The use of medical records in research can yield information that is difficult to obtain by other means. When such records are released to investigators in identifiable form, however, substantial privacy and confidentiality risks may be created. These risks become more common and more serious as medical records move to an electronic format. In 1996, the state of Minnesota enacted legislation with respect to consent requirements for the use of medical records in (...) research. This legislation has been widely criticized because—it is claimed—it creates an unnecessary impediment to research. In this article, we show that these arguments rest upon misinterpretation and/or misrepresentation of the 1996 legislation. A consent requirement had actually been present in Minnesota since 1976 (though codified in a patient rights statute rather than a privacy statute). The 1996 law does not require specific consent, as often claimed, but rather only a general authorization. The campaign against the Minnesota legislation appears to have been motivated by concern with respect to the then impending federal privacy rule. The HIPAA rule, as enacted, is in fact less stringent with respect to consent than the Minnesota consent law. On the other hand, the Minnesota consent law has not been effectively applied or enforced. As we change the way we manage sensitive medical information, new efforts are needed to provide protection against the confidentiality risks in research. Patient consent is an important tool in this regard. New instrumentalities are needed to solicit and document consent. (shrink)

This article presents an analysis of contractual relations in sport from the standpoint of the Croatian legislative system. Due to the complexity of the subject matter, the author considers only a small fragment of it - the significance and the role of sport in Croatian society and the law of contracts „as a cornerstone on which „sports law“ has been built and which is of primary importance in most areas where there is an interface between sport and the law, irrespective (...) of whether the sport is being played at an elite level or at a more humble one“. Bearing in mind the limited extent of this article, the autor tries to provide some clarifications and some guidance on how to deal with the designation and the determination of the applicable law for contracts in the sporting context. Considering that there are different legal regimes which may come into play with regard to the designation of the law applicable to contracts in the sporting context, the author first presents the determination of the applicable law according to the Rome I Regulation and then according to the Croatian Arbitration Act, Swiss Private International Law Act and the CAS Code of Sports-related Arbitration, as the most common in sports practice. Then, the author deals with contracts concluded with minor athletes and the determination of the law applicable to some preliminary questions. Finally, the author presents her perception of the problems encountered and some suggestions for the improvement of the existing legal framework. (shrink)

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in (...) this country continues to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies. (shrink)

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in (...) this country continues to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies. (shrink)

Heath care and public health are typically conceptualized as separate, albeit overlapping, systems. Health care’s goal is the improvement of individual patient outcomes through the provision of medical services. In contrast, public health is devoted to improving health outcomes in the population as a whole through health promotion and disease prevention. Health care services receive the bulk of funding and political support, while public health is chronically starved of resources. In order to reduce morbidity and mortality, policymakers must shift (...) their attention to public health services and to the improved integration of health care and public health. In other words, health care and public health should be treated as two parts of a single integrated health system. Furthermore, in order to maximize improvements in health status, policymakers must consider the impact of all governmental policies on health. (shrink)

Medical Ethics, Law and Communication at a Glance presents a succinct overview of these key areas of the medical curriculum. This new title aims to provide a concise summary of the three core, interlinked topics essential to resolving ethical dilemmas in medicine and avoiding medico-legal action. Divided into two sections; the first examines the ethical and legal principles underpinning each medical topic; while the second focuses on communication skills and the importance of good communication. Medical Ethics, (...) Law and Communication at a Glance offers an accessible introduction to the fundamentals of good medical practice, and will provide indispensable support for undergraduate medical students and nurses, as well as newly qualified healthcare professionals. (shrink)

All scientific activity involves some method of observation and some method of recording what is observed. These activities can be carried out in ways that involve little interaction between subject and object, as is the case when a telescope observes a far-away star. At the other end of the scale are experiments in modern high energy physics in which there is little distinction between the observer and the observed, and the process of observation materially affects the data that are recorded. (...) In this regard, research on human phenomena resembles modern physics more than it does classical astronomy.Research on human phenomena, however, differs from modern physics in the way in which it affects that which is observed. Both the procedures and the findings of research on human phenomena alter the modes of thinking and the self-awareness of the objects of study. (shrink)

All scientific activity involves some method of observation and some method of recording what is observed. These activities can be carried out in ways that involve little interaction between subject and object, as is the case when a telescope observes a far-away star. At the other end of the scale are experiments in modern high energy physics in which there is little distinction between the observer and the observed, and the process of observation materially affects the data that are recorded. (...) In this regard, research on human phenomena resembles modern physics more than it does classical astronomy.Research on human phenomena, however, differs from modern physics in the way in which it affects that which is observed. Both the procedures and the findings of research on human phenomena alter the modes of thinking and the self-awareness of the objects of study. (shrink)

A powerful movement is afoot to create a national computerized system of health records. Advocates claim it could save the health delivery system billions of dollars and improve the quality of health services. According to Lawrence Gostin, a leading commentator on privacy and health records, this new infrastructure is “already under way and [has] an aura of inevitability.” When it is in place, almost any information that is viewed as relevant to a decision in the health care delivery (...) system would be available to a large and yet undetermined number of individuals. The transformation of the collection and communication of health information from texts housed by health care providers and facilities to data electronically transmitted through networks of linked computers has significant implications for confidentiality and for data collection in scientific research. The best evidence clearly indicates that most people in the United States consider confidentiality for health information important and worry that the increased computerization of health records will result in inappropriate disclosure. (shrink)

A powerful movement is afoot to create a national computerized system of health records. Advocates claim it could save the health delivery system billions of dollars and improve the quality of health services. According to Lawrence Gostin, a leading commentator on privacy and health records, this new infrastructure is “already under way and [has] an aura of inevitability.” When it is in place, almost any information that is viewed as relevant to a decision in the health care delivery (...) system would be available to a large and yet undetermined number of individuals. The transformation of the collection and communication of health information from texts housed by health care providers and facilities to data electronically transmitted through networks of linked computers has significant implications for confidentiality and for data collection in scientific research. The best evidence clearly indicates that most people in the United States consider confidentiality for health information important and worry that the increased computerization of health records will result in inappropriate disclosure. (shrink)

The legal environment -- Regulation of nursing practice -- Nurses in legal actions -- Standards of care -- Defenses to negligence or malpractice -- Prevention of malpractice -- Nurses as witnesses -- Professional liability insurance -- Accepting or refusing an assignment/patient abandonment -- Delegation to unlicensed assistive personnel -- Patients' rights and responsibilities -- Confidential communication -- Competency and guardianship -- Informed consent -- Refusal of treatment -- Pain control -- Patient teaching and health counseling -- Medication administration -- Clients (...) with AIDS and HIV testing -- Abusive situations -- Reproductive services -- Restraints -- Emergency psychiatric admissions -- Organ and tissue donation and transplantation -- Discharge against medical advice -- The medical record and documentation standards -- Electronic health information and communications -- Interdependent nursing functions: verbal orders and telenursing -- Event reporting and compliance -- Quality and safety in nursing practice -- Forensic issues -- Employer and employee rights -- Contracts -- Corporate liability -- Employment contracts and unionization -- Employment status liability -- Staffing issues and floating -- Americans with Disabilities Act -- Employees with AIDS/HIV infection and exposure to bloodborne pathogens -- Impaired nurses -- Sexual harassment in the workplace -- Violence in the workplace -- Intentional torts -- Environmental health and safety -- Ethical decision making -- Professional boundaries and patient relationships -- Moral courage and patient advocacy -- Social media and online professionalism -- Reporting illegal, unethical, or unsafe conduct -- Maternal versus fetal rights -- Futility of care -- Advance directives and end-of-life decisions -- Assisted suicide. (shrink)

A practical approach to ethics -- The doctor-patient relationship -- Consent, choice, and refusal : adults with capacity -- Treating adults who lack capacity -- Treating children and young people -- Confidentiality -- Management of health records --Prescribing and administering medication.

This new edition of Law and Medical Ethics continues to chart the ever-widening field that the topics cover. The interplay between the health caring professions and the public during the period intervening since the last edition has, perhaps, been mainly dominated by wide-ranging changes in the administration of the National Health Service and of the professions themselves but these have been paralleled by important developments in medical jurisprudence.

This book provides a clear, concise description of medical law; but it does more than that. It also provides an introduction to the ethical principles that can be used to challenge or support the law. It also provides a range of perspectives from which to analyse the law: feminist, religious and sociological perspectives are all used.

Comprehensive and practical handbook on ethical and legal issues affectingGpsand other practitioners.

Few subjects provoke as much controversy or debate as that of medical care, and the law that governs such an emotive area finds itself with the near-impossible task of simultaneously trying to regulate the medical profession and healthcare provision whilst upholding the rights of the millions of people who use those services every year. Medical Law combines an accessible explanation of the complex and challenging legal rules of medical care in England and Wales with a stimulating (...) examination of the social, political and ethical arguments such care provokes. It examines a broad range of issues, from the structure and organisation of the NHS, through the rules of clinical negligence, as well as focussing on the legal and ethical concerns around such deeply contentious areas as surrogacy, organ donation, abortion and euthanasia. Written very much with newcomers to the area in mind, Leanne Bell lucidly outlines not just what the law is, but how it has developed over time and also provides insights as to how advances in medical technology and techniques may call for it to evolve in the future. (shrink)

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

Current law does not adequately protect patients' privacy or their medical records. Proposals to computerize these records could further erode confidentiality unless new federal laws are enacted.

Abortion has been legal in the United States since the Supreme Court's landmark 1973 ruling in Jane Roe, et al. v. Henry Wade, District Attorney of Dallas County. Over the past forty years, however, access to abortion has diminished as states have devised creative ways to regulate and restrict the abortion procedure. In the first half of 2011, state legislators introduced a record number of antiabortion bills. In 19 states alone, 80 laws ranging from mandatory counseling and waiting periods to (...) gestational laws and bans on insurance coverage were passed, a legislative testimony to the incremental successes of the antiabortion campaign. Since 2011, the rapid increase in restrictive... (shrink)

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and ...

Graeme Laurie stepped down from the Chair in Medical Jurisprudence at the University of Edinburgh in 2019. This edited collection pays tribute to his extraordinary contributions to the field. Graeme has often spoken about the importance of 'legacy' in academic work and has forged a remarkable intellectual legacy of his own, notably through his work on genetic privacy, human tissue and information governance, and on the regulatory salience of the concept of liminality. The essays in this volume animate the (...) concept of legacy as lens of analysis for the study and practice of medical jurisprudence. In this light, legacy reveals characteristics of both benefit and burden, as both an encumbrance to and facilitator of the development of law, policy and regulation. Overall, the contributions reconcile the ideas of legacy and responsiveness and show that both dimensions are critical to achieve and sustain the health of medical jurisprudence itself as a dynamic, interdisciplinary and policy-engaged field of thinking. (shrink)

Summarising the interrelationship between law and medical ethics, I would say that in cases which do not touch the patient's body or integrity, such as professional secrecy, statutory law may take precedence over rules of medical ethics. But in cases where the human subject becomes a victim because of domestic statutory laws which are in contradiction with medical ethics, the medical practitioners should insist on adhering to their professional standards in such a way that the legislators (...) will have to adapt their legislations to the laws of humanity and public conscience. Legislators, as well as medical practitioners, should not forget that the term 'being' is preceded and qualified by 'human'. (shrink)

Mason and McCall Smith's classic textbook discusses the relationship of medical practice and ethics with the operation of the law. The subjects covered include natural and assisted reproduction, the impact of modern genetics on medicine, medical confidentiality, consent to medical treatment, the use of resources and problems surrounding death in the new medical era. It is of significance to anyone with an interest in the ethical and legal practice of medicine.

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

Despite recurring efforts, a gap exists across a variety of contexts between the protection of patients' safety in theory and in practice. This timely Research Handbook highlights these critical issues and suggests both legal and policy changes are necessary to better protect patients' safety. Multidisciplinary in nature, this Research Handbook features contributions from eminent academics, policy makers and medical practitioners from the Global North and South, discussing the essential facets concerning patient safety and the law. It highlights how the (...) role of legislation and case law has the potential to influence, both positively and negatively, medical practice and the quality of care. Chapters explore patient safety and the global health agenda; physiotherapy; 'non-therapeutic' clinical research with children; patient safety awareness in healthcare education; and the increasing use of robotics and artificial intelligence in healthcare. Outlining a wide range of international perspectives on patient safety and the law, this Research Handbook will appeal to academics and researchers specialising in health and medical law, human rights and healthcare regulation. It will also serve as a valuable resource for legal and medical practitioners alike, as well as clinicians and professionals working in healthcare governance. (shrink)

Controversial and amusing, this collection of Kennedy's writings illuminates the rights, duties, and liabilities of doctors as well as other aspects of medical law and ethics.

This special issue of the Modern Law Review addresses a range of key issues - conceptual, ethical, political and practical - arising from the regulatory ...

He notes that parallel to this phenomenon have been developments in the common law of malpractice that give patients a better chance than ever of winning compensation. While these developments benefit patients, Dr. Chapman describes how they have also pointed out a major flaw in malpractice law: the enormous amounts of time and money it takes to bring such cases to court. To overcome these difficulties, Dr. Chapman maintains, the medical profession needs to reconsider the basic concepts on which (...) its ethics rest. No less important is a revision of malpractice law so that it finally begins to serve, fairly and equitably, the purposes for which it originally came into being. Literate, thoughtful, and thought-provoking, Physicians, Law, and Ethics is an important contribution to today's medical care debate. (shrink)

Medical ethics and medical practice -- Public health and the state-patient relationship -- Health rights and obligations in the European Union -- Consent to treatment -- Liability for medical injury -- Medical confidentiality -- Genetic information and the law -- The management of infertility and childlessness -- The control of fertility -- Civil and criminal liability in reproductive medicine -- Health resources and dilemmas in treatment -- Treatment of the aged -- Mental health and human rights (...) -- The body as property -- Medical futility -- The diagnosis of death -- The donation of organs and transplantation -- Euthanasia and assistance in dying -- Biomedical human research and experimentation -- Research on children, fetuses and embryos. (shrink)

Section One - Principles and concepts of healthcare law and ethics -- Section Two - Complaints, disciplinary proceedings and indemnity insurance -- Section Three - Confidentiality, disclosure and apologies -- Section Four - Alternative dispute resolution and relationship with colleagues -- Section Five - Liabilities beyond healthcare practices.

Introduction -- Historical perspectives of medical ethics -- The medical ethics Renaissance: a brief assessment -- Risk disclosure/'informed consent' -- Consent, control and minors: Gillick and beyond -- Sterilisation/best interests: legislation intervenes -- The end of life: total abrogation -- Medical ethics in government-commissioned reports -- Conclusion.

Originally edited by Timothy Stoltzfus Jost, this text examines how different countries around the world approach the same challenges in health care law and ethics: how to finance care for as many people as possible; how to ensure quality care; how to best secure patients' rights; how to regulate abortion, end of life decision making, and assisted reproduction; and how to manage infectious diseases, tobacco use, and human subject research. The new edition considers a broader array of countries, particularly from (...) Asia, Latin America, Africa, and the Middle East. (shrink)

Examining the ways and extent to which systemic factors affect health outcomes with regard to quality, affordability and access to curative healthcare, this explorative book compares the relative merits of tax-funded Beveridge systems and insurance-based Bismarck systems. The Law and Policy of Healthcare Financing charts and compares healthcare system outcomes throughout 11 countries, from the UK to Colombia. Thematic chapters investigate the economic and legal explanations for the relevant similarities, variations and trends across the globe. Concluding that systemic factors may (...) be less significant than previously believed, this comprehensive book notes that no one system consistently outperforms the others, yet incentives and funding improvements may lift performances across all curative healthcare systems. Analytical and comparative, this book will be of interest to academics working in the fields of health law and health economics. Public authorities including health ministries, policymakers and international health organisations will also find this to be an invaluable resource. (shrink)

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific (...) considerations militate against soliciting consent for population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients. (shrink)

Drawing on Sir Ian Kennedy's extensive experience in healthcare law, ethics and public policy-making, this book explores vital issues in the law surrounding healthcare and regulation. The book contains a range of published and unpublished essays and speeches with the addition of notes and commentaries by the author that bring the pieces up to the present day. Those who want to understand developments, from transplants to confidentiality, from COVID-19 to public inquiries to regulation will find a rich seam of rigorous, (...) informed analysis. The author's unique range of experience allows him to share insights on a variety of issues; from the conduct of the disgraced breast surgeon, Ian Paterson, to research at Porton Down, to the economics of innovation in drug development at NICE. His abiding interest in the welfare of children informs his trenchant forensic examination of how children fare in the NHS. Those involved in or with an interest in law, moral philosophy, and public policy will find much food for thought. (shrink)

1. Aim of the guidelines2. Principles of good practice3. Circumcision for medical purposes4. Non-therapeutic circumcision 4.1. The law 4.1.1. Summary: the law 4.2. Consent and refusal 4.2.1. Children’s own consent 4.2.2. Parents’ consent 4.2.3. Summary: consent and refusal 4.3. Best interests 4.3.1. Summary: best interests 4.4. Health issues 4.5. Standards 4.6. Facilities 4.7. Charging patients 4.8. Conscientious objection5. Useful addresses.

Introduction: making the invisible visible -- The nobility of the material -- Research at war -- The guilded age of research -- The doctor as whistle-blower -- New rules for the laboratory -- Bedside ethics -- The doctor as stranger -- Life through death -- Commissioning ethics -- No one to trust -- New rules for the bedside -- Epilogue: The price of success.

Medical records contain important clues about the history of medicine. These documents, which ostensibly describe the course of a patient's illness, are “unique constructions that allow us to observe the social and technical structure of contemporary healing.” As such, the 21st-century hospital medical record reflects the many components of inpatient care: medical interventions, billing, legal documentation, research, and education. It is comprised of a wide array of elements: professionals' notes; vital signs and other descriptive information; laboratory (...) data and test results; demographic information; orders, charges, diagnostic and treatment codes; and other utilization data. It is well understood that many people share and need this information. Current controversies over records involve not control, but computerization, security, and accessibility. Although health professionals offer input, decisions about hospital medical records have been considered largely an administrative responsibility. (shrink)