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

• Superior document: Law, Governance and Technology Series ; v.43
• Author: 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
• Physical Description: 1 online resource (432 pages)

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.