Digital health app (DiGA) manufacturers must implement continuous performance measurement and reporting (AbEM system) to BfArM. Results published in DiGA directory. Up to 20% of reimbursement price will be success-based (outcome-dependent pricing model). Represents major shift from fixed to value-based pricing for digital therapeutics.
BfArM DiGA Fast Track · January 01, 2025
Germany DiGA Performance Reporting Mandatory
DiGA manufacturers must implement continuous performance measurement (AbEM) and report to BfArM; up to 20% of reimbursement becomes outcome-dependent.
Implementation Date
January 01, 2026
Published by BfArM DiGA Fast Track. HealthSignal links to the original document; the summary above is extracted from the source text.