Anyone developing a digital health application who wants it to be covered by statutory health insurance providers has three options: the DiGA Regulation, ZPP certification for apps, and a selective contract with a single health insurance provider. They differ not only in terms of the effort involved, but above all in what you actually receive per user, who pays initially, and what deductions may apply. This article compares the revenue models side by side, providing documented figures where available and clearly stating where no data exists.

Answer nine questions to find out which path to GKV reimbursement best suits your product. After filling out the contact form, you’ll receive the self-assessment.

The amounts are only comparable to a limited extent: DiGA refers to the revenue amount per prescription, ZPP to participation fees and subsidies, and the selective contract to contractually agreed-upon units. They reflect different business models, not uniform revenue per user.

In addition to the duration of the proceedings, there are also development, research, negotiations, and marketing.

For DiGA, the health insurance provider revenues the manufacturer; prices apply per prescription. In the first year following inclusion, the manufacturers’ actual prices apply, subject to any group-specific maximum amounts, which take effect only if a DiGA has been dispensed at least 2,000 times in the first year (reported every 90 days). Thereafter, a revenue amount agreed upon with the GKV-Spitzenverband or set by the arbitration board applies.

The difference is significant. According to the 2025 GKV report, the average manufacturer’s price for the 40 DiGA that had already been negotiated or set by the arbitration board was 552 euros, while the negotiated amount was 227 euros—about 59 percent less. Across all DiGA devices since 2020, manufacturer prices range from 119 to 2,077 euros. In the calendar year 2025, health insurance funds spent 171.3 million euros on 695,000 redeemed codes.

In addition, there are deductions mandated by law. Starting January 1, 2027, the compensation agreement must provide for a volume-based discount: at least 2 percent for more than 3,000 transactions per year, and at least 30 percent for more than 100,000. Furthermore, as of January 1, 2026, the proportion of performance-based price components must amount to at least 20 percent of the remuneration amount. This applies to the remuneration amount starting in the second year, not to the manufacturer’s price in the first year.

The criteria for measuring the success of a DiGA are governed by the application-accompanying success measurement, or AbEM for short. It is mandatory for all permanently listed DiGAs and will be phased in starting February 1, 2026, in accordance with the amended DiGA Regulation. At the beginning and end of use, manufacturers collect structured data on duration of use and discontinuation, patient-reported changes in health status, and satisfaction. Starting in 2028, indication-specific, validated questionnaires will be added. The results are sent to the BfArM, which publishes them, and to the GKV-Spitzenverband. Participation by patients remains voluntary. For you, this means that end-of-use (AbEM) must be factored into product design, data architecture, and data protection strategies from the very beginning, because weak usage and outcome data will be publicly visible in the future and will affect your position in price negotiations.

Demand is highly concentrated. A single application accounted for approximately 44 percent of all payments in 2025, and according to the GKV-Spitzenverband, nine DiGA manufacturers had filed for insolvency by the end of 2025. As of the end of 2025, 58 DiGA were listed; in 2025, there were six additions and seven removals. For the process, you should allow three months from the submission of a complete application (up to three additional months in justified individual cases); if proof is not yet possible, a trial period of up to twelve months (only for risk classes I and IIa) may be required, which can be extended by up to twelve months. Learn more about the process in our article “DiGA: Six Facts for Manufacturers.”

The legal basis is Section 20 of Book V of the Social Code (SGB V) (Primary Prevention and Health Promotion). ZPP courses are behavioral prevention services pursuant to Section 20(4)(1) in conjunction with Section 20(5) of SGB V. Health insurance providers may provide these services if the program is certified in accordance with Section 20(2), second sentence, of SGB V. The GKV-Spitzenverband sets forth the uniform criteria and the certification procedure in the Prevention Guidelines; certification is carried out on its behalf by the Central Prevention Assessment Office.

With the ZPP, you earn what participants pay you. The health insurance company subsidizes them, not you: You fill out the sample certificate of participation, the insured individuals submit it to their health insurance company along with their application for a subsidy, and the health insurance company decides whether to grant the subsidy.

The certification applies to digital prevention. The requirements include evidence of benefit from a study (provisional certification for one year if no study is available), a qualified support person who responds within 48 hours, a data protection impact assessment, and a certified information security management system (ISMS). An app can also be a medical device.

Under Section 140a(4a) of SGB V, health insurance plans may enter into contracts with medical device manufacturers for specialized care involving digital services. The law does not specify a reimbursement rate; it is agreed upon between the contracting parties. There is no requirement to publish the terms of these contracts. Consequently, there is no market overview with prices, and the amounts resulting from DiGA negotiations are not a benchmark, as a separate nationwide procedure applies there. Possible options include, for example, flat rates per usage period or performance-based components. The specific model applied is governed by the individual contract. Access is limited to insured individuals of the participating health insurance plans. It is therefore impossible to say whether a selective contract offers more or less than a DiGA.

All of the figures above represent revenue. Costs associated with clinical trials, regulatory approval, operations, and distribution are not included in these comparisons and are not publicly documented. However, the prerequisites involve costs in every case: for the ZPP, proof of benefit, data protection impact assessment, and information security; for the DiGA, expenses for CE marking as a medical device, BSI certification according to TR-03161, clinical evidence, and proof of the impact on healthcare delivery.

Our self-test will help you determine: Answer nine questions to find out whether ZPP, DiGA, or a selective contract is best suited for your product.

Published average amounts are available for DiGA, which are under pressure due to the performance-based component and, starting in 2027, the volume discount. ZPP certification is a separate path for prevention apps: Revenue depends on participation fees and subsidies; the requirements include clinical trials, data protection, and an ISMS. For selective contracts, market figures are unavailable, and you negotiate the terms yourself. The available figures alone do not allow you to determine which path is more cost-effective. The key factors are your app’s purpose, evidence base, and reach.

• DiGA – From DiGA Development to Approval: Here’s How We Support You.
• DiGA: Six Facts for Manufacturers – Six key points manufacturers should consider before submitting a BfArM application.
• MedicalOne Connect – Platform for DiGA and DTx – The platform for DiGA and DTx, including DiGA services such as code validation and billing.

• GKV-Spitzenverband, DiGA Report 2025
• GKV-Spitzenverband, Criteria for the Certification of Digital Prevention Services, as of December 17, 2025
• GKV-Spitzenverband and MD Bund, Prevention Report 2025 (Reporting Year 2024)
• Federal Office for Social Security, Selective Contracts and Contract Transparency Office