Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.

Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.

For the average person, genetic testing has two very different faces. The rise of genetic testing is often promoted as the democratization of genetics by enabling individuals to gain insights into their unique makeup. At the same time, many have raised concerns that genetic testing and sequencing reveal intensely personal and private information. As these technologies become increasingly available as consumer products, the ethical, legal, and regulatory challenges presented by genomics are ever looming. Assembling multidisciplinary experts, this volume evaluates the different models used to deliver consumer genetics and considers a number of key questions: How should we mediate privacy and other ethical concerns around genetic databases? Does aggregating data from genetic testing turn people into products by commercializing their data? How might this data reduce or exacerbate existing healthcare disparities? Contributing authors also provide guidance on protecting consumer privacy and safety while promoting innovation.

For the average person, genetic testing has two very different faces. The rise of genetic testing is often promoted as the democratization of genetics by enabling individuals to gain insights into their unique makeup. At the same time, many have raised concerns that genetic testing and sequencing reveal intensely personal and private information. As these technologies become increasingly available as consumer products, the ethical, legal, and regulatory challenges presented by genomics are ever looming. Assembling multidisciplinary experts, this volume evaluates the different models used to deliver consumer genetics and considers a number of key questions: How should we mediate privacy and other ethical concerns around genetic databases? Does aggregating data from genetic testing turn people into products by commercializing their data? How might this data reduce or exacerbate existing healthcare disparities? Contributing authors also provide guidance on protecting consumer privacy and safety while promoting innovation.

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.

While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else - patient or physician, secular or devout - interested in how US law interacts with health care and religion.

Behavioral nudges are everywhere: calorie counts on menus, automated text reminders to encourage medication adherence, a reminder bell when a driver's seatbelt isn't fastened. Designed to help people make better health choices, these reminders have become so commonplace that they often go unnoticed. In Nudging Health, forty-five experts in behavioral science and health policy from across academia, government, and private industry come together to explore whether and how these tools are effective in improving health outcomes. Behavioral science has swept the fields of economics and law through the study of nudges, cognitive biases, and decisional heuristics-but it has only recently begun to impact the conversation on health care. Nudging Health wrestles with some of the thorny philosophical issues, legal limits, and conceptual questions raised by behavioral science as applied to health law and policy. The volume frames the fundamental issues surrounding health nudges by addressing ethical questions. Does cost-sharing for health expenditures cause patients to make poor decisions? Is it right to make it difficult for people to opt out of having their organs harvested for donation when they die? Are behavioral nudges paternalistic? The contributors examine specific applications of behavioral science, including efforts to address health care costs, improve vaccination rates, and encourage better decision-making by physicians. They wrestle with questions regarding the doctor-patient relationship and defaults in healthcare while engaging with larger, timely questions of healthcare reform. Nudging Health is the first multi-voiced assessment of behavioral economics and health law to span such a wide array of issues-from the Affordable Care Act to prescription drugs. Contributors: David A. Asch, Jerry Avorn, Jennifer Blumenthal-Barby, Alexander M. Capron, Niteesh K. Choudhry, I. Glenn Cohen, Sarah Conly, Gregory Curfman, Khaled El Emam, Barbara J. Evans, Nir Eyal, Andrea Freeman, Alan M. Garber, Jonathan Gingerich, Michael Hallsworth, Jim Hawkins, David Huffman, David A. Hyman, Julika Kaplan, Aaron S. Kesselheim, Nina A. Kohn, Russell Korobkin, Jeffrey T. Kullgren, Matthew J.B. Lawrence, George Loewenstein, Holly Fernandez Lynch, Ester Moher, Abigail R. Moncrieff, David Orentlicher, Manisha Padi, Christopher T. Robertson, Ameet Sarpatwari, Aditi P. Sen, Neel Shah, Zainab Shipchandler, Anna D. Sinaiko, Donna Spruijt-Metz, Cass R. Sunstein, Thomas S. Ulen, Kristen Underhill, Kevin G. Volpp, Mark D. White, David V. Yokum, Jennifer L. Zamzow, Richard J. Zeckhauser

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. In this collection, the authors explore the impact that the philosophical framing of disability can have on public policy questions, in the clinic, in the courtroom, and elsewhere. They examine the implications of this understanding for legal and policy approaches to disability, strategies for allocating and accessing health care, the implementation of the Americans with Disabilities Act, health care rights, and other legal tools designed to address discrimination. This volume should be read by anyone seeking a balanced view of disability and an understanding of the connection between the framing of disability and policies that have a real-world impact on individuals.

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. In this collection, the authors explore the impact that the philosophical framing of disability can have on public policy questions, in the clinic, in the courtroom, and elsewhere. They examine the implications of this understanding for legal and policy approaches to disability, strategies for allocating and accessing health care, the implementation of the Americans with Disabilities Act, health care rights, and other legal tools designed to address discrimination. This volume should be read by anyone seeking a balanced view of disability and an understanding of the connection between the framing of disability and policies that have a real-world impact on individuals.

The COVID-19 pandemic has had an enduring effect across the entire spectrum of law and policy, in areas ranging from health equity and racial justice, to constitutional law, the law of prisons, federal benefit programs, election law and much more. This collection provides a critical reflection on what changes the pandemic has already introduced, and what its legacy may be. Chapters evaluate how healthcare and government institutions have succeeded and failed during this global 'stress test,' and explore how the US and the world will move forward to ensure we are better prepared for future pandemics. This timely volume identifies the right questions to ask as we take stock of pandemic realities and provides guidance for the many stakeholders of COVID-19's legal legacy. This book is also available as Open Access on Cambridge Core.

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.

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.

Behavioral nudges are everywhere: calorie counts on menus, automated text reminders to encourage medication adherence, a reminder bell when a driver's seatbelt isn't fastened. Designed to help people make better health choices, these reminders have become so commonplace that they often go unnoticed. In Nudging Health, forty-five experts in behavioral science and health policy from across academia, government, and private industry come together to explore whether and how these tools are effective in improving health outcomes. Behavioral science has swept the fields of economics and law through the study of nudges, cognitive biases, and decisional heuristics-but it has only recently begun to impact the conversation on health care. Nudging Health wrestles with some of the thorny philosophical issues, legal limits, and conceptual questions raised by behavioral science as applied to health law and policy. The volume frames the fundamental issues surrounding health nudges by addressing ethical questions. Does cost-sharing for health expenditures cause patients to make poor decisions? Is it right to make it difficult for people to opt out of having their organs harvested for donation when they die? Are behavioral nudges paternalistic? The contributors examine specific applications of behavioral science, including efforts to address health care costs, improve vaccination rates, and encourage better decision-making by physicians. They wrestle with questions regarding the doctor-patient relationship and defaults in healthcare while engaging with larger, timely questions of healthcare reform. Nudging Health is the first multi-voiced assessment of behavioral economics and health law to span such a wide array of issues-from the Affordable Care Act to prescription drugs. Contributors: David A. Asch, Jerry Avorn, Jennifer Blumenthal-Barby, Alexander M. Capron, Niteesh K. Choudhry, I. Glenn Cohen, Sarah Conly, Gregory Curfman, Khaled El Emam, Barbara J. Evans, Nir Eyal, Andrea Freeman, Alan M. Garber, Jonathan Gingerich, Michael Hallsworth, Jim Hawkins, David Huffman, David A. Hyman, Julika Kaplan, Aaron S. Kesselheim, Nina A. Kohn, Russell Korobkin, Jeffrey T. Kullgren, Matthew J.B. Lawrence, George Loewenstein, Holly Fernandez Lynch, Ester Moher, Abigail R. Moncrieff, David Orentlicher, Manisha Padi, Christopher T. Robertson, Ameet Sarpatwari, Aditi P. Sen, Neel Shah, Zainab Shipchandler, Anna D. Sinaiko, Donna Spruijt-Metz, Cass R. Sunstein, Thomas S. Ulen, Kristen Underhill, Kevin G. Volpp, Mark D. White, David V. Yokum, Jennifer L. Zamzow, Richard J. Zeckhauser

The COVID-19 pandemic has had an enduring effect across the entire spectrum of law and policy, in areas ranging from health equity and racial justice, to constitutional law, the law of prisons, federal benefit programs, election law and much more. This collection provides a critical reflection on what changes the pandemic has already introduced, and what its legacy may be. Chapters evaluate how healthcare and government institutions have succeeded and failed during this global 'stress test,' and explore how the US and the world will move forward to ensure we are better prepared for future pandemics. This timely volume identifies the right questions to ask as we take stock of pandemic realities and provides guidance for the many stakeholders of COVID-19's legal legacy. This book is also available as Open Access on Cambridge Core.

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else - patient or physician, secular or devout - interested in how US law interacts with health care and religion.

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.

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.

Can your employer require you to travel to India for a hip replacement as a condition of insurance coverage? If injury results, can you sue the doctor, hospital or insurer for medical malpractice in the country where you live? Can a country prohibit its citizens from helping a relative travel to Switzerland for assisted suicide? What about travel for abortion? In Patients with Passports, I. Glenn Cohen tackles these important questions, and provides the first comprehensive legal and ethical analysis of medical tourism. Medical tourism is a growing multi-billion dollar industry involving millions of patients who travel abroad each year to get health care. Some seek legitimate services like hip replacements and travel to avoid queues, save money, or because their insurer has given them an incentive to do so. Others seek to circumvent prohibitions on accessing services at home and go abroad to receive abortions, assisted suicide, commercial surrogacy, or experimental stem cell treatments. In this book, author I. Glenn Cohen focuses on patients traveling for cardiac bypass and other legal services to places like India, Thailand, and Mexico, and analyzes issues of quality of care, disease transmission, liability, private and public health insurance, and the effects of this trade on foreign health care systems. He goes on to examine medical tourism for services illegal in the patient's home country, such as organ purchase, abortion, assisted suicide, fertility services, and experimental stem cell treatments. Here, Cohen examines issues such as extraterritorial criminalization, exploitation, immigration, and the protection of children. Through compelling narratives, expert data, and industry explanations Patients with Passports enables the reader to connect with the most prevalent legal and ethical issues facing medical tourism today.