What is DiGA in short?
DiGA, short for Digitale Gesundheitsanwendungen, translates to Digital Health Applications in English. The DiGA pathway refers to the unique reimbursement pathway of digital health apps that has recently launched in Germany.
Reimbursement of digital health apps
Pricing and reimbursement pathways for digital and e-health products are primarily shaped by the Health Technology Assessment (HTA) process. This assessment evaluates the clinical and economic value proposition of medical technologies to decide if reimbursement should be granted. Following the HTA, price negotiations are carried out with national, regional, and local payers. The evidence requirements of these decision-makers can vary significantly.
Many digital health applications that achieve CE marking, especially those aiming for DiGA approval, face challenges in obtaining market access. A common issue is the lack of sufficient evidence to satisfy payer requirements. Additionally, discrepancies between the payer’s willingness to pay and the industry’s pricing expectations often result in denied reimbursement, despite regulatory approval.
MedTech companies, digital health app developers, and startups must understand the complexities of the DiGA approval process and navigate the various payer landscapes to ensure reimbursement and achieve market access in Germany.
Germany’s Digital Health Act: The First to Reimburse E-Health
A landmark shift occurred with the introduction of Germany’s Digital Health Act (DVG) on December 19, 2019. This law established Europe’s first pricing and reimbursement pathway for digital health apps, introducing the concept of the “app on prescription,” which allows healthcare providers to prescribe digital health applications (DiGA) as part of patient care. With over 73 million individuals covered by statutory health insurance, these patients can now access healthcare via DiGA apps, with costs reimbursed by health insurers.
What is the DiGA pathway in Germany?
A DiGA is a CE-marked medical device that meets the following criteria:
- Risk class I or IIa (under the Medical Device Regulation or the transitional regulation Medical Device Directive)
- Digital technology forms the core function of the DiGA product
- The medical purpose is mainly achieved by way of its digital function
- The DiGA supports the recognition, monitoring, treatment or alleviation of diseases or disabilities
- The DiGA is used by the patient alone or jointly with a healthcare provider
Nearly 60 DiGAs are reimbursed in Germany
As of 2025, 59 DiGAs are reimbursed in Germany covering a broad range of conditions, including depression, anxiety, diabetes, irritable bowel syndrome, phobias, cancer, endometriosis, insomnia, multiple sclerosis, cognitive impairment, obesity etc.
How does the DiGA approval process work in Germany?
The DiGA approval process is fast-tracked: within three months from the submission of the complete application, the BfArM (Federal Institute for Drugs and Medical Devices) must assess the application. This includes reviewing the product’s qualities—such as data protection, interoperability, and user experience—as well as the evidence of the DiGA’s positive healthcare effect. These are effects through which the state of a patient’s health or their possibilities for dealing with their disease are improved by the use of the DiGA.
Help with reimbursing medtech in Germany via the DiGA pathway
The Innovation Office of the BfArM is the first point of contact providing support to SMEs, start-ups and academic groups. It offers valuable guidance and support during the early development phases of medicinal products and medical devices. These meetings provide support for questions about DiGA regulations and evidence requirements, ensuring a smoother approval process.
The following types of advice are available:
- Kick-off meeting – intended to impart general, orienting and regulatory information during the early development phases of medicinal products and medical devices
- DiGA Advice – assistance in basic questions of understanding that are not answered by the BfArM guides or by further information e.g. from the Ministry of Health, in technical details or questions about the evidence that needs to be provided (3-6m lead time)
Justin Stindt Consultants: Your Partner for DiGA German Market Access
At Justin Stindt Consultants, we specialize in helping MedTech companies navigate the DiGA approval process for seamless market access in Germany. With a strong presence in the German market, our consultancy assists with preparing DiGA medical device dossiers, facilitating BfArM and Innovation Office consultations, and supporting price negotiations. Our agency’s deep expertise in pricing, reimbursement, and regulatory processes positions our experts to effectively support your products’ success.
Why choose us?
- Proven Expertise: Our team offers extensive experience in German and global pricing and reimbursement strategies.
- Tailored Solutions: We provide customized solutions that address the unique needs of your business and the German market.
- Comprehensive Support: From strategic advice to full implementation, we offer end-to-end support for DiGA approval.
- Regulatory Knowledge: Our in-depth understanding of DiGA regulations and experience with the BfArM ensures your product meets all necessary requirements.
Contact our experts today to learn how our agency can tailor our services to meet your unique needs to enable Market Access in Germany.
