The potential for the use of real-world data (RWD) to generate real-world evidence (RWE) that can inform clinical decision-making and health policy is increasingly recognized, albeit with hesitancy in some circles. If used appropriately, the rapidly expanding wealth of health data could improve healthcare research, delivery of care, and patient outcomes.

The development of data governance structures and HTA processes for the use of RWE have been greatly supported by patient advocacy groups, which have facilitated awareness of and education around how these kinds of RWD can help to improve patient outcomes (for example, through public–private partnership initiatives). A common European Health Data Space (EHDS) could support access to different types of health data, with the aim of supporting healthcare delivery, research and policy making. Specifically, this data system is intended to support Member States with data governance and data exchange, data quality, and infrastructure and interoperability. The provisions on data governance – which will largely influence data sharing – are in a more advanced stage of preparation, with the European Parliament aiming to adopt its position on the proposals during the summer of 2021.

In parallel, several Member States are registering complaints about what they regard as excessive privacy safeguards, such as the requirement for repeat users to continually assess the risk of re-identification. For access to health data to inspire trust and be efficient, it is vital that the data governance provisions do not restrict options for the EHDS and provide adapted options depending on the type of RWD needing to be shared.