Big Data Health Law And Bioethics

When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? This timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors.

When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? This timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors.

This book helps readers gain an in-depth understanding of electronic health record (EHR) systems, medical big data, and the regulations that govern them. It analyzes both the shortcomings and benefits of EHR systems, exploring the law's response to the creation of these systems, highlighting gaps in the current legal framework, and developing detailed recommendations for regulatory, policy, and technological improvements. Electronic Health Records and Medical Big Data addresses not only privacy and security concerns but also other important challenges, such as those related to data quality and data analysis. In addition, the author formulates a large body of recommendations to improve the technology's safety, security, and efficacy for both clinical and secondary (such as research) uses of medical data.

This book presents cutting edge research on the new ethical challenges posed by biomedical Big Data technologies and practices. ‘Biomedical Big Data’ refers to the analysis of aggregated, very large datasets to improve medical knowledge and clinical care. The book describes the ethical problems posed by aggregation of biomedical datasets and re-use/re-purposing of data, in areas such as privacy, consent, professionalism, power relationships, and ethical governance of Big Data platforms. Approaches and methods are discussed that can be used to address these problems to achieve the appropriate balance between the social goods of biomedical Big Data research and the safety and privacy of individuals. Seventeen original contributions analyse the ethical, social and related policy implications of the analysis and curation of biomedical Big Data, written by leading experts in the areas of biomedical research, medical and technology ethics, privacy, governance and data protection. The book advances our understanding of the ethical conundrums posed by biomedical Big Data, and shows how practitioners and policy-makers can address these issues going forward.

Data sharing – broadly defined as the exchange of health-related data among multiple controllers and processors – has gained increased relevance in the health sciences over recent years as the need and demand for collaboration has increased. This includes data obtained through healthcare provisions, clinical trials, observational studies, public health surveillance programs, and other data collection methods. The practice of data sharing presents several notable challenges, however. Compliance with a complex and dynamic regulatory framework is essential, with the General Data Protection Regulation being a prominent example in a European context. Recent regulatory developments related to clinical trial transparency, trade secrecy, data access, AI training data, and health data spaces further contribute to the difficulties. Simultaneously, government initiatives often encourage scientists to embrace principles of “open data” and “open innovation.” The variety of regulations in this domain has the potential to impede widespread data sharing and hinder innovation. This edited volume, therefore, compiles comparative case studies authored by leading scholars from diverse disciplines and jurisdictions. The book aims to outline the legal complexities of data sharing. By examining real-world scenarios from diverse disciplines and a global perspective, it explores the normative, policy, and ethical dilemmas that surround data sharing in the health sciences today. Chapter Patient Perspectives on Data Sharing, Chapter Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data after Schrems II are available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

Transparency is a concept that is becoming increasingly lauded as a solution to a host of problems in the American health care system. Transparency initiatives show great promise, including empowering patients and other stakeholders to make more efficient decisions, improve resource allocation, and better regulate the health care industry. Nevertheless, transparency is not a cure-all for the problems facing the modern health care system. The authors of this volume present a nuanced view of transparency, exploring ways in which transparency has succeeded and ways in which transparency initiatives have room for improvement. Working at the intersection of law, medicine, ethics, and business, the book goes beyond the buzzwords to the heart of transparency's transformative potential, while interrogating its obstacles and downsides. It should be read by anyone looking for a better understanding of transparency in the health care context.

Health research around the world relies on access to data, and much of the most valuable, reliable, and comprehensive data collections are held by governments. These collections, which contain data on whole populations, are a powerful tool in the hands of researchers, especially when they are linked and analyzed, and can help to address “wicked problems” in health and emerging global threats such as COVID-19. At the same time, these data collections contain sensitive information that must only be used in ways that respect the values, interests, and rights of individuals and their communities. Sharing Linked Data for Health Research provides a template for allowing research access to government data collections in a regulatory environment designed to build social license while supporting the research enterprise.

The Globalization of Health Care is the first book to offer a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. It ties together the manifestation of this globalization in four related subject areas - medical tourism, medical migration (the physician "brain drain"), telemedicine, and pharmaceutical research and development, and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. The time for such an examination is right. Medical tourism and telemedicine are growing multi-billion-dollar industries affecting large numbers of patients. The U.S. heavily depends on foreign-trained doctors to staff its health care system, and nearly forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past 20 years. NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world, claiming that better access to medicine would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book plots the ways in which this globalization will develop as the reform is implemented.