The Digital Healthcare Act (Digitale-Versogungs-Gesetz, DVG) introduced the “app on prescription” for medical device software (MDSW) for patients (§§ 33a and 139e Fünftes Buch Sozialgesetzbuch).
We support you in developing scientific concepts to prove the positive healthcare effect for the inclusion of your DiGA in the directory of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).
Are you a manufacturer of a digital health application ("medical app" medical device software (MDSW)) and would like to find your way into the statutory health insurance (Gesetzliche Krankenversicherung, GKV) reimbursement system and thus develop a "medical app on prescription"? We are happy to support you in developing scientific strategic approaches in a goal-oriented manner and implementing them in accordance with the requirements of the BfArM.
The Digital Healthcare Act (DVG) of 2019 aims to provide manufacturers of digital health solutions with a significantly accelerated process for the reimbursement of their innovative digital medical devices in a "fast-track procedure". The criteria according to BfArM evaluates new digital health solutions in this process are described in detail and are interpreted according to strictly scientific criteria. In addition to comprehensive proof of technical safety, functional suitability, data protection and data security, as well as the quality of medical content of the digital healthcare application, proof of a so-called positive care effect (German: positiver Versorgungseffekt, pVE) must be provided. A positive care effect must be explicitly proven on the basis of at least one clinical study of sufficient quality. If the criteria are met, the medical apps are listed in the "Directory for Digital Health Applications" in accordance with §139e SGB V.
According to the BfArM, a DiGA must have these characteristics:
The BfArM distinguishes products with:
1. Medical benefit (medizinisches Nutzen, mN)
2. Patient-relevant improvement of structure and processes (Patientenrelevante Struktur- und Verfahrensverbesserung, pSVV)
In its evaluation, the BfArM only considers products that have a direct patient benefit. Products that only reduce the workload or have an economic benefit do not count as digital healthcare application.
Basically, a clinical trial must be conducted to prove that a digital healthcare application is better than not using it.
The digital health application guideline sets clearly defined requirements for the clinical study:
Benefit from our many years of experience in designing and conducting clinical trials!
We are happy to advise you on what specific requirements the Digital Health Applications Ordinance (German, Digitale-Gesundheitsanwendungen-Verordnung, DiGAV), imposes on manufacturers. We offer you support and guidance for the consultation meetings with the BfArM (according to §23 DiGAV) and conduct a systematic risk analysis together with you to identify potential obstacles in the evaluation process.
Phone: +49 30 521 044 80