Effective February 1, 2026, the DiGAV has been amended in several areas. The basis for this was the “Second Regulation Amending the Digital Health Applications Regulation”. Consequently, no longer only one-time evidence is required, but regular assessments using real usage data are also being introduced. Several other amendments are being made in parallel.
Below is a summary of the most relevant changes.
1. Introduction of comprehensive, ongoing effectiveness measurement (§ 6a; §§ 23a ff. DiGAV)
A separate section on in-use effectiveness measurement has been newly introduced. In addition to the existing evidence of positive healthcare effects from one-time studies, this is intended to introduce tracking of the benefits of the DiGA over the entire usage period.
To this end, manufacturers must regularly collect data and report it to the BfArM:
- Fulfilled prescriptions and follow-up prescriptions (§ 23b(2))
- Duration and frequency of use (§ 23c)
- Detailed information on terminations (§ 23c(5): numbers, rates, duration…)
- Patient-reported health status during use (§ 23d)
- Patient satisfaction regarding the quality of the DiGA (§ 23d)
- Additional results regarding health status, if applicable (§ 23e)
In this regard (more specifically, “regarding the creation of datasets within the framework of ongoing effectiveness measurement”), a new permissible processing purpose is inserted in § 4 II No. 3 (see below regarding consent).
2. Formal Requirements: Patient Questionnaires, Data Sets for Transmission
The DiGAV now contains formal requirements for various data collection and transmission processes:
a) Patient Questionnaires
Data on patients’ health status and patient satisfaction is collected using the questionnaires provided in Annex III.
Patients may voluntarily consent to the use of their data regarding patient satisfaction and health status. Further processing for other purposes is prohibited without consent.
b) Structures and formats for data sets
The detailed structure of the data to be transmitted to the BfArM is set forth in Appendix IV.
c) Publication
The relevant results of the effectiveness measurements will, once they reach a certain threshold, also be published by the BfArM and thus potentially broader.
This establishes binding requirements for patient questionnaires as well as scales and evaluations. The values of individual DiGAs will thus also be more comparable and verifiable.
It is recommended to integrate these formal provisions into the products and processes as early as possible and with as much detail as possible.
3. Demonstration of the Maintenance of Earning Capacity
Guidelines are now also provided on how the demonstrated benefit of a DiGA in the form of the maintenance of work capacity is to be structured (§ 11b).
The DiGAV largely refers to the binding requirements for demonstrating positive healthcare effects, meaning that existing experience can partly be relied upon for the procedure.
To this end, a new permissible processing purpose is added in § 4 II No. 2a (see below regarding consent).
4. Interoperability with the ePA
Interoperability is established as a requirement in the DiGAV (§ 6a):
DiGAs must be able to transfer the processed data—with the patient’s consent—to the ePA. To this end, the following is required:
- use of the interface specified by Gematik,
- export in a human-readable format, and
- specifications for semantic and syntactic interoperability (pursuant to § 355(2a) Social Code Book V).
5. New regulation on “significant modifications” (§ 18)
The revised version also specifies when a significant modification has occurred.
Minor or purely editorial changes to the information in the directory and, for example, to the results of the application-accompanying performance measurement can now be reported via simplified notifications (forms from the BfArM)—reported in aggregated form four times per year.
Significant modifications stay the same. These include, for example, modifications with a significant impact on:
- Safety, functionality, and quality of the DiGA,
- Data protection and data security,
- Evidence of positive healthcare effects or the maintenance of earning capacity
On the one hand, this brings simplifications and a potential reduction in the number of reports. On the other hand, determining the significance of modifications in individual cases will create new ambiguities.
6. AI Act
The DiGAV now explicitly refers to the EU AI Act. Manufacturers must now provide information regarding compliance with the requirements of the AI Act, at least to the extent that its applicability extends to the DiGA or parts thereof (§ 2 (1) sentence 2 no. 4a).
7. Recommendations
In light of these changes, the following is particularly recommended:
- Review and, if necessary, adaptation of existing consent processes and texts as well as related information.
In particular, with regard to the application-accompanying performance measurements and evidence regarding the maintenance of earning capacity—for which new permitted purposes have been added in § 4 (2)—new consent concepts are likely to be necessary in many cases. - Alignment of documented data flows with the new requirements for measuring success and providing evidence of earning capacity,
- Review and supplementation of existing data protection impact assessments,
- Creation of processes and formats for the newly introduced reporting obligations,
- Updating of transparency information as well as internal reporting and documentation processes.
This information is intended for initial orientation and does not replace individual legal consultation. We are happy to assist you with a detailed assessment of the implications for your specific DiGA application.