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.

Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process ; accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs.

This book analyses the major issues of research ethics through a careful review of the treatment in official policies on research ethics developed throughout the world (especially North America, Western Europe, and the Pacific Rim). Among the issues covered are animal research, research on human subjects, epidemiological research, genetic research, reproductive research, research on vulnerable subjects, clinical trials, drug approval and the reserch process, and research on women and minorities. Brody also evaluates the content and the methods of developing these policies in light of his philosophical position of pluralistic casuistry. This is the only book that analyses all the major issues in research ethics. It is the only book which deals with these issues from an international perspective rather than just a US perspective. Major official policies from important research-intensive countries are reprinted in the appendix (close to 200 plates of otherwise difficult material).

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.

This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have developed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and provides dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: Bioethics, health and human rights Medical liability Law and emerging health technologies Public health law Personalized medicine The law and ethics of access to medicines in developing countries Medical research in the genome era Emerging legal and ethical issues in reproductive technologies This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics.

Ethics for Psychotherapists and Counselors utilizes positive discussions accompanied by a variety of thought-provoking exercises, case scenarios, and writing assignments to introduce readers to all the major ethical issues in psychotherapy. First book designed to engage students and psychotherapists in the process of developing a professional identity that integrates their personal values with the ethics and traditions of their discipline Authors take a positive and proactive approach that encourages readers to go beyond following the rules and to strive for ethical excellence Utilizes a variety of thought-provoking exercises, case scenarios, and writing assignments Authors present examples from their own backgrounds to help clarify the issues discussed Text emphasizes awareness of one's own ethical, personal, and cultural backgrounds and how these apply to one's clinical practice

Like its pioneering predecessor, this new edition of Professionalism and Ethics: Q & A Self-Study Guide for Mental Health Professionals offers an interactive, case-oriented approach to mental health ethics. Organized around scenarios that pose important-sometimes thorny-ethical questions, the book draws on the diverse clinical and research experience of its contributors, who have backgrounds in medicine, ethics, psychology, law, medical education, religious studies, public health, and related fields. The editor, an internationally recognized scholar in bioethics, psychiatry, and medical education, oversaw a rigorous review process, ensuring that the content meets the highest standard, as befits a text on ethics and professionalism. The book begins with an overview of the role of ethics in caring for people with mental illness, concepts and models of professionalism, and ethics education, followed by a chapter examining ethics in the mental health professions, with emphasis on learning and applying essential skills. Questions and annotated answers follow, and the brief case descriptions that frame each question, presented in single-answer, multiple-choice format, echo the real-life complexities of clinical practice. Psychiatry has evolved significantly since the last edition, and the new edition's plentiful revisions and fresh material reflect these changes: * Assisted suicide and euthanasia, which pose controversial and difficult ethical questions, are explored in-depth, with attention accorded religious views, the complexity of informed consent, and the concern that some who choose euthanasia may be clinically depressed.* Navigating social media, experiencing the loss of anonymity, and engaging in self-disclosure of all kinds presents new challenges for practitioners; the pitfalls, both ethical and psychological, are thoroughly discussed. * The digital age poses many ethical dilemmas regarding patient privacy. Is it acceptable for clinicians to "Google" their patients, or is it merely voyeurism? What about consent? * Burnout among mental health practitioners is growing, and professional well-being is an emergent topic. The book examines the increased expectations of physicians and what setting reasonable limits in an era of the electronic health record might look like.* Over the past few decades, neuroscience has been accepted as the conceptual basis for understanding and treating mental illness, and neuroethics have achieved an attendant importance. Human subjects research and the active question of public trust in science, as well as emerging domains, including neurotechnologies, neurolaw, and philosophy of cognition, are carefully examined. Eloquent, instructive, and pragmatic, Professionalism and Ethics: Q & A Self-Study Guide for Mental Health Professionals offers critical learning to prepare professionals for ethical challenges in care and research and is an essential reference and tool for an increasingly complex world.

This open access book reflects on matters of social and ethical concern raised in the daily practices of those working in and around precision oncology. Each chapter addresses the experiences, concerns and issues at stake for people who work in settings where precision oncology is practiced, enacted, imagined or discussed. It subsequently discusses and analyses bioethical dilemmas, scientific challenges and economic trade-offs, the need for new policies, further technological innovation, social work, as well as phenomenological research. This volume takes a broad actor-centred perspective as, whenever cancer is present, the range of actors with issues at stake appears almost unlimited. This perspective and approach opens up the possibility for further in-depth and diverse questions, posed by the actors themselves, such as: How are cancer researchers navigating biological uncertainties? How do clinicians and policy-makers address ethical dilemmas around prioritisation of care? What are the patients' experiences with, and hopes for, precision oncology? How do policy-makers and entrepreneurs envisage precision oncology? These questions are of great interest to a broad audience, including cancer researchers, oncologists, policy-makers, medical ethicists and philosophers, social scientists, patients and health economists.

In this novel examination of the issue of abortion, the authors offer a primer in the biological aspects of fetal development and its impact on the abortion controversy. Although purely scientific study cannot offer a universal solution to the issue of abortion, nor can a purely political or moral response be fully informed without the benefit of the latest scientific knowledge.

Reviewing the latest developments in molecular biology, evolutionary biology, embryology, and neurophysiology, the authors reveal a surprising agreement of scientific opinion on when 'humanness' begins: with the development of a highly developed cerebral cortex. It is on this issue that the authors focus with sensitivity to the myriad of ethical and religious arguments that surround it.

The current health care crisis in the United States has prompted wide interest in how medical systems around the world regulate themselves. This comprehensive book considers whether or not Britain's General Medical Council of professional conduct jurisdiction acts fairly and justly when dealing both with doctors whose conduct it controls, and members of the public whose interests it was established to protect. By looking at the legal history of the Council since its inception to the present, it is possible to see how the system of medical discipline in Britain developed, to reveal its present anomalies and problems, and to see how best to improve the system, if, indeed, such a system is worthy of preservation. Questions such as the role of lay members on the Council, the use of lawyers and Legal Assessors in hearings, how medical issues are resolved and how standards of conduct are set for the profession, are all considered. Over 2,000 disciplinary cases are then surveyed in terms of the type of allegations made, what sort of doctors are involved, and how they are dealt with. Detailed suggestions are finally made for improving the system.

Catholic health care is about ethics but also "ethos" - not only what we shouldn't do but a vision for what we should do with love. The issues it faces don't just concern academic bioethicists - they concern every faithful Catholic doctor, nurse, practitioner, and even patient. Modern medical practitioners on the ground, day-in, day-out, wrestling with medical moral matters, witnessing what is happening in American medicine today, while also striving to witness to their Catholic faith in living out their medical vocation - these are the primary authors of this unique book, and these are the readers it hopes to serve. Catholic Witness in Health Care integrates the theoretical presentation of Catholic medical ethics with real life practice. It begins with fundamental elements of Catholic care, touching upon Scripture, moral philosophy, theology, Christian anthropology, and pastoral care. The second part features Catholic clinicians illuminating authentic Catholic medical care in their various medical disciplines: gynecology and reproductive medicine, fertility, pediatrics, geriatrics, critical care, surgery, rehabilitation, psychology, and pharmacy. Part three offers unique perspectives concerning medical education, research, and practice, with an eye toward creating a cultural shift to an authentically Catholic medical ethos. Readers of this book will learn essential elements upon which the ethics of Catholic medical practice is founded and gain insights into practicing medicine and caring for others in an authentically Catholic way.

Reproductive health care professionals in fields such as Obstetrics and Gynecology, Family Medicine, and Pediatrics face difficult ethical issues because they work at the crossroads of patient decision-making, scientific advancement, political controversy, legal regulation, and profound moral considerations. The dilemmas these professionals face expose big-picture bioethics questions of interest to everyone. Yet for clinicians striving to deliver excellent patient care, the ethical questions that make daily practice challenging can be just as nuanced. This volume presents a carefully curated compilation of essays written by leading experts in the fields of medicine, ethics, and law, who address key issues at the forefront of reproductive ethics. It is organized into three main sections: I. Contraception and Abortion Ethics - Preventing Pregnancy and Birth, II. Assisted Reproduction Ethics - Initiating Pregnancy, and III. Obstetric Ethics - Managing Pregnancy and Delivery. Each section begins with a short introduction by the editors providing an overview of the area and contextualizing the essays that follow. This volume's primary aim is to be useful to practicing clinicians, students, and trainees by providing short and practical essays covering urgent topics-from race, religion and abortion, to legal liability, violations of confidentiality and maternal choices that risk future children's health. This collection provides clinicians at all levels of training with frameworks they need to approach the intimate and high-stakes encounters central to their profession.

How does the market affect and redefine healthcare? The marketisation of Western healthcare systems has now proceeded well into its fourth decade. But the nature and meaning of the phenomenon has become increasingly opaque amidst changing discourses, policies and institutional structures. Moreover, ethics has become focussed on dealing with individual, clinical decisions and neglectful of the political economy which shapes healthcare. This interdisciplinary volume approaches marketisation by exploring the debates underlying the contemporary situation and by introducing reconstructive and reparative discourses. The first part explores contrary interpretations of 'marketisation' on a systemic level, with a view to organisational-ethical formation and the role of healthcare ethics. The second part presents the marketisation of healthcare at the level of policy-making, discusses the ethical ramifications of specific marketisation measures and considers the possibility of reconciling market forces with a covenantal understanding of healthcare. The final part examines healthcare workers' and ethicists' personal moral standing in a marketised healthcare system, with a view to preserving and enriching virtue, empathy and compassion. Chapter 4 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://s3-us-west-2.amazonaws.com/tandfbis/rt-files/docs/Open+Access+Chapters/9781138735736_oachapter4.pdf Chapter 7 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://s3-us-west-2.amazonaws.com/tandfbis/rt-files/docs/Open+Access+Chapters/9781138735736_oachapter7.pdf

The question of whether abortion should or should not be permitted, and under what circumstances, is among the most difficult and sometimes anguished decisions for contemporary men and women. How we feel about this issue, and what actions we take, help to define our image of who we are as social beings. In the midst of the surrounding political, ethical, and religious debate, people everywhere are once again examining their conscience and their beliefs, and turning to unutilized sources of information as they seek to come to terms with this contentious issue. And as emotions run high, it is helpful to step back from the highly charged arena to reconsider the underlying scientific facts about human development.
In The Facts of Life, Harold Morowitz and James Trefil, two distinguished scientists and science writers, examine what modern biology can contribute to our understanding of this debate. Sensitive to the myriad ethical and religious arguments beyond the realm of science that swirl around abortion, the authors focus on one crucial question--when does a fetus acquire "humanness," that quality that sets us apart from all other living things. From the viewpoint of science, they argue, "humanness" begins with the possession of a highly developed cerebral cortex. While humans are linked via cell structure and cell chemistry with all life on our planet--from monkeys to fruit flies to pumpkins--it is the human brain structure which makes us who we are. Reviewing the latest advances in molecular biology, evolutionary biology, embryology, neurophysiology, and neonatology--fields that all bear on this question--the authors reveal a surprising consensus of scientific opinion on when humanness begins.
A lucid primer on the biological aspects of the abortion issue, The Facts of Life is also a fascinating inquiry, across various scientific disciplines, into what makes us uniquely human. Anyone who struggles with the issue of abortion will be grateful to find a work that moves this heated issue from the intensely emotional area it has occupied to the calmer domain of science.

For sixty years genetic counselors have served as the messengers of important information about the risks, realities, and perceptions of genetic conditions. More than 2,500 certified genetic counselors in the United States work in clinics, community and teaching hospitals, public health departments, private biotech companies, and universities. "Telling Genes" considers the purpose of genetic counseling for twenty-first century families and society and places the field into its historical context.

Genetic counselors educate physicians, scientific researchers, and prospective parents about the role of genetics in inherited disease. They are responsible for reliably translating test results and technical data for a diverse clientele, using scientific acumen and human empathy to help people make informed decisions about genomic medicine.

Alexandra Minna Stern traces the development of genetic counseling from the eugenics movement of the early twentieth century to the current era of human genomics. Drawing from archival records, patient files, and oral histories, Stern presents the fascinating story of the growth of genetic counseling practices, principles, and professionals.

Despite its absence in the written text of the European Convention on Human Rights, the European Court of Human Rights now regularly uses the concept of autonomy when deciding cases concerning assisted dying, sexuality and reproductive rights, self-determination, fulfilment of choices and control over body and mind. But is the concept of autonomy as expressed in the ECtHR reasoning an appropriate tool for regulating reproduction or medical practice? Caring Autonomy reveals and evaluates the type of individual the ECtHR expresses and shapes through its autonomy-based case law. It claims that from a social and ethical perspective, the current individualistic interpretation of the concept of autonomy is inadequate, and proposes a new reading of the concept that is rooted in the acknowledgment and appreciation of human interdependence and the importance of interpersonal trust and care.

In 1985, philosopher Samuel Gorovitz spent seven weeks at Boston's Beth Israel, one of the nation's premier teaching hospitals, where he was given free run as "Authorized Snoop and Irritant-at-Large." In Drawing the Line, he provides an intense, disturbing, and insightful account of his observations during those seven weeks.
Gorovitz guides us through an operating room and intensive care units, and takes us to meetings where surgeons discuss the mishaps of the preceding week, where internists map out their approaches to troublesome cases, where the administration discusses competition in the health care market. He follows as residents walk the ragged edge of physical exhaustion, as experienced physicians wrestle with the uncertainties of their demanding profession, as nurses struggle to care for perpetually declining patients. Most important, he examines the ethical questions that permeate their lives--deeply troubling questions such as who should be making life and death decisions--and how should they be made? How should scarce medical resources be allocated? What rules should govern the use of fetal tissue in research and treatment? Where should we draw the line, and how?
When Samuel Gorovitz published Doctors' Dilemmas, a previous look at medical ethics, it was hailed by Norman Cousins as "stimulating and valuable...the product of a beautifully formed (and informed) mind." Studs Terkel called it "quite remarkable...a very exciting book indeed." In Drawing theLine, Gorovitz offers an unusual look at contemporary health care, combining a moving, hard-hitting glimpse of daily reality at a major hospital with the thoughtful, provocative reflections of a highly respected philosopher.

In one form or another, health care now gets rationed. Not everything beneficial is done for every patient. For the individual the consequences are sometimes tragic. Rationing decisions thus raise a classic dilemma: how can we treat with dignity and genuine respect the person who gets short-changed by an efficient policy that seems best overall? Strong Medicine argues that we can, if those policies represent the hard trade-off preferences of patients controlling resources for their larger lives. Rationing is still strong medicine to swallow, but then it becomes what patients as well as the doctor ordered. Menzel develops this central idea and applies it to major issues of health policy and economics: the notion of pricing life, the long-run cost of prevention, measuring quality of life, imperiled newborns, adequate care for the poor, containing costs by market competition, malpractice suits, procuring organs for transplant, and dying expensively in old age. He provides a hard-hitting, critical philosophical discussion of these issues, in non-technical language accessible to a wide range of readers interested in policy questions the book takes up. The issues are fascinating, the arguments are careful, and the results often surprising.

Five years after publication of the third edition, and reflecting the dynamic nature of the pharmaceutical and medical device industries (as well as the many different areas of law that pertain to the management of these medical technologies), the Fourth Edition incorporates the latest legislative, regulatory, and judicial developments, describes recent scientific advances, and excerpts or references new scholarly contributions to this broad field (the wealth of citations should facilitate use in a seminar setting). Measured by volume, more than 20% of the previous edition has been replaced with new material. The latest edition retains the same basic thematic approach and modular structure of the original, which allows instructors to pick and choose the materials to cover based on their own tastes and areas of expertise.

Offering a compendium of case studies in bioethics, Choosing Well demonstrates real ethical dilemmas that can occur in health care settings. Instructors can draw upon the scenarios in this concise and highly effective resource to encourage analysis, critique, discussion, and debate of hot-button ethical issues.The authors present a diverse selection of complex case studies in bioethics to stimulate in-depth analysis on topics ranging from distributive justice, research ethics, reproductive technologies, abortion, and death and dying, to the health care professional-patient relationship and ethics in the workplace. The text also features case studies that move through time to reflect real-life decision making and cases that present multiple perspectives to illustrate the challenges that can arise from disputes in health care settings. Utilizing the DECIDED strategy for analyzing case studies, instructors can guide students through the steps needed to work through a wide variety of ethical dilemmas and encourage reflection on their own ethical assumptions. Accessible, practical, and highly engaging, Choosing Well offers a helpful and interesting way to explore central issues in contemporary bioethics, making it an indispensable resource for instructors and students of bioethics, biomedical ethics, and health care ethics.

Issues concerning patients' rights are at the center of bioethics, but the political basis for these rights has rarely been examined. In "Bioethics in a Liberal Society: The Political Framework of Bioethics Decision Making," Thomas May offers a compelling analysis of how the political context of liberal constitutional democracy shapes the rights and obligations of both patients and health care professionals. May focuses on how a key feature of liberal society--namely, an individual's right to make independent decisions--has an impact on the most important relational facets of health care, such as patients' autonomy and professionals' rights of conscience.

Although a liberal political framework protects individual judgments, May asserts that this right is based on the assumption of an individual's competency to make sound decisions. May uses case studies to examine society's approach to medical decision making when, for reasons ranging from age to severe mental disorder, a person lacks sufficient competency to make independent and fully informed choices. To protect the autonomy of these vulnerable patients, May emphasizes the need for health care ethics committees and ethics consultants to help guide the decision-making process in clinical settings. "Bioethics in a Liberal Society" is essential reading for all those interested in understanding how bioethics is practiced within our society.

In this companion volume to their 1981 work, A Philosophical Basis of Medical Practice, Pellegrino and Thomasma examine the principle of beneficence and its role in the practice of medicine. Their analysis, which is grounded in a thorough-going philosophy of medicine, addresses a wide array of practical and ethical concerns that are a part of health care decision-making today. Among these issues are the withdrawing and withholding of nutrition and hydration, competency assessment, the requirements for valid surrogate decision-making, quality-of-life determinations, the allocation of scarce health care resources, medical gatekeeping, and for-profit medicine. The authors argue for the restoration of beneficence (re-interpreted as beneficence-in-trust) to its place as the fundamental principle of medical ethics. They maintain that to be guided by beneficence a physician must perform a right and good healing action which is consonant with the individual patient's values. In order to act in the patient's best interests, or the patient's good, the physician and patient must discern what that good is. This knowledge is gained only through a process of dialogue between patient and/or family and physician which respects and honors the patient's autonomous self-understanding and choice in the matter of treatment options. This emphasis on a dialogical discernment of the patient's good rejects the assumption long held in medicine that what is considered to be the medical good is necessarily the good for this patient. In viewing autonomy as a necessary condition of beneficence, the authors move beyond a trend in the medical ethics literature which identifies beneficence with paternalism. In their analysis of beneficence, the authors reject the current emphasis on rights- and duty-based ethical systems in favor of a virtue-based theory which is grounded in the physician-patient relationship. This book's provocative contributions to medical ethics will be of great interest not only to physicians and other health professionals, but also to ethicists, students, patients, families, and all others concerned with the relationship of professional to patient and patient to professional in health care today.

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.

This book provides a bridge between the theory to practice gap in contemporary health care ethics. It explores the messiness of everyday ethical issues and validates the potential impacts on health care professionals as wounded healers who regularly experience close proximity to suffering and pain. This book speaks to why ethics matters on a personal level and how moral distress experiences can be leveraged instead of hidden. The book offers contributions to both scholarship and the profession. Nurses, physicians, social workers, allied health care professionals, as well as academics and students will benefit from this book.