
Contents
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A. Introduction A. Introduction
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B. A Framework for the Critical Analysis of the GDPR B. A Framework for the Critical Analysis of the GDPR
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C. Problems Concerning the Structure of the GDPR C. Problems Concerning the Structure of the GDPR
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1. The Regulation Cannot Protect Genetic Privacy Rights Engaged by the Processing of Scientific Conclusions (Problem 1) 1. The Regulation Cannot Protect Genetic Privacy Rights Engaged by the Processing of Scientific Conclusions (Problem 1)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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2. The Regulation Cannot Protect Genetic Privacy Rights Engaged by Law Enforcement Processing (Problem 2) 2. The Regulation Cannot Protect Genetic Privacy Rights Engaged by Law Enforcement Processing (Problem 2)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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D. Problems Concerning the Protection of Research Subjects’ Genetic Privacy Rights on the Transactional Axis D. Problems Concerning the Protection of Research Subjects’ Genetic Privacy Rights on the Transactional Axis
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1. The GDPR Cannot Protect the Research Subject’s Information Privacy Right to Choose Not to Know Their Own Genetic Data (Problem 3) 1. The GDPR Cannot Protect the Research Subject’s Information Privacy Right to Choose Not to Know Their Own Genetic Data (Problem 3)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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2. The GDPR Cannot Protect the Research Subject’s Spatial Privacy Right Not to Be Informed of Potentially Harmful Genetic Information (Problem 4) 2. The GDPR Cannot Protect the Research Subject’s Spatial Privacy Right Not to Be Informed of Potentially Harmful Genetic Information (Problem 4)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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E. Problems Concerning the Protection of Genetic Relatives’ and Genetic Groups’ Genetic Privacy Rights on the Relational Axis E. Problems Concerning the Protection of Genetic Relatives’ and Genetic Groups’ Genetic Privacy Rights on the Relational Axis
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1. The Regulation Cannot Protect Genetic Groups (Problem 5) 1. The Regulation Cannot Protect Genetic Groups (Problem 5)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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2. The Regulation Cannot Protect Genetic Relatives (Problem 6) 2. The Regulation Cannot Protect Genetic Relatives (Problem 6)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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F. Problems Concerning the Substantive Protection Offered by the GDPR F. Problems Concerning the Substantive Protection Offered by the GDPR
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1. The Regulation Imposes No Obligation to Seek Prior Approval from a DPA (Problem 7) 1. The Regulation Imposes No Obligation to Seek Prior Approval from a DPA (Problem 7)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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2. The Regulation Imposes No Strict Consent Obligation (Problem 8) 2. The Regulation Imposes No Strict Consent Obligation (Problem 8)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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3. The Regulation Provides No Support for Disclosures in the form of Genetic Counselling (Problem 9) 3. The Regulation Provides No Support for Disclosures in the form of Genetic Counselling (Problem 9)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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4. The Regulation Provides No Strict Prohibitions on Third-Party Non-Research Access (Problem 10) 4. The Regulation Provides No Strict Prohibitions on Third-Party Non-Research Access (Problem 10)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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5. The Regulation Does Not Require Public and Accessible Access Policies (Problem 11) 5. The Regulation Does Not Require Public and Accessible Access Policies (Problem 11)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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6. The Regulation Fails to Outline Criminal Sanctions (Problem 12) 6. The Regulation Fails to Outline Criminal Sanctions (Problem 12)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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G. Problems Concerning the Technical Applicability of the GDPR’s Provisions to Biobanking G. Problems Concerning the Technical Applicability of the GDPR’s Provisions to Biobanking
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1. Transparency Provisions Are Technically Unsuited to the Broad Analytical Potential of Genomic Data (Problem 13) 1. Transparency Provisions Are Technically Unsuited to the Broad Analytical Potential of Genomic Data (Problem 13)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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2. Transparency Provisions Are Technically Unsuited to the Uncertain Future Analytical Potential of Genomic Data (Problem 14) 2. Transparency Provisions Are Technically Unsuited to the Uncertain Future Analytical Potential of Genomic Data (Problem 14)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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3. Self-Determination Provisions Are Technically Unsuited to Genomic Data (Problem 15) 3. Self-Determination Provisions Are Technically Unsuited to Genomic Data (Problem 15)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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H. Problems Concerning the Disproportionate Impact of the GDPR on Research H. Problems Concerning the Disproportionate Impact of the GDPR on Research
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1. Disproportionate Impact Associated with the Right to Obtain a Copy of Personal Data Applied to the Biological Sample (Problem 16) 1. Disproportionate Impact Associated with the Right to Obtain a Copy of Personal Data Applied to the Biological Sample (Problem 16)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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2. Disproportionate Impact Associated with Data Portability Rights (Problem 17) 2. Disproportionate Impact Associated with Data Portability Rights (Problem 17)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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3. Disproportionate Impacts Associated with the Size of Administrative Fines (Problem 18) 3. Disproportionate Impacts Associated with the Size of Administrative Fines (Problem 18)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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I. Problems Concerning the Practical Applicability of the GDPR to Biobanking I. Problems Concerning the Practical Applicability of the GDPR to Biobanking
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1. The Conditions of Consent Remain Uncertain for Biobanking (Problem 19) 1. The Conditions of Consent Remain Uncertain for Biobanking (Problem 19)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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2. The DPIA Obligation Is Unclear for Biobanking (Problem 20) 2. The DPIA Obligation Is Unclear for Biobanking (Problem 20)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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3. The Data Protection by Design and Default Obligation Is Unclear for Biobanking (Problem 21) 3. The Data Protection by Design and Default Obligation Is Unclear for Biobanking (Problem 21)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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J. Problems Concerning the Degree to Which the GDPR Harmonises Protection J. Problems Concerning the Degree to Which the GDPR Harmonises Protection
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1. National Interpretations of Generally Applicable Provisions Diverge (Problem 22) 1. National Interpretations of Generally Applicable Provisions Diverge (Problem 22)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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2. National Laws Derogating from the GDPR Diverge (Problem 23) 2. National Laws Derogating from the GDPR Diverge (Problem 23)
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a) Problem a) Problem
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b) Severity and Resolution b) Severity and Resolution
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K. Conclusion K. Conclusion
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10 A Critical Analysis of the Efficacy of the GDPR as a Framework for the Protection of Genetic Privacy in Biobanking
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Published:March 2021
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Abstract
This chapter presents a critical analysis of the efficacy of the General Data Protection Regulation (GDPR) as a framework for the protection of genetic privacy in biobanking. In this regard, it outlines twenty-three problems concerning the standard of protection offered by the GDPR, assessing the degree to which each problem casts doubt on the efficacy of the GDPR. The chapter considers whether there are factors evident which are likely to mitigate the severity of the impact of each problem, as well as whether each problem is subject to resolution——either through the GDPR's internal interpretation and adaptation mechanisms or through external legislation operating in tandem with the GDPR. The analysis demonstrates that the great majority of problems are not as severe as they initially seem and, as a result, do not call into question the efficacy of the GDPR as a framework for the protection of genetic privacy in biobanking. It also shows that all problems which either require a solution, or would benefit from a solution, can be resolved via the GDPR's internal mechanisms or via external law operating in parallel with the GDPR, or both.
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