Jusletter IT

The «Informed Consent» and the General Data Protection Regulation: Challenges for the Clinical Practice in Germany

An Analysis of the Current Legal Situation with a Particular Focus on Broad Consents

  • Autor/Autorin: Tobias Schulz
  • Kategorie: Beiträge
  • Region: Deutschland
  • Rechtsgebiete: Datenschutz
  • Sammlung: Tagungsband IRIS 2018
  • Zitiervorschlag: Tobias Schulz, The «Informed Consent» and the General Data Protection Regulation: Challenges for the Clinical Practice in Germany, in: Jusletter IT 22. Februar 2018
In medical and clinical practice «informed consent» is mandatory prior to any surgical intervention. At the same time, human tissue or human blood deriving from surgical interventions can be of scientific interest and may be used for scientific research or medical education. This paper will present and analyse the legal framework the General Data Protection Regulation and the German Federal Data Protection Act (Bundesdatenschutzgesetz – BDSG) constitute for the processing of health data with a particular focus on the necessity for a prior «informed consent» and the controversial «broad consent».

Table of contents

  • 1. Introduction
  • 2. Legal framework and legal analysis
  • 2.1. Article 9, paragraph 1 GDPR
  • 2.2. Article 9, paragaph 2 GDPR
  • 3. Applicability of the general principles
  • 4. Processing of health data according to the BDSG
  • 5. Written consents as the preferable approach
  • 6. The problem of broad consents
  • 7. Conclusion

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