Saúde digital à luz da filosofia contemporânea / Salud digital a la luz de la filosofía contemporánea / Digital health in the light of contemporary philosophy

Resumo Objetivo discutir as questões relacionadas ao conceito de saúde digital, e de que modo a área da saúde tem se associado à evolução tecnológica e aos novos paradigmas para o cuidado, à luz de alguns pensadores da Filosofia contemporânea. Método trata-se de um ensaio teórico-filosófico. Resultados Michel Foucault destacou o papel das estruturas de poder na saúde digital, alertando para o potencial de vigilância e do controle social. Por outro lado, Pierre Lévy e Mário Bunge enfatizaram a importância da tecnologia na Enfermagem, ressaltando seus benefícios e desafios na busca por soluções adequadas e éticas. Considerações finais e implicações para a prática a saúde digital emerge como um terreno de conflitos e possibilidades, em que os avanços tecnológicos trazem consigo tanto as potencialidades transformadoras, quanto os riscos à privacidade, à autonomia e à qualidade do cuidado. A abordagem filosófica é essencial para questionar o desenvolvimento tecnológico em saúde, especialmente na Enfermagem, de maneira ética, profunda e consciente.

Resumen Objetivo discutir temas relacionados con el concepto de salud digital, y cómo el área de la salud se ha asociado con la evolución tecnológica y nuevos paradigmas para el cuidado, a la luz de algunos pensadores de la Filosofía contemporánea. Método se trata de un ensayo teórico-filosófico. Resultados Michel Foucault destacó el papel de las estructuras de poder en la salud digital, advirtiendo sobre el potencial de vigilancia y del control social. Por otro lado, Pierre Lévy y Mário Bunge destacaron la importancia de la tecnología en Enfermería, destacando sus beneficios y desafíos en la búsqueda de soluciones apropiadas y éticas. Consideraciones finales e implicaciones para la práctica la salud digital emerge como una tierra de conflictos y posibilidades, en la que los avances tecnológicos traen consigo tanto las potencialidades transformadoras como riesgos para la privacidad, la autonomía y la calidad de la atención. El enfoque filosófico es fundamental para cuestionar el desarrollo tecnológico en salud, especialmente en Enfermería, de manera ética, profunda y consciente.

Abstract Objective to discuss issues related to the concept of digital health, and how the area of health has been associated with technological evolution and new paradigms for care, in the light of some contemporary philosophical thinkers. Method this is a theoretical-philosophical essay. Results Michel Foucault highlighted the role of power structures in digital health, warning of the potential for surveillance and social control. On the other hand, Pierre Lévy and Mário Bunge emphasize the importance of technology in nursing, highlighting its benefits and challenges in the search for appropriate and ethical solutions. Final considerations and implications for practice digital health emerges as a land of conflicts and possibilities, in which technological advances bring both transformative potential and risks to privacy, autonomy, and quality of care. The philosophical approach is essential to question technological development in health, especially in nursing, in an ethical, profound, and conscious way.

Confiabilidade da autoavaliação das práticas de segurança do paciente instituídas pelo Sistema Nacional de Vigilância Sanitária: um estudo piloto / Reliability of patient safety self-assessment practices established by the National Health Surveillance System: a pilot study

Resumo Introdução: A Autoavaliação das Práticas de Segurança do Paciente é um ato regulatório para melhoria da qualidade do cuidado. Porém, há dúvidas sobre a validade das suas informações. O objetivo deste estudo foi analisar a sua confiabilidade. Método: Estudo piloto de análise da confiabilidade de 21 indicadores simples e um composto da autoavaliação como forma de embasar uma amostra nacional em estudos futuros. Participaram hospitais com leitos de terapia intensiva e comparou dados da Autoavaliação (AA) e Autoavaliação Revisada (AR) pela vigilância sanitária (Visa) com a Inspeção Presencial (IP). A análise incluiu os coeficientes Kappa e de correlação intraclasse. Resultados: Comparando com a IP, a concordância foi aceitável (Kappa≥0,4) em 12 indicadores da AA e em 18 da AR. Os indicadores menos confiáveis são relativos a protocolos de prevenção de infecções. Quanto ao indicador composto do nível de adesão, a confiabilidade melhorou com revisão da Visa (AA=0,89 e AR=0,94), embora a concordância da classificação de alta conformidade tenha sido baixa. Conclusões: A AR se mostrou essencial para melhorar a confiabilidade da Autoavaliação. Ademais, identificou-se necessidade de revisar alguns indicadores e o instrumento de verificação pela Visa.

Abstract Introduction: The Patient Safety Self-Assessment Practices is a regulatory action to enhance quality of care. However, validation of its information requires attention. This study aimed to analyze reliability of the Patient Safety Self-Assessment Practices. Methods: Pilot study analyzing the reliability of 21 simple indicators and 1 composite of self-assessment to provide a national sample in future studies. Hospitals with intensive unit care beds participated in the study, and data from self-assessment (SA) and revised self-assessment (RSA) by the health surveillance (HS) were compared with on-site inspection (OSI). Analyses included Kappa and intraclass correlation coefficients. Results: Concordance was satisfactory (Kappa ≥ 0.4) in 12 indicators of SA and 18 indicators of RSA compared with OSI. The least reliable indicators were related to infection prevention protocols. Reliability of the adherence level composite indicator improved with HS revision (SA = 0.89 and RSA = 0.94), despite the low concordance of the high compliance classification. Conclusion: RSA was essential to improve reliability of SA. In addition, some indicators and assessment tools of the HS need revision.

Mandatory reporting legislation in Canada: improving systems for patient safety?

Patient safety is a complex systems issue. In this study, we used a scoping review of peer-reviewed literature and a case study of provincial and territorial legislation in Canada to explore the influence of mandatory reporting legislation on patient safety outcomes in hospital settings. We drew from a conceptual model that examines the components of mandatory reporting legislation that must be in place as a part of a systems governance approach to patient safety and used this model to frame our results. Our results suggest that mandatory reporting legislation across Canada is generally designed to gather information about - rather than respond to and prevent - patient safety incidents. Overall, we found limited evidence of impact of mandatory reporting legislation on patient safety outcomes. Although legislation is one lever among many to improve patient safety outcomes, there are nonetheless several considerations for patient safety legislation to assist in broader system improvement efforts in Canada and elsewhere. Legislative frameworks may be enhanced by strengthening learning systems, accountability mechanisms and patient safety culture.

Vascular surgery-related violations of the Emergency Medical Treatment and Labor Act.

OBJECTIVE: The Emergency Medical Treatment and Labor Act (EMTALA) is a federal law established in 1986 to ensure that patients who present to an emergency department receive medical care regardless of means. Violations are reported to the Centers for Medicare and Medicaid Services and can result in significant financial penalties. Our objective was to assess all available EMTALA violations for vascular-related issues. METHODS: EMTALA violations in the Centers for Medicare and Medicaid Services publicly available hospital violations database from 2011 to 2018 were evaluated for vascular-related issues. Details recorded were case type, hospital type, hospital region, reasons for violation, disposition, and mortality. RESULTS: There were 7001 patients identified with any EMTALA violation and 98 (1.4%) were deemed vascular related. The majority (82.7%) of EMTALA violations occurred at urban/suburban hospitals. Based on the Association of American Medical Colleges United States region, vascular-related EMTALA violations occurred in the Northeast (7.1%), Southern (56.1%), Central (18.4%), and Western (18.4%) United States. Case types included cerebrovascular (28.6%), aortic related (22.4%; which consisted of ruptured aortic aneurysms [8.2%], aortic dissection [11.2%], and other aortic [3.1%]), vascular trauma (15.3%), venous-thromboembolic (15.3%), peripheral arterial disease (9.2%), dialysis access (5.1%), bowel ischemia (3.1%), and other (1%) cases. Patients were transferred to another facility in 41.8% of cases. The most common reasons for violation were specialty refusal or unavailability (30.6%), inappropriate documentation (29.6%), misdiagnosis (18.4%), poor communication (17.3%), inappropriate triage (13.3%), failure to obtain diagnostic laboratory tests or imaging (12.2%), and ancillary or nursing staff issues (7.1%). The overall mortality was 19.4% and 31.6% died during the index emergency department visit. Vascular conditions associated with death were venous thromboembolism (31.6%), ruptured aortic aneurysm (21.1%), aortic dissection (21.1%), other aortic causes (10.5%), vascular trauma (10.5%), and bowel ischemia (5.3%). CONCLUSIONS: Although the frequency of vascular-related EMTALA violations was low, improvements in communication, awareness of vascular disease among staff, specialty staffing, and the development of referral networks and processes are needed to ensure that patients receive adequate care and that institutions are not placed at undue risk.

Advancing the Culture of Patient Safety and Quality Improvement.

The American health care system has many great successes, but there continue to be opportunities for improving quality, access, and cost. The fee-for-service health care paradigm is shifting toward value-based care and will require accountability around quality assurance and cost reduction. As a result, many health care entities are rallying health care providers, administrators, regulators, and patients around a national imperative to create a culture of safety and develop systems of care to improve health care quality. However, the culture of patient safety and quality requires rigorous assessment of outcomes, and while numerous data collection and decision support tools are available to assist in quality assessment and performance improvement, the public reporting of this data can be confusing to patients and physicians alike and result in unintended negative consequences. This review explores the aims of health care reform, the national efforts to create a culture of quality and safety, the principles of quality improvement, and how these principles can be applied to patient care and medical practice.

Leaving Hospital: A Step too Far for Risk-Based Regulation?

Discharges from hospital are internationally recognised as a dangerous time in the care pathway of a patient, posing a risk to both their physical wellbeing and dignity. This article examines the effectiveness of risk-based regulation as a tool to address patient safety incidents linked to the hospital discharge process within the English National Health Service. It examines how the risk of this process is identified, conceptualised, and prioritised amongst the relevant statutory regulators, and argues that the risk is neither uniformly recognised by the statutory regulators within the English NHS, nor sufficiently addressed. Professional regulators in particular appear to have a poor awareness of the risk and their role in addressing it. Until these issues are resolved, patients leaving hospitals will continue to be exposed to patient safety incidents which should be avoidable.

Prioritization of patient safety health policies: Delphi survey using patient safety experts in Japan.

Various patient safety interventions have been implemented since the late 1990s, but their evaluation has been lacking. To obtain basic information for prioritizing patient safety interventions, this study aimed to extract high-priority interventions in Japan and to identify the factors that influence the setting of priority. Six perspectives (contribution, dissemination, impact, cost, urgency, and priority) on 42 patient safety interventions classified into 3 levels (system, organizational, and clinical) were evaluated by Japanese experts using the Delphi technique. We examined the relationships of the levels and the perspectives on interventions with the transition of the consensus state in rounds 1 and 3. After extracting the high-priority interventions, a chi-squared test was used to examine the relationship of the levels and the impact/cost ratio with high priority. Regression models were used to examine the influence of each perspective on priority. There was a significant relationship between the level of interventions and the transition of the consensus state (p = 0.033). System-level interventions had a low probability of achieving consensus. "Human resources interventions," "professional education and training," "medication management/reconciliation protocols," "pay-for performance (P4P) schemes and financing for safety," "digital technology solutions to improve safety," and "hand hygiene initiatives" were extracted as high-priority interventions. The level and the impact/cost ratio of interventions had no significant relationships with high priority. In the regression model, dissemination and impact had an influence on priority (ß = -0.628 and 0.941, respectively; adjusted R-squared = 0.646). The influence of impact and dissemination on the priority of interventions suggests that it is important to examine the dissemination degree and impact of interventions in each country for prioritizing interventions.

Marketing of healthcare services in Denmark: the concept of misleading advertising.

As severe ill and incurable patients can be easy victims of misleading advertising activities for dangerous and non-effective healthcare treatments, the marketing of healthcare services are in many jurisdictions legislations tightly regulated. This article reviews the Danish regulation on marketing of healthcare services to identify which types of advertising activities that are legal. As the legislation only allows healthcare authorities to control the marketing and not the content and quality of the marketed healthcare services, their ability to intervene in serious cases of misleading advertising is limited. Misleading advertising are statements with the purpose to exaggerate or underestimate the effects and risks of healthcare services or to prevent patients from seeking conventional medical treatments. From a public health perspective, there is a need for a common EU legislation for regulation of the marketing of healthcare services as the increasing use of information technologies makes it possible for the providers to access consumers and patients directly across countries and legal systems.

Nutraceuticals: A Comparative Analysis of Regulatory Framework in Different Countries of the World.

BACKGROUND: Nutraceutical is a term that is a combination of nutrition and pharmaceutical. They are believed to improve physical and mental health and provide therapeutic benefit in disease conditions. Nutraceuticals are claimed to be beneficial in several disease conditions which include cardiovascular disorder, neurodegenerative disorders, metabolic disorders and cancer prevention. OBJECTIVE: In the current review, we will study the current regulatory framework in some of the major countries of the world by comparing different parameters of these regulations. FINDINGS: Global nutraceutical market is currently expanding at a rapid pace but there are some restraints to the market growth which include poor quality manufacturing and unharmonized regulations leading to trade barriers across the globe. Although there are laws and regulations in place which govern nutraceutical products in different countries, these regulations lack harmonization and differ from country to country. Some of the countries follow stringent regulations, whereas, in some of the countries, well-structured and stern regulations for nutraceuticals are lacking. CONCLUSION: The development of a well regulated, harmonized and research-driven approach can help boost the confidence of consumers in nutraceutical products in the world thereby driving the nutraceutical market.

What are the main patient safety concerns of healthcare stakeholders: a mixed-method study of Web-based text.

OBJECTIVES: Various healthcare stakeholders define quality of care in different ways. Public policy could advocate all these concerns. This study was conducted to identify the main themes on patient safety of stakeholders expressed before and after the Patient Safety Act was enacted in Korea in 2015. DESIGN: Longitudinal observational study of the interests of healthcare stakeholders generated between January 2014 and September 2018. MATERIALS AND METHODS: Text data were collected from 2,487 documents on 18 websites that were identified as representative healthcare stakeholder groups of consumers, providers, government, and researchers. A Korean natural language processing (NLP) package, manual review, and synonym dictionary were used for data preprocessing, and we adopted the unsupervised NLP method of probabilistic topic modeling and latent Dirichlet allocation. A linear trend analysis over time, a qualitative step involving two external experts, and original text reviews were performed to validate the identified topics. RESULTS: Forty-one topics were identified, and the most common concerns of stakeholders were institutional infection control as triggered by the Middle East respiratory syndrome outbreak in early 2015, and infusion-related infection from late 2017 until the middle of 2018. The other top-three concerns of the stakeholder groups were highly similar, while research topics were limited to the perceptions of providers and the activities and culture of hospitals. Five topics showed statistically significant increasing trends over time, while another five showed decreasing trends (both P < 0.05). In the qualitative step, we confirmed 35 themes and revised the other 6. CONCLUSIONS: A common concern among stakeholders was hospital infection control, ranging from nosocomial infections to those brought in by family visiting patients. Government policies and systemic approaches to patient safety were highlighted by different stakeholders. Researchers were focused on hospital sociocultural factors at both the organizational and clinician levels. These identified concerns all should be advocated by the public health policy.

Experience from a Singapore tertiary hospital with restructuring of a vascular surgery practice in response to national and institutional policies during the COVID-19 pandemic.

Singapore was one of the first countries to be affected by COVID-19, with the index patient diagnosed on January 23, 2020. For 2 weeks in February, we had the highest number of COVID-19 cases behind China. In this article, we summarize the key national and institutional policies that were implemented in response to COVID-19. We also describe in detail, with relevant data, how our vascular surgery practice has changed because of these policies and COVID-19. We show that with a segregated team model, the vascular surgery unit can still function while reducing risk of cross-contamination. We explain the various strategies adopted to reduce outpatient and inpatient volume. We provide a detailed breakdown of the type of vascular surgical cases that were performed during the COVID-19 pandemic and compare it with preceding months. We discuss our operating room and personal protective equipment protocols in managing a COVID-19 patient and share how we continue surgical training amid the pandemic. We also discuss the challenges we might face in the future as COVID-19 regresses.

Rogue stem cell clinics.

Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures. Such providers have been known to recommend, prescribe, or deliver so called 'stem cell' preparations without sufficient data to support their true content and efficacy. In this annotation, we outline the current environment of stem cell-based treatments and the strategies of marketing directly to consumers. We also outline the difficulties in the regulation of these clinics and make recommendations for best practice and the identification and reporting of illegitimate providers. Cite this article: Bone Joint J 2020;102-B(2):148-154.

Gadolinium Retention as a Safety Signal: Experience of a Manufacturer.

OBJECTIVES: The purpose of this manuscript is to review the successive regulatory actions and decisions following the initial publication by Kanda and colleagues in 2014 regarding gadolinium retention in the human brain after multiple gadolinium-based contrast agents (GBCAs) administrations. MATERIALS AND METHODS: Starting from 2014, the actions and decisions made by all regulatory authorities were collected and summarized region by region. Volumes of GBCA sales in 2018 per region and main countries are also presented as an indicator of patients' exposure to those products. RESULTS: All regulatory authorities agreed on the absence of evidence of any harmful effect of gadolinium retention in humans. However, based on the same amount of preclinical and clinical evidence available in adults and children, regulatory authorities used different approaches resulting in different actions and decisions regarding the labeling and market authorizations of GBCAs, as well as the specific actions requested to the manufacturers. CONCLUSIONS: The manufacturers of GBCAs had to face different situations according to the countries, due to the different positions and expectations from regulatory agencies. They have adapted their responses to the different positions of the regulatory agencies and conducted specific preclinical and clinical investigations to provide the expected evidence. It is also their responsibility to continuously monitor the benefit-risk balance of the products and to propose risk minimization measures to the regulatory agencies.

[What regulations have launched autonomous communities to going forward on patient safety culture in healthcare organizations?] / ¿Qué normativas han desarrollado las comunidades autónomas para avanzar en cultura de seguridad del paciente en sus organizaciones sanitarias?

INTRODUCTION: Patient Safety Culture is based on learning from incidents, developing preventive strategies to reduce the likelihood to happen and recognizing and accompanying those who have suffered unnecessary and involuntary harm derived from the health care received. To go ahead on patient safety culture entails facilitating the implementation of these behaviors and attitudes in healthcare professionals. Objective was to describe the regulations of some autonomous communities and national proposals for regulations changes. MATERIAL AND METHODS: Search of normative changes made in the autonomous communities of Catalonia, Navarra and the Basque Country. Proposals for legislative changes at national level were agreed. RESULTS: Activities and normative changes made in the autonomous communities of Catalonia, Navarre and the Basque Country are described and proposals for normative changes at the national level at short-term and long-term changes are made. In such a way that it is easier to advance in creating culture of patient safety in the whole National Health System CONCLUSION: Currently there is no global regulation that facilitates to advance in patient safety culture. Changes at the national legislation level are essential. It is at the Inter-territorial Council where the proposed legislative amendment should be defined, promoted by the representatives of the health systems of the autonomous communities.

Facts to help you keep pace with the vaccine conversation.

In the United States, we have a robust system to monitor vaccine safety and an efficient system to compensate those who experience adverse reactions. Here's how it works.