Innovation Fund (2025): Funding for digital health solutions

Many manufacturers of medical software and health apps are faced with the question: How can digital solutions be used to build a sustainable business model?

The market for self-paying patients in the German healthcare system is relatively small, and the path to reimbursement by health insurance companies is challenging.

Although there are established reimbursement channels, such as inclusion in the DiGA directory or individual remuneration via selective contracts, these access routes can be lengthy, complex, and costly.

It is therefore worth considering alternative financing options while working toward inclusion in standard care. One such alternative for financing and reimbursing digital health solutions is the innovation fund under Section 92a of the German Social Code, Book V (SGB V).

In this expert article, we explain …

• what opportunities the Innovation Fund offers,
• which requirements must be met in order to receive funding,
• how high the chances of success are for software products,
• and for which types of digital concepts applications can be submitted.

Table of contents

• 1. Definition of the Innovation Fund
  • 1.1 What is the Innovation Fund?
  • 1.2 How much funding is available?
  • 1.3 Who manages the Innovation Fund?
  • 1.4 Who is involved?
  • 1.5 Overview of funding categories
    • 1.5.1 Category 1: New forms of care
    • 1.5.2 Category 2: Health services research
• 2. Difference between funding & reimbursement
• 3. Requirements for funding from the Innovation Fund
  • 3.1 Which projects are eligible for funding?
  • 3.2 Which projects are not eligible for funding?
• 4. The application procedure for the Innovation Fund
  • 4.1 What application procedures are there?
  • 4.2 Which application procedure is right for my project?
  • 4.3 What are the requirements for an application?
  • 4.4 What are the criteria for funding?
  • 4.5 Example of a project funded by the Innovation Fund: INTEGRATE-ATMP
  • 4.6 Was passiert nach Projektende?
• 5. Which software products are eligible for innovation fund funding?
  • 5.1 Complex supply solutions
  • 5.2 Products with high evidence requirements
  • 5.3 Niche indications and rare diseases
  • 5.4 Prevention and care management tools
• 6. Conclusion: Is the innovation fund worthwhile for manufacturers of medical software?
• 7. Where can I find further information about the Innovation Fund?

1. Definition of the Innovation Fund

1.1 What is the G-BA Innovation Fund?

The Innovation Fund was established at the beginning of 2016 by the GKV Care Strengthening Act and is based at the Joint Federal Committee (G-BA).

Its aim is to promote new forms of healthcare provision and healthcare research that go beyond the standard care currently available. Specifically, innovative approaches in healthcare are to be scientifically tested in order to make care more efficient, more patient-centered, and of higher quality. The fund has since established itself as a key instrument for testing (digital) innovations in healthcare under real-life conditions.

1.2 How much funding is available?

Since its launch, around €200 million in funding has been made available each year. The fund was originally set up as a temporary measure (until 2019, later extended to 2024), but following a positive evaluation, it was made permanent and will continue from 2025 onwards.

The majority of the budget (€160 million) will go toward projects for new forms of care, while €40 million has been set aside for care research.

1.3 Who manages the Innovation Fund?

The Innovation Committee of the Joint Federal Committee (G-BA) is responsible for this. It sets out thematic priorities and criteria in regular funding announcements and decides on applications.

Projects typically run for up to three (sometimes four) years and are accompanied by scientific support.

Once a project has been completed, the results are evaluated and forwarded to the relevant bodies to determine whether the innovation should be incorporated into standard care.

The Innovation Committee is made up of representatives from the G-BA’s sponsoring organizations (health insurance funds, associations of statutory health insurance physicians, hospitals) as well as the Federal Ministry of Health and the Federal Ministry of Research. It also includes independent experts from the fields of science and healthcare.

Composition of the Innovation Committee

1.4 Who is involved?

Typically, various stakeholders in the healthcare sector form consortia for innovation fund projects. These include, for example:

• Health insurance companies
• Hospitals and university clinics
• Medical networks or medical care centers
• Research institutions
• Private companies (e.g., in the field of digital health)

Together, they develop a care concept that is then tested under everyday conditions for several years. Digital health solutions are often a central component of this—for example, for coordination, communication, or diagnostics.

1.5 Overview of funding categories

The Innovation Fund distinguishes between two areas of funding in accordance with Section 92a of the German Social Code, Book V (SGB V):

• Category 1: New forms of care
• Category 2: Health services research

Funding categories and funding volume of the Innovation Fund (2025)

1.5.1 Category 1: New forms of care

This includes projects that test new care models or organizational processes in patient care. Digital health applications are often part of the concept, such as telemedicine platforms, digital communication tools, or AI-supported diagnosis and therapy management.

Important: These projects take place under everyday conditions in healthcare—for example, as pilot programs with real service providers and patients. The digital solution is always embedded in a healthcare concept, for example to optimize processes or overcome sector boundaries.

The whole process will be accompanied by a scientific evaluation to measure the effects on healthcare provision and patient care.

This category is particularly relevant for manufacturers of medical software, as it specifically evaluates completely new solutions and structures.

1.5.2 Category 2: Health services research

This area is not concerned with implementing new healthcare models, but rather with analyzing the current state of healthcare provision. Funding is available for scientific studies evaluating G-BA guidelines, guideline development, and health economic analyses, for example.

This category is only relevant for manufacturers if their own digital solution is already part of standard care and is to be evaluated as part of a study.

If, on the other hand, the product still needs to be brought to market, the project does not fall into this category but belongs to the ‘new forms of supply’ category.

Note: In this article, we focus exclusively on the funding area ‘New Forms of Care’, as this is significantly more relevant to medical software manufacturers in practice than the funding available in the area of healthcare research.

2. Difference between funding & reimbursement

When discussing the financing of digital health solutions, it is important to understand the difference between funding and reimbursement. Reimbursement – as is the case with DiGA, for example – means that the application is included in the SHI benefits catalog and every use is paid for by the health insurance company. This creates predictable revenues and is part of standard care.

The Innovation Fund works differently: it is not a permanent benefit, but rather temporary project funding.

For manufacturers of software products, funding from the Innovation Fund means that the costs of software implementation in the project are covered, whether as a contractor or consortium partner. And even if the software is not yet officially reimbursed by health insurance companies, money is already flowing through the G-BA funding pot.

At the same time, real healthcare data is generated, which can later serve as a basis for further reimbursement methods, such as selective contracts or remuneration via the DRG system.

3. Requirements for funding from the Innovation Fund

3.1 Which projects are eligible for funding?

Funding will be provided for new forms of care that

• aim in particular to further develop cross-sector care:
  • Overcoming the separation of sectors
  • Optimizing intersectoral interfaces
  • Further developing selective contractual care
• demonstrate a viable evaluation concept, and
• have sufficient potential for long-term inclusion in the healthcare system (implementation potential).

Further information can be found here.

3.2 Which projects are not eligible for funding?

Not every project is eligible for funding from the Innovation Fund. There are a number of exclusion criteria that applicants should be aware of before investing time and resources. Here are the most important points:

• Economically driven product development: The Innovation Fund is not a funding program for traditional product development with a direct commercial objective. Projects in which commercial enterprises have a direct economic interest in the outcome are excluded, such as the development or testing of a product with the aim of subsequently selling it directly.
• Traditional R&D, regulatory or drug studies
  • Research and development of medical devices or pharmaceuticals
  • Clinical trials in accordance with EU Medical Device Regulation (EU) 2017/745
  • Performance evaluation tests for in vitro diagnostic medical devices
  • AMNOG studies on the early benefit assessment of medicinal products
  • Studies to test new examination and treatment methods (Section 137e SGB V)
• DiGA and DiPA verification studies: Studies verifying positive effects of care within the framework of DiGA (Section 33a SGB V) or DiPA (Section 40a SGB XI) are also not eligible for funding. This verification must be provided separately via the BfArM or corresponding procedures and does not fall within the remit of the Innovation Fund.
• Projects already in progress or receiving other funding: Projects or plans that have already started and are already receiving other funding (e.g., from public funds) at the time of application are not eligible. The Innovation Fund does not fund duplicate structures or retroactive measures.
• Double applications are not permitted: You may only submit one application for each of the funding announcements for ‘New Forms of Care’ published in a given year. Double or parallel applications with the same project approach are not permitted.

4. The application procedure for the Innovation Fund

4.1 What application procedures are there?

The Innovation Fund distinguishes between four different funding formats in the area of new forms of care. These differ in terms of the topics covered, the process structure (one-stage vs. two-stage) and the project duration:

1. Open-topic funding – Single stage, long

In this procedure, a complete application is submitted directly. The project must already be comprehensively planned, including an evaluation concept, a time and financial plan, and a consortium.

2. Open-topic funding – Single stage, short

This format is aimed at smaller, faster-starting projects with a maximum duration of 24 months. Here, too, the application is submitted directly and completely in one step.

3. Topic-specific funding – two-stage long

There are two phases in this process:

• Stage 1: Concept phase – submission of a rough idea on a given topic.
• Stage 2: Full application – A complete funding application is submitted with a fully developed care concept, specific care objectives and implementation plan, a validated evaluation concept, a time and financial plan, and binding commitments from all consortium partners.

This method is suitable for complex projects with extensive planning requirements.

4. Open-topic funding – two-stage long

Here, too, the procedure is two-stage:

• Stage 1: Concept phase – rough sketch of ideas without any specific theme.
• Stage 2: Full application – as for the topic-specific variant.

This funding line thus offers scope for innovative ideas that require greater development effort.

Please note: All procedures require that the application documents are submitted in full and on time. The documents required (e.g., project description, consortium agreement, financing plan, ethics concept) are specified in detail in the respective funding announcements.

→ Link to the current tenders:
https://innovationsfonds.g-ba.de/foerderbekanntmachungen/

4.2 Which application procedure is right for my project?

When which application is most appropriate depends on the maturity of the project idea.

1. Mature project status:
   1. The project idea has been fully developed.
   2. A well-developed supply concept is in place.
   3. Consortium partners (e.g., health insurance funds, healthcare providers) are bound by the agreement.
   4. The evaluation concept, schedule, and budget have been planned in detail.
      ➔ single-stage process
      
2. Less mature project status:
   1. The basic idea is there, but it has not yet been worked out in detail.
   2. There is still a lack of validated partners, concrete evaluation, and precise implementation planning.
   3. The aim is to refine the project idea in a six-month concept phase (stage 1).
   4. After that, a full application can be submitted in stage 2.
      ➔ two-stage process

Comparison of the single-stage and two-stage procedures: