Patients' safety, privacy and effectiveness--a conflict of interests in health care information systems?

Information technology (IT) is finding its way into daily clinical work. IT is primarily seen as a tool for providing quality of service, cutting costs and promoting efficiency in every aspect of health care, but improvements for patients' safety are also a driving force. IT-solutions can be found both at an administrative and a clinical level, supporting everything from documentation, distribution and storing of patient data to workflows, monitoring and decision making. However, the increasing use of IT in health care raises questions. What is the impact on patients' rights and privacy? Does the law benefit IT-solutions in health care, or does it raise barriers for optimized use? Which interests does the law safeguard in the health care sector, and in the light of an increasing use of IT, do any of these identified interests collide? In conjunction with a governmental national project (InfoVU) during 2001-2004, the Swedish National Board of Health and Welfare (NBHW) had to address these issues and other legal aspects of IT use in health care. The agency's analysis was published in November 2005. The purpose of this article is to present some of the agency's conclusions on legal issues pertaining to the management and processing of patient data. It will show, from a Swedish legislative point of view, the need for a common information security strategy for health care information management as well as discussing other legislative issues in order to meet both the patients' and the health care provider's interests in an electronic environment.     

Compliance with international standards on patients' rights and implementation of the Law on the Protection of Patients' Rights in the Republic of Macedonia

In 2008, Macedonia adopted the Law on the Protection of Patients' Rights. This was a big step forward in the field of health care and regulation of patients' rights and responsibilities, as well as the rights and responsibilities of the health care providers. The Law introduces some new patients' rights (for example, right to second expert opinion) and new mechanisms for protection of patients' rights (Councilors for protection of patients' rights, Commissions for promotion of patients' rights). As this paper shows, the implementation of this Law is lagging behind. This paper argues that, besides a good law and political will, a continuous promotion of patients' rights and lifelong training of health care professionals is key to achieving promotion and protection of patients' rights in practice. The paper presents the findings from the comparison of the provisions of the Law on the Protection of Patients' Rights and the relevant international documents.     

A review of health and human rights after five years of democracy in South Africa

South Africa became a democratic state with a supreme Constitution and Bill of Rights in 1994. Between 1994 and 1996 South Africans drafted a new constitution which came into force in 1997. While, the right to health, as well as socio-economic rights is provided for, the health care system in post-apartheid South Africa still mirrors that which existed during the apartheid years. There are still two health care systems. The poorly funded public sector services the majority, while the well-funded private sector services the privileged few. A lack of resources is blamed by the state for its inability to provide better and more widespread health services. This article examines, from a human rights perspective, the successes and challenges in developing the right to health between 1994 to 1999, and provides an overview of the present state of health in South Africa. This article further examines the constitutional provisions on health, and discusses recent constitutional court decisions relevant to the right to health. New and controversial health laws and regulations, affecting health care professionals, medical aid schemes and the availability of pharmaceuticals, are critiqued. The move to devolving health care to the provinces is described. Also discussed are the controversial steps taken by the Department of Health to restructure health structures and services. Progress on key health issues such as HIV/Aids, tobacco, tuberculosis, polio, measles, hepatitis, malaria and abortion are also described. Attention is focused on the role of the Truth and Reconciliation Commission's health hearings in bringing to light violations of human rights in health during apartheid as well as the recommendations made to address these problems.     

Human rights in medicine and law

Human rights are discussed in the context of the technological advances in modern medicine and the complex sociological settings in which major issues, such as accessibility, availability, costs and quality and health care, scarce resources, and shifting values, have led to reconsideration of the present systems. Rights in the field of medicine and law are discussed in general, and patients' rights in particular.     

Legal rights, constitutional controversies, and access to health care: lessons from Canada

This paper provides a critical analysis of the use of legal claims to assert rights to access health care. Using Canada's system of public health insurance as an example, the paper discusses two significant Supreme Court of Canada cases in which claimants use legal mechanisms to influence health care reform. While one case seeks to expand the range of services covered by public health insurance, the other challenges the government "monopoly" over health care and advocates an expanded role for private health care. These legal claims play out in an adversarial setting where the focus is on the rights claims advanced by individual litigants. Yet, the outcomes of these cases involve broad implications regarding allocation of scarce health care resources and the very structure of the health care system. This paper discusses the benefits and limits of using legal claims in this context and also considers the role of courts in making decisions that may have the effect of constraining policy options available to government decision-makers.     

Patients' rights in New Zealand: complaints resolution and quality improvement

"Patients' rights" has become a familiar catchword in western countries in recent years. In New Zealand the Office of the Health and Disability Commissioner was established in 1994 to promote and protect patients' rights. The Commissioner also facilitates the resolution of complaints relating to the infringement of patients' rights as set out in the Code of Health and Disability Services Consumers' Rights. Victims of medical misadventure in New Zealand are compensated through a no-fault, state-funded rehabilitation and compensation scheme. The regulatory environment is rehabilitative rather than punitive. This framework is consistent with a systems approach to reducing errors and improving patient safety, and the Commissioner seeks to use the resolution of individual complaints as a tool for improving the quality of care throughout the health care system.     

Pharmacogenetics: a new challenge for health law

Developments in pharmacogenetics make it possible to determine the genetic factors that influence variations in response to medicine. Differences in response to medication may be related to the genetic characteristics of the individual, to the genetic make-up of the diseased tissue or to both. Advantages include optimal therapeutic effect, safe medication, minimised side-effects, and development of medication for small groups of patients. Strict adherence to patients' rights and to the medical professional standard must prevent negative effects of pharmacogenetics on individual rights, notably the right (not) to know, to privacy and informed consent. Use of pharmacogenetics by third parties for non-health related purposes may bring about a disproportionate intrusion of the privacy of an individual; it may result in barriers for accessing primary social goods, and it may be a disincentive for the individual to have a pharmacogenetic analysis performed for individual health care purposes or to participate in a drug trial. Medical examinations before employment must be justified by the health requirements unavoidably inherent to the job (their objective being the protection of health and not the financial interests of the employer). In a system that relies on private insurance for having access to primary social goods (health, disability--and life insurance), the use and the outcome of a pharmacogenetic analysis for the purpose of differentiation between insurance candidates on the basis of their "risk-profile" must be restricted; where appropriate measures should take into account justified interests of the insurance company to prevent adverse selection. Current measures in several European countries are not effective enough to meet the concerns specifically inherent to pahrmacogenetics. Human rights principles must be at the basis of national and European policies for providing adequate protection against disproportionate intrusion into private life, for guaranteeing equity in access to health care and accessibility of other primary social goods.     

Mediation in the Belgian health care sector: analysis of a particular issue--the material scope of application of mediation

In this paper, the material scope of application of mediation regulated in the Belgian Act of August 22nd, 2002 on Patient's Rights will be discussed in detail. In accordance with this Act, a mediator only has the competence to handle patients' complaints concerning the medical and care aspects of patients' rights, such as complaints relating to informed consent, access to medical files, etc. In practice, it has been observed that issues relating to administrative matters also give rise to complaints and that some patients do not know with whom they should lodge such complaints. Some clarification is necessary for a clear and proper complaints procedure that works. One possible solution is the creation of a single institution that would be in charge of handling both kinds of complaints. Such a solution has to be enacted in accordance with Belgian federalism.     

Impeding access? Stigma, individual responsibility and access to post-HIV-exposure prophylaxis (PEP) in South Africa

Opponents of rights-based access to health care services often emphasize individual responsibility for health and well-being, in justifying restrictions on public health care. Where individuals are co-responsible for their ill health, so the argument goes, the public obligation to alleviate their hardship should be limited. This discourse not only denies the socially determined nature of individual behaviour and systemic factors that impact on population health, but also exacerbates the stigmatization of the ill. As such, it is inimical to a human rights approach to health. Unfortunately, it pervades much of health law and policy, especially in relation to HIV/AIDS. This article conducts a human rights analysis of access to postexposure prophylaxis (PEP) treatment for HIV in South Africa. It criticizes the manner in which current South African law and policy in this regard prioritizes access to treatment by persons who display characteristics of'appropriate victimhood', while discouraging access by those regarded as co-responsible for their illness and accordingly as undeserving of treatment. Ultimately, the article advocates for broader and de-stigmatized access to PEP in the public and private health sectors.     

Legislation and patients' rights: some necessary remarks

The essence of a patient's rights and legislation framework requires an answer to the question on how legislation can work towards better defining, respecting, protecting and effectiveness of these rights. First, it is necessary to give a short introduction to patients' rights, their definition and different classifications. In the long list of human rights, patients' rights obviously take one of the very important places. Human life and health are the values, which, in comparison with all other human values, are considered as values of the highest rank. Patients' rights represent a legal expression of something, which every person basically and naturally expects from a doctor, medical staff, and from a health care system in general. The subject of the second part of this paper presents the intention, scope and conception of necessary legislation. How should it be considered - in a wider sense or as a special law? Some theoretical and practical questions regarding interaction between medical ethics regulation, confidentiality, and legislation are discussed as well. In the European context there are numerous examples of laws with the specific purpose of protecting patients' rights. Special attention and critical review will be paid to the situation of patients' rights in Serbia. The paper concludes with the point that the role of legislation is evidently important, but the traditional view should be replaced with a new one, due to the reason that modem health law puts the protection of patients' rights on a higher level. De lege lata, the whole system of health law in its diversity (civil, penal and administrative) is characterized by better understanding of rights, duties and legal relations, either through regulation or the protection of patients' rights.     

Responsibility and liability in health care: some differences between dentistry and medicine

The dentist's lineage goes back to the town barbershop, whereas the physician's ancestor was the tribal witch doctor. Both physicians and dentists are naturally expected to attend to their patients' health, but while the physician may try and attend to the patients' overall well-being, dentists have clients that they must satisfy by attending to their desires and interests. In many respects the aims and targets of medicine and dentistry are different. Whereas in medicine there is a clear distinction between hospital work and private, such a distinction hardly exists in dentistry. In hospitals there is teamwork and responsibility is shared accordingly. In a private dental clinic the responsibility is imposed solely on the dentist also for work done by others who are not his employees. Medicine and dentistry are studied in different schools, organized within different associations and have different rules of ethics. Are they two different professions or only two branches of the same profession? The paper discusses these matters and tries to see if there is any difference between the responsibilities of professionals in oral health care as opposed to professionals in other health or medical care.     

The right to medical care

The right to medical care, as a category of human rights, falls under the heading of Leistungsrechte; that is, rights of the individual that require of the state that it do something--in this instance to provide the services concerned. In South Africa the government's health care policy contemplated involves (a) differentiation based on race in the provision of health care services; and (b) privatization of such services. It is submitted that in developing societies, where private initiative cannot cope with the demands in respect of health care, privatization would be premature and existing inequalities in health care services provided for the different racial groups require greater government involvement, with a view to eliminating racial discrimination through programmes of affirmative action. Privatization, furthermore, requires government-sponsored incentives, such as tax concessions, that would inspire private persons to contribute financially towards health care services.     

Psychiatric nursing care in Brazil: legal and ethical aspects

Human rights, considered as rights inherent to all human beings, must be respected unconditionally, especially during health care delivery. These rights became actually protected by International Law when the UN was created in 1945 and, later, when the Universal Declaration of Human Rights was issued in 1948, giving rise to various subsequent treaties. Based on the historical evolution of Human Rights in the international sphere, associated with the principles of constitutional, penal and civil law and psychiatric patient rights in Brazil, we aim to understand some dilemmas of psychiatric nursing care: individuals' rights as psychiatric patients, hospitalization and nursing professionals' practice. In their practice, nurses attempt to conciliate patients' rights with their legal role and concerns with high-quality psychiatric care. In coping with these dilemmas, these professionals are active in three spheres: as health care providers, as employees of a health organization and as citizens.     

Mental health and quality of mental health care

Mental health is an intrinsic part of health. Its prevailing position as secondary to physical health and its consequent neglect are based on inaccurate assumptions about mental health. Nowhere in the world, in either the developed or the developing countries, has mental health work been given priority as part of social policy, health policy or public policy. Yet all countries readily admit the major impact of mental health disturbances on the national economy and public health. The mentally sick are at the bottom of the list in service systems the world over, and the common attitude towards them tends to be highly negative. Meanwhile there is convincing evidence of the global and growing need for mental health services. The international debate on mental health policy has its origins in two arenas: in human rights issues and in service reform issues. The debate on human rights concerns legislation on mental health, compulsory treatment and coercive measures. As to the service reform process, the universal focus has been on the financing of health care, on cuts and downsizing, where no priority has been given to the quality of care. The social consequences of mental illnesses may be far more seriously marginalising for the patient than is the illness itself. They are caused by the inexperience and the exclusion mechanisms of the social community. They are evident also in non-institutional services, causing isolation and rejection. The state of mental health patients will not improve without the strong involvement of health policy planners, quality assurance developers and the medical and scientific community. We need far more studies and research in the field. We need also the empowerment of the patients themselves and their relatives.     

The Bulgarian Health Care Reform and Health Act 2004

Since 1997 post-communist Bulgaria has started structural and financial Health Care reform. The reform's framework is laid down by new health legislation. The main law regulating the broad framework of the health system is the Bulgarian Health Act (BHA) 2004 which came into force in January 2005. The aim of this paper is to introduce and analyze the main features of the Bulgarian Health Care Reform and Health Care Act 2004. Key issues in BHA include: organization and financing of health care; health protection; health promotion, patients' rights, accessibility and quality of health care, mental health, alternative medical services, medical education, medical profession and medical science, and administrative-punitive measures. BHA is a policy document justifying that Bulgaria is prepared and willing to meet the challenge to bring the health status of the Bulgarian population to the current average European health level, as well as that in the EU Member States.     

Balancing the need for innovative drugs while providing lower cost alternatives to consumers: Hatch-Waxman reviewed

There is a long continuum of differing positions amongst academia, the private sector, and the public sector in determining the appropriate balance between providing incentives to both innovator drug companies and generic drug manufacturers, while at the same time also protecting legitimate patent rights. Juxtaposed to these issues is the fact that the cost of biomedical research is enormous and it continues to grow as the government seeks to provide for the health and welfare of a public that not only seeks therapeutic medicine and medical care when sick, but also wants prophylactic and diagnostic products. Furthermore, personalized medicine, resulting from the advances in functional genomics and new and increased use of lifestyle drugs providing therapies ranging from male pattern baldness to erectile dysfunction, is indicative of the ever-increasing expectations for a greater range of products. The debate then is not only how to make such products available but also how to make them affordable. With more than 500 drug patents scheduled to expire between 2004 and 2009 (with 26 of these drugs accounting for more than 38 billion dollars in sales annually), the stakes are high, for not only the generic and brand name manufacturers, but also for the consumer.     

The number and distribution of computerised tomography scanners in Turkey

The goal of this study was to investigate the number and distribution of CT scanners in Turkey. Our results show 173 CT scanners in Turkey in 1994, which equals 2.9 scanners per million people. All of the scanners are located in 45 cities, where 81 % of the population resides. The other 31 cities in Turkey have no scanners. Of the 173 scanners, 103 (59.6 %) are owned by the private sector and the other 70 are owned by the public sector. Of Turkey's CT scanners, 49.2 % are located in private health centres, 21.9 % in university hospitals, 16.7 % in Ministry of Health (MOH) hospitals, 10.4 % in private hospitals and 1.8 % in social security hospitals. Received: 7 August 1998; Revision received: 13 November 1998; Accepted: 17 November 1998     

Accommodaton of constitutional due process rights within the new patients' rights legislation in Slovenia

The Constitutional Court of the Republic of Slovenia issued several decisions concerning the protection of patients' rights (e.g. decisions on involuntary commitment, on access to health care, on rights related to obligatory and voluntary health insurance). Consequently, the Parliament renewed Health Legislation by the enactment of the Patients' Rights Act (February 2008) and of the Mental Health Act (July 2008). Both bills enshrine a charter of patients' rights that may be considered as concretization of several human rights that are protected by the Constitution. The discussion is focused on the due process rights (e.g. equal protection of rights, right to judicial protection, right to legal remedies, legal guarantees in proceedings related to deprivation of personal liberty) that were in particular addressed by the Court. The results demonstrate that their effective implementation was one of the most important demands that the Legislature had to accommodate when enacting new bills.     

Healthcare law in France: towards healthcare emancipation for minors

In France, since 1974 the rights of minors have been gaining ground. The first provisions to this end concerned medical acts in relation to the minor's sexuality (contraceptives and pregnancy termination). The law dated March 4, 2002, relating to patients' rights, gave more scope to this movement, by widening minors' rights so that they could demand confidentiality with regard to their parents. The minor's exercising of these rights can pose a lot of problems. In French law, parental authority is the main representation of the minor. The medical doctor treating a minor must obtain parental authorization. However, the public healthcare code provides that the doctor can override parental wishes during some situations (emergency; parents refuse). But these situations are exceptional. Since 2002, the legislator has gone further, by allowing the doctor to grant requests for care by the minor without parental authorization. However, parental authority remains the normal framework for the protection of a minor. The doctor will have to judge the reasoning and motives of a minor requesting confidentiality regarding their parents in order to decide whether he should grant or refuse care in such conditions.     

Has Israel and the Russian Federation legislation a full set of laws securing the protection of mental patients relative to United Nations' proposals and do they require modification?

This paper compares sections of laws dealing with the care and protection of mental patients in Israel and in the Russian Federation and matches them with the 24 recommendations on the subject proposed by the United Nations (UN) in 1988. Particular attention is given to issues related to forensic and ethical subjects. The UN proposals constitute a most laudable reform-inducing guideline for global mental health care systems, especially because of their emphasis on the preservation of mental patients' basic human rights. The proposals' strength springs from their influence regarding the prevention of misuse of psychiatry with focus on the care of inpatients and control over executive agencies. The detailed analysis of the similarities between the Israeli and Russian legislative approach reveals some badly matched organizational structure of many articles in comparison with the UN mandate. Forensic and ethical concepts present in the UN 1988 proposals are well addressed in both the Israeli and Russian mental health legislation. We conclude that the 1991 UN recommendations would demand further modification of the national standards.