OBJECTIVES: Digital Health Technologies (DHT) have the capacity to personalise healthcare, improve access to services and enhance patient outcomes. This can, in turn, reduce the burden on healthcare resources. The timely integration of DHTs into health systems relies on Accelerated Coverage Pathways for Innovation (ACPIs) which facilitate early access to these innovative solutions. This research aims to compare the various ACPIs for DHT coverage in Germany, France, and the United Kingdom.

METHODS: All publicly available documents on regulations, guidelines, and evaluation processes of the ACPIs in the three countries up to 2023 were identified and used to map available details of the programs. A theoretical evaluation using publicly available ACPI criteria was conducted to compare the likelihood of coverage of two technologies, used as case studies. This was done to comprehend the factors that may influence the adoption of DHT in respective countries.

RESULTS: The most appropriate DHT ACPIs were identified; one per country in scope: the AI in Health and Care award in the UK, DiGA in Germany, and PECAN Coverage in France. The pathways were compared to detect similarities and differences in coverage criteria. The theoretical evaluation resulted in 100% of the devices being eligible in the UK, 50% in Germany and 50% in France. (Theoretical evaluations were based on public information but actual authority evaluations could differ.)

CONCLUSIONS: Innovative pathways for DHT adoption in the three countries all aim to expedite the delivery of life-saving, revolutionary technology. Our study showed that Germany has a smaller acceptance of the type of technologies they cover (risk class I & IIa) and strict evidence and technical requirements. Though France has a wider acceptance (Risk class I-III & remote patient monitoring devices), it only covers CE-marked digital devices. UK’s ACPI aims to support various devices through different lifecycle stages and differing levels of evidence generation.