Algorithmic discrimination: examining its types and regulatory measures with emphasis on US legal practices.

Introduction: Algorithmic decision-making systems are widely used in various sectors, including criminal justice, employment, and education. While these systems are celebrated for their potential to enhance efficiency and objectivity, they also pose risks of perpetuating and amplifying societal biases and discrimination. This paper aims to provide an indepth analysis of the types of algorithmic discrimination, exploring both the challenges and potential solutions. Methods: The methodology includes a systematic literature review, analysis of legal documents, and comparative case studies across different geographic regions and sectors. This multifaceted approach allows for a thorough exploration of the complexity of algorithmic bias and its regulation. Results: We identify five primary types of algorithmic bias: bias by algorithmic agents, discrimination based on feature selection, proxy discrimination, disparate impact, and targeted advertising. The analysis of the U.S. legal and regulatory framework reveals a landscape of principled regulations, preventive controls, consequential liability, self-regulation, and heteronomy regulation. A comparative perspective is also provided by examining the status of algorithmic fairness in the EU, Canada, Australia, and Asia. Conclusion: Real-world impacts are demonstrated through case studies focusing on criminal risk assessments and hiring algorithms, illustrating the tangible effects of algorithmic discrimination. The paper concludes with recommendations for interdisciplinary research, proactive policy development, public awareness, and ongoing monitoring to promote fairness and accountability in algorithmic decision-making. As the use of AI and automated systems expands globally, this work highlights the importance of developing comprehensive, adaptive approaches to combat algorithmic discrimination and ensure the socially responsible deployment of these powerful technologies.

Building Capacity and Advancing Regulatory Measures to Improve Food Environments in the Region of the Americas.

Noncommunicable diseases (NCDs) are the main cause of death globally (70%) and in the Region of the Americas (80%), and poor diets are a leading driver of NCDs. In response, the Pan American Health Organization (PAHO)/World Health Organization (WHO) introduced a set of evidence-based regulatory measures to help countries improve diets through the reduced consumption of processed and ultra-processed foods. This paper aims to describe the needs of and propose actions for key actors to advance these measures. A workshop was designed to assess member states' regulatory capacity. A thematic analysis was conducted to analyze regional needs, successes and challenges. Thereafter, the Government Capacity-Building Framework for the prevention and control of NCDs was used to examine findings. The findings were organized in two sets: (i) PAHO/WHO actions to support member states and (ii) key actors' actions to advance regulatory policies. The results show notable regulatory progress across the Region of the Americas. However, progress differs between countries, with opportunities to strengthen measures in most countries, mainly in conflict of interest management. The results identified important actions to strengthen the regulatory capacity of PAHO/WHO member states. To maximize momentum for these actions, timelines must be identified, and political commitment can be boosted by applying human rights-based and food system-wide approaches.

Balancing Intelectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia.

The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area.

Artificial Intelligence (AI) Chatbots in Medicine: A Supplement, Not a Substitute.

This editorial discusses the role of artificial intelligence (AI) chatbots in the healthcare sector, emphasizing their potential as supplements rather than substitutes for medical professionals. While AI chatbots have demonstrated significant potential in managing routine tasks, processing vast amounts of data, and aiding in patient education, they still lack the empathy, intuition, and experience intrinsic to human healthcare providers. Furthermore, the deployment of AI in medicine brings forth ethical and legal considerations that require robust regulatory measures. As we move towards the future, the editorial underscores the importance of a collaborative model, wherein AI chatbots and medical professionals work together to optimize patient outcomes. Despite the potential for AI advancements, the likelihood of chatbots completely replacing medical professionals remains low, as the complexity of healthcare necessitates human involvement. The ultimate aim should be to use technology like AI chatbots to enhance patient care and outcomes, not to replace the irreplaceable human elements of healthcare.

Hazard and health risk assessment of exposure to pharmaceutical active compounds via toxicological evaluation by zebrafish.

The uncontrolled or continuous release of effluents from wastewater treatment plants leads to the omnipresence of pharmaceutical active compounds (PhACs) in the aquatic media. Today, this is a confirmed problem becoming a main subject of twin public and scientific concerns. However, still little information is available about the long-term impacts of these PhACs on aquatic organisms. In this review, efforts were made to reveal correlation between the occurrence in the environment, ecotoxicological and health risks of different PhACs via toxicological evaluation by zebrafish (Danio rerio). This animal model served as a bioindicator for any health impacts after the exposure to these contaminants and to better understand the responses in relation to human diseases. This review paper focused on the calculation of Risk Quotients (RQs) of 34 PhACs based on environmental and ecotoxicological data available in the literature and prediction from the ECOSAR V2.2 software. To the best of the authors' knowledge, this is the first report on the risk assessment of PhACs by the two different methods as mentioned above. RQs showed greater difference in potential environmental risks of the PhACs. These differences in risk values underline the importance of environmental and experimental factors in exposure conditions and the interpretation of RQ values. While the results showed high risk to Danio rerio of the majority of PhACs, risk qualification of the others varied between moderate to insignifiant. Further research is needed to assess pharmaceutical hazards when present in wastewater before discharge and monitor the effectiveness of treatment processes. The recent new advances in the morphological assessment of toxicant-exposed zebrafish larvae for the determination of test compounds effects on the developmental endpoints were also discussed. This review emphasizes the need for strict regulations on the release of PhACs into environmental media in order to minimize their toxicity to aquatic organisms.

Research on the Formation Mechanism of Health Insurance Fraud in China: From the Perspective of the Tripartite Evolutionary Game.

The problem of fraud in China's health insurance has existed for a long time and is becoming more serious, which needs to be solved urgently. This article constructs a tripartite evolutionary game model to study the formation mechanism of the Health Insurance fraud, game participants including medical administrative organization (MAO, a government department responsible for health insurance supervision), medical institutions (MI, such as hospitals), and insured individuals (II, who participating in medical and healthcare insurance). By analyzing the equilibrium of the tripartite evolutionary game, this paper makes an in-depth study on the formation and resolution of health insurance fraud. The results show that: (1) How to prevent the fraud behavior of the medical institutions is the difficulty and core of the problem. It is necessary to achieve effective supervision of the MAO, improve the internal management of the MI and give play to the supervisory role of the II. (2) The regulatory behavior of the MAO needs to focus on protecting the interests of the II, not only to encourage them to actively play the role of supervision and reporting but also to prevent their collusion with MI. (3) On the one hand, the MAO needs to strengthen supervision and increase the punishment for fraud. On the other hand, they also need to take incentive measures to guide all subjects to form a sound internal management mechanism.

The use of cigarettes, hookahs, electronic cigarettes, and other tobacco indicators among Brazilian schoolchildren: data from National School Health Survey 2019 / O uso de cigarro, narguilé, cigarro eletrônico e outros indicadores do tabaco entre escolares brasileiros: dados da Pesquisa Nacional de Saúde do Escolar 2019

Objective: To describe the prevalence of smoking indicators among Brazilian students according to sociodemographic characteristics in 2019, and compare the prevalence between 2015 and 2019. Methods: Data from the National Survey of School Health 2015 and 2019 were used. Indicators related to tobacco use were analyzed. Indicators were compared between the 2015 and 2019 editions. Prevalence and respective 95% Confidence Interval (95%IC) were calculated for the total population and according to sex, age group and type of school. Results: 22.6% (95%CI 21.7­23.4) of the students had tried any cigarette and it was higher between 16 and 17 years of age (32.6%; 95% CI 31.4­33, 8) and in males (35.0%; 95%CI 33.6­36.4). The experimentation of hookah, electronic cigarette and other tobacco products are also high, with 26.9% (95%CI 26.0­27.8), 16.8% (95%CI 16.2­17.4) and 9.3% (95%CI 8.8­9.8), respectively, being higher among boys aged 16 to 17 years. It is noteworthy that there were no changes in the indicators of cigarette experimentation, smoking for the first time before the age of 13, smoking in the 30 days prior to the survey, and at least one of the smoking parents. Conclusion: Although smoked tobacco indicators are stable between 2015 and 2019, the high prevalence of experimentation with products such as hookah and electronic cigarettes is highlighted, drawing attention to the need for new regulatory measures.

Objetivo: Descrever a prevalência de indicadores do tabagismo entre escolares brasileiros segundo características sociodemográficas em 2019 e comparar as prevalências entre 2015 e 2019. Métodos: Utilizaram-se dados da Pesquisa Nacional de Saúde do Escolar de 2015 e 2019. Foram analisados os indicadores referentes ao uso do tabaco, que foram comparados entre as edições de 2015 e 2019. Foram calculadas as prevalências e os respectivos intervalos de confiança de 95% (IC95%) para a população total e segundo sexo, faixa etária e tipo de escola. Resultados: Dos escolares, 22,6% (IC95% 21,7­23,4) já experimentaram cigarro alguma vez, porcentagem mais elevada entre os de 16 a 17 anos de idade (32,6%; IC95% 31,4­33,8) e no sexo masculino (35,0%; IC95% 33,6­36,4). A experimentação de narguilé, cigarro eletrônico e outros produtos do tabaco também se mostra elevada, com 26,9% (IC95% 26,0­27,8), 16,8% (IC95% 16,2­17,4) e 9,3% (IC95% 8,8­9,8), respectivamente, sendo mais alta entre os escolares do sexo masculino de 16 a 17 anos. Destaca-se que não houve mudanças nos indicadores "experimentação do cigarro", "fumar pela primeira vez antes dos 13 anos", "fumar nos 30 dias anteriores à pesquisa" e "ter ao menos um dos pais fumantes" entre os anos indicados. Conclusão: Embora os indicadores de tabaco fumado estejam estáveis entre 2015 e 2019, destacam-se as elevadas prevalências de experimentação de produtos como narguilé e cigarro eletrônico, que chamam a atenção para a necessidade de novas medidas regulatórias.

O uso de cigarro, narguilé, cigarro eletrônico e outros indicadores do tabaco entre escolares brasileiros: dados da Pesquisa Nacional de Saúde do Escolar 2019 / The use of cigarettes, hookahs, electronic cigarettes, and other tobacco indicators among Brazilian schoolchildren: data from National School Health Survey 2019

RESUMO: Objetivo: Descrever a prevalência de indicadores do tabagismo entre escolares brasileiros segundo características sociodemográficas em 2019 e comparar as prevalências entre 2015 e 2019. Métodos: Utilizaram-se dados da Pesquisa Nacional de Saúde do Escolar de 2015 e 2019. Foram analisados os indicadores referentes ao uso do tabaco, que foram comparados entre as edições de 2015 e 2019. Foram calculadas as prevalências e os respectivos intervalos de confiança de 95% (IC95%) para a população total e segundo sexo, faixa etária e tipo de escola. Resultados: Dos escolares, 22,6% (IC95% 21,7-23,4) já experimentaram cigarro alguma vez, porcentagem mais elevada entre os de 16 a 17 anos de idade (32,6%; IC95% 31,4-33,8) e no sexo masculino (35,0%; IC95% 33,6-36,4). A experimentação de narguilé, cigarro eletrônico e outros produtos do tabaco também se mostra elevada, com 26,9% (IC95% 26,0-27,8), 16,8% (IC95% 16,2-17,4) e 9,3% (IC95% 8,8-9,8), respectivamente, sendo mais alta entre os escolares do sexo masculino de 16 a 17 anos. Destaca-se que não houve mudanças nos indicadores "experimentação do cigarro", "fumar pela primeira vez antes dos 13 anos", "fumar nos 30 dias anteriores à pesquisa" e "ter ao menos um dos pais fumantes" entre os anos indicados. Conclusão: Embora os indicadores de tabaco fumado estejam estáveis entre 2015 e 2019, destacam-se as elevadas prevalências de experimentação de produtos como narguilé e cigarro eletrônico, que chamam a atenção para a necessidade de novas medidas regulatórias.

ABSTRACT: Objective: To describe the prevalence of smoking indicators among Brazilian students according to sociodemographic characteristics in 2019, and compare the prevalence between 2015 and 2019. Methods: Data from the National Survey of School Health 2015 and 2019 were used. Indicators related to tobacco use were analyzed. Indicators were compared between the 2015 and 2019 editions. Prevalence and respective 95% Confidence Interval (95%IC) were calculated for the total population and according to sex, age group and type of school. Results: 22.6% (95%CI 21.7-23.4) of the students had tried any cigarette and it was higher between 16 and 17 years of age (32.6%; 95% CI 31.4-33, 8) and in males (35.0%; 95%CI 33.6-36.4). The experimentation of hookah, electronic cigarette and other tobacco products are also high, with 26.9% (95%CI 26.0-27.8), 16.8% (95%CI 16.2-17.4) and 9.3% (95%CI 8.8-9.8), respectively, being higher among boys aged 16 to 17 years. It is noteworthy that there were no changes in the indicators of cigarette experimentation, smoking for the first time before the age of 13, smoking in the 30 days prior to the survey, and at least one of the smoking parents. Conclusion: Although smoked tobacco indicators are stable between 2015 and 2019, the high prevalence of experimentation with products such as hookah and electronic cigarettes is highlighted, drawing attention to the need for new regulatory measures.

The Impact of State Support Measures on the Sphere of Recreation and Tourism of the Region.

Using the example of the Krasnodar krai, the article analyzes the mutual influence of the total financial support of the region's economy (including revenues from the state budget, Russian and foreign investments) and the tourist flow entering the region. Analysis of statistical data for the period from 2009 to 2019 showed the presence of reliable correlations between the rate of change in financial support and the rate of change in the tourist flow. Based on the identified correlations, equations are proposed that can be used to predict changes. In addition, the article shows that in the postcrisis period, a full recovery of the recreation and tourism sector requires an annual increase in the total financial flow of the Krasnodar krai by 15%.

COVID-19: Implications for plastic reduction, with a focus on Personal Protective Equipment (PPE).

With over 190 million cases reported and nearly 4.1 million deaths worldwide, COVID19 has been the center of global attention. This pandemic has changed many aspects of daily life and has, perhaps, indelibly changed the way we live and it is quite likely that there will be no full return to normality. Owing to its impacts across all societal aspects - from micro- and macroeconomics, information management and research, education, to governance, mental health and even territorial integrity and cohesion - the global ecosystem upon which modern society has evolved will have to be redesigned. Many have, indeed, pointed out that the economy will have to be restructured and growth will have to be defined as prosperity - not continuous growth. Perhaps nowhere is this more evident than in the environment.

Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020.

IntroductionAntimicrobial resistance (AMR) is one of the most important challenges in modern clinical practice. The European regulatory network has a strategy to support prevention of AMR by applying specific referral procedures.AimThe aim of this study was to evaluate post-authorisation changes made in the product information of key antibiotics that underwent referral procedures between 2007 and 2020.MethodIn a comprehensive analysis of the changes made for antibiotics, we extracted information on changes from the European Commission community register of medicinal products and the European Medicines Agency's database for antibiotics that went through referrals. Changes made in the specific sections of the summary of product characteristics of each referral procedure were scrutinised.ResultsWe identified 15 antibiotics from seven classes of antibiotics during the study period. The outcome of all referrals included the restriction of antibiotic use. Therapeutic indications were revised for all antibiotics, with septicaemia and gonorrhoea most common diseases removed. Posology and/or method of administration was updated for all; the majority of referrals included adjustment of dosage for specific populations. Information on contraindication (most regarding hypersensitivity) and information on warnings was amended for all referrals.ConclusionOur findings highlight the importance of the regulatory actions. The changes made in the product information aim to ensure appropriate use. Ongoing harmonisation activities are likely to lead to further refinements and restrictions on individual antibiotics in support of rational use. However, further research is required to examine the impact of post-referral label changes on the clinical practice.

Applicability of EU(7)-PIM criteria in cross-national studies in European countries.

BACKGROUND: The European Union (EU)(7)-PIM (potentially inappropriate medication) list presents the most comprehensive and up-to-date tool for evaluation of PIM prescribing in Europe; however, several country-specific studies have documented lower specificity of this list on pharmaceutical markets of some countries. The aim of our study was to describe approval rates and marketing of PIMs stated by EU(7)-PIM criteria in six EU countries [in comparison with the American Geriatric Society (AGS) Beers 2015 criteria]. METHODS: Research teams of six EU countries (Czech Republic, Spain, Portugal, Serbia, Hungary and Turkey) participated in this study conducted by WG1b EU COST Action IS1402 group in the period October 2015-November 2018. Data on approval rates of PIMs and their availability on pharmaceutical markets have been obtained from databases of national drug-regulatory institutes and up-to-date drug compendia. The EU(7)-PIM list and AGS Beers 2015 Criteria (Section 1) were applied. RESULTS: PIMs from EU(7)-PIM list were approved for clinical use more often than those from the AGS Beers 2015 criteria (Section 1). Approval rates for EU(7)-PIMs ranged from 42.8% in Serbia to 71.4% in Spain (for AGS criteria only from 36.4% to 65.1%, respectively). Higher percentages of approved PIMs were documented in Spain (71.4%), Portugal (67.1%) and Turkey (67.5%), lower in Hungary (55.5%), Czech Republic (50.2%) and Serbia (42.8%). The majority of approved PIMs were also currently marketed in all countries except in Turkey (19.8-21.7% not marketed PIMs) and less than 20% of PIMs were available as over-the-counter medications (except in Turkey, 46.4-48.1%). CONCLUSIONS: The EU(7)-PIM list was created for utilization in European studies; however, applicability of this list is still limited in some countries, particularly in Eastern and Central Europe. The EU project EUROAGEISM H2020 (2017-2021) that focuses on PIM prescribing and regulatory measures in Central and Eastern European countries must consider these limits.

An integrated approach to investigate the relationship of coupling coordination between social economy and water environment on urban scale - A case study of Kunming.

With a rapid economic growth and social development in China, the associated problems of water pollution and shortage of water resources would limit the sustainable and coordinated development of socioeconomic and water environmental systems of urban cities. To investigate the relationship of coupling coordination between social economy and water environment on urban scale, we introduced an integrated approach that enables the dynamic evaluation of coupling coordination degree (CCD), which consists of a system dynamics model and a coupling coordination degree model; and applied it to a case study in Kunming in 2016-2025. The business-as-usual (BAU) scenario and five alternative regulating scenarios are simulated to evaluate the effectiveness exerted by various socioeconomic development patterns and water protection efforts in improving CCD. We found that the improvement of CCD could attribute to both the sufficient water protection efforts and the maintaining sustainable speed and scale of socioeconomic development patterns. Under BAU scenario, Kunming would maintain the current state of barely balanced development with CCD at 0.5-0.8, predominantly due to substantial water consumption and pollution. Through the comparison of dynamic evolutions of system indicators and CCD under five alternative regulating scenarios, it is realistic for Kunming to plan its future development in accordance to M-H scenario (Medium-speed socioeconomic development pattern; High-intensity water protection effort). Following this scenario, Kunming's CCD would conform to a steadily increasing trend in 2016-2025 and remain above 0.8 in 2022-2025, tracing a shift in the development stage of that coupling coordination from "barely balanced development" to "highly balanced development" despite the difficulty to cut NH3-N emission significantly. The effective and feasible regulatory measures such as reducing productive or domestic water pollutants and consumptions; improving collection and reuse rates of wastewater, should be prioritized when adjusting coordination development during decision-making.

Impact of regulatory measures on antipsychotics drug consumption in Castilla y León, Spain.

OBJECTIVES: Antipsychotics are currently used to treat different diseases; even some off-labelled conditions are treated with this medication. Consumption and cost of antipsychotic drugs sharply increased in Spain after second-generation drugs were marketed; several regulatory measures were adopted to curb this trend. The aim of this study was to examine the impact of these measures upon the use and cost of antipsychotics. STUDY DESIGN: Study of drug use (SDU) from 1995 to 2012. Consumption and cost data were obtained from the CONCYLIA database; this database contains the retail community pharmacies sales of medicinal products reimbursed by the National Health System in Castilla y León (Spain). METHODS: Data are presented as defined daily doses per 1000 inhabitants per day (DID) and day treatment cost (DTC). RESULTS: First-generation antipsychotics prescriptions gradually decreased from 3.0 to 1.8 DID; meanwhile, prescriptions for second-generation antipsychotics considerably increased from 0.3 to 9.9 DID. The use of risperidone dropped after the marketing of its structural derivative paliperidone with a similar efficacy but with a substantially higher cost per day. In 2011 and thereafter, patients in Spain began to pay a part of the medications cost, but this did not decrease antipsychotics consumption. Global cost of antipsychotics only began to fall after measures were adopted to lower the price of medicines because of the economic collapse in Spain after May 2010. CONCLUSION: Several health policy measures have tried to reduce antipsychotics consumption in Spain, special ways of dispensing, marketing of generic drugs and special economic measures for patients. These measures eventually failed to avoid the increase in antipsychotics use. The cost only dropped when lowering prescription drug prices took place.

Faster drug approval: challenges for safety.

INTRODUCTION: More rapid drug premarketing procedures pose a challenge for regulatory agencies in terms of innovation and improving real-world safety and effectiveness Areas covered: This review considers the blockbuster drugs used over the previous fifteen years with adverse reactions after marketing, the elements and time span of risk identification and the measures implemented or considered, based on the existing literature and reports from the agencies Expert opinion: Risk prediction is founded on several factors: randomization, sample size, a well-established endpoint for safety, use of a comparator rather than placebo and a longer Phase-III period, in which a serious illness may be identified by early signs of alteration in the primary parenchyma with the latest biochemical, instrumental and imaging techniques. In comparative non-inferiority evaluations, increased safety should be preferred, with the exception of drugs that may be useful in serious or life-threatening diseases for which there are few or no effective existing therapies. A period of restricted use may be required to test and dispense new drugs, as well as to implement specific methods for the early detection of adverse events. It is important not to regard a new medicine axiomatically as the best treatment before it comes into wide use.

Problems and Regulatory Measures for the Implementation of Drug Clinical Trials in China / 中国药房

OBJECTIVE:To put forward suggestions for drug monitoring authorities to effectively supervise drug clinical trials.METHODS:Problems about the implementation of drug clinical trials and the problems faced by authorities were analyzed to propose regulatory measures.RESULTS & CONCLUSIONS:It is suggested that supervision and administration before and after the facts turn into process control,daily supervision and administration should integrate with checking register,rules and regulations should be improved and relevant responsibility should be implemented,the capability of supervisors should be improved.Drug clinical trial results are the key to drug development and evaluation.Strengthened supervision is the best way to improve the overall level of drug clinical trials in China.

Application of Quinolones Evaluated from Perspective of Its Consumption Sum before and after the Enforcement of Regulatory Measures / 中国药房

OBJECTIVE:To evaluation the effects of the regulatory measures on the clinical application of quinolones. METHODS: The consumption sum and its proportion in the total in major clinical departments before and after the enforcement of the regulatory measures were analyzed, which were compared with the data from the synchronous case files so as to evaluate the rationality of the use of quinolones. RESULTS & CONCLUSION: Quinolones were predominantly used in six departments including the department of respiratory diseases. After the initiation of the regulatory measures, the consumption sum of quinolones decreased in most departments, suggesting the positive effect of the regulatory measures.