Guide to the BfArM ‘DiGA’ Fast-Track for Digital Health Apps in Germany

 

Register Digital Health Apps in Germany

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.

Click to read more about BfArM DiGA Fast Track Process: A Complete Guide to the BfArM ‘DiGA’ Fast-Track for Digital Health Apps in Germany — DDReg pharma

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