Expert Opinions & Reports

Data Privacy in European Me­dical Research: A Contempo­rary Legal Opinion

Authors: Christian Dierks, Philipp Kircher, Charlotte Husemann, Julia Kleinschmidt and Martin Haase
Publisher: Medizinisch Wissenschaftliche Verlagsgesellschaft
DOI: 10.32745/9783954666034

Open Access Version | Cite | Download Citation [in German]

Ethik & Datenschutz
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The European Data Protection Regulation applies since May 25th, 2018. It creates a uniform data protection legal framework within the EU. National and international medical research projects, regardless of whether they were started before or after the introduction of the GDPR, are obliged to follow this new regulation and implement it promptly. This raises various challenges for a large number of medical research projects.

The University Medicine Greifswald commissioned this legal report, that was prepared by DIERKS+COMPANY. Two real-world research projects, the Baltic Fracture Competence Centre (BFCC) as well as the German Centre for Cardiovascular Research (DZHK) provide use cases, questions, and context for this legal report. It addresses questions regarding all steps of data processing. The report provides practical answers to a wide array of technical and organisational questions in the area of data protection-compliant processing of research data.

A comprehensive guide to GDPR-compliant data processing has been developed, which both summarises the broad legal environment and provides specific assistance in the design and implementation of GDPR-compliant data management processes, including Informed Consent, Legal Consequences of Withdrawal, and Privacy by Design.

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Citation

Dierks, C., Kircher, P., Husemann, C., Kleinschmidt, J., Haase, M., Data Privacy in European Medical Research: A Contemporary Legal Opinion. 2022, Medizinisch Wissenschaftliche Verlagsgesellschaft, Berlin, https://www.mwv-open.de/site/books/m/10.32745/9783954666034/.

1st Edition, 128 Pages, 2021
€ 39,95 [D], ISBN: 978-3-95466-592-1

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Table of Contents

Part I of the legal opinions: Lawfulness of Processing

  1. Executive Summary
  2. Legal requirements of data collection and migration

Part II of the legal opinions: Detailed Questions on organisational and technical measures

  1. Transparency
  2. Auditing
  3. Erasure of Personal Data
  4. Information Duty
  5. Consent
  6. Legal consequences of withdrawal
  7. Standard Operating Procedure (SOP)
  8. Ethics Committee Vote
  9. Quality assurance in the Trusted Third Party
  10. Authorisation of Study Leaders
  11. Dealing with deceased study participants
  12. Studies within the European Union
  13. Storage limitation
  14. Purpose limitation
  15. End of a project
  16. Possession and ownership of data
  17. Data Protection Management System
  18. Privacy by Design
  19. Use of eGK number or KV number
  20. Technical and Organisational Measures (TOM)
  21. Data usage by industrial partners
  22. Necessity of documents
  23. Responsible supervisory authority
  24. Release from Obligation to Secrecy
  25. Necessity of a contract on data processing

Appendix

  1. List of Questions
  2. Keywords Glossary