A milestone for Digital Health: Unlocking Europe’s health data future together
Posted on 18.03.2025
Brussels, 18 March 2025 – The publication of the European Health Data Space (EHDS) Regulation in the Official Journal of the EU marks a significant milestone for digital health in Europe. The EHDS has the potential to transform healthcare by improving access to and the use of electronic health data, fostering innovation, strengthening Europe’s competitiveness in the health sector. To build trust and maximise the impact of this new health data ecosystem, MedTech Europe highlights the following points that should be considered for the implementation.
It is important to take best practices into account through a continuous dialogue with the EU health stakeholder community. Together with 38 other European health stakeholders, MedTech Europe has shared key recommendations for the EHDS governance, including the urgent establishment of the EHDS board and the stakeholder forum. This will ensure an effective and future-proof functioning of the system.
To maximise the full potential of the EHDS, a harmonised implementation across EU Member States is essential. A fragmented approach could limit its impact, and therefore, a consistent application of the new rules is crucial. For example, Health Data Access Bodies must receive clear, comprehensive guidance on their responsibilities and for the interpretation of this new legal framework, also when it comes to the safeguards for trade secrets and IP rights. Achieving a harmonised implementation will require robust coordination by the EHDS Board and, where appropriate, at the national levels.
A workable approach for Electronic Health Record (EHR) systems is necessary. This approach should also consider the complex design of innovative and highly specialised medical technologies, when providing further guidance. For systems that need to comply with the technical requirements, it is important to have a better understanding of those, to ensure that manufacturers have adequate time to prepare for the EHDS implementation. For this, best practices from industry and standard developing organisations should be taken into account.
“The EHDS is a game-changer. But only if we get it right. This is not just about data; it’s about people, patients, and the future of healthcare in Europe. If we work together, policymakers, healthcare professionals, industry, and patients, we can make sure this regulation becomes a real driver of innovation, better care, and stronger health systems across Europe.”, said MedTech Europe CEO Oliver Bisazza.
MedTech Europe and its members look forward to contributing to this journey and ensuring that the EHDS becomes the cornerstone of Europe’s digital health transformation and competitiveness.