Hasil untuk "Medical legislation"

Kenneth Färnqvist, Luisa Thiele, Sophie Johnsson et al.

Abstract BackgroundThe number of cancer survivors is steadily increasing worldwide, leading to an increased demand for long-term follow-up and supportive care. Many survivors face ongoing physical and psychosocial issues that highlight the need for innovative management approaches. Mobile health apps offer potential benefits by facilitating patient-led follow-up, self-management, and more efficient use of health care resources. Although the market for cancer-related mobile apps has grown rapidly, their sustainability and scientific basis remain unclear. In the European Union, the Medical Device Regulation (MDR), in effect since May 2021, introduced stricter criteria for classifying medical devices, including certain software apps. While aiming to improve patient safety, the MDR could pose challenges for small companies and academic developers, potentially limiting the availability of such apps. No scoping review has delineated changes in active apps before and after implementation of the legislation regulating medical devices. ObjectiveThis scoping review aimed to evaluate the current availability and longevity of English-language mobile apps supporting cancer recovery, with a specific focus on changes before and after the implementation of the European Union MDR, and to assess the extent to which these apps are supported by clinical evidence. MethodsSearches were conducted in mobile app stores (Apple’s App Store and Google Play) and literature databases (MEDLINE, Embase, Cochrane Library, and Web of Science), using predefined terms. Mobile apps targeting cancer recovery and published articles on their effectiveness were included. Two reviewers independently extracted data. A descriptive analysis was conducted to report trends in mobile device app availability and updates over time. ResultsA total of 151 mobile apps were identified in 2018. However, by 2024, only 45 of 151 (30%) were still available. Among these, 25 of 151 (17%) were updated within the past 2 years. During the search in December 2024, 1 new mobile app supported by scientific evidence was discovered. This mobile app was developed to assist cancer survivors in managing insomnia through cognitive behavioral therapy. Rapid turnover and a potential lack of sustainability in the mobile health app market for cancer survivors were evident, with most mobile apps identified in 2018 no longer available by 2024. ConclusionsThis review revealed a limited number of publicly available mobile apps that support cancer recovery. The longevity of existing mobile apps is limited, potentially because of regulatory and financial barriers. Prioritizing rigorous effectiveness trials, addressing implementation barriers, and developing sustainable business models are essential to ensure the long-term availability and success of mobile health apps in cancer survivorship care.

Alex Kalonji, Arriel Makembi Bunkete, Joseph Nsiala et al.

Introduction: Road traffic collisions are a significant global health burden, with motorcyclists facing disproportionate risks due to limited protection. In low-resource settings like Kinshasa, this vulnerability is worsened by low helmet use and deficiencies in prehospital care. Characterizing polytrauma profiles is essential to inform targeted prevention and improve critical care strategies. Objective: To describe the sociodemographic, clinical, and outcome profiles of motorcycle-related polytrauma patients admitted to intensive care units (ICUs) in Kinshasa, providing insights to inform policy and clinical practice. Materials and Methods: A retrospective, multicenter study was conducted across six ICUs in Kinshasa from January 2021 to December 2023. We included adult patients with polytrauma following motorcycle accidents. Data on demographics, injury mechanisms, clinical presentation, management, and outcomes were analyzed using chi-square and Student's t-tests. Logistic regression identified independent predictors of mortality (p < 0.05). Results: Of 450 screened cases, 238 were analyzed. The mean age was 36 ± 12 years, with men comprising 82.4%. Drivers accounted for 64.3% of victims, yet helmet use was documented in only 20.2%. Motorcycle–vehicle collisions were the primary mechanism (57.6%). Head trauma (59.7%) and musculoskeletal injuries (70.6%) predominated. Interventions included oxygen therapy (70.6%), fluid resuscitation (64.7%), and surgery (47.1%). The overall mortality rate was 38.7%. Helmet use was significantly protective, associated with a mortality rate of 25% compared to 42% in non-users (p = 0.02), highlighting its impact on outcomes. Conclusions: Strengthening helmet legislation enforcement and trauma care capacity offers a meaningful opportunity for medical researchers and public health officials to reduce preventable deaths among young males with severe injuries.

Oleksandr Bilash, Nataliia Rosul

The article is devoted to the legal regulation analysis of professional chaplaincy integration into the healthcare institutions of Ukraine, the identification of the main steps to be taken in the cooperative relations between state authorities and religious organizations in order to guarantee the rights of patients and medical workers to freedom of religion, the evolution of the health care chaplaincy starting from the volunteer movement of the clergy to their further professionalization. Based on the analysis of the legislation and the key aspects of legal regulation of chaplaincy activities in medical institutions of Ukraine, the authors have reached the conclusion that the legal status of hospital chaplains in Ukraine until 2022 reflected the religious component only, defining a chaplain rather as a clergyman, a member and a representative of a religious organization who provides pastoral, spiritual care to patients, and not as a qualified employee of a healthcare institution. Only since 2022, in the conditions of the full-scale war of the Russian Federation against Ukraine and due to the increasing public attention to the issue of regulating state-confessional relations in the field of healthcare, the status of a hospital chaplain was legally consolidated, no longer as a clergyman carrying out his activities on a voluntary basis, but as a professional in spiritual care in the sphere of healthcare. This justifies that the legal status of a chaplain in healthcare today is characterized by the presence of religious and medical elements, which affects the determination of the requirements for professional qualifications, the scope of chaplain’s authority, and the features of his pastoral activities as an employee in a healthcare institution. The article outlines the main problems of legal regulation and substantiates the main directions for improving legislation in the field of health care chaplaincy in Ukraine.

Peter McCulloch, April Shaw, Gail Gilchrist et al.

Background The barriers and facilitators to engagement with Opiate Substitute Treatment and Needle and Syringe Provision need to be better understood to develop interventions to attract people into services. Objective(s) We conducted a multi-method realist evaluation to generate an in-depth theory of the factors that influence the optimal provision of services in terms of access, engagement, retention and successful exit. Design Multi-method involving an online survey of United Kingdom drug and alcohol service commissioning leads and a meta-synthesis of qualitative literature (phase 1) to facilitate the development of an initial theory of optimal provision; and, in phase 2, a realist evaluation to test and refine the initial theory, involving in-depth interviews across three United Kingdom sites, with service commissioners, managers, staff and service users. We used routine treatment and staffing data to estimate the additional staff costs of implementing optimal service provision within one context of our refined theory. Results Findings indicated that optimal provision could be understood with reference to five main contexts [(1) agency and empowerment, (2) self-esteem and respect, (3) knowledge and communication, (4) goals, needs and preferences and (5) resources and demands]. The analysis suggested that optimal provision could be facilitated via specific mechanisms of action, operating at the ‘Systems level’ (policy, legislation and funding) and ‘Service level’ (delivery of services, service pathways, staff roles and responsibilities and organisational culture). Our analysis also identified the potential importance of independent ‘mediating mechanisms’ (e.g. confidence, trust and self-efficacy) which can operate to increase the likelihood of successful service outcomes. A costing analysis estimated the costs associated with a smaller caseload for shared care workers and the implementation of a salary increment scheme at one of the study sites. Limitations The survey sample size limited generalisability. There was a limited number of United Kingdom studies within the meta-synthesis. The findings of the realist evaluation highlight that provision was not optimised in the observed sites, limiting examples of best practice. However, the conceptual theory of optimal provision can direct future research to facilitate the development and implementation of optimal policy and practice. Conclusions We have provided a rich understanding of the contexts, mechanisms and actions by which optimal delivery of Opiate Substitute Treatment and Needle and Syringe Provision services may increase the likelihood of successful service provision. A multiagency approach applying various mechanisms within the various contexts of optimal provision may need to be implemented to optimise the provision. Future work Future research should focus on the development of a multiple-system toolkit or intervention to help drug services to implement optimal provision. More research is also needed to assess, the barriers and facilitators, that vulnerable underserved population and people from minority ethnic groups may face, and the mechanisms to improve provision for these populations. Study registration This study is registered as PROSPERO 2020 CRD42020209646. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129798) and is published in full in Health Technology Assessment; Vol. 29, No. 64. See the NIHR Funding and Awards website for further award information. Plain language summary The aim of the study was to explore and understand how services providing opiate substitution therapy and/or needle and syringe programmes can be improved. Specifically, the aim was to improve the services to ensure as many people as possible can access and engage with these services, be retained in these services and successfully leave services having achieved any desired outcomes (e.g. drug-free or ongoing support to achieve employment). Phase 1 of our study involved summarising all of the existing literature of qualitative studies in this area and conducting an online survey seeking the views of service managers around the United Kingdom. The findings of these research methods contributed to an initial theory of optimal service provision. In phase 2, we then conducted an in-depth consultation with a wide range of service users and staff in three study sites in the United Kingdom (two in England; one in Scotland) to test and refine the initial theory. Findings from our review of qualitative studies identified problems and deficits with service delivery. The results of our online survey gave some insight into the way in which services are currently being delivered. Data from our in-depth qualitative consultation were helpful towards understanding about the facilitators to optimal service delivery. Our refined theory of optimal provision could be understood around improving service provision in the contexts of agency and empowerment; self-esteem and respect; knowledge and communication; goals, needs and preferences; and resources and demands. In our costing analysis, we estimated the additional staff costs in one study site of facilitating characteristics of optimal service provision. Scientific summary Background Illicit drug use is an escalating problem in the UK, which now has one of the highest estimated populations of people who use drugs in Western Europe. Injecting drug use is associated with numerous health-related harms, including a high incidence of blood-borne virus infection, soft-tissue and skin infection, premature mortality from overdose, suicide and other causes of death. Two central elements of global, European and UK’s harm reduction approach in relation to illicit drug use are opiate substitution therapy (OST) and needle and syringe programmes (NSPs). Engagement and retention in OST is a recognised problem globally. To prevent and reduce further harms, it is imperative that different models of service provision are better understood to attract and retain more service users in harm reduction services. Objectives The overall aim of the study was to generate a theory of optimal service provision with in-depth knowledge of the contextual factors and the mechanisms that influence access, engagement, retention and exit of OST/NSP services. We conducted a multi-method realist evaluation (RE) over two phases to meet four study objectives. Phase 1 Objective 1: To conduct a meta-synthesis (MS) of qualitative studies using systematic review methods to identify the barriers and facilitators that impact on the use of OST and NSP services. Objective 2: To conduct a UK-wide online survey of service commissioners to map current models of OST prescribing and practices to better understand current service provision/delivery. Phase 2 Objective 3: To undertake a qualitative RE using a case study approach to establish the contexts and mechanisms that impact on the use of OST and NSP provision in the UK. Objective 4: To estimate additional staff costs of implementing characteristics of ‘optimal’ OST provision identified by the qualitative RE in one study site. Methods Patient and public involvement took place throughout the study. Meta-synthesis methods We conducted a systematic review and MS of qualitative studies. A prior protocol was published: PROSPERO 2020 CRD42020209646; available from: www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020209646. A sensitive search strategy was developed and then run in multiple online research databases in January 2021: MEDLINE; Cumulative Index to Nursing and Allied Health Literature; British Nursing Index and Archive; Applied Social Science Index and Abstracts; Social Sciences Citation Index and PsycInfo® (American Psychological Association, Washington, DC, USA). In addition, the following grey literature sources were searched: OpenGrey and PsycEXTRA. Any primary or secondary qualitative studies conducted anywhere in the world that sought to understand the optimal provision of NSP and OST services from the perspectives of key stakeholders were included. Studies should have been seeking to understand issues regarding: Access, Engagement, Retention and Exits of OST and/or NSP. All included publications were subject to a global assessment of study quality. Drawing on methods proposed by Noblit and Hare, data synthesis was rigorous and multistaged. Online survey methods A cross-sectional online survey was sent to commissioners of OST and NSP services across the UK, including Northern Ireland. The survey was distributed in Spring 2021. A short survey instrument was developed to obtain information on which areas provide OST and NSP services, what the model of service provision is in relation to OST, how they are provided and additional questions about workforce composition and prescribing arrangements. Realist evaluation methods In-depth interviews were conducted with a range of key stakeholders. The target population were the following, sampled from three study sites (two in England and one in Scotland): (1) service users in contact with OST and/or NSP services; (2) service users out of contact with OST and/or NSP services; (3) core drug service managers; (4) core drug service staff; (5) non-core drug service staff and (6) Service commissioners. Study sites were selected purposively to reflect the diversity of models of OST and NSP provision, for example, to include sites that use various models of OST prescribing, including shared care with general practitioners, specialist medical models and pharmacy models. Individual interviews were aimed to be held with six key stakeholder groups (minimum total per study site n = 24): service users in regular contact (target = 8 per site); service users not in regular contact (target = 5 per site); core service managers (target = 3 per site); core service staff (target = 3 per site); non-core services staff (target = 3 per site) and service commissioners (target = 2 per site). All service users were interviewed face to face in a private consultation room at the core service. Some core service managers and staff and non-core drug service staff were also interviewed face to face in private consultation rooms within the core services. All other interviews were carried out by telephone or via Microsoft Teams (Microsoft Corporation, Redmond, WA, USA). The anonymity and confidentiality of participants were protected throughout. Framework analysis was used to analyse the interview data. Costing analysis methods A smaller caseload for shared care workers (SCWs) and the implementation of a salary increment scheme were identified by the RE as mechanisms to facilitate service optimisation. The target for an optimal SCW caseload of 50 per full-time equivalent (FTE) worker was specified by the service manager. The caseload of SCWs in site A was estimated using anonymous event-level treatment data for both SCWs and service users within one of the English study sites was accessed from the local electronic service user records, which provide data for the National Drug Treatment Monitoring System. The treatment data covered 13 weeks from April to June in 2023, 2022 and 2019. To assess the impact of differences in service user complexity on staff workload, univariable and multivariable linear regressions were performed using service user-level data, with total appointments booked as the dependant variable and substance use type, opiate use in the last 28 days and housing problem as covariates. The event-level treatment data for SCWs were linked to data supplied by the service on the FTE and years of employment for each worker and any periods of work leave. The mean caseload per FTE in each period was estimated using appointments booked and measures of available staff capacity and full staff capacity. Staff turnover was also estimated. The number of additional FTE workers required for a caseload of 50 per FTE worker was estimated for each period. The salary-related cost of the additional FTE workers required for a caseload of 50 per FTE worker was estimated using a unit salary cost of a FTE worker on spinal point 15 of the 2023–4 National Joint Council for Local Government Services pay scale, and salary oncosts and overheads were estimated to be 35% of the salary cost. The initial additional annual cost of introducing an illustrative salary increment scheme was calculated using data on the years of employment for each SCW and an estimated unit salary cost of a FTE worker and selected increment costs from the 2023–4 National Joint Council for Local Government Services pay scale. Results Meta-synthesis From 63 included studies (53 OST-related and 10 NSP-related), it was noted that none included the views of commissioners of services; thus their views are absent. Twenty of the included studies (13 OST and 7 NSP) included a total of 449 (15%) staff participants, and 53 studies (45 OST and 8 NSP) included a total of 2518 (85%) service user participants. The views of staff, and to a much greater extent, service users, are therefore well represented in the MS. Studies were conducted across a wide range of countries (mainly North America), with nine being conducted in the UK (six OST/three NSP). The majority (n = 31) were published within the previous 5 years. The barriers and facilitators identified in the MS significantly contribute to our understanding of four important ‘contexts’ within which services are delivered. Within these contexts, the barriers and facilitators that were identified contributed towards hypothesised mechanisms that could lead to optimal provision regarding successful access, engagement, retention and exit. This contributed significantly to the identification of an initial programme theory (IPT) of how services can ensure optimal service provision. Online survey Thirty-two respondents from 183 commissioning areas surveyed responded (response rate of 17%). Respondents were commissioners, service managers, public health specialists and specialist pharmacists. The COVID pandemic is likely to have had a negative impact, contributing to a very low response rate among already overstretched services, limiting the representativeness and generalisability of the findings. The findings from the survey were triangulated with the findings from the MS, which supported the identified IPT. Realist evaluation In-depth interview data were collected from 86 participants in 3 sites between April and September 2022: 29 participants were service users in regular contact with services; 15 were service users not in regular contact with services; 15 were core drug service staff; 12 were core drug service managers; 9 were non-core drug services staff and 6 were drug service commissioners. Testing of the four contexts of the IPT, via in-depth interview data, indicated that there are examples of best practice and areas of weakness where contemporary service provision needs improvement. As a result, the initial theory was developed into a refined theory with five main contexts, representing the need for services to provide an adequate level of the following factors. Agency and empowerment This context indicates that optimal service delivery can be achieved and understood with reference to the following three mechanisms: Service users are empowered via a person-centred approach to make decisions regarding treatment. Services deliver tailored non-punitive, non-restrictive harm reduction approaches that make minimal demands of service users (low-threshold services). Service users have access to those involved in their care. Self-esteem and respect This context indicates that optimal service delivery can be achieved and understood with reference to the following two main mechanisms: Staff recognise the importance of confidentiality and a non-stigmatising approach. Service users are supported to develop strengths-based competencies, recovery capital and self-esteem. Knowledge and communication This context indicates that optimal service delivery can be achieved and understood with reference to the following three mechanisms: All stakeholders proactively encourage partnership working. A peer network programme is embedded into the core service. Staff have the knowledge and skills required to provide high-quality care. Goals, needs and preferences This context indicates that optimal service delivery can be achieved and understood with reference to the following four main mechanisms: Recording system(s) are fit for purpose to manage care plan reviewing effectively. A commitment to providing services that facilitate a shared ethos, understanding and responsibility between all key stakeholders. Access to a full range of services to meet treatment goals and wider needs. Appointments take account of service user needs and preferences, and staff are given time and resources to facilitate a proactive approach to meet these. Resources and demands This new context includes mechanisms related to understanding the multiple demands upon services and the required resources to satisfy those demands, and it indicates that optimal service delivery can be achieved and understood with reference to the following five main mechanisms: Understanding service demands to inform service delivery and design so that resources can be allocated appropriately. Staff are supported and resourced to overcome barriers to their ability to effect good treatment outcomes and to work effectively and efficiently in their demanding roles. Core services receive adequate, reliable and sustained resources to create the right circumstances for good recruitment and retention of staff. Funding of core drug services and wider drug service-related initiatives is sufficient, reliable and accessible. A range of key performance indicators are measured to direct effective service delivery, ensuring provision remains person-centred. Our analysis of the data across all contexts also indicates that, within the hypothesised mechanisms, specific ‘mechanisms of action’ exist. Furthermore, we propose that these mechanisms of action can be understood as mechanisms operating at either of two levels: a ‘Systems level’ which relates to high-level strategic influence upon the delivery of services (e.g. policy decisions, legislation and funding); and a ‘Service level’ which relates to the delivery and organisation of services (e.g. service provision pathways; staff roles and responsibilities and organisational culture). Our analysis also identified the potential importance of ‘mediating mechanisms’ (e.g. confidence, trust and self-efficacy) which can operate to increase the likelihood of successful access, engagement, retention and exit. Costing analysis In our single case study site, the FTE staff capacity decreased between the 13-week periods in 2019 and 2022 and then increased in 2023. Long-term leave accounted for 5% (1.4/26.0) of the FTE capacity in 2023 and by taking long-term leave into account, the available FTE capacity increased by 8% (1.9/24.6) between 2019 and 2023. There was a high turnover in staff over time, with 60% (18/30) of available staff in 2023 having also worked in the service in 2022, and this experience compares to 58% (15/26) of available staff in 2022 having also worked in the service in 2019. The FTE staff with < 2 years employment in the service increased from 22% (5.3/23.7) in 2019 to 48% (11.7/24.6) in 2023. The RE identified a smaller caseload for SCWs and the implementation of a salary increment scheme as key characteristics of the ‘optimal’ OST provision. The 24.6 FTE available staff working in 2023 had a mean caseload of 67.8 service users per FTE available staff compared to 82.9 in 2022 and 76.3 in 2019. Implementation of a mean caseload of 50 would require an increase in available staff capacity from 24.6 FTEs to 33.4 FTEs, associated with an additional annual staff cost of 32.5%, £328,798. If operating at full staff capacity (26.0 FTEs), then the increase in annual staffing cost would be 27.3%, £276,251. Having accounted for measures of service user complexity, the mean number of appointments booked per service user was lower in 2023 compared to 2019. The introduction of an illustrative salary increment scheme to aid retention of staff with three annual increments would entail a 3.5% increase in annual staffing cost in 2023, representing £35,726, resulting in a combined cost of £311,977 for the estimated 33.4 FTEs, associated with a caseload of 50 service users per FTE. Conclusions We have provided a rich understanding of the contexts, mechanisms and actions by which the optimal delivery of OST and NSP services may be understood in order to increase the likelihood of successful access to, engagement with, retention in and exit from services. Services may wish to consider how well they are currently operating regarding the contexts and mechanisms we have identified and to determine where they may be deficient and then use the descriptions we have provided as a road map to make improvements in those areas. Study registration This study is registered as PROSPERO 2020 CRD42020209646. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129798) and is published in full in Health Technology Assessment; Vol. 29, No. 64. See the NIHR Funding and Awards website for further award information.

Mason Marks

After decades of prohibition, psychedelics are generating intense public and private interest. Scientists are researching the therapeutic properties of these substances, and mounting evidence supports their ability to treat a variety of mental health conditions. Meanwhile, dozens of cities and states are proposing or enacting psychedelics legislation to promote research, increase therapeutic and non-therapeutic access, and decrease criminal penalties associated with producing, possessing, or consuming psychedelics. This article is the first to produce a typology of state and local psychedelic laws, which fall into five general categories: decriminalization, supported adult use, medical use, clinical research, and policy analysis. The article defines each category and explains how some jurisdictions create hybrid psychedelic laws that blend elements of multiple categories. Following enactment, government agencies can shift laws from one category to another during the rulemaking process.

Chen Q, Tian W, Zheng L et al.

Qiang Chen,1 Wei Tian,2 Long Zheng,3 Taoying Li1,4 1Law School, Xinjiang University, Urumqi, People’s Republic of China; 2Department of Foreign Languages, Guangxi Science & Technology Normal University, Laibin, People’s Republic of China; 3Graduate School and Open Learning College, Cavite State University, Indang, Philippines; 4Department of Law, Jiangxi Police College, Nanchang, People’s Republic of ChinaCorrespondence: Long Zheng, Graduate School and Open Learning College, Cavite State University, Indang City, Cavite Province, Philippines, Tel +8618279129539, Email 645873409@qq.comAbstract: Older people in rural China enjoy the right to health under Chinese law. However, the problems of economic difficulties, the unbalanced allocation of medical resources between urban and rural areas and the weakening of the traditional function of the family as a provider of old-age care in reality make the elderly in rural areas face a higher risk of health problems. The law is an important tool to mitigate these problems. Although China has made great efforts to legally guarantee the right to health of the rural elderly, it has not yet fully implemented the requirements of Article 12 of the International Covenant on Economic, Social and Cultural Rights, Article 14 of the Madrid Political Declaration and International Plan of Action on Ageing. China needs to further improve the relevant legislation to provide adequate legal support for the exercise of the right to health of the elderly in rural areas.Keywords: elderly people in rural China, the right to health, legal protection, legislation

Rubens Correia Junior, Emanuele Seicenti de Brito, Patrícia de Paula Queiroz Bonato et al.

O presente trabalho teve por objetivo compreender a percepção dos usuários de drogas internados involuntariamente em uma clínica terapêutica do interior de Minas Gerais, sobre a vivência de seus direitos humanos, com foco em situações de exclusão favorecidas pela evolução legislativa, políticas públicas e práticas dos serviços de saúde para usuários de drogas. Tratou-se de pesquisa qualitativa, cuja coleta de dados deu-se por meio de entrevistas semiestruturadas, observação participante e análise documental, tendo como referência a abordagem dialética, em que o pesquisador, ao olhar o indivíduo, interpreta suas falas considerando o ambiente que o cerca e também ponderando e distinguindo as nuances culturais, emocionais e sociais do discurso. Os resultados identificaram a exclusão dos usuários de drogas e a consolidação intramuros de um caráter segregador e repressor, sem o compromisso com a ressocialização e reinserção de pessoas vulneráveis na sociedade. As entrevistas revelaram a ausência da percepção por parte dos usuários de drogas de seus direitos e garantias fundamentais. Ademais, verificou-se um desamparo em relação ao protagonismo de sua fala e a ausência de possibilidades de escuta e autonomia. Concluiu-se que os usuários de drogas pertencem a uma parcela da sociedade excluída e fragilizada pelo objeto de consumo que acaba por mitigar e descontruir seus direitos e voz.

M. Rotermann

Mu-Chen Li, J. Brady, C. DiMaggio et al.

Carmen Cerda Aguilar

La administración de justicia espera del perito investigador, no que dictamine a favor de una u otra parte, sino que proporcione una información sólida y veraz sobre la materia de su competencia para ilustrar a los juristas quienes, a su vez, deben formar al respecto su propia opinión. Problemas como la retribución económica, no contar con todas las fuentes de información, haber participado en la terapia del paciente, adoptar posturas en favor de los imputados o de las víctimas, firmar informes de colegas sin revisarlos, apartarse de la objetividad y de la prudencia, pueden salir a la luz en un juicio y entorpecer la labor, no sólo del investigador encargado del caso, sino de todos sus colegas. El trabajo forense  plantea dilemas éticos que han sido poco abordados, por lo que es necesario propiciar discusiones con todos los actores que intervienen en la pericia  a fin de garantizar que el enfoque bioético sea cada vez más considerado en la investigación forense.

K. Cour, Line Lindahl Jacobsen

All practising clinicians will inevitably have to deal with the death of their patients. It is very important that we acknowledge our own biases and subjugate those to the needs of the patient for whom we are caring. Doctors prescribe drugs to alleviate symptoms or apply organ support to those whose bodies are failing. They can be asked, by patients or families, to provide life-sustaining treatments that do not offer any clinical relief or to administer drugs to ‘end suffering’. At both extremes, there are laws to protect both patient and doctor. It is this legislation, case law, and General Medical Council guidance that will be reviewed in this chapter. Discussion will focus on the right to refuse life-sustaining treatment; the role of the Mental Capacity Act and respecting ‘best interests’; the legal (and philosophical) distinction between withholding and withdrawing treatment; the doctrine of double effect; assisted suicide; and euthanasia.

Kinton Rossman, Paul Salamanca, K. Macapagal

Adam W. Gaffney, D. McCormick

Renata Solimini, Francesco Paolo Busardò, Filippo Gibelli et al.

<i>Background and objective</i>: Telemedicine or telehealth services has been increasingly practiced in the recent years. During the COVID-19 pandemic, telemedicine turned into and indispensable service in order to avoid contagion between healthcare professionals and patients, involving a growing number of medical disciplines. Nevertheless, at present, several ethical and legal issues related to the practice of these services still remain unsolved and need adequate regulation. This narrative review will give a synthesis of the main ethical and legal issues of telemedicine practice during the COVID-19 pandemic. <i>Material and Methods</i>: A literature search was performed on PubMed using MeSH terms: Telemedicine (which includes Mobile Health or Health, Mobile, mHealth, Telehealth, and eHealth), Ethics, Legislation/Jurisprudence, and COVID-19. These terms were combined into a search string to better identify relevant articles published in the English language from March 2019 to September 2021. <i>Results</i>: Overall, 24 out of the initial 85 articles were considered eligible for this review. Legal and ethical issues concerned important aspects such as: informed consent (information about the risks and benefits of remote therapy) and autonomy (87%), patient privacy (78%) and confidentiality (57%), data protection and security (74%), malpractice and professional liability/integrity (70%), equity of access (30%), quality of care (30%), the professional–patient relationship (22%), and the principle of beneficence or being disposed to act for the benefit of others (13%). <i>Conclusions</i>: The ethical and legal issues related to the practice of telehealth or telemedicine services still need standard and specific rules of application in order to guarantee equitable access, quality of care, sustainable costs, professional liability, respect of patient privacy, data protection, and confidentiality. At present, telemedicine services could be only used as complementary or supplementary tools to the traditional healthcare services. Some indications for medical providers are suggested.

M. Olfson

Mayely Cedillo, Ángela Díaz Moreno, Ólman Gradis Santos et al.

Justificación: Las fallas en la responsabilidad profesional médica representan un problema de interés por el impacto que tienen en la salud de los pacientes y de los médicos. Objetivo: Evaluar cuál es el nivel de conocimientos de los profesionales de la medicina hondureños sobre aspectos relevantes de la responsabilidad profesional o mala praxis médica. Metodología: Se realizó un estudio transversal descriptivo; la recolección de datos se hizo mediante un instrumento tipo encuesta electrónica con formato de Google®, la cual se validó con un grupo de expertos y cubrió, variables sociodemográficas; de los encuestados, así como cinco ámbitos de conocimiento definidos como: el ámbito legal, el conceptual, el de derechos de los pacientes, el de deberes del médico y el de condicionantes para la denuncia. La población encuestada: estudiantes de medicina con seis o más años cursados de la carrera, indistintamente de la universidad donde estudiaron; médicos residentes y profesionales, ya sea médicos generales o especialistas, todos hondureños. El análisis de los datos se realizó utilizando Excel® 2010, y el Programa R, versión 3.6. Para mejor comprensión de los resultados se construyó una escala descriptiva de acuerdo a los porcentajes de acierto obtenidos. De 0-39% “deficiente”, de 40-59% “insuficiente”, de 60 a 80% “aceptable”, 81-90% “adecuado”, de 91% en adelante se clasificó como “conoce el tema”. Resultados: El nivel de conocimiento de los médicos, indistintamente de su formación académica, edad, sexo o centro donde labora, se ubicó en un nivel entre insuficiente y aceptable, siendo el ámbito donde se observó el menor puntaje, con 51,2% de aciertos. Conclusiones: Las fallas en la responsabilidad profesional podrían estar estrechamente ligadas al déficit de competencias y habilidades adecuadas de estudiantes y médicos durante el acto médico.

Nicolás Sabillón, Heydi Rodas

Femenina de 36 años de edad, obesa, con cuadro de inicio súbito de dolor abdominal e irradiación a región lumbar de aproximadamente cuatro horas de evolución, acompañado de episodios de lipotimias, pérdida de la consciencia y muerte. La autopsia reveló aneurisma ateroesclerótico sacular, roto en la arteria iliaca izquierda (fotos insertas; flechas) y hematoma retroperitoneal. El aneurisma se define como una dilatación anormal localizada de un vaso sanguíneo. Los aneurismas de la arteria iliaca son muy poco frecuentes, con una incidencia de 0.03 % en series de autopsias, el 80 % son causados por ateroesclerosis y debido a su localización son de difícil diagnóstico 1.

Tyan Ferdiana Hikmah, Agnes Widanti, I. Edward Kurnia SL

HIV / AIDS is a health problem in the world which is constantly increasing, especially in women during pregnancy. The government has made efforts to prevent the spread of HIV / AIDS from mother to child where one of its components is to screen for pregnant women. Implementation of HIV / AIDS screening at Puskesmas Bantul District still focuses on increasing coverage of visit in Puskesmas, not yet paying attention to how the protection of human rights for pregnant women. The research method was sociological juridical, with descriptive analytical specification. Primary data were obtained from interviews with 4 midwifes, 4 persons in charge of the program, 4 heads of community health centers and 4 heads of health center and 1 person in Health Office’s Bantul District and 8 pregnant women as well as observation at four health centers in Bantul district. Secondary data were legal materials, official documents, books and research journals. Data analysis using qualitative was inductive. Implementation of HIV / AIDS screening for pregnant women is regulated in Minister of Health Regulation Number 97, 2017 and Minister of Health Regulation Number 51, 2013 about prevention of mother to child transmission of HIV / AIDS related to the protection of human rights for pregnant women. The protection of human rights for pregnant women in the implementation of HIV / AIDS screening at the Bantul District Health Center has not been fulfilled in terms the rights of information, the rights of consent, and the rights of confidentiality. Supporting factors include the availability of health facilities, supporting health resources, supporting facilities and infrastructures while inhibiting factors are health services, limited number of counselors, social support (husbands, health workers, community leaders), affordability, pregnant women working, knowledge, social factors, and the implementation of legislation.

Ben Chevallereau, Gracie Carter, Sweta Sneha

PURPOSE The healthcare system in the United States is unique. From payor to provider, patients have many choices but they lack in the ability to manage or share their health information. This complicated care paradigm places patients at a distinct disadvantage. Legislation clearly defines government expectations of data availability but not how to achieve exchange. Because methods of sharing are left to the discretion of care providers and software vendors, non-interoperability is the standard. METHODS The OpenPharma Blockchain on Fast Healthcare Interoperability Resources (FHIR) (OBF) solution is interoperable by design. OBF empowers patients with data access through biometric identity authentication, blockchain, and machine-–to-machine secure data access. OBF provides authenticated users read-only, real-time access to patient records using the healthcare interoperability standard HL7 FHIR. OBF is built around a modern, browser-based user interface, blockchain technologies (leveraging either Ethereum or the Hedera protocols) and modular, modern software exposed as Application Programming Interfaces (APIs). This allows OBF to meet the Office of National Coordinator for Health Information (ONC) metrics, which include sending, receiving, and finding information from outside sources and using that information to make informed clinical decisions without additional burden on clinicians or patients. RESULTS Building on the HL7 FHIR application community practices, OBF is a SMART-on-FHIR plug-in for Electronic Medical Record (EMR) systems. Using OBF, patients can identify themselves and gain access to their medical records using their voice. This unique feature is accomplished through the Saavha voice print biometrics technology. Saavha returns a unique member ID that is passed directly to the OBF blockchain smart contract for storage and interoperable patient record access (the ID does not contain public health information [PHI]). To ensure complete privacy, all information is passed through multiple layers of encryption where no keys are stored locally. Additionally, no PHI is shared to the blockchain. To ensure privacy, OBF creates a new encrypted address for the FHIR patient record object, using the Saavha generated member ID as the unique identifier. This encrypted address is then published on chain, making it available to participating providers. Providers must register their relationships to patients before OBF will permit online viewing of patient records. Patient record access is accomplished through voice verification and real-time surfacing of encrypted patient data through the OBF FHIR Viewer. CONCLUSIONS OBF is a lightweight, flexible, secure, and stable interoperable solution that places data stewardship with patients. Using industry-wide data standards, biometrics, Smart contracts, Ethereum, and OpenPharma’s data viewer for the first-time patients can authorize read-only record exchange using their voice.

L. Turner