Regulatory Concerns Research Articles

Leveraging Blockchain Technology for Enhanced Data Sharing in Environmental Science

Data sharing is essential for advancing research and policy in environmental science, where diverse data types including ecological, climatic, and socioeconomic information are generated. Traditional data sharing methods often fall short in security and efficiency, leading to challenges such as data loss and reluctance to share. This essay explores the transformative potential of blockchain technology as a solution for secure, transparent, and efficient data sharing among stakeholders in environmental science. By examining relevant use cases, particularly in marine environments, we highlight how blockchain can facilitate trust, enhance data integrity, and improve collaboration across sectors. Despite its promising applications, challenges such as scalability, regulatory concerns, and the need for stakeholder education remain. The paper concludes with insights into future research directions and the critical role of interdisciplinary collaboration in overcoming these obstacles. Keywords: Blockchain Technology, Data Sharing, Environmental Science, Security, Transparency, Marine Environments, Scalability, Regulatory Concerns, Interdisciplinary Collaboration

Chemical Risk in Hospitals: An Overview of Monitoring Strategies and International Regulatory Practical Concerns

Chemical risk in hospital settings is an increasing worry that health professionals and regulatory bodies must address on a daily basis. Chemical risk exposure varies depending on the hospital department and can result from a variety of causes, including the use of sterilizing agents, disinfectants, detergents, solvents, heavy metals, toxic medications, and anesthetic gases. Strengthening preventative methods and continuously monitoring the presence and level of potentially harmful compounds in employees (biological monitoring) and working surroundings (environmental monitoring) may minimize the risk of exposure and contamination dramatically. The goal of this article is to provide an overview of the current international legislation, the chemical pollutants to which medical and paramedical staff are mostly exposed, and the techniques devised to combat them. Key Word: Risk assessment; Occupational medicine; Environmental monitoring; Biological monitoring; Sampling techniques

Texas’s Water Future: Legal, Business, Environmental, and Regulatory Concerns

Around the world freshwater is increasingly scarce, and Texas is no different. Texas continuously operates at a shortage, where freshwater supply cannot meet demand. Projections show that this deficit will increase over the next decade, which would cause billions of dollars in losses for the Texas economy. But Texas is in a unique position to correct its water problems and take corrective measures to avoid such losses. Innovations around hydraulic fracturing in the oil and gas industry, namely recyclable “produced water” and the burgeoning “water midstream” sector will play an important role in remediating Texas’ freshwater scarcity concern. Furthermore, the technological advancements in recyclable produced water, combined with an effective business model and operational infrastructure of the water midstream sector, would generate a consistent source of freshwater for industrial, manufacturing, and agricultural uses that will mitigate the strain on natural freshwater sources. Private actors continue to fund and build facilities to gather, recycle, and distribute produced water; but there are barriers to expansion of these systems. While the private sector has a foundational blueprint to utilize recyclable produced water, there are business, legal, environmental, and regulatory concerns that must be addressed by the Texas government to pioneer a sustainable water future that will greatly benefit Texas’s economy and residents. The Texas government must adopt a proactive approach to thi

Safe Technical Innovation: Development and Implementation of a Robotic Breast Operation Program.

Safe Technical Innovation: Development and Implementation of a Robotic Breast Operation Program.

Nanosystems in Cosmetic Products: A Brief Overview of Functional, Market, Regulatory and Safety Concerns.

Nanosystems exhibit various innovative physico-chemical properties as well as a range of cosmetic functions, including increased skin retention for loaded compounds. The worldwide nano-market has therefore been consistently extensive in recent decades. This review summarizes the most important properties of nanosystems that are employed in cosmetics, including composition, functions and interactions with skin, with particular attention being paid to marketed products. Moreover, the worldwide regulatory landscape of nanomaterials used as cosmetic ingredients is considered, and the main safety concerns are indicated. In general, advanced physico-chemical characterization is preliminarily needed to assess the safety of nanomaterials for human health and the environment. However, there is currently a shortfall in global legislation as a universally accepted and unambiguous definition of a nanomaterial is still lacking. Therefore, each country follows its own regulations. Anyhow, the main safety concerns arise from the European context, which is the most restrictive. Accordingly, the poor dermal permeation of nanomaterials generally limits their potential toxic effects, which should be mainly ascribed to unwanted or accidental exposure routes.

Extemporaneous Compounding Practice for Dermatologic Preparations in Ethiopian Public Hospitals: Regulatory Requirements and Quality Concerns.

Extemporaneous compounding is among the key hospital pharmacy services that promotes pharmaceutical care. It is a long-standing practice in dermatology for patients who need custom-made drug products. The practice of dermatologic compounding practice in Ethiopian public hospitals is found at the beginning and very few hospitals have started the practice so far. This research communication aimed at examining Ethiopian public hospitals’ extemporaneous compounding practice for dermatologicals with emphasis on regulatory requirement and quality control activities. To benefit patients from these products, good compounding practice should be obeyed in line with the expansion of the service. Gaps have been observed in the facilities with regard to quality assurance system and compliance with the country’s regulatory requirements. This implies a need to take appropriate and timely actions by the responsible stakeholders and expand the service in the country by fulfilling the regulatory requirement.

Artificial Intelligence and Healthcare Regulatory and Legal Concerns

We are in a stage of transition as artificial intelligence (AI) is increasingly being used in healthcare across the world. Transitions offer opportunities compounded with difficulties. It is universally accepted that regulations and the law can never keep up with the exponential growth of technology. This paper discusses liability issues when AI is deployed in healthcare. Ever-changing, futuristic, user friendly, uncomplicated regulatory requirements promoting compliance and adherence are needed. Regulators have to understand that software itself could be a software as a medical device (SaMD). Benefits of AI could be delayed if slow, expensive clinical trials are mandated. Regulations should distinguish between diagnostic errors, malfunction of technology, or errors due to initial use of inaccurate/inappropriate data as training data sets. The sharing of responsibility and accountability when implementation of an AI-based recommendation causes clinical problems is not clear. Legislation is necessary to allow apportionment of damages consequent to malfunction of an AI-enabled system. Product liability is ascribed to defective equipment and medical devices. However, Watson, the AI-enabled supercomputer, is treated as a consulting physician and not categorised as a product. In India, algorithms cannot be patented. There are no specific laws enacted to deal with AI in healthcare. DISHA or the Digital Information Security in Healthcare Act when implemented in India would hopefully cover some issues. Ultimately, the law is interpreted contextually and perceptions could be different among patients, clinicians and the legal system. This communication is to create the necessary awareness among all stakeholders.

ASA Survey Results: Top Regulatory Concerns

ASA Survey Results: Top Regulatory Concerns

Investors’ regulatory concerns and the SEC’s regulation SHO pilot program on the NYSE

ABSTRACT Examining the private-information content of short sales surrounding the implementation of the SEC’s Regulation SHO-pilot program, we that informativeness of short sales on the NYSE has disappeared in pilot stocks during the pilot program. Both the shorting efficiency hypothesis and the regulatory concern hypothesis are proposed to explain this anomaly. Empirical testing results support the regulatory concern hypothesis, suggesting that the SEC’s Regulation SHO-pilot program may be a problematic natural experiment because there is a propounding difference between the pilot and control samples concerning short-sellers’ trading behaviour.

Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature.

Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP’s key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars.

Environmental and Regulatory Concerns During the COVID-19 Pandemic: Results from the Pandemic Food and Stigma Survey.

In this article, we present data from the monthly Pandemic Food and Stigma Survey (PFSS), a nationwide representative sample of adults in the United States designed to identify how the pandemic is affecting concerns about food and the environment. Two surveys were conducted in May and June 2020. Our analysis suggests that the public’s concern about contracting COVID-19 has been high; however, infection with COVID-19 was not the only concern. A majority of respondents remained strongly concerned about environmental issues, such as climate change, while responses to sudden relaxations of environmental and food safety policies varied. We analyze the PFSS data to identify factors associated with concerns about pandemic and environmental regulatory changes. In general, we find that people whose food security has been threatened by COVID-19 remain concerned about relaxation of environmental regulations, and those most inclined to take steps to reduce spread of the virus, such as wearing masks and social distancing, are more concerned about relaxed regulations than those less willing to take mitigating actions.Electronic supplementary materialThe online version of this article (10.1007/s10640-020-00438-9) contains supplementary material, which is available to authorized users.

Regulatory Concerns about Medical Device Manufacturing Using 3D Printing: Current State of the Issue

Custom-made implants, orthotics, orthoses, models for surgical planning and education, and much more are now created using 3D printers. In this article, the authors suiiunarized information on laws and regulations in the domain of legal support for 3D printing of medical devices in Russia and abroad. 3D printing is one of the promising avenues in developing new methods of treatment, so iiiunediate establishing of clear criteria for its legal regulation is necessary. As is, there are still many gaps in the legislative framework. The issues of the quality of 3D models, material standardization and manufacturing processes using 3D printing technologies remain unresolved. When using custom-made medical devices, respecting the rights of patients and preventing the use of prohibited or restricted materials are essential. Yet, legal barriers to this irmovative direction of medicine must be avoided.

Regulatory Concerns for Nanomaterials in Sunscreen Formulations

Regulatory Concerns for Nanomaterials in Sunscreen Formulations

WhatsApp in Stroke Systems: Current Use and Regulatory Concerns.

Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

CRISPR-Cas in Medicinal Chemistry: Applications and Regulatory Concerns.

A rapid search in scientific publication's databases shows how the use of CRISPR-Cas genome editions' technique has considerably expanded, and its growing importance, in modern molecular biology. Just in pub-med platform, the search of the term gives more than 3000 results. Specifically, in Drug Discovery, Medicinal Chemistry and Chemical Biology in general CRISPR method may have multiple applications. Some of these applications are: resistance-selection studies of antimalarial lead organic compounds; investigation of druggability; development of animal models for chemical compounds testing, etc. In this paper, we offer a review of the most relevant scientific literature illustrated with specific examples of application of CRISPR technique to medicinal chemistry and chemical biology. We also present a general overview of the main legal and ethical trends regarding this method of genome editing.

Probiotics for Health Benefits: The Regulatory Concerns and Suggestive Roadmap

Probiotics for Health Benefits: The Regulatory Concerns and Suggestive Roadmap

Supplier Resources in the Sharing Economy: Three Regulatory Concerns

This article explores three legal and regulatory concerns that primarily affect the supply side of marketing channels in the sharing economy. The sharing economy depends on resources and relationships between and among numerous networks and actors, including government regulators, emerging businesses, service providers, and end users who interact directly with the supply chain. Although providing economic prospects for companies and contractors, the sharing economy presents a variety of challenges for all parties, including the proper classification of the employment relationship; the use of, and access to, private property; and data privacy and security. The nascent state of theory and regulation means that companies and other stakeholders are potentially and unwarily assuming significant risk in the structure and implementation of the supply chain.

Editorial: Regulatory and Quality Concerns for Healthcare Products

Editorial: Regulatory and Quality Concerns for Healthcare Products

Report on the 17th Annual Land O'Lakes Bioanalytical Conference.

17th Annual Land O'Lakes Bioanalytical Conference, Madison, WI, USA, 11-14 July 2016 The 17th Annual Land O'Lakes Bioanalytical Conference, titled 'Biomarker Validation, Stability, and Regulatory Concerns', was held on 11-14 July 2016 (Monday through Thursday) in Madison, WI, USA. The Land O'Lakes Conference is presented each year by the Division of Pharmacy Professional Development within the School of Pharmacy at the University of Wisconsin-Madison (USA). The purpose of this 3-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. The conference is designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference, the program is a mixture of lectures, interactive discussions and a poster session. This report summarizes the presentations at the 17th Annual Conference.