Digital health applications (DiGAs) briefly explained
You have wondered what DiGAs are and why they need to be listed in a directory? Below, you will learn the basics about the requirements for listing, what the “positive healthcare effect” has to do with it, as well as future requirements for DiGAs.
What are DiGAs?
Digital health applications, or DiGAs for short, have been available in Germany since 2019. According to the Digital Healthcare Act (DVG), people with statutory health insurance can have DiGAs prescribed by their doctor or psychotherapist. If there is a corresponding indication, the health insurance fund can also reimburse the use of a DiGA without a medical prescription. The goal is to provide patients with a digital assistant to support them in addition to medical or therapeutic treatment.
DiGAs are used by patients alone or together with healthcare providers. While general health apps are often focused on fitness, wellness, or general health monitoring, DiGAs have a specific medical purpose. They support the detection, monitoring, treatment, or alleviation of diseases, as well as the detection, treatment, alleviation, or compensation of injuries or disabilities. DiGAs may not be used for primary prevention.
Currently, DiGAs may only be classified as class I or IIa, but in the future, it will also be possible to have class IIb DiGAs [1].
Why should you aim for a DiGA listing?
Not every software that is certified as a medical device is also a DiGA. Medical device software can be standalone software, such as a hospital information system. Software can also be integrated into hardware, for example, in a robot that calculates and performs the precise placement of needles.
A DiGA differs from this in that, unlike “normal” medical device software, it is used directly by patients themselves. DiGA usage can also be linked to hardware such as wearables. It is important that the main function is digital and that the hardware is only necessary for its use.
Due to the differences in how software and DiGAs are used, the reimbursement options for manufacturers also differ. With the listing of a DiGA as a reimbursable medical device, its prescription can be reimbursed by health insurance in a similar way to medications.
Listing: Fast-Track Procedure and DiGA Directory
In order to be reimbursed as a “prescription app,” a DiGA must undergo an evaluation process at the Federal Institute for Drugs and Medical Devices (BfArM) and be included in the DiGA directory. For this, the manufacturer must submit an application, and BfArM must assess it within three months (fast-track procedure). It is important that, for listing, the DiGA carries a CE mark, meaning it has already completed the conformity assessment procedure with a notified body (DiGA Guide 2023).
The requirements for the application are regulated in the Digital Health Applications Ordinance (DiGAV) [1]. Relevant application forms and checklists can be found in the BfArM application portal [2].
The DiGA directory provides information on the features and performance of the DiGA (§20 DiGAV) [4]. It can be accessed via the BfArM website.
Positive Healthcare Effects
The evaluation covers product characteristics such as data protection, user-friendliness, and positive healthcare effects. These positive healthcare effects must be demonstrated for permanent listing in a comparative study (randomized controlled trial, RCT). Positive healthcare effects for class I and IIa include medical benefit or patient-relevant improvements in structure and processes (pSVV), i.e., new opportunities to improve care. For class IIb, medical benefit is mandatory, and pSVVs can be additionally collected [2]. If there is not yet any evidence of positive healthcare effects, only a preliminary listing is possible, and the evidence must be provided within a trial period. The trial period is 1 year and can be extended to 2 years in exceptional cases [1]. The path of preliminary listing is not available for class IIb DiGAs; these must be permanently listed directly.
Application-related Success Measurements
From 2026 onwards, all listed DiGAs will likely be subject to application-related success measurements (AbEM) [2]. This includes usage duration and frequency, patient satisfaction, and the health status of patients during use [5].
Electronic Patient Record and Health ID
Since 2024, it is also new that DiGAs must be entered into the electronic patient record (ePA) and authentication must be done via the Health ID. The manufacturer must have successfully completed the confirmation process by gematik [6] (National Digital Health Agency Germany) for the use of components or products of the telematics infrastructure (TI) and submit the confirmation to BfArM. For already listed DiGAs, this is a significant change that must be reported to BfArM [3].
Other Stakeholders
The required documents also include an evaluation concept, which must be prepared by a scientific institution independent of the manufacturer. This includes a systematic data analysis and a justification of how the evidence of improved care will be provided during the trial period [1].
Conclusion
There are several points to consider before starting the listing process for a DiGA. With the amendment of the DiGAV and the integration with the ePA, there are also significant changes underway. Nevertheless, DiGAs represent a growing market and are becoming an increasingly integral part of medical care.
Sources
- DiGA Guide v. 3.5, 28.12.2023
- BfArM Webinar from 14.05.2024, slides available for download at https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2024-05-14-diginar.html?nn=1108154
- https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/DiGA-und-DiPA/DiGA/Wissenswertes/_node.html
- Digital Health Applications Ordinance of April 8, 2020 (Federal Law Gazette I p. 768), last amended by Article 4 of the Act of March 22, 2024 (Federal Law Gazette 2024 I No. 101) (DiGAV)
- Draft report of the Federal Ministry of Health: Second Ordinance to Amend the Digital Health Applications Ordinance of 03.01.2025
- https://fachportal.gematik.de/informationen-fuer/diga-hersteller
