GDPR and Biobanking : : Individual Rights, Public Interest and Research Regulation Across Europe.

GDPR and Biobanking : : Individual Rights, Public Interest and Research Regulation Across Europe.

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Bibliographic Details
Superior document:Law, Governance and Technology Series ; v.43
:
Slokenberga, Santa.
TeilnehmendeR:
Tzortzatou, Olga.
Reichel, Jane.
Place / Publishing House:Cham : : Springer International Publishing AG,, 2021.
©2021.
Year of Publication:2021
Edition:1st ed.
Language:English
Series:Law, Governance and Technology Series
Online Access:
Physical Description:1 online resource (432 pages)
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Table of Contents:
  • GDPR and Biobanking
  • Contents
  • Introduction
  • Part I: Setting the Foundations
  • Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking
  • 1 Introduction
  • 2 EU and Biobanking: Building a Research Regime in the Data Protection Framework?
  • 3 Building Blocks of the GDPR and the Research Regime
  • 4 Clarifying Key Concepts and Definitions
  • 4.1 Concepts of Interest
  • 4.2 Biobank and Biobanking
  • 4.3 Scientific Research, Individual Rights and Public Interest Under the GDPR and Implications
  • 4.3.1 Scientific Research
  • 4.3.2 Individual Rights
  • 4.3.3 Public Interest
  • 4.3.4 Interaction Between Scientific Research, Individual Rights and Public Interest
  • 4.3.5 Implications
  • 5 Concluding Remarks
  • References
  • Striking a Balance Between Personalised Genetics and Privacy Protection from the Perspective of GDPR
  • 1 Introduction
  • 2 Personalised Genetics
  • 3 The Central Value of Privacy
  • 4 Balancing Privacy with Research Interests from a Human Rights Perspective and the Principle of Proportionality
  • 4.1 Premise 1: Promote the Free and Secure Flow of Data Across Borders
  • 4.2 Premise 2: Make Sure Informed Consent and/or Ethical Approval Covers All Use of Data
  • 4.3 Premise 3: Establish Codes of Conduct for Facilitating Joint Research Projects
  • 5 Conclusions
  • References
  • Part II: GDPR Insights
  • The Impact of the GDPR on the Governance of Biobank Research
  • 1 Introduction
  • 2 Processing Personal Data for Scientific Research Purposes
  • 3 Pseudonymized and Anonymized Data
  • 3.1 Introductory Remarks
  • 3.2 Pseudonymized Data
  • 3.3 Anonymization of Data
  • 4 Governance Models for Accessing Genomic and Health Data
  • 4.1 Governance Models: An Overview
  • 4.2 Open-Access
  • 4.3 Controlled-Access
  • 4.4 Registered Access.
  • 5 Relevant Data Sharing and Access Oversight Bodies and Tools
  • 5.1 Data Access Committees
  • 5.2 Data Protection Impact Assessment and Appointment of Data Protection Officers (DPOs)
  • 5.3 Data Access Agreements and Data/Material Transfer Agreements
  • 6 Conclusions
  • References
  • Biobank and Biomedical Research: Responsibilities of Controllers and Processors Under the EU General Data Protection Regulation
  • 1 Introduction
  • 2 GDPR and Biobanking Activities
  • 2.1 Substantive Scope of the GDPR
  • 2.2 Geographical Scope of the GDPR
  • 3 Notion of Controller and Processor in Biobanking
  • 3.1 Definition of Controller and Processor
  • 3.2 Joint-Controllers and Joint-Processors
  • 3.3 Relationship Between Controllers and Processors
  • 4 Duties of Biobanks as Controllers and Processors
  • 4.1 Accountability
  • 4.2 Lawfulness of Data Processing
  • 4.2.1 Categories of Personal Data and Lawfulness in Biobanking
  • 4.2.2 Modalities for Lawful Data Processing in Biobanking
  • General Remarks
  • Necessity-Based Model
  • Consent-Based Model
  • 4.3 Fairness and Transparency of Data Processing
  • 4.4 Purpose Limitation of Data Processing
  • 4.5 Data Protection by Design
  • 4.6 Data Stewardship
  • 5 Conclusion
  • References
  • Individual Rights in Biobank Research Under the GDPR
  • 1 Introduction
  • 2 Individual Rights and the Impact on Biobank Research
  • 2.1 The Right to Be Informed
  • 2.2 The Right of Access
  • 2.3 The Right to Rectification
  • 2.4 The Right to Erasure
  • 2.5 The Right to Restrict Processing
  • 2.6 The Right to Data Portability
  • 2.7 The Right to Object
  • 2.8 Rights in Relation to Automated Decision Making and Profiling
  • 3 Limits on Individual Rights
  • 3.1 Limitations
  • 3.2 Knowledge of the Processing of Data
  • 3.3 Lawful Derogations
  • 4 Conclusion
  • References.
  • Safeguards and Derogations Relating to Processing for Scientific Purposes: Article 89 Analysis for Biobank Research
  • 1 Introduction
  • 2 The Special Regime for Processing of Personal Data for Scientific Research Applied to Biobanks
  • 3 Derogations to Data Subjects' Rights When Processing Personal Data for Scientific Research in the Context of Biobanks
  • 3.1 On Derogations
  • 3.2 Derogation to the Information Requirements
  • 3.3 Derogation to the Duration Requirements
  • 4 Possible Appropriate Safeguards When Processing Personal Data for Scientific Research in the Field of Biobanks
  • 5 Concluding Reflections
  • References
  • Biobank Oversight and Sanctions Under the General Data Protection Regulation
  • 1 Introduction
  • 2 Biobank Oversight Under the GDPR
  • 2.1 Introduction
  • 2.2 Ex Ante Assessment Under the GDPR
  • 2.3 Prior Notification and Approval Under the GDPR
  • 2.4 Ongoing Oversight Under the GDPR
  • 2.5 General Oversight Under the GDPR
  • 2.6 The Interplay of Actors in the GDPR Biobank Oversight Ecosystem
  • 3 Biobank Sanctions Under the GDPR
  • 3.1 Introduction
  • 3.2 Liability and Compensation Sanctions
  • 3.3 Administrative Sanctions
  • 3.4 The GDPR's Sanctions Mechanism in the Biobank Sanctions Ecosystem
  • 4 Problems with Biobank Oversight and Sanction Mechanisms Under the GDPR
  • 4.1 Introduction
  • 4.2 The Lack of Clarity in the DPIA Obligation (Problem 1)
  • 4.3 The Lack of Obligation to Seek Prior Approval (Problem 2)
  • 4.4 The Size of Administrative Fines (Problem 3)
  • 5 Conclusion
  • References
  • Brexit and Biobanking: GDPR Perspectives
  • 1 Introduction
  • 2 Biobanking in the UK: The Current Position
  • 2.1 The Context: National Biobanks Within European and Global Networks
  • 2.2 Overview of the Current Law and Governance Arrangements for Biobanks in the UK.
  • 2.3 Lawfulness of Processing, Transfer of Data Within the EU, and Transfer to 'Third Countries' in the Context of Biobanking in the UK
  • 2.3.1 Lawfulness of Processing and the UK Biobank
  • 2.3.2 Consent as a Basis for Lawful Processing
  • 2.3.3 Legitimate Public Interest as a Basis for Lawful Processing
  • 2.3.4 Adequacy Decisions, 'Appropriate Safeguards' (Standard Contractual Clauses and Binding Corporate Rules), and Special Circumstances as a Basis for Transfer of Data to 'Third Countries'
  • 3 The Political and Legal Processes of Brexit to Date
  • 4 The Legal Position for GDPR Aspects of Biobanking Post-Brexit
  • 4.1 Domestic Legislation, Statutory Instruments, 'Soft Law', Guidance
  • 4.1.1 Soft Law and Guidance on Data Protection Post-Brexit
  • 4.1.2 Data Protection Under the EU (Withdrawal) Act 2018
  • 4.1.3 The Data Protection, Privacy and Electronic Communications (Amendments Etc) (EU Exit) Regulations 2019
  • (a) Adequacy Decisions
  • (b) Standard Data Protection Contractual Clauses and Binding Corporate Rules
  • (c) Information Exchange and Cooperation
  • (d) Procedural and Remedial Safeguards
  • (e) General Principles of EU Law
  • 4.2 The EU-UK Withdrawal Agreement and Biobanking
  • 4.2.1 Data Protection Law Under the Withdrawal Agreement
  • 4.2.2 Other Law Relevant to Biobanking Under the Withdrawal Agreement
  • 4.2.3 Domestic Implementation of the EU-UK Withdrawal Agreement
  • 4.3 The Law If 'No Deal' Brexit
  • 4.3.1 The EU's Position
  • 4.3.2 The UK Position
  • 5 Conclusion
  • References
  • Part III: National Implementation
  • An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules
  • 1 Biobank Infrastructure
  • 1.1 What Is a Biobank
  • 1.2 Types of Biobanks and Biobank Networks in Belgium
  • 2 Regulatory Environment for Biobank Research in Belgium.
  • 2.1 Legal Framework for Biobanks
  • 2.1.1 The Act of 19 December 2008 on Human Body Material
  • 2.1.2 The Royal Decree of 9 January 2018
  • 2.1.3 The Compendium on Biobanks, Issued by the Federal Agency for Medicines and Health Products (FAMHP)
  • 2.1.4 Belgian Data Protection Legislation
  • 2.1.5 'Associated Data' as Personal Data
  • 2.1.6 The Act of 30 July 2018
  • 2.1.7 Interplay Between the Belgian Data Protection and Biobank Rules
  • 2.2 Procedure for Samples Collection
  • 2.2.1 In Theory
  • 2.2.2 In Practice
  • 3 Biobank Research Oversight
  • 3.1 General Remarks
  • 3.2 Ethics Committees
  • 3.3 The Federal Agency for Medicines and Health Products (FAMHP)
  • 3.4 Data Protection Officer
  • 4 Law in Context: Individual Rights and Public Interests
  • 4.1 General Remarks
  • 4.2 Issues Pertaining to (Presumed) Consent for Obtaining HBM
  • 4.3 Issues Pertaining to the Processing of Data Associated to HBM
  • 4.4 Issues Pertaining to Information Provided to the Donor of HBM
  • 5 GDPR Impact and Future Possibilities for Biobanking
  • 5.1 The Impact of GDPR on Biobanking in Belgium
  • 5.2 Allocation of Responsibilities According to Biobanking and Data Protection Rules
  • 5.3 Allocation of Research Oversight Responsibilities Between Data Protection Officers and Ethics Committees
  • 6 Future Possibilities for Biobanking
  • 7 Conclusion
  • Figures
  • References
  • Balancing of Individual Rights and Research Interests in Danish Biobank Regulation
  • 1 Introduction
  • 2 Biobank Infrastructure and Regulatory Environment
  • 2.1 The Danish Biobank Landscape
  • 2.2 Collection of Samples
  • 2.3 Regulation of Biobank Research
  • 3 Individual Rights and Safeguards
  • 4 Law in Context: Individual Rights and Public Interest
  • 5 GDPR Impact and Future Possibilities for Biobanking
  • 6 Conclusion
  • References
  • Regulatory Environment for Biobanking in Estonia.
  • 1 Introduction.

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