From Policy to Practice: Implementing the EHDS for Responsible Data Sharing

From Policy to Practice: Implementing the EHDS for Responsible Data Sharing

In May 2022, the European Commission introduced the proposal for the European Health Data Space (EHDS) to establish a unified framework for the secure and standardized sharing of electronic health data across all EU member states. The EHDS Regulation, finalized and entered into force for implementation on March 26, 2025, is the inaugural initiative among nine planned European sector-specific data spaces. As a new regulatory framework, EHDS introduces significant opportunities that encompass two core components: (1) patient rights regarding access and control of their electronic health data, supported by the necessary infrastructure; (2) provisions for access and secondary use of health data for research, innovation, policy development, and other approved uses. The implementation of these components requires harmonization of data governance mechanisms across diverse health systems of EU member states.

The MRCT Center has partnered with Vivli to co-host a series of online, invitation-only forums for interested pharmaceutical and biotechnology companies to support stakeholders in understanding and navigating this evolving landscape. A range of issues, including the implementation of EHDS, the importance of harmonizing data governance, data protection, and compliance, have been discussed to date, with additional topics slated for presentation and discussion at upcoming forums. Additionally, commentary and responses to the EHDS draft guidelines are presented and discussed in the forums. Through this collaborative approach, we aim to identify and address opportunities and challenges, ensuring that EHDS fulfills its promise of advancing personal health, innovation, and clinical research across Europe.

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