The future of medicine is called evidence.

In many respects, health is a sensitive topic.  Already in the context of quality and risk management, the focus is not only on the question of whether the products and methods used can cause avoidable damage to the patient, but in particular on the question of whether the desired benefit of the product actually occurs. These questions can only be reliably answered by evidence-based medicine. is therefore dedicated, as a manufacturer-independent institute in the sense of Section 139e (4) SGB V, to the creation of and compliance with standards for as well as the monitoring of evaluations of digital products in medicine and can rely on strong partners from the fields of study services and health services research.

Step 1: Evaluation Concept

The first step is the evaluation concept. With the Digital Care Act (DVG), regulations were incorporated into the Sozialgesetzbuch V, which for the first time created a basis for the reimbursement of digital health care applications (diGA). The eligibility for reimbursement of such an application depends largely on its positive effect on health care provision. This is to be proven by studies within the framework of a one-year test phase. For the effective planning and implementation of the trial phase, it is essential to draw up an evaluation concept in advance. We advise and support you in the preparation of such an evaluation concept and thus make you fit for the trial phase

Step 2: Support of Studies

Digital health applications (diGA) have only recently been used for services in the health system. However, the evaluations and reviews carried out so far have been rather superficial and subsequently not very meaningful. For the sustainable use of digital health applications in medicine, however, a comprehensive evaluation and review is essential. The concept of the Digital Active Study (DAS) developed by together with our cooperation partners offers a solution to this problem. Based on the evaluation concept, the focus is not only on proving a positive effect of care but also on including digital communication with patients, doctors and other participants. The Digital Active Study thus takes into account the fact that the digital possibilities can be fully exploited for the framework of the evaluation and that data medicine can also be used at this point for effective and sustainable results.

Step 3: Price Negotiation

Finally, the Digital Supply Act (DVG) stipulates that the manufacturers of digital health care applications (diGA) must enter into price negotiations with the GKV-Spitzenverband on the level of reimbursement for their product. Various methods can be used to determine the price. Optimal planning and preparation of price negotiations with the GKV-Spitzenverband is essential to achieve the highest possible price for the product. supports you, as a manufacturer-independent institute in sense of Section 139e (4) SGB V in choosing the appropriate pricing methodology and actively accompanies you through the price negotiations with the GKV-Spitzenverband.