Introduction Switzerland has been discussing digital health and data interoperability for many years, but progress has often been slow and fragmented. Health information is distributed across cantonal systems, hospitals, private practices, laboratories, insurers and research institutions, with limited coordination between them. This fragmentation affects not only continuity of care but also the ability to conduct research,… Continue reading The Swiss Health Data Space: Status, Progress, and Future Direction
Category: Regulatory
European Health Data Space (EHDS): Status, Implications for Patients and Doctors
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
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
How Local Healthcare Systems Shape the Availability and Quality of Real World Data
Real-world evidence (RWE) research is deeply influenced by the way healthcare systems are structured. Local regulations, institutions, reimbursement models, and IT infrastructure all shape how real-world data (RWD) are generated, collected, stored, and made accessible. By tracing the patient’s journey through a country’s healthcare system, we can understand where data are generated, who controls them,… Continue reading How Local Healthcare Systems Shape the Availability and Quality of Real World Data
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