Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly affect the prices of the apps. In this blog, we highlight the main legal amendments and address how they affect manufacturers.

I. Launched in 2020, DiGA have become established in the German healthcare system

Digital Health Applications were first recognized as reimbursable therapeutic devices in Germany in 2020. Germany was the first country in the world that introduced the reimbursement of digital health apps. Established through the Digital Care Act (“Digitale-Versorgung-Gesetz”), DiGAs are defined as software medical devices that are intended to assist patients or healthcare providers in the diagnosis, monitoring, treatment, or alleviation of diseases, injuries or disabilities.

To qualify for patient-use and reimbursement as a DiGA, the app must be a medical device and CE-marked. Further, the manufacturer must provide evidence of positive healthcare effects (“positive Versorgungseffekte”) and demonstrate compliance with safety, quality and usability requirements. Furthermore, the app must meet specific data protection, data security and interoperability standards. If all requirements are met, the app may be listed in the DiGA directory, which enables healthcare providers to prescribe it.

While adoption grew steadily, there have been ongoing discussions about the evaluation of the effectiveness and regulation of DiGAs. Since September 2020, when the first DiGA was listed, more than 75 DiGA have been available in Germany. Just over 20% have lost their coverage in the meantime, 15% are being offered temporarily while still under review, and about 65% have been approved for permanent reimbursement.

II. Latest Amendments of the DiGAV – What has changed?

The newest amendments to the ordinance governing DiGAs, the DiGAV, were published just last week in the German federal gazette on 29 January 2026 and came into force last Sunday, on 1 February 2026. Below, we discuss key changes.

1. Real-World Measurement of the DiGA Success

Under the new rules, DiGA manufacturers must provide data for an “accompanying success measurement” (“anwendungsbegleitende Erfolgsmessung”) on their DiGA. Going forward, DiGA manufacturers must provide additional data showing measurable patient benefits of the real-world use of their DiGA.

2. What do manufacturers of already reimbursable DiGA have to do?

Under the new rules, manufacturers of permanently reimbursable DiGA are required to collect and provide data on three main parameters:

The average duration and frequency of use of the DiGA
This includes data on how many minutes the DiGA is being used per week on average, the average number of user interactions per week and the number of cases in which patients discontinue the use of the DiGA.

Patient-reported satisfaction
This data is to be generated through a user survey based on a template questionnaire provided as an annex to the DiGAV. Patient participation is voluntary.

Patient-reported health status
Likewise, to generate this category of data, manufacturers must use a template questionnaire. Patient participation is voluntary.

Starting in the third quarter of 2026, data for these parameters must be generated for each quarter, and the manufacturer must submit the data in anonymized and aggregated form every six months by fixed deadlines to the Federal Institute for Drugs and Medical Devices (BfArM). The first submission is due by 15 April 2027 and must include the data for the 3rd and 4th quarter of 2026. Also, the data set for each quarter must state the total amount of redeemed prescriptions for the DiGA and the total amount of redeemed follow-up prescriptions.

In this context, it is noteworthy that the processing of personal data for the purpose of creating the quarterly data set is subject to Section 4 (3) DiGAV. Thus, it may only be processed in Germany, in an EU member state or EEA country, in Switzerland, or in a country with an adequacy decision pursuant to Art. 45 GDPR.

Manufacturers who submit the aggregated data for the first time, must also include reasoned information on the recommended weekly minutes of use of the DiGA, the recommended frequency of use per week, the duration of use, and the intended minimum and maximum duration of use.

Upon receipt, the BfArM conducts a plausibility check on the data. Once the manufacturer submits for the first time data on usage frequency for at least 200 users in a quarter, the BfArM publishes the data in an explanatory and graphically presented form in the DiGA directory.

3. What do manufacturers have to do if their app is not yet listed in the DiGA directory?

Manufacturers of DiGA that have not yet been permanently listed in the DiGA directory and that apply for a permanent inclusion in the DiGAV must provide comparative studies on the positive healthcare effect (“positiver Versorgungseffekt”) of their app. While this requirement applied before the most recent amendment of the DiGAV, the study requirements have now been extended. The revised DiGAV requires that the studies also include accompanying surveys (“begleitende Erhebungen”) on the duration and frequency of use in accordance with the new requirements for the “accompanying success measurement.

4. Impact of the “accompanying success measurement” on DiGA pricing

While provisions on pricing of DiGA are outside the scope of the now amended ordinance, the German Social Code (SGB V) requires from 1 January 2026 onward, that at least 20% of the remuneration for each DiGA is based on the actual performance of the DiGA. Standing agreements between manufacturers and the public health insurance that do not contain such a performance-based component have to be renegotiated. In future DiGA pricing agreements, the outcomes of the accompanying success measurement will play a significant role.

5. New Requirement: Confirming Compliance with the EU AI Act

Insofar as DiGA contain AI, the provisions of the EU AI Act apply in addition to the EU medical device laws and must be observed regarding the marketability as a medical device. As part of the application for inclusion in the DiGA directory, the amended DiGAV now requires manufacturers to provide information on “compliance with the requirements of Regulation 2024/1689 [“EU AI Act”], if applicable”. The DiGAV’s explanatory memorandum indicates that such information is only required if the DiGA is (already) covered by the EU AI Act, both in terms of subject matter and time. If this is the case, “(…) the manufacturer is only required to provide information on the applicability of the AI Act.” Further information would not be required as compliance with the requirements for functionality and safety would already be presumed under Section 3 DiGAV due to the device’s CE-mark.

6. New Requirements for DiGA that are used to maintain earning capacity

Another noteworthy change concerns DiGA with the purpose of maintaining the user’s earning capacity. This point is rooted in previous legislation but has now been further specified. Under German law, public retirement funds may reimburse DiGA that help maintaining the patient’s earning capacity. Manufacturers of such DiGA not only have to prove a positive healthcare effect (“positiver Versorgungseffekt”) of the DiGA, they also have to demonstrate that its use maintains the earning capacity of the patient. While the DiGAV did not previously address the evidence requirements for studies on the maintenance of the earning capacity, it now clarifies that the provisions on the positive healthcare effect of a DiGA apply accordingly for this parameter.

III. Key Takeaways for the Industry

The revised DiGAV brings significant new obligations for DiGA manufacturers. While the amendments strengthen transparency and solidify the evidence base for digital therapeutics, they also introduce substantial operational work, some of which can directly influence pricing:

• As part of the “accompanying success measurement”, manufacturers must now provide ongoing, structured reporting on usage behaviour, patient satisfaction, and patient dropout rates.
• Manufacturers whose applications are not yet listed in the DiGA directory, must conduct additional surveys on the duration and frequency of use alongside the studies on positive healthcare effect of their product.
• As from January 2026, at least 20% of a DiGA’s remuneration must be linked to performance‑based factors, the outcome of the new “accompanying success measurements” will directly influence DiGA remuneration and long‑term price structures.
• Manufacturers whose DiGA is subject of the EU AI act must declare conformity with the AI Act’s provisions when applying for a listing in the DiGA registry.
• The Ministry of Health has now clarified which DiGAV provisions apply for DiGA that are intended to maintain the patient’s earning capacity.

IV. Further comments and Outlook

With the updated DiGAV, the German regulatory framework for digital health applications is becoming more demanding. The new rules bring added reporting and evaluation duties, and many manufacturers will feel the weight of that. It can be expected that the new obligations will require significant resources, which may well be invested in potentially more impactful efforts. At present, it is hard to imagine that the “accompanying success measurement” will have a significant impact on the quality of DiGA and therefore increase the quality of patient care. However, the new reporting obligations will almost certainly have a decisive effect on negotiations regarding DiGA prices. After all, negotiations are soon taking place with “open books”.

The Life Sciences Team of Covington & Burling LLP in Frankfurt (Germany) will keep you posted about the next developments and stands ready should you have questions on the recent regulatory changes for Digital Health Applications in Germany.

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