Healthcare organizations are investing heavily in both real-world evidence (RWE) studies and artificial intelligence (AI). At first glance, these two fields seem to rely on the same raw material: large healthcare datasets drawn from electronic health records (EHRs), claims databases, registries, genomics, imaging, and patient-generated data. Because the source data often overlaps, it is tempting… Continue reading Data feasibility in Healthcare: Comparing fit-for-purpose and fit-for-training
Tag: RWD
How EMA Is Redefining Credibility in Real-World Evidence
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
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