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?
Tag: RWE
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
When Real-World Data Aren’t So “Real” Anymore
As a data-driven endurance athlete, I use several devices to track my performance and progress. Like many others, I occasionally end up in troubleshooting communities (especially those dedicated to Garmin products) trying to understand why a metric looks off or how to recalibrate a sensor. It’s really fascinating to read the discussions. You quickly… Continue reading When Real-World Data Aren’t So “Real” Anymore
Conducting Real-World Evidence (RWE) Studies in Obesity: Opportunities and Challenges
By Patrick Wulf Hanson (Reviewed, adjusted and approved by Dr. Frederik Persson, Head of Clinic, Steno Diabetes Center, Copenhagen, Denmark) 1. Introduction Globally, obesity has emerged as a critical public health challenge, contributing to substantial morbidity and mortality, and it is a leading risk factor for diseases such as type 2 diabetes, cardiometabolic… Continue reading Conducting Real-World Evidence (RWE) Studies in Obesity: Opportunities and Challenges