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 open door. But getting listed and getting prescribed are two different things, and most teams learn that too late.
A DiGA (Digitale Gesundheitsanwendung) is a low-risk digital medical device that physicians and psychotherapists can prescribe and statutory insurance reimburses. It's listed via the BfArM fast-track (about 90 days), either permanently (benefit proven) or provisionally (proven during a trial period). Reimbursement starts from day one of listing. The catch: a listing makes you reimbursable, not prescribed — and closing that gap is a commercial job, not a regulatory one.
Through the DiGA framework, introduced by the Digitale-Versorgung-Gesetz (DVG) in 2019, a digital health application can be prescribed and reimbursed by Germany's statutory health insurance — which covers roughly 73 million people.
For an evidence-based product in chronic disease, mental health or prevention, that is unusual: a clear, explicit reimbursement pathway into a large paying market, rather than the improvised route digital health faces almost everywhere else. The market is small today but growing, and the door is genuinely open.
The framework solves access. It does not solve adoption — and that is where entry actually succeeds or quietly fails.
Listing runs through the BfArM (Federal Institute for Drugs and Medical Devices), which maintains the official DiGA directory and runs a fast-track assessment of about 90 days.
Either way, you earn from day one of inclusion — which is what makes the provisional route attractive: revenue while you generate the evidence.
A DiGA is a regulated medical device before it is a reimbursable app. Four requirements decide whether you get listed — and one is routinely underestimated.
The data-security bar is high and rising: it's not a checkbox but a certified engineering programme, and it should start early because it gates the listing regardless of how good the clinical evidence is.
This is where most DiGA entries stall. Being in the directory does not put you in front of patients.
You are reimbursable. BfArM listing, data security and evidence are cleared. The regulatory battle is won.
Physician awareness of DiGA is uneven and prescribing habits are conservative. 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. Patients can also obtain a DiGA directly through their insurer's approval — a second demand channel most foreign teams overlook.
Getting listed is a project. Getting prescribed is a go-to-market campaign.
In a focused session we map permanent vs provisional listing, the data-security and evidence gaps, a first-year pricing view, and the physician-awareness plan that turns a listing into prescriptions.