The European Health Data Space (EHDS) regulation is a groundbreaking initiative designed to enable secure, interoperable, and efficient health data exchange across the EU. This effort holds the potential to transform healthcare delivery, foster innovation, and enhance patient access to critical health information.
In partnership with the XpanDH project, MedTech Europe and COCIR affirm their commitment to supporting the successful implementation of the EHDS by addressing key challenges, particularly those related to the regulation’s broad definition of Electronic Health Record (EHR) systems.
This paper will address three pivotal topics: the need for use-case-driven guidance for interpreting requirements across digital health product categories, scaling testing frameworks for EHDS interoperability, and ensuring the separation of exchanged content and transport transactions within a simplified interoperability architecture.