Public Webinar: From Policy to Practice: EHDS Implementation to Support Better Real-World Evidence for HTA/Payers

The Regulation for a European Health Data Space, adopted in April 2024, establishes a transformative framework for the use and sharing of health data across the EU. It aims to foster secure and efficient access to health data to improve healthcare delivery, drive research and innovation and support policy decisions, including HTA. By creating a harmonised EU digital ecosystem for health data, the EHDS will be key to unlock the potential of RWE to enable patient access to innovative therapies.

To meet the objectives of the EHDS, Member States will need to establish interoperabele digital infrastructures and robust governance mechanisms for health data. With varying levels of maturity in digitalisation of health data, setting a common baseline for capabilities – such as data formats, secure data-sharing protocols and alignment with data protection laws – will be essential. To ensure effective implementation, healthcare stakeholders including HTA/Payers need to be consulted when setting up the system. National and EU-level initiatives play a pivotal role in bridging these gaps.

The EHDS implementation faces several roadblocks ahead, including technical challenges, legal and ethical concerns, and organisational issues. This webinar identified actionable solutions and best practices in overcoming these obstacles for the secondary use of RWD, exploring how Member States are developing implementation models and drawing insights from these initiatives.