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MedTech Europe supports the project of the European Health Data Space (EHDS). The medtech industry is at the heart of the health data ecosystem. The industry’s digital health solutions annotate and enrich data to turn raw data into datasets of high value. Innovation in the development of new treatments and protocols is highly dependent on its ability to access and appropriately utilise health data.

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.

MedTech Europe welcomes the opportunity to provide feedback on the proposed European Health Data Space (EHDS) regulation, please find our full answer attached. • The EHDS regulation is meant to complement other EU laws, including existing sectoral and horizontal legislation.

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.

The European Health Data Space (EHDS) Regulation represents an important step towards enabling the secure, trustworthy and efficient secondary use of electronic health data across the European Union. MedTech Europe welcomes the Commissions efforts to operationalise the EHDS by specifying requirements for dataset descriptions.