Enhancing the reuse of health data for research purposes: laws and regulations as pillars of trust

Abstract

Abstract Background Routinely recorded health data are increasingly used for research purposes and indispensable to stimulating appropriate and sustainable health care. In many countries access to data has proven to be a challenge. Trust by researchers, organisations and the general public is key, and adherence to the rule of law is one of the key elements determining that trust. We investigated the laws and regulations regarding the reuse of health data and how they work out practically for researchers. Methods Our study focuses on France, Finland, Denmark, Germany, England and The Netherlands. We investigated consent mechanisms, the possibilities of record linkage, and how the sharing of data for research purposes was organised, with a combination of desk research and interviews with researchers in these countries. Results All countries investigated except England are subject to the General Data Protection Regulation. However, explicit consent is the default in Germany and the Netherlands, while other countries maintain an opt-out system or even a system of neither consent nor opt-out. A central data access authority is in place in all countries investigated except Germany and the Netherlands. The nature and level of detail of data varies widely. Conclusions GDPR does not dictate a specific modality for the reuse of data. In terms of the reuse of health data, Germany and the Netherlands are lagging. The Netherlands seems to be the only country with continuing discussions about consent modalities. A broader societal debate about the balance between trust and the reuse of health data is needed, also against the background of a European Health Data Space. In the Netherlands, widespread government distrust is one of the challenges. Options to counteract this distrust will be discussed. Key messages • European countries vary in the way routine health data are accessible for research purposes. • This will affect the feasibility of a uniform European Health Data Space.