Effective February 1, 2026, the DiGAV has been amended in several areas. The basis for this was the \u201cSecond Regulation Amending the Digital Health Applications Regulation\u201d. 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.<\/p>\n\n\n\n
Below is a summary of the most relevant changes.<\/p>\n\n\n\n
1. Introduction of comprehensive, ongoing effectiveness measurement (\u00a7 6a; \u00a7\u00a7 23a ff. DiGAV)<\/strong> To this end, manufacturers must regularly collect data and report it to the BfArM: <\/p>\n\n\n\n In this regard (more specifically, \u201cregarding the creation of datasets within the framework of ongoing effectiveness measurement\u201d), a new permissible processing purpose is inserted in \u00a7 4 II No. 3 (see below regarding consent).<\/p>\n\n\n\n 2. Formal Requirements: Patient Questionnaires, Data Sets for Transmission<\/strong> a) Patient Questionnaires 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. 3. Demonstration of the Maintenance of Earning Capacity<\/strong> 4. Interoperability with the ePA<\/strong> 5. New regulation on \u201csignificant modifications\u201d (\u00a7 18)<\/strong> 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)\u2014reported in aggregated form four times per year.<\/p>\n\n\n\n Significant modifications stay the same. These include, for example, modifications with a significant impact on: <\/p>\n\n\n\n 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.<\/p>\n\n\n\n 6. AI Act<\/strong> 7. Recommendations<\/strong> 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.<\/p>\n","protected":false},"excerpt":{"rendered":" Effective February 1, 2026, the DiGAV has been amended in several areas. The basis for this was the \u201cSecond Regulation Amending the<\/p>\n
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.<\/p>\n\n\n\n
The DiGAV now contains formal requirements for various data collection and transmission processes:<\/p>\n\n\n\n
Data on patients\u2019 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.<\/p>\n\n\n\n
It is recommended to integrate these formal provisions into the products and processes as early as possible and with as much detail as possible.<\/p>\n\n\n\n
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 (\u00a7 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 \u00a7 4 II No. 2a (see below regarding consent).<\/p>\n\n\n\n
Interoperability is established as a requirement in the DiGAV (\u00a7 6a):
DiGAs must be able to transfer the processed data\u2014with the patient\u2019s consent\u2014to the ePA. To this end, the following is required: <\/p>\n\n\n\n
The revised version also specifies when a significant modification has occurred.<\/p>\n\n\n\n
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 (\u00a7 2 (1) sentence 2 no. 4a).<\/p>\n\n\n\n
In light of these changes, the following is particularly recommended: <\/p>\n\n\n\n
In particular, with regard to the application-accompanying performance measurements and evidence regarding the maintenance of earning capacity\u2014for which new permitted purposes have been added in \u00a7 4 (2)\u2014new consent concepts are likely to be necessary in many cases.<\/li>