1. Vaccines immunize people; legislation immunizes vaccine manufacturers. Legislation in the United States Regulating liability for the manufacture, distribution and administration of vaccinesThomas Allan Heller, 2021, izvirni znanstveni članek Opis: Infectious diseases have caused widespread misery, and have wreaked havoc physically, mentally, economically, politically, and socially. Fortunately, in more recent years, scientists have developed vaccines. Vaccines are generally very safe, but cause side effects in a small percentage of cases. The United States Congress has passed two major pieces of legislation that provide sweeping tort immunity to vaccine manufacturers and others. In 1986 Congress passed the National Childhood Vaccine Injury Act (NCVIA) and in 2005 it passed the Public Readiness and Emergency Preparedness Act (PREP ACT). Both Acts were passed to encourage manufacturers to develop vaccines, particularly in times of public emergencies, in exchange for expansive liability protection. Both Acts established no-fault type compensation schemes to compensate those suffering injury or death from vaccines without having to resort to typical litigation. The author discusses both Acts in detail, in the context of the current Covid-19 crisis.
Ključne besede: vaccines, pandemics, Public Readiness and Emergency Preparedness Act, immunity from liability, National Childhood Vaccine Injury Act
Objavljeno v DKUM: 19.08.2024; Ogledov: 68; Prenosov: 8
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2. Obligatory insurance as a form of social engineering : a comparison paper between the United States, Italy, Aruba and PolandThomas Allan Heller, Silvia Rigoldi, Jessica Burgos, Mateusz Sasinowski, 2019, izvirni znanstveni članek Opis: Insurance has been around for centuries. Traditionally, it has been purchased to protect the purchaser, namely, the insured. Over time, the insurance industry has developed an increasing number of products, so that at present one can purchase insurance to cover nearly every risk imaginable. The concept of mandatory or obligatory insurance is a fairly recent development. It traces its origins to the widespread use of the motor vehicle and also employment. Obligatory insurance is designed to protect certain classes of persons, such as workers and those who sustain injury and damage at the hands of others. In this article, the authors compare the current state of obligatory insurance in four democratic countries: the United States, Italy, Aruba and Poland. The aim of the article is to catalogue the similarities and differences in obligatory insurance in those four countries. The countries studied all have obligatory insurance designed to offer some degree of protection to workers injured on the job, and in the course and scope of their work, and to those involved in vehicular collisions. The other primary takeaway from our research is that, predictably, there is less obligatory insurance in the United States than in the other countries studied.
Ključne besede: obligatory insurance, obligatory motor vehicle insurance, obligatory health insurance, obligatory professional liability insurance, workers, compensation insurance, social insurance
Objavljeno v DKUM: 15.01.2021; Ogledov: 898; Prenosov: 21
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4. Selected legal problems of EEG biofeedback therapy under the Polish lawAleksandra Nowak-Gruca, 2018, izvirni znanstveni članek Opis: The use of EEG biofeedback for therapeutic or healing purposes has its justification in modern research and recently one can notice the increasing popularity of this method. Possible threats which may be associated with improper training and EEG biofeedback therapy may result from error in the diagnosis or incorrect selection of the training protocol. The effectiveness of therapy depends largely on the efforts of the patient himself, however, the range of waves will be amplified or suppressed by diagnosticians and therapists. If during an EEG biofeedback, the correct neuronal signal is amplified or suppressed, this can have adverse effects. In Poland, there are no legal regulations regarding the acquisition of qualifications for conducting neurotherapy. Likewise, there are no indications as to which institutions have the right to assign appropriate powers to use this type of apparatus. The lack of legal regulations means that now everyone can practice neurotherapy. The article presents selected legal problems related to conducting EEG biofeedback therapy under law, especially under Polish regulations, including the problem of the responsibility of the therapist or trainer.
Ključne besede: EEG biofeedback, EEG applications, neurotheraphy, neurotherapist, legal liability, medical device, medical profession, patient's consent to treatment
Objavljeno v DKUM: 09.10.2018; Ogledov: 1408; Prenosov: 200
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5. Combating counterfeiting of medicines in the Republic of Belarus : legal analysisPavel Saschenko, 2017, izvirni znanstveni članek Opis: Counterfeiting of medicines constitutes as a threat to public health, which nowadays has a “pandemic character”. In this regard, the legislation of the Republic of Belarus should properly address the risks caused by counterfeited medicines. Being a member of several economic alliances aimed at simplifying turnover of goods, including medical products, Belarus needs to develop comprehensive preventive measures and provide effective and proportionate criminal and other sanctions for the commission of acts connected with counterfeiting of medicines. This article focuses on key factors which impact the development of Belorussian legislation. The main obstacles for effective international cooperation in criminal matters concerning turnover of counterfeit medicines are also explored. Amendments to legislation aimed at improving the effectiveness of combating counterfeiting of medicines will also be discussed.
Ključne besede: medicine, counterfeiting of medicines, crime, criminal liability, administrative liability, Belarus
Objavljeno v DKUM: 09.10.2018; Ogledov: 1351; Prenosov: 96
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6. Patient's right to protection of personal data in the legal system of Bosnia and HerzegovinaMarko Bevanda, Maja Čolaković, 2017, izvirni znanstveni članek Opis: Health-related personal data belong to a category of sensitive data which, therefore, must be specially protected. The protection of personal health data is one of the patients´ fundamental rights. Doctors protect their patients´ interests only when the information gained about patients, while providing them medical treatment, are kept secret. In this paper, the authors provide an overview of the legal framework for the protection of health-related personal data in the legal system of Bosnia and Herzegovina. In addition to the analysis of the relevant legal provisions and considering the situation in practice, it can be concluded that formal harmonisation of legislation with the acquis communautaire in this field is not followed by effective implementation of regulation in practice.
Ključne besede: privacy, doctor, medical malpractice, liability for damage
Objavljeno v DKUM: 09.10.2018; Ogledov: 1070; Prenosov: 155
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7. No fault compensation for medical injuriesVojko Flis, 2016, pregledni znanstveni članek Opis: For decades in both Europe and the United states , the issue of compensation for victims f medical injuries has led to lively debates. Many scholars have analyzed the adverse effects of the "tort system" (based on negligence standards and court proceedings) on the increasing costs of insurance premiums, on the patient-doctor relationship and the quality of care. These debates have led to changes in compensation in some countries. Compensation would be based not on negligence, but rather on a broader avoidable medical injury standard. Some nations have long operated administrative schemes based on no fault principle. No fault compensation model for victims of medical injuries might be characterized by the choices it makes regarding some key issues: (a) the definition of compensation criteria in particular the status given to fault; (b) the organization of the decision -making process. What type of body adjudicates medical claims? (c) Who finances the mechanism. What injuries are likely to be compensated for, to what extent and by whom? This article reviews the origins and operations of the no fault systems, the evolution of their compensation criteria, and how these criteria are actually applied.
Ključne besede: injury, compensation, liability, medical errors, negligence
Objavljeno v DKUM: 08.10.2018; Ogledov: 1690; Prenosov: 161
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8. Medical-legal aspects of confidentiality in the field of pharmaceutical health careHajrija Mujovic, 2017, izvirni znanstveni članek Opis: The field of pharmaceutical health care is becoming increasingly established. Modernly, pharmacists learn more from patients about their prescriptions and other very personal, sensitive information. However, having access to an ever-increasing amount of sensitive, personal information raises serious issues pertaining to patient secrets and confidentiality. The term professional secrecy (hereinafter confidentiality) as well as any other form of discretion connected with a professional activity is construed broadly. However, the precise scope of confidentiality is not strictly defined in legislation. Obligation of professional secrecy has been diminished partly due to the general progress in a society and the progress of medical professions. The development of the protection of human rights is a continuous process.
Ključne besede: pharmaceutical services, privacy, confidentiality, professional secrecy, liability
Objavljeno v DKUM: 02.08.2018; Ogledov: 986; Prenosov: 72
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9. The implementation of the antitrust damages directive in Slovenia : tensions with the (lurking) preventive character of liability in damages?Petra Weingerl, 2016, izvirni znanstveni članek Opis: In December 2016, Member States need to implement the Antitrust Damages Directive. The Directive adopts the full compensation principle and expressly prohibits overcompensation. I will embark on an enquiry whether such an approach departs from the Slovene general regime of civil liability, in particular liability in damages. At face value, one might argue that the Slovene civil liability regime prohibits non- compensatory rationales for awarding damages. This article challenges this perception. It argues that there is a space for interpreting the rationale for damages in the Slovene private law, when this is justified with dissuasiveness and sufficient reasons are given, as well as embracing non- compensatory considerations, prevention and deterrence in particular. Regrettably, the judiciary does not necessarily keep in step with such an interpretation. However, there are tendencies in the legal scholarship to change the established case law. In this setting, the special liability regime based on the Directive, which prohibits overcompensation, can be seen as an exception to the general regime for damages awards in certain contexts. This approach is contrasted with damages awards regime in the labour law context, which is also based on the EU regulation. In this context, the Slovene legislator expressly embraced prevention and deterrence as rationales for the award of damages. Thus, legislation which is based on or influenced by EU law can lead to different outcomes in practice. It can either reinforce preventive tendencies of the general regime of civil liability or, as it is seen in the competition law context, undermine them. Nevertheless, the (proposed) Slovene implementing legislation opts for a solution that accommodates both the Antitrust Damages Directive and the general regime of civil liability.
Ključne besede: Antitrust Damages Directive, civil liability, damages, full compensation, prevention, deterrence
Objavljeno v DKUM: 02.08.2018; Ogledov: 1149; Prenosov: 81
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