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The EHDS Inception Impact Assessment sets out ambitious objectives linking together the need for secure and trusted health data sharing for what will be the creation of the first European data space. The EHDS has the potential to be the single market for digital health products and services, and the global centre of development of secure AI powered digital health.

RWE4Decisions welcomes the Commission’s EHDS proposal: it is an ambitious step forward that can contribute to a sustainable real-world data (RWD) ecosystem by addressing the current fragmentation and lack of health data infrastructure within and across Member States, making sure the data are interoperable and of high-quality.

DIGITALEUROPE is a great supporter of the ambitions outlined in the Commission’s proposal for a regulation on the European Health Data Space (EHDS) which in our view is not a mere regulation but rather a holistic vision for the future of health and care for Europe. More effective use of health data is necessary to address diseases impacting often vulnerable communities.

The RWE4Decisions initiative welcomes this draft Implementing Regulation. As a multi-stakeholder initiative dedicated to improving the generation and use of realworld evidence (RWE) to inform HTA and payer decisionmaking, we strongly support the objective of enhancing transparency, discoverability, interoperability and trust in electronic health data for secondary use across the EU.

Overall, the draft act lacks clear mechanisms for defining confidentiality levels and access conditions, creating a critical gap in the protection of intellectual property (IP) and trade secrets (TS) in EHDS implementation. Missing safeguards: There is no clear process or tag for data holders to label commercially sensitive information or define confidentiality levels.