What are Digital Health Applications (“DiGAs”)?

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.

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 diagnosis. 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.

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.

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.

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 depression 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.

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.

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.