Update on the BfArM Fast-Track procedure
update on the current status of the Fast-Track procedure for digital health applications
Nearly three months ago all legal prerequisites and information gaps regarding the application procedure have been closed with the Digital Health Applications Ordinance (DiGA-V) and the "Fast-Track" guide for digital health applications (DiGA). Since the beginning of June, the corresponding online portal has been accessible for the submission of applications. We are currently halfway through the application period. Moreover, the first DiGAs could be applied in the context of the German health care system at the end of August. This seems to be a good time for a status review.
Within the scope of the "DiGA Sprechstunde", a new format of the Health Innovation Hub, in which participating regulatory actors present and discuss their concepts, the BfArM reported in detail on the status of the applications received. Since the publication of the guideline in May, about 50 consultations with DiGA manufacturers have been held to clarify procedural issues and pave the way for the application procedure. As of July 16th, 14 applications have been submitted and are currently being processed and evaluated. 50% of the applications are for direct inclusion in the DiGA register and the other 50% for provisional inclusion with simultaneous testing and re-evaluation after 12 months. At the end of August, the first DiGA is expected to be included in the DiGA register.
As soon as a DiGA is included in the register, it can be prescribed by all physicians and will be reimbursed by the Statutory Health Insurances (SHI). Content and structure of the register are still in development but are expected to be finalized in August before the first DiGA is accepted. So far, it is known that the register will be publicly accessible and, in addition to the listing of all prescriptible and reimbursable DiGAs and relevant product data, contain essential additional information for doctors as well as - in an understandable form - for patients. The exact procedure for negotiating the remuneration amounts with the National Association of Statutory Health Insurance Funds (GKV-SV) in accordance with § 134 SGB V is also still unclear. The corresponding framework agreement ("Rahmenvereinbarung") is currently being negotiated between the GKV-SV and the federal associations representing the DiGA manufacturers.
For the process of prescribing and reimbursing DiGAs, health insurance companies, the GKV-SV and representatives of the DiGA manufacturers have developed a joint technical solution, which was also presented at the "DiGA Sprechstunde". Details on this process will be provided in the next SKC-blog.