| Nota di contenuto |
Intro -- Preface -- Taking Responsibility: The Value and Handling of Data in Modern Medicine in the Light of the New GDPR -- Acknowledgement -- Contents -- Introduction -- References -- Medical Research and Data Protection in Europe. The Emergence of General Legal Principles -- References -- Part I: Syllabus of the Burning Questions -- Anonymisation (Part I) -- 1 Introduction -- 2 Anonymisation in the General Data Protection Regulation -- 3 General Framework for Data Access in the EHDS Proposal -- 4 Conclusions: The Anonymisation of Health Data in Health Research Projects -- References -- Anonymisation: The Trap for Biobanking (Part II) -- 1 Introduction -- 2 Coded Data in Biobanking and the Concept of Anonymisation -- 3 Consequences of Anonymisation of Personal Data -- 4 Conclusion -- References -- Applying National Law in Cross-Border Research Activity -- 1 Introduction -- 2 Application of GDPR at National Levels: The Laws Relevant to Cross-Border Research Projects and Conflict of Laws -- 3 Equal Treatment of All Individuals in One Study/Research Activity -- 4 The Answers From the European EDPB About a Heterogeneous/Different Legal Basis for Processing Health Data of Different Indiv... -- 5 The Lack of Rules with Regard to the Issue of a Possible Intra-EU Conflict of Laws in the Scenario of the GDPR -- 6 The One-Stop-Shop Mechanism Identifies the Lead Supervisory Authority for Cross-Border Processing -- 7 Is Using Recital 153 GDPR in an Analogic Manner a Potential Solution? -- 8 Conclusion -- References -- Archived Tissue -- 1 Introduction -- 2 The Possible Definitions of `Archive´ and, Consequently, of `Archived Tissues´ -- 3 Consent Required for the Use of Biological Materials and Related Personal Data in Research Activities -- 4 Historical Tissue Archives and the Absence of Express Consent.
5 Current Tissue Archives, Secondary Use and Conservation Obligation -- 6 Conclusion -- References -- Blockchain and Dynamic Consent -- 1 Introduction -- 2 The Blockchain for Biobanking: The Most Relevant Projects So Far -- 3 Valuable Blockchain Functions for Dynamic Consent in Biobanking -- 4 Blockchains for Biobanking Under the GDPR -- 5 Conclusion -- References -- Brexit Effects -- 1 Introduction -- 2 The `Brexit Effect´ on Data and Biological Samples -- 3 The Flow of Health Data: Waiting for an Adequacy Decision -- 4 The Transfer of Biological Samples -- 5 Conclusion -- References -- Broad Consent -- 1 Introduction -- 2 Advantages and Disadvantages of Broad Consent -- 3 Donors´ Views on Broad Consent -- 4 Consent for Governance -- 5 Conclusion -- References -- Cloud -- 1 Introduction. The Use of the Cloud in Research -- 2 Risks of the Cloud -- 3 Measures and Penalties -- 4 Conclusion -- References -- Consent Requirements -- 1 Introduction -- 2 The Adequacy of the Information -- 3 Information to Be Provided -- 3.1 Relationships with the Research Group and Research Establishment -- 3.2 Legal Base, Purpose and Context of the Research Activity -- 3.3 Risks and Other Consequences -- 3.4 Information Concerning Storage, Security and Confidentially -- 3.5 Categories of Recipients and International Transfer of Data and Materials -- 3.6 Rights of the Person Involved in the Research Activities -- 3.7 Additional Information -- 4 Withdrawal and Freedom of Consent -- 5 Form of the Information and of Consent -- 6 Conclusion -- References -- Consent and Assent by Children -- 1 Introduction -- 2 Children´s Consent or Assent in Biobanks -- 2.1 The Legal Context -- 2.2 Age to Be Considered -- 3 What Should Be Done When They Reach the Age: Obligations and Recommendations -- 4 Conclusion -- References -- Consent and Technology -- 1 Introduction.
2 A New Model for Consent: Dynamic Consent -- 3 The Potential of a Dynamic Consent Interface -- 4 Conclusion -- References -- Consent from Children and Vulnerable People -- 1 Introduction -- 2 Consent as an Ongoing Process for Medical Assistance -- 3 The Legal Representative and Best Interest Decisions -- 4 The Spanish Example in Tackling Health and Disability -- 5 Conclusion -- References -- Consent Withdrawal -- 1 Introduction -- 2 Some Elements to Focus the Meaning of Withdrawal in Light of the GDPR -- 3 The Impact of the Withdrawal on the Purely Research Activity and/or Clinical Trial -- 4 The Case of Withdrawal of Consent and Other Legal Bases for Personal Data -- 5 Conclusion -- References -- Covid-19 -- 1 Introduction -- 2 Alternative Legal Basis to Consent: Public Interest or Legitimate Interest of the Data Controller -- 3 Management of Personal Data for Scientific Research Purposes Related to the COVID-19 Pandemic: Transparency, Information, Re... -- 4 Conclusion -- References -- Dynamic Consent -- 1 Introduction -- 2 Setting the Scene for Dynamic Consent -- 3 Dynamic Consent in Practice -- 4 The Information Conveyed and How to Express Dynamic Consent -- 5 Conclusion -- References -- Ethics Committees -- 1 Introduction -- 2 Ethics Committees -- 3 Mandatory and Non-Mandatory Ethics Committees -- 4 Composition and Functions of the Ethics Committees -- 5 Ethics Advisors Within EU Programmes -- 6 Conclusion -- References -- Ethic and Biobanks -- 1 Introduction -- 2 Data Protection Impact Assessment -- 3 The Population Biobank Code of Ethics -- 4 Towards a Model of `Mixed´ (Specific and Broad) Informed Consent -- 5 Conclusion -- References -- Ethical Principles and Legal Provisions -- 1 Ethical Principles Within EU Law -- 2 Dignity -- 3 Self-Determination -- 4 Solidarity -- 5 Prevention of Risks and the Precautionary Principle.
6 Proportionality -- 7 Proportionality and Research Biobanks -- References -- EU Legislation and Health Data Protection -- 1 Introduction -- 2 Personal Data Protection and the EU Treaties: Are There Articles of the EU Founding Treaties that Regulate Personal Data Pro... -- 3 The Bridge Between the EU Treaties and the GDPR: What Is the Role of the GDPR in the Legal Mechanism for Personal Data Prote... -- 4 The Key Principles of Personal Data Protection in the European Union: Which Principles Apply to Personal Data Protection in ... -- 5 Conclusions: How Efficient Is the Legal Mechanism that Regulates the Protection of Personal Data? -- References -- Forensic Databases (Part I) -- 1 Introduction -- 2 Legislation Applicable and Standards of Conduct -- 3 Data and Material Retention -- 3.1 Criteria for Entering Individual Profiles -- 3.2 Rules for the Destruction of the Sample Used for the Creation of the DNA Profile -- 3.3 Retention Time of the DNA Profile of a Convicted Person -- 3.4 Circumstances Requiring the Deletion of the DNA Profile -- 4 Conclusion -- References -- Forensic Databases (Part II) -- 1 Introduction: Issues Regarding the Circulation of DNA Profiles Within the EU and Non-EU Countries -- 2 Challenges Surrounding the Prüm Decisions -- 3 Controversies Around Secondary Uses -- 4 Ethical Questions Associated with the Use of Forensic DNA Databases -- 5 Conclusion -- References -- Future Research -- 1 Introduction -- 2 Defining `Scientific Research´ -- 3 Ethical Dimensions of Research Activity -- 4 `Academic Expression´ and Scientific Research in Light of the GDPR -- 5 Current State of Knowledge and Future Research -- 6 Conclusion -- References -- Genetic Data -- 1 Introduction -- 2 The Special Status of Genetic Data -- 3 The Use of Genetic Information in the Context of Research Activities in Particular: The Specific Issues.
4 Information Shared Between Persons of the Same Genetic Group -- 5 Conclusions -- References -- Granularity -- 1 Introduction -- 2 `Granularity´ of Consent and Special Rules for Consent in Research Activities -- 3 Issues Concerning the Exceptions to the Requirement for Specific Consent -- 4 Conclusions -- References -- Imaging Biobank -- 1 Introduction -- 2 Imaging Biobanks -- 3 The Relationship Between GDPR and Images in the Light of Imaging Biobanks and Imaging Biomarkers -- 4 Fairness in AI Systems in the Light of the GDPR -- 5 Conclusion -- References -- Industry Perspective -- 1 Introduction -- 2 The GDPR as One Element Within a Complex Legal Framework -- 3 The Decisive Factor: Taking a Stance on Anonymisation -- 4 Contractual Building Blocks: Covering the Past, the Present and the Future -- 5 Conclusion -- References -- Joint Controller Agreement -- 1 Introduction -- 2 The Essence of the Joint Controller Agreement: Purposes and Means of the Processing of Personal Data -- 3 Terms of the Arrangement Between Joint Controllers -- 4 The Arrangement Between Controller and Processor -- 5 Conclusion -- References -- Legitimate Interests -- 1 Introduction -- 2 Legitimate Interest as Grounds for Data Processing -- 3 Processing Retrospective Health Data and Tumour Tissue on Grounds of Legitimate Interest -- 4 Conclusion -- References -- Ownership of Human Biological Material -- 1 Introduction -- 2 The Legal Framework May Be Subject to the Processing for Commercial and Research Purposes Because of Human Tissues -- 3 Some Legal Issues for Biobank Policies and Procedures for the Exploitation of Material Stored in a Biobank and Associated Da... -- 4 Conclusion -- References -- Paediatric Biobanks (General Overview) -- 1 Introduction. The Principle of Solidarity and Research Biobanks.
2 General Framework for Ethics and Functioning of a Paediatric Biobank: Benefits and Risks.
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GDPR Requirements for Biobanking Activities Across Europe
