Developing digital health applications – evidence-based recommendations for DiGA

Digital health applications (DiGA) have been part of standard healthcare in Germany since 2020. They open up new possibilities for patient-centered, location- and time-independent care and at the same time strengthen the active role of patients. Germany has taken on a pioneering role in the implementation of DiGA. At the same time, new questions arise: How can DiGA be meaningfully integrated into existing treatment pathways? What effects are observed in everyday care? And what added value do DiGAs actually offer for the healthcare system? Evidence-based findings on these questions are needed so that DiGAs can be further developed in a meaningful way and sustainably integrated into healthcare.

This is precisely where the project ImplementDiGA comes in, which is being carried out under the direction of Dr. Madlen Scheibe at the Center for Evidence-based Healthcare (Director: Prof. Jochen Schmitt). The project partners are Techniker Krankenkasse, BARMER, DAK-Gesundheit, AOK Bayern - Die Gesundheitskasse, BAG SELBSTHILFE e.V. and the National Association of Statutory Health Insurance Physicians (KBV).

Research from Dresden for the digital healthcare of tomorrow

In the ImplementDiGA project, an interdisciplinary team from Dresden University Medicine is researching the implementation process and the effects of DiGA in standard care. The aim is to gain reliable scientific findings on the acceptance, use and prescription of DiGA. In addition, the project will examine how DiGAs are integrated into existing care processes, what effects the use of a DiGA has on personal health and medical care in general, and what costs are associated with it.

The perspectives of all key stakeholders in the healthcare system are included - from patients and doctors to health insurance companies and DiGA manufacturers. On this basis, evidence-based recommendations are derived for the further development of DiGA care in the German healthcare system.

Four project modules - a comprehensive look at digital care

The research project follows a multi-method approach and is divided into four modules:

• Module 1: Analysis and continuous characterization of all approved DiGA and assessment of the risk of bias of their approval studies.
• Module 2: Germany-wide surveys and interviews with DiGA-using insured persons, physicians, psychotherapists, health insurers and DiGA manufacturers on the acceptance, use and added value of DiGA.
• Module 3: Analysis of the billing data of the participating health insurance companies to examine prescription behavior, usage patterns, care effects and costs.
• Module 4: Consolidation of all results to derive evidence-based recommendations for the further development of care with DiGA

Evidence-based dialog between science and healthcare practice

A special feature of the project is the structured exchange with key stakeholders in the healthcare system (Module 4). Representatives from science, health insurance companies, self-administration, service providers and patient organizations contribute their perspectives to the process.

A total of five consensus-building workshops between 2024 and 2026 form the framework for this dialog. The consensus-building process was methodically based on the standards of evidence-based guideline development of the Association of the Scientific Medical Societies in Germany (AWMF). Recommendations are proposed by the project partners on the basis of the research results, discussed, further developed and agreed together.

Recommendations for the further development of care with DiGA

The last of the five consensus workshops took place on March 26, 2026. As a result, a catalog with a total of 62 evidence-based recommendations was agreed upon. These provide concrete starting points for the further development of digital healthcare, with a focus on, among other things

• Further development of the DiGA offering,
• a user-centered further development of the DiGA directory,
• the quality and transparency of DiGA approval studies,
• the value-added integration of DiGA into care pathways and guidelines,
• ensuring the needs-based use of DiGA by patients

34 of the 62 recommendations have already been published in the E-Health Monitor 2025(https://www.mckinsey.de/~/media/mckinsey/locations/europe%20and%20middle%20east/deutschland/publikationen/2025-12-18%20e-health%20monitor%202025/mckinsey_e-health%20monitor%202025.pdf). All recommendations agreed in the project will be published in the second half of 2026.

Impetus from healthcare research for politics, self-administration and healthcare provision

The project is an example of how healthcare research from Dresden University Medicine can contribute to the evidence-based further development of digital innovations in the healthcare system and their sustainable integration into healthcare practice.

The team at the Center for Evidence-based Healthcare is thus making an important contribution to the design of modern, digital and patient-centered healthcare.

Further information on the project: www.implementdiga.de

Contact person:
Dr. Madlen Scheibe
Head of Digital Health Research at ZEGV and Consortium Leader of ImplementDiGA
E-mail: Madlen.Scheibe@ukdd.de
Phone: 0351 458-5665