Digital health applications (DiGA): apps on prescription

Digital health applications (DiGA) are mobile apps or web applications that may be prescribed for medical purposes. They support the detection and treatment of illnesses. DiGA can also support people with injuries or disabilities.

DiGA are also called health apps or apps on prescription. DiGA are certified medical devices for treating illnesses. Cardiac pacemakers and x-ray machines are other types of medical device.

DiGA are subject to a rigorous inspection and review process by the Federal Institute for Drugs and Medical Devices (BfArM). DiGA do not include fitness or prevention apps or health promotion apps. 

All digital health applications that are currently approved are listed in the DiGA directory compiled by BfArM.

Digital health applications (DiGA) listed in the DiGA directory (“DiGA-Verzeichnis”) support the treatment of illnesses, such as:

• migraine
• tinnitus
• various types of cancer
• obesity (severe overweight)
• back pain
• anxiety disorders
• depression
• diabetes mellitus

Additional apps and web applications for various illnesses are added to the list on an ongoing basis.

Each individual DiGA has unique content and functions. Some serve to detect or monitor symptoms that require further investigation. Others promote the health literacy of users and enable them to manage their own health. Most DiGA provide direct support for managing illnesses and relieving symptoms.

A DiGA may also serve the purpose of detecting, monitoring, and treating injuries or disabilities. In addition, DiGA may also help people manage injuries or disabilities on a daily basis or to relieve symptoms.

Sometimes you have to wait a while between doctor visits. In the case of chronic diseases, for example, patients often need support between doctor visits and want to be able to monitor the progress of their treatment.

Digital health applications (DiGA) can help with this, e.g. by offering a daily journal where users can record data relating to pain, medication, and measurements. Other treatments require patients to complete regular exercises at home to ensure a successful outcome. In this case, DiGA can provide instructions, send reminders, and run analyses.

In some DiGA, medical data can be transferred electronically to the doctor’s office, even between doctor visits. However, this can only be done with the patient’s explicit consent. This keeps doctors in the loop regarding your progress and provides them with important information in advance of the next visit.

For more information about the electronic transfer of health data to doctors’ practices, see the article about telemonitoring.

Many DiGA offer extensive information about the relevant illness. They explain causes and symptoms or integrate practical audio and video recordings – for example, for exercises to relieve back pain or how to cope with alcohol cravings.

Doctors and medical psychotherapists can prescribe a suitable digital health application (DiGA) to patients if necessary. Only apps listed in the directory compiled by the Federal Institute for Drugs and Medical Devices (BfArM) can be prescribed.

The manufacturer of a DiGA submits an application for approval to BfArM. DiGA are subject to rigorous approval requirements, e.g. in terms of data protection and information security.

In addition, sufficient evidence must be provided of the effectiveness of the DiGA, i.e. it must be shown to have a positive effect on the user’s healthcare (“positive healthcare effect”). In other words, the DiGA must have a medical benefit or must enable important structural and procedural improvements for patients. These structural and procedural improvements may include, for example, enhanced patient safety, enhanced health literacy, or greater likelihood of compliance with treatment recommendations.

Digital health applications (DiGA) record sensitive health data, such as personal measurements, medication plans, or information about an individual’s medical history. This type of data must be particularly well protected.

For this reason, data privacy and the protection of this sensitive health data are important criteria that must be met before an app can be included in the DiGA directory of the Federal Institute for Drugs and Medical Devices (BfArM). This ensures compliance with high standards of data privacy and data security when you use an app on prescription.

You can access a digital health application (DiGA) with a prescription. The prescription can be issued by doctors and medical psychotherapists after you decide in consultation with them that it makes sense in your case to use a DiGA.

You then submit this prescription to your health insurance provider, which will send you an activation code for the DiGA. You can then enter this activation code in the app or on the manufacturer’s website to use the DiGA free of charge.

For more information about DiGA, see the article Apps on prescription: examples of content and benefits.  This article uses a range of examples to illustrate how apps on prescription can support the treatment of various illnesses.