AI, Machine Learning, and Ethics in Health Care.

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The importance of corrosion resistance test of cannulas in the quality control of hypodermic needles

According to Anvisa risk rating, hypodermic needles offer medium risk to the user's health. This study discussed the importance of the corrosion resistance test in tubes of hypodermic needles, in the product quality control. A review of cannulas of hypodermic needles was carried out according to ISO 9626:2003 and 9259:1997 ABNT NBR. For the results evaluation, a scale which classifies the extent of corrosion was adjusted. 174 samples of PNI needles from 17 States and 9 different record holders were analyzed. According to the methodology of ISO 9626:2003, 100% of the samples were considered satisfactory. However, in accordance with the methodology of ISO 9259:1997, 97.1% of the samples were rejected. Irregularities can lead to impairment of product quality, resulting in risks to the consumer's health. Since 2011 the product has undergone certification, so it is necessary to reflect on the importance of corrosion resistance testing and mandatory certification for health monitoring.

Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the area of blood glucose and insulin concentrations.

Most requests for authorization to bear health claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate health claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of health claims.

An Analysis of the Massachusetts Healthcare Law.

Healthcare in the United States has been one topic of the debates and discussion in the country for many years. The challenge for affordable, accessible, and quality healthcare for most Americans has been on the agenda of federal and state legislatures. There is probably no other state that has drawn as much individual attention regarding this challenge as the state of Massachusetts. While researching the topic for this article, it was discovered that financial and political perspectives on the success or failure of the healthcare model in Massachusetts vary depending on the aspect of the system being discussed. In this article the authors give a brief history and description of the Massachusetts Healthcare Law, explanation of how the law is financed, identification of the targeted populations in Massachusetts for which the law provides coverage, demonstration of the actual benefit coverage provided by the law, and review of the impact of the law on healthcare providers such as physicians and hospitals. In addition, there are explanations about the impact of the law on health insurance companies, discussion of changes in healthcare premiums, explanation of costs to the state for the new program, reviews of the impact on the health of the insured, and finally, projections on the changes that healthcare facilities will need to make to maintain fiscal viability as a result of this program.

El modelo del Institut Català de la Salut para la Sanidad Penitenciaria / The model of Institut Català de Salut for Prison Healthcare

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Remarks on Italian Law 27/2012 and court's technical consultancy / Observaciones sobre la Ley italiana 27/2012 y asesoría técnica del tribunal

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Upholding science in health, safety and environmental risk assessments and regulations.

A public appeal has been advanced by a large group of scientists, concerned that science has been misused in attempting to quantify and regulate unmeasurable hazards and risks.1 The appeal recalls that science is unable to evaluate hazards that cannot be measured, and that science in such cases should not be invoked to justify risk assessments in health, safety and environmental regulations. The appeal also notes that most national and international statutes delineating the discretion of regulators are ambiguous about what rules of evidence ought to apply. Those statutes should be revised to ensure that the evidence for regulatory action is grounded on the standards of the scientific method, whenever feasible. When independent scientific evidence is not possible, policies and regulations should be informed by publicly debated trade-offs between socially desirable uses and social perceptions of affordable precaution. This article explores the premises, implications and actions supporting the appeal and its objectives.

Where do we stand?

This president's column provides the current position of the Collaborative Family Healthcare Association (CFHA) in reference to the law passed in North Carolina on March 23, 2016, limiting the civil rights of LGBTQ people. This law troubles the CFHA deeply. This is an organization that promotes collaborative patient- and family-centered care. It currently celebrates diversity and rejects discrimination in any form. After considerable thought and review of alternative actions, the Board of CFHA determined that our best course is to proceed with plans for an annual conference in Charlotte, a city that has attempted to strengthen legal protection of the rights of its LGBTQ citizens. CFHA will use this opportunity to demonstrate our support for inclusion and cultural competence by convening a robust and timely conversation about the underlying issues raised by House Bill 2 and our role as collaborative care professionals. (PsycINFO Database Record

Las agresiones a profesionales sanitarios en España: análisis tras la reciente modificación del Código Penal / Aggressions towards healthcare workers in Spain: Status a after the recent modification of the Spanish Penal Code

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CRISPR Critters and CRISPR Cracks.

This essay focuses on possible nonhuman applications of CRISPR/Cas9 that are likely to be widely overlooked because they are unexpected and, in some cases, perhaps even "frivolous." We look at five uses for "CRISPR Critters": wild de-extinction, domestic de-extinction, personal whim, art, and novel forms of disease prevention. We then discuss the current regulatory framework and its possible limitations in those contexts. We end with questions about some deeper issues raised by the increased human control over life on earth offered by genome editing.

La responsabilidad profesional médica en Europa / Medical professional liability in Europe

La Academia Internacional de Medicina Legal ha elaborado una Guía sobre la metodología, la aproximación y los criterios de evaluación de la mala praxis médica y la demanda de responsabilidad profesional. Reunidos en Roma los representantes de los países se trabajó en: 1) la situación de la responsabilidad profesional en el país correspondiente, desde la perspectiva jurídica y médica y 2) el Grupo de trabajo para discusión de aportaciones y acuerdos sobre contenidos de la Guía y elaboración final de esta. La respuesta consensuada recoge lo que es común, así como los procedimentos no comunes que suponen una mejora cuando se incorporen a los países donde este procedimento no es habitual. Estas European Guidelines on Methods of Ascertaiment and Criteria of Evaluation of the Malpractice and Medical Liability contribuirán a unificar y armonizar la pericia médica en Europa, alcanzando mayor calidad y rigor (AU)

The International Academy of Legal Medecine has developed a guideline about methodology and evaluation criteria in case of medical malpractice with complaint, for professional liability. Representatives from different countries met in Rome with the following schedule: - Situation of professional liability in each country. Legal perspective (legal regulation, legal procedure). Medical point of view (official experts intervention, experts proposal, access to clinical documents, clinical or judicial autopsy, judicial issue, whether or not mediation teams). - Working group with the authors of the contributions, discussion and agreements about the guideline contents. Final preparation of the Guide. In this article we present the consensus of the working group, the common aspects to participating countries as well as particularities (performances, procedures) usual in a few of them, which can be an improvement for other countries when they could be incorporated. We believe that this European Guidelines will help to unify and harmonize the medical expertise in Europe, achieving higher quality and rigor (AU)

The case for moderate gun control.

In addressing the shape of appropriate gun policy, this essay assumes for the sake of discussion that there is a legal and moral right to private gun ownership. My thesis is that, against the background of this right, the most defensible policy approach in the United States would feature moderate gun control. The first section summarizes the American gun control status quo and characterizes what I call "moderate gun control." The next section states and rebuts six leading arguments against this general approach to gun policy. The section that follows presents a positive case for moderate gun control that emphasizes safety in the home and society as well as rights whose enforcement entails some limits or qualifications on the right to bear arms. A final section shows how the recommended gun regulations address legitimate purposes, rather than imposing arbitrary restrictions on gun rights, and offers concluding reflections.

WHO-definition of health must be enforced by national law: a debate.

BACKGROUND: On its establishment, the World Health Organization (WHO) defined health as a fundamental human right deserving legal protection. Subsequently, the Ottawa Charter reaffirmed health as a fundamental right, and emphasized health promotion as the most appropriate response to global health issues. Here we suggest that the WHO definition of health as more than simply the absence of illness is not normative, and therefore requires standardization. To date such standardization unfortunately is lacking. DISCUSSION: National legislatures must actively ensure fair access to health care, both nationally and internationally, and also must reduce social inequality. To achieve this requires practical action, not statements of intentions, commitments or targets. Protecting fundamental rights to health care can be a fruitful focus for legislatures. Legislative action can build an objective legal framework for health care law, and guide its interpretation and application. Additionally, it is important to ensure the law is appropriate, useful and sustainable. SUMMARY: Action is needed to protect the fundamental right to health care. Legislators should appropriately incorporate the WHO recommendations regarding this right into national law. Additionally, professional experts should help interpret and codify concepts of health and join the interdisciplinary discussion of a variable health standard.

How to regulate medical tourism (and why it matters for bioethics).

A growing literature examines descriptive and normative questions about medical tourism such as: How does it operate? What are its effects? Are home country patients or their governments failing in moral duties by engaging in or permitting medical tourism? By contrast, much less has been written on the regulatory dimension: What might be done about medical tourism if we were convinced that it posed ethical issues and were motivated to act? I shall argue that this kind of regulatory analysis is essential for bioethical analysis of medical tourism. This article focuses on these regulatory questions more directly, evaluating available methods, restrictions, costs, and benefits of home and destination country unilateral regulatory moves. This article also discusses more briefly multilateral treaty and private sector responses.