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Reusing clinical health data for research faces legal and technical hurdles. Overcoming these requires robust governance and infrastructure, not just regulatory compliance, to benefit patients.

Keywords:
Data governanceEuropean Health Data Space (EHDS)Interdisciplinary data sharingMultimodal data integrationNational implementationSecondary use of health dataSecure processing environment

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Area of Science:

  • Health Informatics
  • Medical Research
  • Bioinformatics

Background:

  • Clinical health data reuse is vital for research advancement but faces significant barriers.
  • The TumorScope initiative in Belgium aims to create a secure, multimodal data environment for glioblastoma research.

Purpose of the Study:

  • To examine the legal, technical, and organizational challenges in reusing clinical health data.
  • To identify obstacles and facilitators for effective data access, linkage, and reuse in a glioblastoma research context.

Main Methods:

  • Case study analysis of the TumorScope initiative over five years.
  • Integration of imaging, genetic, tissue-based, and clinical datasets.
  • Examination of legal, ethical, technical, and operational barriers.

Main Results:

  • Identified technical issues: fragmented data flows, pseudonymization complexities, and limited interoperability.
  • Highlighted legal/ethical barriers: General Data Protection Regulation (GDPR) interpretations, medical secrecy, and intellectual property.
  • Noted operational challenges: unclear governance, resource limits, and ethics committee capacity.

Conclusions:

  • Meaningful health data reuse necessitates strong governance, institutional coordination, and investment beyond regulatory compliance.
  • The European Health Data Space Regulation (EHDS) presents potential but requires careful national implementation.
  • Findings inform strategies for ethical and practical health data reuse to improve patient outcomes.