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The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
This open access book focuses on the discrepancies in biobank research regulations that are among the most significant hurdles to effective research collaboration. The General Data Protection Regulation (GDPR) has established stringent requirements for the processing of health and genetic data, while simultaneously allowing considerable multi-level exceptions for the purposes of scientific research. In addition to directly applicable exceptions, the GDPR places the regulatory responsibility for further defining how the Member States strike a balance between the individuals' rights and the public interest in research within their national legal orders. Since Member States' approaches to the t...
Hallinan argues that the substantive framework presented by the GDPR offers an admirable base-line level of protection for the range of genetic privacy rights engaged by biobanking.
This timely volume provides a comprehensive examination of how the proposed new European Health Data Space (EHDS) legislation will impact upon health and genetic data, individual privacy and providers of health services. With the current legal framework recognised as insufficient in protecting data-related rights, the book spotlights the opportunities and challenges posed by the EHDS in balancing the interests of individuals with policymakers and researchers. It considers the impact on individual EU member states while highlighting issues such as changes to patients’ rights, wearable technology, developments in e-health and the secondary use of medical data. Critically, it also examines ho...
"This timely volume provides a comprehensive examination of how the proposed new European Health Data Space (EHDS) legislation will impact upon health and genetic data, individual privacy, and providers of health services. Including contributions from some of the leading scholars in this area, this ground-breaking book will be key reading for students and researchers across Law and Public Health"--