The Federal Institute for Drugs and Medical Devices (BfArM) has successfully implemented the first data transmission as part of the genome sequencing model project in accordance with § 64e SGB V. The project “Model project for comprehensive diagnostics and therapy discovery by means of genome sequencing in rare and oncological diseases” is a central component of the National Strategy for Genome Medicine of the Federal Ministry of Health. The aim is to integrate genomic medicine into standard care in order to enable patients with rare diseases or advanced cancers to make faster, more precise diagnoses and personalized therapies.

The pilot project networks 28 university hospitals and specialised clinical networks, supported by a broad alliance of experts in data protection, ethics, research, politics as well as patient representatives and health insurance companies. The data platform, operated by the BfArM, stores pseudonymised clinical data in clinical data nodes at university hospitals and genomic data in six genome data centres approved by the BfArM, which are operated by research institutions. Pseudonymisation is carried out by the Trust Office at the Robert Koch Institute in order to ensure the highest data security standards.

In July 2025, the first data was successfully transmitted to operational data nodes, and the BfArM issued the first registration confirmations required for billing with the health insurance companies. This milestone marks the beginning of the productive operation of the data infrastructure. Genome sequencing allows for the analysis of the entire genome to identify the genetic causes of diseases, allowing for more precise diagnoses, customized therapies, and better prevention measures, especially for rare diseases and cancer.

In addition to patient care, the pilot project promotes research by providing researchers with access to extensive genomic and clinical datasets. The BfArM will set up a public application register to create transparency about the use of data. Financed with 700 million euros by the statutory health insurance companies, the project will run for five years and is intended to pave the way to standard care through an evaluation. The results could set international standards for genome medicine.

Further information

genomDE: National Strategy for Genome Medicine of the BMG

BfArM information page on the model project

Editor: X-Press Journalistenbüro GbR

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