Administering a Chill Pill? Better Regulation and the Potential for Regulatory Chill in European Union Health Policy.

The European Union's 'good governance' programme, known as Better Regulation, seeks to improve the quality of EU legislation by controlling the policy-making process. Despite its importance, it is rarely accounted for in the EU health policy literature. Seeking to address this gap, this article introduces Better Regulation in the context of health policy-making. We conceptualise a model of regulatory chill, drawn from the literature on international trade, to interrogate the impact of Better Regulation on EU policy-making processes. Using examples from the literature and data from a series of interviews with EU officials, we explore potential pathways of response and anticipatory chill, identifying direct enforcement of Better Regulation, its utilisation by corporate actors, interpretation of its provision by officials, and feedback loops as possible routes of influence. We argue that such an approach presents methodological challenges, but also offers a valuable way of conceptualising the relevance of political institutions in general, and Better Regulation specifically, for health. As part of broader calls for attention to the political determinants of health, our findings highlight the particular, and often overlooked, importance of meta-regulatory policy frameworks.

Improving health literacy using the power of digital communications to achieve better health outcomes for patients and practitioners.

Digital communication tools have demonstrated significant potential to improve health literacy which ultimately leads to better health outcomes. In this article, we examine the power of digital communication tools such as mobile health apps, telemedicine and online health information resources to promote health and digital literacy. We outline evidence that digital tools facilitate patient education, self-management and empowerment possibilities. In addition, digital technology is optimising the potential for improved clinical decision-making, treatment options and communication among providers. We also explore the challenges and limitations associated with digital health literacy, including issues related to access, reliability and privacy. We propose leveraging digital communication tools is key to optimising engagement to enhance health literacy across demographics leading to transformation of healthcare delivery and driving better outcomes for all.

International health regulations and pre-travel health practices of international travelers at Nigerian airport: a cross-sectional study.

BACKGROUND: International Health Regulations (IHR) were developed by the World Health Organization (WHO) to curb the trans-border spread of epidemics. To our knowledge, no airport-based studies have assessed travelers' health practices against a combination of diseases subject to IHR 2005. Therefore, we aimed to generate and describe the baseline travelers' pre-travel health practices towards Cholera, Yellow Fever (YF), and Plague at Murtala Muhammed International Airport (MMIA) in Nigeria. METHODS: A cross-sectional study was employed to collect data from 486 international travelers using a multistage sampling technique. Pre-travel health practices (a combination of pre-travel consultation, pre-travel vaccination, and preventive measures against insect bites) were assessed using an interviewer-administered questionnaire. Logistic regression models were used to estimates the association between selected variables and pre-travel health practices. Statistical significance level was set at 5%. RESULTS: A total of 479 complete questionnaires were analyzed. The median age of respondents was 34.0 years Interquartile range (IQR) = 28.0, 44.0). Of the total respondents, 311 (64.3%) were aware of pre-travel health consultation and sources of information, amongst others, including friends/relatives in 180 (37.6%) travelers, social media/internet in 155 (32.4%) travelers, and health professionals in 102 (21.3%) travelers. Two hundred and seventy-one (56.6%) had pre-travel consultation, 156 (32.6%) had YF vaccination, and 226 (47.2%) were prepared to use preventive measures against insect bites. Only 10.6% had good pre-travel practices against the diseases subject to 2 International Health Regulations (IHR). Travelers with bachelor/college degrees, when compared to those with secondary/high education, had 2.91 times higher odds of having good practices when adjusting for other factors (95% C.I: 1.10, 7.70; p < 0.03). Also, those traveling to destinations endemic for YF infection, when compared to those who are not traveling to endemic countries/areas, had 48% lower odds of having good practices after adjusting for other factors (95% C.I: 1.41, 7.77; p < 0.01). CONCLUSIONS: Our study revealed a low prevalence of good pre-travel health practices among participants. Educational level and endemicity of YF at the destination were predictors of pre-travel health practices. Introducing topics on travelers' health into schools' curriculums may have a ripple positive effect on health practices among international travelers. Also, there is a need for public enlightenment programs on pre-travel health practices using social media platforms.

Attributes That Influence Human Decision-Making in Complex Health Services: Scoping Review.

BACKGROUND: Humans currently dominate decision-making in both clinical health services and complex health services such as health policy and health regulation. Many assumptions inherent in health service models today are underpinned by Ramsey's Expected Utility Theory, a prominent theory in the field of economics that is rooted in rationality. Rational, evidence-based metrics currently dominate the culture of decision-making in health policy and regulation. However, as the COVID-19 pandemic has shown, rational metrics alone may not suffice in making better policy and regulatory decisions. There are ethical and moral considerations and other complex factors that cannot be reduced to evidence-based rationality alone. Therefore, this scoping review was undertaken to identify and map the attributes that influence human decision-making in complex health services. OBJECTIVE: The objective is to identify and map the attributes that influence human decision-making in complex health services that have been reported in the peer-reviewed literature. METHODS: This scoping review was designed to answer the following research question: what attributes have been reported in the literature that influence human decision-making in complex health services? A clear, reproducible methodology is provided. It is reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) standards and a recognized framework. As the topic of interest merited broad review to scope and understand literature from a holistic viewpoint, a scoping review of literature was appropriate here. Inclusion and exclusion criteria were developed, and a database search undertaken within 4 search systems-ProQuest, Scopus, PubMed, and Web of Science. RESULTS: The results span 46 years, from 1976 to 2022. A total of 167 papers were identified. After removing duplicates, 81 papers remained. Of these, 77 papers were excluded based on the inclusion and exclusion criteria. The remaining 4 papers were found to be relevant. Citation tracking was undertaken, identifying 4 more relevant papers. Thus, a total of 8 papers were included. These papers were reviewed in detail to identify the human attributes mentioned and count the frequency of mentions. A thematic analysis was conducted to identify the themes. CONCLUSIONS: The results highlight key themes that underline the complex and nuanced nature of human decision-making. The results suggest that rationality is entrenched and may influence the lexicon of our thinking about decision-making. The results also highlight the counter narrative of decision-making underpinned by uniquely human attributes. This may have ramifications for decision-making in complex health services today. The review itself takes a rational approach, and the methods used were suited to this. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/42353.

Violation of Food Advertising Regulations in Iran: A Systematic Review.

Background: The prevalence of non-communicable diseases (NCDs) and the status of nutritionally high-risk behaviors in the country are not promising. Because of undeniable impact of media advertising on food choices, to combat the problem some regulations on food advertisements are developed in the country. However, the high prevalence of NCDs warns of the possibility that either the laws are not given the necessary attention or they are not implemented properly. Therefore in the present review, all studies on how the country's visual and written mass media comply with regulations related to food product advertisement were systematically reviewed. Methods: We searched all studies, including Persian and English articles, dissertations, and research projects, published and unpublished reports in eight domestic and international databases and search engines during the years 1996 to December of 2020 (25 years). Then, the content of the eligible studies was extracted, evaluated, and reported. Results: A total of 18 eligible studies (articles and reports) were included in the review. The results indicated violations of rules and regulations including displaying food products of low nutritional value and obese people, misleading/exaggerating claims, award offers, induction of gluttony, consumerism, and inconsistency with scientific facts. Most of the studies (55%) had, implicitly or explicitly, targeted children and adolescents. Conclusions: The results of this study indicated a violation of the rules and regulations of health policies, mainly in the field of promoting foods of low nutritional value during the study period. Violations of the ban on advertising for children were also reported in more than half of the studies.

IHR-PVS National Bridging Workshop in Cameroon: An interactive and participatory approach to engage stakeholders in the development of a One Health road map.

Introduction: Stakeholders involved in the implementation of the One Health (OH) welcome support for the operationalization of the approach and advice on how to address OH collaboration challenges. The IHR/PVS National Bridging Workshop (NBW) is an operational and outcome-oriented tool approach that allows animal health, human health and other relevant sectors to focus on their coordination. This paper describes how Cameroon leveraged on the NBW success factors to engage stakeholders in strengthening multisectoral collaboration. Methods: Stakeholder's engagement was implemented in two phases. Phase one consisted of engaging the multisectoral national task team for the preparation of the workshop. Phase two consisted of the bridging exercise itself during a three day workshop. The WOAH-WHO standardized IHR/PVS NBW toolkit was used throughout the workshop. Results: A total of 66 participants took part in the exercise. In total, 36% each came from human and animal health sectors with 23% and 5% from the environmental health and other sectors respectively. A total of 55% participants came from the national level and 39% from the regional level. The joint roadmap contained 55 activities and 13 objectives. Priority objectives were the establishment of a OH platform at all levels (62% of the vote) and building stakeholder's capacity on the OH approach (56% of the vote). A total of 67% of the activities required low or moderate cost and 87% would have a high impact on multisectoral collaboration. Conclusion: The NBW allowed consensus on operational activities to fill the gaps in coordination to build health security capacities. It enabled Cameroon to create a joint road map for enhanced multisectoral collaboration for health security. The output will be integrated in the National Action Plan for Health Security operational plan and support operational One Health activities. It would be crucial to develop global capacity assessment frameworks for environmental health, which could be included in the NBW, to incorporate interconnections with environmental sector. This should allow for a stronger multisectoral linkage of sectors all together for a more the robust OH approach in responding to emerging public health threats.

Universal health coverage mitigated COVID-19 health-related consequences in Asia Oceania.

The COVID-19 pandemic has been a continual challenge since 2020, and it continues to impact people and industries as a disaster caused by a biological hazard. This study examined universal health coverage (UHC) scores in relation to the performance in combating COVID-19 in the Southeast Asian region (SEAR) and the Western Pacific region (WPR), along with the State Party Self-Assessment Annual Reporting (SPAR) index under the international health regulations (IHC). The numbers of infections and deaths per million population from December 2019 to June 2022 were used as primary outcomes to measure countries' performance. Countries with UHC scores of 63 or higher had a significantly lower number of infected patients and deaths. In addition, several inter-capacity correlations within the SPAR capacities, including with C8 (the National Health Emergency Framework), as well as a very strong correlation to C4 (Food Safety), C5 (Laboratory), and C7 (Human Resources). Furthermore, C9 (Health Service Provisions) has a very strong correlation to C1 (Legislation and Financing), C2 (International Health Regulation Coordination and a National IHR Focal Point function), and C4 (Food Safety), suggesting that the capability to manage an emerging infectious disease form blocks of capacities. In conclusion, UHC clearly mitigated the health-related consequences of COVID-19 in South-East Asia Region (SEAR) and Western Pacific Region (WPR). Investigating the correlation between the SPAR capacities and UHC is a promising approach for future research, including the importance of the provision of health services, points of entry, and, most importantly, risk communications as critical factors for managing pandemic. This study constitutes a good opportunity to apply the SPAR index to define which capacities correlate with the outcome of the pandemic in terms of infections and deaths.

A regulação do trabalho em saúde em tempos complexos e instáveis / Health workforce regulation in complex and unstable times

Resumo No Brasil, a saúde é considerada direito de todos e dever do Estado. A regulação do trabalho em saúde é atividade essencial para garantir a segurança, qualidade e eficácia dos serviços de saúde prestados, que exigem profissionais com competências, habilidades e atitudes condizentes. O trabalho em saúde deve ainda ser exercido com condições de trabalho dignas aos profissionais de saúde e aos pacientes. Este ensaio apresenta uma análise crítica e atual das principais características do modelo de regulação do trabalho em saúde no Brasil. O texto descreve, inicialmente, de que forma está estruturada a regulação do exercício profissional na área da saúde, abordando temas como a autonomia regulatória dos Conselhos Profissionais, a regulação de novas profissões de saúde e a judicialização dos conflitos regulatórios. Finalmente, são analisadas as características da regulação da formação de nível superior na área da saúde e o papel protagonista do Ministério da Educação nesse campo regulatório. As reflexões aqui apresentadas objetivam apontar possíveis caminhos para o aperfeiçoamento do modelo de regulação do trabalho em saúde no Brasil, tendo como norte a consolidação do Sistema Único de Saúde (SUS) e a plena efetivação do direito à saúde no Brasil.

Abstract In Brazil, health is considered a right of all and a duty of the State, and health workforce regulation is essential to ensure the safety, quality and effectiveness of the health services provided, which require professionals with skills, abilities and attitudes consistent with the service in question, as well as to guarantee dignified working conditions for health professionals and patients. This essay is a critical and up-to-date analysis of the main characteristics of Brazil's health workforce regulation model. We first describe how the health workforce regulation is structured, addressing topics such as the regulatory autonomy of Professional Councils, the regulation of new healthcare professions and the judicialization of conflicts in the field. We then analyze the regulation of health higher education and the leading role of the Ministry of Education in this regulatory field. The present reflections point out possible ways to improve Brazil's health workforce regulation model, having the consolidation of the Brazilian National Health System (SUS) and the full implementation of the right to health as guides.

Human Decision-making in an Artificial Intelligence-Driven Future in Health: Protocol for Comparative Analysis and Simulation.

BACKGROUND: Health care can broadly be divided into two domains: clinical health services and complex health services (ie, nonclinical health services, eg, health policy and health regulation). Artificial intelligence (AI) is transforming both of these areas. Currently, humans are leaders, managers, and decision makers in complex health services. However, with the rise of AI, the time has come to ask whether humans will continue to have meaningful decision-making roles in this domain. Further, rationality has long dominated this space. What role will intuition play? OBJECTIVE: The aim is to establish a protocol of protocols to be used in the proposed research, which aims to explore whether humans will continue in meaningful decision-making roles in complex health services in an AI-driven future. METHODS: This paper describes a set of protocols for the proposed research, which is designed as a 4-step project across two phases. This paper describes the protocols for each step. The first step is a scoping review to identify and map human attributes that influence decision-making in complex health services. The research question focuses on the attributes that influence human decision-making in this context as reported in the literature. The second step is a scoping review to identify and map AI attributes that influence decision-making in complex health services. The research question focuses on attributes that influence AI decision-making in this context as reported in the literature. The third step is a comparative analysis: a narrative comparison followed by a mathematical comparison of the two sets of attributes-human and AI. This analysis will investigate whether humans have one or more unique attributes that could influence decision-making for the better. The fourth step is a simulation of a nonclinical environment in health regulation and policy into which virtual human and AI decision makers (agents) are introduced. The virtual human and AI will be based on the human and AI attributes identified in the scoping reviews. The simulation will explore, observe, and document how humans interact with AI, and whether humans are likely to compete, cooperate, or converge with AI. RESULTS: The results will be presented in tabular form, visually intuitive formats, and-in the case of the simulation-multimedia formats. CONCLUSIONS: This paper provides a road map for the proposed research. It also provides an example of a protocol of protocols for methods used in complex health research. While there are established guidelines for a priori protocols for scoping reviews, there is a paucity of guidance on establishing a protocol of protocols. This paper takes the first step toward building a scaffolding for future guidelines in this regard. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/42353.

A judicialização da fosfoetanolamina sintética no Brasil / The judicialization of synthetic phosphoethanolamine in Brazil

Este artigo analisou a judicialização da fosfoetanolamina sintética no Brasil, a partir de estudo exploratório das decisões judiciais da vara de fazenda pública da comarca de São Carlos, em São Paulo, após a interrupção do fornecimento da substância pela Universidade de São Paulo. O estudo catalogou os argumentos constantes da Ação Direta de Inconstitucionalidade 5.501/DF, que julgou inconstitucional a Lei n. 13.269/2016, que autorizou a produção e a prescrição da fosfoetanolamina sintética para quaisquer tipos de câncer (neoplasia maligna) enquanto os estudos clínicos não fossem concluídos. As sentenças de primeira instância concederam a fosfoetanolamina com base no testemunho dos pacientes sobre impactos positivos do uso da substância em sua saúde e pela ausência de registro de efeitos colaterais. Juízes que concederam acesso à fosfoetanolamina tinham ciência da carência de evidências científicas de segurança e eficácia, bem como do necessário registro da substância como medicamento no órgão  regulador, nos termos da legislação sanitária. No Supremo Tribunal Federal, a ausência de evidências científicas e a utilização de legislação para criar exceção casuísta levaram à declaração de inconstitucionalidade da norma pela maioria dos votos. O estudo registra, todavia, certa indisposição do Poder Judiciário em incorporar no processo decisório a avaliação das autoridades de regulação e fiscalização em saúde como fonte da correta avaliação da segurança e eficácia de medicamentos. Em conclusão, o testemunho dos pacientes sobre as perspectivas de cura ou redução do sofrimento, somado à ausência de provas nos processos judiciais sobre os riscos do consumo da fosfoetanolamina, foram cruciais para tais decisões.

This article analyzed the judicialization of phosphoethanolamine in Brazil, based on an exploratory study of court decisions in the district of São Carlos/SP after the supply of the substance was interrupted by the University of São Paulo. The study cataloged the arguments contained in the Direct Action of Unconstitutionality 5,501/DF that deemed Law 13,269/2016, which authorized the production and prescription of synthetic phosphoethanolamine for any type of câncer (malignant neoplasm) unconstitutional, while the clinical studies were not completed. The results indicated that the judges authorized the use of the substance based on the patients' testimony about the positive impacts of the use of phosphoethanolamine on their health and the absence of side effects. The judges were aware of the lack of scientific evidence of safety and efficacy, as well as the obligation to register the substance as a medicine by the regulatory agency, according to health legislation. In the Supreme Court, the mentioned lack of scientific evidence and the strategic use of legislation to create a case-by-case exception led to the declaration of unconstitutionality of the Law by a majority of Ministers votes. The study registers, however, a certain unwillingness of the Judiciary to incorporate in the decision-making process the evaluation of the health regulatory agency as a source of the correct evaluation of medicines. In conclusion, the convinced patients' testimony about the perspectives of cure or reduction of suffering added to the absence of evidence in the legal proceedings regarding the risks of the consumption of phosphoethanolamine was crucial to the judicial decisions.

Relevance of the world health organization in a multipolar world in solving global health challenges.

There have been many criticisms about the World Health Organization (WHO) in the last decade. In a multipolar world, there are rivalries between nations and geopolitical regions. However, health issues remain outside the murky world of politics due to their far-reaching consequences on human society. The power conferred on the WHO is very significant in protecting the health and well-being of the global population. As a neutral organization, the WHO is supposed to uphold people's rights to health, especially in controlling diseases of international importance. The paper highlighted the significant roles of the WHO in leadership issues, research and development, solving disputes among countries, providing resources for low-performing regions, regulating international health laws, responding to a humanitarian crisis, and communicating during the crisis. Further, evidence from global literature critically analyzed the enforcement role of WHO on international health regulations (IHRs).

Assessing core capacities for addressing public health emergencies of international concern at designated points of entry in cameroon during the COVID-19 Pandemic.

BACKGROUND: Points of Entry (POEs) are at the frontline for prevention, detection and response to international spread of diseases. The objective of this assessment was to ascertain the current level of existing International Health Regulations (IHR) core capacities of designated airports, ports and ground crossings in Cameroon and identify critical gaps for capacity building for prevention, early warning and response to public health threats including COVID-19. METHODS: Data were collected from April to May 2020 in 5 designated POEs: Yaounde Nsimalen International Airport (YIA), Douala international Airport (DIA), Douala Autonomous Port (DAP), Garoua-Boulai ground crossing, Kye-Ossi ground crossing which were all selected for their high volume of passenger and goods traffic. The World Health Organization (WHO) assessment tool for core capacity requirements at designated airports, ports and ground crossings was used to collect data on three technical capacities: (i) communication and coordination, (ii) Capacities at all times and (iii) capacities to respond to Public Health Emergencies of International Concern (PHEIC). RESULTS: All the investigated POEs scored below 50% of capacities in place. YIA recorded the highest percentage for all groups of capacities, coordination and communication and for core capacity at all times with a percentage of 42%, 58% and 32% respectively. For core capacity to respond to PHEIC, all the POEs recorded below 50%. The DAP and all ground crossings lacked trained personnel for inspection of conveyances. Only DIA had a public health emergency plan. There is no isolation/quarantine and transport capacity at the POEs. CONCLUSION: All POEs assessed did not meet IHR standards and need significant improvement to fulfill the IHR requirements. Unstructured communication channels between stakeholders make the implementation of IHR challenging. A coordination mechanism, with clear functions and structure, is necessary for well-coordinated response efforts to health emergencies at POEs. This assessment will serve as a baseline to inform planning and IHR implementation at designated POEs in Cameroon.

Vigilância Sanitária em Debate: 10 anos de contribuição ao conhecimento em saúde / Health Surveillance in Debate: 10 years of contributions to knowledge in healthcare

Este debate, resultado de um breve estudo sobre o periódico Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Visa em Debate) em sua primeira década, teve como objetivo apresentar uma visão panorâmica das publicações, que foram classificadas em categorias previamente definidas; também foram identificadas as instituições às quais os autores das publicações estavam vinculados. A categoria Objetos sob Controle Sanitário abriga o maior quantitativo de publicações, com 72,0% do total, entre as quais predominam alimentos, medicamentos, e serviços de saúde e de interesse da saúde. As categorias Sistema Nacional de Vigilância Sanitária; Regulação e Vigilância Sanitária; Doenças, Agentes, Epidemiologia; e Tecnologias Analíticas apresentam quantitativos semelhantes, em torno de 7,0%. Entre as instituições de vínculos dos autores, as universidades e outras instituições de ensino superior são aquelas com maior número de vínculos, em todas as regiões. A Região Sudeste concentra o maior número de referências, seguida do Nordeste, Sul, Centro-Oeste e, por último, a Região Norte. Também foram referidos vínculos a universidades de outros países, como Canadá, França, Portugal e Colômbia. Observou-se uma grande diversidade de temáticas em todas as categorias de classificação das publicações, também lacunas e/ou poucos trabalhos em certos temas relevantes para a área. Este estudo denota que o periódico vem se constituindo um relevante veículo de disseminação do conhecimento em saúde em geral e vigilância sanitária em especial. Neste pouco tempo já foi indexada em importantes bases de dados científicos e conta com uma boa classificação Qualis/Capes na área interdisciplinar da saúde, o que contribui para um número crescente de publicações oriundas de renomadas universidades.

This debate is the result of a brief study in the journal Health Surveillance in Debate: Society, Science & Technology (Visa em Debate) in its first decade. The objective is to present a panoramic view of the publications of this journal. The articles were classified into previously defined categories and the institutions to which the authors of the publications were linked were also identified. The category "Objects Under Sanitary Control" contains the largest number of publications, with 72.0% of the total, among which food, medicines and health services predominated. The categories "National Health Surveillance System", "Health Regulation and Surveillance", "Diseases, Agents, Epidemiology", and "Analytical Technologies" presented similar amounts of around 7.0%. Among the authors' affiliation institutions, universities and other higher education institutions are the ones with the highest number, in all regions. The Southeast region possesses the largest number of references, followed by the Northeast, South, Midwest, and finally the North region. In addition, links to universities in other countries, such as Canada, France, Portugal, and Colombia, were mentioned. A great diversity of themes was observed in all categories of classification and there are still gaps and/or few works in certain themes that are relevant to the area. This study shows that the journal has become a relevant vehicle for the dissemination of knowledge in health in general, and sanitary surveillance, in particular. In this short time, this journal has already been indexed in relevant scientific databases and has a good Qualis/Capes classification in the interdisciplinary area of health, which contributes to a growing number of publications from renowned universities.

Joint external evaluation of the international health regulations (2005) capacity in South Sudan: assessing the country´s capacity for health security.

Introduction: joint external evaluation is a voluntary and collaborative process to assess a country´s capacity under International Health Regulations (2005) to prevent, detect, and respond to public health threats. The main objective is to measure a country´s status in building the necessary capacities to prevent, detect, and respond to infectious disease threats and establish a baseline measurement of capacities and capabilities. The Republic of South Sudan conducted the Joint External Evaluation from 16-20 October 2017, where its capacities were assessed to public health threats per the International Health Regulation (2005). Methods: cross-sectional descriptive study of the Joint External Evaluation process and the findings are described along with major findings and recommendations for the country. Results: South Sudan's overall mean score across 48 indicators was 1.5 (min= 1, max= 4) and 42/48 indicators (87.5%) scored < 2 on a 1 to 5 scale. Technical areas in the prevent category with the lowest score were antimicrobial resistance, biosafety and biosecurity, and National legislation, policy, and financing. In the detect category, the mean score was 2. Technical areas with the lowest mean scores were workforce development and the National Laboratory System. Preparedness, medical countermeasures, personnel deployment, linking public health, and security authorities had the lowest scores in the respond category. Chemical events, radiation emergencies, and points of entry had a score of 1 in the other IHR-related hazards and points of entry category. Conclusion: South Sudan's mean score of 1.5 can be attributed to several civil conflicts experienced, which have impacted negatively on the health system. Recommendations from the Joint External Evaluation need to be implemented and these must be aligned with the costed National Action Plan for Health Security.

Effect of municipal and state regulation on access and outcomes for cervical cancer patients in Rio de Janeiro, Brazil: An interrupted time series analysis.

BACKGROUND: Cervical cancer (CC) is one of Brazil's most prevalent neoplasms, and organizing health care flows that guarantee adequate and timely referral is a challenge. This paper analyzes the effect of municipal and state regulation on access and outcomes for CC patients treated in Rio de Janeiro. METHODS: Retrospective, quasi-experimental study, applying interrupted time series, using data from Cancer Registry from January-2012 to December-2017. We analyzed the implementation of the municipal (August-2013) and state (June-2015) regulation systems for the treatment of CC. The primary outcomes were 1. Time from diagnosis to the first Specialist Visit (TSV); 2. Time from a specialist visit to Treatment Initiation (TSV-TTI); 3. Time from diagnosis to treatment initiation (DTTI); 4. Percentage of patients with adequate Time to Treatment Initiation (PATTI); 5. Percentage of patients with a positive outcome (PPO). RESULTS: were included 4119 women. 71.04 % were between 30 and 59 years old, 55.57 % were black or brown, and 50.52 % had completed elementary school. The monthly average TSV was 43 days in 2012. After the first intervention, TSV increased by seven days, with a decreasing trend of 1 day per month until December-2017. Similarly, after June-2015, DTTI increased to 63 days, decreasing by one day per month until December-2017. After both interventions, there was an increase of 11.98 % in PATTI, with an increasing monthly trend of 0.18 %. PPO remained stable throughout the analyzed period. CONCLUSION: the results suggest that regulation organized access flow for specialized care. However, other relevant issues must be addressed, such as an internal backlog at the institutions, which compromises a timely start of treatment. POLICY SUMMARY: To improve access to the diagnosis and treatment of CC in its early stages, it is necessary to invest in health policies to adjust the supply to the required demand and thus reduce mortality from this pathology.

Lockdown Efficacy in Controlling the Spread of COVID-19 May Be Waning Due to Decline in Public Compliance, Especially among Unvaccinated Individuals: A Cross-Sectional Study in Israel.

Public compliance is paramount for the success of public health measures and decision making, such as lockdowns, in controlling the spread of diseases. The aim of this population-based cross-sectional study was to investigate the level of reported compliance with home isolation among the adult Israeli population (n = 940) during the first three national lockdowns, compliance with a potential fourth national lockdown if enacted, risk perception of COVID-19, vaccination uptake status, perceived effectiveness of the vaccine, and compliance with additional protective health behaviors (e.g., mask wearing and social distancing). Following widespread compliance with initial lockdowns (90.7% reported "high" or "very high" compliance), as few as 60.1% of participants indicated that they would comply with a fourth lockdown if the government decides to enact it. Non-vaccinated individuals reported the lowest levels of compliance with previous lockdowns, compared to participants who received one or two vaccines and participants vaccinated with three doses. Adjusted for gender and age, the results suggest that fearing being infected with COVID-19, perceiving the vaccine to be effective, and reporting being compliant with other health behaviors-such as mask wearing and maintaining social distance from others-are predictors of lockdown compliance. Considering the effect of pandemic lockdown fatigue, there is little support for additional lockdowns among the Israeli public, unless dramatic changes occur in the characteristics of the COVID-19 pandemic. Compliance with lockdowns is reduced among individuals who are at higher risk of contracting COVID-19, therefore rendering this non-pharmaceutical intervention even less effective in reducing the spread of the disease.

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.

What Makes Artificial Intelligence Exceptional in Health Technology Assessment?

The application of artificial intelligence (AI) may revolutionize the healthcare system, leading to enhance efficiency by automatizing routine tasks and decreasing health-related costs, broadening access to healthcare delivery, targeting more precisely patient needs, and assisting clinicians in their decision-making. For these benefits to materialize, governments and health authorities must regulate AI, and conduct appropriate health technology assessment (HTA). Many authors have highlighted that AI health technologies (AIHT) challenge traditional evaluation and regulatory processes. To inform and support HTA organizations and regulators in adapting their processes to AIHTs, we conducted a systematic review of the literature on the challenges posed by AIHTs in HTA and health regulation. Our research question was: What makes artificial intelligence exceptional in HTA? The current body of literature appears to portray AIHTs as being exceptional to HTA. This exceptionalism is expressed along 5 dimensions: 1) AIHT's distinctive features; 2) their systemic impacts on health care and the health sector; 3) the increased expectations towards AI in health; 4) the new ethical, social and legal challenges that arise from deploying AI in the health sector; and 5) the new evaluative constraints that AI poses to HTA. Thus, AIHTs are perceived as exceptional because of their technological characteristics and potential impacts on society at large. As AI implementation by governments and health organizations carries risks of generating new, and amplifying existing, challenges, there are strong arguments for taking into consideration the exceptional aspects of AIHTs, especially as their impacts on the healthcare system will be far greater than that of drugs and medical devices. As AIHTs begin to be increasingly introduced into the health care sector, there is a window of opportunity for HTA agencies and scholars to consider AIHTs' exceptionalism and to work towards only deploying clinically, economically, socially acceptable AIHTs in the health care system.