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The effects of unregulated (laissez-faire) capitalism on working class people and on landscapes are often only beneficial in the short-term. This research examines labor’s effects on landscapes and on the living conditions of homesteaders and timber workers using a multidisciplinary approach including dendroarchaeology, historical records, and artifact analysis from four mid-20th century archaeological sites in the Cebolla Canyon area of west-central New Mexico. Results are examined using theoretical perspectives from Marxism and labor archaeology and from landscape archaeology. The insights from this combination of approaches help us to better understand labor conditions, including identifying periods of heavy logging in the area, examining how logging sites were structured and grew over time, and assessing the living conditions of workers and their families. They also reveal long term landscape and ecological effects of logging under these labor conditions.

Purpose: The study's objective is to examine the impact of financial repression on Bangladesh's economy. Moreover, the impact of individual policy tools such as real deposit rate, interest rate restriction, capital account control, share of state-owned commercial bank in total advances, and statutory liquidity ratio will be investigated to find the specific policy that hampers economic activities. Method: The autoregressive distributed lag (ARDL) method, originated by Pesaran and Shin (1999) and expanded by Pesaran, Shin, and Smith (2001), will be used to look at the long-term relationship. The study uses time series data for Bangladesh's economy from 1973 to 2022. Results: The findings of the ARDL approach confirm that repressive policies reduce economic growth over the sample period, and the effect becomes weaker after liberalizing the foreign exchange market. However, among the repressive policies, interest rate restrictions, statutory liquidity ratio, and the share of the state-owned bank in the commercial banks have significant adverse effects on economic growth. Implication: Policymakers should take proper measures to liberalize the financial sector to boost economic activity. The interest rate restrictions, which are already in effect and hamper the fair functioning of the loan market, should be withdrawn.

Objectives Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for prescribable health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. Methods We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. Results When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. Conclusions Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

Proceeding of 6th Annual International Research Conference "Modelling and implementation of the financial policy of Ukraine to ensure macroeconomic stability", December 22, 2023, Kyiv, Ukraine.

This study aims to analyze the factors that influence the motivation of muzakki in paying professional zakat on the State Civil Servant of Cilacap Regency. The factors studied were religiosity, government regulations, service quality, institutional trust, income, knowledge of zakat, level of zakat promotion, accountability, and transparency. This study uses a quantitative approach with multiple linear regression analysis. The population in this study are State Civil Sevant in Cilacap who are Muslim and have distributed professional zakat. The sampling method used in this study is accidental sampling method. In this study, a questionnaire was used, both filled offline and online using Google Form with a total of 223 respondents. The results of this study indicate that the variables of religiosity, knowledge, and transparency have a significant positive effect on the motivation of muzakki of the State Civil Servant in Cilacap Regency in paying professional zakat. Government regulation variables, service quality, income level, promotion level, accountability have no significant effect on the motivation of the Cilacap Regency State Civil Servant muzakki in paying professional zakat. Meanwhile, the institutional trust variable has a significant negative effect on the motivation of the State Civil Servant of Cilacap Regency in paying professional zakat.

In this chapter, we investigate the properties of the Pareto-efficient frontier, the two endpoints of which indicate the monopoly optimum and the social optimum, respectively. To facilitate our analyses and avoid redundancy, we approximate the matching frictions using the deductive matching model based on the first-come-first-served matching scheme; the models using other approximation methods can be analysed in a similar manner. We also discuss the various regulations that may be imposed by a government to induce a ride-sourcing platform to choose a Pareto-efficient strategy that effectively balances the trade-off between the platform profit and social welfare. Moreover, we discuss a variety of government regulations, namely, price regulation, wage regulation, commission cap regulation and fleet size control. © 2023 Elsevier Inc. All rights reserved.

Objectives To examine the relationship between structural characteristics of Australian residential aged care facilities (RACFs) and breaches of the aged care quality standards. Methods Facility-level analysis of audits, sanctions and non-compliance notices of all accredited Australian RACFs between 2015/16 and 2018/19. Structural factors of interest included RACF size, remoteness, ownership type and jurisdiction. Two government data sources were joined. Each outcome was analysed to calculate time trends, unadjusted rates and relative risks. Results Non-compliance notices were imposed on 369 RACFs (13%) and 83 sanctions on 75 RACFs (3%). Compared with New South Wales (NSW), non-compliance notices were less likely in Victoria, Queensland and the Northern Territory (NT), more likely in South Australia (SA), and comparable in Western Australia (WA), Tasmania and the Australian Capital Territory (ACT). RACFs with more than 100 beds and RACFs located in remote and outer regional areas (vs. major cities) also increased the likelihood of non-compliance notices. Compared with NSW, sanctions were less likely in Victoria, Queensland, NT and WA and comparable in SA, Tasmania and ACT. Additionally, the likelihood of sanctions was higher for RACFs with more than 40 beds. For both non-compliance notices and sanctions, no significant relationship was found with RACF ownership type. Conclusions We partially confirmed other Australian findings about the relationship between RACF structural characteristics and regulatory sanctions and reported new findings about non-compliance notices. Routine and standardised public reporting of RACF performance is needed to build trust that Australia's latest aged care reforms have led to sustained quality improvements.

We estimate the cost of compliance with the US Food Safety Modernization Act (FSMA) Produce Safety Rule by commodity and own- and cross-prices elasticities of demand for 18 fruits and 20 vegetables. These are used as inputs in an equilibrium displacement model that simulates the price and welfare effects of the rule. We find that consumer and farm prices increase by 0.55% and 1.69% for fruits and 0.15% and 0.59% for vegetables. Costs associated with implementation are estimated to reduce producer welfare by 0.63% for fruits and 0.51% for vegetables (as a share of revenue). If the rule’s provisions were enacted unilaterally by growers of individual commodities, producer welfare losses would be 0.93% of total revenue for fruits and 0.31% for vegetables.

Indonesian government has reformed the taxation law in 2007. One form of this reform is ratification the new income tax law, Act No. 36 of 2008. This regulation is revealed that companies listed on capital market can obtain reduced income tax rate by 5%. Decrease in income tax rates is granted to domestic corporate taxpayers listed on capital market that have public ownership over 40% of the total paid shares and the shares owned by at least 300 party. The purpose of this research is to analyze the differences of stock ownership structure and capital structure before and after the ratification of Act No. 36 of 2008. This research used property, real estate, and building construction companies listed on Indonesia Stock Exchange (IDX) as a sample. Sample selection is performed based on purposive sampling method. The result indicates that government regulation related to tax incentives which was aimed to increase the proportion of public ownership is still less effective. In addition, this study also showed that the proportion of public ownership has no significant effect on firm performance.

BackgroundDuring the COVID-19 pandemic, the use of telemedicine as a way to reduce COVID-19 infections was noted and consequently deregulated. However, the degree of telemedicine regulation varies from country to country, which may alter the widespread use of telemedicine. This study aimed to clarify the telepsychiatry regulations for each collaborating country/region before and during the COVID-19 pandemic.MethodsWe used snowball sampling within a global network of international telepsychiatry experts. Thirty collaborators from 17 different countries/regions responded to a questionnaire on barriers to the use and implementation of telepsychiatric care, including policy factors such as regulations and reimbursement at the end of 2019 and as of May 2020.ResultsThirteen of 17 regions reported a relaxation of regulations due to the pandemic; consequently, all regions surveyed stated that telepsychiatry was now possible within their public healthcare systems. In some regions, restrictions on prescription medications allowed via telepsychiatry were eased, but in 11 of the 17 regions, there were still restrictions on prescribing medications via telepsychiatry. Lower insurance reimbursement amounts for telepsychiatry consultations v. in-person consultations were reevaluated in four regions, and consequently, in 15 regions telepsychiatry services were reimbursed at the same rate (or higher) than in-person consultations during the COVID-19 pandemic.ConclusionsOur results confirm that, due to COVID-19, the majority of countries surveyed are altering telemedicine regulations that had previously restricted the spread of telemedicine. These findings provide information that could guide future policy and regulatory decisions, which facilitate greater scale and spread of telepsychiatry globally.

In this study, the main modifications introduced in the capacity to approve laws and administrative rules by the aragonese government are analized. It has been done from a comparative perspective taking into account the state basic regulation and the sentences of the constitucional court. The legislation applied to the general administration of the spanish state is also considered through all the article., La Ley 4/2021, de 29 de junio, de modificación de la Ley 2/2009, de 11 de mayo, del Presidente y del Gobierno de Aragón, modifica el Título VIII, dedicado a la capacidad normativa del Gobierno de Aragón. En este estudio se analizan las principales modificaciones introducidas por esta norma en el ejercicio de la iniciativa legislativa y de la potestad para dictar normas por el Gobierno de Aragón. Se realiza además desde una perspectiva comparada, teniendo en cuenta la legislación básica del Estado en esta materia, la jurisprudencia constitucional así como la regulación en el ámbito de la Administración General del Estado.

The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.

The Pan American Health Organization (PAHO) Strategic Plan 2020–2025 committed to reduce children’s consumption of energy-dense nutrient-poor food and beverage products high in fat, sugar and salt (HFSS) and promote healthy eating patterns to reduce malnutrition in all forms. This paper describes the capacity-building needs in PAHO’s Member States to restrict the marketing of HFSS food and beverages to children. We asked Ministries of Health officials or national institutes/departmental representatives (n = 35) to complete a 28-item web-based survey (January to July 2020). Capacity-building needs were assessed using an adapted version of the World Health Organization’s government capacity-building framework with three modules: public health infrastructure, policies and information systems. Notable achievements for the PAHO’s Plan of Action were identified. State representatives reported strong infrastructure and information systems; however, policy improvements are needed to increase comprehensive national responses. These include using a constitutional health and human rights approach within the policies, policies that document conflict of interest from non-state actors, and strengthening regulatory oversight for digital media platforms. These findings provide baseline data and we suggest priorities for further action to strengthen national governments’ capacity-building and to accelerate the development, implementation, and monitoring systems to restrict the marketing of HFSS food and non-alcoholic beverages to children in the region of the Americas.

This article describes the upcoming changes in the jewelry industry in Russia due to the introduction of the jewelry labeling system. The terms of implementation, the position of the regulator and current market participants are considered in detail. The upcoming financial and labor costs for the industry enterprises are analyzed. The results obtained allowed us to draw conclusions about the future of the precious metals and precious stones market in the near future., В настоящей статье раскрываются предстоящие изменения в ювелирной отрасли России в связи с внедрением системы маркировки ювелирных изделий (ГИИС ДМДК). Детально рассмотрены сроки внедрения, позиция регулятора и действующих участников рынка. Проанализированы предстоящие финансовые и трудовые издержки для предприятий отрасли. Полученные результаты позволили сделать выводы о будущем рынка драгоценных металлов и драгоценных камней на ближайшую перспективу.

The overall aim of this study is to examine vape shop business operations during COVID-19 among a cohort of 88 vape shops in the Greater Los Angeles area in Southern California, located in ethnically diverse communities. A total of six web- and/or phone-based assessments were conducted over a 12-week period (April 1, 2020-June 10, 2020), extending from the mandated closure of nonessential businesses (Stage 1; Assessments 1-3) to the reopening of nonessential sectors (Stage 2; Assessments 4-6), to evaluate business operations (open and closure statuses). The proportion of vape shops found to be noncompliant with the Governor's executive order (i.e., open) during Stage 1 gradually increased from 54 (61.4%) at Assessment 1 (week of April 1, 2020) to 58 (65.9%) at Assessment 3 (week of April 29, 2020). Moreover, vape shops located in Hispanic/Latino and Korean/Asian communities (vs. those in non-Hispanic White and African American communities) were more likely to stay open both during and after the shutdown at Assessments 1 and 6. More specifically, vape shops located in Hispanic/Latino communities were significantly more likely to offer walk-in service during Assessment 1 (during the shutdown), and vape shops in Hispanic/Latino and Korean/Asian were significantly more likely to offer walk-in service during Assessment 6 (after the re-opening). This study demonstrates high rates of noncompliance with shutdown orders among vape shops located in ethnic communities, thus suggesting higher contextual risk factors of COVID-19 exposure among certain ethnic communities.

The development of Social Networking Sites have affected the users. One phenomena is identity deception, widely known as 'catfish.’ Catfish appears because users can choose their own identities on social networking sites. Users may choose an identity that is considered ideal identity, even though it does not reflect the reality. In this situation, identity is being constructed and used to achieve something. This can be a threat for social networking sites users because it can be considered an infringement in the use of social networking sites. This study discuss the regulation made by the Indonesian government to deal with the threat of catfish as a form of identity deception. The research method used was the qualitative method., Perkembangan Situs Jejaring Sosial turut memberikan dampak pada para penggunanya, salah satunya adalah penipuan identitas yang disebut sebagai fenomena ‘catfish’. Catfish muncul karena di situs jejaring sosial, penggunanya dapat memilih identitas yang dia anggap sebagai identitas yang ideal walaupun hal tersebut tidak sesuai dengan kenyataan yang ada. Identitas dalam hal dikonstruksi sedemikian rupa dan digunakan untuk tujuan-tujuan tertentu yang tentunya merugikan bagi para korbannya. Hal ini tentunya menjadi ancaman tersendiri bagi para pengguna situs jejaring sosial karena hal ini merupakan salah satu bentuk pelanggaran dari penggunaan situs jejaring sosial. Penelitian ini akan membahas mengenai kebijakan peraturan yang dibuat oleh pemerintah untuk menghadapi ancaman dari catfish sebagai bentuk penipuan identitas. Metode penelitian yang digunakan adalah metode kualitatif.

The Pan American Health Organization (PAHO) Strategic Plan 2020–2025 committed to reduce children’s consumption of energy-dense nutrient-poor food and beverage products high in fat, sugar and salt (HFSS) and promote healthy eating patterns to reduce malnutrition in all forms. This paper describes the capacity-building needs in PAHO’s Member States to restrict the marketing of HFSS food and beverages to children. We asked Ministries of Health officials or national institutes/departmental representatives (n = 35) to complete a 28-item web-based survey (January to July 2020). Capacity-building needs were assessed using an adapted version of the World Health Organization’s government capacity-building framework with three modules: public health infrastructure, policies and information systems. Notable achievements for the PAHO’s Plan of Action were identified. State representatives reported strong infrastructure and information systems; however, policy improvements are needed to increase comprehensive national responses. These include using a constitutional health and human rights approach within the policies, policies that document conflict of interest from non-state actors, and strengthening regulatory oversight for digital media platforms. These findings provide baseline data and we suggest priorities for further action to strengthen national governments’ capacity-building and to accelerate the development, implementation, and monitoring systems to restrict the marketing of HFSS food and non-alcoholic beverages to children in the region of the Americas.

The grain economy of Russia has now reached a new high level of development, providing ample opportunities for the expansion of Russian grain to the world market. The research reveals the following main threats to further strengthening the position of Russian wheat in the world market: instability of yields and inappropriate production and logistics infrastructure, which determines overestimated transaction costs and low flexibility of supply. The article analyzes the structure of importers of Russian wheat to characterize the instability of the world wheat market and high competition on it. The aim of the research is to form key directions for ensuring the sustainability and efficiency of wheat exports. The development of the grain product subcomplex of the Russian agro-industrial complex is presented by the authors from the position of priority in ensuring the food security of the population by fully meeting the needs of the domestic market, while exports are assigned the role of an instrument for regulating the grain market. Increasing wheat exports is not a priority for the development of grain farming; however, under the current conditions, this is the main incentive for increasing grain production and a way of obtaining foreign exchange income for agrarians. In this regard, it seems necessary to increase the regulatory role of the state in managing the country's grain balance and intensify investment processes in the industry through improving the country's fiscal and monetary policy in relation to the agricultural sector., La economía de cereales de Rusia ha alcanzado ahora un nuevo alto nivel de desarrollo, proporcionando amplias oportunidades para la expansión del grano ruso en el mercado mundial. La investigación revela las siguientes amenazas principales para fortalecer aún más la posición del trigo ruso en el mercado mundial: inestabilidad de los rendimientos e infraestructura de producción y logística inadecuada, lo que determina costos de transacción sobreestimados y baja flexibilidad de suministro. El artículo analiza la estructura de los importadores de trigo ruso para caracterizar la inestabilidad del mercado mundial de trigo y la alta competencia en él. El objetivo de la investigación es aportar orientaciones para asegurar la sostenibilidad y eficiencia de las exportaciones de trigo. El desarrollo del subcomplejo de productos de cereales del complejo agroindustrial ruso es presentado por los autores desde la posición de prioridad para garantizar la seguridad alimentaria de la población al satisfacer plenamente las necesidades del mercado interno, mientras que a las exportaciones se les asigna el papel de un instrumento de regulación del mercado de cereales. El aumento de las exportaciones de trigo no es una prioridad para el desarrollo del cultivo de cereales; sin embargo, en las condiciones actuales, este es el principal incentivo para incrementar la producción de granos y una forma de obtener ingresos en divisas para los agrarios. En este sentido, parece necesario incrementar el rol regulador del Estado en la gestión del balance de granos del país e intensificar los procesos de inversión en la industria mediante la mejora de la política fiscal y monetaria del país en relación con el sector agrícola.

ObjectiveCoronavirus disease 2019 (COVID-19) poses societal challenges that require expeditious data and knowledge sharing. Though organizational clinical data are abundant, these are largely inaccessible to outside researchers. Statistical, machine learning, and causal analyses are most successful with large-scale data beyond what is available in any given organization. Here, we introduce the National COVID Cohort Collaborative (N3C), an open science community focused on analyzing patient-level data from many centers.Materials and methodsThe Clinical and Translational Science Award Program and scientific community created N3C to overcome technical, regulatory, policy, and governance barriers to sharing and harmonizing individual-level clinical data. We developed solutions to extract, aggregate, and harmonize data across organizations and data models, and created a secure data enclave to enable efficient, transparent, and reproducible collaborative analytics.ResultsOrganized in inclusive workstreams, we created legal agreements and governance for organizations and researchers; data extraction scripts to identify and ingest positive, negative, and possible COVID-19 cases; a data quality assurance and harmonization pipeline to create a single harmonized dataset; population of the secure data enclave with data, machine learning, and statistical analytics tools; dissemination mechanisms; and a synthetic data pilot to democratize data access.ConclusionsThe N3C has demonstrated that a multisite collaborative learning health network can overcome barriers to rapidly build a scalable infrastructure incorporating multiorganizational clinical data for COVID-19 analytics. We expect this effort to save lives by enabling rapid collaboration among clinicians, researchers, and data scientists to identify treatments and specialized care and thereby reduce the immediate and long-term impacts of COVID-19.

Online supplemental material is available for this article. See also the editorial by Grant in this issue.

The Pan American Health Organization (PAHO) Strategic Plan 2020–2025 committed to reduce children’s consumption of energy-dense nutrient-poor food and beverage products high in fat, sugar and salt (HFSS) and promote healthy eating patterns to reduce malnutrition in all forms. This paper describes the capacity-building needs in PAHO’s Member States to restrict the marketing of HFSS food and beverages to children. We asked Ministries of Health officials or national institutes/departmental representatives (n = 35) to complete a 28-item web-based survey (January to July 2020). Capacity-building needs were assessed using an adapted version of the World Health Organization’s government capacity-building framework with three modules: public health infrastructure, policies and information systems. Notable achievements for the PAHO’s Plan of Action were identified. State representatives reported strong infrastructure and information systems; however, policy improvements are needed to increase comprehensive national responses. These include using a constitutional health and human rights approach within the policies, policies that document conflict of interest from non-state actors, and strengthening regulatory oversight for digital media platforms. These findings provide baseline data and we suggest priorities for further action to strengthen national governments’ capacity-building and to accelerate the development, implementation, and monitoring systems to restrict the marketing of HFSS food and non-alcoholic beverages to children in the region of the Americas.

Objectives: Internationally, healthcare quality regulators are criticized for failing to respond to patients' complaints. Patient involvement is, therefore, an important item on the policy agenda. However, it can be argued that there is a discrepancy between the patients' perspective and current regulatory approaches. This study examines whether a discrepancy exists between the perspectives of patients and regulators on healthcare quality. Methods: A questionnaire was sent to 996 people who had registered a complaint with the Dutch Healthcare Inspectorate to measure expectations of and experiences with the Inspectorate. A taxonomy was used to classify their complaints into the clinical, relationship, or management domains. Results: The response was 54%. More complaints about clinical issues (56%, P = 0.000) were investigated by the regulator than complaints about organizational (37%) and relational issues (51%). Patients with complaints about management issues less often indicated (13%, P = 0.002) that healthcare is improved by making their complaint than patients with complaints about clinical or relationship issues did (22%–23%). Patients who reported about relational issues with care providers attached more importance to issuing sanctions against the care provider than other patients (mean score 2.89 versus 2.62–2.68, P = 0.006). Conclusions: The predominant clinical approach taken by regulators does not match the patients' perspective of what is relevant for healthcare quality. In addition, patients seem to be more tolerant of what they perceive to be clinical or management errors than of perceived relational deficiencies in care providers. If regulators want to give patients a voice, they should expand their horizon beyond the medical framework.

Research relevance. Consumption of addictive goods and its impact on the human capital is widely discussed in contemporary research literature, not only on the micro- and macro- but also on the meso-level. At the present stage of the ongoing transformations we are prompted to reassess current approaches to this problem and to re-evaluate its public significance; moreover, practical application of available research outcomes should also be reconsidered. In Russia, consumption of addictive goods is subject to significant regional variations determined by socio-economic and other factors. Research aim. The study is aimed at investigating the impact of consumption of addictive goods (alcohol) on the quality of Russian consumers’ human capital and at building a system of indicators to estimate this impact. Data and methods. The study uses the methods of comparative analysis, expert estimation, ranking, and economic-statistical analysis, it also proposes a spatial approach to problems associated with regional variations in human capital of consumers of addictive goods. The study relies on the Russian and international research evidence; the data of the Federal State Statistics Service and its regional offices; expert estimates and the authors’ own calculations. Results. The study demonstrates the connection between consumption of addictive goods and consumers’ human capital. It also describes a system of statistical indicators that can be used for estimating the impact of alcohol consumption on human capital and the criteria such indicators should meet. Based on the proposed indicator set, the study analyzes and compares the trends in human capital deterioration on the regional and national levels. As a result of cross-regional analysis, regions with the highest and lowest figures of human capital deterioration are identified. Conclusions. As their addiction progresses, alcohol consumers face an increasing devaluation of their human capital. This parameter varies signific, Актуальность. Разработка научной проблемы формирования человеческого капитала потребителей аддиктивных товаров приобретает все большую актуальность не только на микро- и макроуровне, но и на мезоуровне. Современный этап трансформационных процессов заставляет переосмысливать представления об указанной проблеме, ее общественной значимости, использовании прикладных результатов исследований. В российских условиях актуальность изучения территориальных аспектов дифференциации потребления аддиктивных товаров связана с высокой поляризацией социально-экономического положения регионов и многообразием факторов ее определяющих. Цель исследования. Выявить результаты влияния аддиктивных товаров на качество человеческого капитала потребителей в регионах России (на примере потребления алкогольной продукции) и сформировать систему показателей, определяющих тенденции указанного процесса. Данные и методы. В исследовании были использованы методы сравнительного анализа, экспертных оценок, ранжирования, методы экономико-статистического анализа. Предложен пространственный подход к исследованию проблем региональной дифференциации показателей человеческого капитала потребителей аддиктивных товаров. Информационную базу исследования составили результаты исследований отечественных и зарубежных экономистов потребления аддиктивных товаров; официальные данные Федеральной службы государственной статистики и ее территориальных органов, а также экспертные оценки и авторские расчеты. Результаты. Раскрыта связь между потреблением аддиктивных товаров и человеческим капиталом потребите- ля; обоснованы требования к показателям, которые целесообразно использовать для оценки влияния на человеческий капитал потребления алкоголя; с учетом данных требований предложена совокупность статистических показателей; проведена оценка динамики показателей деградации человеческого капитала на общероссийском уровне и межрегиональные сравнения. В ходе межрегиональных сравнений выделены регионы с наиболее высокими и наибол

В данной статье рассмотрены методы государственного регулирования, принимаемые в отношении объектов торговой деятельности в Республике Беларусь, раскрыты такие понятия, как торговля, торговый объект, оптовая и розничная торговля, общественное питание; приведена классификация форм осуществления торговли.

BackgroundDuring the COVID-19 pandemic, the use of telemedicine as a way to reduce COVID-19 infections was noted and consequently deregulated. However, the degree of telemedicine regulation varies from country to country, which may alter the widespread use of telemedicine. This study aimed to clarify the telepsychiatry regulations for each collaborating country/region before and during the COVID-19 pandemic.MethodsWe used snowball sampling within a global network of international telepsychiatry experts. Thirty collaborators from 17 different countries/regions responded to a questionnaire on barriers to the use and implementation of telepsychiatric care, including policy factors such as regulations and reimbursement at the end of 2019 and as of May 2020.ResultsThirteen of 17 regions reported a relaxation of regulations due to the pandemic; consequently, all regions surveyed stated that telepsychiatry was now possible within their public healthcare systems. In some regions, restrictions on prescription medications allowed via telepsychiatry were eased, but in 11 of the 17 regions, there were still restrictions on prescribing medications via telepsychiatry. Lower insurance reimbursement amounts for telepsychiatry consultations v. in-person consultations were reevaluated in four regions, and consequently, in 15 regions telepsychiatry services were reimbursed at the same rate (or higher) than in-person consultations during the COVID-19 pandemic.ConclusionsOur results confirm that, due to COVID-19, the majority of countries surveyed are altering telemedicine regulations that had previously restricted the spread of telemedicine. These findings provide information that could guide future policy and regulatory decisions, which facilitate greater scale and spread of telepsychiatry globally.

Background: Government-directed policy plays an important role in the regulation and supervision of healthcare quality. Effective implementation of these policies has the potential to significantly improve clinical practice and patient outcomes, including the prevention of healthcare-associated infections. A systematic review of research describing the implementation of government-directed policy in the hospital setting was performed with the aim to identify policy intervention characteristics that influence implementation. Methods: A systematic search of four electronic databases was undertaken to identify eligible articles published between 2007 and 2017. Studies were included if published in the English language and described the implementation of government-directed policy in a high-income country hospital setting. Data on policy and implementation were extracted for each article and interpretive syntheses performed. Results: A total of 925 articles were retrieved and titles and abstracts reviewed, with 69 articles included after review of abstract and full text. Qualitative synthesis of implementation data showed three overarching themes related to intervention characteristics associated with implementation: clarity; infrastructure; and alignment. Conclusion: Better understanding and consideration of policy intervention characteristics during development and planning will facilitate more effective implementation although research describing implementation of government-directed policy in the hospital setting is limited and of variable quality. The findings of this study provide guidance to staff tasked with the development or implementation of government-directed policy in the hospital setting, infection prevention and control professionals seeking to maximise the impact of policy on practice and improve patient outcomes.

Objective: To quantify the consequences of a total ban on indoor tanning for short-term regulatory enforcement, for consumers, and the longer-term health economic effects. Methods: Instances of illegal solarium prosecutions and tanning bed confiscations in the state of Victoria (population 7 million) were obtained from government surveillance records. Consumer interest for indoor tanning and spray/fake tanning were assessed using Google Trends’ Search Volume Index (range 0 to maximum 100). Long-term health economic effects were estimated using a Markov cohort model. Results: The Victorian Government completed 13 prosecutions and confiscated 39 illegal tanning units. Consumer interest for indoor tanning reduced to less than one quarter of pre-regulation seasonal peaks (Search Volume Index 12/48) while spray tanning interest remained high (70–88). For young Australians over their remaining lives, banning commercial indoor tanning is expected to avert 31,009 melanomas (−3.7%), avert 468,249 keratinocyte cancers (−3.6%) and save over AU$64 (US$47) million in healthcare costs and produce over AU$516 (US$375) million in productivity gains. Conclusions: Three years after the nationwide ban, regulation enforcement activities have decreased, and consumers have adopted substitute tanning methods.

Large, ever more complex, technological systems surround us and provide products and services that both construct and define much of what we consider as modern society. Our societal bargain is the trade-off between the benefits of our technologies and our constant vigilance over the safe workings and the occasional failures of these often hazardous sociotechnical systems during their operating life. Failure of a system's infrastructure, whether a complex subsystem or a single component, can cause planes to crash, oil rigs to burn, or the release of radioactivity from a nuclear power plant. To prevent catastrophes, much depends not only on skilled and safe operations, but upon the effective maintenance of these systems. Using the commercial nuclear power industry, of the United States, as a case study, this dissertation examines how nuclear power plant maintenance functions to ensure the plants are reliable and can safely operate for, potentially, eighty years; the current, government regulation defined limit, of their functional life. This study explores the history of U.S. nuclear maintenance regulatory policy from its early Cold War political precursors, the effect of the 1979 Three Mile Island reactor melt-down accident, through its long development, and finally its implementation by nuclear power licensees as formal maintenance programs. By investigating the maintenance of nuclear power plants this research also intends to expand the conceptual framework of large- technological-system (LTS) theory, in general, by adding a recognizable, and practically achievable, end-of-life (EOL) phase to the heuristic structure. The dissertation argues that maintenance is a knowledge producing technology that not only keeps a sociotechnical system operating through comprehension, but can be a surveillance instrument to make system end-of-life legible; that is both visible and understandable. With a discernible and legible view of system end-of-life, operators, policy makers, a

This paper presents features, approaches and institutional conditions, implications of digital technologies focused on the sustainable industrial development of the regional economy. The objective of the study is to analyse possibilities of the practical implementation of measures on digital ecosystem creation of separate region, Kostanay Region of the Republic of Kazakhstan, the industrial region of country having a certain innovation potential. This paper uses scientific methods of enquiry, statistical data and mathematical modelling in economics. In the result of study digital technology development priorities at the national level were established and the digitalization impact on the regional development was emphasised. The empirical analysis basis served the results of studies conducted within R&D Developing the Government Regulation Policy on Accelerated Clustering of Industrial Regions conducted under the grant financing of Ministry of Education and Science of the Republic of Kazakhstan. © The Authors, published by EDP Sciences, 2020.

Title X of the Public Health Act has provided access to confidential reproductive care for low-income adolescents and adults since 1970, helping to bring adolescent pregnancy rates to historic lows. Recent regulatory changes in program funding eligibility and provider counseling options may reverse this trend. This policy brief will address the history and impact of Title X funding on adolescent access to reproductive health care, explain the implications of these recent regulatory changes in Title X implementation, and encourage advocacy to protect health care provider practice and adolescent access to confidential care.

BackgroundNepal was a monarchy, then a dictatorship, then a democracy. This paper reviews how tobacco control progressed in Nepal in the context of these changes in government from 1950 through 2006.MethodsWe triangulated tobacco industry documents, newspaper articles and key informant interviews.ResultsUntil 1983, the tobacco industry was mostly state owned. Transnational tobacco companies entered the Nepalese market through ventures with Surya Tobacco Company Private Limited (with Imperial Tobacco Company and British American Tobacco) in 1983 and Seti Cigarette Factory Limited (with Philip Morris International [PMI]) in 1985. Seminars and conferences on tobacco, celebrations of World No Tobacco Day (WNTD) and efforts by WHO helped promote tobacco control in Nepal beginning in the 1970s. Tobacco advocates in Nepal pushed the government to issue executive orders banning smoking in public places in 1992 and tobacco advertising in electronic media in 1998, and to introduce a tobacco health tax in 1993. The tobacco industry lobbied against these measures and succeeded in keeping the tobacco tax low by challenging it in court. Tobacco advocates sued the government in 2003 and 2005, resulting in a June 2006 Supreme Court decision upholding the smoking and advertising bans and requiring the government to enact a comprehensive tobacco control law.ConclusionsPolitical instability, conflict, weak governance and the dictatorship significantly affect tobacco control activities in low-income and middle-income countries. Nepal shows that tobacco control advocates can take advantage of global events, such as WNTD, and use domestic litigation to maintain support from civil societies and to advocate for stronger tobacco control policies.

The Tobacco Regulatory Science Program is a collaborative research effort between the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). In 2013, the NIH funded 14 Tobacco Centers of Regulatory Science (TCORS), which serve as partners in establishing research, training, and professional development programs to guide FDA. Each of the fourteen TCORS, and two other NIH-funded research programs, the Center for the Evaluation of Nicotine in Cigarettes (CENIC) and the Consortium on Methods Evaluating Tobacco (COMET), pursued specific research themes relevant to FDA's priorities. A key mandate for FDA is to reduce tobacco use among young people. This article is a review of the peer-reviewed research, including published and in-press manuscripts, from the TCORS, CENIC, and COMET, which provides specific data or other findings on youth (ages 10-18 years) and/or young adults (ages 18-34 years), from 2013 to 2018. Citations of all TCORS, CENIC, and COMET articles from September 2013 to December 2017 were collected by the TCORS coordinating center, the Center for Evaluation and Coordination of Training and Research. Additional citations up to April 30, 2018 were requested from the principal investigators. A scoring rubric was developed and implemented to assess study type, primary theme, and FDA priority area addressed by each article. The major subareas and findings from each priority area are presented. There were 766 articles in total, with 258 (34%) focusing on youth and/or young adults. Findings relevant to FDA from this review concern impact analysis, toxicity, health effects, addiction, marketing influences, communications, and behavior.ImplicationsThe Tobacco Centers of Regulatory Science, CENIC, and COMET have had a high output of scientific articles since 2013. These Centers are unique in that the FDA supports science specifically to guide future regulatory actions. The 258 articles that have focused on youth and/or young adults are provid

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ObjectivesElectronic cigarettes (e-cigarettes) are available in nontraditional flavors (eg, fruit and candy) that are banned in combustible cigarettes in the United States. Whether adolescent use of e-cigarettes in nontraditional flavors prospectively predicts continuation of vaping and progression to more frequent vaping is unknown.MethodsHigh school students in Los Angeles, California, completed 5 semiannual surveys (2014-2017 [10th grade to 12th grade]). Among past-6-month e-cigarette users at survey waves 1 to 4 (N = 478), e-cigarette flavor (or flavors) used was coded into 2 mutually exclusive categories at each wave (use of ≥1 nontraditional flavors [fruit, candy, sweet or dessert, buttery, blends or combinations, and other] versus exclusive use of tobacco, menthol or mint, or flavorless). Flavor used during waves 1 to 4 was modeled as a time-varying, time-lagged regressor of vaping status and frequency outcomes 6 months later at waves 2 to 5.ResultsAcross waves 1 to 4, there were 739 (93.8%) observations of nontraditional-flavor use and 49 (6.2%) observations of exclusive use of tobacco, mint or menthol, or flavorless e-cigarettes. Use of e-cigarettes in nontraditional flavors (versus only tobacco, mint or menthol, or flavorless) was positively associated with vaping continuation (64.3% vs 42.9%; adjusted odds ratio = 3.76 [95% confidence interval 1.20 to 10.31]) and past-30-day number of puffs per nicotine vaping episode (mean: 3.1 [SD 5.5] vs 1.5 [SD 3.8]; adjusted rate ratio = 2.41 [95% confidence interval 1.08 to 5.92]) 6 months later. Flavor used was not associated with the subsequent number of past-30-day vaping days or episodes per day.ConclusionsAdolescents who vaped e-cigarettes in nontraditional flavors, compared with those who exclusively vaped tobacco-flavored, mint- or menthol-flavored, or flavorless e-cigarettes, were more likely to continue vaping and take more puffs per vaping occasion 6 months later.

BackgroundOver the last several decades, scientists and social groups have frequently raised concerns about politicization or political interference in regulatory science. Public actors (environmentalists and industry advocates, politically aligned public figures, scientists and political commentators, in the United States as well as in other countries) across major political-regulatory controversies have expressed concerns about the inappropriate politicization of science. Although we share concerns about the politicization of science, they are frequently framed in terms of an ideal of value-free science, according to which political and economic values have no legitimate role to play in science. For several decades, work in philosophy of science has identified serious conceptual and practical problems with the value-free ideal.ObjectivesOur objectives are to discuss the literature regarding the conceptual and practical problems with the value-free ideal and offer a constructive alternative to the value-free ideal.DiscussionWe first discuss the prevalence of the value-free ideal in regulatory science, then argue that this ideal is self-undermining and has been exploited to delay protective regulation. To offer a constructive alternative, we analyze the relationship between the goals of regulatory science and the standards of good scientific activity. This analysis raises questions about the relationship between methodological and practical standards for good science, tensions among various important social goods, and tensions among various social interests. We argue that the aims of regulatory science help to legitimize value-laden choices regarding research methods and study designs. Finally, we discuss how public deliberation, adaptive management, and community-based participatory research can be used to improve the legitimacy of scientists as representatives of the general public on issues of environmental knowledge.ConclusionsReflecting on the aims of regulator

Background: In the last 20 years governments have sought to introduce policy that improves the quality of care provided in hospitals, yet little research has been done to understand how these policies are implemented, factors that affect the implementation process or what should be considered by decision-makers during policy development or implementation planning. Experts with real-life experience in the introduction and implementation of policy are best placed to provide valuable insight into practical issues that affect implementation and the associated outcomes of these policies. Methods: A modified Delphi study of experts in hospital policy development and implementation was undertaken to investigate factors influencing the implementation of government-directed policy in the hospital setting. This study built on the findings of two previous studies - a qualitative study of clinician perspectives of policy implementation and a systematic review and meta-synthesis, in which common contextual factors and policy characteristics associated with policy implementation were ascertained. International experts with extensive experience in government-directed policy implementation at global, national, corporate, jurisdictional and organisational levels were asked to provide opinions on predetermined factors and the feasibility of considering these in policy development and implementation planning. Survey design and analysis was guided by the Consolidated Framework for Implementation Research. Results: Eleven experts from four countries and with different health system perspectives participated in the study. Consensus was reached on the importance of all predetermined factors in the first survey round with additional factors for investigation highlighted by participants for examination in subsequent rounds. On study completion, expert consensus was reached on 24 factors of importance; only 20 of these factors reached consensus for feasibility. Conclusions: Study findings

With the advent of interoperability standards such as FHIR, SMART, CDS Hooks, and CQL, interoperable clinical decision support (CDS) holds great promise for improving healthcare. In 2018, the Agency for Healthcare Research and Quality (AHRQ)-sponsored Patient-Centered CDS Learning Network (PCCDS LN) chartered a Technical Framework Working Group (TechFWG) to identify barriers, facilitators, and potential solutions for interoperable CDS, with a specific focus on addressing the opioid epidemic. Through an open, multi-stakeholder process that engaged 54 representatives from healthcare, industry, and academia, the TechFWG identified barriers in 6 categories: regulatory environment, data integration, scalability, business case, effective and useful CDS, and care planning and coordination. Facilitators and key recommendations were also identified for overcoming these barriers. The key insights were also extrapolated to CDS-facilitated care improvement outside of the specific opioid use case. If applied broadly, the recommendations should help advance the availability and impact of interoperable CDS delivered at scale.

The number of diabetes patients is steadily increasing worldwide. Consequently, the social burden of diabetes is huge, requiring urgent countermeasures. We performed an intensive survey of antidiabetic drugs approved in Japan, the United States, and the European Union., info:eu-repo/semantics/published

The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems.

The adaptive immune system is known to play an important role in anti-neoplastic responses via induction of several effector pathways, resulting in tumor cell death. Because of their ability to specifically recognize and kill tumor cells, the potential use of autologous tumor-derived and genetically engineered T cells as adoptive immunotherapy for cancer is currently being explored. Because of the variety of potential T cell-based medicinal products at the level of starting material and manufacturing process, product-specific functionality assays are needed to ensure quality for individual products. In this review, we provide an overview of in vitro potency assays suggested for characterization and release of different T cell-based anti-tumor products. We discuss functional assays, as presented in scientific advices and literature, highlighting specific advantages and limitations of the various assays. Because the anticipated in vivo mechanism of action for anti-tumor T cells involves tumor recognition and cell death, in vitro potency assays based on the cytotoxic potential of antigen-specific T cells are most evident. However, assays based on other T cell properties may be appropriate as surrogates for cytotoxicity. For all proposed assays, biological relevance of the tests and correlation of the read-outs with in vivo functionality need to be substantiated with sufficient product-specific (non-)clinical data. Moreover, further unraveling the complex interaction of immune cells with and within the tumor environment is expected to lead to further improvement of the T cell-based products. Consequently, increased knowledge will allow further optimized guidance for potency assay development.

The widespread use of new information technologies in management, processes of digitalization of the economy, the need for an assessment of the regulatory impact of legal norms in the field of information technologies predetermine the relevance of the research topic and the need to summarize management experience in this area in the Russian Federation and the Republic of Kazakhstan. The analysis allowed the author to substantiate and formulate a number of provisions: the author’s definition of a digital economy; theoretical provisions on the need to expand the existing index of information technology development, on the creation of an information technology development index in the framework of the EAEU integration association; proposals on the concept of the Model Law “On Information, Information Technologies and Protection of Information” and others., Широкое использование новых информационных технологий в управлении, процессы цифровизации экономики, потребность в оценке регулирующего воздействия норм права в сфере информационных технологий предопределяют актуальность темы исследования и необходимость обобщения опыта управления в этой сфере в Российской Федерации и Республике Казахстан. Проведенный анализ позволил автору обосновать и сформулировать ряд положений: авторское определение цифровой экономики; теоретические положения о необходимости расширения существующего индекса развития информационных технологий, о создании индекса развития информационных технологий в рамках интеграционного объединения ЕАЭС; предложения о концепции Модельного закона «Об информации, информационных технологиях и о защите информации» и другие.

У тезах визначено фактори, які негативно впливають на демографічну ситуацію. Сформульовано передумови реалізації ефективної регіональної демографічної політики. In the theses the factors that affect the demographic situation were determined. Preconditions of implementation of the effective regional population policies were formulated.

The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data. From a regulatory perspective, when evaluating a new medicine before approving marketing authorization, there will never be enough patients studied in all subgroups that may potentially be at higher risk for adverse outcomes, or sufficient patients to detect rare adverse events, or sufficient follow-up time to detect late adverse events that require long exposure times to develop. It may therefore be relevant that post-marketing trials sometimes have more pragmatic characteristics, if there is a need for further efficacy and safety information. A pragmatic study design may reflect a situation close to clinical practice, but may also have greater potential methodological concerns, e.g. regarding the validity and completeness of data when using routinely collected information from registries and health records, the handling of intercurrent events, and misclassification of outcomes. In a regulatory evaluation it is important to be able to isolate the effect of a specific product or substance, and to have a defined population that the results can be referred to. A study feature such as having a wide and permissive inclusion of patients might therefore actually hamper the utility of the results for regulatory purposes. Randomization in a registry-based setting addresses confounding that could otherwise complicate a corresponding non-interventional design, but not any other methodological issues. Attention to methodological basics can help generate reliable study results, and is more important than labelling studies as 'pragmatic'.

BackgroundPolicies to mitigate climate change by reducing greenhouse gas (GHG) emissions can yield public health benefits by also reducing emissions of hazardous co-pollutants, such as air toxics and particulate matter. Socioeconomically disadvantaged communities are typically disproportionately exposed to air pollutants, and therefore climate policy could also potentially reduce these environmental inequities. We sought to explore potential social disparities in GHG and co-pollutant emissions under an existing carbon trading program-the dominant approach to GHG regulation in the US and globally.Methods and findingsWe examined the relationship between multiple measures of neighborhood disadvantage and the location of GHG and co-pollutant emissions from facilities regulated under California's cap-and-trade program-the world's fourth largest operational carbon trading program. We examined temporal patterns in annual average emissions of GHGs, particulate matter (PM2.5), nitrogen oxides, sulfur oxides, volatile organic compounds, and air toxics before (January 1, 2011-December 31, 2012) and after (January 1, 2013-December 31, 2015) the initiation of carbon trading. We found that facilities regulated under California's cap-and-trade program are disproportionately located in economically disadvantaged neighborhoods with higher proportions of residents of color, and that the quantities of co-pollutant emissions from these facilities were correlated with GHG emissions through time. Moreover, the majority (52%) of regulated facilities reported higher annual average local (in-state) GHG emissions since the initiation of trading. Neighborhoods that experienced increases in annual average GHG and co-pollutant emissions from regulated facilities nearby after trading began had higher proportions of people of color and poor, less educated, and linguistically isolated residents, compared to neighborhoods that experienced decreases in GHGs. These study results reflect preliminary e

Introduction Clinical decision support science is expanding to include integration from broader and more varied data sources, diverse platforms and delivery modalities, and is responding to emerging regulatory guidelines and increased interest from industry.Objective Evaluate key advances and challenges of accessing, sharing, and managing data from multiple sources for development and implementation of Clinical Decision Support (CDS) systems in 2016-2017.Methods Assessment of literature and scientific conference proceedings, current and pending policy development, and review of commercial applications nationally and internationally.Results CDS research is approaching multiple landmark points driven by commercialization interests, emerging regulatory policy, and increased public awareness. However, the availability of patient-related "Big Data" sources from genomics and mobile health, expanded privacy considerations, applications of service-based computational techniques and tools, the emergence of "app" ecosystems, and evolving patient-centric approaches reflect the distributed, complex, and uneven maturity of the CDS landscape. Nonetheless, the field of CDS is yet to mature. The lack of standards and CDS-specific policies from regulatory bodies that address the privacy and safety concerns of data and knowledge sharing to support CDS development may continue to slow down the broad CDS adoption within and across institutions.Conclusion Partnerships with Electronic Health Record and commercial CDS vendors, policy makers, standards development agencies, clinicians, and patients are needed to see CDS deployed in the evolving learning health system.

After proposing the "Deeming Rule" in 2014, the U.S. Food and Drug Administration (FDA) began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette) products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles-area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations) at two time points one year apart to better understand what vape shop retailers would do given FDA's soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014) and Year 2 surveying 61 shops (2015-2016). Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2) were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule). Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc.) over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.

__Background:__ Changes in Dutch policy towards long-term care led to the Dutch Health and Youth Care Inspectorate testing a regulatory framework focusing on care networks around older adults living independently. This regulatory activity involved all care providers and the older adults themselves. __Methods:__ Semi-structured interviews with the older adults, and focus groups with care providers and inspectors were used to assess the perceived added value of, and barriers to the framework. __Results:__ The positive elements of this framework were the involvement of the older adults in the regulatory activity, the focus of the framework on care networks and the open character of the conversations with the inspectors. However, applying the framework requires a substantial investment of time. Care providers often did not perceive themselves as being part of a care network around one person and they expressed concerns about financial and privacy issues when thinking in terms of care networks. __Conclusions:__ The experiences of the client were seen as important in regulating long-term care. Regulating care networks as a whole puts cooperation between care providers involved around one person on the agenda. However, barriers for this form of regulation were also perceived and, therefore, careful consideration when and how to regulate care networks is recommended.