There is an increasing body of research on what kind of ethical challenges health care professionals experience regarding the quality of care. In the Netherlands the Dutch Health Care Inspectorate is responsible for monitoring and regulating the quality of health care. No research exists on what kind of ethical challenges inspectors experience during the regulation process itself. In a pilot study we used moral case deliberation as method in order to reflect upon (...) inspectors’ ethical challenges. The objective of this paper is to give an overview of the ethical challenges which health care inspectors encounter in their daily work. A thematic qualitative analysis was performed on cases that were collected from health care inspectors in a moral case deliberation pilot study. Eight themes were identified in health care regulation. These can be divided in two categories: work content and internal collaboration. The work of the health care inspectorate is morally loaded and our recommendation is that some form of ethics support is provided for health care inspectors. (shrink)

In “The Ethics of Advertising for Health Care Services” (2014), Schenker, Arnold, and London argue that advertisements for physicians, hospitals, and other health care services are morally problematic and ought to be regulated by the Food and Drug Administration (FDA) as it regulates prescription drug ads. I argue that the regulation of prescription drug ads has been so ineffective that, if the harms of health care service ads are similar to the harms of (...) drug ads, such regulation is bound to fail. This is a major public health concern, because any good produced by these ads does not necessarily morally compensate for the harm caused. If the ads cannot be banned entirely, I propose a regulatory strategy that involves redesigning them from the ground up. (shrink)

The principle of solidarity is one of the fundamental legal principles applied in the field of health care regulation. This article analyses EU and Lithuanian legal acts, judicial practice, the doctrine of law and foreign scientific resources in order to reveal the content of solidarity principle and to discuss its role in the legal regulation of health care both at EU and national levels. The article is divided into three parts. The first part of (...) the paper examines the correlation between the right to health established in the EU Charter of Fundamental Rights (the Charter) and the principle of solidarity as the fundamental value upon which the EU is ‘founded’ and which it seeks to ‘preserve and develop’, as the preamble to the Charter states. It is noticed that the principle of solidarity is one of the principles which characterize the European law on social protection. In the summary of the findings of the article, the author states that this principle can be considered as a tool to achieve a greater social cohesion within the EU Member States in defining and implementing all policies and activities in order to ensure a high level of human physical, mental and social health protection through, first of all, a reduction of health care inequalities. For that it is necessary to tackle the factors which determine health care inequalities among the EU Member States. (shrink)

Through the Louisiana Purchase in 1803, the United States expanded its size by over 800,000 square miles. But neither President Thomas Jefferson nor Congress knew exactly what they had bought until 1806, when Meriwether Lewis and William Clark returned from their famous expedition. One of the most significant contributions of the Expedition was a better perception of the geography of the Northwest. Lewis and Clark prepared approximately 140 maps and filled in the main outlines of the previously blank map of (...) the northwestern United States. Robert I. Field has done much the same for the vast territory of U.S. health care regulation.On the front cover of Fields new book, Health Care Regulation in America: Complexity, Confrontation, and Compromise, is a picture of a giant three-dimensional labyrinth. Rarely is cover art so perfectly appropriate. (shrink)

In all countries where health care access is considered a social right, regulation is both a tool of performance improvement as well as an instrument of social justice. Both social (equity in access) and economical (promoting competition) regulation are at stake due to the nature of the good itself. Different modalities of regulation do exist and usually new regulatory cycles include the creation of stronger regulatory agencies. Indeed, health care regulation is rising (...) steadily in most developed countries as a consequence of the introduction of the New Public Management perspective to provide essential public goods.Health care is delivered by different organisations with very different cultural backgrounds—public and private (profit and non-profit)—that should be accountable for their decisions. Control by regulatory agencies is instrumental to accomplish this goal. However, there is some dispute with regards the degree of regulatory autonomy. The objective of this paper is to determine if independent regulatory agencies (IRAs) are effective in carrying out health care regulation. The authors apply Walshe’s analytical framework to the Regulatory Authority of Health (Portugal) to answer the question if independent regulation works.In conclusion, the two year experience of the Regulatory Authority of Health is important not only because the primary goals of independent regulation were achieved but also because this authority is now a full partner in the health care sector. However, independent agencies need to develop strong mechanisms of accountability because good regulatory governance is the paradigm of this institutional innovation. (shrink)

ILaw, Regulation and Ethics introduces students to the responsibilities and standards in health care derived from legal, ethical and regulatory frameworks. The text approaches ethics and law for health care in an integrated and accessible way, covering governance, professional identity, and professional responsibility whereby accountability plays an important role. The text combines examples of legal and administrative decisions with the reasoning behind decisions, to introduce students to societal expectations of institutions and persons engaged in (...) class='Hi'>health care. Sourced from a variety of regulatory, ethics, and policy arenas, the examples equip students with the ability to identify and understand appropriate standards in order to practice safely and competently, and to recognize when a situation is problematic and deserving of greater reflection or expert advice. Practice-oriented case examples and critical-reflection questions enhance the text and encourage students to develop effective practice habits, whereby active reflection, reasoning, problem solving and mindfulness become essential components of working in the health care sector. (shrink)

Hastings Center Report, Volume 51, Issue 5, Page 6-7, September‐October 2021.

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of drug (...) efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. (shrink)

On January 22, 2002, California Governor Gray Davis released the state's long-anticipated, proposed regulations establishing hospital nurse-to-patient ratio requirements. The Safe Staffing Law mandating minimum ratios was enacted in October 1999 in response to legislators concerns that [q]uality of patient care is jeopardized because of staffing changes implemented in response to managed care. While the law was scheduled to take effect by January 1, 2002, conflict within the medical community regarding appropriate ratios slowed down the rulemaking process. Lawmakers (...) now anticipate that the rule will be implemented by January 2003. Approximately 5,000 new nurses will need to be hired for California's hospitals to come into compliance with the proposed regulation. (shrink)

The legal regulation of standards of medical practice has two main forms. The more direct of these comprises legislation and judicial precedents concerned with the delivery of medical care. Typically this form sets out the meaning of consent to treatment, establishes negligence thresholds and imposes duties of confidentiality. The second form of regulation is entrusted to a supervisory body, established by law and given jurisdiction to enforce standards of conduct by controlling entry to the profession and through (...) the use of disciplinary powers. (shrink)

In any given society, rights are said to co-exist. When rights, however, begin to conflict, a balance must be sought. In few fields has the ability of governments to accommodate two conflicting sets of rights been so controversial as it has in the case of conscientious objection in reproductive health care. Today, states have an obligation under international law to protect the right to the freedom of thought, conscience, and religion of medical providers. They also, however, have an (...) obligation to protect right to the highest attainable standard of health and other fundamental rights of women. Considering the extent to which CO has been invoked in the context of reproductive health care, international law recognizes limits to its use. Over the years, human rights bodies have sought to develop guidelines around CO in order to ensure the protection of women’s basic rights. While some state practices have shown to be consistent with guidelines established at the international level, some countries have struggled to provide an effective balance so as to protect women’s fundamental rights. Taking the example of countries in Latin America and Europe, this article provides an overview of the different ways states have sought to regulate CO in the medical context and the various difficulties ensued. (shrink)

This four-volume collection covers the organization, financing and regulation of health care systems in four distinct contexts: financing and delivering health care, reforming health care systems, new forms of health system, and rethinking health care systems. A general introduction provides a review of the collection as a whole, and individual introductions set the context for each volume, providing a unique and valuable resource for student and scholar alike.

The right to health care is a right to care that is not too costly to the provider, considering the benefits it conveys, and is effective in bringing about the level of health needed for a good human life, not necessarily the best health possible. These considerations suggest that, where possible, society has an obligation to provide preventive health care, which is both low cost and effective, and that health care regulations (...) should promote citizens’ engagement in reasonable preventive health care practices. (shrink)

The Truth and Reconciliation Commission of Canada made it clear that understanding the historical, social, cultural, and political landscape that shapes the relationships between Indigenous peoples and social institutions, including the health care system, is crucial to achieving social justice. How to translate this recognition into more equitable health policy and practice remains a challenge. In particular, there is limited understanding of ways to respond to situations in which conventional practices mandated by the state and regulated by (...) its legal apparatus come into direct conflict with the values and autonomy of Indigenous individuals, communities, and nations. In this paper, we consider two cases of conflict between Indigenous and biomedical perspectives to clarify some of the competing values. We argue for the importance of person‐ and people‐centered approaches to health care. These value conflicts must be understood at multiple levels to clarify their personal, social, cultural, and political dimensions. Taking into account the divergence between epistemic cultures and communities allows us to understand the multiple narratives deployed in decision‐making processes in clinical, community, and juridical contexts. Recognizing the knowledge claims of Indigenous peoples in health care can help clinicians avoid reinforcing the divides created by the structural and institutional legacy of colonialism. This analysis also provides ways to adjudicate conflicts in health care decision‐making by disentangling cultural, political, medical, and pragmatic issues to allow for respectful dialogue. Insofar as the engagement with cultural pluralism in health care rights is conducted with reciprocal recognition, the medical community and Indigenous peoples can address together the difficult question of how to integrate different epistemic cultures in the health care system. (shrink)

The truth about health care policy lies between two exaggerated views: a market view in which individuals purchase their own health care from profit maximizing health-care firms and a control view in which costs are controlled by regulations limiting which treatments health insurance will pay for. This essay suggests a way to avoid on the one hand the suffering, unfairness, and abandonment of solidarity entailed by the market view and, on the other hand, (...) to diminish the inflexibility and inefficiency of the control view. It suggests that the way to mitigate these problems is to recognize the malleability of motivation and the range of factors, in addition to financial incentives, that may influence the behavior of patients and especially physicians. (shrink)

The question of corporate moral responsibility – of whether it makes sense to hold an organisation corporately morally responsible for its actions,rather than holding responsible the individuals who contributed to that action – has been debated over a number of years in the business ethics literature. However, it has had little attention in the world of health care ethics. Health care in the United Kingdom(UK) is becoming an increasingly corporate responsibility, so the issue is increasingly relevant (...) in the health care context, and it is worth considering whether the specific nature of health care raises special questions around corporate moral responsibility. For instance, corporate responsibility has usually been considered in the context of private corporations, and the organisations of health care in the UK are mainly state bodies. However, there is enough similarity in relevant respects between state organisations and private corporations, for the question of corporate responsibility to be equally applicable. Also, health care is characterised by professions with their own systems of ethical regulation. However, this feature does not seriously diminish the importance of the corporate responsibility issue, and the importance of the latter is enhanced by recent developments. But there is one major area of difference. Health care, as an activity with an intrinsically moral goal, differs importantly from commercial activities that are essentially a moral, in that it narrows the range of opportunities for corporate wrongdoing, and also makes such organisations more difficult to punish. (shrink)

The Patient Protection and Affordable Care Act represents the most significant reform of the United States health care system in decades. ACA also substantially amplifies the federal role in health care regulation. Among other provisions, ACA expands government health care programs, imposes detailed federal standards for commercial health insurance policies, creates national requirements on employers and individuals, and enlists state administrative capacity to implement various federal reforms. In response, a persistent voice (...) in the protracted, contentious debate surrounding ACA was, and continues to be, resistance from states. The rhetoric of federalism — states’ rights, reserved powers, state sovereignty, limited government, and local diversity — resonates deeply even around provisions of ACA that do not specifically implicate state interests. For example, the loudest and most persistent state objections target the new mandate that individuals maintain health insurance, a requirement imposed by ACA and enforced through federal tax penalties. (shrink)

This paper provides an interpretation, based on the social systems theory of German sociologist Niklas Luhmann, of the recent paradigmatic shift of mental health care from an asylum-based model to a community-oriented network of services. The observed shift is described as the development of psychiatry as a function system of modern society and whose operative goal has moved from the medical and social management of a lower and marginalized group to the specialized medical and psychological care of (...) the whole population. From this theoretical viewpoint, the wider deployment of the modern social order as a functionally differentiated system may be considered to be a consistent driving force for this process; it has made asylum psychiatry overly incompatible with prevailing social values (particularly with the normative and regulative principle of inclusion of all individuals in the different functional spheres of society and with the common patterns of participation in modern function systems) and has, in turn, required the availability of psychiatric care for a growing number of individuals. After presenting this account, some major challenges for the future of mental health care provision, such as the overburdening of services or the overt exclusion of a significant group of potential users, are identified and briefly discussed. (shrink)

Travelling internationally to acquire medical treatments otherwise unavailable or inaccessible in one’s home country is not a novel concept. Conventionally, such medical travel largely entailed patients from developed countries or wealthy patients from the developing world seeking care in Western facilities like the Mayo Clinic in the U.S. and myriad private clinics along Harley Street in London, England. What is different about the topical phenomenon known as “medical tourism” is the growing trend of health services export in the (...) opposite direction. The number of patients travelling from the developed world to low- and middle-income countries for treatments has ballooned in recent years, primarily driven by difficulties with accessing affordable care at home. According to a liberal estimate by the Deloitte Center for Health Solutions, the number of Americans travelling abroad for care rose from 750,000 in 2007 to 1.6 million in 2012. On the flip side, Thailand reportedly treated a total of 1.3 million foreign nationals in 2007, which represented a 16% leap from 2001. (shrink)

Health care organization is entering a new age. Focus is increasingly shifting from individual health care institutions to interorganizational collaboration and health care networks. Much hope is set on such networks which have been argued to improve economic efficiency and quality of care. However, this does not automatically mean they are always ethically justified. A relevant question that remains is what ethical obligations or duties one can ascribe to these networks especially because networks (...) involve many risks. Due to their often amorphous and complex structure, collective responsibility and accountability may increase while individual responsibility goes down. We argue that a business ethics approach to ethical obligations for health care networks, is problematic and we propose to opt for a patient perspective. Using the classic four principles of biomedical ethics it is possible to identify specific ethical duties. Based on the principle of justice, health care networks have an ethical duty to provide just and fair access for all patients and to be transparent to patients about how access is regulated. The principle of nonmaleficence implies an obligation to guarantee patient safety, whereas the principle of beneficence implies an obligation for health care networks to guarantee continuity of care in all its dimensions. Finally, the principle of autonomy is translated into a specific obligation to promote and respect patient choice. Networks that fail to meet any of these conditions are suspect and cannot be justified ethically. Faced with daunting challenges, the health care system is changing rapidly. Currently many hopes ride on integrated care and broad health care networks. Such networks are the topic of empirical debate, but more attention should be given to the ethical aspects. Health care networks raise new and pressing ethical issues and we are in need of a framework for assessing how and when such networks are justified. (shrink)

: Widespread collection and use of identifiable information can promote social goods while, at the same time, infringing on personal privacy. Information systems are developing within the context of a fundamental transformation in the organization, delivery, and financing of health care. Changes in the health care system include rapid development of employer-sponsored health coverage, managed care organizations, and integrated delivery systems. These complex, multifaceted arrangements for delivering and paying for health care require (...) ever-more-sophisticated information systems that facilitate extensive sharing of personal data. Systemic flows of sensitive health information occur both vertically and horizontally among employers, hospitals, insurers, laboratories, and suppliers. Beyond this complex web of vertical and horizontal sharing are the multiple demands for information management, quality assurance, research, governmental regulation, and public health. Theoretical problems exist with the law and ethics of informational privacy. The traditional method of exercising control over personal health information is through informed consent. Informed consent, however, within a modern health information infrastructure becomes highly complex. In this kind of environment, the doctrine of informed consent is flawed and does not provide sufficient control over personal information to assure adequate protection of privacy. (shrink)

Biology incorporated into other disciplines is often distorted, alarmingly so in some areas of medicine. Together with other forms of bias, this may have detrimental effects for patients depending on medical research for their health. A case study concerning omeprazole (Losec), one of the acid-suppressive drugs against gastric ulcers, and NSAIDs, non-steroid anti-inflammatory drugs, confirms that distorted biology together with biased health care policies foster disasters in current biomedicine and medical practice. In our country, The Netherlands, omeprazole (...) is presumably the most commonly used medication. NSAIDs are also used in large quantities, increasingly since they have become available as analgesic over-the-counter drugs. Unofficial and official sources tend to inform the general public that the drugs promote human health. We argue that their being used on a massive scale is actually a medical disaster. The health of many patients would be served better if the drugs they take were replaced by proper forms of diet, but the pharmaceutical industry, the most potent force affecting medication policies, appears to prevent a shift in the balance from over-medicalization towards healthy life styles. The shift should come from government agencies responsible for regulation in the medication market. Policies of these agencies are now a dismal failure. (shrink)

In recent years, the rights of patients have assumed a more pivotal role in international discussion. Stricter laws on the protection of patients place greater priority on the perspective and the status of patients. The purpose of this study is to emphasize ethical aspects in communication, the role of patient advocates as contacts for the concerns and suggestions of patients, and how many problems of ethics disappear when communication is highlighted. We reviewed 680 documented cases of consultation in a 10-year (...) period of patient advocates’ activity at a big German university hospital with 1,300 beds. On the basis of this extensive material, the article will focus on the intersection of the advocate’s work with the problems of patients in hospitals. Deficits in the level of communication between health care professionals and patients were frequently uncovered. Patients primarily complain about the lack of dialogue and empathy. Middle-aged patients consulted the patients’ advocate disproportionately more often. Measured against this baseline, the group of 65 and older complained less frequently. Besides complaints the advocate was asked in more than one-third of all cases for information about medical matters, hospital regulations or administrative problems. Patients obviously see the advocate as a well-connected and ideally unbiased contact person for uncertainties concerning their malady or a potential stay in hospital. Those seeking help often set hope in the information given by the voluntary patient representative. It should be highly recommended for every German hospital to establish the position of a patient advocate. Furthermore, patients can profit from regular exchange between the advocate and the Ethics Committee, also, to help ensure that their rights are taken into account and implemented in an ethically desirable context. (shrink)

It is generally agreed that the current methods of providing health care in the West need to be reformed. Such reforms must operate within the practical limitations to which any future system of health care will be subject. These limitations include an increase in the demand for costly end-of-life health care coupled with a reduction in the proportion of the population who are working taxpayers (and hence a reduction in the proportionate amount of (...) class='Hi'>health care funding that can be secured through taxation) and the fact that the imposition of bureaucratic regulations on health care systems is costly. Recognizing these limitations should naturally lead one to consider market-based reforms. Yet despite the practical impetus for such reforms, there is still widespread concern that market-based health care is unethical. The purpose of this paper is to address this concern and, in so doing, to pave the way for the market-based reform of health care to proceed. (shrink)

Advertising by health care institutions has increased steadily in recent years. While direct-to-consumer prescription drug advertising is subject to unique oversight by the Federal Drug Administration, advertisements for health care services are regulated by the Federal Trade Commission and treated no differently from advertisements for consumer goods. In this article, we argue that decisions about pursuing health care services are distinguished by informational asymmetries, high stakes, and patient vulnerabilities, grounding fiduciary responsibilities on the part (...) of health care providers and health care institutions. Using examples, we illustrate how common advertising techniques may mislead patients and compromise fiduciary relationships, thereby posing ethical risks to patients, providers, health care institutions, and society. We conclude by proposing that these risks justify new standards for advertising when considered as part of the moral obligation of health care institutions and suggest that mechanisms currently in place to regulate advertising for prescription pharmaceuticals should be applied to advertising for health care services more broadly. (shrink)

Throughout the post-World War II decades, the United States has wrestled in its own unique style with a problem that is shared by all modern societies: how to achieve a reasonably equitable distribution of health care, without losing control of total spending on health care, and without suffocating the delivery system with controls and regulations that inhibit technical progress.Because an equitable distribution of health care inevitably requires at least some government regulation, and because (...) government regulations tend to impose rigidity on any system, it is widely believed in the United States that a trade-off actually exists between fairness in the distribution of care and the health system’s ability to innovate. This troublesome trade-off bedevils American policy makers to this day. (shrink)

Acting on what started as a hunch, Dr. Francis Martin has cataloged well over 20,000 distinct approaches to counseling and psychotherapy that are advertised on the webpages of licensed, practicing mental health providers. No doubt some portion of them are harmful, but the sheer volume of advertised practices and techniques, often with names deceptively similar to actual evidence-based practices, should be cause for concern among all stakeholders in the helping professions - from educators and researchers to policy makers and (...) insurance companies and, especially, consumers. Based on this significant original study, and drawing from other research and supports, Therapy Thieves describes a near-universal crisis in the field and recommends ways to rescue mental health care from itself. The crisis is caused by declining competence among counselors and psychotherapists who have failed to regulate themselves and who, therefore, deliver inadequate - if not harmful - services. In presenting a simple, yet powerful indictment of the field, Dr. Martin advocates for major reforms in several areas of mental health care, including how prospective licensees are trained, supervised and licensed, a major reworking of professional ethics, and the need to establish regulations for mental health care providers. In short, the book calls for major, specific, and urgently needed reforms. (shrink)

A multiracial, socioeconomically diverse sample of 45 lesbians describe power relations in both satisfactory and problematic health care encounters with physicians. Whether doctors act in solidarity or dominate them is pivotal to lesbians' health care experiences. Solidarity means compassionate competence, empowering information exchange, and negotiated action. Domination takes form in the withholding of information, doomsaying, defensive dismissals, sexist comments, body sculpting, reproductive regulation, and bodily transgression.

The language of rights is increasingly used to regulate access to health care and allocation of resources in the health care field. The right to health has been grounded on different theories of justice. Scholars within the liberal tradition have grounded the right to health care on Rawls's two principles of justice. Thus, the right to health care has been justified as being one of the basic liberties, as enabling equality of (...) opportunity, or as being justified by the maximin principle. In this article, Filc analyzes—from a radical egalitarian standpoint—the limitations of the different attempts to ground an equal right to health on Rawls's theory of justice and offers a first approximation to a radical egalitarian formulation of the right to health. (shrink)

This collection examines questions of medical accountability and ethics. It analyses how the criminal justice system regulates health care practice, and to what extent it is appropriate to use it as a tool to resolve ethical conflict in health care.

The Harvard Report, published in April 1999 for public consultation in Hong Kong, proposed a fundamental restructuring in its health care delivery and financing systems. The Report claims to be evidence-based in its approach (Hsiao et al., 1999a). While 'evidence' has been widely collected by the consultancy team through surveys, consultations and focus groups, the recommendations put forth are not value-free. They carry clear ideological preferences. The value assumptions and ethical presuppositions underlying the report are discussed in this (...) paper. The Harvard consultancy study is in favor of a positive government role in regulation and control, a single central body to administer compulsory health insurance for all citizens, and a purchaser-provider split to induce competition. Such preference is based on pre-existing ideology and generic health care management concepts, which are still in the experimental phase internationally. While value and ideology are inevitable factors in any policy choice, the challenge is to lay these values open for reflection and public debate. For Hong Kong, the challenge is also to take on local substantive issues in health care and deal with them head-on, rather than putting hope in a universal, generic solution. (shrink)

Beginning my third year with the Kansas City Chiefs and being also a medical student at McGill University, I was at first a little reluctant to comment on Glenn Cohen et al.’s critique of the National Football League's structure involving player health and team doctors, but the opportunity to provide a perspective as both a football player and a medical student was too much to forgo. Because of my athletic and academic background, I am often asked what I think (...) about injuries in professional sports and about the role of sports medicine physicians, and Cohen et al.’s article demands a thoughtful reaction. I want to suggest that the fundamental principles concerning the medical profession and the doctor-patient relationship provide additional arguments for some of the solutions that Cohen et al. discuss. The professional self-regulation that the proposed medical committee could provide and the reliance on a doctor who was not hired by the player's employer—the club—for a second opinion are both good ways to minimize conflicts of interest. (shrink)

Citizens in wealthy liberal democracies are typically expected to see to basic needs like food, clothing, and shelter out of their own income, and those without the means to do so usually receive assistance in the form of cash transfers. Things are different with health care. Most liberal societies provide their citizens with health care or health care insurance in kind, either directly from the state or through private insurance companies that are regulated like (...) public utilities. Except perhaps for small co-pays or deductibles, citizens are not expected to see to their health needs out-of-pocket, at least for some basic level of care. Instead, when a citizen gets sick, the state or her insurance company foots the... (shrink)

In order for children to receive the best possible medical treatment, it is essential that research is conducted to discover safe and effective interventions and dosages. This article focuses on the legal and ethical implications of recruiting into health-care research minors who are not competent to consent. It considers the role played by best interests in obtaining valid parental consent for the participation of children in research, both at common law and under the Regulations that govern clinical trials (...) of medicinal products. In doing so it questions the legality of parental consent to children's involvement in research, and identifies some inconsistencies in parental understandings of best interests in relation to medical research and treatment. (shrink)

Health care reform poses numerous challenges. A core challenge is to make health care more efficient and effective without causing more harm than benefit. Additionally, those fashioning health-care policy must encourage patients to exercise caution and restraint when expending scarce resources; restrict the ability of politicians to advance their careers by promising alluring but costly entitlements, many of which they will not be able to deliver; face the demographic challenges of an aging population; and (...) avoid regulations that create significant inefficiencies and restrict access to health care. Given such real-world challenges, how should health care be reformed in the United States or elsewhere? This number of The Journal of Medicine and Philosophy examines many of the complex issues that must be considered in reforming a health-care system. (shrink)

A dearth of clinical research involving children has resulted in off-licence and sometimes inappropriate medications being prescribed to the paediatric population. In this environment, recent years have seen the introduction of a raft of regulation aimed at increasing the involvement of children in clinical trials research and generating evidence-based medicinal preparations for their use. However, this regulation pays scant attention to the autonomy of competent minors. In particular, it makes no provision for the ability of competent minors to (...) consent to participate in medical research and is therefore at odds with best ethical practice. This article explores the tensions between law and ethics in relation to clinical research involving minors and concludes that greater respect should be given to the autonomy of those minors who are competent to decide for themselves. (shrink)

Undisputedly, the United States’ health care system is in the midst of unprecedented complexity and transformation. In 2014 alone there were well over thirty‐five million admissions to hospitals in the nation, indicating that there was an extraordinary number of very sick and frail people requiring highly skilled clinicians to manage and coordinate their complex care across multiple care settings. Medical advances give us the ability to send patients home more efficiently than ever before and simultaneously create (...) ethical questions about the balance of benefits and burdens associated with these advances. Every day on every shift, nurses at the bedside feel an intense array of ethical issues. At the same time, administrators, policy‐makers, and regulators struggle to balance commitments to patients, families, staff members, and governing boards. Ethical responsibilities and the fiduciary, regulatory, and community service goals of health care institutions are not mutually exclusive; they must go hand in hand. If they do not, our health care system will continue to lose valued professionals to moral distress, risk breaking the public's trust, and potentially undermine patient care. At this critical juncture in health care, we must look to new models, tools, and skills to confront contemporary ethical issues that impact clinical practice. The antidote to the current reality is to create a new health care paradigm grounded in compassion and sustained by a culture of ethical practice. (shrink)

Background Seven wards from three Norwegian mental health care institutions participated in a study in which regular ethics reflection groups focusing on coercion had been implemented and evaluated (2011–2015). This article presents (1) a thematic overview of the ethical challenges identified based on a systematic qualitative analyses of 161 ethics reflection groups and (2) some general observations on these ethical challenges. Results The ethical challenges are divided into four main thematic categories: (1) formal coercion, (2) informal coercion, (3) (...) uncertainty related to the Norwegian legislation on coercion and (4) professional role and identity. Some ethical challenges did not fit into these categories. Only 36% of the ethical challenges were related to the use of formal coercion or the interpretation of the health law. Conclusion Even within coercion regulated by law, weighing different moral values remains important to reflect upon the appropriateness of the possible use of coercion. (shrink)

The current health care system is not operating with a properly functioning market. Health care costs are hidden and often shifted, consumers and providers are insulated from the economic consequences of their decisions, and costs therefore go up dramatically. Instead of attacking both the structural deficiencies and the consequent inequities of the current employer based insurance system, the Clinton Plan simply expands them, and adds a heavier level of government regulation. The ultimate choice for the (...) public is between a health care system based on consumer choice or a government controlled system. In pursuing a market based health care reform that enhances personal freedom and responsibility, two ethical principles are served. First, American consumers will be made aware of the true costs of health care services, and market forces will thus introduce incentives on the part of providers to control costs. Second, justice will be served; for not only will providers of medical services receive their due, but public policy makers can target relief more effectively to those who need it most. Keywords: Clinton health plan, free market, freedom, responsibility CiteULike Connotea Del.icio.us What's this? (shrink)

Patient and public involvement is widely thought to be important in the improvement of health care delivery and in health equity. Purpose: The article examines the role of experiential knowledge in service co-production in order to develop opiate substitution treatment services (OST) for high-risk opioid users. Method: Drawing on social representations theory and the concept of social identity, we explore how experts’ by experience and registered nurses’ understandings of OST contain discourses about the social representations, identity, and (...) citizenship of the participants and the effects these may have on developing or hindering inclusive and bottom-up forms of patient and public involvement. Results: The meeting sessions that potentially offer room for creativity and problem-solving fail to provide any new propositions for fixing the system. The health care professionals primarily identify themselves as regulators who protect the correctness of their actions and show little interest in considering experiential knowledge on opioid addiction. Conclusion: The participation of patients has been one of the prominent reforms implemented in health care. The goal of client-centered thinking is often emphasised; however, the implementation is not simple due to the strongly institutionalised knowledge and related working patterns and practices in health care. (shrink)

In March 2020, the Portuguese Government issued a remarkable regulation by which irregular migrants who had previously started the regularization procedure were temporarily regularized and thus allowed full access to all social benefits, including healthcare. The Portuguese constitutional and legal framework is particularly generous regarding the right to healthcare to irregular migrants. Nevertheless, until now, several practical barriers prevented full access to healthcare services provided by the national health service, even in situations in which it was legally granted. (...) This decision is not only remarkable in light of the fulfilling of migrants’ rights to health, as imposed by international commitments assumed by, but also in view of the fight against COVID-19. The decision is grounded both on human rights and in public health reasons. The paper is divided in two main parts. In the first one, it analyzes national State obligations with regard to healthcare provision to migrants in irregular situation. In the second part, it analyzes the Portuguese solution, using this case study to discuss the possible mechanisms to comply with such obligations. (shrink)

Although there is no federal legislation yet on e-cigarettes, the U.S. Food and Drug Administration proposed regulations in April 2014 that would prohibit sales of e-cigarettes to anyone under eighteen and require that they be approved by the FDA as a tobacco product and carry warning labels for consumers on their packaging. Only three U.S. states have extended the same restrictions placed on tobacco products to e-cigarettes; however, eighteen states have passed legislation enacting use restrictions on venues such as schools, (...) state property, or workplaces. Until there is applicable legislation at the federal, state, or municipal levels, health care organizations will have to develop institutional policies if they wish to consistently address the use of e-cigarettes by patients and visitors on their property. (shrink)

Most hospitals are considered charities under common law because they were established for the benefit of the public. The law granted them benefits, but also imposed duties. Under the cy-pres doctrine, if a charitable purpose becomes obsolete or incapable of being carried out, the court could modify those purposes to meet current needs of the organization and the community. Modern laws attempt to find a purpose as near as possible to original purposes set up by donors. In the case of (...) hospital conversion, some regulators say assets must be used to support hospital health care, while others say they can be used in the broad sense of health care. That has been a continuing conflict between communities and regulators.Since 1996, 30 conversion statutes have been enacted, covering hospitals, HMOs, and insurers. (shrink)