🇩🇪Germany

DSGVO-Bußgelder bei Forschungsdatenmanagement

2 verified sources

Definition

In der Biotech-Forschung mit sensiblen biologischen Daten (z.B. Patientendaten aus klinischen Studien) verursacht manuelles Data Management Verstöße gegen DSGVO, da Nachverfolgbarkeit und Integrität fehlen. de.NBI hebt Risiken wie Datenverlust und mangelnde Reproduzierbarkeit hervor, was zu hohen Strafen führt.

Key Findings

  • Financial Impact: €20.000–€20 Mio. pro Verstoß (DSGVO-Bußgelder); typisch 2–5% Umsatz
  • Frequency: Häufig bei Tax Audits (Betriebsprüfung) oder Datenschutzprüfungen
  • Root Cause: Manuelles Handling großer Datensätze ohne automatisierte Compliance-Tools

Why This Matters

This pain point represents a significant opportunity for B2B solutions targeting Biotechnology Research.

Affected Stakeholders

Forschungsleiter, Data Manager, CFO

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Financial Impact

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

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