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

The recent study on the EU HTA Regulation for Digital Medical Devices (DMDs), including Artificial Intelligence-based technologies, highlights the need for adaptive assessment and European harmonisation to ensure market access and effective reimbursement. The study explores challenges and opportunities in the sector, such as the lack of focus on AI and the difficulties of adapting to the short life cycles of DMDs, but also points to improvements through the incorporation of real-world evidence. It highlights the importance of regulatory transparency and fast-track access routes, with innovative examples such as DiGA in Germany and PECAN in France. The harmonisation of assessment methodologies in the European Union is essential to foster innovation and competitiveness in the digital medical device sector.