well as in more sustainable health care systems. However, Nivel research shows that there is too much variation between member states in implementing the General Data Protection Regulation, in order to create such a joint infrastructure. Additional legislation and guidelines are needed to resolve this.
GDPR leaves room for individual member states to decide how it should be implemented. Within the GDPR framework, every member state is free to find its own balance between basic rights of individuals to decide upon the use of their own health data and the need to use this data for scientific research purposes and statistics.
The ‘room’ for individual interpretation of privacy legislation has led to a fragmented health data landscape. In some member states active informed consent is always necessary for any type of health data use. In other countries ‘informed opt-out’ can be applied for some types of health data use. This fragmentation precludes a more co-ordinated European approach to health care and health research into the spread and treatment of diseases.
International guidelines and legislation on the use of health data in the health care delivery process and healthcare research can contribute to awareness and clear interpretation of the GDPR within the field of privacy protection. Such guidelines can help to regulate data use in a more uniform way. In addition, guidelines and legislation should take into account the structure of the health care system as a whole in the various countries.
Decision-making on this issue requires a broad representation of interests of different stakeholders, as well as a coordinated European approach.
Results of this project were based on a series of expert workshops in the first months of the covid crisis and a series of questionnaires sent out to experts in all member states. The report contains a number of case studies and a concise description of the situation in each member state. The project was a joint effort of Nivel, the Dutch Institute for Health and the Environment (RIVM), the Royal College of Surgeons in Ireland, the MLC Foundation and Health Connect Partners.
This research project relates to Nivel's research program Learning Health System (lead by prof. Robert Verheij, PhD).