Presentation (CTI)

OBJECTIVES: An automated, AI-enabled registry platform operating at scale across multiple US therapeutic areas has established a validated model for real-world evidence generation through automated structured and unstructured EHR data capture, natural language processing of clinical records, and multi-source data harmonization. This study proposes the European Commission's 2025 Digital Decade composite eHealth indicator as a proxy for digital health ecosystem maturity and derives an EU market stratification framework for site-level automated registry deployment
METHODS: The 2025 Digital Decade eHealth Indicator full report (29 countries) provides composite scores and 12 sub-indicators across four thematic layers, evaluated as proxies for five site-level operational prerequisites aligned with the ISPOR EHR data suitability framework (Fleurence et al., 2024): clinical data digitization, data category completeness, data currency, format standardization, and overall ecosystem digital maturity. The EC's 4-cluster taxonomy - Trendsetters (>=90%), Fast-trackers (82-89%), Followers (70-78%), Beginners (<70%) - was used for market readiness stratification
RESULTS: Seven Trendsetter countries (Belgium, Estonia, Denmark, Lithuania, Malta, Poland, Norway; composite >=90%) present conditions most conducive to direct transfer of the US-validated automated extraction model. Notably, the five largest EU economies cluster in Fast-tracker or lower tiers, reflecting healthcare system fragmentation rather than economic underdevelopment. High-maturity data categories - ePrescription/eDispensation (88%), laboratory results (84%), and hospital discharge reports (82%) - reflect broad data availability for automated extraction in top-tier markets. Medical imaging (26%) and medical device data (55%) represent the lowest-maturity categories across all tiers, requiring supplementary strategies regardless of tier. The EHDS Regulation (2025) strengthens the mandate for cross-border health data standardization.
CONCLUSIONS: Mapping a US-validated automated registry model against the EU Digital Decade eHealth composite score enables systematic, evidence-based market entry prioritization. This approach translates proven real-world evidence infrastructure into a globally scalable deployment framework, with immediate applicability for sponsors designing multi-country evidence generation programs under evolving EU and global HTA requirements.