What is a DiGA?
The abbreviation DiGA stands for "Digital Health Application." It refers to a digital offering or program that can be prescribed by doctors or psychotherapists since October 2020. The basis for this is the DVG (Digital Healthcare Act).
What a DiGA really is becomes clearer through the colloquial term "app on prescription." However, a DiGA does not necessarily have to be an app.
Web applications and other programs can also be approved as such. What they all have in common is that they must be a CE-certified medical device of risk class I or II a. This classification indicates that the certified product poses at most a low risk to the user and cannot cause physical harm.
This clearly distinguishes a DiGA from the now very common health apps and should not be confused with them.
The requirements for the "app on prescription" are, as described above, very high. They are subject to strict controls and must demonstrate their medical benefit and effectiveness. A health app, on the other hand, can be labeled as such by any manufacturer. There is no definition for the term "health app," and the health benefit does not need to be proven. Also, labeling as a medical device is at most optional for health apps, not mandatory.
A DiGA is made for the user and is primarily intended to provide them with a benefit.
It should help them recognize, monitor, treat, or alleviate illnesses, which is referred to as medical benefit. Other applications improve the structures and processes surrounding the user's medical care. This is called structural and procedural improvement.
How does a user get to the "app on prescription"?
The user can have the DiGA prescribed by their doctor or psychotherapist. Another option, if one cannot obtain a prescription, is to submit an application to the health insurance company for the use of the DiGA. However, a diagnosis must be present that can demonstrate that the use is appropriate.
The user will then typically receive a code that they must enter in the respective app to be able to use it.
By Sabine Croci.
This article is medically reviewed. Last updated (06/2024).
Information on the website and within the app cannot replace a consultation with a doctor, but can certainly complement it.
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