Germany has taken a bold step toward digital transformation in healthcare. The introduction of the “DiGA Fast-Track” by the Federal Institute for Drugs and Medical Devices (BfArM) enables digital health applications to achieve rapid approval and reimbursement. This framework allows patients to access certified digital therapies prescribed by healthcare professionals under the statutory health insurance system.
This blog provides a complete guide to understanding what DiGAs are, how the BfArM fast-track process works, and how developers and manufacturers can align with regulatory and clinical requirements to secure listing in Germany’s official DiGA Directory.
What Is a DiGA?
DiGA stands for Digitale Gesundheitsanwendungen, or Digital Health Applications. These are medical device software solutions designed to support patient care, disease management, or treatment monitoring through digital technology.
A DiGA must:
- Qualify as a medical device under the Medical Device Regulation (MDR).
- Fall under risk class I or IIa.
- Be primarily digital, delivered via smartphone, tablet, or computer.
- Demonstrate a direct medical benefit or a measurable improvement in patient care.
DiGAs differ from wellness or fitness apps. They are clinical-grade tools that require CE marking and proof of positive healthcare effects (pVE).
Legal Foundation: Digital Healthcare Act (DVG)
The Digital Healthcare Act (DVG), enacted in 2019, marked a significant policy shift. It established a legal basis for digital therapeutics reimbursement and authorized BfArM to evaluate and approve applications through an accelerated process.
Once listed in the official DiGA Directory, a product becomes prescribable by physicians and psychotherapists and reimbursable by statutory health insurance (SHI). This integration allows digital health technologies to move from pilot innovation to clinical routine.
The DVG has also prompted other European regulators to explore similar models, further positioning Germany as the regulatory benchmark for digital health innovation.
BfArM DiGA Fast-Track Process
BfArM’s DiGA process is structured, transparent, and efficient. The agency typically completes evaluations within three months. The process consists of five main stages:
- Eligibility Verification
The developer must confirm that the product:
- Is CE-marked under MDR.
- Falls under risk class I or IIa.
- Offers digital functionality with a clear medical purpose.
- Application Submission
Applicants must submit documentation covering:
- Product information and intended use.
- Data protection and cybersecurity compliance in line with GDPR.
- Interoperability and usability data.
- Evidence supporting positive healthcare effects (pVE).
All documents are submitted in German or accompanied by certified translations.
- Temporary Listing (Optional)
If complete clinical evidence is not yet available, the manufacturer can apply for provisional listing in the DiGA Directory. This allows time to generate additional data while the product becomes available to patients. Provisional listing is valid for 12 months and may be extended once to a total of 24 months.
- Evidence Evaluation
To achieve permanent listing, the manufacturer must demonstrate positive healthcare effects. This refers to measurable improvements in patient outcomes or care processes, validated through clinical trials or real-world data.
- Reimbursement Negotiation
Once BfArM grants approval, the manufacturer negotiates reimbursement conditions with the National Association of Statutory Health Insurance Funds (GKV-SV). The app becomes fully reimbursable for patients under Germany’s statutory health insurance scheme.
BfArM’s Evaluation Criteria
BfArM evaluates DiGA applications based on a set of defined parameters:
Evaluation Area | Key Requirements |
Safety | MDR conformity, technical documentation |
Data Protection | GDPR compliance, secure data processing |
Functionality | Verified usability and performance claims |
Interoperability | Compatibility with healthcare systems |
Evidence | Clinical validation of positive healthcare effects |
Common Challenges in DiGA Applications
Several applications face delays or rejections because of incomplete documentation or unclear evidence strategies.
Common issues include:
- Insufficient clinical proof of positive healthcare effects.
- Missing or inconsistent data privacy documentation.
- Weak interoperability standards or lack of API integration.
- Unclear distinction between DiGA and wellness functionality.
Developers can avoid these challenges by aligning early with BfArM’s evaluation framework and involving regulatory experts who specialize in digital health submissions.
What Happens After a DiGA Is Approved?
Once approved, the DiGA is published in the official DiGA Directory maintained by BfArM. Physicians and psychotherapists can prescribe it directly to eligible patients. Patients access these apps through their devices and receive reimbursement through their health insurers.
Manufacturers are responsible for ongoing post-market surveillance, continuous data protection compliance, and updates to maintain MDR conformity.
Future of Digital Health Regulation in Germany
Germany continues to strengthen its position as a leader in digital therapeutics (DTx). The success of the DiGA framework has inspired the introduction of DiPA (Digital Care Applications), extending similar access pathways to people requiring long-term care.
BfArM is also collaborating with European partners to harmonize standards for digital health evaluation under the MDR and the European Health Data Space (EHDS) initiative.
This evolution opens opportunities for international developers to expand their market reach into the EU through Germany’s proven digital health infrastructure.
How DDReg Supports DiGA Submissions
At DDReg, we assist digital health innovators, MedTech companies, and software developers in navigating the complex German regulatory landscape. Our team supports every stage of the DiGA approval process, from eligibility assessment to dossier preparation and BfArM submission. With DDReg’s deep regulatory expertise, companies can confidently achieve faster approval timelines, robust compliance, and successful reimbursement outcomes in the German market.
Key Takeaways
- DiGA refers to certified digital health applications under Germany’s Digital Healthcare Act (DVG).
- BfArM’s Fast-Track Process allows approval within three months for eligible products.
- Positive healthcare effects are central to gaining and maintaining approval.
- GDPR compliance and MDR alignment are essential for success.
- Expert regulatory guidance from DDReg ensures a complete, compliant, and efficient submission process.
Read more from DDReg resource hub: Regulatory Dossier Digitization: How eCTD 4.0 Is Redefining Submission Strategy