In the DiGA process, a positive care effect is the evidence that a digital health application improves care for its target group. Under Section 139e SGB V, this effect can be either medical benefit or a patient-relevant improvement in care structures and procedures. If final proof is not yet available, a DiGA in a lower risk class may, under certain conditions, be provisionally included in the DiGA directory for a testing phase.
Two Forms of Care Effect
Medical benefit relates to patient-relevant improvements in health status, duration of illness, survival, or quality of life, as well as a reduction in side effects. Patient-relevant structural and procedural improvements, by contrast, cover advantages in the care process that must be noticeable to patients. The BfArM guide treats both categories as independent pathways to demonstrating a positive care effect.
An effect is not positive simply because an application works technically or carries a CE mark. For inclusion in the directory, requirements such as safety, functional suitability, and data protection must also be met. The care effect additionally requires scientific evidence that can be clearly attributed to the specific patient group applied for and the described use situation.
Provisional Listing for Testing
For a provisional listing, the manufacturer must plausibly demonstrate that a positive care effect can be proven during a testing phase. This requires systematic data evaluation and a scientific evaluation concept. The concept describes which effect the study is intended to examine, which target group and comparison group are planned, which endpoints will be used, and how the evaluation will be conducted.
The provisional listing for testing is time-limited. The law initially provides for twelve months and allows for a one-time extension. It does not lower the requirements for product safety or data protection. Its specific purpose is to generate, within a regulated care setting, the evidence required for permanent approval for a DiGA with a plausible prospect of success.
Distinction from Reimbursement, CE Marking, and Approval
The positive care effect is a German reimbursement criterion for digital health applications, not an approval standard. CE marking and the provisions of the EU Medical Device Regulation concern conformity and the placing of a product on the market as a medical device. Entry in the DiGA directory additionally requires that the social law prerequisites for providing care to statutorily insured patients be met.
The established term medical device describes the product category; CE marking and EU MDR 2017/745 relate to conformity assessment. Digital biomarker likewise addresses a different question, namely the digital measurement of a biological or clinical characteristic. None of these terms replaces the requirement to demonstrate a positive care effect in the DiGA process.
The effect applied for should be narrowly defined before the study begins. “Better care” is not a measurable endpoint. What is required is a clear link between the intervention, the target group, the comparison, and a patient-relevant outcome. For a structural and procedural improvement, it must be traceable which step in the care process generates the benefit and why it reaches patients. A mere shortening of an administrative process is not sufficient if no patient-relevant benefit results from it.
The provisional listing does not allow evidence generation to be separated from product development. Changes to the software, its content, or the usage concept can affect whether the study results still apply to the same DiGA. Version management, clear documentation of the intervention, and secure storage of the evaluation data are therefore particularly important for the evaluation concept. The evidence must assess the application that is intended to be permanently listed after the testing phase concludes.
Finally, the presentation of results must distinguish between permanent listing and evidence from the testing phase. A provisionally positive decision is not a statement that the care effect has already been conclusively demonstrated through a complete study.
For applications with high user dependency, it should also be recorded whether actual use corresponds to the intended intervention. Low adherence or deviating use can significantly alter conclusions about the care effect.
The comparison group must also correspond to the effect applied for. An unsuitable comparison can create a false impression of a care difference—either overstating or concealing it—thereby jeopardizing the suitability of the study as evidence for inclusion in the directory.
Relevance for clinical trials
Studies for DiGAs must reflect the specific use situation: target group, care pathway, comparison, and endpoints must align with the claimed effect. For patient-relevant structural and procedural improvements, a technical metric alone is not sufficient; the impact on patients must be clearly demonstrated. For the testing phase, the protocol, data sources, sample size planning, evaluation strategy, and milestones of the evaluation concept must be coordinated early on.
Full-service CROs such as Mediconomics support the development of DiGA-specific study protocols, the selection of patient-relevant endpoints, and the conduct of studies for permanent or provisional listing. They coordinate clinical project management, data management, biostatistics, and medical writing, ensuring that systematic data evaluation and the evaluation concept precisely substantiate the claimed care improvement.
Frequently Asked Questions (FAQ)
Is a CE mark sufficient for permanent DiGA listing?
No. In addition to the product requirements, a positive care effect must be demonstrated, unless a provisional listing for testing is applied for.
Can a care improvement be relevant without a direct medical benefit?
Yes. In addition to medical benefit, the law explicitly recognizes patient-relevant structural and procedural improvements.
Is the provisional listing for testing an unlimited reimbursement?
No. It is a time-limited provisional listing during which the positive care effect is to be demonstrated.
Regulatory References
- Section 139e SGB V – defines listing, care effect, and testing phase in the DiGA directory.
- Digital Health Applications Ordinance (DiGAV) – specifies the procedure and documentation required for listing.
- BfArM Guide on DiGA – explains evidence requirements and the evaluation concept.
- Regulation (EU) 2017/745 on Medical Devices – establishes the framework for medical device conformity.