Reimbursement 101
Regulatory approval gets a product onto the market; reimbursement and market access decide whether it reaches patients at scale. This page walks through the DiGA pathway as the role-model timeline, defines the core concepts and regulatory frameworks, and shows the commercial models that co-exist across global markets.
The role model
Germany built the world's first national reimbursement route for digital therapeutics. Its milestones are the reference other markets measure themselves against — from the enabling law to today's shift toward outcome-linked pricing.
The Digital Healthcare Act (DVG) enters into force
On 19 December 2019 the DVG created the “app on prescription” — the first time a G7 health system gave its statutory-insured population (~73 million people) a legal entitlement to prescribed, reimbursed software.
The DiGA Ordinance (DiGAV) & the BfArM fast-track open
Implementing rules define the “fast-track”: BfArM assesses a complete application within three months, checking safety, data protection, interoperability and a “positive healthcare effect.”
The first DiGA go live in the directory
velibra (anxiety, permanent), Kalmeda (tinnitus, provisional) and somnio (insomnia) become the first apps physicians and psychotherapists can prescribe and statutory insurers reimburse.
Price negotiations begin
Manufacturers set their own price for the first 12 months; after that a negotiated rate with the GKV-Spitzenverband (national association of statutory insurers) kicks in — the first negotiated DiGA prices land.
Provisional listings convert to permanent
Apps that entered on a trial listing complete their evidence and convert to permanent listing — while debate grows over pricing guardrails and real-world uptake.
The Digital Act (DigiG) upgrades the framework
Streamlines activation codes, opens the pathway to higher-risk (class IIb) applications, and lays the ground for mandatory success measurement.
Success measurement & outcome-linked pricing
Mandatory performance reporting and pricing tied to demonstrated benefit begin — the market shifts from simply “listed” to “proven,” with price caps and performance clauses tightening.
The vocabulary
These terms overlap but aren't synonyms. Broadly: SaMD is the regulatory category, DTx is a clinical sub-type of it, and DMD is a reimbursement bucket used in France. Getting them straight matters because approval and payment run on different tracks.
Software that delivers an evidence-based therapeutic intervention to prevent, manage or treat a medical disorder — clinically validated, and often prescribed (a “prescription digital therapeutic,” PDT). The software itself is the treatment.
Examples: deprexis (depression), somnio (insomnia), CureApp HT (hypertension).
France's term for a “digital medical device” — a reimbursement bucket rather than a clinical definition. It spans both DTx and medical telemonitoring solutions eligible under the PECAN early-access and LPPR/LATM permanent pathways.
Scope: DTx + remote patient monitoring; the label that routes a product into French reimbursement.
The regulatory umbrella (IMDRF definition): software intended for a medical purpose that performs that purpose without being part of a hardware device. All DTx are SaMD, but not all SaMD are DTx — diagnostics and clinical-decision tools are SaMD too.
Relationship: SaMD ⊇ DTx. Regulators classify SaMD by risk.
Remote patient monitoring (RPM) uses connected devices/software to track patients between visits; it's often reimbursed through billing codes rather than a DTx pathway. Germany's DiPA is a separate “digital care application” track for long-term care.
Why it matters: the same app can qualify under different rules depending on claim & setting.
A product must first clear regulatory requirements to be legally marketed, then separately win reimbursement to be paid for. The main regulatory frameworks:
How it gets paid for
Market access isn't a single switch. Products move along a spectrum from narrow, self-funded access to broad, statutory entitlement — and within any one country several of these models operate at once. A product often climbs the ladder as its evidence matures.
The patient (or employer) pays out of pocket. Fast to launch, no payer negotiation — but access depends on ability to pay.
Time-limited, evidence-generating access, often publicly funded. Designed to test value before a permanent decision.
Specific insurers, employers or regions contract for a product — coverage depends on which plan or area the patient belongs to.
A national entitlement: any eligible patient can get the product, funded by the statutory system regardless of their insurer.