Digital Health
Umbrella termThe umbrella term for any digital technology in healthcare — fully encompasses eHealth, and with it mHealth, health apps and DTx.
ProofNone — not a legal term.
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:
The full picture
Eight terms that are often used interchangeably in practice — but don't mean the same thing. This containment diagram builds from the bottom up: what's contained in what, and at which level a proof-of-effectiveness requirement kicks in.
From here on: a medical or care-related purpose applies — meaning approval and proof of benefit are required. Three separate pathways lead across this line.
Illustrative overview — not legal or reimbursement advice.
DigiHealthAccess
🇩🇪 DiGA and DiPA are Germany-only reimbursement pathways, with no equivalent elsewhere.
The umbrella term for any digital technology in healthcare — fully encompasses eHealth, and with it mHealth, health apps and DTx.
ICT infrastructure for healthcare delivery (WHO definition). mHealth is a sub-category of it, per WHO.
Healthcare delivered via mobile devices — explicitly more than just apps, per WHO.
The app-based part of mHealth — ranging from free wellness tools to regulated DTx.
The regulated, evidence-based part of health apps: the software itself is the treatment, not just something accompanying it.
Germany's national DTx pathway: listed by BfArM, prescribable, and reimbursed by statutory health insurance (GKV).
Germany's app pathway for long-term care — separate from DiGA, requiring proof of care-related rather than therapeutic benefit.
Remote treatment and monitoring: the technology transmits the physician's service, it doesn't replace it — so this isn't DTx, even when the patient-facing part is an app.
What separates these terms isn't the technology — it's the proof-of-effectiveness and approval requirement. The four outer levels are umbrella terms nobody has to prove. Past the regulation threshold, three separate pathways apply, depending on who's treating: the physician (telemedicine and RPM, via EBM), long-term care (DiPA, SGB XI), or the software itself (DTx, and — when reimbursed — DiGA, under SGB V).
Note: products in our database can be flagged as discontinued once the vendor has shut down or the offering is no longer available — discontinued products are excluded from the reimbursement counts on the National Checklists page.
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.