Germany built one of the world's first reimbursement routes for digital health — the “app on prescription.” For a foreign company it's a rare gift: a clear path into a market of statutory-insured patients. Most companies discover the catch too late.
Through the DiGA framework (Digitale Gesundheitsanwendungen), a digital health application can be prescribed by physicians and psychotherapists and reimbursed by statutory health insurance.
The market is small today but growing fast — among the few in European health where the reimbursement pathway is explicit rather than improvised. For an evidence-based product in chronic disease, mental health or prevention, that is an unusually open door.
The catch: the framework solves access, not adoption. A listing makes you reimbursable. It does not make doctors prescribe you — and that is where entry actually succeeds or quietly fails.
DiGAs are reimbursed by Germany's statutory health insurance, which covers roughly 73 million people — a large, explicitly addressable paying market.
Listing runs through the BfArM (Federal Institute for Drugs and Medical Devices), which maintains the DiGA directory and runs a fast-track assessment of about 90 days.
If you can already demonstrate a positive healthcare effect (positiver Versorgungseffekt) — a medical benefit or a patient-relevant structural / procedural improvement — you list permanently.
Listed for a trial period (typically up to a year) during which you prove the effect through a study to German standards. Reimbursable throughout — revenue while you generate evidence.
Either way, listing is reimbursable from day one of inclusion — which is what makes the provisional route attractive: you earn while you build the evidence base.
Germany's bar is high and rising: GDPR compliance, BfArM's data-security requirements, and a security certificate from the BSI (federal cyber-security office). For non-EU companies this is often the hardest and most underestimated hurdle.
Evidence German assessors accept — which usually means a study designed with the German reimbursement context in mind, not repurposed home-market data.
DiGA pricing follows a logic foreign companies will recognise from pharma — the first-year price is both a revenue lever and an anchor for the negotiation that follows.
In the first year after listing the manufacturer sets the price freely. Set it strategically, not by default — it anchors what comes next.
Prices are then arranged with the GKV-Spitzenverband (the statutory insurers' association) — the first-year anchor shapes the outcome.
This is where most DiGA entries stall. Being in the directory does not put you in front of patients.
You are reimbursable. The regulatory battle is won: BfArM listing, data security, evidence cleared.
Physician awareness is uneven, prescribing habits are conservative — and a listed app with no prescriptions earns nothing.
The work that turns a listing into revenue is commercial, not regulatory: physician awareness, the right specialist and association channels, patient pathways, and a credible local presence behind the product. That is the layer we own.
A “we got them listed” claim without an uptake story reads as hollow to anyone who knows this market. We own the part that turns a listing into prescriptions.
Run with specialist partners, kept aligned to the commercial plan — so the listing and the launch aren't disconnected projects.
A focused working session plus a short written output — so you know the realistic route, price and uptake picture before committing budget.
Tell us your product and condition area — we'll come back with the route, the pricing view and the uptake plan.
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