This book examines patent law and policy in biotechnology across the full lifecycle of the patent, focusing on the patent bargain and the public interest. It considers the central issues of how to strike an effective balance of rights, and whether public interest is adequately safeguarded - two issues that are particularly important in areas of rapidly emerging technology. Expert contributors are brought together to explore patent eligibility in biotechnology, focusing on the fields of precision medicine, biofabrication and non-invasive prenatal testing. Chapters also explore the construction and coherence of exceptions to patentability,an examination of FRAND licensing in the context of the internet of medical things, and the possibility of using licensing to encourage or ensure the ethical use of patented technologies. With its carefully constructed analysis, this book will be an excellent resource for academic researchers, and students, in the fields of biotechnology law, pharmaceutical law and intellectual property law. It will also be useful for legal practitioners and policymakers, as well as charitable bodies and non-governmental organisations.

The current suicide public health crisis and advances in clinical practice have increased the need for clear, evidence-informed guidance on suicide prevention in healthcare. This clinical suicide prevention handbook is an essential resource for mental health and primary care professionals, and any practitioner aiming to ensure their practice is up-to-date, patient-centred and consistent with the most current standards of care. Starting with a summary of the science and public health model of suicide, the book offers quick tips for suicide screening, risk assessment, interventions, and follow-up communication. It discusses medicolegal risk management, how health systems can prevent suicide and provides highly specialized guidance for clinicians following the loss of a patient to suicide. Focused sections include incorporating social media into care plans, telemedicine, issues related to culture and race/ethnicity, and working with specific populations. It introduces an integrated, prevention-oriented approach to suicide prevention, incorporating realistic supports, foreseeable changes, and strategies.

"No doctor, however great his capacity or original his ideas, has the right to choose martyrs for science or for the general good." Human Guinea Pigs: Experimentation on Man.Whistle-blowers tend not to be very popular. Maurice Pappworth's whistle was in the form of Human Guinea Pigs, the controversial book published in 1967 which examined unethical medical experimentation on humans and identified the researchers and institutions responsible. The ground-breaking text took the medical establishment by storm and provoked questions in Parliament. Brilliant, Jewish, already an outsider, Pappworth was recognised as the best medical teacher in the country. But convinced that the reason for these experiments being carried out was purely to advance the careers of ambitious practitioners, Pappworth had to speak up. In the wake of his expose, stricter codes of practice for human experimentation were put into place and the establishment of the research ethics committees was formed, which remains in place today. Maurice Pappworth's daughter, the late Joanna Seldon, re-assesses the importance of Human Guinea Pigs in her book Whistle-blower: The Life of Maurice Pappworth. She considers her father's text a major milestone in the development of current medical research ethics and demands a re-evaluation of the pioneering medical ethicist who compromised his own career in order to ensure the protection of the patient.

This book provides a practical guide for all those working in or with Medical Examiner Services in England and Wales. It is an adjunct to the e-learning and face-to-face training required to fulfil the Medical Examiner and Medical Examiner Officer roles. Medical Examiner Services also work closely with a wide range of stakeholders including bereavement and mortuary teams, Coroners and their Officers, Registrars, Funeral Directors and those working in clinical governance and patient safety. This book provides an essential overview of all aspects of the Medical Examiner system for anyone working in these areas, or in any aspect of the support and management of the deceased and bereaved. A concise guide including the knowledge base required to develop and run a Medical Examiner Service Content is completely aligned with required training Written by those with direct experience of establishing and working with Medical Examiner Services Relevant to a wide range of stakeholders who work with patients and the bereaved

This book is a philosophically-oriented introduction to bioethics. It offers the reader an overview of key debates in bioethics relevant to various areas including; organ retrieval, stem cell research, justice in healthcare and issues in environmental ethics, including issues surrounding food and agriculture. The book also seeks to go beyond simply describing the issues in order to provide the reader with the methodological and theoretical tools for a more comprehensive understanding of current bioethical debates. The aim of the book is to present bioethics as an interdisciplinary field, to explore its close relation to other disciplines (such as law, life sciences, theology and philosophy), and to discuss the conditions under which bioethics can serve as an academically legitimate discipline that is at the same time relevant to society.

As a systematic and methodologically rigorous overview, " Bioethics: Methods, Theories and Principles "will be of particular interest to academics and students in the disciplines of Law, Medicine, Ethics and Philosophy.

'This is a book that embraces neither a single ethical theory nor a pragmatic melange of just-so-principles. It is a thoughtful and engaging analysis of diverse theoretical foundations in Bioethics. It is also an enormous step towards conceptual and philosophical clarity in this fascinating area.' - Professor Christian Illies, Chair for Practical Philosophy at the Otto-Friedrich University Bamberg, Germany

Analyzing the level of claims for clinical negligence in the light of the most recent trends and discovering whether there is indeed a litigation crisis in healthcare, this book is a topical and compelling exploration of healthcare and doctor-patient relationships.

The author:

• identifies and analyzes the growing pressures on doctors in modern society, placing their role in context
• explores some of the myths surrounding media claims about malpractice
• considers the practice of 'defensive medicine' and the difference between defensive practices and sensible risk management
• examines external pressures, such as political interference with clinical practice in the form of target-setting and what might be described as a culture of creeping privatization of healthcare.

Covering the topics of medicine and the media and the causes of occupational stress among doctors, this volume is a must read for all students of medical law and medical ethics.

Your primary source for information on the legal issues of pharmaceutical practice, care, and activity Today's pharmacist is faced with legal, ethical, and moral concerns in making the transition from traditional pharmacy practice to an expanded role in clinical pharmacy and patient drug management services. Pharmacy Law Desk Reference is a primer on the legal aspects of pharmaceutical practice, providing background on foundational legal concepts, and guidance on the Food, Drug, and Cosmetic Act (FDCA), the Controlled Substances Act (CSA), and the Federal Trade Commission. This unique book examines the major topics that impact pharmaceutical care, including professional liability insurance; the need for supportive personnel in pharmacy practice; patent law, trademarks, and copyrights; law and ethics; business law; HIPAA privacy in the pharmacy; electronic prescribing; and medication error reporting. Handy tables, figures, and exhibits make complex information easy to access and understand. The better pharmacists understand the regulatory and legislative framework that shapes their practice, the better they will be able to carry out their responsibilities to patients. Pharmacy Law Desk Reference offers a broad scope on established legal subjects, the current direction of the profession, and important contemporary topics that affect the clinical role of the practicing pharmacist. Each chapter is authored by a nationally recognized authority on one or more aspect of pharmacy law and many of the contributors are active in the American Society of Pharmacy Law. Topics addressed in Pharmacy Law Desk Reference include: telepharmacy collaborative drug therapy management trade secrets and trade secret protection anti-competitive practices the threat of civil and criminal liability the Health Insurance Portability and Accountability Act of 1996 (HIPAA) FDA inspections consumer protection laws credentialing pharmacy compounding accreditation employment contracts Medicaid and Medicare controlled substance registration and prescription orders forged prescription orders and many more Pharmacy Law Desk Reference is a comprehensive resource on the professional, legal, and contemporary issues in pharmacy practice. It is a primary reference guidebook for pharmacy practitioners, leaders of state and national pharmacists associations, members of state boards of pharmacy, educators and students, and an essential addition to all pharmacy libraries.

Your primary source for information on the legal issues of pharmaceutical practice, care, and activity Today's pharmacist is faced with legal, ethical, and moral concerns in making the transition from traditional pharmacy practice to an expanded role in clinical pharmacy and patient drug management services. Pharmacy Law Desk Reference is a primer on the legal aspects of pharmaceutical practice, providing background on foundational legal concepts, and guidance on the Food, Drug, and Cosmetic Act (FDCA), the Controlled Substances Act (CSA), and the Federal Trade Commission. This unique book examines the major topics that impact pharmaceutical care, including professional liability insurance; the need for supportive personnel in pharmacy practice; patent law, trademarks, and copyrights; law and ethics; business law; HIPAA privacy in the pharmacy; electronic prescribing; and medication error reporting. Handy tables, figures, and exhibits make complex information easy to access and understand. The better pharmacists understand the regulatory and legislative framework that shapes their practice, the better they will be able to carry out their responsibilities to patients. Pharmacy Law Desk Reference offers a broad scope on established legal subjects, the current direction of the profession, and important contemporary topics that affect the clinical role of the practicing pharmacist. Each chapter is authored by a nationally recognized authority on one or more aspect of pharmacy law and many of the contributors are active in the American Society of Pharmacy Law. Topics addressed in Pharmacy Law Desk Reference include: telepharmacy collaborative drug therapy management trade secrets and trade secret protection anti-competitive practices the threat of civil and criminal liability the Health Insurance Portability and Accountability Act of 1996 (HIPAA) FDA inspections consumer protection laws credentialing pharmacy compounding accreditation employment contracts Medicaid and Medicare controlled substance registration and prescription orders forged prescription orders and many more Pharmacy Law Desk Reference is a comprehensive resource on the professional, legal, and contemporary issues in pharmacy practice. It is a primary reference guidebook for pharmacy practitioners, leaders of state and national pharmacists associations, members of state boards of pharmacy, educators and students, and an essential addition to all pharmacy libraries.

This innovative and engaging book argues that because our genetic information is directly linked to the genetic information of others, it is impossible to assert a ‘right to privacy’ in the same way that we can in other areas of life. This position throws up questions around access to sensitive data. It suggests that we may have to abandon certain intuitions about who may access our genetic information; and it raises concerns about discrimination against people with certain genetic characteristics. But the author asserts that regulating access to genetic information requires a more nuanced perspective that does not rely on the familiar language of rights. The book proposes new ways in which we may think about who has access to what genetic information, and on what basis they do so. Conceptually challenging, the book will prove engaging reading for scholars and students interested in the area of bioethics and medical law, as well as policy makers working with these pressing issues.

In Our Veterans, Suzanne Gordon, Steve Early, and Jasper Craven explore the physical, emotional, social, economic, and psychological impact of military service and the problems that veterans face when they return to civilian life. The authors critically examine the role of advocacy organizations, philanthropies, corporations, and politicians who purport to be "pro-veteran." They describe the ongoing debate about the cost, quality, and effectiveness of healthcare provided or outsourced by the Department of Veterans Affairs (VA). They also examine generational divisions and political tensions among veterans, as revealed in the tumultuous events of 2020, from Black Lives Matter protests to the Trump-Biden presidential contest. Frank and revealing, Our Veterans proposes a new agenda for veterans affairs linking service provision to veterans to the quest for broader social programs benefiting all Americans.

This text offers a comprehensive insight into the management of, and the legal, medical and financial aspects of, medical insurance claims. The co-operation of a number of major insurance companies enabled one third of all medical claims in a ten-year period to be studied.

Whether you are a doctor, nurse, student, or otherwise interested reader, the stories here will help you to understand how medicine works and how medical error can happen. The lifelong process of learning that is a medical career requires healthcare workers to find a way to live through these setbacks without either becoming too adept at putting them 'down to experience' and forgetting their social significance, or 'burning out' and leaving medicine. The stories and discussions here present detailed narratives, analyses, and reflections on medical errors through actions, omissions, and misunderstandings. They offer a uniquely honest perspective on the social implications of medical error and will enable healthcare workers at all levels to analyse and learn from it without losing sight of its impact.

This book examines the idea of a fundamental entitlement to health and healthcare from a human rights perspective. The volume is based on a particular conceptual reasoning that balances critical thinking and pragmatism in the context of a universal right to health. Thus, the primary focus of the book is the relationship or contrast between rights-based discourse/jurisprudential arguments and real-life healthcare contexts. The work sets out the constraints that are imposed on a universal right to health by practical realities such as economic hardship in countries, lack of appropriate governance, and lack of support for the implementation of this right through appropriate resource allocation. It queries the degree to which the existence of this legally enshrined right and its application in instruments such as the International Covenant on Economic, Social and Cultural Rights (ICESCR) and the Universal Declaration of Human Rights (UDHR) can be more than an ephemeral aspiration but can, actually, sustain, promote, and instil good practice. It further asks if social reality and the inequalities that present themselves therein impede the implementation of laudable human rights, particularly within marginalised communities and cadres of people. It deliberates on what states and global bodies do, or could do, in practical terms to ensure that such rights are moved beyond the aspirational and become attainable and implementable. Divided into three parts, the first analyses the notion of a universal inalienable right to health(care) from jurisprudential, anthropological, legal, and ethical perspectives. The second part considers the translation of international human rights norms into specific jurisdictional healthcare contexts. With a global perspective it includes countries with very different legal, economic, and social contexts. Finally, the third part summarises the lessons learnt and provides a pathway for future action. The book will be an invaluable resource for students, academics, and policymakers working in the areas of health law and policy, and international human rights law.

*Presents a user-friendly wealth of useable, practical, and viable malpractice solutions *Explains in-depth advice on avoiding malpractice claims and their negative consequences for doctors in every field *Offers a valuable resource of precise and practical strategies to prepare for depositions, court testimony, and a doctor's defense in the event of litigation

*Presents a user-friendly wealth of useable, practical, and viable malpractice solutions *Explains in-depth advice on avoiding malpractice claims and their negative consequences for doctors in every field *Offers a valuable resource of precise and practical strategies to prepare for depositions, court testimony, and a doctor's defense in the event of litigation

Presents a provocative look at various syndromes familiar to forensic psychologists, as applied to criminal cases and the pathology of suicide and homicide victims Provides information previously available only in the Spanish-language edition Combines the work of world-renowned experts to look at the criminal, legal, and psychological facets of various diagnoses and case examples Offers insight into the psychological state of suicide victims, considering their state of mind as a "psychological autopsy"

This book provides a practical guide for all those working in or with Medical Examiner Services in England and Wales. It is an adjunct to the e-learning and face-to-face training required to fulfil the Medical Examiner and Medical Examiner Officer roles. Medical Examiner Services also work closely with a wide range of stakeholders including bereavement and mortuary teams, Coroners and their Officers, Registrars, Funeral Directors and those working in clinical governance and patient safety. This book provides an essential overview of all aspects of the Medical Examiner system for anyone working in these areas, or in any aspect of the support and management of the deceased and bereaved. A concise guide including the knowledge base required to develop and run a Medical Examiner Service Content is completely aligned with required training Written by those with direct experience of establishing and working with Medical Examiner Services Relevant to a wide range of stakeholders who work with patients and the bereaved

This book shows how the legal systems of individual European countries protect patient autonomy. In particular, it explains the role of criminal law, that is, what criminal law protection of patient autonomy looks like on a European scale in both legal and social dimensions. Despite EU integration processes, the work illustrates that the legal orders of individual European countries are far from uniform in this area. The concept of patient autonomy here is generally in the context of the patient's freedom from unwanted medical activities: the so-called negative freedom. At the same time, in countries where there are no regulations clearly criminalising the performance of a therapeutic activity without the patient's consent, the so-called positive freedom is also discussed. The book will be a valuable reference work for academics, researchers and policy-makers working in Health Law, Medical Ethics, Applied Ethics and Criminal Law.

Is it lawful for a doctor to give a patient life-shortening pain relief? Can treatment be lawfully provided to a child under 16 on the basis of her consent alone? Is it lawful to remove food and water provided by tube to a patient in a vegetative state? Is a woman's refusal of a caesarean section recommended for the benefit of the fetus legally decisive? These questions were central to the four focal cases revisited in this book. This book revisits nine landmark cases. For each, a new leading judgment is attributed to an imagined judge, Athena, who operates within the constraints of the legal system of England and Wales. Her judgments accord with an innovative legal theory, referred to as 'modified law as integrity', and are linked as a line of precedent. The result is a re-spinning of extant judicial threads into a web of legal principles with a greater claim to coherence and defensibility than those in the original cases. The book will be of great interest to scholars and students of medical law, criminal law, bioethics, legal theory and moral philosophy.

This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit's impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.

This volume explores different models of regulating the use of restrictive practices in health care and disability settings. The authors examine the legislation, policies, inspection, enforcement and accreditation of the use of practices such as physical, mechanical and chemical restraint. They also explore the importance of factors such as organisational culture and staff training to the effective implementation of regulatory regimes. In doing so, the collection provides a solid evidence base for both the development and implementation of effective approaches to restrictive practices that focus on their reduction and, ultimately, their elimination across health care sectors. Divided into five parts, the volume covers new ground in multiple respects. First, it addresses the use of restrictive practices across mental health, disability and aged care settings, creating opportunities for new insights and interdisciplinary conversations across traditionally siloed sectors. Second, it includes contributions from research academics, clinicians, regulators and mental health consumers, offering a rich and comprehensive picture of existing regulatory regimes and options for designing and implementing regulatory approaches that address the failings of current systems. Finally, it incorporates comparative perspectives from Australia, New Zealand, the Netherlands, Germany and England. The book is an invaluable resource for regulators, policymakers, lawyers, clinicians, consumer advocates and academics grappling with the use and regulation of restrictive practices in mental health, disability and aged care contexts.

Forensic science is in crisis and at a cross-roads. Movies and television dramas depict forensic heroes with high-tech tools and dazzling intellects who-inside an hour, notwithstanding commercials-piece together past-event puzzles from crime scenes and autopsies. Likewise, Sherlock Holmes-the iconic fictional detective, and the invention of forensic doctor Sir Arthur Conan Doyle-is held up as a paragon of forensic and scientific inspiration-does not "reason forward" as most people do, but "reasons backwards." Put more plainly, rather than learning the train of events and seeing whether the resultant clues match those events, Holmes determines what happened in the past by looking at the clues. Impressive and infallible as this technique appears to be-it must be recognized that infallibility lies only in works of fiction. Reasoning backward does not work in real life: reality is far less tidy. In courtrooms everywhere, innocent people pay the price of life imitating art, of science following detective fiction. In particular, this book looks at the long and disastrous shadow cast by that icon of deductive reasoning, Sherlock Holmes. In The Sherlock Effect, author Dr. Thomas W. Young shows why this Sherlock-Holmes-style reasoning does not work and, furthermore, how it can-and has led-to wrongful convictions. Dr. Alan Moritz, one of the early pioneers of forensic pathology in the United States, warned his colleagues in the 1950's about making the Sherlock Holmes error. Little did Moritz realize how widespread the problem would eventually become, involving physicians in all other specialties of medicine and not just forensic pathologists. Dr. Young traces back how this situation evolved, looking back over the history of forensic medicine, revealing the chilling degree to which forensic experts fail us every day. While Dr. Young did not want to be the one to write this book, he has felt compelled in the interest of science and truth. This book is measured, well-reasoned, accessible, insightful, and-above all-compelling. As such, it is a must-read treatise for forensic doctors, forensic practitioners and students, judges, lawyers adjudicating cases in court, and anyone with an interest in forensic science.

This easy-to-read book explains the nuts and bolts of the Mental Capacity Act 2005 that clinicians need to understand and use in their daily practice. This Act now gives all clinicians the authority to provide medical care and treatment for people over 16 years of age who lack the capacity to consent for themselves. It covers: how to assess whether a person lacks capacity and how to clarify the threshold of decision-making incapacity; the range, scope and limitations of the various authorities to treat (including 'best interests' decisions, advance decisions and lasting powers of attorney); the range of safeguards in place (such as the Deprivation of Liberty Safeguards (DoLs), the Court of Protection and Independent Mental Health Advocates); and relevant aspects of the Human Rights Act 1998, the Mental Health Act (including all recent amendments) and illustrative case law. There have been numerous developments in case law in the two years since the first edition. The second edition expands on clinically relevant issues from the courts, and assists in bridging the gap between court judgments and the frontline clinician.

Whether you are a doctor, nurse, student, or otherwise interested reader, the stories here will help you to understand how medicine works and how medical error can happen. The lifelong process of learning that is a medical career requires healthcare workers to find a way to live through these setbacks without either becoming too adept at putting them 'down to experience' and forgetting their social significance, or 'burning out' and leaving medicine. The stories and discussions here present detailed narratives, analyses, and reflections on medical errors through actions, omissions, and misunderstandings. They offer a uniquely honest perspective on the social implications of medical error and will enable healthcare workers at all levels to analyse and learn from it without losing sight of its impact.

This book examines the legal, ethical and regulatory debates surrounding the rise of the cosmetic procedures industry. In the past, cosmetic procedures were often seen as limited to a small number of wealthy older women. Today, such procedures have gone mainstream, partly facilitated by the rise of 'non-invasive' techniques, such as the use of Botox and Dermal Fillers. While still a business dominated by the female consumer, there is also an increasing number of males undertaking cosmetic procedures as social expectations around appearance and ageing are challenged. At the same time, the rapid expansion of this business and the incoherent, diverse approach to its regulation have given rise to concern. It has been seen as a 'Wild West'. If cosmetic procedures go wrong, such procedures give rise to real risks of harm. This book examines the historical backdrop, current practice and risks associated with cosmetic procedures. It discusses the ethical and regulatory challenges for this area. It also examines the current legal frameworks concerning people, practitioners and products in the UK. The book also draws lessons from regulatory approaches in other jurisdictions with particular reference to the United States, Brazil and France. It then sets out a legal and regulatory framework that might better protect and empower the cosmetic consumer, now and in the future. The book is likely to be of particular interest to those working in the areas of health and medical law, socio-legal studies and political science.