In the European Union, data on racial or ethnic origin are classified as a “special category” under Article 9 of the GDPR, which generally prohibits their processing unless specific conditions are met, such as explicit consent or substantial public interest safeguards. As a result, several EU countries, including France, Germany, Denmark, and Sweden, do not… Continue reading Do We Still Need Country-Specific Data?
Category: Regulatory
Regulatory Insights from FDA Review of the External Control Arm in a Pediatric Rare Disease Trial
The approval of eflornithine (brand name Iwilfin) for pediatric high-risk neuroblastoma offers an interesting example of how the FDA evaluates single-arm trials supported by external control arms (ECAs). External controls are increasingly common in oncology and rare disease drug development, but they remain a source of careful regulatory scrutiny. In this case, the FDA’s assessment… Continue reading Regulatory Insights from FDA Review of the External Control Arm in a Pediatric Rare Disease Trial
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