Hasil untuk "Medical legislation"

Aneliz Ninahuanca Terán , Beatriz Luna Barrón , Silvana María Limache Valderrama

Objetivo. Determinar la filiación genética con pruebas de ADN mediante el uso de muestras de comparación no convencionales (plasma sanguíneo y cepillo dental) Introducción. Los estudios de determinación de parentesco empleando herramientas genéticas han ido evolucionando en las últimas décadas debido a la necesidad de resolución de casos de paternidad, maternidad, hermandad y otros para esclarecer juicios por herencia, u otros. No siempre se logra contar con muestras de referencia ideales, como ser sangre o hisopado bucal del individuo en estudio, ya que en ocasiones, únicamente se tiene muestras u objetos personales, o la presencia de familiares cercanos. Métodos. Un padre solicita análisis de maternidad de su esposa fallecida para sus dos hijas. De la supuesta madre se procesó plasma sanguíneo. De la hija mayor de 7 años se colectó un cepillo dental y de la hija menor de 1 año se colectó hisopado bucal empleando el kit DNA genotek®. También se colectó hisopado bucal del padre. Se extrajo el ADN empleando proteinasa K 15mg/uL con el kit Wizard® Genomic DNA Purification Kit (Promega). La muestra de plasma sanguíneo se procesó con el kit Geneaid DNA/RNA y proteinasa K 15mg/uL. Se cuantificó y realizó la PCR con el kit PowerPlex® Fusion 6C. Se realizó la electroforesis capilar en el analizador genético ABI 3500 (Applied Biosystems®), el análisis se hizo empleando el programa informático GeneMapper®. Para el análisis estadístico se utilizaron los modelos matemáticos propuestos por Carralero (1) y las frecuencias alélicas de la población boliviana. Resultados. El análisis cualitativo reveló la presencia de los alelos maternos en todos los marcadores STRs amplificados en las muestras de ambas menores, así la probabilidad de maternidad fue mayor al 99,99999999%. Discusión. Se empleó un protocolo de extracción sencillo y económico para obtener material genético a partir de muestras no utilizadas comúnmente como indubitadas, tal como el cepillo dental y el plasma sanguíneo. Como lo demuestran otros estudios (2) fue factible la obtención de perfiles genéticos completos (Fig. 1), siendo posible la realización de estudios de parentesco (3, 4). Fig. 1 Electroferogramas parciales de STRs a partir del plasma sanguíneo(A) y del cepillo dental (B). Conclusión. Se evidenció el grado de parentesco materno en dos niñas empleando ADN extraído de muestras biológicas no convencionales (plasma sanguíneo y cepillo dental).

Jocelyn Schroeder, Barbara Pesut, Lise Olsen et al.

Abstract Background Medical Assistance in Dying (MAiD) was legalized in Canada in 2016. Canada’s legislation is the first to permit Nurse Practitioners (NP) to serve as independent MAiD assessors and providers. Registered Nurses’ (RN) also have important roles in MAiD that include MAiD care coordination; client and family teaching and support, MAiD procedural quality; healthcare provider and public education; and bereavement care for family. Nurses have a right under the law to conscientious objection to participating in MAiD. Therefore, it is essential to prepare nurses in their entry-level education for the practice implications and moral complexities inherent in this practice. Knowing what nursing students think about MAiD is a critical first step. Therefore, the purpose of this study was to develop a survey to measure nursing students’ knowledge, attitudes and beliefs, influences, and willingness to be involved in MAiD in the Canadian context. Methods The design was a mixed-method, modified e-Delphi method that entailed item generation from the literature, item refinement through a 2 round survey of an expert faculty panel, and item validation through a cognitive focus group interview with nursing students. The settings were a University located in an urban area and a College located in a rural area in Western Canada. Results During phase 1, a 56-item survey was developed from existing literature that included demographic items and items designed to measure experience with death and dying (including MAiD), education and preparation, attitudes and beliefs, influences on those beliefs, and anticipated future involvement. During phase 2, an expert faculty panel reviewed, modified, and prioritized the items yielding 51 items. During phase 3, a sample of nursing students further evaluated and modified the language in the survey to aid readability and comprehension. The final survey consists of 45 items including 4 case studies. Discussion Systematic evaluation of knowledge-to-date coupled with stakeholder perspectives supports robust survey design. This study yielded a survey to assess nursing students’ attitudes toward MAiD in a Canadian context. Conclusion The survey is appropriate for use in education and research to measure knowledge and attitudes about MAiD among nurse trainees and can be a helpful step in preparing nursing students for entry-level practice.

NEGOITA, Catalina

Cannabis sativa L. culture has encountered various legislative challenges throughout history, and these have varied according to the social, political and economic context of each period. Historical stigma and prohibitions brought restrictions on cannabis, and anti-drug and prohibition policies adopted in the 20th century led to the prohibition of the cultivation of Cannabis sativa L. Its incorrect association with drugs of abuse and its classification as a narcotic substance complicated the legislation. Problems in differentiating between recreational and medical use have created confusion in law. Global inconsistency in cannabis rules and regulations has created difficulties in international trade and research cooperation. The recent evolution of legislation, marked by ambiguities and inconsistencies regarding the medical, industrial, and food use of cannabis, has raised questions and challenges. Production and marketing issues, such as strict regulations and licensing hurdles affect the cannabis industry in the Republic of Moldova too. These challenges are constantly changing, reflecting the diversity of perspectives and societal developments.

Min Jae Kim, Dong Eun Lee, Jong Kun Kim et al.

Abstract Background The demand for organ transplants, both globally and in South Korea, substantially exceeds the supply, a situation that might have been aggravated by the enactment of the Life-Sustaining Treatment Decision Act (LSTDA) in February 2018. This legislation may influence emergency medical procedures and the availability of organs from brain-dead donors. This study aimed to assess LSTDA’s impact, introduced in February 2018, on organ donation status in out-of-hospital cardiac arrest (OHCA) patients in a metropolitan city and identified related factors. Methods We conducted a retrospective analysis of a regional cardiac arrest registry. This study included patients aged 16 or older with cardiac arrest and a cerebral performance category (CPC) score of 5 from January 2015 to December 2022. The exclusion criteria were CPC scores of 1–4, patients under 16 years, and patients declared dead or transferred from emergency departments. Logistic regression analysis was used to analyse factors affecting organ donation. Results Of the 751 patients included in this study, 47 were organ donors, with a median age of 47 years. Before the LSTDA, there were 30 organ donations, which declined to 17 after its implementation. In the organ donation group, the causes of cardiac arrest included medical (34%), hanging (46.8%), and trauma (19.2%). The adjusted odds ratio for organ donation before the LSTDA implementation was 6.12 (95% CI 3.09–12.12), with non-medical aetiology as associated factors. Conclusion The enactment of the LSTDA in 2018 in South Korea may be linked to reduced organ donations among patients with OHCA, underscoring the need to re-evaluate the medical and legal aspects of organ donation, especially considering end-of-life care decisions.

K Moodley

The sanctity of the doctor-patient relationship is deeply embedded in tradition – the Hippocratic oath, medical ethics, professional codes of conduct, and legislation – all of which are being disrupted by big data and ‘artificial’ intelligence (AI). The transition from paper-based records to electronic health records, wearables, mobile health applications and mobile phone data has created new opportunities to scale up data collection. Databases of unimaginable magnitude can be harnessed to develop algorithms for AI and to refine machine learning. Complex neural networks now lie at the core of ubiquitous AI systems in healthcare. A transformed healthcare environment enhanced by innovation, robotics, digital technology, and improved diagnostics and therapeutics is plagued by ethical, legal and social challenges. Global guidelines are emerging to ensure governance in AI, but many low- and middle-income countries have yet to develop context- specific frameworks. Legislation must be developed to frame liability and account for negligence due to robotics in the same way human healthcare providers are held accountable. The digital divide between high- and low-income settings is significant and has the potential to exacerbate health inequities globally.

H. Clarke, H. Clarke, H. Clarke et al.

Although used therapeutically for millennia, cannabis has been a prohibited substance worldwide for most of the 20th Century. With revision of prohibitive regulations in many jurisdictions during the past 2 decades, cannabis is increasingly available to patients as a potential treatment option for various symptoms. Pain relief, sleep promotion and alleviation of distress, depression and anxiety are the most common reasons for cannabis use. Canada has been at the forefront of medical cannabis (MC) legislation revisions to enable and facilitate access for therapeutic use. Although initially viewed with caution and stigma, attitudes to cannabis in general have changed. Medical cannabis is identified as the herbal plant product sourced from a grower/producer and is not at present a regulated pharmaceutical product. Medical cannabis use is currently prevalent in Canada but has bypassed the rigorous study required for usual drug approval. Although uptake has been enthusiastic by patients, the medical community has voiced cautions and concerns. Access to medical cannabis is fairly easy once an approval document is obtained from a healthcare professional, but without obligation for medical or pharmacy oversight. The greatest concern is a dearth of sound clinical evidence for effects and harms. Emerging concerns include prevalent patient self-management with information based on personal research, an abundance of on-line information which may not always be accurate, the emergence of designated “cannabis clinics,” potential risks to society due to accidents, and high cost of the legal medical product leading to access via the recreational market. With cannabis now entrenched in Canadian healthcare, physicians must be sufficiently knowledgeable to provide guidance that is evidence-based and will ensure personal and societal harm reduction. Examination of the changing culture of medical cannabis in Canada will provide insight for countries that may be anticipating similar revisions of cannabis regulations to allow cannabis access for their patient population and learn from the issues created by recreational legalization.

Elisabetta Biasin, Burcu Yaşar, Erik Kamenjašević

The regulation of cybersecurity for medical devices keeps evolving in the European Union (EU). In the past few years, new pieces of legislation have been added to the initial framework for medical device cybersecurity, including the Medical Device Regulation, the General Data Protection Regulation and the Cybersecurity Act. The Artificial Intelligence Act, the European Health Data Space Regulation and the Data Act are forthcoming laws that contain cybersecurity-related requirements applicable to medical devices. This article examines the requirements stemming from each of these, as well as their role vis-a-vis the existing legal framework. We observe that despite being comprehensive and wide ranging in their changes, these new regulations may be inadequate for the task of ensuring the cybersecurity of medical devices. In our view, this approach by the EU legislature is inadequate because it fails to foresee cybersecurity requirements in a way that is truly linked with the already existing cybersecurity laws. To help address this problem, the article offers a set of workable recommendations that EU legislators would be well advised to take on board in respect of specific regulations, as well as in general, when establishing cybersecurity-related requirements.

Antonello Campagna, Rosa Maria Russo

Adequate medical facilities on passenger ships are essential to ensuring the quality of medical care and public health actions. Their design and construction is complex, as they have to comply with several regulations and recommendations from different authorities (IMO, ILO, EU, WHO), national flag legislation and advices from scientific societies. Therefore, proper authorization procedures become very important. The working guideline, developed in the light of our experience gained in new Italian cruise ships/ferries’ medical facilities’ authorization processes is presented. Innovative points are the participative continuous approach “from the board to the sea” and the Dynamic-Planning Method based on “what if” scenario model. A careful balance of the required features and standards against costs without compromising the quality of care is possible. The guidelines are open to be continually reviewed, updated, and expanded with the contribution of stakeholder’s. Readers are encouraged to provide feedback and to contribute material for further updates.

Thelma Sanchez, Edilberto Peña, Bernardo Ng

As of June 2020 the number of Coronavirus cases in Canada, Mexico, Central America and the Caribbean are just under 2.5 million infections and over 140,000 deaths. The health systems in half of the countries in the Americas and the rest of the world have faced the pandemic positioned from different perspectives. While Canada and the United States already had extensive experience in the practice of telemedicine, other countries such as Mexico and the Caribbean, doctors from both private and public sectors have been forced to start practicing medicine remotely. As a result there have been limitations such as poor access to technology, lack of privacy legislation, and difficulties with fee collection among many others. These situations must be taken in account to understand what is happening in the region. On the other hand, the need to continue providing medical attention is indisputable. We understand that COVID 19 besides other systems damages the CNS, patients present severe neuropsychiatric symptoms that range from headache, anosmia, ageusia, confusional state alteration of consciousness, toxic metabolic encephalopathies, encephalitis, seizures, cerebral vascular events, Guillan Barre-type demyelinating neuropathies, to the extent of conditions such as anxiety, acute stress disorder, post-traumatic stress disorder, depression, and eventually psychotic episodes. As time passes we try to differentiate the origin of the symptoms. We will learn which of these symptoms are a result of metabolic complications, which others are due to drug's secondary effects and which ones are adaptive response. Therefor our contribution to the editorial supplements is given in two lines of analysis: disease physiopathology and ways to deliver treatment to the population.

Ken Masters

Publication bias (the tendency for studies with positive results to be more easily published than studies with null or negative results) and outcome switching (the adjustment of study aims to match results) have long been problematic in medical research. Recent legislation, protocol-registration sites, and agreements by medical journals have led to a reduction of these problems in medical research. In medical education specifically, however, there is no such legislation, registration, or agreement. This paper argues for the creation of such a registration site and agreement by medical education journals as a matter of ethical necessity.

Cleber Sanfelici Otero, Tamara Simão Arduini

In the present study, there is a legal analysis about the triangular relationship established between patient, physician and hospital. In this scenario, the patient is naturally vulnerable, either to the hospital, because he relies on the health services that will be provided often paid with considerable values, or before the medical professionals, as he entrusts his life and physical integrity to the hands of those who will attending, believing in your technical skills. From this relationship can result damages to patients' rights, including non-material damages. The majority of the population is dissatisfied with health services, whether public or private, precisely because of the lack of care in the provision of services. Due to this, it is demonstrated the indispensability of civil liability to compensate for the non-material damages resulting from these relationships. With a bibliographical review, the method of deductive approach and the method of comparative procedure are used to analyze the problem from the Constitution and the legislation to the specificity of situations when comparing the forms of medical acting together with the hospitals.

Sri Lestari Ningsih, A Widanti S, Suwandi Suwandi

Health development is an effort undertaken by all components of the nation to increase awareness, willingness and ability to live healthily Midwifery services is an integral service of health care system. A Midwife is one health worker who has an important and strategic position, especially in reducing the number of infant deaths Newborn. The purpose of this research is to know the role of the midwife in giving health service t a newborn baby based on Permenkes Number 53 the Year 2014 About neonatal health service the newborn. This research is a sociological Juridical research with analytic descriptive research specification. This research uses primary data and secondary data. Method of collecting primary data through the interview to respondent and resource person. The respondents consisted of 10 midwives who worked at Kaleroang Community Health Center and the parents of newborns 10 people. While the speakers consisted of Head of Puskesmas Kaleroang, village cadres. Secondary data obtained through literature study which then analyzed qualitatively. Implementation of the role of midwives in providing neonatal health services to newborns only 4 midwives who have done their job thoroughly and 6 midwives have not done their job. And has not accomplished his duties as an implementer and educator. The role of the midwife as the implementer has not done the newborn care in the neonatal period (0-28 days), and the umbilical cord care. While the role of midwives as educators has not provided counseling and breastfeeding counseling, as well as the fostering of community participation in the field of maternal and child health. The supporting factors are Puskesmas, Puskesmas Pembantu, and Posyandu. While the inhibiting factors are the lack of health personnel (midwives), inadequate transportation facilities, the lack of midwifery knowledge so that the skills are still low, and the health equipment in some villages is not yet complete

P. Ekmekci

Mitchel Otieno Okumu, F. Ochola, A. O. Onyango et al.

Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.

Helen Intania Surayda

Abstract Legal protection for the interests of sexual violence victims either through the judicial process or by means of social care, is part of the legal policy. The legislation that becomes the reference for handling the sexual violence cases makes it difficult for women to access justice. The elasticity of Islamic law is highly adaptable to the dynamics of social change and the advance of the world. Multidimensional nature within the scope of Islamic law covers all aspects of human life. The purpose of the establishment of Islamic law is to realize the benefit for mankind. Just as the recovery of sexual violence victims is related to the victim's invidual benefit. The problems in this thesis are: a) how legal protection for sexual violence victims seen from positive law, b) how the legal protection for sexual violence victims in the concept of Islamic law study. To answer the problems, research with juridical normative approach method with specification of analytical descriptive research is conducted. The type of data used in this research is secondary data. Based on the conducted research, it is found that protection for sexual violence victims have not been optimally facilitated by the state. The recovery of the violence victims must be broadly understood, not only in medical, legal or psycho-social interventions but also in the creation of situations in which the victims of violence can be fully empowered, so they are able to take decisions in their lives and are able to resume their roles in society as women and citizens. The law is always positive law, and the legal positivism lies on the fact that the law is created and abolished by human actions, so apart from the morality and the norm systems themselves. The aspects of maslahah mursalah if applied to the legal protection for the victims of violence do not use normative approach as the case in general but the one which is used is the rights of the victims to take precedence in its handling.

Oleg E. Karpov, Dmitriy N. Nikitenko, Victor V. Tretyakov et al.

The article is focused on legal regulation of informational process in medical activities. Particular attention is paid to analysis of institute of medical secrecy in the Russian legislation and jurisprudence. The positive effect of medical informational systems on patient’s rights to medical secrecy is found out. The definition of medical service is proposed. Emphasized the need for the adoption of a law regulating public relations that arise from the application of telemedicine technologies.

Ayal Hassidim, Tzfania Korach, Rony Shreberk-Hassidim et al.

ObjectivesConfidentiality of health information is an important aspect of the physician patient relationship. The use of digital medical records has made data much more accessible. To prevent data leakage, many countries have created regulations regarding medical data accessibility. These regulations require a unique user ID for each medical staff member, and this must be protected by a password, which should be kept undisclosed by all means.MethodsWe performed a four-question Google Forms-based survey of medical staff. In the survey, each participant was asked if he/she ever obtained the password of another medical staff member. Then, we asked how many times such an episode occurred and the reason for it.ResultsA total of 299 surveys were gathered. The responses showed that 220 (73.6%) participants reported that they had obtained the password of another medical staff member. Only 171 (57.2%) estimated how many time it happened, with an average estimation of 4.75 episodes. All the residents that took part in the study (45, 15%) had obtained the password of another medical staff member, while only 57.5% (38/66) of the nurses reported this.ConclusionsThe use of unique user IDs and passwords to defend the privacy of medical data is a common requirement in medical organizations. Unfortunately, the use of passwords is doomed because medical staff members share their passwords with one another. Strict regulations requiring each staff member to have it's a unique user ID might lead to password sharing and to a decrease in data safety.

M. Murakami, M. Narukawa

Qing Yang, G. Miller

S. Sealy-Jefferson, J. Vickers, A. Elam et al.