Establishment of Advanced Regulatory Innovation for Clinical Trials Transformation (ARICTT): a multi-stakeholder public-private partnership-based organization to accelerate the transformation of clinical trials.

Clinical trials have evolved with digital technologies and tend towards patient-centricity. A multi-stakeholder approach is needed to address the emerging complexities in clinical trials. In particular, the introduction of digital technologies and an emphasis on patient-centricity are the major trends in clinical trials. In response, we established a public-private partnership-based organization named Advanced Regulatory Innovation for Clinical Trials Transformation (ARICTT). Eleven organizations in total, from academia, industry, and regulatory agencies, participate in ARICTT. Based on multi-stakeholder collaboration from academia, industry, and government/regulatory bodies, we collected and prioritized current topics in clinical trials based on an internal survey. We established a three-year roadmap with axes that were termed trend, goal, structure, theme, topic, and method. In addition, we planned the development of recommendations based on real-world cases with feasibility studies. We developed appropriate organizational structure to fulfill the roadmap of ARICTT. The selected topics were decentralized clinical trials during the first year, followed by the three topics that were awarded the highest priority according to the internal survey: advances in the informed consent process, supporting sites using digital technology, and an effective recruitment strategy. We developed a case-based recommendation paper presenting an overview of the regulatory landscape and practical considerations with explanatory cases. We also designed and conducted fully decentralized trials to evaluate considerations in real-world settings for the selected topics. Overall engagement and communication were supported by the online platform and annual symposiums. In conclusion, we established a multi-stakeholder, public-private partnership-based organization to accelerate the transformation of clinical trials.

How external and agency characteristics are related to coordination in homecare - findings of the national multicenter, cross-sectional SPOTnat study.

BACKGROUND: Homecare client services are often distributed across several interdependent healthcare providers, making proper care coordination essential. However, as studies exploring care coordination in the homecare setting are scarce, serious knowledge gaps exist regarding how various factors influence coordination in this care sector. To fill such gaps, this study's central aim was to explore how external factors (i.e., financial and regulatory mechanisms) and homecare agency characteristics (i.e., work environment, workforce, and client characteristics) are related to care coordination in homecare. METHODS: This analysis was part of a national multicentre, cross-sectional study in the Swiss homecare setting that included a stratified random sample of 88 Swiss homecare agencies. Data were collected between January and September 2021 through agency and employee questionnaires. Using our newly developed care coordination framework, COORA, we modelled our variables to assess the relevant components of care coordination on the structural, process, and outcome levels. We conducted both descriptive and multilevel regression analyses-with the latter adjusting for dependencies within agencies-to explore which key factors are associated with coordination. RESULTS: The final sample size consisted of 1450 employees of 71 homecare agencies. We found that one explicit coordination mechanism ("communication and information exchange" (beta = 0.10, p <.001)) and four implicit coordination mechanisms-"knowledge of the health system" (beta = -0.07, p <.01), "role clarity" (beta = 0.07, p <.001), "mutual respect and trust" (beta = 0.07, p <.001), and "accountability, predictability, common perspective" (beta = 0.19, p <.001)-were significantly positively associated with employee-perceived coordination. We also found that the effects of agency characteristics and external factors were mediated through coordination processes. CONCLUSION: Implicit coordination mechanisms, which enable and enhance team communication, require closer examination. While developing strategies to strengthen implicit mechanisms, the involvement of the entire care team is vital to create structures (i.e., explicit mechanisms) that enable communication and information exchange. Appropriate coordination processes seem to mitigate the association between staffing and coordination. This suggests that they support coordination even when workload and overtime are higher.

La débil garantía constitucional del derecho a la protección de la salud en España: una propuesta de reforma / A frágil garantia constitucional do direito à proteção da saúde na Espanha: uma proposta de reforma / The weak constitutional guarantee of the right to health protection in Spain: a reform proposal

Objetivo: discutir el derecho a la protección de la salud en España y su no inclusión en la categoría de derecho fundamental. Metodología: Revisión crítica de documentos normativos españoles e internacionales - Constitución, leyes y tratados internacionales - desde la perspectiva del análisis de la salud como un derecho fundamental. Resultados: La garantía y efectividad del derecho a la salud en España no son satisfactorias, ya que a partir de la regulación legislativa y, a menudo, administrativa del tema, surgen reclamaciones jurídicas bien definidas y exigibles ante los órganos jurisdiccionales, como derechos subjetivos individuales. Esto faculta al legislador introducir retrocesos significativos en la determinación del alcance del derecho a la salud. Conclusión: Se impone una reforma constitucional que signifique la reconfiguración de un derecho y su inclusión en la lista de aquellos considerados fundamentales en la Sección 1ª del Capítulo II del Título I de la Constitución, a fin de dotarlo de un contenido esencial, vinculante para el legislador y para que él mismo sea beneficiario de una garantía jurisdiccional directa y máxima, tanto ordinaria como extraordinaria ante el Tribunal Constitucional.

Objetivo: discutir o direito à proteção da saúde na Espanha e o seu não enquadramento na categoria de direito fundamental. Metodologia: revisão crítica de documentos normativos espanhóis e internacionais ­ Constituição, Leis e tratados internacionais na perspectiva de análise da saúde como um direito fundamental. Resultados: a garantia e efetividade do direito à saúde na Espanha não são satisfatórios visto que a partir da regulamentação legislativa e, muitas vezes, administrativa do tema, surgem reivindicações jurídicas bem definidas e exigíveis perante os órgãos judiciais, como direitos subjetivos individuais. Isso permite ao legislador introduzir retrocessos significativos na determinação do alcance do direito à saúde. Conclusão: Impõe-se uma reforma constitucional que signifique a reconfiguração de um direito e sua inclusão na lista daqueles considerados fundamentais na Seção 1ª do Capítulo II do Título I da Constituição, a fim de dotá-lo de um conteúdo essencial, vinculativo para o legislador e para que ele mesmo seja beneficiário de uma garantia jurisdicional direta e máxima, tanto ordinária quanto extraordinária perante o Tribunal Constitucional.

Objective: to discuss the right to health protection in Spain and its non-inclusion in the category of fundamental rights. Methodology: Critical review of Spanish and international normative documents - Constitution, laws, and international treaties - from the perspective of analyzing health as a fundamental right. Results: The guarantee and effectiveness of the right to health in Spain are not satisfactory, as from the legislative and often administrative regulation of the topic, well-defined and enforceable legal claims arise before judicial bodies, as individual subjective rights. This allows the legislator to introduce significant setbacks in determining the scope of the right to health. Conclusion: A constitutional reform is necessary to reconfigure a right and include it in the list of those considered fundamental in Section 1 of Chapter II of Title I of the Constitution, in order to endow it with an essential content, binding for the legislator, and so that it itself benefits from direct and maximum jurisdictional guarantee, both ordinary and extraordinary, before the Constitutional Court.

The "Creuseurs" ("Diggers"), at the Center of the World's Push for EVs, are in Peril: Part Two-Obstacles and Opportunities to Improve Conditions for Miners.

In part one, we reported on some of the shocking working conditions that the Electronics Watch team found on our visit to cobalt mines in the DRC. Now, we look at the vested interests in Congolese politics, the mining industry, the Congolese government's desire to regulate the cobalt supply chain, and what else might be done to improve conditions.

The "Creuseurs" ("Diggers"), at the Center of the World's Push for EVs, are in Peril: Part One-The Precarious Reality of Artisanal Mines.

Electronics Watch travelled to Kolwezi in the province of Lualaba, in the south of the Democratic Republic of Congo. Two worlds live side by side here, without ever crossing paths. On the one hand, the world of industrial mines, with their huge machines. On the other, the tens of thousands of "diggers" in small-scale artisanal mines, armed with a simple crowbar to exploit a mineral vein, in extremely dangerous conditions. The DRC alone has 80% of the world's cobalt stocks needed to manufacture batteries to serve the demand for electric vehicles, and no less than 30% of this stock is mined in an artisanal way. One to two million Congolese people depend on this production directly or indirectly, while world demand is booming.

Triumphs and trials with the UK abortion law: The power of collaboration in abortion reform.

The UK is usually viewed as having liberal abortion regulations, providing good access to abortion care within a publicly funded health service. However, the underlying laws are authoritarian, dating from an era when public executions drew large crowds and 67 years before women were able to vote. Abortion is only legal when two doctors certify it meets the permitted grounds, and the penalty for self-managed abortion is up to life imprisonment for both the woman and any accomplice. These laws had prevented the use of mifepristone and misoprostol at home. Changes to the regulations for misoprostol in 2018 and mifepristone in 2020 permitted home use, but the government announced they were rescinding the approval for mifepristone in 2022. This article discusses how, despite the opposition of government, significant progressive changes to the abortion laws were achieved. Early medical abortion at home is now protected in law, and safe access zones protect patients and staff from harassment and intimidation from protesters. Despite this progress, increasing numbers of women are facing criminal investigation and face long prison sentences if convicted. The need for decriminalization and for abortion care to be regulated like all other health care is the next pressing issue.

Research on safety risk control of prepared foods from the perspective of supply chain.

Prepared foods bring great convenience to people's lives, but they also entail safety risks in all aspects, from production to sales. The cooperation of the supply chain and the supervision of the government are key to promoting the safety management of prepared foods. This paper considers the government's regulation, focuses on the interaction relationship between the producer and the retailer of prepared foods, and builds an evolutionary game model to analyze the influence of collaborative decision-making between prepared food producers and retailers in preventing and controlling food safety risks under the government's regulatory strategy. The research finds that: (1) Under certain conditions, there are three stable equilibrium strategies within the prepared foods supply chain: bilateral low-safety inputs, unilateral high-safety inputs, and bilateral high-safety inputs. (2) Government regulators can influence the safety input behaviors of prepared food supply chain enterprises by adjusting investigation probabilities and punishment severity. (3) The safety input behaviors of these enterprises are influenced by various factors, including costs, revenues, brand image, reputation, and the consequences associated with contractual violations. This paper represents the first systematic analysis of prepared food safety from a supply chain perspective. It fills a gap in the existing literature in this area, offering guidance and suggestions for prepared food supply chain enterprises, as well as references and recommendations for government regulators.

Consumer preferences and willingness to pay for safe pork products in rural Kenya.

Designing interventions to support the safe development of rapidly growing livestock value chains in sub-Saharan Africa requires a clear understanding of consumer demands. This study aimed to determine purchase patterns, consumers' preferences, and willingness to pay for safe pork attributes; specifically, the presence of a veterinary inspection stamp and the cleanliness of the butchery. A discrete choice experiment-based survey was used to investigate the purchasing behavior of 401 pork consumers: 253 buying raw pork for household consumption, and 148 buying cooked pork for out-of-home consumption. The study findings indicate that the average quantity of pork purchased by consumers was approximately 0.4 Kg per transaction, with the majority of consumers making several purchases per week. The average price per Kg of pork was KES 310 (Approx. 2.60 USD) at the time of the study. Data from the choice experiment showed that consumers were willing to pay a price premium of KES 245 (Approx. 2.1 USD) and KES 164 (Approx. 1.4 USD) per Kg for evidence of better veterinary meat inspection and higher butchery hygiene respectively; further, these were the two most important attributes they considered while making a pork purchase decision. These findings highlight the potential to leverage consumers' willingness to pay to improve the food safety within pork value chains in this context. Investing to increase consumer awareness on food safety issues should be considered to generate an effective market demand, especially in rural areas with relatively lower literacy levels.

Pharmacy Benefit Managers in the Eye of the Storm: Growing Multipartite Scrutiny.

The high cost of prescription drugs in the U.S. remains an ongoing national challenge. A recurring focal point in discussions over this distressing steady state is the role(s) played by Pharmacy Benefit Managers (PBMs) who negotiate drug prices with pharmaceutical manufacturers, conduct drug utilization reviews, engage in disease management, and see to formulary creation. At their inception, the multiple newly established PBMs were arguably intent on constraining the rise of prescription drug prices. At the time of this writing, however, the lion share of a far less competitive PBM market is controlled by CVS Caremark, Express Scripts, and OptumRx. It is this evolving reality which could be interpreted to mean that the PBMs may have become part of the problem, rather than part of the solution. Expanded scrutiny of the PBMs by Federal and State authorities as well as by Professional Medical Associations must not be delayed with an eye toward affording the public with relief from the high cost of prescription drugs.

Experiences and challenges with the new European Clinical Trials Regulation.

BACKGROUND: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. METHODS: We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. RESULTS: While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. CONCLUSIONS: CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response. TRIAL REGISTRATION: This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022).

Assessing Mental Healthcare Worker Experiences of Workplace Fairness and Organizational Value: A National Survey of Peer-Support Specialists.

BACKGROUND: Peer-support specialists-individuals with diagnosed mental illnesses who provide support services to other adults with diagnosed mental health issues-often feel stigmatized and undervalued at work, leading to negative personal- and job-related outcomes. Given their important link to positive service user outcomes, this study assessed how peer-support specialists perceive fairness and feel valued in the workplace. METHODS: Peer-support specialists (N = 274) were recruited online from peer-support specialist listservs, social media groups, and patient-run organizations to take a cross-sectional survey that included a 14-item scale on how workplace fairness relates to job satisfaction and four questions on how valued they felt by administrators, clinicians, the people they serve, and fellow peer-support specialists. Descriptive and bivariate statistics were used to assess total scores and differences by gender and race. FINDINGS: Ranging in age from 20 to 77 years and identifying predominantly as White (81.0%) and female (62.9%), respondents noted that fair practices in the workplace would increase their job satisfaction, with no significant differences observed by gender or race. Most peer-support specialists felt valued by the people they serve (97.1%) and fellow peer-support specialists (92.7%). However, fewer reported feeling valued by administrators (64.6%) and clinicians (60.6%). CONCLUSIONS/APPLICATION TO PRACTICE: Peer-support specialists value fairness at the workplace and feel undervalued by some staff. This study highlights peer-support specialists' important role in behavioral health services and suggests that healthcare professionals, including occupational health specialists, are important stakeholders in creating fairer workplaces and increasing peer-support specialists' sense of being valued, leading to improved personal and organizational outcomes.

[Securing the implantable medical device circuit]. / Arrêté du 8 septembre 2021 : sécurisation du circuit des dispositifs médicaux implantables.

OBJECTIVES: The decree concerning quality management of implantable medical device circuits came into force in healthcare establishments on 26 May 2022. The aim of this project is to assess the level of safety of this circuit within the pharmacy, in order to improve it and bring it into line with this future regulation. METHODS: A grid for compliance with the decree was drawn up, enabling compliance rates to be calculated. A second grid was drawn up in accordance with internal procedures. All these criteria were audited in pairs. Priority areas for improvement were identified and working groups were formed. The action plan was monitored by the Steering Committee. Control audits ensure the implementation and relevance of the action plan, as well as the effective securing of the circuit. RESULTS: The rate of circuit compliance with the decree rose from 58% (initial audits) to 72% (control audits). Over a period of 18 months, six workgroups were set to implement improvement measures allowing to ensure regulatory compliance and circuit security. Obstacles (equipment, IT) nevertheless hindered the presence of the unique identifier for medical devices at every stages of the circuit. CONCLUSIONS: This cross-functional project was carried out in "project mode", thanks to the involvement of field staff. It will be pursued at hospital level by the person in charge of the quality management system.

How regulatory frameworks drive differences in home-care agencies: Results from a national multicenter cross-sectional study in Switzerland.

INTRODUCTION: The sustainability and rising costs of the health-care system are of concern. Although health-care reforms impact various areas of care, there is only limited evidence on how regulations affect home-care agencies and health-care delivery. OBJECTIVES: The primary aim was to explore different financial and regulatory mechanisms and how they drive differences in the organizational structures, processes, and work environment of home-care agencies. DESIGN AND METHODS: We used data from a national multicenter cross-sectional study of Swiss home care that included a random sample of 88 home-care agencies with a total of 3223 employees. Data was collected in 2021 through agency and personnel questionnaires including geographic characteristics, financial and regulatory mechanisms, service provision, financing, work environment, resources and time allocation, and personnel recruitment. We first conducted a cluster analysis to build agency groups with similar financial and regulatory mechanisms. We then performed Fisher's exact, ANOVA, and Kruskal-Wallis tests to determine group differences in organizational structures, processes, and work environments. Finally, we performed a lasso regression to determine which variables were predictive for the groups. RESULTS: Four agency groups were built, differing in view of financial and regulatory mechanisms and we found differences in the range and amount of services provided, with regard to employment conditions and cost structures. DISCUSSION: The most prominent differences were found between agency groups with versus agency groups without a service obligation. Financial incentives must be well aligned with the goal of achieving and maintaining financially sustainable, accessible, and high-quality home care.

Implementação de tecnologias em saúde no Brasil: análise de orientações federais para o sistema público de saúde / Implementation of health technologies in Brazil: analysis of federal guidelines for the public health system

Resumo O objetivo foi identificar o arcabouço regulatório e as orientações federais que sustentam o processo de implementação de tecnologias em saúde no Sistema Único de Saúde (SUS), por meio da análise de documentos e legislações relacionados à Política Nacional de Gestão de Tecnologias de Saúde, publicados entre 2009 e 2021. Foi realizada busca e seleção dos documentos e posterior extração de dados, agrupados por três categorias: normativas estruturantes, recomendações na avaliação de tecnologias e recomendações nas diretrizes clínicas. Em 38,8% das normativas, foram identificadas citações à implementação relacionadas principalmente às diretrizes clínicas do SUS, mas nenhum documento dedicado a orientar as ações de implementação. As recomendações relacionadas às implementações foram identificadas em 27,1% dos relatórios e em 66,1% das diretrizes, mas sem padronização e, de modo geral, pouco detalhadas, com foco em recursos e ações necessárias para a disponibilização da tecnologia, ao invés de métodos e intervenções para implementação. Os resultados confirmam a existência de uma lacuna de diretrizes formais para guiar o processo de implementação no Brasil, o que se constitui em oportunidade para o desenvolvimento de modelos alinhados à realidade do SUS.

Abstract This study aimed to identify the regulatory framework and federal guidelines that support the process of implementing health technologies in the Unified Health System (SUS) through analysis of documents and legislation related to the National Health Technology Management Policy, published between 2009 and 2021. The search and selection of documents and subsequent data extraction were carried out. The documents were grouped into three categories: structural regulatory documents, recommendations on evaluation of technologies, and recommendations on clinical guidelines. In 38.8% of the regulatory documents, citations to implementation related mainly to SUS clinical guidelines were identified; however, no document dedicated to guiding implementation actions was identified. Recommendations related to implementations were identified in 27.1% of the reports and 66.1% of the guidelines, although without standardization and, in general, in little detail, focusing on resources and actions needed for making technology available rather than on methods and interventions for its implementation. The results evidence a gap in formal guidelines to guide the implementation process in Brazil, representing an opportunity for the development of models aligned with the reality of the SUS.

Advancing sustainable financial management in greening companies through big data technology innovation.

Incorporating sustainability into financial management procedures has emerged as a critical component in the modern business landscape for organizations looking to strengthen their environmental stewardship while guaranteeing financial viability. The study "Advancing Sustainable Financial Management in Greening Companies through Big Data Technology Innovation" explains the crucial role that big data technologies play in empowering businesses to incorporate environmental sustainability into their financial management strategies. The research the strong link between big data analytics and the optimization of sustainable financial management in businesses from year 1990 to 2022. The study's findings show that big data analytics enables firms to make data-driven decisions, significantly increasing the effectiveness of their sustainability activities. With the enormous amounts of data that big data technologies can analyze, businesses can access actionable insights that make it easier to identify and reduce environmental impacts, use resources more efficiently, and streamline supply chains to support sustainability. To emphasizes the businesses can match their financial goals with sustainability objectives through big data technology without sacrificing profitability. Big data analytics may help businesses assess environmental risks and find possibilities for sustainable investment, enabling them to make well-informed financial decisions consistent with their commitment to environmental stewardship. The conclusion emphasizes the businesses to adopt big data technology focusing on long-term financial management strategically. The growing environmental problems that endanger the world's ecosystems underscore even more how crucial it is to include these advancements. Therefore, integrating sustainability into financial management using big data technology is not just a choice but a requirement for businesses to succeed in this century. The study demonstrated that the businesses, decision-makers, and other stakeholders to understand and use big data technologies' potential to advance sustainable financial management and build more resilient and sustainable corporate environments.

Antibiotic Use in Hospital Urinary Tract Infections After FDA Regulation.

BACKGROUND: The FDA issued a "black box" warning regarding risks of fluoroquinolones in 2008 with updates in 2011, 2013, and 2016. OBJECTIVE: To examine antimicrobial use in hospital-treated UTIs from 2000 to 2020. DESIGN: Cross-sectional study with interrupted time series analysis. PARTICIPANTS: Patient encounters with a diagnosis of UTI from January 2000 to March 2020, excluding diagnoses of renal abscess, chronic cystitis, and infection of the gastrointestinal tract, lungs, or prostate. MAIN MEASURES: Monthly use of fluoroquinolone and non-fluoroquinolone antibiotics were assessed. Fluoroquinolone resistance was assessed in available cultures. Interrupted time series analysis examined level and trend changes of antimicrobial use with each FDA label change. KEY RESULTS: A total of 9,950,790 patient encounters were included. From July 2008 to March 2020, fluoroquinolone use declined from 61.7% to 11.7%, with similar negative trends observed in inpatients and outpatients, age ≥ 60 and < 60 years, males and females, patients with and without pyelonephritis, and across physician specialties. Ceftriaxone use increased from 26.4% encounters in July 2008 to 63.6% of encounters in March 2020. Among encounters with available culture data, fluoroquinolone resistance declined by 28.9% from 2009 to 2020. On interrupted time series analysis, the July 2008 FDA warning was associated with a trend change (-0.32%, < 0.001) and level change (-5.02%, p < 0.001) in monthly fluoroquinolone use. CONCLUSIONS: During this era of "black box" warnings, there was a decline in fluoroquinolone use for hospital-treated UTI with a concomitant decline in fluoroquinolone resistance and rise in ceftriaxone use. Efforts to restrict use of a medication class may lead to compensatory increases in use of a single alternative agent with changes in antimicrobial resistance profiles.

The impacts of working time flexibilization on occupational safety and health: an expert survey.

The policy proposal by the current Korean government that proposes flexible overtime rules is causing social controversy. This study has explored the 612 experts' opinions on the occupational safety and health impacts of the policy using an online self-report survey. They expected short-term overwork (87.25%), overwork inequality (86.44%), irregular working hours (84.31%), chronic overwork (84.15%), long working hours (83.66%), and unpredictability of working hours (81.86%) as a result of the policy change. They also responded that the policy change would increase industrial accident deaths (87.25%), mental illnesses (87.09%), deaths due to overwork or cardiovascular diseases (83.84%), and accidents (83.33%). They disagreed that the government's flexibilization policy, while agreeing that the necessity of policies on regulating night work (94.77%), guaranteeing wages to eliminate overtime (90.36%), establishing working time regulations for the bogus self-employed (82.84%), and applying the 52-hour workweek system to all workplaces (76.47%). These expert opinions are consistent with previous research on the health effects of working hours.

Design, implementation, and inferential issues associated with clinical trials that rely on data in electronic medical records: a narrative review.

Real world evidence is now accepted by authorities charged with assessing the benefits and harms of new therapies. Clinical trials based on real world evidence are much less expensive than randomized clinical trials that do not rely on "real world evidence" such as contained in electronic health records (EHR). Consequently, we can expect an increase in the number of reports of these types of trials, which we identify here as 'EHR-sourced trials.' 'In this selected literature review, we discuss the various designs and the ethical issues they raise. EHR-sourced trials have the potential to improve/increase common data elements and other aspects of the EHR and related systems. Caution is advised, however, in drawing causal inferences about the relationships among EHR variables. Nevertheless, we anticipate that EHR-CTs will play a central role in answering research and regulatory questions.

Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation.

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.

An overview and visual analysis of research on government regulation in healthcare.

Objective: During the period of COVID-19, government regulation (GR) played an important role in healthcare. This study examines the current research situation of GR in healthcare, discusses the research hotspots, the most productive authors and countries, and the most common journals, and analyzes the changes in GR in healthcare before and after the outbreak of COVID-19. Methods: This study followed PRISMA guidelines to collect literature on GR in healthcare. And the VOSviewer software was used to perform a quantitative analysis of these documents to obtain a visual map, including year, country, institution, journal, author, and research topic. Results: A total of 1,830 papers that involved 976 academic journals, 3,178 institutions, and 133 countries were identified from 1985 to 2023. The United States was the country with the highest production (n = 613), followed by the United Kingdom (n = 289). The institution with the largest number of publications was the University of London in the UK (n = 103); In the author collaboration network, the biggest cluster is Bomhoff M, Bouwman R, Friele R, et al. The top five journals in terms of the number of articles were BMC Health Services Research (n = 70), Plos One (n = 35), Health Policy (n = 33), Social Science & Medicine (n = 29), Health Policy and Planning (n = 29), and Frontiers in Public Health (n = 27). The existing literature mainly focused on "health policy," "public health," "China," "mental health," "India," "qualitative research," "legislation," and "governance," et al. Since 2020, research on "COVID-19" has also become a priority in the domain of healthcare. Conclusion: This study reveals the overall performance of the literature on GR published in healthcare. Healthcare needs GR, especially in response to the COVID-19 epidemic, which has played an irreplaceable role. The outbreak of COVID-19 not only tested the health systems of various countries, but also changed GR in healthcare. With the end of COVID-19, whether these changes will end remains to be further studied.