RWE 201 – EU – EU4Health Program


EU4Health is an ambitious EU health program for the years 2021-2027. Its primary goal is to bolster the resilience of Europe’s health systems and to spur innovation in the health sector. The program has a budget of €5.3 billion, making it one of the largest health budgets in the history of the European Union.

Key objectives include:

– Strengthening health systems so that they can face epidemics and other long-term challenges.

– Supporting global commitments and protecting citizens from serious cross-border health threats.

– Making medicines and medical devices available and affordable, and fostering innovation.

[1]  Real-World Data (RWD) and Real-World Evidence (RWE):

– RWD refers to data that are collected outside of conventional clinical trials. This includes electronic health records (EHRs), claims and billing activities, product and disease registries, and patient-related activities in smartphones and wearables.

– RWE is the evidence derived from RWD through the analysis of these real-world outcomes. RWE can provide insights into medication safety and effectiveness, treatment guidelines, and health technology assessment (HTA).

[2] Context of RWD and RWE in EU4Health: The EU recognizes the potential of RWD and RWE to bring about significant changes in healthcare decisions. By tapping into the vast amount of data generated daily in healthcare settings, decision-makers can:

– Understand the real-world effectiveness of treatments.

– Inform regulatory and reimbursement decisions.

– Understand disease patterns and trends.

[3] EU RWD Collection and RWE Generation Action Plan: This action plan represents a strategic effort to harness the power of RWD and RWE. Some of its goals and activities may include:

– Standardizing the collection and use of RWD across EU member states.

– Collaborating with stakeholders to ensure the quality and reliability of RWE.

– Building infrastructures that support data sharing and analytics.

– Training professionals in the methodologies of RWE.

It’s worth noting that as the landscape of RWD and RWE evolves, so too will the EU’s strategies and policies. The collaboration between healthcare professionals, policymakers, patients, and other stakeholders will be crucial in harnessing the full potential of RWD and RWE in the EU4Health framework.

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