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<p>The growing integration of genomic data into personalized medicine offers significant potential to improve our understanding of disease mechanisms, inform clinical decision-making, and enable more patient-centered care. At the same time, it raises important challenges related to data protection, ethical oversight, and regulatory governance. Within the European Union, the General Data Protection Regulation (GDPR) classifies genetic data as a&#xa0;special category of personal data, requiring particularly stringent safeguards. In Germany, the interplay between the GDPR and national laws—such as the Federal Data Protection Act (BDSG) and Social Code Book V (SGB&#xa0;V)—has resulted in a&#xa0;complex and multi-level legal framework. This article reviews the current landscape of genomic data protection in Germany, compares it with international practices, and highlights recent developments such as the Health Data Use Act (GDNG) and the establishment of the Research Data Center for Health (FDZ Gesundheit). Using real-world examples—including the national Network Genomic Medicine (nNGM) Lung Cancer, DigiNet, and pilot projects under §&#xa0;64e&#xa0;SGB&#xa0;V—it explores how data protection can be implemented in a&#xa0;way that supports innovation. Secure and ethically governed data access is not only essential for safeguarding individual rights, but also a&#xa0;critical enabler of continuous research, improved care quality, and the broader adoption of genomic and data-driven healthcare.</p>

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Datenschutzaspekte bei der Genomsequenzierung und personalisierten Medizin: Herausforderungen und Chancen

  • 期刊论文

  • 发表日期：

    2025年8月6日

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  • Uwe Lührig,
  • Jürgen Wolf,
  • Anna Kron

摘要

The growing integration of genomic data into personalized medicine offers significant potential to improve our understanding of disease mechanisms, inform clinical decision-making, and enable more patient-centered care. At the same time, it raises important challenges related to data protection, ethical oversight, and regulatory governance. Within the European Union, the General Data Protection Regulation (GDPR) classifies genetic data as a special category of personal data, requiring particularly stringent safeguards. In Germany, the interplay between the GDPR and national laws—such as the Federal Data Protection Act (BDSG) and Social Code Book V (SGB V)—has resulted in a complex and multi-level legal framework. This article reviews the current landscape of genomic data protection in Germany, compares it with international practices, and highlights recent developments such as the Health Data Use Act (GDNG) and the establishment of the Research Data Center for Health (FDZ Gesundheit). Using real-world examples—including the national Network Genomic Medicine (nNGM) Lung Cancer, DigiNet, and pilot projects under § 64e SGB V—it explores how data protection can be implemented in a way that supports innovation. Secure and ethically governed data access is not only essential for safeguarding individual rights, but also a critical enabler of continuous research, improved care quality, and the broader adoption of genomic and data-driven healthcare.