Presentation (CTI)

OBJECTIVES: The EU Health Technology Assessment (HTA) Regulation (HTAR) and European Health Data Space (EHDS) are expected to increase use of real-world data (RWD) in HTA. For Medical Devices Artificial Intelligence (MDAI), RWD may help address evidentiary uncertainty across lifecycle. This study explored European HTA bodies’ perspectives on MDAI assessment, RWD and Health Data Access Bodies (HDABs).
METHODS: A semi-structured online survey was developed within the EU-funded SHAIPED project and distributed to 63 HTA bodies (HTAb) across 30 EU/EEA countries. Closed-ended and open-text questions addressed MDAI evaluation challenges, RWD use, fit-for-purpose criteria and HDAB enabling conditions. Quantitative responses were descriptively analyzed, and qualitative responses thematically analyzed.
RESULTS: Twenty-one responses were received from 16 EU/EEA countries. Preliminary findings indicated limited MDAI-specific formal HTA pathways, with several reporting assessments through general medical-device/digital-health routes. The main HTA challenge identified was the lack of adequate methods to assess technologies that may change over time. A second challenge concerned data-related issues, relevant to adaptive and static MDAI, including data protection and security. Respondents highlighted the need to adapt traditional HTA methods by moving beyond one-time assessment. Suggested adaptations included extending assessment timeframes, defining reassessment triggers, periodically monitoring algorithm drift and setting up conditional reimbursement agreements. Informers emphasized the importance of assessing data-source quality. The prioritized data-quality domains were representativeness, validation against controlled data, and completeness and standardization. HDABs were seen as potentially helping resolve RWD access challenges, by promoting interoperability and data harmonization, enabling secure and timely access to data and supporting data quality, completeness and accuracy.
CONCLUSIONS: This expert consultation gathered EU HTAb perspectives on existing methods for HTA of MDAI and the role of RWD. HTAb highlighted the need for methodologies that accommodate the evolving nature of MDAI and strong reliance on RWD. Experts reported that HDABs under EHDS could help effectively support HTA processes for MDAI.