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?
Author: Nadia Barozzi
Passionate about data-driven insights and the advancement of Real World Evidence research, drug safety and pharmacovigilance.
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
Do Pharma Still Need Large CROs for RWD Studies?
In the traditional model of real-world evidence (RWE) generation, sponsors relied almost automatically on contract research organizations (CROs) to manage observational studies end to end. That model made sense when data were fragmented, technology limited, and sponsors lacked internal capacity. Today, the landscape is very different. Data networks are richer, analytical platforms are significantly more… Continue reading Do Pharma Still Need Large CROs for RWD Studies?
The Health Data Lab in Germany: A Country Initiative with a Central Role in Health Data Science
What the Health Data Lab Is and How It Works In recent years, Germany has taken important steps toward building a national infrastructure for health data that can support research, planning, and policy. One of the most ambitious initiatives in this direction is the Health Data Lab (Gesundheitsdatenlabor, HDL), managed by the Federal Institute… Continue reading The Health Data Lab in Germany: A Country Initiative with a Central Role in Health Data Science