Hasil untuk "Medical legislation"

Zachary Mokosak, Barbara Pesut, Sally Thorne

In passing legislation in 2016 to allow medical assistance in dying (MAID), Canada became the world’s first jurisdiction to allow nurse practitioners (NPs) to act as MAID assessors and providers. Health Canada’s annual report shows that the demand for MAID in Canada increases each year, as does the proportion of MAID cases that NPs provide. The purpose of this study was to better understand factors that motivate or deter nurse practitioners from becoming MAID assessors and providers. The study design was a secondary analysis of a large qualitative dataset guided by interpretive description methodology. Primary data collection took place from 2018 to 2023 via semi-structured interviews with nurses and NPs. Secondary analysis of transcripts of all of the NPs interviewed for the primary study allowed for identifying significant motivational and deterring themes in their accounts. The analysis yielded two categories of motivating factors (philosophical perspectives; experiences with death and dying) and three deterring factors (moral complexity; health system barriers; professional and social considerations), and further generated insights around supports and practices that make NP MAID work viable. As the first study that explicitly sought to understand what explains Canadian NPs’ willingness to participate in MAID, these findings fill a gap in the available knowledge.

І. Анікін, Л. Стрижак

To evaluate the eff ects of increased protein and L-carnitine supplementation in the feeding program of term infants with perinatal conditions on improving physical development outcomes, changes in body composition and hospital outcomes. The aim is to evaluate the eff ect of short-term increased protein intake in term infants and L-carnitine supplementation on body composition and key indicators of physical development in children. Material and methods. To test the proposed hypothesis of neonatal nutrition, we studied the vital signs of 59 term infants randomized into two groups. The fi rst group (n = 30) received standard breastmilk (BM) or formula feeding, and the second group (n = 29) received a protein- fortifi ed (PF) formula and L-carnitine supplementation during the hospital stay. At the beginning and end of treatment, the children’s physical development and body composition were assessed using bioelectrical impedance. The study protocol was agreed and approved by the Regional Bioethics Committee of the Zaporizhzhia State Medical and Pharmaceutical University. The study was conducted in accordance with the moral and ethical standards of the IGH/GCP, the Declaration of Helsinki (1964 with amendments of 1975, 1983, 1989, 1996, 2000), the Convention of the Council of Europe on Human Rights and Biomedicine, and the legislation of Ukraine. Written informed consent was obtained from the parents of the patients before the start of the study. All statistical analyses were performed using the software Statistica 13.0, TIBCO Software Inc (licence number JPZ804I382130ARCN10-J) and Microsoft Excel 2013 (licence number 00331-10000-00001-АА404). The probability of the diff erence in the absolute values of the means was determined using non-parametric methods of statistical analysis: the Mann-Whitney test (U) for unrelated groups and the Wilcoxon signed rank test (T) for related groups. Statistical signifi cance was defi ned as p < 0.05. The study was conducted within the framework of the research work of the Department of Anaesthesiology and Intensive Care Medicine of the Zaporizhzhia State Medical and Pharmaceutical University of the Ministry of Health of Ukraine – «Optimization of diagnosis and intensive care of multi etiological lesions of the brain, gastrointestinal tract, kidneys in newborns and older children», state registration number 0118U007142. Results. Infants in both groups had similar characteristics of weight, length and head circumference at baseline. The proportions of infants of both sexes were within the 50 % percentile. In general, the proposed feeding strategy contributed to better indicators of infant physical development and a statistically signifi cant, faster recovery of body weight in the fortifi ed group. Thus, the generalised indicator of body weight of children in the GZ group was 3966.90 ± 439.08 g, compared to 3554.62 ± 452.28 g in the SC group, p = 0.0033. In general, the children who consumed more protein were transferred out of intensive care sooner – 10.00 (8.00, 12.00) days vs. 12.00 (11.00, 16.00) days, U = 235.00; p = 0.0024; discharged from hospital sooner – 21.00 (19.00, 27.00) days vs. 26.50 (22.00, 31.00) days, U = 267.00, p = 0.0109. This strategy proved to be safe, as evidenced by normal phenylalanine and urea levels at all stages of the children’s examination. Percentage analysis of body composition showed an increase in the formation of more dry mass in children on the standard diet, without protein fortifi cation and without carnitine supplementation. Thus, the percentage of FFM in the children on the standard diet was 84.71 (83.27; 85.47) % at the end of the study, compared with 83.09 (81.93; 83.96) % in the GZ group, U = 117.00; p = 0.0020. The total cohort indicator was infl uenced by the changes in body composition found in the women: in the GZ group, the percentage was 82.21 (81.55;83.10) % versus 84.71 (83.65;85.30) % in the SC group, U = 8.0; p = 0.0051. Thus, increased protein supplementation in term girls was associated with greater accumulation of fat mass, even with short-term supplementation. Conclusions. Consumption of more protein and carnitine supplementation in term neonates in the intensive care unit promotes better growth against a background of body composition with higher fat content in females, a fact that limits the use of this strategy without further studies.

Zhang Yuxin, Zhou Zhiwei, Pan Xiaoqi et al.

Establishing public health committees within the village (neighborhood) committees is an explicit provision of the Constitution of the People’s Republic of China and an inevitable requirement to promote the implementation of the Health China strategy and ensure people’s health. In practice, fragmentation, lagging and blurring of relevant legislation, differences in regional construction, barriers to information flow, omissions in emergency response mechanisms, scarcity of cross-disciplinary talents, and lack of personnel training in the rule of law are the primary legal regulation dilemmas in the construction and operation of public health committees. Given this, based on building a systematic, complete, and normative system, we should form a coordinated and highly efficient working mechanism and develop a comprehensive work team that equips with talents with both medical and legal knowledge.

Mireya Matamoros

Ya que no fue la inmortalidad un don concedido a los hombres, claramente la muerte es un hecho ineludible. Sin embargo, a pesar de su carácter ineludible; la muerte súbita de un ser amado representa una pérdida irreparable, especialmente porque deja en los sobrevivientes profundos sentimientos de dolor, incertidumbre, temor y desesperanza frente a las interrogantes que se plantean, ante tal evento.

Yeni Vitrianingsih, Slamet Suhartono, Yovita Arie Mangesti et al.

The lack of legal understanding by the parties concerned and the lack of legal protection for both patients and health workers. So the results of the nurses' hard work in providing health services if they are not successful will be faced with the law and even categorized as malpractice with criminal sanctions. Focus problems, namely: Doctors' legal protection of midwives and nurses professionals in medical actions in hospitals.The method used in this study is normative juridical research, which is a study using legislation that includes three layers of legal science consisting of the study of legal science, legal theory and legal philosophy. The results of the discussion found that the delegation of Doctor's authority to the nurse profession in medical action from a legal perspective. Nurses are someone who plays a role in caring for and helping someone by protecting them from pain, injury and the process of aging. It is not in accordance with the regulations of Law No. 38 of 2014 concerning Nursing Article 32 Paragraph (1) and Minister of Health Regulation No. 2052 of 2011 Article 23 Paragraph (1). The nature of the act of giving a medical diagnosis and the determination of medical therapy should not be delegated to nurses of Law No. 17 of 2023. The authority of nurses is as follows: Article 30 paragraph 1 and 2. The two legal umbrellas can certainly make nurses' understanding and protection in carrying out medical duties.

C. Morris, R. Scott, M. Mars

The use of WhatsApp in health care has increased, especially since the COVID-19 pandemic, but there is a need to safeguard electronic patient information when incorporating it into a medical record, be it electronic or paper based. The aim of this study was to review the literature on how clinicians who use WhatsApp in clinical practice keep medical records of the content of WhatsApp messages and how they store WhatsApp messages and/or attachments. A scoping review of nine databases sought evidence of record keeping or data storage related to use of WhatsApp in clinical practice up to 31 December 2020. Sixteen of 346 papers met study criteria. Most clinicians were aware that they must comply with statutory reporting requirements in keeping medical records of all electronic communications. However, this study showed a general lack of awareness or concern about flaunting existing privacy and security legislation. No clear mechanisms for record keeping or data storage of WhatsApp content were provided. In the absence of clear guidelines, problematic practices and workarounds have been created, increasing legal, regulatory and ethical concerns. There is a need to raise awareness of the problems clinicians face in meeting these obligations and to urgently provide viable guidance.

Elena Emilia ȘTEFAN

Meeting general interest needs has always been a concern of public authorities. The performance of the activity, both in the public and in the private sector was challenged to continuous adjustment in order to meet social needs and to provide certain services. On this occasion, on first sight, public medical services stood out as important from the rest of the public services, due to the fact that the concern of the authorities for the protection of public health was globally highlighted in the foreground. From this point of view, it is all the more necessary to have a coherent legal framework to regulate in an unitary way the general legal regime of public services, as there is a tendency to digitize public administration. Therefore, we are urged by the regulation of public services in the Administrative Code to analyze the legislator’s perspective on this matter. At the same time, the states are concerned to transpose European normative acts, acts with binding legal force, into the national legislation. In this respect, this paperwork will be focused on certain public services, by way of a case study, namely it will analyze the way of transposing the European legislation on road transport into our national legislation. Finally, we will draw the conclusion that emerges from the documentation of the proposed topic.

Widiyo Ertanto, Endang wahyati Y., Val Suroto

Abstract: RSUD dr. H. Soewono Kendal is one of the health service units designated by the Government as a Covid-19 referral hospital for the people of Kendal so that medical workers and health workers on duty at Dr H.Soewondo Kendal Hospital, especially in the emergency room, must make physical contact and have close contact with suspected COVID-19 patients and those who have tested positive for COVID-19. This causes the risk of transmission of Covid-19 to health workers to be great, so there is a need for legal protection for medical workers and health workers who work in the emergency room as one of the main entry points for patients at the hospital. This research is a sociological juridical research with a descriptive-analytical research specification. This study uses primary data and secondary data. Data collection in this study was carried out through field studies and literature studies to obtain the necessary data. The data analysis method used is qualitative. The implementation of legal protection for health workers in the emergency room against the risk of transmission of Covid-19 has been well implemented through preventive legal protection in the form of screening, triage, the establishment of a 3M task force, the existence of various internal regulations related to PPI during a pandemic, provision of health insurance and covid-19 vaccination, repressive legal protection is carried out by providing health services for exposed health workers as well as providing incentives and death benefits. There are factors that hinder and support its implementation, namely social factors, juridical factors and technical factors. As a result of these factors, patient fluctuations still occur in the ED because the inhibiting factor causes the risk of transmission to remain because of this. Keywords: legal protection, pandemic, covid-19, health workers, emergency room   Abstrak: RSUD dr.H. Soewono Kendal merupakan salah satu unit pelayanan kesehatan yang ditunjuk oleh Pemerintah sebagai rumah sakit rujukan covid-19 bagi masyarakat Kendal sehingga tenaga medis dan tenaga kesehatan yang bertugas di RSUD dr.H.Soewondo Kendal khususnya di ruang IGD harus melakukan kontak fisik dan kontak erat dengan pasien terduga covid-19 maupun yang sudah positif covid-19. Hal ini menyebabkan risiko penularan covid-19 kepada petugas kesehatan menjadi besar, sehingga perlu adanya pelindungan hukum bagi tenaga medis dan tenaga kesehatan yang bertugas di ruang IGD sebagai salah satu pintu utama masuknya pasien di rumah sakit. Penelitian ini merupakan penelitian yuridis sosiologis dengan spesifikasi penelitian desktiptif-analitis. Penelitian ini menggunakan data primer dan data sekunder. Pengumpulan data pada penelitian ini dilakukan melalui studi lapangan dan studi kepustakaan untuk memperoleh data yang diperlukan. Metode analisis data yang digunakan adalah kualitatif. Pelaksanaan pelindungan hukum bagi tenaga kesehatan di IGD terhadap risiko penularan covid-19 sudah dilaksanakan dengan baik melalui pelindungan hukum preventif berupa skrining, triase, pembentukan satgas 3 M, adanya berbagai peraturan internal terkait PPI di masa pandemi, pemberian asuransi kesehatan dan vaksinasi covid-19, pelindungan hukum represif dilakukan dengan pemberian layanan kesehatan bagi tenaga kesehatan yang terpapar serta pemberian insentif dan santunan kematian. Terdapat faktor yang menghambat dan mendukung pelaksanaannya yaitu faktor sosial, faktor yuridis dan faktor teknis. Akibat faktor-faktor tersebut adalah di IGD masih terjadi penumpukan pasien karena faktor penghambat menyebabkan risiko penularan tetap masih ada karena hal tersebut. Kata kunci: pelindungan hukum, pandemi, covid-19, tenaga kesehatan, IGD

D. Rees, J. Sabia, Laura M. Argys et al.

In an effort to address the opioid epidemic, a majority of states recently passed some version of a Good Samaritan law (GSL) and/or a naloxone access law (NAL). Good Samaritan laws provide immunity from prosecution for drug possession to anyone who seeks medical assistance in the event of a drug overdose; NALs allow laypersons to administer naloxone, which temporarily counteracts the effects of an opioid overdose. Using data from the National Vital Statistics System multiple-cause-of-death mortality files for 1999–2014, this study is the first to examine the effects of these laws on overdose deaths involving opioids. The estimated effects of GSLs on opioid-related mortality are consistently negative but not statistically significant. Adoption of an NAL is associated with a statistically significant 9–10 percent reduction in opioid-related mortality, although the negative association between NALs and opioid-related mortality appears to be driven by early adopters—states that passed legislation before 2011.

J. Paradise

The US Food and Drug Administration (FDA) oversees safety and efficacy of a broad spectrum of medical products (ie, drugs, biologics, and devices) under the auspices of federal legislation and agency regulations and policy. Complex and emerging nanoscale products challenge this regulatory framework and illuminate its shortcomings for combination products that integrate multiple mechanisms of therapeutic action. This article surveys current FDA regulatory structures and nanotechnology-specific guidance, discusses relevant nanomedicine products, and identifies regulatory challenges.

A. Vellido

Background: Medicine is becoming an increasingly data-centred discipline and, beyond classical statistical approaches, artificial intelligence (AI) and, in particular, machine learning (ML) are attracting much interest for the analysis of medical data. It has been argued that AI is experiencing a fast process of commodification. This characterization correctly reflects the current process of industrialization of AI and its reach into society. Therefore, societal issues related to the use of AI and ML should not be ignored any longer and certainly not in the medical domain. These societal issues may take many forms, but they all entail the design of models from a human-centred perspective, incorporating human-relevant requirements and constraints. In this brief paper, we discuss a number of specific issues affecting the use of AI and ML in medicine, such as fairness, privacy and anonymity, explainability and interpretability, but also some broader societal issues, such as ethics and legislation. We reckon that all of these are relevant aspects to consider in order to achieve the objective of fostering acceptance of AI- and ML-based technologies, as well as to comply with an evolving legislation concerning the impact of digital technologies on ethically and privacy sensitive matters. Our specific goal here is to reflect on how all these topics affect medical applications of AI and ML. This paper includes some of the contents of the “2nd Meeting of Science and Dialysis: Artificial Intelligence,” organized in the Bellvitge University Hospital, Barcelona, Spain. Summary and Key Messages: AI and ML are attracting much interest from the medical community as key approaches to knowledge extraction from data. These approaches are increasingly colonizing ambits of social impact, such as medicine and healthcare. Issues of social relevance with an impact on medicine and healthcare include (although they are not limited to) fairness, explainability, privacy, ethics and legislation.

Athos Antoniades, Maria Papaioannou, Apostolos Malatras et al.

Biobanks have long existed to support research activities with BBMRI-ERIC formed as a European research infrastructure supporting the coordination for biobanking with 20 country members and one international organization. Although the benefits of biobanks to the research community are well-established, the direct benefit to citizens is limited to the generic benefit of promoting future research. Furthermore, the advent of General Data Protection Regulation (GDPR) legislation raised a series of challenges for scientific research especially related to biobanking associate activities and longitudinal research studies. Electronic health record (EHR) registries have long existed in healthcare providers. In some countries, even at the national level, these record the state of the health of citizens through time for the purposes of healthcare and data portability between different providers. The potential of EHRs in research is great and has been demonstrated in many projects that have transformed EHR data into retrospective medical history information on participating subjects directly from their physician's collected records; many key challenges, however, remain. In this paper, we present a citizen-centric framework called eHealthBioR, which would enable biobanks to link to EHR systems, thus enabling not just retrospective but also lifelong prospective longitudinal studies of participating citizens. It will also ensure strict adherence to legal and ethical requirements, enabling greater control that encourages participation. Citizens would benefit from the real and direct control of their data and samples, utilizing technology, to empower them to make informed decisions about providing consent and practicing their rights related to the use of their data, as well as by having access to knowledge and data generated from samples they provided to biobanks. This is expected to motivate patient engagement in future research and even leads to participatory design methodologies with citizen/patient-centric designed studies. The development of platforms based on the eHealthBioR framework would need to overcome significant challenges. However, it would shift the burden of addressing these to experts in the field while providing solutions enabling in the long term the lower monetary and time cost of longitudinal studies coupled with the option of lifelong monitoring through EHRs.

Gigi A. Cuckler, Andrea M. Sisko, J. Poisal et al.

D. Kręgiel

Soft drinks consumption is still a controversial issue for public health and public policy. Over the years, numerous studies have been conducted into the possible links between soft drink intake and medical problems, the results of which, however, remain highly contested. Nevertheless, as a result, increasing emphasis is being placed on the health properties of soft drinks, by both the industry and the consumers, for example, in the expanding area of functional drinks. Extensive legislation has been put in place to ensure that soft drinks manufacturers conform to established national and international standards. Consumers trust that the soft drinks they buy are safe and their quality is guaranteed. They also expect to be provided with information that can help them to make informed decisions about the purchase of products and that the information on product labels is not false or misleading. This paper provides a broad overview of available scientific knowledge and cites numerous studies on various aspects of soft drinks and their implications for health safety. Particular attention is given to ingredients, including artificial flavorings, colorings, and preservatives and to the lesser known risks of microbiological and chemical contamination during processing and storage.

Francois R. Lamy, Raminta Daniulaityte, A. Sheth et al.

Arrie Budhiartie, Muh Nasser

Asas hukum, merupakan suatu bagian dari tatanan sistem hukum yang selalu ada di dalam maupun di balik keberadaan sistem hukum itu sendiri. Asas hukum memberikan arah terhadap lahirnya perumusan berbagai kaedah hukum dan kaedah perilaku, sekaligus berfungsi sebagai suatu batu uji terhadap keabsahan suatu kaedah hukum. Demikian halnya dengan hukum keperawatan, melalui keberadaan UU Nomor 38 Tahun 2014 tentang Keperawatan, penetapan asas-asas hukum di dalamnya tidaklah terlepas dari nilai-nilai etis yang menjadi karakteristik khusus pelayanan kesehatan keperawatan. Salah satu asas hukum tersebut adalah asas otonomi profesi yang menjadi landasan filsafati pendukung asas kesetaraan yang menjiwai keberadaan UU Keperawatan. Asas otonomi memberikan landasan terbentuknya kaedah-kaedah hukum yang memberikan perlindungan terhadap kebebasan dalam menjalankan fungsi-fungsi kolaboratif, komplementer, dan mandiri keperawatan berdasarkan wewenang profesinya. Asas otonomi ini diharapkan mampu mengembangkan sistem hukum kesehatan yang berkeadilan profetik dalam mendukung terwujudnya tujuan pembangunan kesehatan nasional.

Rena M. Conti, Kevin H. Nguyen, Meredith B. Rosenthal

Background In the United States (U.S.), large price increases for selected generic drugs have elicited public outrage. Recent legislative proposals aim to increase price transparency and identify outlier drug “price spikes.” It is unknown how many and what types of products would be highlighted by such efforts. Methods IQVIA Health Incorporated’s National Sales Perspectives™ provided sales, use and price data for all generic prescription products (unique molecule-manufacturer-formulation combinations) sold in the U.S. We estimated annual prescription price levels and changes between 2013 and 2014. We identify drugs with annual prescription price increases in excess of the medical consumer price index (CPI), and in excess of 15% or 20%, per legislative proposals. We reported annualized inflation-adjusted mean, standard deviation (SD), median, and 95th percentile prescription price increases and percentage of products exceeding the growth in the medical CPI. We fitted logistic regression models to identify characteristics of drugs associated with each category of price increase. Results We analyzed data for 6,182 generic products. The mean inflation-adjusted price increase among all generic products was 38% (SD 1,053%), the median, 2%; the 95th percentile, 135%; and the mean price level, $29.69 (SD $378.44). Approximately half of all products experienced price increases in excess of the growth in the medical CPI; 28% had price increases greater than 15% and 23% had price increases greater than 20%. Drugs exceeding outlier thresholds exhibited lower baseline price levels than the mean price level observed among all generic drugs. The most consistent characteristic predicting whether a product would exceed “price spike” thresholds proposed in legislation is the being supplied by only one manufacturer. Conclusions “Price spikes” among generic drugs in 2014 were more common than newspaper stories and legislative hearings suggest. While the cross-sectional association between an indicator of being sold by only a single manufacturer and the probability of meeting specific price growth thresholds is suggestive of an economically intuitive causal story, future work should delve more deeply into whether decreases in generic competition explain the dramatic price increases that have captured the public’s attention in recent years.

Alana Cattapan, Dave Snow

This article examines how medical and scientific professionals experience and engage with the governance of embryo research in Canada. Drawing on the history of embryo regulation in Canada and the findings of a survey conducted with lab directors in Canadian fertility clinics, we identify a disjuncture between the rules established by legislation, regulations, and research ethics guidelines and the real-life experiences of professionals in the field. This disjuncture, we argue, is the result of both the absence of implementation mechanisms that would give substance to the governing framework, as well as an inability on the part of medical and scientific professionals to engage in robust self-regulation. Overall, we demonstrate that in an ethically charged and highly technical area of policy-making like embryonic research, clarity about the roles and responsibilities of government and professionals in policy-making and implementation is critical to effective governance.

J. Acton

piia tint, Karin Reinhold, Ada Traumann

<span style="font-family: Times New Roman; font-size: small;"> </span><p class="MsoNormal" style="margin: 0cm 1cm 0pt; text-align: justify; mso-layout-grid-align: none;"><span style="font-size: 9pt; mso-ansi-language: EN-GB;" lang="EN-GB"><span style="font-family: Times New Roman;">The composition of the mixture of chemicals in the work environment depends mostly on the temperature of the air or processing temperature of the raw material or the intermediate products. For determination the chemicals in the air FTIR/FT-NIR spectrometer Interspec 301-X with open optical path and Dräger tubes were used. The toxicology of the gaseous components was determined on the basis of the scientific literature. On the basis of these investigations and the<span style="mso-spacerun: yes;"> </span>legislation on the chemicals safety (exposure limits) the health risk assessment model (HRA) was worked out. This model connects the hazards in the work environment and the health risk to the workers and also gives the possibility to the medical personnel to determine the frequency of the medical examinations and biomonitoring for the workers continuously working in the hazardous conditions. The novelty of the study includes in the possibility to keep under control the chemicals concentration in the work environment air through the use of HRA model and the measurement with modern measurement equipment (FTIR/FT-NIR).</span></span></p><span style="font-family: Times New Roman; font-size: small;"> </span><p>DOI: <a href="http://dx.doi.org/10.5755/j01.ms.21.3.7345">http://dx.doi.org/10.5755/j01.ms.21.3.7345</a></p>