Digital health applications (DiGA): apps on prescription
Digital health applications (DiGA) – also known as apps on prescription – can be used to enhance the treatment of a wide range of illnesses by imparting information, providing context, or guiding patients through exercises. DiGA can help reduce symptoms and improve patients’ management of their illnesses.
At a glance
- Digital health applications (DiGA) are health apps and web applications that are available on prescription.
- They support the detection, monitoring, and treatment of various physical and mental illnesses.
- DiGA must meet strict requirements, e.g. in terms of the quality of their medical content, data protection, and effectiveness.
- They are used, for example, for depression, anxiety disorders, excessive alcohol consumption, cancer, obesity (severe overweight), and migraine.
- To use a DiGA, you need a prescription from a doctor or written proof of a relevant diagnosis.
- There are various ways for patients to access support when using DiGA.
What are digital health applications (DiGA)?
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. Unlike health apps that are available without prescription, DiGA are regarded as 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 that are available without a prescription.
All digital health applications that are currently approved are listed in the DiGA directory compiled by BfArM.
What is the purpose of DiGA?
Digital health applications (DiGA) listed in the DiGA directory (“DiGA-Verzeichnis”) support the treatment of illnesses, such as:
- various types of cancer
- obesity (severe overweight)
- multiple sclerosis
- anxiety disorders
- sleep disorders
- after a stroke
Additional apps and web applications for various illnesses are added to the list on an ongoing basis.
The content and functions of each DiGA are unique. 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 help detect, monitor, treat, alleviate, or compensate for injuries or disabilities.
How can DiGA be used to benefit treatment?
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.
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.
What are the approval criteria for DiGA?
The Digital Healthcare Act (DVG) allows doctors and psychotherapists to prescribe a suitable digital health application (DiGA) as needed. 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. The quality of the medical content, the application’s usability and robustness, and patient safety are all inspected prior to approval. BfArM also conducts a risk/benefit analysis for each app, and the benefits must always clearly outweigh the risks.
Finally, sufficient evidence must be provided for 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 help reduce symptoms for the majority of users or have another positive impact on their health. A positive healthcare effect could be a reduction in pain or improved knowledge and understanding of the illness, enabling the patient to manage it more effectively.
In the case of some apps or web applications submitted for approval, sufficient research has not been conducted at the time the approval application is submitted and so the effectiveness of the app cannot be proven. In this case, the manufacturer can use the “Fast Track” process to apply for provisional approval and listing in the DiGA directory. In this case, they must provide additional scientific evidence of the app’s positive effect over the course of the first year.
How secure is user data?
Data privacy and the protection of user data are also important criteria that must be met before an application can be added to the directory of digital health applications (DiGA) that can be prescribed. Apps available for use on prescription must guarantee high standards of data privacy and data protection.
How are DiGA accessed?
If you have decided, in consultation with your doctor, to use a digital health application (DiGA), your doctor will create a prescription for you that indicates the name of the DiGA and its pharmaceutical registration number (PZN). You then submit this to your health insurance provider.
After the manufacturer and the statutory health insurance fund cross-check the anonymized data, you will receive 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.
Important: If you have a document indicating your diagnosis, you can, as an alternative to submitting a prescription, present this document as proof to the health insurance fund and indicate that you wish to use the DiGA. This could be a doctor’s letter or another document offering proof of a current diagnosis, for example. The health insurance fund may also require proof that there are no contraindications to the use of the app, i.e. that there is no medical reason why you should not use the DiGA. If there are no such contraindications, the DiGA will be approved.
What support is available when using a DiGA?
If you’re using a digital health application (DiGA) and have any questions about doing so, you can first check the FAQ section in the app to see if you can find the answer you’re looking for among the frequently asked questions and the responses to these. If not, you can contact the manufacturer using the contact form, the e-mail address provided, or their phone number. You will find the contact data on the app’s contact page or in the legal notice. Alternatively, you can ask your doctor for help.
If you require general support with using apps and web applications, contact your health insurance fund. Health insurance providers offer special training to help you or your loved ones use a smartphone or computer, with the aim of making DiGA accessible to as many people as possible.
Where can I find more information about DiGA?
For more information about the topic of 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.
- Federal Institute for Drugs and Medical Devices (BfArM). The Fast-Track Process for Digital Health Applications (DiGA) according to §Section 139e SGB V – A Guide for Manufacturers, Service Providers and Users. Updated 23 October 2020. Accessed on 06/07/2021.
- Federal Ministry of Health (Bundesministerium für Gesundheit). Ärzte sollen Apps verschreiben können – Digitale-Versorgung-Gesetz (“Doctors should be able to prescribe apps – the Digital Healthcare Act”) (article in German). Accessed on 06/08/2021.
- Federal Institute for Drugs and Medical Devices (BfArM). DiGA – digital health applications. Accessed on 06/08/2021.
- Health innovation hub. DVG – A summary of Germany’s new law for digital health applications. Accessed on 06/08/2021.