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<p>The use of artificial intelligence (AI) in diabetology is subject to complex legal, regulatory, and ethical frameworks. In the European context, the Medical Device Regulation (MDR) and the AI Act are particularly important, complemented by international standards, national laws, and data protection regulations such as the General Data Protection Regulation (GDPR). Ethical guidelines, scientific position papers, and user perspectives are also central to responsible implementation. The AI systems are subject to strict MDR requirements and must be safe, effective, and compliant with data protection laws. Many AI applications in diabetes care fall into high-risk categories, requiring adherence to technical standards and targeted cybersecurity measures. The AI Act further establishes a&#xa0;binding legal framework for the development and deployment of AI, demanding traceability and human oversight. Since health data are particularly sensitive, AI systems must comply strictly with GDPR, which mandates privacy by design and by default. Under product liability law, manufacturers of AI systems are liable for faulty functions, while physicians remain responsible for the use, patient education, and documentation of AI in the treatment process. Position papers from the scientific community and the diabetes community highlight the risks of AI systems from different angles but share a&#xa0;common demand for the protection of health data. Finally, the use of AI in healthcare raises ethical questions—particularly regarding the lack of representativeness in training data, which can lead to unequal treatment.</p>

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Rahmenbedingungen der künstlichen Intelligenz in der Diabetologie

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年7月21日

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  • Stefanie Hossmann,
  • Hanne Ballhausen,
  • Martina Rothenbühler

摘要

The use of artificial intelligence (AI) in diabetology is subject to complex legal, regulatory, and ethical frameworks. In the European context, the Medical Device Regulation (MDR) and the AI Act are particularly important, complemented by international standards, national laws, and data protection regulations such as the General Data Protection Regulation (GDPR). Ethical guidelines, scientific position papers, and user perspectives are also central to responsible implementation. The AI systems are subject to strict MDR requirements and must be safe, effective, and compliant with data protection laws. Many AI applications in diabetes care fall into high-risk categories, requiring adherence to technical standards and targeted cybersecurity measures. The AI Act further establishes a binding legal framework for the development and deployment of AI, demanding traceability and human oversight. Since health data are particularly sensitive, AI systems must comply strictly with GDPR, which mandates privacy by design and by default. Under product liability law, manufacturers of AI systems are liable for faulty functions, while physicians remain responsible for the use, patient education, and documentation of AI in the treatment process. Position papers from the scientific community and the diabetes community highlight the risks of AI systems from different angles but share a common demand for the protection of health data. Finally, the use of AI in healthcare raises ethical questions—particularly regarding the lack of representativeness in training data, which can lead to unequal treatment.