BfArM - Federal Institute for Drugs and Medical Devices

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Application Process

DACO has a broad range of responsibilities related to data access applications:

  • Standardized Process: DACO is developing a clear and uniform procedure to link data from the Health Data Lab and state cancer registries securely.
  • Application Processing: DACO receives applications for access to health data and forwards them to the responsible authorities.
  • Communication Support: DACO helps applicants communicate with the relevant institutions, ensuring a smooth and efficient process.
  • Application Review and Approval: Applications for data linkage and use will be carefully reviewed and approved if all requirements are met.
  • Secure Data Processing: For each request, DACO designates a secure processing environment to ensure that data is handled safely and in compliance with regulations.
  • Error Management: If personal information is unintentionally revealed during data processing, DACO will accept reports from data users and immediately notify the responsible authorities to ensure data protection.

Future Vision: A Harmonized, Secure, and Integrated Application Process

DACO is working on the development of a data access application management system that will simplify the process of requesting access to Germany's health data, ensure compliance with national and EU regulations, and integrate with the EHDS application system.

The planned system will allow for:

  • A centralized application platform that serves as the single access point for submitting requests.
  • A user-friendly design that allows researchers and institutions to submit applications securely and efficiently.
  • Transparency and tracking to provide a clear overview of the status of each application at all stages.
  • European interoperability to enable seamless integration with the EHDS processes for cross-border health data access.