Since April 21, 2020, the DIGA Legal Ordinance (DIGA-RV) has come into force, which can open up a wide range of possibilities for patients who want to use digital health applications as „apps on prescription“. According to the manufacturer of digital health applications (DIGA), this guarantees around 73 million people in Germany the right to receive DIGA, which can be prescribed by doctors and psychotherapists, in order to support the detection and treatment of illnesses, but also to ensure the path to a self-determined, health-promoting lifestyle. However, the Federal Institute for Drugs and Medical Devices, or BfArM for short, decides which products from which manufacturer are included in the list of apps that can be prescribed on prescription. From the end of May 2020, any manufacturer can submit an application to the BfArM for the listing of their DIGA. Only at the end of August, when the corresponding portal is activated, will the decision be made as to which DIGA is reimbursable. The exact framework agreement between the GKV-Spitzenverband and the DIGA manufacturers‘ associations is still to be negotiated. In any case, the BfArM is the authority with the most power, because it decides whether DIGA is eligible for reimbursement by the health insurance funds after providing appropriate proof of benefit by means of qualitative and quantitative evaluations using studies, which include retrospective studies as a minimum. The prerequisite must be a positive effect on care. The framework agreement, which has not yet been determined, initially allows for relatively arbitrary pricing, which will be replaced after one year by final prices after negotiations. The BfArM is also the authority that ultimately has to approve and declare DIGA binding on the basis of its study plan after evaluations of morbidity and mortality data, quality of life, patient symptoms and adherence, etc. have been clarified. In addition, interoperability specifications must be observed, which refer to technical and semantic specifications. Machine-readable, interoperable data sets according to the vesta-directory have to be considered. Vesta is the interoperability directory in the German health care system. It specifies the technical and semantic standards, profiles and guidelines that must meet the high IT standards in the healthcare industry. The interoperability process must be taken into account against the background of the interface to the electronic patient record (ePA). An application for inclusion in vesta for own interfaces is therefore urgently required. However, there are also applications on which a decision will only have to be made in the course of the next six months. According to the DIGA-RV, these include a so-called DIGA portal, which is to go online soon, in a few months‘ time, and on which, as a transparency platform, all DIGA listed with the BfArM, which are also reimbursable, can be viewed.
