What the EHDS is and why it was established The European Health Data Space (EHDS) is a European Regulation (EU 2025/327) that entered into force in March 2025. It creates a common framework for using electronic health data across the European Union (EU). The main motivation behind the EHDS is the increasing need for… Continue reading European Health Data Space (EHDS): Status, Implications for Patients and Doctors
Tag: Regulatory
The Role of Real-World Data in HTA Reassessments
Health technology assessments (HTAs) are the foundation of evidence-based decision-making for reimbursement, and coverage of medicines and medical technologies. Traditionally, the process has been heavily anchored in evidence from randomized controlled trials (RCTs), assessed at the time of market entry. However, healthcare systems have been evolving and are increasingly shifting toward a lifecycle approach to… Continue reading The Role of Real-World Data in HTA Reassessments
Label Expansion and the Role of RWD
In the lifecycle of a pharmaceutical product, initial regulatory approval is often just the beginning. A newly authorized drug typically enters the market with a carefully defined label specifying the disease, population, dose, and setting for its use based on data from randomized controlled trials (RCTs). But often label specifications evolve. Real world clinical needs… Continue reading Label Expansion and the Role of RWD
The Potential of RWD in Veterinary Medicine: A New Frontier for Pet Health
In recent years, Real-World Data (RWD) has revolutionized human healthcare, driving better decision-making, drug development, and patient outcomes. Yet, another promising and rapidly evolving area for RWD innovation lies in veterinary medicine. As pets are increasingly becoming cherished family members and demand for advanced veterinary care, RWD offers an unprecedented opportunity to also transform animal… Continue reading The Potential of RWD in Veterinary Medicine: A New Frontier for Pet Health
Methodological Considerations in RWD Studies by Intended Use
The growing acceptance of real-world data (RWD) and real-world evidence (RWE) has expanded the horizon for how we generate insights to support decision-making across the product lifecycle. However, while the value of RWD is increasingly recognized by regulators, payers, and safety bodies, the design and methodological rigor of these studies must be carefully tailored to… Continue reading Methodological Considerations in RWD Studies by Intended Use