Hírek

Estonia has announced several new national-level investments to support digital health, AI in diagnostics, and cross-border data infrastructure. The initiative aims to attract healthtech innovators seeking a supportive environment for RWE generation and early HTA work. The announcements include: - expanded access to anonymized health data, - sandboxes for testing digital therapeutics, - and cooperations with Nordic countries on health economics modelling. This positions Estonia as one of Europe’s leading ecosystems for digital, data-driven evidence development. IS4Health remains committed to supporting innovators operating in this dynamic landscape.

EUnetHTA 21 has released its final consolidated guidance on evidence generation and submission for Joint Clinical Assessments. The document focuses on clinical effectiveness, safety data requirements, and methodological expectations for systematic literature reviews. The guidance highlights the need for transparent search strategies, clear risk-of-bias evaluation, and consistent reporting of endpoints. It also encourages early dialogue between manufacturers and assessment bodies to ensure alignment with regulatory and payer expectations. This consolidated guidance is expected to form the backbone of early JCA procedures in 2025

The European Union’s new HTA Regulation (EU 2021/2282) officially entered its transitional operational phase this quarter. Joint Clinical Assessment (JCA) procedures for oncology medicines and ATMPs are expected to begin in January 2025, with medical technologies following in later years. Several Member States have already announced updates to their national submission templates to align with upcoming EU-level evidence requirements. Early preparation from manufacturers is strongly recommended, particularly in the areas of evidence completeness, comparator selection, and health economic justification. IS4Health will continue monitoring the implementation steps, guidance updates, and pilot JCA outcomes as they become available.