Data Protection Framework for Medical Research
Requirements of the EU General Data Protection Regulation and National Laws
Download [in German]: Open Access Version

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The European General Data Protection Regulation (EU GDPR) has been applicable since May 2018. National laws at federal and state levels have been adapted to this new, directly applicable European regulation. In addition, the involvement of service providers by people subject to a duty of confidentiality has been newly regulated in German criminal law and medical professional law. In light of this, the TMF Data Protection Workgroup collected questions on the significance of this new legal framework for research with personal medical data and the practical implementation of the new requirements.
This legal opinion provides a comprehensive description of the data protection framework for medical research and answers the specific questions from the research community collected by the Data Protection Workgroup. In a concluding chapter, the expert assesses the new regulations. He considers how practicable the regulations are and to what extent they enable medical research projects and the implementation of privacy protection.
In addition to the pure presentation of the legal framework, the report aims to provide information on how a practical concordance can be achieved between the protection of fundamental informational rights and the freedom of medical research, which is urgently needed in the current pandemic situation. This volume thus provides the research community with recommendations for the legally secure and data protection-compliant implementation of medical research projects.
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Citation
Weichert, T., Datenschutzrechtliche Rahmenbedingungen medizinischer Forschung. Vorgaben der EU-Datenschutz-Grundverordnung und national geltender Gesetze. 2022, Medizinisch Wissenschaftliche Verlagsgesellschaft, Berlin, https://www.mwv-open.de/site/books/m/10.32745/9783954667000/.
1st edition, 243 pages, 2022
€ 59,95 [D], ISBN: 978-3-95466-700-0
Downloads [in German]
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Inhaltsverzeichnis
- Einführung
- Verfassungsrechtliche Grundlagen
- Insbesondere Forschungsfreiheit
- Rechtsgrundlagen
- Verantwortlichkeiten
- Berufliche Schweigepflicht
- Die Rolle der Einwilligung
- Zweckbindung, Zweckänderung
- Technisch-organisatorische Vorkehrungen
- Datenminimierung
- Datenschutzmanagement
- Betroffenenrechte
- Auslandskooperationen
- Kritik und Verbesserungsmöglichkeiten
- Fragenkatalog des TMF-Rechtsgutachtens aus dem Pflichtenheft