This book provides expert advice on the practical implementation of the European Union’s General Data Protection Regulation (GDPR) and systematically analyses its various provisions. Examples, tables, a checklist etc. showcase the practical consequences of the new legislation. The handbook examines the GDPR’s scope of application, the organizational and material requirements for data protection, the rights of data subjects, the role of the Supervisory Authorities, enforcement and fines under the GDPR, and national particularities. In addition, it supplies a brief outlook on the legal consequences for seminal data processing areas, such as Cloud Computing, Big Data and the Internet of Things.Adopted in 2016, the General Data Protection Regulation will come into force in May 2018. It provides for numerous new and intensified data protection obligations, as well as a significant increase in fines (up to 20 million euros). As a result, not only companies located within the European Union will have to change their approach to data security; due to the GDPR’s broad, transnational scope of application, it will affect numerous companies worldwide.

GDPR: Personal Data Protection in the European Union Mariusz Krzysztofek Personal data protection has become one of the central issues in any understanding of the current world system. In this connection, the European Union (EU) has created the most sophisticated regime currently in force with the General Data Protection Regulation (GDPR) (EU) 2016/679. Following the GDPR’s recent reform – the most extensive since the first EU laws in this area were adopted and implemented into the legal orders of the Member States – this book offers a comprehensive discussion of all principles of personal data processing, obligations of data controllers, and rights of data subjects, providing a thorough, up-to-date account of the legal and practical aspects of personal data protection in the EU. Coverage includes the recent Court of Justice of the European Union (CJEU) judgment on data transfers and new or updated data protection authorities’ guidelines in the EU Member States. Among the broad spectrum of aspects of the subject covered are the following: – right to privacy judgments of the CJEU and the European Court of Human Rights; – scope of the GDPR and its key definitions, key principles of personal data processing; – legal bases for the processing of personal data; – direct and digital marketing, cookies, and online behavioural advertising; – processing of personal data of employees; – sensitive data and criminal records; – information obligation & privacy notices; – data subjects rights; – data controller, joint controllers, and processors; – data protection by design and by default, data security measures, risk-based approach, records of personal data processing activities, notification of a personal data breach to the supervisory authority and communication to the data subject, data protection impact assessment, codes of conduct and certification; – Data Protection Officer; – transfers of personal data to non-EU/EEA countries; and – privacy in the Internet and surveillance age. Because the global scale and evolution of information technologies have changed the data processing environment and brought new challenges, and because many non-EU jurisdictions have adopted equivalent regimes or largely analogous regulations, the book will be of great usefulness worldwide. Multinational corporations and their customers and contractors will benefit enormously from consulting and using this book, especially in conducting case law, guidelines and best practices formulated by European data protection authorities. For lawyers and academics researching or advising clients on this area, this book provides an indispensable source of practical guidance and information for many years to come.

This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

From May 2018, the General Data Protection Regulation 2016/679 (GDPR) replaces the Data Protection Directive 95/46/EC, representing a significant overhaul of data protection law in the European Union. Applicable to all EU Member States, the GDPR's relevance spans not only organizations operating within the EU, but also those operating outside the EU. This commentary, published in association with German Law Publishers, provides a detailed look at the individual articles of the GDPR and is an essential resource aimed at helping legal practitioners prepare for compliance. Content includes: full text of the GDPR's articles and recitals, article-by-article commentary explaining the individual provisions and elements of each article; a general introduction to data protection law with a focus on issues such as: how to adapt a compliance management programme; whether or not to appoint a data protection officer; 'privacy by design' and 'privacy by default'; the consequences of non-compliance with the GDPR; data portability; and, the need for data protection impact assessments, a detailed index. In addition to lawyers and in-house counsel, this book is also suitable for law professors and students, and offers comprehensive coverage for law professors and students, and offers comprehensive coverage of this increasingly important area of data protection legislation. Book jacket.

This new book provides an article-by-article commentary on the new EU General Data Protection Regulation. Adopted in April 2016 and applicable from May 2018, the GDPR is the centrepiece of the recent reform of the EU regulatory framework for protection of personal data. It replaces the 1995 EU Data Protection Directive and has become the most significant piece of data protection legislation anywhere in the world. The book is edited by three leading authorities and written by a team of expert specialists in the field from around the EU and representing different sectors (including academia, the EU institutions, data protection authorities, and the private sector), thus providing a pan-European analysis of the GDPR. It examines each article of the GDPR in sequential order and explains how its provisions work, thus allowing the reader to easily and quickly elucidate the meaning of individual articles. An introductory chapter provides an overview of the background to the GDPR and its place in the greater structure of EU law and human rights law. Account is also taken of closely linked legal instruments, such as the Directive on Data Protection and Law Enforcement that was adopted concurrently with the GDPR, and of the ongoing work on the proposed new E-Privacy Regulation.

There are relatively few resources that are built for US based legal practitioners who are not already steeped in data privacy and security. The EU GDPR General Data Protection Regulation: Answers to the Most Frequently Asked Questions provides straight-forward and practical answers to core questions that are raised by most attorneys and privacy professionals that grapple with the GDPR.

Nearly two decades after the EU first enacted data protection rules, key questions about the nature and scope of this EU policy, and the harms it seeks to prevent, remain unanswered. The inclusion of a Right to Data Protection in the EU Charter has increased the salience of these questions, which must be addressed in order to ensure the legitimacy, effectiveness and development of this Charter right and the EU data protection regime more generally. The Foundations of EU Data Protection Law is a timely and important work which sheds new light on this neglected area of law, challenging the widespread assumption that data protection is merely a subset of the right to privacy. By positioning EU data protection law within a comprehensive conceptual framework, it argues that data protection has evolved from a regulatory instrument into a fundamental right in the EU legal order and that this right grants individuals more control over more forms of data than the right to privacy. It suggests that this dimension of the right to data protection should be explicitly recognised, while identifying the practical and conceptual limits of individual control over personal data. At a time when EU data protection law is sitting firmly in the international spotlight, this book offers academics, policy-makers, and practitioners a coherent vision for the future of this key policy and fundamental right in the EU legal order, and how best to realise it.

The rapid development of information technology has exacerbated the need for robust personal data protection, the right to which is safeguarded by both European Union (EU) and Council of Europe (CoE) instruments. Safeguarding this important right entails new and significant challenges as technological advances expand the frontiers of areas such as surveillance, communication interception and data storage. This handbook is designed to familiarise legal practitioners not specialised in data protection with this emerging area of the law. It provides an overview of the EU’s and the CoE’s applicable legal frameworks. It also explains key case law, summarising major rulings of both the Court of Justice of the European Union and the European Court of Human Rights. In addition, it presents hypothetical scenarios that serve as practical illustrations of the diverse issues encountered in this ever-evolving field.

Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .

The complexities of implementing the General Data Protection Regulation (GDPR) continue to grow as it progresses through new and ever-changing technologies, business models, codes of conduct, and decisions of the supervisory authorities, and the courts. This eminently practical guide to implementing the GDPR – written in an original, problem-solving style by a highly experienced data protection expert with equal knowledge of both law and technology – provides a step-by-step project management approach to building a GDPR-compliant data protection system, assessing, and documenting the risks and then implementing these changes through processes at the operational level. With detailed attention to case law (Member State, ECJ, and ECHR), especially where affecting high-risk areas that have attracted scrutiny, the guidance proceeds systematically through such topics and issues as the following: required documentation, policies, and procedures; risk assessment tools and analysis frameworks; children’s data; employee and health data; international transfers post-Schrems II; data subject rights including the right of access; data retention and erasure; tracking and surveillance; and effects of technologies such as artificial intelligence, biometrics, and machine learning. With its practical examples derived from the author’s experience in building GDPR-compliant software, as well as its analysis of case law and enforcement priorities, this incomparable guide enables company data protection officers and compliance staff to advise on key issues with full awareness of the legal and reputational risks and how to mitigate them. It is also sure to be of immeasurable value to concerned regulators and policymakers at all government levels. “…it's going to be the go to resource for practitioners.” Tom Gilligan, Data Protection Consultant, September 2021 "I purchased this book recently and I’m very glad I did. It’s the textbook I have been waiting for. As someone relatively new to data protection, I was finding it very difficult to find books on the practical side of data protection. This book is very clearly laid out with practical examples and case law given for each topic, which is immensely helpful. I would recommend it to any data protection practitioners." Jennifer Breslin, LLM CIPP/E, AIPP Member