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    Why German Statutory Health Insurers Reimburse Digital Health Applications

    In 2019 Germany became the first country to create a statutory reimbursement pathway for prescription software. The Digitale-Versorgung-Gesetz established the DiGA framework — CE-marked medical device software listed in the BfArM directory — as a recognised treatment modality within GKV. This article explains why the framework was created, how it has evolved through three legislative acts, and where it stands five years on.

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    In December 2019, Germany enacted legislation that made it the first country in the world to create a formal statutory reimbursement pathway for prescription software. The decision transformed a consumer technology category into a recognised treatment modality within the statutory health insurance system — and set in motion a framework that has since been studied, debated, and partially emulated internationally.

    Understanding why that decision was taken — and how the framework has developed through five years of real-world use — explains both what the system covers and why large categories of digital health tools fall outside it.

    The problem the framework was designed to solve

    By the late 2010s, Germany faced structural healthcare challenges that digital tools were positioned to partially address. The number of patients with chronic conditions was growing faster than the specialist capacity available to treat them. Access to care varied significantly between urban centres and rural areas where waiting times for specialist appointments could stretch to months. And a growing body of clinical research was documenting that structured digital interventions — software with defined therapeutic protocols and documented outcomes — could produce measurable patient benefit in areas including mental health, chronic pain management, and metabolic conditions.

    The policy challenge was not whether digital tools could be useful. It was how to create a framework that allowed useful tools to reach patients reliably, while maintaining the evidence standards that govern other reimbursed medical interventions. The pharmaceutical model — requiring large-scale randomised controlled trials before reimbursement — was considered too slow and costly for software, where iteration cycles are measured in months rather than years. The result was a new approach: a regulatory fast-track based on CE marking plus an evidence demonstration, with provisional listing during an evidence collection period.

    Three legislative acts, five years

    December 2019: The Digitale-Versorgung-Gesetz (DVG)

    The Digitale-Versorgung-Gesetz — the Digital Care Act — was enacted on 9 December 2019 (BGBl. I S. 2562). It inserted §33a into the Fifth Social Code (SGB V), creating a statutory entitlement for GKV-insured persons to be supplied with listed digital health applications. It also inserted §139e SGB V, which established the BfArM DiGA directory and the fast-track certification process.

    What distinguished the DVG was the structure of its evidence requirement. CE marking under EU MDR confirmed that the software was a safe and functional medical device. But the DVG added a separate, healthcare-specific test: manufacturers had to demonstrate positive care effects — patient-relevant endpoints or documented structural improvements in care quality. Critically, the DVG introduced provisional listing: a manufacturer without a completed evidence package could receive temporary listing for twelve months, during which it gathered real-world data, before seeking permanent inclusion.

    The process was designed to take three months from a complete application. The first DiGA was listed in September 2020.

    June 2021: The DVPMG

    The Digitale-Versorgung-und-Pflege-Modernisierungs-Gesetz — the Digital Care and Care Modernization Act — came into force on 9 June 2021 (BGBl. I S. 1309). It extended the DiGA model to digital nursing applications (DiPA), refined procedural aspects of the BfArM process, and strengthened interoperability requirements to prepare DiGA for integration with the broader digital healthcare infrastructure including the electronic patient record (ePA).

    March 2024: The Digital-Gesetz (DigiG)

    The Digital-Gesetz of 22 March 2024 (BGBl. I Nr. 101) made a structurally significant expansion: it extended DiGA eligibility to risk class IIb medical devices under EU MDR. The DVG had originally limited coverage to risk classes I and IIa. Risk class IIb — which covers software producing outputs used to make clinical decisions in potentially serious situations — had been excluded. The Digital-Gesetz brought higher-complexity clinical applications, including some telemonitoring tools, into the framework.

    The Digital-Gesetz also introduced the statutory basis for performance-based DiGA pricing: from 1 January 2026, at least 20 percent of DiGA remuneration must be linked to demonstrated performance — shifting the framework from one based primarily on regulatory listing toward one tied to real-world evidence of effect.

    February 2026: The Second DiGAV Amendment

    The DiGAV — the Digital Health Applications Ordinance that sets out detailed requirements for the fast-track process and ongoing obligations of listed DiGA — was most recently amended by the Second DiGAV Amendment (Zweite Verordnung zur Änderung der DiGAV), published on 29 January 2026 and in force from 1 February 2026.

    The amendment operationalised the AbEM — application-accompanying success measurement. Manufacturers of permanently listed DiGA must now collect quarterly data on three parameters: average usage frequency and duration; patient-reported satisfaction (via a standardised BfArM questionnaire, participation voluntary); and patient-reported health status (also via standardised questionnaire, voluntary). Starting in Q3 2026, this data must be submitted to BfArM in anonymised, aggregated form every six months, with the first submission due by 15 April 2027.

    The amended DiGAV includes a data localisation requirement for AbEM data: it may only be processed in Germany, an EU or EEA member state, Switzerland, or a country with an adequacy decision under Article 45 GDPR. This places the data security standard for DiGA success measurement squarely within — and, in some respects, beyond — standard GDPR requirements for health data transfers.

    A further new requirement in the amendment: where a DiGA contains artificial intelligence components covered by the EU AI Act (Regulation (EU) 2024/1689), the manufacturer must declare compliance with the AI Act's requirements as part of the BfArM application.

    Five years in: what the data shows

    The DiGA-Report 2025, published by the Spitzenverband Digitale Gesundheitsversorgung (SVDGV) in 2026, provides the most recent comprehensive picture of the framework's trajectory. Key figures as of 31 December 2025:

    • 58 DiGA are listed in the BfArM directory — 48 permanently, 10 provisionally.
    • 1.6 million activation codes have been redeemed since October 2020.
    • Approximately 70 percent of provisionally listed DiGA have successfully completed their evidence year and achieved permanent listing.
    • More than 75 DiGA have been available in the directory at various points since September 2020; some have subsequently been removed following failure to demonstrate positive care effects, or following manufacturer withdrawal.

    The growth trajectory shows the framework stabilising rather than expanding rapidly. Increasing regulatory requirements — data security certification under BSI TR-03161 (mandatory since 1 January 2025), now supplemented by AbEM obligations — have raised the threshold for new applicants. The SVDGV has noted that this regulatory complexity carries the risk of deterring innovation without a corresponding improvement in patient care quality.

    The performance-based pricing element from January 2026 represents the framework's most significant structural evolution: what began as a reimbursement model gated primarily by regulatory listing is becoming one where ongoing funding is increasingly linked to demonstrated real-world outcomes.

    Germany as a model and the EU dimension

    Germany did not build this framework in isolation. The DVG's design — evidence-based listing via regulatory fast-track, with provisional access during evidence generation — has attracted international attention and partial adoption.

    From 1 July 2026, Swiss mandatory health insurance (OKP) will reimburse selected German DiGA for cognitive-behavioural therapy in mild-to-moderate depressive episodes and recurrent depressive disorder, used as a supplement or bridge to psychotherapy — with deprexis (already permanently listed in Germany's DiGA-Verzeichnis) as the first product listed in the Swiss MiGeL (Quickbird Medical, Schweiz: Erste DiGA ab Juli 2026 erstattungsfähig, 2026). This marks the first extension of the DiGA model into another country's statutory health system on the basis of Germany's regulatory assessment.

    At the EU level, the European Health Data Space Regulation (Regulation (EU) 2025/327), which entered into force on 26 March 2025, creates a cross-border framework for health data exchange and interoperability standards that digital health tools across the EU will need to meet. Germany's existing DiGA requirements — particularly the data security certification obligations and the EEA-only processing requirement for AbEM data introduced in February 2026 — are already closely aligned with the trajectory the EHDS is setting for the broader European digital health ecosystem.

    The direction of travel across both the German domestic framework and EU-level policy is consistent: higher evidence requirements, stronger data protection obligations, performance-linked funding, and increasing integration of digital health tools into the core health information infrastructure.

    What this framework does not include

    The DiGA reimbursement pathway covers CE-marked medical device software with a defined medical intended purpose. It does not extend to apps that operate outside EU MDR — whether because they make no medical claims (wellness apps) or because they have not completed CE marking — nor does it cover §20 SGB V prevention courses, which follow a separate certification structure and funding mechanism.

    The distinction is legal, not a matter of clinical relevance or consumer preference. It is determined by the intended purpose the manufacturer has defined for the product, and by whether that product has been assessed by BfArM against the requirements of §139e SGB V.

    Where Sam Health fits in

    Sam is a wellness app that reads health data from Apple Health on iPhone — which means users with Apple Watch, Garmin, Oura, WHOOP, or any other device that syncs to Apple Health can supply data to Sam — and presents trends and lifestyle insights for personal health awareness. It is not listed in the BfArM DiGA directory. It does not seek CE marking as a medical device. It operates in the consumer wellness space, outside the reimbursement frameworks described here.

    Sam is a wellness app, not a medical device. It does not diagnose, detect, treat, or screen for any medical condition. For any health concern, always consult a qualified healthcare professional.

    Try Sam Health
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    Frequently Asked Questions

    Why did Germany create the DiGA reimbursement framework?+

    The Digitale-Versorgung-Gesetz (DVG) of December 2019 created the DiGA framework to address structural gaps in healthcare access — chronic disease burden, specialist shortages, and geographic care disparities — using digital tools with a demonstrated clinical evidence base. Germany was the first country in the world to create a formal statutory reimbursement pathway for prescription software.

    When was the first DiGA listed in the BfArM directory?+

    The first DiGA was listed in September 2020, following the DVG's enactment in December 2019 and BfArM's establishment of the fast-track certification process under §139e SGB V.

    How many DiGA are currently listed?+

    As of 31 December 2025, 58 DiGA are listed in the BfArM directory — 48 permanently and 10 provisionally. More than 75 DiGA have been available in the directory at various points since September 2020; some have been removed after failing to demonstrate positive care effects or following manufacturer withdrawal.

    What is application-accompanying success measurement (AbEM) and why was it introduced?+

    AbEM is a real-world data collection requirement introduced by the Second DiGAV Amendment of February 2026. Manufacturers of permanently listed DiGA must collect quarterly data on usage frequency, patient-reported satisfaction, and patient-reported health status, then submit it to BfArM in anonymised, aggregated form. The outcomes of this measurement directly influence DiGA pricing, given that at least 20 percent of remuneration must be performance-based from 1 January 2026.

    Is the German DiGA model being adopted by other countries?+

    Other countries are following Germany's example. Swiss mandatory health insurance (OKP) will reimburse selected German DiGA for mild-to-moderate depression from 1 July 2026, starting with deprexis — the first cross-border extension of the DiGA model to another country's statutory health system.

    What is the European Health Data Space and how does it relate to DiGA?+

    The European Health Data Space Regulation (Regulation (EU) 2025/327) entered into force in March 2025. It creates a framework for cross-border health data exchange and interoperability across EU member states. Germany's DiGA framework — with its existing data security certification requirements and its EEA-only data processing requirement for AbEM data under the amended DiGAV — is already aligned with the direction EHDS is pushing the wider EU digital health ecosystem.

    Can a wellness app become a DiGA?+

    Not directly. Becoming a DiGA requires the developer to establish a medical intended purpose for the software, obtain CE marking as a medical device under EU MDR, satisfy BfArM's requirements for positive care effects, data security (TR-03161 certificate), and interoperability, and price the product through the DiGA remuneration framework. A wellness app that makes no medical claims sits outside EU MDR entirely and is not on a pathway to DiGA listing — because its fundamental premise (no medical intended purpose) would need to change first.

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