Medical and healthcare law Books

Book SynopsisAs new medical technologies and treatments develop with increasing momentum, the legal and ethical implications of medicine are being called into question as never before. Martin Levine''s collection brings together the seminal papers written on the nexus between mental illness, its treatment and its relationship to the law. The volume also provides an informative introduction, summarizing the area and the relevance of the articles chosen.Trade Review'...an asset in any institutional library' Journal of Mental Health Law 'This tremendously important collection of international papers on the subject of mental illness, medicine and the law has never been so urgently needed.' Criminal Law News '...willl be a valuable resource in any mental health library, and a useful resource for students and clinicians from a range of disciplines.' Metapsychology Online ReviewsTable of ContentsContents: Part I The Seriously Ill: Involuntary Short-Term Treatment: Ethical benefits and costs of coercion in short-term inpatient psychiatric care, Lars Kjellin, Kristina Andersson, Inga-Lill Candefjord, Tom Palmstierna and Tuula Wallstein; Involuntary outpatient commitment, Elyn R. Saks; Treatment Rights: Ethics in community mental health care. The legislative tenets of client’s right to treatment in the least restrictive environment and freedom from harm: Implications for care providers, Douglas A. Marty and Rosemary Chapin; Privacy in psychiatric treatment: threats and responses, Paul S. Applebaum; Patient Autonomy: The right to refuse mental health treatment: a therapeutic jurisprudence analysis, Bruce J. Winick; Advance directives in psychiatry resolving issues of autonomy and competence, Janet Ritchie, Ron Sklar and Warren Steiner; Advocacy: Protection and advocacy: an ethics practice in mental health, D.P.Olsen; Ethical conflicts at the interface of advocacy and psychiatry, Martin L. Levine and Martha Lyon-Levine; The Social Construction of Madness: Psychiatry and the control of dangerousness: on the apotropaic function of the term 'mental illness', Thomas Szasz; Dangerousness, mental disorder, and responsibility, J.R. McMillan; Sanism, social science, and the development of mental disability law jurisprudence, Michael L. Perlin and Deborah A. Dorfman; Deinstitutionalization: The success of deinstitutionalization: empirical findings from case studies on state hospital closures, Aileen B. Rothbard and Eri Kuno; Build a better state hospital: deinstitutionalization has failed, Alexander Gralnick; Keeping the mentally ill out of jail, Richard Lamb; Cross-Cultural Psychiatry: Depression, somatization and the 'new cross-cultural psychiatry', Arthur M. Kleinman; Mental health law and ethics in transition: a report from Japan, Paul S. Applebaum; Psychiatric diagnosis and racial bias: empirical and interpretative approaches, Roland Littlewood; Providing cultu

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Book SynopsisCommunication problems between science and the courts are widely deplored and sometimes exploited by a variety of groups. The U.S. Supreme Court has twice tightened the law of evidence to control the flow of information, but amazingly little has been written to analyze the nature of the problem and reduce the barriers. Expert Witnesses: Explaining and Understanding Science results from the first-hand experience of the contributors-who include scientists, expert witnesses, litigators, and a judge-that the cultural and interdisciplinary communications barriers between science and the law can be greatly reduced to everybody's advantage if the parties understand and respect each other's needs and positions.Trade Review"This book will be of interest to any professionals who have been called upon to serve as an expert witness, whether it is the first or 100th litigation they have been involved in."-Journal of Environmental QualityTable of ContentsWhat Judges, Scientists, Physicians and Attorneys Ought to Know about Each Other, C. MeyerAre Jurors Smart Enough to Understand Scientific Evidence? P.M. Ayd and M.M. TroegerThe Fundamental Differences between Science and Law, R.A. BohrerThe End of Splendid Isolation: Tensions between Science and Clinical Practice, A.L. GreerExpert Testimony Involving Chemists and Chemistry, R. Bjur and J.T. RichardsonThe Role of Experts in German Environmental Law, C-P. MartensDistinguishing Good Science, Bad Science, and Junk Science, C. MeyerThe Five Dimensions of Scientific Testimony, K.M. VerdealPresenting Sophisticated Scientific Evidence Persuasively: The Role of the Scientific Expert and the Attorney at Trial, P.M Ayd and M.M. TroegerForensic Techniques for Establishing the Origin and Timing of a Contaminant Release, R.D. MorrisonUsing Epidemiology to Explain Disease Causation to Judges and Juries, L. ErdreichMedical and Scientific Evidence of Causation: Guidelines for Evaluating Medical Opinion Evidence, S.R. PoulterExplaining Toxic Chemical Risk in the Courtroom Authority, Storytelling, and Science, W. Roth-NelsonThe Role of Technical Expert Witnesses in Patent Litigation, M. Kaminski

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Book SynopsisAfter nearly a year of debate, in March 2010, Congress passed and the president signed the Patient Protection and Affordable Care Act to reform the U.S. health care system. The most significant social legislation since the civil rights legislation and the creation of Medicare and Medicaid, the bill's passage has been met with great controversy. Political pundits, politicians, health care economists, and policy analysts have filled the airwaves and the lay press with their opinions, but little has been heard from those who have the most invested in health care delivery reformpatients and their doctors.Understanding Health Care Reform: Bridging the Gap Between Myth and Reality provides readers with the information to make informed decisions and to help counter the bias of political pundits and the influence of the for-profit health care industry. The author introduces readers to a group of dedicated doctors, administrators, and patients whose experiences illusTable of ContentsIntroduction. Reforming the Private Insurance Industry. How Will Health Care Reform Affect the Medicare and Medicaid Populations? Can We Lower Health Care Costs by Eliminating Waste? The Role of Disease Prevention in Health Care Reform. How Will Health Care Reform Affect the Medically Underserved and the Safety Net Hospitals That Care for Them? How Can We Improve the Quality of Care in the United States? Will There Be Enough Doctors to Care for 35 Million New Patients? Can Research Guide Us to Improved Care at Lower Costs? How Will Health Care Reform Change the Way We Practice Medicine? Will We Ever See Tort Reform in the United States? Conclusion. Index.

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Book SynopsisThis book examines the rise of the direct-to-consumer genetic testing industry (DTC) and its use of 'wrap' contracts. It uses the example of DTC to show the challenges that disruptive technologies pose for societies and for regulation. It also uses the wrap contracts of DTC companies to explore broader issues with online contracting.

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Book Synopsis"I would highly recommend this book...It is high quality, clear and comprehensive and will no doubt prove an invaluable source of reference. Five stars on all counts." Tim Kevan, co-editor, PIBULJ.COM This book remains the only text of its kind to cover both the medical and legal aspects of medical negligence. Written by a team of more than 60 experts, it continues to provide the most comprehensive and authoritative guidance on all aspects of clinical negligence claims, from bringing an action for damages to presenting expert evidence in court. It also includes detailed consideration of funding and cost implications. Those needing clear guidance to make the best possible preparations for an action will find all they need here. The new 6th edition has been fully revised and restructured, including new chapters on the future of clinical negligence litigation, cardiology, gynaecology, obstetrics, haematology , and also includes coverage and analysis of recent key cases such as: - Williams v Bermuda Hospitals [2016] UKPC 4 (causation) - R (on the application of Maughan) v HM Senior Coroner for Oxfordshire [2020] UKSC 46 (suicide in inquests) - Darnley v Croydon Health Authority [2018] UKSC 50 (duty of care owed by receptionist) - ABC v St George's Hosp [2020] EWHC 455 (Huntington's chorea confidentiality) - Swift v Carpenter [2020] EWCA Civ 1295 (future accommodation costs) - Whittington Hospital NHS Trust v XX [2020] UKSC 14 (damages for surrogacy) - Khan v Meadows [2021] UKSC 21 (scope of duty of care) - Nguyen v HM Assistant Coroner for Inner West London [2021] EWHC 3354 (sufficiency of inquiry) Easy-to-access structure The new edition maintains its easy-to-access, two-part structure. The first part, set out in 16 chapters, deals with legal aspects of medical malpractice, including complaints procedures, poor performance and medical professional governance, preparation of medical evidence, settlements and trial. There are also chapters on product liability, and coronial law. The final 27 chapters in the second part cover the risks associated with particular areas of specialist medical practice. This title is included in Bloomsbury Professional's Clinical Negligence online service.Trade ReviewThere are certain law books that stand out as in a class of their own and this fifth edition of 'Clinical Negligence' stands tall among them... I would highly recommend this book for those practising in this area. It is high quality, clear and comprehensive and will no doubt prove an invaluable source of reference. Five stars on all counts. -- Tim Kevan * PIBULJ.COM *It retains its place as a key guide for practitioners in this area.I have been looking forward to the new edition and am notdisappointed. There is little in the field of clinical negligence that is not at least touched upon and the text either provides useful guidance (procedural or medical) or at least points in the right direction. -- Phillipa Luscumbe, Partner, PI, Penningtons * NLJ March 2016 *Table of ContentsForeword Preface Contributors Table of Statutes Table of Cases Chapter 1 Clinical Negligence Litigation: the Problem, the Solution - the Future? Chapter 2 The Law Chapter 3 Improving Safety, Reducing Harm and Subsequent Claims Chapter 4 The Role of NHS Resolution Chapter 5 Human Rights Chapter 6 Compensation Schemes Chapter 7 Funding Clinical Negligence Claims Chapter 8 The Coroner’s Inquest Chapter 9 The Duties of the Expert Witness and the Medical Expert Reporting Process Chapter 10 The Conduct of Proceedings Chapter 11 Consent Chapter 12 Limitation of Actions Chapter 13 Product Liability for Medical Products Chapter 14 Damages Awards: Lump Sums and Periodical Payments Chapter 15 Causation Chapter 16 Epidemiology and Statistics in Litigation Chapter 17 Negligence in General Practice Chapter 18 Emergency Medicine Chapter 19 Cardiology Chapter 20 Endocrinology Chapter 21 Neurology Chapter 22 Oncology Chapter 23 Psychiatry Chapter 24 Litigation in Clinical Radiology Chapter 25 Ophthalmology Chapter 26 General Surgery Chapter 27 Vascular Surgery Chapter 28 Chronic Pain Chapter 29 Anaesthesia Chapter 30 Neurosurgery Chapter 31 Spinal Surgery Chapter 32 Otolaryngology – Head and Neck Surgery Chapter 33 Orthopaedics Chapter 34 Urological Surgery Chapter 35 Cardiothoracic Surgery Chapter 36 Dental Surgery Chapter 37 Obstetrics Chapter 38 Gynaecology Chapter 39 Neonatology Chapter 40 Imaging for Perinatal and Early Childhood Neurological Problems Chapter 41 Medicolegal Issues in Haematology Index

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Book SynopsisThis book provides mental capacity practitioners with accessible ethical guidance and applicable tools for applying the Mental Capacity Act (MCA) 2005. It shows how clients' relationships can impact their capacity in positive and negative ways, and which communication skills practitioners can use to enable and empower those with impairment. It also covers how to engage in self-reflection and transparent debate about values to improve the quality of assessments. Helping practitioners interpret complex issues of mental capacity in the most beneficial way for clients, this book is essential reading for students and practitioners of law, medicine, mental health services and social care.Trade ReviewThis book grapples with the boundaries of capacity law, and the ways in which narratives themselves can empower and disempower. It is an accessibly written guide to the challenging ethical and legal questions facing social care practitioners today. -- Dr Lucy Series, Wellcome Research Fellow and Lecturer in Law, Cardiff School of Law and Politics, Cardiff University, UKThis is an extremely practical book replete with case examples and checklists of reflective questions. It is both accessible and intensely thought-provoking. The authors are two expert guides who take us on a fascinating journey through the intricacies of mental capacity law. -- Professor Penny Cooper, BSc (Hons), Barrister, PhD, Chair of The Advocate's Gateway, Council of the Inns of CourtA valuable and welcome book that focuses on the relational aspects of the Mental Capacity Act 2005; considering the individuals at the heart of best interests decision making to the practitioner, this book encourages us to all reflect on what makes us as individual human beings, what shapes us and apply that in how we engage with others.Ensuring decision makers see the person first, this book focuses on how practitioners can do just that, intertwining with existing case law, capacity assessments and ultimately best interests decision making. A valuable resource for all that work in this area. -- Jakki Cowley, Advocate & Director of Empowerment Matters, an Advocacy & Mental Capacity Act, Resource, Support & Information AgencyTable of Contents1. The legal landscape and the challenge for practitioners. 2. What is autonomy? 3. Why relationships matter. 4. Enabling and disabling narratives. 5. The ethical role of the capacity and best interests assessor. 6. Capacity and best interests: a not-so-bright line. 7. Conclusion. 8. Bibliography. 9. Appendices: theoretical resources. 10. Appendix: practical resource. 11. Statutes and cases.

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Book SynopsisTopical and compelling, this volume provides an excellent re-evaluation of the ‘best interests’ test in the healthcare arena; the ways in which it has developed, the inherent difficulties in its use and its interpretation in legal cases concerning the medical care of children.Comprehensively covering both the English and Scottish position within the context of the European Convention of human Rights and the UN Convention on the Rights of the Child, the author examines a wide range of healthcare situations, from the commonly occurring to the unusual, offering a detailed analysis of legislation, case law, cases and their implications.It includes discussions on: the extent to which a child’s body can be examined, operated on and affected by medicines, devices or procedures intended to bring about medical change the appropriate scope of parental choice and authority and at what stage of their development children should be allowed to make their own decisions the response to situations where the interests of children may be in conflict – the cases of conjoined twins or the donation of organs to siblings. This work is a key resource for postgraduates and researchers working and studying in the fields of law, healthcare and medicine. Table of Contents1. Introduction 2. Standards in Decision Making Concerning Children 3. Best Interests and Consent 4. Best Interests and Refusal 5. Best Interests between Children 6. Best Interests and Withholding/Withdrawing Treatment 7. Best Interests and Medical Research 8. Conclusions

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Book Synopsis'In the light of impending environmental catastrophe, people all over the world, in all walks of life, are becoming more aware of the pressing need to act globally. The need to base our decisions and actions less on parochial national advantage, sequestered in hate and suspicion of other nation's playing the same game of Russian roulette, have to give way to a new appreciation of the fact that our global village is indeed so very small and perilously frail. We depend upon one another as never before and, unless we insure the health and human rights of all, we shall surely each perish individually...' In "Health, Human Rights and the United Nations", Theodore H MacDonald carefully analyses the origin, development and structure of the United Nations (UN) and its key agencies, and considers its capacity to mediate the Universal Declaration of Human Rights. He takes a detailed look into human rights abuses in Sudan's Darfur province, Burma, Liberia, the Occupied Palestinian Territories and the United Kingdom. By investigating the development of the World Health Organization (WHO) and the pressures being brought to bear upon it, MacDonald exposes contradictions in the aims of both the WHO and the UN. Does the current global political scene and its neoliberal policies nullify the work of both? Is the UN fit for purpose? Can drastic reforms result in equitable solutions? Can a new trans-national body be developed, to arbitrate global trade, health, human rights and fiscal issues? This remarkable book is ideal for anyone interested in international law, human rights, global health, public health and health promotion. Public health and health promotion professionals, including international healthcare organisations, care agencies, and international charities will find the analysis enlightening. It is also of great interest to policy makers and shapers in communities and government, political activists and all those with an interest in equality and globalisation.Trade Review'Professor MacDonald provides a well-argued critique of the activities of the United Nations and the provision of primary health care throughout the world[...] Relevant to anyone working in, or with an interest in, global medicine.' MEDICAL PROTECTION SOCIETY CASEBOOKTable of ContentsOur partially paralysed United Nations. The UN and human rights. The Darfur crisis. The well-hidden regime of Myanmar. Human rights in the context of conflict. The Palestinians. Human rights violations in Great Britain. WHO mediates the global right to health? Can the UN promote WHO's objectives? Transnational advocacy and mediation.

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Book SynopsisThis book addresses a wide range of topics including: negligence; decision-making; confidentiality; the role of the nurse prescriber; the regulation of reproduction; end-oflife issues; and the contract of employment. The author draws on case law, legislation, human rights instruments, and professional standards in order to provide a holistic and detailed analysis of the topics.Table of ContentsChapter 1: Introduction Chapter 2: An Introduction to the Irish Legal System Chapter 3: The Nursing and Midwifery Board of Ireland Chapter 4: Negligent Practice in Nursing and Midwifery Chapter 5: Patient Autonomy and Decision-Making Chapter 6: Confidentiality and Access to Personal Health Information Chapter 7: The Administration of Medicines Chapter 8: Legal Aspects of Pregnancy Chapter 9: Legal Aspects of End-of-Life Treatment and Care Chapter 10: Research Ethics

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Book SynopsisAreas addressed include: maternal deaths, deaths in psychiatric care, human rights and causation issues. Other topics covered are: practice and procedure in medical inquests, evidence, documentation and pandemics/Covid-19. Medical Inquests critically assesses the pace of change of the law on coroner’s inquests and examines the case for change. The work is eagerly awaited in an area of law which is topical and specialised, yet of great public interest. This book will appeal to all sitting coroners, as well as barristers, solicitors, law students, bereaved families and all those who must interact with the coroner’s service, following a patient’s death, including doctors, nurses and hospital managers.Table of Contents• The Coroner’s Court: History and Function • The Changing Landscape: The 2019 Coroners Act • Causation and The Coroner’s Court • Practice and Procedure At Inquest Part I • Practice and Procedure At Inquest Part II • Documents At Inquest • Verdicts and Recommendations • Human Rights • Maternal Deaths • Judicial Review • Covid-19 and Major Disaster

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Book SynopsisThe articles address the key areas of legal controversy that exist in the ongoing defining of the parameters of medical negligence litigation in Ireland. Each article is presented as a response to a specific question which defines the issue that is being further clarified or has been recently resolved. These issues include: • the revised definition of the standard of care in medical negligence litigation; • the emerging understanding of a cause of action based upon informed consent; • the existence of a cause of action for nervous shock of a relative of someone who has received negligent medical care; • the existence of a cause of action for wrongful birth; • the status of blind reviews, hindsight bias and intra-observer variability in the analysis of evidence; • the test for causation as a ‘but for’ test and/or one of ‘material contribution’; • the effect of the resolution of a claim for damages upon a subsequent claim by a statutory dependant, after the death of the original claimant • the wider time limits for the institution of medical negligence proceedings; • the tolerance of issuing proceedings but not serving them in medical negligence litigation; • the effects of the statutory duty of disclosure upon the defence of medical negligence litigation; • the implications of mediation for the defence of a medical negligence action; • the constitutionality of the Personal Injuries Guidelines of the Judicial Council in so far as they establish a statutory cap upon general damages; This volume is also written as a festschrift in honour of Mr Justice Kevin Cross to mark his unique contribution to the development of the law, together with his facilitation of the hearing of cases, in this area for many years prior to his retirement as a Judge of the High Court in 2021.Table of ContentsContent Includes • Has the duty of care for medical professionals been changed by the introduction of the test of ‘the standard of approach’ into the duty of care? (Julia Best and Oisín Quinn SC) • Is there a new understanding of a cause of action based upon informed consent? (Eoghan Quinn and Luán ó Braonáin SC) • Does a cause of action arise for nervous shock through witnessing the harm caused to a family member by reason of medical negligence and if so, in what circumstances does it arise? (Hugh O’Leary and Adrienne Egan SC) • Is there a cause of action for wrongful birth? (Sophie Treacy and Timothy O’Leary SC) • Forward to the past: are the concepts of a blind review, hindsight bias and intra-observer variability now established in medical negligence litigation practice? (Ashling Gallagher and Conor Halpin SC) • Has causation in medical negligence litigation now moved from the ‘but for’ test to one of ‘material contribution’? (Anne Spillane and Eoin McCullough SC) • Are the time limits for medical negligence litigation essentially different to those which apply in personal injuries litigation? (Trinity Geddis and Richard Kean SC) • Does the resolution of a claim of a parent for damages prohibit a subsequent claim by a statutory dependant, after the death of the parent, for the loss of the free services of that parent? (Kate McCullough and Oonah McCrann SC) • Are there adverse implications for the parties in a medical negligence action in engaging in mediation prior to trial? (Fionn O’Callaghan and Sara Moorhead SC)

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Book SynopsisLaut wissenschaftlicher Studien könnten 30 bis 70 Prozent unerwünschter Arzneimittelwirkungen vermieden werden. Strittig ist, ob die Sicherheitsprobleme ausreichend an Ärzte und Öffentlichkeit kommuniziert werden. Die Beiträge des XVIII. Kölner Symposiums der "Arbeitsgemeinschaft Rechtsanwälte im Medizinrecht" schildern die rechtlichen und ökonomischen Anforderungen u.a. an die Entwicklung neuer Medikamente. Ein Arbeitsbuch für die tägliche Praxis.Table of Contents1.- Probleme der Pharmaindustrie bei der Entwicklung neuer Medikamente.- Arzneimittelsicherheit und der Umgang mit unerwünschten Nebenwirkungen.- Ethik-Kommissionen – ein Beitrag zur Arzneimittelsicherheit?.- 2.- Rechtliche Rahmenbedingungen der Arzneimitteltherapie.- Arzneimittelregress: Bezahlt der Arzt in Zukunft die Medikamente seiner Patienten? Beispiel: „Spezielle Schmerztherapie“.- Arzneimittelregress in der anwaltlichen Haftung.- Die Arzneimittelhaftung nach § 84 AMG n.F. anhand des Beispiels VIOXX ®.- 3.- Neue Aspekte der Arzneimittelhaftung.- Entscheidungen der Gutachterkommission zur Arzneimitteltherapie.- Aufklärungspflicht in der Arzneimitteltherapie aus der Sicht der Gutachterkommission.

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Book Synopsis1 Einleitung.- 2 Selbstbestimmung in Gesundheitsangelegenheiten.- 3 Vertretung i. R. d. Gesundheitssorge vor Einführung des 1358 BGB n. F..- 4 Anwendungsbereich des Ehegattenvertretungsrechts i. S. d. 1358 BGB n. F..- 5 A Ausschluss der Vertretungsberechtigung.- 6 Befugnisse des vertretenden Ehegatten.- 7 Bescheinigung nach  1358 Abs. 4 BGB n. F..- 8 Verhältnis zu (weiterhin) bestehenden Regelungen und Innenverhältnis des  1358 BGB n. F..- 9 (Rechtspolitische) Kritik an  1358 BGB n. F..- 10 Haftungs- und strafrechtliche Implikationen.- 11 Schlussbetrachtung.

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Book SynopsisThis concise, introductory handbook discusses the basic principles of medical ethics, and includes practical, realistic guidance on how to evaluate and manage common ethical problems, focusing on the care of elderly patients Typical scenarios faced in clinical practice, such as issues of mental capacity and consent, resuscitation, near death decisions, quality of life, and health care expenditure, are discussedTable of ContentsPrinciples of medical ethics; determining mental capacity and competence; informed consent; advance directives; decisions on life-sustaining therapy - nutrition and fluid; cardiopulmonary resuscitation; achieving "a good death"; the use of physical restraints; ethical issues in dementia; ethical issues in stroke management; quality of life in health care decisions; ethical issues and expenditure on health and social care.

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Book SynopsisThe general scope of the book is the patentability and morality of human embryonic stem cell research in US, EU and China. The book observes fraudsters operate unsafe human embryonic stem cell therapies and officialdom turns a blind eye to the immoral human embryonic stem cell research in China. The book highlights that both patent control and federal funding control are inefficient and ineffective way to monitoring human embryonic stem cell research. The book finally proposed an approach for china to regulating human embryonic stem cell research-regulating research itself at the reconciled international regime. The potential reader includes academics and practitioners dealing with intellectual property, patent law and stem cell inventions. The topic discussed will also be interesting to a broad readership, including experts, regulators, policy makers and medical researchers in both ethical and legal disciplines in the field of embryonic stem cell research.Table of ContentsValues of Human Embryonic Stem Cell Research, the phenomenon of “Stem Cell Tourism” and Inadequate regulation of Human Embryonic Stem Cell in China.- The Moral Maze In Human Embryonic Stem Cell Research: the moral status of human embryo and the moral source of human embryonic stem cell.- China: inconsistent moral standards of human embryonic stem cell research between patent law and practical application.- The United States: Inconsistent policies on federal funding control of human embryonic stem cell research.- The European Union: Inconsistent interpretations of moral provisions in Patent Convention addressing human embryonic stem cell research.- A proposal for controlling human embryonic stem cell research in China: regulate research itself in a reconciled human embryonic stem cell regulation at the international regime.

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Book SynopsisAnalyzes how life-and-death decision makers are selected, the interventions they weigh in on, the information they seek and evaluate, the values and memories they draw on, the criteria they weigh, the outcomes they choose, the conflicts they become embroiled in, and the challenges they face.

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Book SynopsisRemedicalizing Cannabis discovers the historical ins and outs of cannabis as a botanical product with medical applications. Addressing questions about patient access, the effectiveness of international drug control systems, and the role of expert advice, it reveals how we have arrived at the current classification of cannabis as a medical product.Trade Review"A thorough historical account of the modern cannabis debate, showing how international treaties and laws can blur the lines, resulting in cannabis being classed as both an illicit drug and a licit medicine." Greenslensblog.com

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Book SynopsisKatherine Fierlbeck and Gregory Marchildon examine public health services and coverage in Canada that predate or have developed in parallel to the Canada Health Act. Explaining their logic, operation, and internal political tensions, The Boundaries of Medicare sheds light on the challenges and opportunities facing Medicare in Canada today.Trade Review“Thoroughly exploring the complicated landscape of medical services in Canada, Fierlbeck and Marchildon offer an extremely well-researched, clear, and useful resource to health and medicine scholars and professionals. The Boundaries of Medicare is an enjoyable and unique read.” Catherine Carstairs, University of Guelph and author of The Smile Gap: A History of Oral Health and Social Inequality“An indispensable resource for policy experts, politicians, scholars, educators, and Canadians who want to know more about Medicare, the CHA, and these other systems that provide health-care coverage to Canadians. By focusing on these Medicare-straddling health services, this book invites Canadians to consider how future health-care reforms will affect certain population groups and to envision better ways of extending coverage to everyone who lives and works within Canada’s borders.” H-Sci-Med-Tech"This descriptive work presents an analysis that can be useful to health planners and related professionals, ... . Recommended. Graduate students, faculty, and professionals." Choice

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Book SynopsisExploring the history of eugenics in the U.S.Trade ReviewAs a nation with lofty ambitions, the United States has had a mixed relationship with eugenics. The first country to prohibit procreation by criminals and 'idiots' — in the state of Indiana in 1907 — today it embraces the Human Genome Project and the possibility of genetic enhancement. Law professor Paul Lombardo examines US legislation and attitudes to human selection in the past century, and the likelihood of such pressures arising again in modern genetics. * Nature *Valuable and welcome . . . * BULLETIN HISTORY OF MEDICINE *[T]here are indeed valuable lessons to be learnt from . . . this book; the editor was probably wise to confine its scope to the narrower brief of American compulsory sterilisation . . . .Nov. 2011 * Human Genetics *Valuable and welcome . . .Vol. 85.4 Winter 2011 * BULLETIN HISTORY OF MEDICINE *A noted historian of the eugenics movement, editor Lombardo has divided this book into essays . . . The final two essays are perhaps the most important, as they look at the implications for contemporary medicine and law regarding the renewed interest in 'better breeding' as a result of the Human Genome Project. . . . Recommended.October 2011 * Choice *Paul Lombardo has assembled a compelling argument for close monitoring of modern genetic policies in the Human Genome Era . . . It is essential reading. April 20, 2011 * The Internet Review of Books *Table of ContentsContentsPreface and AcknowledgmentsIntroduction: Looking Back at Eugenics / Paul A. LombardoPart 1. The Indiana Origins of Eugenic Sterilization 1. The Hoosier Connection: Compulsory Sterilization as Moral Hygiene / Elof Axel Carlson 2. The Indiana Way of Eugenics: Sterilization Laws, 1907–74 / Jason S. LantzerPart 2. Eugenics and Popular Culture 3. From Better Babies to the Bunglers: Eugenics on Tobacco Road / Paul A. Lombardo 4. "Quality, Not Mere Quantity, Counts": Black Eugenics and the NAACP Baby Contests / Gregory Michael Dorr and Angela LoganPart 3. State Studies of Eugenic Sterilization 5. From Legislation to Lived Experience: Eugenic Sterilization in California and Indiana, 1907–79 / Alexandra Minna Stern 6. Eugenics and Social Welfare in New Deal Minnesota / Molly Ladd-Taylor 7. Reassessing Eugenic Sterilization: The Case of North Carolina / Johanna Schoen 8. Protection or Control? Women's Health, Sterilization Abuse, and Relf v. Weinberger / Gregory Michael DorrPart 4. Eugenics in the Human Genome Era 9. Are We Entering a "Perfect Storm" for a Resurgence of Eugenics? Science, Medicine, and Their Social Context / Linda L. McCabe and Edward R. B. McCabe 10. Modern Eugenics and the Law / Maxwell J. MehlmanList of ContributorsIndex

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Book SynopsisAbortion in Latin America and the Caribbean is the first major book to analyze the abortion laws of the Latin American and Caribbean nations that are parties to the American Convention on Human Rights. Making use of a broad range of materials relating to human rights and abortion law not yet available in English, the first part of this book analyzes how Inter-American human rights bodies have interpreted the American Convention's prenatal right to life. The second part examines Article 4(1) of the American Convention, comparing and analyzing the laws regarding prenatal rights and abortion in all twenty-three nations that are parties to this treaty. Castaldi questions how Inter-American human rights bodies currently interpret Article 4(1). Against the predominant view, she argues that the purpose of this treaty is to grant legal protection of the unborn child from elective abortion that is broad and general, not merely exceptional.Abortion in Latin America and the CaTrade Review“There is no other academic work that I know of, in any language, that gathers together the wealth of information presented here. Abortion in Latin America and the Caribbean will be useful to any scholar interested in the law and politics of abortion and related controversies in this hemisphere.” —Paolo Carozza, author of Italian Constitutional Justice in Global Context

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Book SynopsisNursing Law and Ethics explores a variety of key legal and ethical issues in nursing practice using a thought-provoking and holistic approach. It addresses both what the law requires and what is right, and explores whether these two are always the same. The book provides an overview of the legal, ethical and professional dimensions of nursing, followed by exploration of key issues in greater depth. This edition features updated legislation and new material on patient safety. Key topics are accompanied by both a legal and an ethical perspective, covering both law and ethics Case examples throughout place concepts in a real-life context Written by experts in the field and includes contributions from leading nurses, lawyers and ethicists Accessible, relevant, and comprehensive, this title is ideal for pre- and post-registration nurses.Table of ContentsNotes on Contributors vii Preface to the Fourth Edition ix Preface to the Third Edition xi Preface to the Second Edition xiii Preface to the First Edition xiv Part One: The Dimensions 1 1 The Legal Dimension: Legal System and Method 3 John Hodgson 2 The Ethical Dimension: Nursing Practice, Nursing Philosophy and Nursing Ethics 22 Alan Cribb 3 The Regulatory Perspective: Professional Regulation of Nurses and Midwives 34 Fiona Culley and Anupama Thompson 4 The Complaints Dimension: Patient and Family Complaints in Health Care 51 Peter Walsh 5 The Policy Dimension: Moving Beyond the Rhetoric Towards a Safer NHS 68 John Tingle Part Two: The Perspectives 99 6 Negligence A The Legal Perspective 101 Charles Foster B An Ethical Perspective – Negligence and Moral Obligations 118 Harry Lesser 7 Consent and the Capable Adult Patient A The Legal Perspective 128 Jean McHale B An Ethical Perspective – Consent and Patient Autonomy 151 Bobbie Farsides 8 Responsibility, Liability and Scarce Resources A The Legal Perspective 166 Tracey Elliott B An Ethical Perspective – How to Do the Right Thing 192 David Seedhouse 9 Mental Health Nursing A The Legal Perspective 201 Leon McRae B An Ethical Perspective – Compulsion and Autonomy 235 Harry Lesser 10 The Critically Ill Patient A The Legal Perspective 249 Jo Samanta B An Ethical Perspective 271 Robert Campbell 11 Clinical Governance A The Legal Perspective 286 Vanessa L. Mayatt B An Ethical Perspective 304 Lucy Frith 12 Clinical Research and Patients A The Legal Perspective 320 Natasha Hammond-Browning B An Ethical Perspective – Nursing Research 358 Richard Ashcroft 13 The Elderly A Older People and Nursing Care 368 Jonathan Herring B Person-Centred Care, Personal Identity and the Interests of People with Dementia 394 Michael Dunn Table of Cases 401 Table of Statutes 410 Index 413

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Book SynopsisAre you alive? Most people believe that some law defines our status as living (or not) for all purposes. But Foley shows that “not being dead” isn’t necessarily the same as being alive, in the eyes of the law. The need for more organ transplants and conservation of health care resources is exerting pressure to expand the legal definition of death.Trade ReviewFoley’s book is essentially a primer or textbook on these legal issues of life and death, suitable for ethicists interested in learning about the law and for lawyers interested in learning about ethics… Foley ably lays out the moral arguments and legal disputes, and persuasively criticizes poorly reasoned judicial opinions. -- Eric Posner * New Republic online *Foley presents a profoundly intelligent, distinctive, and disturbing book. In seven short chapters, she dissects the legality behind what makes a person alive or dead… This work will be appreciated by legislators, serious readers, and legal and medical professionals. -- Harry Charles * Library Journal *Elizabeth Price Foley takes us on an agile and insightful romp through the briar patch of state and federal laws governing medical practice at the beginning and end of life. American politics is mired in legal debates over the limits of life and death practices, including embryo research, abortion, transplantation, treatment termination, suicide, and, most recently, ‘death panels.’ The Law of Life and Death deserves close attention from anyone trying to understand why lawyers have more influence than physicians on birth and death. -- George J. Annas, author of Worst Case Bioethics

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Book SynopsisDemocrats and Republicans fight endlessly over health care, but neither side disputes one of the system’s most basic flaws: the foisting on patients of substantial costs through deductibles, copayments, and coinsurance. Marshalling a decade of research, Christopher Robertson shows why this model is dysfunctional and offers ideas for improvement.Trade ReviewRead this important and timely book. Then send it to every politician and health policy wonk you know. Your financial solvency and health depend on their learning what this book teaches. -- Arthur L. Caplan, NYU Langone Medical CenterA masterful forensic dissection of the self-imposed plague of health care financing, and options for potential cures. A must-read for all health care students, leaders, and elected officials. -- Richard Carmona, 17th Surgeon General of the United StatesIn this sweeping and superb book, Robertson exposes the dark side of an appealing American narrative: that giving insured patients ‘cost-sharing’ responsibilities is good for us all. Exposed reveals that doing so creates problems much bigger than the one it aims to solve. -- Michelle M. Mello, Stanford Law SchoolExposed forcefully and persuasively demolishes the shibboleth that the so-called ‘cost-share’ elements of insurance in the U.S. cut costs and improve healthcare decisions and outcomes. A must-read for anyone interested in making sense of the morass of U.S. healthcare. -- George Loewenstein, Carnegie Mellon UniversityA powerful argument against patient cost-sharing. Through extensive data, international experiences, and a deep dive into theory and philosophy, Exposed convincingly demonstrates that charging sick people is not only a blatantly unfair practice, but one that also has little financial benefit and risks further health impairment. -- Thomas Rice, UCLA Fielding School of Public HealthAn important addition to a debate that is sure to be front and center in the 2020 elections. -- Glenn Altschuler * Florida Courier *Compassionate, timely, content heavy, and incredibly well written…After reading it, one hopes that Robertson, one of the true expert voices in health law and policy, continues engineering creative ideas for years and years to come. -- Isaac D. Buck * Journal of Legal Medicine *

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Book SynopsisDelivering Policy explores how the tension between science and politics shaped the long and fraught path to Canada’s Assisted Human Reproduction Act.Trade ReviewIn Delivering Policy, Francesca Scala provides a comprehensive, fascinating and well-written study of the evolution of assisted reproductive technology policies in Canada. Through the concept of boundary work, Scala demonstrates how different actors – scientists, policy-makers, activists - have attempted to challenge, blur or reinforce the boundary between science and politics since the appointment of the Royal Commission on New Reproductive Technologies in 1989. Weaving a detailed analysis of policy documents with engaging testimonies from participants in those debates, the book ultimately presents a nuanced and persuasive account of the impact of discursive strategies and the broader political and institutional contexts. -- Prize Jury, 2020 Donald Smiley PrizeTable of Contents1 Politics, Science, and ARTs Policy in Canada2 Normalizing and Resisting Assisted Reproductive Technologies: Canadian and Comparative Perspectives3 Claiming and Contesting Epistemic Authority: The Royal Commission on New Reproductive Technologies4 Science and the Public Weigh In: The Discursive Terrain of ARTs Policy Making5 “Proceed with Care”: (Re)negotiating the Science/Politics Divide6 Setting Boundaries and Crafting ARTs Legislation7 Science, Boundary Work, and Parliamentary Politics: The Passing of Bill C-68 Understanding Boundary Work and ARTs Policy in CanadaNotes; References; Index

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Book SynopsisDelivering Policy explores how the tension between science and politics shaped the long and fraught path to Canada’s Assisted Human Reproduction Act.Trade ReviewIn Delivering Policy, Francesca Scala provides a comprehensive, fascinating and well-written study of the evolution of assisted reproductive technology policies in Canada. Through the concept of boundary work, Scala demonstrates how different actors – scientists, policy-makers, activists - have attempted to challenge, blur or reinforce the boundary between science and politics since the appointment of the Royal Commission on New Reproductive Technologies in 1989. Weaving a detailed analysis of policy documents with engaging testimonies from participants in those debates, the book ultimately presents a nuanced and persuasive account of the impact of discursive strategies and the broader political and institutional contexts. -- Prize Jury, 2020 Donald Smiley PrizeTable of Contents1 Politics, Science, and ARTs Policy in Canada2 Normalizing and Resisting Assisted Reproductive Technologies: Canadian and Comparative Perspectives3 Claiming and Contesting Epistemic Authority: The Royal Commission on New Reproductive Technologies4 Science and the Public Weigh In: The Discursive Terrain of ARTs Policy Making5 “Proceed with Care”: (Re)negotiating the Science/Politics Divide6 Setting Boundaries and Crafting ARTs Legislation7 Science, Boundary Work, and Parliamentary Politics: The Passing of Bill C-68 Understanding Boundary Work and ARTs Policy in CanadaNotes; References; Index

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Book SynopsisScience and technology are advancing more rapidly than regulations or the law can interpret and integrate them into a supportive or regulatory framework. This book is written for all clinicians in the neurosciences specialties who need to examine and re-examine the ethical and legal implications of advances in clinical neurosciences. Trade Review"Medical, ethical and legal issues interact acutely in neurological patients, and Dr. Szalados’s book on these issues is vital reading for the administrators, nurses, physicians, lawyers and ethicists who care for them." -- Denham Ward * M.D., Ph.D. *Table of ContentsDisclaimer Dedication Preface I. Morality, Ethics, and the Law: An Overview of the Foundations of Contemporary Clinical Ethical Analysis II. Case Studies: Ethical and Legal Challenges in the Care of the Neurologically Injured Critically Ill Patient III. Civil Law and Liability: The Law of Medical Malpractice IV. Legal Reasoning, Legal Process, Legal Proof and Why it is Confusing to Clinician Scientists V. Regulatory Law and the Clinical Practice of the Neurosciences VI. Digital Medicine and the Data Revolution Managing Digital Distraction and EMR Liability While Leveraging Opportunities in Teleneurology and Telecritical Care VII. Developing and Leading a Sustainable High Reliability High Performing Unit: Theories of Quality, Teamwork, Medical Error and Patient Safety VIII. Neurolaw and the Integration of Neuroscience, Ethics, and the Law: The New Frontiers IX. Conclusions and Afterword Acknowledgements About the Author Index

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Book SynopsisPersonal rights, such as the right to procreate - or not -and the right to die generate endless debate. This book maps out the legal, political, and ethical issues swirling around personal rights.Trade ReviewIn this truly fascinating and spellbinding work, Ball tells many tales. * Choice *A wonderful book dealing with personal issues each of us as individuals may face. Well-written and absorbing reading with numerous case studies that rely on materials and insider accounts from the private papers of the justices, this is a book for the general public and specialists alike to savor. -- Sheldon Goldman,University of Massachusetts, Amherst...A thorough summary of the trajectory of current case law on the legal regulation of U.S. citizens' intimate lives. . . . A valuable introduction to increasingly important and salient legal questions about the constitutional limits on the state's ability to shape intimate lives in the United States. * Political Science Quarterly *Despite the controversial content of many of the cases, Mr. Ball maintains an air of bemused detachment and does not openly take sides. This is not a polemic. With few exceptions, the prevailing tone is light and scholarly. The goal is to illuminate, not to persuade. * New York Law Journal *...A worthy assessment of the law of intimate association and personal decision-making. For those intrigued by the Court's human side, Ball provides a sufficient glimpse without raising the curtain on its realm of privacy that the justices have strived to protect. * Trial *Table of Contents1 "Fundamental" Rights versus State Interests: The Balancing Process 2 Marriage and Marital Privacy 3 The "Rhapsody of the Unitary Family" 4 Motherhood or Not, That Is Her Decision 5 Raising the Child: "Father Knows Best"? 6 "Let Me Go!": Death in the Family 7 Family and Personal Privacy in the Twenty-First Century

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Book SynopsisThis book examines informed consent to psychoanalysis. It reviews the law. It examines informed consent as a theoretical matter: e.g., is it possible, is it countertherapeutic? It reports on a survey of analysts. The goal is to shed psychoanalytic light on a concept which has changed the delivery of healthcare.Trade Review"An important and well-designed study. Saks and Golshan have described a new, uncharted field of inquiry: how standards of 'informed consent' might bear on -- and matter within -- psychoanalytic treatment. Their book intelligently frames a variety of new practical questions." -- -Martin Stone Cardozo Law School "Professors Elyn Saks and Shahrokh Golshan have given us a fascinating and eye-opening account of the legal, theoretical, and empirical dimensions of informed consent to psychoanalysis." -- Anne Dailey, University of Connecticut School of Law -Journal of the American Psychoanalytical Association

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Book SynopsisThe expert chapters focus on patents as well as an array of regulatory instruments, including pricing and drug registration policies.Trade Review‘. . . this book will appeal strongly to a wide range of professionals, academics and students with interest in and involvement in public health issues worldwide, specifically the pharmaceutical industry. . . the book is timely, topical, and packed with carefully researched information which puts a number of major issues relating to pharmaceuticals in perspective. Of great value to researchers are the copious footnotes and extensive bibliographies which follow most of the articles. . . this book certainly provides you with an impressive mine of information if you find yourself having to argue your corner on any number of legal, economic and ethical issues in this complex field of study.’ -- Phillip Taylor MBE and Elizabeth Taylor, The Barrister Magazine‘Since the 1970s the pharmaceutical industry has undergone significant changes in its research and development paradigm, trade and production. Regulatory frameworks have also changed substantially, particularly in the area of intellectual property rights. This book provides much needed empirical evidence on the impact of these and other changes on the pharmaceutical sector and on access to medicines in developing countries. The studies, conducted with a common methodology, on nine developing countries (including major producers of pharmaceuticals such as China and India) and on Canada, make an outstanding contribution to the literature in the field. The data and analysis in the book are of immediate interest to policy makers and to scholars in various fields, including innovation economics, industrial policy, health systems and intellectual property.’ -- Carlos Correa, University of Buenos Aires, Argentina‘This impressive collection offers fascinating new perspectives on the impact of pharmaceutical patents on access to medicines in developing countries. The volume’s editors have put together an important book that sets out clearly the challenges to public health in a wide range of national contexts. The book will be a valuable text for all scholars and decision-makers interested in the global politics of intellectual property rights and public health.’ -- Duncan Matthews, Queen Mary, University of London, UKTable of ContentsContents: 1. Globalization, Intellectual Property Rights, and Pharmaceuticals: Meeting the Challenges to Addressing Health Gaps in the New International Environment Kenneth C. Shadlen, Samira Guennif, Alenka Guzmán and N. Lalitha 2. Pharmaceutical Production and Access to Essential Medicines in South Africa Heinz Klug 3. Intellectual Property and Access to Medicines: Paradoxes in Moroccan Policy Gaëlle Krikorian 4. The Invisible Threat: Trade, Intellectual Property, and Pharmaceutical Regulations in Colombia Tatiana Andia 5. The Challenges of Constructing Pharmaceutical Capabilities and Promoting Access to Medicines in Mexico under TRIPS Alenka Guzmán 6. Corporate Power and State Resistance: Brazil’s Use of TRIPS Flexibilities for its National AIDS Program Matthew Flynn 7. The Politics of Patents and Drugs in Brazil and Mexico: The Industrial Bases of Health Policies Kenneth C. Shadlen 8. Pharmaceutical Patent Policy in Developing Countries: Learning from the Canadian Experience Jean-Frédéric Morin and Mélanie Bourassa Forcier 9. Access to Indian Generic Drugs: Emerging Issues N. Lalitha 10. Sufficient but Expensive Drugs: A Double-Track System that Facilitated Supply Capability in China Mariko Watanabe and Luwen Shi 11. Access to Essential Drugs in Thailand: Intellectual Property Rights and Other Institutional Matters Affecting Public Health in a Developing Country Samira Guennif 12. The TRIPS Agreement and Health Innovation in Bangladesh Padmashree Gehl Sampath Index

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Book SynopsisThis book examines the potential of litigation as a strategy to advance the right to health by holding governments accountable for these obligations. It asks who benefits both directly and indirectlyand what the overall impacts on health equity are. Included are case studies from Costa Rica, South Africa, India, Brazil, Argentina and Colombia.

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Book SynopsisThis seminal book delivers an international examination of the duty of medical confidentiality and a patientâs right to privacy in the face of contemporary threats such as cyber-security, patient autonomy, and the greater reliance on telemedicine post Covid-19 pandemic.Trade Review‘In an era where our health data is increasingly collected, shared, and exploited by a variety of actors—including, at times, without our knowledge or consent—Vansweevelt and Glover-Thomas offer a timely international comparative overview of how privacy and medical confidentiality are protected and promoted in healthcare, and how to attain an effective balance of interests between patients and medical professionals, and wider public interests. This is a must-read for all health privacy law scholars.’ -- Edward S. Dove, University of Edinburgh, UKTable of ContentsContents: Foreword viii 1 Introduction: privacy and medical confidentiality in healthcare 1 Thierry Vansweevelt and Nicola Glover-Thomas 2 Privacy and health in Belgium 5 Thierry Vansweevelt, Nils Broeckx and Filip Dewallens 3 Privacy and health in Canada 24 Emily Baron and Trudo Lemmens 4 Privacy and health in Germany 55 Benedikt Buchner 5 Japanese law of privacy and health 72 Eiji Maruyama 6 Privacy and health in the Nordic countries 91 Mette Hartlev 7 Data protection, privacy, and confidentiality in Qatar’s health system 114 Barry Solaiman 8 Privacy, medical confidentiality, and health in Tanzania 140 Ferdinand Marcel Temba 9 Patient confidentiality rules in South Africa: a legal and ethical perspective 164 Sylvester C. Chima 10 Patient privacy and health information confidentiality in the United States of America 241 Stacey A. Tovino 11 The obligation of medical confidence in the UK 271 Nicola Glover-Thomas 12 Comparative conclusions: towards a global vision of privacy and medical confidentiality? 293 Thierry Vansweevelt and Nicola Glover-Thomas Index 304

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Book SynopsisHelps you develop your skills and confidence in approaching everyday medical ethics and legal issues - from consent to capacity and confidentiality. This title provides a practical approach to common ethical and legal issues.Trade Review“Despite being written for doctors, this is a useful reference for all healthcare professionals and students on the everyday legal issues they may face in their work.” (Nursing Management, 21 August 2013)Table of ContentsMedical Ethics Committee xvii List of case examples xix Preface xxiii 1 A practical approach to ethics 1 Does medical ethics help and how? 2 Key terms and concepts 2 Professionalism 4 Duties and rights 5 The public interest 5 Medical law and healthcare law 6 Statute and common law 6 Human rights law 7 Quasi (or soft) law 8 Ethical decision making 9 Approaching an ethical problem 10 The BMA’s approach 11 Recognise that a dilemma exists 11 Dissect the problem 13 Do you need more information? 13 Identify and apply relevant legal or professional guidance 13 Analyse the facts 14 Can you justify the decision with sound arguments? 15 A final word on problem solving 15 References 16 2 The doctor–patient relationship 17 Setting the scene 17 Responsibilities for patients and the duty of care 18 The duty of care 19 Independent assessors 21 Professionals with dual obligations 22 Continuity of care and patients’ rights to change 22 Delegation of tasks and referral of patients 23 Patient autonomy and choice 24 Managing patients’ expectations 24 Do patients have choices about who provides care? 24 Rights of homeless people, detainees and asylum seekers 25 Can patients insist on having the drugs they prefer? 25 Do patients have the right to a second opinion? 26 Patients’ rights to combine NHS and private care 26 Patients’ rights to reject medical advice 27 What are the rights of patients who are violent or misuse services? 28 Patients’ rights to complain 28 Truth-telling and good communication 29 Giving bad news 29 Telling patients about unfunded treatments 31 Reporting mistakes and telling patients about them 32 Keeping patients’ trust 34 Managing confl icts of interest 34 Conflicts when commissioning services 35 Payment for referrals or recommendations 36 Accepting gifts and bequests 36 Covert medication 37 Recording consultations 38 Covert recording and surveillance 38 Chaperones and accompanying persons 39 Intimate examinations 40 Recognising boundaries 41 Managing personal relationships with patients 41 When a friendship becomes inappropriate 42 Intimate relationships 43 Use of social media 44 Health professionals acting as witnesses to legal documents 46 Advance decisions about medical treatment 46 Acting as a legal advocate for a patient 46 Firearms certifi cates 47 Health professionals’ personal beliefs 47 Conscientious objection 49 Breakdown of the doctor–patient relationship 50 Limits or boundaries on advertising services 51 Treating oneself, friends and family 52 Self-diagnosis and treatment 52 Treating family or close friends 53 Staff who are also patients 53 Providing a safe service 54 Whistle-blowing 54 Emergency situations 55 Ensuring competence in daily practice 56 Locums, out-of-hours services and arranging medical cover 57 Vetting and barring 57 Students, shadowing and work experience 59 Writing references for colleagues 59 A last word on the doctor–patient relationship 60 References 60 3 Consent, choice and refusal: adults with capacity 65 Setting the scene 65 The importance of information 67 Offering information for contemporaneous and advance decisions 67 Translation and signing services 69 What type of information? 70 Information to make an advance decision 71 Information about participating in a research project 72 How much information? 72 The duty to warn about risks 73 Can information be withheld? 76 Can patients refuse information? 77 Refusal of treatment 78 Seeking consent 80 Who should seek the patient’s consent? 80 What type of consent or refusal is valid? 81 Implied decisions and explicit or express decisions 81 Written and verbal decisions 82 Voluntary and pressured decisions: Do patients mean what they say? 82 Undue influence 82 Cultural influences 85 The influence of incentives 85 Documenting the decision 86 Documenting consent 86 Documenting refusal 86 Documenting views about future medical treatment 87 Advance requests 88 Advance decisions refusing treatment: The law in England and Wales 89 Advance refusals in Scotland 91 Advance refusals in Northern Ireland 91 Implementing the decision 91 Does having consent mean the procedure must proceed? 91 A last word about patient consent and refusal 92 References 92 4 Treating adults who lack capacity 96 Setting the scene 96 The law concerning treatment and non-treatment of adults lacking capacity to consent 98 General legal principles across the UK 98 England and Wales 99 Scotland 99 Certificate of incapacity and the general authority to treat 99 Common law in Northern Ireland 100 Assessing patients’ capacity 101 What is mental capacity? 101 How is it assessed? 102 What factors indicate capacity? 102 What factors indicate impaired capacity? 103 Fluctuating capacity 104 Who should assess capacity and when? 105 Providing care and treatment for adults lacking mental capacity 106 Best interests and benefit for patients 106 Exceptions to best interests 107 Involving people close to the patient 107 Best interests and covert medication 108 The role of proxy decision makers 108 Power of attorney in England and Wales 108 The power to make health and welfare decisions 109 Disputes arising in relation to LPAs 110 Court-appointed deputies (England and Wales) 110 Independent mental capacity advocates (IMCAs) (England and Wales) 110 The role of IMCAs in decisions to withhold or withdraw serious medical treatment 111 The role of IMCAs in decisions about where patients should live 111 Attorneys and guardians in Scotland 111 Resolving disputes (Scotland) 113 Decisions needing special safeguards 113 Giving treatment with serious implications 113 Withholding treatment with serious implications 115 Taking legal advice and involving the courts 116 The Official Solicitor (England and Wales) 116 Withholding or withdrawing life-sustaining treatment 117 Clinically assisted nutrition and hydration 118 Safeguards for participation in research 120 Dementia research 120 Emergency research 121 Control, restraint and deprivation of liberty 121 Deprivation of Liberty Safeguards 124 England and Wales 124 Scotland 124 Northern Ireland 125 The difference between protection, restraint and deprivation of liberty 125 A last word on caring for adults who lack capacity 126 References 127 5 Treating children and young people 131 Setting the scene 131 Consent to examination and treatment 132 Competence to consent to or refuse treatment or examination 133 Consent or refusal on behalf of babies and young children 133 Parental responsibility 134 Best interests 134 Disagreements between people with parental responsibility 137 Refusal by people with parental responsibility 137 Involving older children in decisions 138 Unaccompanied minors 139 Confi dentiality 139 Assessing competence in children and young people 140 Competence to consent 141 Competence to refuse 143 Consent and refusal by competent young people 143 Consent 143 Refusal 144 Research involving children and young people 147 Parental consent or refusal for children and babies 147 Assent from children who lack competence 148 Consent or refusal by competent children and young people 148 Emergency research involving children and babies 149 Availability of research and trial data 149 Consent and refusal in exceptional circumstances 149 Male infant circumcision 149 Serious difference of opinion between parents and health professionals 150 Paternity testing 151 Consent to testing 151 Refusal of testing 151 Testing and best interests 152 Advance decision making 152 Using restraint to provide treatment 152 Refusal of medical or psychiatric examination under the Children Act 1989 153 Child protection 153 Confidentiality and disclosure of information about abuse or neglect 157 Advisory services and involving the courts 159 A last word on treating children and young people 160 References 160 6 Patient confidentiality 165 Setting the scene 165 What is confidential? 167 Identifiable data 168 Anonymised data 168 Pseudonymised data 169 Keeping information secure 170 Informing patients about possible uses of their health information 171 The law on confidentiality and disclosure 172 The common law protecting confi dentiality 172 Data Protection Act 1998 172 Health and Social Care Act 2012 (England) 173 The NHS Future Forum and the review of information governance 174 Statutory disclosures 174 Statutory restrictions on disclosure 175 Human Rights Act 1998 (UK-wide) 176 NHS Act 2006 (England and Wales) 177 Comparable arrangements in Northern Ireland 178 Comparable arrangements in Scotland 178 Computer Misuse Act 1990 (UK-wide) 178 Use of patient information for purposes directly related to care 178 Consent by patients with capacity 178 Sharing information with other health professionals 180 Sharing information with relatives, parents and patients’ friends 181 Sharing information for social care 181 Leaving phone messages for patients and texting them 182 When adults lack capacity 182 Sharing information to invoke a Lasting Power of Attorney (LPA) 182 Sharing information with other proxy decision makers 183 Information sharing when children lack competence 183 Uses of patient information for purposes indirectly related to care 184 Secondary uses of data 184 Clinical audit 185 Financial audit and other healthcare management purposes 185 Commissioning agencies’ use of patient information 186 Teaching 187 Medical research 187 Public health 188 Disclosures unrelated to health care 189 Employment, insurance, immigration and social benefits 189 Reports to insurers and employers 189 Disclosure to government departments 190 Disclosure to the driver and vehicle licensing agency (DVLA) 190 Releasing health information to the media 190 Disclosures to identify and address poor health care 191 Patient complaints 191 Involving elected representatives 192 Whistle-blowing about substandard care 192 Disclosure to agencies monitoring standards 192 Disclosure requested by regulatory bodies 193 Disclosures related to crime prevention, detection or prosecution 193 Disclosure to the police and investigatory agencies 193 Gunshot and knife wounds 195 Domestic violence 195 Abuse of vulnerable adults and minors who lack capacity 196 Disclosure to courts and tribunals 196 Disclosure to solicitors 197 Disclosures in the public interest 198 The confidentiality owed to deceased patients 201 Factors to consider before disclosure 201 The needs of the bereaved 202 The interests of justice 202 Investigations by a coroner or procurator fiscal 203 Access to records in relation to claims 203 Freedom of Information Act 2000 203 A last word on confidentiality 204 References 204 7 Management of health records 211 Setting the scene 211 Defining medical records 212 Manual and electronic patient records 212 Images 213 Visual and sound recordings 213 Patients who lack capacity (including children) 214 Recording telephone calls 214 Making a health record 215 What to include in the record 215 Standardising hospital records 215 Recording discussion with patients and noting their wishes 216 Aggressive or threatening behaviour 216 What to exclude from the record 216 Records made and shared by several professionals 217 National summary records 218 Changing medical records or adding to them 218 Disputes about accuracy 218 Patient requests to omit or remove some information 218 Altering or tampering 219 Adding information later to the record 219 Adding or removing information when the record is shared 220 Transsexual patients 220 Adopted patients 220 Tagging records 221 Primary and secondary uses of records 221 Primary uses of records 221 Secondary uses of records 221 Secondary uses of children’s records 222 Using material in publications or other media 222 Giving access to patient records and reports 223 Ownership of records 223 NHS records 223 Private records 224 Access by patients 224 Information which should not be disclosed 225 Access by solicitors 226 Access by people other than the subject 226 Access to the records of children and young people 227 Access to the records of incapacitated adults 228 Access to the records of deceased persons 228 Access to reports for insurance or employment 228 Security of data 229 The obligation to protect identifi able data 229 Records management policies 230 Transmission of information 231 By fax 231 NHSmail 231 Transfer of information within the NHS 231 Transfer of GP records 232 Sending information abroad 232 Retention and destruction of records 233 Accessing records after the duty of care has ended 233 Recommended retention times 233 Disposal of manual records 235 Storing and disposing of recordings 235 A last word about records management 235 References 236 8 Prescribing and administering medication 241 Setting the scene 241 Talking to patients and obtaining consent 242 Giving information about a prescription 242 Concordance/medicines adherence 243 Taking account of patients’ values and religion 244 Prescribing placebos 244 Pressure from patients 245 Patients’ requests for complementary and alternative medicines (CAMs) 246 Requests for repeat prescriptions 247 ‘Lifestyle drugs’ 249 Choosing the right product for the patient 250 Responsibility for prescribing 250 Clinical freedom 250 Prescribing errors 251 Pressure from employers 252 Complying with official guidance 253 NICE (England and Wales) 253 Comparable arrangements for technology evaluation in Scotland 254 Arrangements for technology appraisals in Wales 254 Arrangements for technology appraisals in Northern Ireland 255 Prescribing and monitoring resources 255 ‘Topping up’ NHS treatment 256 Generic prescribing 256 Drug switching 257 Off-label prescribing and unlicensed drugs 257 Prescribing drugs off-label to save money 258 Reporting adverse drug reactions and adverse incidents 259 Shared prescribing and continuity of care 259 Prescribing shared between different doctors 260 Prescribing shared between primary and secondary care 260 Prescribing shared between the NHS and the private sector 261 Patient group directions (PGDs) 261 Prescribing shared between doctors and other health professionals 262 Supplementary prescribing and independent non-medical prescribers 262 Prescribing shared with practitioners of complementary therapies 263 Continuity of care 263 Exchange of information between doctors in referrals and discharge summaries 263 Prescribing for people at a distance – internet, email or telephone 264 Prescribing for patients abroad 266 Prescription-only medicines on the internet 266 Prescribing for different patient groups 267 Controlled drugs and prescribing for addicts 267 Prescribing strong opioids for pain in adult palliative care 269 Use of opioids and the principle of double effect 269 Prescribing for older people 270 Involving older people in concordance 270 Over-medication of older people 271 Prescribing for children 272 Prescribing for oneself, friends or family 272 Conflicts of interest 273 Financial interests in health-related products or services 273 Ownership of pharmacies 274 Dispensing doctors 274 Gifts and hospitality from pharmaceutical companies 274 Participation in market research 276 Administering medication 276 Following guidance and protocols 277 When medication needs special safeguards 277 Covert medication 278 Patients with capacity 278 Patients who lack mental capacity 279 A last word about prescribing and administering medicine 279 References 280 Index 287

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Book Synopsis

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Book SynopsisThis book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research.Trade Review “Clinical Research and the Law” provides thoughtful and practical information on a broad range of legal topics related to clinical research, with an emphasis on subject injury liability. The book is useful for anyone who is not an expert in a particular area of law, with numerous citations for further investigation.” (Journal of Clinical Research Best Practices, 1 October 2012) Table of ContentsPreface, ix Chapter 1: Research malpractice and negligence, 1 1.1 Background, 1 1.2 Drugs: brief description of definitions, 4 1.3 Brief overview: conduct of clinical trials, 5 1.4 Medical devices, 6 1.5 Research malpractice: the basics, 7 1.6 Negligence actions and research: interesting aspects of medical research negligence cases, 8 Chapter 2: Duty of care: understanding the legal differences between medical treatment and medical research, 23 2.1 Establishing duty of care, 23 2.2 Do sponsors have a legal duty?, 27 Chapter 3: Establishing standard of care and violation of standard of care, 33 3.1 Research malpractice and using expert testimony to establish the standard of care, 34 3.2 Lessons learned from surgical innovation cases, 35 3.3 Standard of care and informed consent cases, 36 Chapter 4: Informed consent in clinical research, 37 4.1 Basics on informed consent in the clinical treatment setting: background, 37 4.2 Informed consent as applied to the research setting, 40 4.3 Informed consent and federal regulations, 42 4.4 Case law and federal regulations, 43 4.5 Clinical trials and pediatric patients, 46 Chapter 5: Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs), 55 5.1 Liability for negligence, 56 5.2 Standard of care, 57 5.3 Proximate cause and damages, 59 5.4 Defense, 60 5.5 Practical considerations: the need for indemnification, 62 5.6 Special considerations for DSMBs, 62 Chapter 6: Legal aspects of financial conflicts of interest in clinical trials, 65 6.1 Overview, 66 6.2 Legislative background: road to creating financial conflicts of interest, 68 6.3 Financial conflicts of interest: evidence that financial conflicts of interest are problematic, 69 6.4 Regulations/legislation, 70 6.5 Litigation involving financial conflicts of interest in clinical trials, 74 6.6 Applying novel legal theories to financial conflicts of interest cases, 79 6.7 Other clinical trial cases involving financial conflicts of interest claiming constitutional violations, 81 Chapter 7: Disclosure of clinical trial information: legal ramifications of withholding study results, 87 7.1 GlaxoSmithKline, 89 7.2 Vioxx and Merck, 91 7.3 Government and other clinical trial disclosure requirements, 97 7.4 Medical journal editors and disclosure of clinical trial information, 98 Chapter 8: Clinical trials and insider trading, 105 8.1 Purpose of insider trading laws, 105 8.2 Proving insider trading, 106 8.3 Penalties, 108 8.4 Insider trading cases and clinical trials, 108 8.5 Beware: investigators and relationships with the investment industry—a risk of recent vintage, 111 8.6 Setting the stage, 113 Chapter 9: Clinical trials and criminal law, 117 9.1 How clinical trial investigators have been implicated in criminal acts, 119 9.2 False Claims Act cases and health-care fraud, 120 9.3 Clinical trial False Claims Act cases, 122 9.4 Enforcement of the False Claims Act against institutions, 130 9.5 Anti-kickback law, 132 9.6 Health-care fraud, 138 9.7 Mail and wire fraud/making false statements to government officials, 141 9.8 Proposed new FDA rule, 143 Chapter 10: Clinical trial contracts, 145 10.1 Key terms/scope of study, 146 10.2 Costs/payments, 147 10.3 Data, 147 10.4 Intellectual property, 148 10.5 Indemnification/injuries, 148 10.6 Publications, 149 10.7 Various sundry provisions, 149 Appendix A: Glossary of common terms used in connection with clinical trials, 151 Appendix B: Research involving human subjects, 163 Appendix C: Best pharmaceuticals for Children Act, 173 Appendix D: Pediatric research Equity Act of 2003, 193 Appendix E: Title 21–food and drugs: additional safeguards for children in clinical investigations, 203 Appendix F: Proposed standardized/harmonized clauses for clinical trial agreements, 209 Appendix G: Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors, 225 Index, 257

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Book SynopsisOffers an innovative plan to eliminate inequalities in American health care and save the lives they endanger Over 84,000 black and brown lives are needlessly lost each year due to health disparities: the unfair, unjust, and avoidable differences between the quality and quantity of health care provided to Americans who are members of racial and ethnic minorities and care provided to whites. Health disparities have remained stubbornly entrenched in the American health care systemand in Just Medicine Dayna Bowen Matthew finds that they principally arise from unconscious racial and ethnic biases held by physicians, institutional providers, and their patients. Implicit bias is the single most important determinant of health and health care disparities. Because we have missed this fact, the money we spend on training providers to become culturally competent, expanding wellness education programs and community health centers, and even expanding access to health insurance will have only a moTrade Review"Just Medicine is a must-read for everyone! Weaving together from insights from research in history, sociology, psychology, law, and more, Matthew crushes the argument that racial disparities in health and health care are due to factors like biology and bad behavior. Time and time again, Matthew exposes the role of racial bias and discrimination in disparate outcomes. More so, she offers meaningful and achievable suggestions for resolving these problems. Lets hope those with the most power to create these changes are paying attention to this important scholarly contribution!" -- Angela Onwuachi-Willig,Charles M. and Marion J. Kierscht Professor of Law, University of Iowa College of Law"A powerful socio-legal reflection on the history of health disparities and how that terrible legacy now further impedes racial equality and results in death. . . . Masterfully written. The author provides a captivating narrative that is at once stark and grizzly (how many ways can people of color suffer at the hands of medicine) and yet so provocatively and artfully written that one cannot stop reading. Not since Harriet Washington's page-turning (and award-winning) book, Medical Apartheid, has there been another that makes medical discourse so captivating." -- Michele Goodwin,Chancellor’s Professor of Law, University of California, Irvine"A remarkably ambitious and provocative book on the ways that implicit bias exacerbates racial disparities in health. Matthew provides a critical analysis and call to action that should be taken seriously by all health care professionals, policymakers, and anyone interested in health equality." -- Osagie K. Obasogie,UC Hastings"The book is highly engaging and worthwhile reading for health care providers, hospital administrators, insurers, medical students and educators, and those involved in civil rights law." * Health Affairs *"Having presented a thorough picture of the problems facing minorities in the health care system, Matthew proposes a solution: reform of specific sections of the Civil Rights Act of 1964, which she claims would provide a legal and moral basis to hold liable those who unconsciously discriminate and would help to establish a new standard of care in medicine....[F]ood for thought here." * Kirkus Reviews *"Her ambitious book lays out a case for a legal remedy for racial health inequality." * Los Angeles Review of Books *"Just Medicine is necessary reading for all who envision a society in which health equity is a moral imperative. I would place Matthew's contributions on the scale of Michelle Alexander's transformational book, The New Jim Crow. Matthew not only documents the problem of color-blind racism but also provides solution-oriented road maps for a way forward." * Political Science Quarterly *"This book will spark much debate." * Choice Connect *

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