The European Medicines Agency has published a revised reflection paper setting out updated guidance on the use of real-world data
EMA publishes updated reflection paper on RWD use in non-interventional studies Read Post »
Germany’s Forschungsdatenzentrum Gesundheit (FDZ) has announced an extension to its data model that now incorporates ambulatory specialist care, meaningfully broadening
FDZ Gesundheit announces extended data model covering ambulatory specialist care Read Post »
The FDA has published draft guidance addressing the use of artificial intelligence and machine learning tools in drug development contexts
FDA issues draft guidance on AI/ML in drug development using real-world data Read Post »
The European Commission has released draft implementing act specifications for Health Data Access Bodies (HDABs) under the European Health Data
EHDS implementing acts consultation: Commission releases draft HDAB specifications Read Post »
Published 11.08.2026 — MEDDDICAL Editorial FDZ Gesundheit opened in October 2025 with a ministerially endorsed target of at least 300
Published 05.08.2026 — MEDDDICAL Editorial The European Health Data Space Regulation (Regulation EU 2025/327) entered into force on 26 March
If you’re planning a health outcomes study in Germany, choosing between statutory and commercial claims data isn’t about which dataset
Does Your Research Question Demand Statutory or Commercial Data? Read Post »
Germany just unlocked access to decades of statutory health insurance data covering most of its population, but there’s a catch:
Germany’s Health Data Use Act & EHDS: Dual-Layer Policy Transformation Read Post »
Getting German health insurance claims data wrong at the start cascades through every downstream deliverable in your HEOR strategy. One
Statutory vs Commercial German Claims Data: Which Access Route Fits? Read Post »
If you’re planning research with German statutory health insurance data, there’s a critical structural break in 2019 that could invalidate
Data Model 3 Granularity Gains: Detail Improvements from 2019 Onwards Read Post »
