Data is a cornerstone for innovation and better health care. Responsible data governance is key to the public’s trust in science and the sustainability of research. The European Health Data Space (EHDS) is the European Commission’s response to the pressing need for a trustworthy health data infrastructure that reaches across member states. Needless to say, this ambitious endeavour does not come without challenges. To support the development of this ecosystem, we recently issued a brief on the topic, informed by a multidisciplinary expert workshop held in Brussels in June 2023.
Organised by the Danish Board of Technology and De Montfort University, experts from the fields of legal, ethical/societal and technical disciplines came together on the 22nd of June to identify and describe challenges for achieving responsible data governance in the European Health Data Space. Three key challenges were prioritised by the experts.
- Engagement with and Participation of Stakeholders
Healthcare is a multifaceted ecosystem, and EHDS involves a multitude of stakeholders: individuals, healthcare providers, researchers, policymakers, and more. The first challenge lies in fostering active engagement and considering the diverse perspectives of these stakeholders. Building bridges and ensuring cooperation is essential for EHDS to gain the trust and support it needs to succeed.
- Rights, Legitimate Interests, and Responsibilities
EHDS represents a paradigm shift in how we manage health data, challenging our established concepts of data governance. The second challenge revolves around defining and safeguarding the rights of individuals over their data, acknowledging the legitimate interests of various stakeholders, and delineating the responsibilities of data handlers. It’s a delicate balance between data access and protection, and aligning with the boundaries of our current understanding.
- System Security
With greater access to health data comes an increased responsibility for its security. The third challenge revolves around ensuring the utmost security within the EHDS infrastructure. This encompasses implementing rigorous security measures, preventive strategies, and incentives for compliance with rules and high standards. It’s about safeguarding the confidentiality and integrity of health data.
Addressing these challenges isn’t merely a technical or legal matter; it’s a societal necessity. Confronting these issues head-on will not only establish responsible data governance but could also improve public support and provide clarity to all stakeholders. This, in turn, enhances EHDS’s likelihood of fulfilling its intended purpose.
By Anna Holm Bodin
Danish Board of Technology. (2023). Challenges for Achieving Responsible Data Governance in European Health Data Space. Zenodo. https://doi.org/10.5281/zenodo.8320909