New EU HTA Regulation for Digital Medical Devices (including AI)

The recent study on the European Union's Health Technology Assessment (HTA) Regulation for Digital Medical Devices (DMDs), including artificial intelligence-based devices, provides a comprehensive overview of the current state and future trends of this rapidly evolving sector. The report highlights the urgent need for an adaptive and harmonized assessment to ensure adequate market access and effective reimbursement for these innovative devices.

Adaptive Assessment and European Harmonization
Although DMDs have great potential to transform healthcare, their clinical adoption faces significant challenges due to the lack of a consolidated regulatory framework and uniform coverage decisions in Europe. The study highlights the importance of an adaptive evaluation system that responds to rapid technological change, as well as the need for European harmonization to overcome disparities between Member States. Initiatives and projects are underway to establish a European infrastructure to support the assessment of DMDs, both at European and national level.

Challenges and Opportunities in the Evaluation of DMDs
The report identifies several limitations in current evaluation methodologies, including the lack of focus on artificial intelligence and the difficulty in adapting evaluation timelines to the shorter life cycles of DMDs. However, it also points to significant opportunities to improve evaluation methodologies, including the incorporation of real-world evidence. In addition, it highlights the need for regulatory transparency to strengthen predictability and trust in the DMD assessment process.

New Pathways for Access and Reimbursement
Several European countries are implementing fast-track access routes for innovative technologies, such as DiGA in Germany and PECAN in France. These pioneering programs offer accelerated access models, allowing for faster reimbursement and stimulating innovation. The study underlines the importance of generating evidence, with a focus on real-world data and comparative studies, to demonstrate the clinical and economic value of devices. Increasing transparency about regulatory requirements and evaluation processes for DMDs is essential to support access to the European market.

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