Language and Meaning: Asymptomatic Alzheimer's Disease in the Clinic and Society.

As the biological, biomarker-driven framework of Alzheimer's disease (AD) becomes formalized through revised, consensus clinical criteria, clinicians will confront more and more patients in the earliest, asymptomatic stages of disease. The language and diction used by practitioners to characterize these early patients, whether they are diagnosed with AD, and how their condition is documented in medical and legal records have important implications for both their care and their medical-legal status outside of the health system. Investigation is needed urgently to better understand clinicians' views and practices regarding early AD, as we adapt to new disease definitions in this unprecedented era of care.

Creating an Unprotected Class: Addressing Legal Risks in the Era of Biologically-Defined Alzheimer's Disease.

Background: Documentation of preclinical biomarker tests for Alzheimer's disease (AD) in the medical record may expose patients to employment and insurance discrimination risks. There is a gap in research describing clinicians' approaches to documenting biomarker results. Objective: To evaluate discrimination risks faced by patients undergoing biomarker testing for AD through a qualitative analysis of clinician documentation practices. Methods: Semi-structured interviews using hypothetical patient scenarios. The qualitative analysis focused on interviewees' responses related to documentation and disclosure of results. Results: We collected and analyzed 17 interviews with dementia experts; and identified three approaches to documenting biomarkers as: an association with active AD, noninformative, and an increased susceptibility for AD. Those who associated biomarkers with active disease were more likely to favor disclosure to employers and insurers, which could increase discrimination risks. Conclusions: This study demonstrates the variety of documentation and disclosure practices likely to emerge for preclinical AD biomarker tests and highlights a need for guidelines in this area.

Medicolegal aspects of domestic violence against children.

The routine of the dental profession exposes dentists not only to medical challenges but also to ethical and legal ones. Compared to other physicians, dentists are more likely to encounter children who are victims of domestic violence. This reality exposes them to legal liability due to the reporting obligations and the risk of misdiagnosing injuries. This paper aims to examine the importance of dentists in diagnosing injuries to children caused by domestic violence and the inherent dangers of failing to make such a diagnosis.

Medico-legal liability of injuries arising from laryngoscopy.

OBJECTIVE: Dental and mucosal injuries from laryngoscopy in the peri-operative period are common medico-legal complaints. This study investigated lawsuits arising from laryngoscopy. METHODS: Westlaw, a legal database containing trial records from across the USA, was retrospectively reviewed. Plaintiff and/or defendant characteristics, claimed injuries, legal outcomes and awards were extracted. RESULTS: Of all laryngoscopy-related dental or mucosal injuries brought before a state or federal court, none (0 per cent) resulted in a defence verdict against the provider or monetary gain for the patient. Rulings in the patient's favour were observed only when laryngoscopy was found to be the proximate cause of multiple compounding complications that culminated in severe medical outcomes such as exsanguination, septic shock or cardiopulmonary arrest. CONCLUSION: Proper laryngoscopy technique and a robust informed-consent process that accurately sets patients' expectations reduces litigation risk. Future litigation pursuits should consider the low likelihood of malpractice allegation success at trial.

Professional liability subsequent to the Cartabia Reform: implications for pathologists.

The Cartabia Reform modifies the standard used by the Public Prosecutor for the submission of requests for filing or referral for trial. The standard has shifted to the "reasonable prediction of conviction" by moving the principle of in dubio pro reo to the investigation phase. The scope of the legislative amendment is focused on protecting the rights of investigated individuals, who are too often brought to trial without adequate supporting evidence. The implications that this reform has on legal proceedings concerning the criminal liability of healthcare professionals, including pathologists, is discussed.

Telemedicine and the standard of care: a call for a new approach?

Telemedicine, understood as the provision of health care by a health professional to a patient who is physically not in the same location as the health professional, has many actual and potential benefits. It also has some disadvantages though, including a higher risk of misdiagnosis or another unfavorable outcome of certain remotely-provided services. In principle, the regime of legal liability for medical malpractice is the same for telemedicine as for traditional physical care. The general outline of the standard of care, which includes respect for medical science, the patient's individuality and objective possibilities, is abstract and flexible enough to be used for remote care without the need for redefinition. The quality of health care should be evaluated on the basis of the whole scale of risks and benefits it brings to a particular patient, including accessibility and comfort. In general, it should be permissible to provide a medical service remotely on the condition that its overall quality is at least as good as its comparable physical alternative. In other words, certain decrease in quality of some aspects of remote care can be compensated by other advantages. In terms of public health, support for telemedicine may bring a great improvement in the access to health care, and thus help significantly the individual members of the population. From the individual perspective, respect for personal autonomy implies that a patient should have every right to opt for a remote service, provided that there exists a true choice between meaningful options which is made on the basis of full information. If telemedicine is to fulfill its potential without sacrificing the protection of patients and their rights, reasonable guidelines for remote services need to be defined for particular medical fields, and for specific procedures within them. Among other issues, these guidelines must address the question of when it is necessary to refer the patient to physical care.

Judicial and legislative practice and related suggestions on off-label drug use in China.

BACKGROUND: Off-label drug use exists widely in medical practice and is also an area which easily triggers controversy between patients and medical institutions. Previous studies have identified the reasons why off-label drug use long exists. However, there is no multidimensional analysis on real judicial precedents about off-label drug use. This study aimed to investigate the dispute points on off-label drug use based on real cases in China, and proposed suggestions based on newly-leased Physicians Law. METHODS: Our study is a retrospective study with all the 35 judicial precedents on off-label drug use extracted from China Judgments Online from 2014 to 2019. This study mainly used the methods of statistical analysis, inferential analysis, exemplification, literature summarization and comparative analysis. RESULTS: According to the analysis of the 35 precedents of jurisdictions from 11 different aspects, it can be seen that the second-instance and retrial rates of this kind of cases are high, and the disputes between patients and medical institutions are fierce. In judicial practice of off-label drug use, medical institutions are determined whether to bear civil liability according to the constituent elements of medical tort liability: the rate of medical institutions' bearing liability for off-label drug use is not high, and medical institutions are not directly identified as infringing acts and they don't bear tort liability. The clear provisions about off-label drug use in Law of the People's Republic of China on Physicians which was implemented in March 2022 confirm this at the legislative level. CONCLUSIONS: By analyzing the current judicial practice of China's off-label drug use cases, and summarizing the dispute points between medical institution and patients, the constituent elements of tort liability, and the rules of evidence etc., suggestions are proposed to further regulate off-label drug use and promote safe and rational drug use.

On the Possible Ethical Risks and Corresponding Prevention Paths of ChatGPT in the Medical Field / 中国医学伦理学

With the continuous development of artificial intelligence technology, ChatGPT, as an emerging natural language processing technology, although there is currently no mature application mode, its application prospects in the medical field are becoming increasingly broad. However, its application also faces some possible ethical risks and challenges, including personal privacy data leakage, discrimination and bias in machine algorithms, difficulty in defining responsibility, inexplicability of algorithms, and lack of supervision and so on. It is necessary to strengthen the training of relevant personnel, guide public opinion to pay attention to risks, focus on algorithm validation standards, emphasize multi-party cooperation and co-governance, strengthen medical ethics research, as well as deepen regulatory supervision and standardization construction to solve the above problems.

Artificial Intelligence in Medicine: Issues When Determining Negligence.

The introduction of novel medical technology, such as artificial intelligence (AI), into traditional clinical practice presents legal liability challenges that need to be squarely addressed by litigants and courts when something goes wrong. Some of the most promising applications for the use of AI in medicine will lead to vexed liability questions. As AI in health care is in its relative infancy, there is a paucity of case law globally upon which to draw. This article analyses medical malpractice where AI is involved, what problems arise when applying the tort of negligence - such as establishing the essential elements of breach of duty of care and causation - and how can these can be addressed. Product liability under Australian Consumer Law is beyond the scope of this article. In order to address this question, the article: (1) identifies the general problems that black box AI causes in the health care sector; (2) identifies the problems that will arise in establishing breach and causation due to the "black box" nature of AI, with reference to the Civil Liability Act 2002 (NSW) and common law through two hypothetical examples; and (3) considers selected legal solutions to the problems caused by "black box" AI.

Reclamações fundamentadas de âmbito odontológico no PROCON do estado da Paraíba / Grounded dental complaints in PROCON of the state of Paraíba

Introdução: A relação entre pacientes e profissionais, vista como contratação de prestação serviços, em conjunto com o advento do Código de Defesa do Consumidor, traz como consequência o maior conhecimento sobre direitos por parte dos consumidores, os quais passaram, com mais frequência, a reclamar e a buscar ressarcimentos pelos possíveis danos causados. Objetivo: Analisar as reclamações fundamentadas de âmbito odontológico obtidas do PROCON da Paraíba. Material e Métodos: Estudo observacional documental, com universo composto de todos os processos de reclamações fundamentadas oriundos dos relatórios disponibilizados, através do Sistema Nacional de Informações de Defesa do Consumidor, pelo PROCON da Paraíba, sendo a amostra representada pelas reclamações de âmbito odontológico entre 2015 e 2021, as quais foram analisadas de forma descritiva. Resultados: Foram registradas 13.893 reclamações fundamentadas, sendo 66 de âmbito odontológico (0,47%); o ano com maior percentual encontrado foi o de 2020 (0,73%); das reclamações de âmbito odontológico, houve maior frequência de casos relacionados aos planos odontológicos (66,66%), seguidos das clínicas ou consultórios odontológicos (31,81%), restando apenas uma reclamação registrada na categoria cirurgiões-dentistas (1,51%); os principais motivos relatados foram problemas com o Serviço de Atendimento ao Consumidor (SAC), cobrança indevida ou não autorizada e publicidade enganosa; e houve predominância de atendimentos às reivindicações. Conclusão: Não houve constância de crescimento das reclamações de âmbito odontológico obtidas do PROCON/PB entre os anos de 2015 a 2021, os planos odontológicos constituíram seu maior alvo, tendo como principal motivo a reclamação contra o SAC

Introduction: The relationship between patients and professionals, seen as contracting services, together with the advent of the Consumer Protection Code, brings as a consequence greater knowledge about rights on the part of consumers, who have more often claim and seek compensation for possible damages caused. Objective: To analyze substantiated dental complaints obtained from PROCON in Paraíba. Material and Methods: Observational documentary study, with a universe composed of all substantiated complaints processes arising from the reports made available, through the National Consumer Protection Information System, by PROCON of Paraíba, with the sample represented by dental complaints between 2015 and 2021, which were analyzed in a descriptive way. Results: 13,893 substantiated complaints were registered, of which 66 were related to dentistry (0.47%); the year with the highest percentage found was 2020 (0.73%); of dental complaints, there was a higher frequency of cases related to dental plans (66.66%), followed by dental clinics or offices (31.81%), leaving only one complaint registered in the dental surgeons category (1.51% ); the main reasons reported were problems with the Customer Service (SAC), improper or unauthorized billing and misleading advertising; and there was a predominance of requests for assistance. Conclusion: There was no constant growth in dental complaints obtained from PROCON/PB between the years 2015 to 2021, dental plans were its biggest target, with the main reason being the complaint against the SAC

Health Care Workers' Legal Liability and Immunity During the COVID-19 Pandemic.

The coronavirus disease (COVID-19) pandemic is the most unprecedented crisis facing modern health care governance in a century. Many health care activities are attracting scrutiny from ethical and legal perspectives. Therefore, health care professionals are concerned about legal ambiguity regarding legal liability and immunity in their areas of practice. Law is a key response activity that promotes a sense of safety and security among health care workers. This article describes why it is important formally to address issues of altered operations in health care practice during emergencies. Furthermore, this article provides suggestions regarding solutions to the issue of legal liability during disasters. Implementing ethical and legal clarity during a disaster response is necessary for a strong health care system at international and local levels to achieve a stable health care workforce operating for the public good within a safe and secure working environment.

Definition of legal concept of pharmaceutical care and its legal liability / 中国药房

OBJECTIVE To pro vide so lutions for the appli cation of legal liability caused by the confusion of the concept of pharmaceutical care. METHODS Literature research and comparative method were adopted to clarify the legal concept of pharmaceutical care ，analyze the civil and administrative liabilities arising from different forms of pharmaceutical care ，and standardize the new responsibilities of pharmacists in pharmaceutical care. RESULTS & CONCLUSIONS The legal concept of pharmaceutical care has the function of judgement standard. Only such behaviors can belong to pharmacists ’liability under legal regulation，which are based on mutual agreements ，ensure the public medication safety and optimize patient treatment effect through the application of pharmaceutical expertise related to drug treatment. Under this definition ，the civil liability of pharmaceutical care needs to distinguish the professional degree of pharmaceutical care in different situations ，so as to establish a typed civil liability system and provide different levels of protection for patients ；regarding administrative liability ，it is necessary to improve the pharmaceutical regulatory system with the dual core of the Drug Administration Law and the Pharmacist Law from the perspective of liability integration.

Educational needs of medical practitioners about medical billing: a scoping review of the literature.

INTRODUCTION: The World Health Organization has suggested the solution to health system waste caused by incorrect billing and fraud is policing and prosecution. However, a growing body of evidence suggests leakage may not always be fraudulent or corrupt, with researchers suggesting medical practitioners may sometimes struggle to understand increasingly complex legal requirements around health financing and billing transactions, which may be improved through education. To explore this phenomenon further, we undertook a scoping review of the literature to identify the medical billing education needs of medical practitioners and whether those needs are being met. METHODS: Eligible records included English language materials published between 1 January 2000 and 4 May 2020. Searches were conducted on MEDLINE, PubMed, Google Scholar, CINAHL, LexisNexis and Heinonline. RESULTS: We identified 74 records as directly relevant to the search criteria. Despite undertaking a comprehensive, English language search, with no country restrictions, studies meeting the inclusion criteria were limited to three countries (Australia, Canada, US), indicating a need for further work internationally. The literature suggests the education needs of medical practitioners in relation to medical billing compliance are not being met and medical practitioners desire more education on this topic. Evidence suggests education may be effective in improving medical billing compliance and reducing waste in health systems. There is broad agreement amongst medical education stakeholders in multiple jurisdictions that medical billing should be viewed as a core competency of medical education, though there is an apparent inertia to include this competency in medical education curricula. Penalties for non-compliant medical billing are serious and medical practitioners are at risk of random audits and investigations for breaches of sometimes incomprehensible, and highly interpretive regulations they may never have been taught. CONCLUSION: Despite acknowledged significance of waste in health systems due to poor practitioner knowledge of billing practices, there has been very little research to date on education interventions to improve health system efficiency at a practitioner level.

EXPERIMENTAL MODEL OF AN INTEGRATED APPROACH TO THE TRAINING OF LEGAL AND HEALTH CARE PROFESSIONALS ON ISSUES OF INFECTION WITH ESPECIALLY DANGEROUS INFECTIOUS DISEASES.

OBJECTIVE: The aim: Developing integration training (educational) programs for medical and legal students, interns, masters, doctors. PATIENTS AND METHODS: Material and methods: When performing the work, on a set of search and analytical methods: analytical, bibliographic, systemic, informational, statistical; interdisciplinary interactive teaching methods for students of Sumy State University. RESULTS: Results: The results of the integrated training course are the formation of a new style of interdisciplinary relations between participants of the educational process and practical medicine and jurisprudence; new educational environment; classes with multi - and transdisciplinary experts-consultants; development of personal attitudes, future professional contacts, and practical skills. CONCLUSION: Conclusions: The introduction of new teaching methods using an interdisciplinary integrated approach increases the level of education quality (35.8% higher than the initial result) and conduct applied research in the field of public health, jurisprudence.

Proteção jurídica dos profissionais de saúde envolvidos no atendimento em contexto da pandemia da COVID-19 / Legal protection of health professionals involved in care in the context of the COVID-19 pandemic / Protección jurídica de los profesionales sanitarios involucrados en la atención en el contexto de la pandemia COVID-19

A COVID-19 é a primeira crise contemporânea de saúde pública com potencial para sobrecarregar o sistema público de saúde mundial. A assistência à saúde é um recurso da sociedade compartilhada e, portanto, os princípios éticos que orientam seu racionamento exigem que serviços, medicamentos e equipamentos sejam aplicados onde forem mais eficazes, o que prioriza os pacientes com maior probabilidade de se beneficiar do tratamento. Os prestadores de serviços de saúde tomam decisões racionais com recursos escassos e merecem uma liberdade considerável para as suas deliberações de boa-fé, guiadas por estruturas éticas estabelecidas. O padrão de atendimento adequadamente aplicado sofre modulação em sua aplicação, o que requer uma mitigação da responsabilidade civil médica dentro de certos parâmetros objetivos. A lógica normativa é fundamentada no princípio da reciprocidade. Quando a sociedade pede que alguns de seus membros corram grandes riscos pessoais ao servir os interesses do público, é razoável esperar que a sociedade assuma algumas responsabilidades por eles em troca dos riscos assumidos. É apropriado que os formuladores de políticas públicas articulem padrões de atendimento especiais para desastres em massa, como a COVID-19. O objetivo do artigo é identificar como, no Brasil, Portugal e Espanha, a objetiva alteração das circunstâncias impôs a adequação da análise judicial de padrões de conduta profissionais a um panorama de calamidade.

COVID-19 is the first contemporary public health crisis with the potential to overwhelm the public health system worldwide. Health care is a resource of the shared society and, therefore, the ethical principles that guide its rationing require that services, medicines and equipment be applied where they are most effective, which prioritizes patients most likely to benefit from treatment. Health service providers make rational decisions with scarce resources, and deserve considerable freedom for their deliberations in good faith guided by established ethical structures. The standard of care properly applied is modulated in its application, which requires a mitigation of medical liability within certain objective parameters. The normative logic is based on the principle of reciprocity. When society asks some of its members to take great personal risks in serving the interests of the public, it is reasonable to expect society to take some responsibility for themin exchange for the risks taken. It is appropriate for public policy makers to articulate special care standards for mass disasters, such as COVID-19. The objective of the article is to identify how in Brazil, Portugal and Spain, the change in circumstances imposed the adequacy of the judicial analysis of professional standards of conduct to a panorama of calamity.

COVID-19 es la primera crisis de salud pública contemporánea con el potencial de abrumar al sistema de salud pública en todo el mundo. La atención de la salud es un recurso de la sociedad compartida y, por tanto, los principios éticos que orientan su racionamiento exigen que los servicios, medicamentos y equipos se apliquen donde sean más efectivos, lo que prioriza a los pacientes con mayor probabilidad de beneficiarse del tratamiento. Los proveedores de servicios de salud toman decisiones racionales con recursos escasos y merecen una libertad considerable para sus deliberaciones de buena fe guiadas por estructuras éticas establecidas. El estándar de atención aplicado correctamente se modula en su aplicación, lo que requiere una mitigación de la responsabilidad médica dentro de ciertos parámetros objetivos. La lógica normativa se basa en el principio de reciprocidad. Cuando la sociedad pide a algunos de sus miembros que asuman grandes riesgos personales para servir a los intereses del público, es razonable esperar que la sociedad asuma alguna responsabilidad por ellos a cambio de los riesgos asumidos. Es apropiado que los formuladores de políticas públicas articulen estándares de atención especial para desastres masivos, como la COVID-19. El objetivo del artículo es identificar cómo en Brasil, Portugal y España, el cambio objetivo de circunstancias impuso la adecuación del análisis judicial de los estándares de conducta profesional a un panorama de calamidad.

A prospective evaluation of treatment recommendations compared to outcomes for a lung cancer multidisciplinary team and legal implications.

INTRODUCTION: This cross-sectional study compared treatment recommendations made by a respiratory multi-disciplinary team with the treatment received by those patients in practice. The aim was to evaluate the rate at which patients were treated in keeping with MDT recommendations. It was hypothesised that most patients would be treated in accordance with these recommendations. These data were then used to provide a practical basis to consider the potential legal liability of multi-disciplinary teams. METHODS: All patients discussed in the Princess Alexandra Hospital Lung MDT over a three-month period were included. The recommendations made by the MDT were compared with the treatment received. Where available, the reason for any change in management plan was recorded. RESULTS: 74/109 evaluable patients were treated in accordance with the MDT recommendation. A further 7 patients had commenced treatment prior to MDT discussion. The most common reasons for change in management were patient choice (n = 6) or deterioration in clinical condition prior to treatment (n = 6). CONCLUSION: As hypothesised, there was a high rate of treatment in accordance with recommendations made by the MDT. Changes in management are mostly related to patient preference or change in condition after MDT discussion. In practice, there are only limited opportunities for an MDT to be liable for patient outcomes. It is suggested however that careful documentation and representation of cases where appropriate could further mitigate this risk.

Reciprocity and Liability Protections during the Covid-19 Pandemic.

During the Covid-19 pandemic, as resources dwindled, clinicians, health care institutions, and policymakers have expressed concern about potential legal liability for following crisis standards of care (CSC) plans. Although there is no robust empirical research to demonstrate that liability protections actually influence physician behavior, we argue that limited liability protections for health care professionals who follow established CSC plans may instead be justified by reliance on the principle of reciprocity. Expecting physicians to do something they know will harm their patients causes moral distress and suffering that may leave lasting scars. Limited liability shields are both appropriate and proportionate to the risk physicians are being asked to take in such circumstances. Under certain narrow circumstances, it remains unclear that the standard of care is sufficiently flexible to protect physicians from liability. Given this uncertainty, the likelihood that physicians would be sued for such an act, and their desire for such immunity, this limited protection is morally legitimate.

Tightening legal restrictions for drivers with epilepsy in Japan.

Epilepsy is a highly prevalent condition around the world, and many countries impose restrictions on drivers with epilepsy. After toughening the law in Japan, the number of refused driving license applications for patients with epilepsy increased markedly. However, the number of collisions caused by drivers with epilepsy did not decrease.

Risk factors for self-harm in psychiatric wards: A judicial case analysis.

Patients hospitalized in a psychiatric ward may engage in self-injurious behavior secretly, leading to fatal consequences. This study aimed to identify risk factors for self-harm in psychiatric wards. In this review, the framework of Taylor and Hignett's medical malpractice analysis was utilized. In the search conducted from March to April 2020, keywords were used to collect relevant judgments and previous studies. The final assessment comprised of 5 cases and 13 previous studies. The results of this study emphasize the creation of a ward environment where inpatients can feel secure, and the staff can actively engage in therapeutic communication.

Dentists' Legal Liability and Duty of Explanation in Dental Malpractice Litigation in Japan.

INTRODUCTION: Dental litigation accounts for approximately 10% of medical cases in Japan. This study sought to identify factors related to dentists' legal liability in Japan, including their duty to explain procedures and treatments to their patients. METHODS: We analysed court decisions in 166 dental malpractice cases litigated in Japan between 1978 and 2017. To identify factors related to the legal liability of dentists, an analysis was performed to evaluate the associations among patient characteristics, dentist characteristics, litigation, and dentists' explanatory behaviour. RESULTS: Of the 36 cases related to dentist liability, the study identified 23 cases (63.9%) of litigation in which the dentists were found to be in violation of their duty to provide an explanation. Regarding the severity of injury, the ratio of death and permanent disability was significantly higher in decisions in which the purpose of the explanation was something other than obtaining the patient's consent compared with decisions to obtain the patient's consent (P = .014). CONCLUSIONS: In cases in which the dentist was found legally responsible, the proportion of cases involving procedural negligence with the explanation of medical guidance was significantly higher. Dentists should pay careful attention not only to the patient's consent but also to their explanations, including "medical guidance." Moreover, they should recognise that inappropriate explanations correlate with serious errors.