Challenge

Digital Health Technologies (DHT), including Digital Therapeutics, AI-powered tools, and telehealth services, are becoming increasingly important in healthcare. However, their adoption across Europe is weakened by fragmented regulatory and assessment approaches. Current Health Technology Assessment (HTA) frameworks are not well-adapted to the dynamic nature of DHTs, particularly those based on artificial intelligence or developed through iterative updates. This lack of harmonisation limits patient access to effective technologies and restricts the potential of a unified digital health market across the EU.

Solutions

ASSESS-DHT responds to these challenges by creating a comprehensive and trustworthy HTA assessment framework tailored to the specificities of DHTs. The project brings together key players from across Europe, including four national HTA bodies, prominent academic and non-profit institutions, professional and patient organisations, and industry representatives. By co-developing specialised assessment pathways based on a newly developed typology of DHTs, the project ensures that different categories of digital health solutions are appropriately evaluated. A semantically searchable evidence library, comprehensive manuals, and tools will support both HTA bodies and developers in the assessment and validation of DHTs. The framework is built using a structured, participatory approach involving regulators, healthcare providers, and ministries to ensure long-term relevance and usability.

Results

ASSESS-DHT lays the foundation for a more unified digital health market across Europe by facilitating cross-border adoption of effective DHTs. It ensures that digital innovations are assessed in a trustworthy and interoperable way, enabling both patients and health systems to benefit from the best-available technologies, regardless of national borders. The project contributes to the digital transformation of health services by providing practical, actionable tools and a sustainable infrastructure for evaluating digital health technologies. It also boosts industry confidence by offering a clear pathway for validation and reimbursement, encouraging innovation and competitiveness in the European digital health sector.