Authors:

Alexandra Heuel, Project Manager at BAYOOMED

Julia Schliesch, Marketing Generalist at BAYOOMED

Effective July 1, 2026, new requirements apply to permanently listed digital health applications (DiGA) as part of the application-accompanying effectiveness measurement (AbEM). This means manufacturers will face additional DiGA requirements that go far beyond mere documentation obligations.

While the focus has primarily been on demonstrating a positive impact on care, the actual use of digital health applications in everyday clinical practice will also become increasingly important in the future.

Manufacturers must be able to provide verifiable evidence of how their DiGA is used and must collect, analyze, and submit the necessary data to the Federal Institute for Drugs and Medical Devices (BfArM) in a manner that complies with regulatory requirements. These requirements therefore apply not only to regulatory processes but also to technical implementation, reporting, and, in the long term, the economic evaluation of a DiGA.

Measuring success throughout the course of use thus becomes an integral part of a DiGA’s product life cycle—with implications for development, operation, and, in the future, reimbursement as well.

Through the post-implementation effectiveness assessment (AbEM), lawmakers aim to understand how digital health applications are actually used in everyday healthcare practice following their regulation. At the same time, the goal is to align reimbursement for digital health applications more closely with their actual use and to allocate statutory health insurance funds in a more targeted manner.

Among other things, the focus is on the following questions:

In the future, the data collected will be used in both the regulatory and economic evaluation of a DiGA. Starting in 2027, the results of the AbEM may affect up to 20% of the reimbursement for a permanently listed DiGA.

The introduction of real-world outcome measurement presents DiGA developers with new professional, technical, and regulatory challenges. Unlike with retrospective data analysis, the requirements of real-world outcome measurement must be taken into account as early as the design and development phases of a DiGA.

Among the most important challenges are:

Those who do not take these requirements into account until shortly before implementation often have to expect additional development work, adjustments to the software architecture, and delays in the project schedule.

Under the first phase of the AbEM, which has been in effect since July 1, 2026, objectively measurable usage data will initially be collected. The goal is to be able to track how a DiGA is actually used in everyday healthcare practice following its regulation.

The data currently being collected includes, among other things:

Data collection takes place directly within the DiGA. External data collection methods such as email, text messages, or push notifications are not provided for under the AbEM. At the same time, data collection is limited to the information defined by regulations—comprehensive user tracking is expressly not the goal of the AbEM.

Participation in the surveys for later phases of the program is voluntary for insured individuals. If users decide not to participate, they will not face any disadvantages as a result, and they are not required to explain their decision.

The collected data is recorded automatically, standardized, and then submitted quarterly to the Federal Institute for Drugs and Medical Devices (BfArM) as part of a report.

Plans are already in place to gradually expand the measurement of outcomes during treatment. While the first phase of expansion focuses on objective usage data, subsequent phases will also collect patient-reported information such as the Patient Global Impression of Change (PGI-C), patient satisfaction, and indication-specific Patient-Reported Outcome Measures (PROMs).

The technical implementation of performance measurement within applications goes far beyond simply collecting usage data. The goal is to integrate the necessary analytics mechanisms into existing applications in such a way that data collection is automated, reliable, and compliant with regulatory requirements.

The new features must be seamlessly integrated into the existing system architecture without compromising the user experience. At the same time, aspects such as data quality, traceability, and the standardized processing of the collected information for reporting to the BfArM must be taken into account.

Those who take these requirements into account early on in the design and development of a DiGA lay the groundwork for efficient implementation and significantly reduce the effort required for later adjustments.

BAYOOMED has already implemented the first phase of its in-use effectiveness measurement for a digital health application.

Analytics solutions were implemented in accordance with current best practices to automatically and reliably collect the usage data required by regulators. Particular attention was paid to seamless integration into the existing application and to establishing a robust foundation for future reporting to the BfArM.

Measuring success throughout the use of a digital health application is much more than just a new regulatory requirement. It is bringing about lasting changes to the types of data that digital health applications will need to collect in the future and to how manufacturers develop, operate, and improve their products.

With AbEM, usage data becomes an integral part of the DiGA lifecycle. At the same time, it is becoming increasingly important not only for regulatory purposes but also for the economic evaluation of an application.

For manufacturers, this means that those who integrate these requirements early on in the design, development, and operation phases lay the groundwork for efficient implementation, reduce the need for later adjustments, and are best prepared for future regulatory developments.

Measuring success during use is just one component of a DiGA’s lifecycle. From the initial idea through development and approval to operation, further development, and regulatory requirements, we support manufacturers throughout the entire product lifecycle. Learn how BAYOOMED supports you throughout the entire DiGA lifecycle.