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[Nationally standardized broad consent in practice: initial experiences, current developments, and critical

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Standardized consent documents for secondary use of patient data were introduced across 27 of 32 Medical Informatics Initiative (MII) sites. While creating a uniform legal basis, comprehensive implementation remains challenging.

Keywords:
Broad description of purposeGeneral Data Protection RegulationImplementation supportInformed consentSecondary use of health data

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Area of Science:

  • Medical Informatics
  • Health Law
  • Digital Health

Context:

  • Digitalization in healthcare enables secondary use of patient data for learning healthcare systems.
  • The Medical Informatics Initiative (MII) developed standardized consent documents to establish an ethical and legal framework.
  • This study monitors the introduction of these consent documents across MII sites.

Purpose:

  • To describe the systematically monitored introduction of standardized consent documents at MII sites.
  • To assess the effectiveness and challenges of implementing these documents for secondary data use.
  • To evaluate stakeholder feedback and adapt materials accordingly.

Summary:

  • 27 out of 32 MII sites have implemented the consent documents, gathering over 173,000 consents.
  • Implementation revealed heterogeneous organizational conditions, necessitating supplementary versions and information materials.
  • The introduction establishes a uniform legal basis but faces challenges in comprehensive site-wide adoption.

Impact:

  • Facilitates a unified legal foundation for secondary patient data use in German university hospitals.
  • Highlights the need for minimum patient information requirements and best practice recommendations.
  • Developed participation and transparency mechanisms remain relevant despite evolving legal frameworks for research.