Real-world evidence (RWE) is built on the premise that data generated during routine clinical care can reveal how medicines and interventions actually perform outside the environment of controlled trials. Electronic health records (EHRs) and disease registries are often treated as the foundational infrastructure of this approach. To improve data quality, many systems increasingly rely on… Continue reading The Hidden Architecture of RWE: When Complete Data Stop Being True Data
Tag: RWD
The RWE Paradox: Plenty of Data, Fragile Structure
For more than a decade, we have framed real-world evidence (RWE) challenges as a data problem. Not enough access. Not enough scale. Not enough linkage. Not enough quality. However, this narrative has become increasingly difficult to sustain. Across major markets, data availability has expanded, platforms have matured, and analytical methods have become more standardized and… Continue reading The RWE Paradox: Plenty of Data, Fragile Structure
EHDS Section 60: The Illusion of Neutral Data Sharing?
Reading the EHDS regulation carefully, and in particular Section 60, leaves a sense of discomfort that is not really about legal drafting, but about how knowledge is produced and legitimized. The text is cautious, layered with safeguards, and repeatedly reassures the reader that intellectual property, trade secrets, and commercial confidentiality remain protected. And yet, between… Continue reading EHDS Section 60: The Illusion of Neutral Data Sharing?
The Swiss Health Data Space: Status, Progress, and Future Direction
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
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