International Market Access Strategies for Artificial Intelligence-Based Medical Devices: Can We Standardize the Process to Faster Patient Access?

The reimbursement of artificial intelligence (AI)-based medical devices (MDs) is a complex and challenging issue, depending on national market access pathways. We aim to analyze these pathways and propose recommendations for standardized market access processes. In the USA, companies sell AI-based MDs to each health insurance provider separately. In Europe, Germany is a pioneer in digital MD reimbursement, followed by France. However, it varies markedly without specific pathways in other European countries. In Asia and Australia, health insurance reimburses them. Despite important variations in assessment policies, reimbursement restrictions, and a lack of transparency in decision-making processes, collaboration among health technology assessment agencies at an international level can enhance evidence-based coverage decision-making. Regarding current barriers to market access standardization, understanding each country's needs and building high-quality evidence are mandatory. Solutions to promote standardized market access pathways are as follows: (1) accelerating approval; (2) standardizing health technology assessment; (3) generating health economics evidence; and (4) expanding insurance coverage. These perspectives aim to change paradigm from market access to patient access through a standardized assessment of AI-based MDs.