Why Governance May Become the New Competitive Advantage in RWE The publication of the European Medicines Agency’s new Data Quality Framework for EU medicine regulation: application to Real-World Data (RWD) marks an important moment in the evolution of Real-World Evidence (RWE) research in Europe. While much of the discussion around RWE has traditionally focused… Continue reading How EMA Is Redefining Credibility in Real-World Evidence
Tag: RWD
Germany’s DiGA Programme: the Evolution of Digital Therapeutics Reimbursement
When Germany introduced reimbursement for prescription digital health applications in 2020, it became the first country to create a national pathway for digital therapeutics to enter routine healthcare. The policy, embedded in the Digital Healthcare Act (Digitale-Versorgung-Gesetz), allowed physicians to prescribe certified medical apps (known as Digital Health Applications, or DiGAs) and have them reimbursed… Continue reading Germany’s DiGA Programme: the Evolution of Digital Therapeutics Reimbursement
Opt-Out Health Data Governance: Comparing Germany’s and France’s Regulatory Model
The ability to reuse routinely collected healthcare data has become a central aspect of modern clinical research and real-world evidence (RWE) generation. Across Europe, governments are reforming their legal frameworks to enable large-scale health data analysis while maintaining strong protections for patient privacy and individual rights. Two particularly instructive examples are Germany and France. … Continue reading Opt-Out Health Data Governance: Comparing Germany’s and France’s Regulatory Model
When the Real World Emerges from the Trial Shadow: Cardiovascular RWE at an Inflection Point
by Mathieu Ghadanfar, MD, FESC, FAHA Cardiovascular medicine has entered an era of extraordinary randomized evidence. DAPA-HF, EMPEROR-Reduced, EMPA-KIDNEY, the SELECT trial (1, 2, 3): each enrolling tens of thousands of patients, each reshaping guidelines. And yet the questions that dominate daily clinical decision-making remain unanswered by any of them. No large randomized… Continue reading When the Real World Emerges from the Trial Shadow: Cardiovascular RWE at an Inflection Point
Do We Still Need Country-Specific Data?
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?