What are DiGA? 

DiGA (digital health applications) are digital medical devices (CE marked) such as apps or web applications for smartphones, tablets or computers. Since the Digital Healthcare Act (DVG) came into force in 2019, the costs of DiGA have been reimbursed in Germany by the statutory health insurers if they have been included in the directory of the Federal Institute for Drugs and Medical Devices (BfArM). 

All reimbursable DiGA can be found in the BfArM directory: DiGA directory.

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Which conditions are DiGA available for?

The BfArM's "DiGA directory" provides a complete overview of all reimbursable DiGA and the conditions for which they can be used.

DiGA are currently available for the following conditions

• Metabolic diseases such as diabetes
• Cardiovascular diseases
• Cancer
• Diseases of the muscles, bones and joints (e.g. knee or back pain)
• Mental health conditions (e.g. depression, stress management, sleep disorders, nicotine or alcohol dependence)
• Diseases of the nervous system
• Diseases of the genital organs
• Diseases of the ear (e.g. tinnitus)
• Speech and language disorders
• Diseases of the digestive tract 

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What are DiGA used for?

The scope of DiGA is defined in Book V of the German Social Code (SGB V). 

On the one hand, DiGA support the

• detection,
• monitoring,
• treatment or
• alleviation 

of diseases.

On the other hand, DiGA support the 

• detection,
• monitoring,
• treatment,
• alleviation or
• compensation 

of injuries or disabilities.

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How can patients receive care with DiGA?

There are two ways for patients to receive care with DiGA. The most common is a prescription from a doctor or psychotherapist. Alternatively, patients can apply for a DiGA from their statutory health insurer themselves. In this case, the insurer reviews the application and decides whether to cover the costs.

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1. Get a DiGA prescribed

Like medicines or medical aids, DiGA are prescribed by doctors and psychotherapists. Simply visit the practice you trust and ask for a DiGA prescription.

2. Redeem the prescription

Have you got your DiGA prescription?
Submit it to your statutory health insurer.
The insurer will issue an activation code that you use to start the DiGA (e.g. in an app).
You can also use the free prescription services, which take care of this step for you. Almost all manufacturers now offer such a service.

3. Use the DiGA

The DiGA can be started with the activation code from the statutory health insurer. Enter the activation code you received from your insurer in the DiGA (e.g. in the app or on the website). Once the DiGA period has ended, you can obtain a follow-up prescription if needed.

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How are DiGA developed?

Developing a DiGA is a complex process involving several phases. First, the concept for a DiGA is developed on the basis of a specific medical need. The concept is then implemented as a software application. Doctors, programmers and scientists often work closely together in this process. The development process must meet strict regulatory requirements to ensure the safety and the positive healthcare effect of the application.

Before a software application can enter the BfArM's DiGA assessment procedure, it must first be certified as a medical device (CE marking). To this end, it undergoes a conformity assessment procedure comprising several modules, depending on its risk class. As part of this procedure, the manufacturer's technical documentation and quality management are reviewed, for example. Manufacturers must demonstrate, firstly, that they have suitable processes in place to ensure the safety and performance of their products on an ongoing basis and, secondly, that their products themselves are safe and perform as intended.

Another key part of development is the assessment in the BfArM procedure. This includes studies intended to demonstrate the medical benefit of the DiGA. Manufacturers must also collect data on the safety, functionality and clinical effectiveness of their application and submit it to the Federal Institute for Drugs and Medical Devices (BfArM), which decides on listing.

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What are the requirements for DiGA?

To be included in the BfArM directory, a DiGA must undergo an extensive assessment procedure in which manufacturers have to provide a wide range of evidence:

• Data protection: Every DiGA must meet the requirements of the General Data Protection Regulation (GDPR) and the Digital Health Applications Ordinance (DiGAV). For example, DiGA manufacturers may not use users' data for anything other than the intended purpose (i.e. to demonstrate positive healthcare effects or to ensure the technical functionality on an ongoing basis). Commercial use of health data is also expressly prohibited. All personal data must be deleted immediately once use of the application has ended.
• IT security: DiGA must meet various information security requirements based on the recommendations of the Federal Office for Information Security (BSI). A distinction is made between basic requirements, which must be met without exception, and additional requirements, which apply to DiGA with a high need for protection.
• Interoperability: A DiGA must be capable of interacting with other organisations or technical systems, such as the ePA (electronic patient record). This is ensured by using specific interfaces or standards.

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When applying for provisional listing of a DiGA in the directory, the manufacturer must plausibly demonstrate the so-called "positive healthcare effect", among other things by means of an evaluation concept drawn up in accordance with generally recognised scientific standards. The positive healthcare effect may consist, for example, of an improvement in health status, a reduction in disease symptoms or an improvement in quality of life. These evaluation concepts are reviewed by scientific institutes that are independent of the manufacturer.

To be permanently included in the BfArM's DiGA directory, manufacturers must prove the positive healthcare effect of their application through studies. The underlying study results must be reviewed and verified by independent experts.

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What is the difference between DiGA and health apps?

DiGA differ from other health apps that can be used for prevention or treatment in the areas of lifestyle, fitness and medicine. Health apps do not have to be medical devices, and they have not gone through the BfArM assessment procedure for inclusion in the DiGA directory.

Overviews are provided, for example, by KV-AppRadar and the DiGA directory.

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It is important to note that the costs of a DiGA are only covered by the statutory health insurers if it has been included in the BfArM's official DiGA directory. This directory contains all approved applications and provides an overview of their areas of application and scientific background.

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DiGA: conclusion

DiGA represent a new development in healthcare and offer patients digital and innovative options for self-help and therapy. Strict regulation and evidence-based research ensure that these digital applications are both safe and effective. For patients, DiGA offer a simple and often highly effective way to improve their health or prevent illness. The number of available digital health applications is growing steadily.

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Answers to frequently asked questions about DiGA

What are DiGA?

DiGA are digital medical devices such as apps or web applications whose costs are covered in full by the statutory health insurers in Germany if they have been included in the BfArM's DiGA directory.

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What requirements must DiGA meet?

A digital health product must meet the following requirements to be included in the BfArM's DiGA directory:

• Certification as a medical device (CE marking)
• Its purpose is to support the detection, monitoring, treatment or alleviation of diseases, injuries or disabilities.
• Compliance with legal requirements on safety, functional capability, quality, interoperability, data protection and data security
• Proof of a positive healthcare effect

How are DiGA prescribed?

Patients can receive care with DiGA in two ways.

• Doctors or psychotherapists can prescribe a DiGA if there is a corresponding indication (condition).
• Or patients can apply for a DiGA from their statutory health insurer if they can prove a corresponding indication. The insurer then decides whether to cover the costs.

In both cases, patients receive an activation code from their statutory health insurer with which they can activate the DiGA.

Which DiGA are available?

The BfArM's DiGA directory lists all reimbursable DiGA and their areas of application. DiGA are currently available, for example, for the following conditions:

• Metabolic diseases such as diabetes
• Cardiovascular diseases
• Cancer
• Mental health conditions (including depression or sleep disorders)
• Diseases of the muscles, bones and joints (e.g. knee or back pain)
• Diseases of the nervous system
• Diseases of the genital organs
• Diseases of the ear (e.g. tinnitus)
• Speech and language disorders
• Diseases of the digestive tract

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