OBJECTIVES: Market access, reimbursement, and patient access for Digital Health Technologies (DHT) vary considerably across Europe. Understanding country-specific reimbursement requirements is essential for entering the international digital healthcare market. This analysis aims to identify the differences in DHT market access pathways in two Western (Germany, Spain) and two Eastern (Poland, Hungary) European countries and to compare the resulting consequences for manufacturers.

METHODS: National authority websites were reviewed for legal frameworks, supplemented by a targeted literature review.

RESULTS: Manufacturers of DHTs face distinct challenges and opportunities when entering the German, Spanish, Polish, and Hungarian health care markets. Based on our research, Germany offers a clear "Fast Track" process for DHT, allowing quick market entry and reimbursement if medical benefits or structural/procedural improvements are proven (3 to 4 months). In Spain, the dual national and regional evaluation processes create complexity, requiring manufacturers to navigate regional variability in coverage and engage with multiple stakeholders (timeline variable). Poland currently offers limited opportunities for non-therapy-related DHTs, but therapeutic DHTs classified as medical devices can follow a defined reimbursement pathway involving assessment by the HTA organization and pricing negotiations (timeline variable). Hungary’s biggest challenges is due to the lack of specific guidelines for DHT reimbursement, necessitating engagement with multiple entities like national health insurance, HTA bodies, potentially resulting in delays. Manufacturers must tailor their strategies to each market's unique requirements and continuously monitor policy developments, especially in Poland and Hungary.

CONCLUSIONS: To successfully enter these markets, manufacturers should ensure 1) the DHT meets EU medical device regulations (MDR) if applicable, 2) generate robust clinical and economic evidence, 3) engage early with relevant authorities and stakeholders, 4) monitor policy developments, especially in Poland and Hungary, and 5) potentially consider a phased approach, starting with more structured markets like Germany.