BBMRI-ERIC Responds to the European Health Data Space (EHDS) Initiative

4 February 2021

The European Commission published the roadmap for the European Health Data Space (EHDS) initiative in December 2020. The roadmap was open for feedback for 6 weeks. Read BBMRI-ERIC’s feedback abstract here. The initiative is scheduled to be adopted in late 2021. 

Read BBMRI-ERIC’s full statement here. 

In general, BBMRI-ERIC welcomes the initiative for a European Health Data Space (EHDS). The roadmap/impact assessment correctly identifies problems hindering the creation of a single European market for data (section “Problems the initiative aims to tackle”) and discriminates health data between health care and health research data, including the peculiar issues with data privacy, sharing, and interoperability linked to sensitive data (“Context” and “Evaluation”). This marks a sharp, and very welcome change in approach by the Commission, which rightfully reassesses the large social impact of the European Health Data Space (“Likely social impacts”).

The development of the EHDS cannot be timelier, with the launch of groundbreaking initiatives across the competences of the Commission, ranging from health (Beating Cancer Plan, COVID-19 response) to research (Horizon Europe Missions), innovation (AI) that can all tie together under a new EHDS to unlock the full potential of both a single European health data market.

However, we believe it is imperative for the EHDS to acknowledge that the line between health care and health research is often blurry in practice and a division between primary use and secondary use of health data cannot be strictly upheld. Personalised medicine is a prominent example where health care and health research go increasingly hand in hand. Health data and digital workflows are at the intersection of primary care and research and need to be conceptualized from the start as complementary to reduce errors, avoid duplication of procedures and allow for innovative digital health solutions in the sector of health, as care and research are intertwined in practice. We therefore highly welcome the approach of this initiative to address the use of health data in its different aspects.

The existing regulatory framework seems insufficient to deliver on the promises of the EHDS. Health data governance remains fragmented at national and regional level, hindering any effort to scale up research and healthcare solutions. Most importantly, it is necessary to protect and promote the use of health data, defining clear pan-European rules to overcome the existing gaps in practice. Therefore, it is necessary to complete the EU regulatory panorama to fill the gaps left in the GDPR concerning the use of health data. The EHDS shall take inspiration and build on existing efforts to provide clarity to the data protection legislation and health research, such as the Code of Conduct for Health Research. Since a mere harmonized implementation of the GDPR will most likely not address all challenges sufficiently (see also attachment), we strongly support policy option A from the roadmap/impact assessment, leading to a new, specific regulatory framework to protect the ethical and safe secondary use of health data.

Finally, the EHDS must be established based on existing European research infrastructures and exploit already developed models for joint services provided by BBMRI-ERIC and other RIs (e.g., via the cluster-projects CORBEL or EOSC-Life) for example, through joint Service Level Agreements. In order to reach the declared goals of the EHDS as well as implement them in due time, it is critical to connect to the achievements of the initiatives or research infrastructures already working towards these joint goals (e.g., 1MGP, ADOPT BBMRI-ERIC, EOSC-Life, AMRI). The upcoming EHDS should take the know-how, tools or full fletched infrastructures of the multiple contexts working with health data into account. In addition, the creation of the EHDS can be built on the experience regarding the collection and use of health data for research purposes in an ethically and legally compliant way. RIs already facilitate access to health data, and have a crucial and well-established harmonization and standardization role within the scientific and health research community.