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Cham : Springer International Publishing AG, 2021

1 online resource (432 pages)

ISBN 9783030493882 (electronic bk.)

ISBN 9783030493875

Law, Governance and Technology Ser. ; v.43

Print version: Slokenberga, Santa GDPR and Biobanking Cham : Springer International Publishing AG,c2021 ISBN 9783030493875

4.2 Open-Access -- 4.3 Controlled-Access -- 4.4 Registered Access.

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 ---

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 ---

1.2 Types of Biobanks and Biobank Networks in Belgium -- 2 Regulatory Environment for Biobank Research in Belgium.

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 ---

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.

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 ---

1 Introduction.

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 ---

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 ---

1.2 Types of Biobanks and Biobank Networks in Belgium -- 2 Regulatory Environment for Biobank Research in Belgium.

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 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 ---

3.2 Knowledge of the Processing of Data -- 3.3 Lawful Derogations -- 4 Conclusion -- References.

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.

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 ---

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 ---

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 ---

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 ---

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 ---

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 ---

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 ---

001895348

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(Au-PeEL)EBL6451168

(MiAaPQ)EBC6451168

(OCoLC)1231606717