Towards a European research area for health research : the interplay between the FAIR data principles, the GDPR and the EHDS regulation

Abstract

Health research has limitless potential to enhance medical treatment and services for individuals and society at large. However, there are many practical and legal obstacles. In an era of big data and stringent data protection laws also applicable to scientific research activities, common challenges include access to data and striking the right balance between protecting research participants' data privacy and confidentiality without undermining research transparency and integrity. From a data protection perspective, health research entails the processing of personal and special category data and must comply with the GDPR. In this article, we assess the legislative status quo, considering the GDPR's requirements for scientific research and undertaking an examination of the recently adopted European Health Data Space (EHDS) Regulation as it pertains to the secondary use of health data for research purposes, in light of the FAIR Principles and in the broader context of the European Research Area. We analyse whether the EHDS Regulation serves to enable health research in a manner that complies with the GDPR, upholds the FAIR Principles, and contributes towards the broader objective of achieving a true European Research Area without barriers to the free flow of research data and output.