What are Digital Health Applications (“DiGAs”)?

Note: This information describes the situation in Germany. Other countries will have different rules regulating the use and coverage of digital health applications.

Digital Health Applications (DiGAs) are designed to help people who have an illness diagnose, monitor and treat the illness. DiGAs usually come in the form of apps for mobile devices or computers. Some of them are browser-based tools.

DiGAs are assessed and certified by Germany’s Federal Institute for Drugs and Medical Devices (BfArM). This means they meet certain requirements to do with things like data privacy and content quality. They’re covered by statutory health insurers in Germany and can be prescribed by doctors or psychotherapists.

What can DiGAs do?

DiGAs can be used for things like

  • keeping a record of how an illness develops by entering data such as symptoms or readings,
  • supporting treatment by reminding you to take medication or explaining how to do certain exercises, or
  • strengthening your capabilities by giving tips on how to manage the illness or cope with stress.

How do I get a DiGA?

There are two possibilities:

  • You can get a prescription from your doctor or psychotherapist, which you then pass on to your health insurer.
  • You have a document (like a doctor’s letter) that shows your . Then you can send a copy of it to your health insurer along with a note of the DiGA you’d like to use for your illness. The health insurer might ask your doctor or psychotherapist for proof that there’s no reason for you not to use the DiGA.

The health insurer then sends you an email or a letter with an activation code to log in to the application.

DiGAs are considered to be treatments, so they are prescribed for a specific length of time. If they’re needed for longer, a new prescription is required.

Which illnesses can you get DiGAs for?

DiGAs are available for a wide variety of illnesses, including diabetes, breast cancer, back pain, and depression. There is a directory that lists all DiGAs you can get on prescription with detailed information on what each application includes and how to use them. It also describes any research already done on the specific DiGA.

The directory is published by the Federal Institute for Drugs and Medical Devices (BfArM). It is intended for users and as a guide for healthcare professionals who prescribe DiGAs.

How are DiGAs assessed?

Since DiGAs are classed as “medical devices,” they have to comply with the EU regulations for medical devices to be included in the directory. If they provide the required safety and functionality, as well as meeting other criteria, they are awarded a CE marking (showing that it meets those criteria and can be sold in Europe).

The BfArM then checks aspects such as

  • data privacy,
  • user friendliness, and
  • quality of content.

The most important aspect, however, is whether research has shown that the app has “positive healthcare effects” or whether such effects are at least plausible and the manufacturer is planning to investigate them.

One part of the data privacy requirement is that health insurers must not be able to access the data collected by the application. Your data is only passed on to healthcare professionals if you give your explicit consent.

What are “positive healthcare effects”?

According to the BfArM, a “positive healthcare effect” can mean:

  • Improvement in a person’s health due to the DiGA. For example, their pain or gets better.
  • Increased quality of life.
  • Easier management of the illness. Examples would be the ability to keep a record of how the illness develops (by measuring things like the person’s weight or how long they sleep) or reminding the person to take their medication.
  • Improved treatment processes or “gap-filling” until treatment can begin.

To provide proof of these effects, DiGA manufacturers have to submit research carried out in Germany. However, the requirements for the research are lower than for the usual decisions about which treatments statutory health insurers reimburse.

Why are some DiGAs only temporarily included in the directory?

DiGAs are temporarily included if it’s thought they could be effective but there hasn’t been enough research yet. The application's developer then has one year to supply proof that it has positive healthcare effects.

At the end of the year, the BfArM checks to see whether proof has been provided. If it has, the DiGA is permanently added to the directory. If it hasn’t, it’s removed and health insurers no longer cover it.

Further information

For more information on DiGAs, visit the BfArM website.

In addition, the North Rhine Association of Statutory Insurance Physicians (KV Nordrhein) has produced a video that explains how DiGAs work (in German).

There are also Digital Nursing Applications (DiPAs), designed to support the day-to-day care provided for people requiring nursing care. You can apply to your long-term care insurer to get a DiPA.

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). DIGA-Verzeichnis (Auswahl aus digitalen Gesundheitsanwendungen (DiGA), die vom BfArM gemäß § 139e SGB V bewertet wurden). 2023.

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on March 14, 2024

Next planned update: 2027


Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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