Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi

Objectives and agenda

This implementation dialogue will discuss the implementation of the European Health Data Space (EHDS) Regulation, including the potential for simplification.

The EHDS Regulation aims to create a patient-centred framework that strengthens patients' control over their personal electronic health data, while ensuring continuity of care in cross-border scenarios and patient safety.

Moreover, the EHDS has the potential to transform Europe into a global leader in health innovation by unlocking the value of vast European health data resources and by removing fragmentation that currently hampers the digital health market. It has two core pillars:

• primary use of electronic health data for healthcare delivery
• secondary use of electronic health data for research, innovation, and policy-making.

The purpose of the implementation dialogue is to gather input to ensure that the EHDS delivers its intended benefits with minimal administrative burden. The event will collect input from stakeholders, particularly industry, with a view to incorporating their feedback to shape the implementation of the EHDS Regulation.

The objective is to identify the main challenges stakeholders are facing in the implementation of the EHDS Regulation and to discuss ways to address them, simplify the implementation, and minimise administrative burden and implementation costs.

Agenda

• Introduction and welcome
• Presentation of the EHDS Regulation and its implementation timeline
• Discussion on challenges and way forward
• Conclusion and next steps

Stakeholder participation

Companies, both large and SME from the health industry, such as pharmaceutical companies, medical device companies, as well as research organisations, patient organisations, professional associations and hospital federations.