Liability Risk Research Articles

Narrative Review: Telemedicine Quality after the COVID-19 Public Health Emergency: Time to Reevaluate?

OBJECTIVE: This narrative review explores concerns and potential solutions for improving the quality of synchronous telemedicine visits for high utilizers like primary care, particularly after the COVID-19 pandemic. METHODS: A literature review identified studies published within the past 10 years focusing on telemedicine quality, primary care, and related aspects like liability, virtual exams, and patient safety. RESULTS: Despite the surge in popularity of telemedicine visits, concerns regarding their quality linger. These concerns encompass various aspects of the patient experience, administrative processes, and potential safety risks. Limitations in physical exam capabilities and the lack of readily available vital signs during telemedicine visits raise concerns about the accuracy of diagnoses. This is particularly true for situations requiring a more comprehensive physical assessment. Incomplete documentation due to abbreviated patient histories, missing physical exam findings, and the reliance on generic templates pose liability risks. This lack of thorough information makes it challenging to accurately capture the patient's condition and raises concerns about the quality of care provided. Patients themselves have expressed concerns about accuracy of a virtual visit, thus raising questions about the effectiveness of telemedicine in building rapport and ensuring clear communication. From an administrative standpoint, fears of misdiagnosis due to the limitations of virtual exams, inconsistencies in insurance coverage for telemedicine services, and unclear reimbursement standards for thorough visits continue to pose challenges. These uncertainties create ambiguity and make it difficult for healthcare providers to fully embrace telemedicine as a viable option. Finally, although mirroring in-person visit protocols for patient safety is considered crucial, many organizations currently lack standardized measures to ensure safety throughout the entire telemedicine journey. This includes potential risks during scheduling, appointment execution, and post-visit follow-up, highlighting the need for more robust safety protocols specifically designed for the telemedicine setting. Addressing these concerns is essential for ensuring the quality and sustainability of telemedicine integration. CONCLUSION: While telemedicine offers significant benefits, improving quality is essential for its sustainable integration into primary care. Standardizing protocols, educating clinicians and patients, implementing comprehensive physical exam procedures, and ensuring patient safety throughout the visit are key areas for improvement. Continuous monitoring and data analysis are crucial for identifying and addressing weaknesses and ensuring quality telemedicine care.

"Protection for the public, better use of resources and clearer lines": Interviews with genetic counselors and their colleagues on the need for regulation in Quebec.

In Canada, the field of genetic counseling is rapidly evolving alongside the increasing integration of and demand for genetics in healthcare practice. In tandem, there is a growing body of literature advocating for the regulation of genetic counseling, as legal recognition can protect patients from potential risk of harm and provide counselors with support by legally defining their roles and duties. However, there is a need for empirical qualitative research regarding the risks and challenges associated with the current lack of regulation to help inform these discussions. This article presents findings from 23 interviews with genetic counselors and their professional healthcare colleagues in Quebec. Themes were identified via interdisciplinary social scientific and legal content analysis. Notably, all participants were in favor of regulation, for varied reasons. Participant responses highlighted legal, organizational, and structural risks and challenges associated with the lack of legal recognition. First, the lack of role clarity creates issues with genetic counselors' working relationships and public recognition. Second, the autonomy of practitioners varies significantly, raising risks of liability and clinical preparedness when counselors have high autonomy or perform controlled acts. Third, the lack of recognition ultimately exacerbates structural strains on delivery and access to care. Results indicate that legal recognition stands to foster safer and more efficient provision of genetics services by increasing public awareness, instituting title protection and accountability mechanisms, clarifying professional scope, and mitigating liability risks. To the best of our knowledge, this is the first qualitative study to bring practicing stakeholders from across genetics services to the discussion on the lack of regulation of genetic counseling. Findings support the continued pursuit of legal recognition in Quebec and can inform similar initiatives in other jurisdictions.

Never Say “NO” (Strategies for Nurses to Communicate Politely)

Effective communication is the cornerstone of quality patient care and nurses are essential in fostering understanding, compassion, and respect in their interactions with patients, families, and other healthcare professionals. In the current healthcare system, one of the frequent complaints that patients express on post-discharge satisfaction surveys is rude behavior of the staff. By directly saying “NO”, nurses make patients to feel unwanted and neglected. Many times, this neglect has landed in the loss of patient attachment and lead to an increased risk of liability and dissatisfaction. In this article the impact of saying no to the patient and alternative strategiesof saying no has been discussed

Advancements and limitations in integrating robotics into medicine: A comprehensive review

The integration of robotics into medicine represents a groundbreaking advancement with transformative potential across various medical domains. This comprehensive review delves into both the remarkable advancements and the significant limitations associated with this integration. Advancements in robotic medicine include precision surgery, which facilitatesintricate procedures with enhanced accuracy and minimal invasiveness. Robotic systems enable teleoperation, allowing surgeons to perform procedures remotely, and expanding access to specialized care. Enhanced imaging and navigation capabilities further augment surgical precision and efficiency. Additionally, robotics play a vital role in rehabilitation therapy, aiding in personalized patient recovery. However, these advancements have substantial limitations. The cost of acquiring and maintaining robotic systems poses a significant barrier to widespread adoption, particularly in resource-constrained healthcare settings. Moreover, mastering robotic surgical techniques demands extensive training, contributing to a steep learning curve for healthcare professionals. Technical challenges such as system reliability and interoperability also present hurdles to seamless integration. Ethical considerations surrounding patient autonomy, accountability, and data privacy must be carefully addressed. Legal frameworks and regulatory standards are essential to ensure patient safety and mitigate liability risks associated with robotic-assisted interventions. Furthermore, disparities in access to robotic technology may exacerbate existing healthcare inequalities. Addressing these limitations requires concerted efforts from healthcare stakeholders, policymakers, and technology developers. Collaborative initiatives are needed to overcome financial, educational, technical, ethical, and regulatory barriers to integrating robotics into mainstream medical practice. By navigating these challenges, the full potential of robotics in medicine can be realized, ushering in an era of enhanced precision, efficiency, and accessibility in healthcare delivery.

인공지능의 민사책임에 대한 소고

The recent development of artificial intelligence (AI) technology is bringing about changes at a faster pace and on a larger scale than any other period in human history. With technological advancements overcoming the limitations of medical AI through training with databases, AI technology has made remarkable progress since the inception of deep learning for image processing with convolutional neural networks (CNN) in 2012. The recent advancements in natural language processing (NLP) have accelerated the utilization of AI through sophisticated natural language processing, enabling machines to identify and understand data regardless of the complexity of the language. This has laid the foundation for the rapid and precise development of generative AI. In the era where generative AI is being utilized without pausing in its developmental speed, we considered the civil liability of AI in our civil law principles, taking into account the inherent characteristics of AI such as unpredictability, opacity, and the black box effect. To do this, we first examined the legal liability considering the stages of AI technology development in discussing the tort liability caused by AI. Even “Weak AI,” created by AI developers, may fall under “Gefahr,” and while not all types, some may apply to strict liability in terms of risk liability. Furthermore, while reviewing civil liability applicable to AI under fault-based and no-fault liability, we also looked at the trends in the EU comparatively. In discussing no-fault liability, particularly under the Product Liability Act, we examined the possibility and implications of applying risk liability to pharmaceutical manufacturing using generative AI technology as a representative example to overcome the limitations of the existing Product Liability Act. Humanity currently lives in an era of rapid technological development and exploding big data, enjoying numerous benefits due to these advancements. As user convenience improves and massive added value is created through technological progress, the meaning of risk liability in the realm of civil liability can gain more significance. Generative AI has already drastically reduced the costs and time required for new drug development, providing substantial profits to pharmaceutical companies. However, even if the existing Product Liability Act is applied, it may be difficult to adequately remedy the harm to victims due to the reasonable alternative possibility defense regarding design defects. In the era of generative AI, we examined the possibility of applying enhanced risk liability by assuming the case of pharmaceutical manufacturing.

Identification of Ethical Issues and Practice Recommendations Regarding the Use of Robotic Coaching Solutions for Older Adults: Narrative Review.

Technological advances in robotics, artificial intelligence, cognitive algorithms, and internet-based coaches have contributed to the development of devices capable of responding to some of the challenges resulting from demographic aging. Numerous studies have explored the use of robotic coaching solutions (RCSs) for supporting healthy behaviors in older adults and have shown their benefits regarding the quality of life and functional independence of older adults at home. However, the use of RCSs by individuals who are potentially vulnerable raises many ethical questions. Establishing an ethical framework to guide the development, use, and evaluation practices regarding RCSs for older adults seems highly pertinent. The objective of this paper was to highlight the ethical issues related to the use of RCSs for health care purposes among older adults and draft recommendations for researchers and health care professionals interested in using RCSs for older adults. We conducted a narrative review of the literature to identify publications including an analysis of the ethical dimension and recommendations regarding the use of RCSs for older adults. We used a qualitative analysis methodology inspired by a Health Technology Assessment model. We included all article types such as theoretical papers, research studies, and reviews dealing with ethical issues or recommendations for the implementation of these RCSs in a general population, particularly among older adults, in the health care sector and published after 2011 in either English or French. The review was performed between August and December 2021 using the PubMed, CINAHL, Embase, Scopus, Web of Science, IEEE Explore, SpringerLink, and PsycINFO databases. Selected publications were analyzed using the European Network of Health Technology Assessment Core Model (version 3.0) around 5 ethical topics: benefit-harm balance, autonomy, privacy, justice and equity, and legislation. In the 25 publications analyzed, the most cited ethical concerns were the risk of accidents, lack of reliability, loss of control, risk of deception, risk of social isolation, data confidentiality, and liability in case of safety problems. Recommendations included collecting the opinion of target users, collecting their consent, and training professionals in the use of RCSs. Proper data management, anonymization, and encryption appeared to be essential to protect RCS users' personal data. Our analysis supports the interest in using RCSs for older adults because of their potential contribution to individuals' quality of life and well-being. This analysis highlights many ethical issues linked to the use of RCSs for health-related goals. Future studies should consider the organizational consequences of the implementation of RCSs and the influence of cultural and socioeconomic specificities of the context of experimentation. We suggest implementing a scalable ethical and regulatory framework to accompany the development and implementation of RCSs for various aspects related to the technology, individual, or legal aspects.

Trustee personal liability for contaminated land remediation: the UK position

Abstract Part IIA of the Environmental Protection Act 1990 creates a liability risk for trusts and trustees. Trustees may indeed be found liable pursuant to Part IIA’s definition of an “owner” of contaminated land. This definition includes trustees to avoid the situation of people evading liability by transferring affected land into trust funds. However, the risk to trustees is sufficiently low. The law shows that trustees possess a lien over their trust funds that can be used to indemnify liabilities. Furthermore, Part IIA’s proportionate approach to sustainable development considers the “hardship” that liability can cause to trustees and obviates the risk.

Preclinical Evaluation of JAB-2485, a Potent AURKA Inhibitor with High Selectivity and Favorable Pharmacokinetic Properties.

As a critical mitotic regulator, Aurora kinase A (AURKA) is aberrantly activated in a wide range of cancers. Therapeutic targeting of AUKRA is a promising strategy for the treatment of solid tumors. In this study, we evaluated the preclinical characteristics of JAB-2485, a small-molecule inhibitor of AURKA currently in Phase I/IIa clinical trial in the US (NCT05490472). Biochemical studies demonstrated that JAB-2485 is potent and highly selective on AURKA, with subnanomolar IC50 and around 1500-fold selectivity over AURKB or AURKC. In addition, JAB-2485 exhibited favorable pharmacokinetic properties featured by low clearance and good bioavailability, strong dose-response relationship, as well as low risk for hematotoxicity and off-target liability. As a single agent, JAB-2485 effectively induced G2/M cell cycle arrest and apoptosis and inhibited the proliferation of small cell lung cancer, triple-negative breast cancer, and neuroblastoma cells. Furthermore, JAB-2485 exhibited robust in vivo antitumor activity both as monotherapy and in combination with chemotherapies or the bromodomain inhibitor JAB-8263 in xenograft models of various cancer types. Together, these encouraging preclinical data provide a strong basis for safety and efficacy evaluations of JAB-2485 in the clinical setting.

Legal Regulation оf Insurance оf Clinical Trials оf Medicinal Products іn Ukraine

The article examines the current state and prospects of development of insurance for clinical trials of medicinal products in Ukraine, and also substantiates the need to introduce certain types of insurance in this area. As a result of a systematic analysis of current legislation, scientific literature and international acts, the author classifies persons participating in clinical trials of medicinal products into: 1) clinical trial subjects and 2) participants of such a scientific and medical experiment. In addition, the author outlines the main risks that arise for individual trial participants throughout the entire dynamics of clinical trials of medicines and proposes to minimize them by: changing the regulatory approach to making insurance mandatory by clarifying the subject matter of the insurance contract (insurance of liability of the investigator and sponsor of clinical trials); introduction of property insurance and liability insurance of manufacturers of medicinal products with state support; introduction of professional liability insurance of the investigator/co-investigator of clinical trials of medicinal products; introduction of insurance of investment and financial risks in the field of clinical trials of medicinal products with state support. It is also established that the peculiarities of the legal status of clinical trial participants, the specifics of their interests, and the need to participate in the trial influence the formation of the theory of multiple risks arising in the course of a clinical trial of a medicinal product and can be manifested as cases with negative consequences. The theory of multiple risks makes it possible to group them into different areas depending on the criterion of personalization (status of a person participating in a medical experiment: subject/ participant): 1) personal risks; 2) property risks; 3) liability risks.

Professionalization of Clinical Ethics Consultants: A Need for Liability Protection?

Clinical Ethics Consultation (CEC) has grown significantly in the last decade, and efforts are being made to professionalize the practice. The American Society for Bioethics and Humanities (ASBH) has been instrumental in this process, having published the Code of Ethics and Professional Responsibilities for Healthcare Ethics Consultants and founded and endorsed the creation of the Healthcare Ethics Consultant Certified (HCEC) Certification Commission. The ASBH also published "core competencies" for healthcare ethics consultants and has delineated a clear identity and role of such consultants distinct from that other healthcare professionals. In addition, more enter the field armed with advanced degrees (MA and PhD) or certification in clinical ethics consultation. While some have questioned the trend toward professionalization, the momentum is clearly in its favor. This paper explores three questions: Does the professionalization of healthcare ethics consultation expose those engaged in the field to the types of liability claims faced by professionals in other fields? What specific liabilities could affect a healthcare ethics consultant? And finally, what should healthcare ethics consultants do to protect themselves against liability claims? We conclude that while the risk of liability remains low, those engaged in the field should accept that risk just as part of their status as professionals and, like those in allied professions, seek appropriate protection in the form of liability insurance.

Green orthodontics - A review article

Eco-friendly dentistry often known as green dentistry, is a wellness-based dental practice that uses cutting-edge technology, conserves energy, money, and minimizes waste and pollution. In the course of their work, dentists employ a wide range of materials and tools, some of which could pose environmental risks. It is the duty of dentists to take several safety measures to guarantee that patients, employees, and the surroundings are safeguarded. Green dentistry increases the environmental awareness among dental professionals. This review article identifies the common wastes produced by dentistry and recommendations for reducing the environmental effect that can ensure patients as well as worker safety and prevent the risk of future liability which help in protecting our air, water and land.

Exploring the multifaceted potential of (R)-ketamine beyond antidepressant applications.

(R, S)- and (S)-ketamine have made significant progress in the treatment of treatment-resistant depression (TRD) and have become a research focus in recent years. However, they both have risks of psychomimetic effects, dissociative effects, and abuse liability, which limit their clinical use. Recent preclinical and clinical studies have shown that (R)-ketamine has a more efficient and lasting antidepressant effect with fewer side effects compared to (R, S)- and (S)-ketamine. However, a recent small-sample randomized controlled trial found that although (R)-ketamine has a lower incidence of adverse reactions in adult TRD treatment, its antidepressant efficacy is not superior to the placebo group, indicating its antidepressant advantage still needs further verification and clarification. Moreover, an increasing body of research suggests that (R)-ketamine might also have significant applications in the prevention and treatment of medical fields or diseases such as cognitive disorders, perioperative anesthesia, ischemic stroke, Parkinson's disease, multiple sclerosis, osteoporosis, substance use disorders, inflammatory diseases, COVID-19, and organophosphate poisoning. This article briefly reviews the mechanism of action and research on antidepressants related to (R)-ketamine, fully revealing its application potential and development prospects, and providing some references and assistance for subsequent expanded research.

Bleeding Control Protections Within US Good Samaritan Laws.

In the United States, all 50 states and the District of Columbia have Good Samaritan Laws (GSLs). Designed to encourage bystanders to aid at the scene of an emergency, GSLs generally limit the risk of civil tort liability if the care is rendered in good faith. Nation-wide, a leading cause of preventable death is uncontrolled external hemorrhage. Public bleeding control initiatives aim to train the public to recognize life-threatening external bleeding, perform life-sustaining interventions (including direct pressure, tourniquet application, and wound packing), and to promote access to bleeding control equipment to ensure a rapid response from bystanders. This study sought to identify the GSLs in each state and the District of Columbia to identify what type of responder is covered by the law (eg, all laypersons, only trained individuals, or only licensed health care providers) and if bleeding control is explicitly included or excluded in their Good Samaritan coverage. Good Samaritan Laws providing civil liability qualified immunity were identified in all 50 states and the District of Columbia. One state, Oklahoma, specifically includes bleeding control in its GSLs. Six states - Connecticut, Illinois, Kansas, Kentucky, Michigan, and Missouri - have laws that define those covered under Good Samaritan immunity, generally limiting protection to individuals trained in a standard first aid or resuscitation course or health care clinicians. No state explicitly excludes bleeding control from their GSLs, and one state expressly includes it. Nation-wide across the United States, most states have broad bystander coverage within GSLs for emergency medical conditions of all types, including bleeding emergencies, and no state explicitly excludes bleeding control interventions. Some states restrict coverage to those health care personnel or bystanders who have completed a specific training program. Opportunity exists for additional research into those states whose GSLs may not be inclusive of bleeding control interventions.

소위 ‘약한 인공지능(AI)’ 영역에서의 민사책임에 관한 연구

Now, the core of the discussion is how artificial intelligence (AI), as a rapidly developing advanced technology, can solve many of the most difficult problems facing humanity beyond solving severe social problems. Therefore, the true value of artificial intelligence (AI) as a cutting-edge technology is to solve huge problems facing humanity, such as social problems such as gun violence, food shortages, incurable diseases, and global warming caused by carbon emissions, and to contribute to human development. The concern, though, is that no one knows exactly how current artificial intelligence (AI) works. In other words, it is similar to developing a bomb that does not know when it will explode without a safety device.
 Already, artificial intelligence (AI) is causing damage by providing false information. So, if we don't know how to control better artificial intelligence (AI) when it appears, dangerous things can happen. Therefore, there will be a need for international norms on artificial intelligence (AI), which will be made possible by international treaties. The European Union has already enacted the AI Act as the first regulatory law on AI. This contains stronger regulations on the AI industry than in the United States or Asia. In particular, the Act stipulates the obligation to display AI-generated content. Thus, the EU's AI regulation law can be evaluated as legislation designed to ensure the safety of AI-generated products, such as cars and toys. In addition, in September 2022, the European Union (EU) issued a directive on AI accountability. It focuses on the legal principles of compensation for damages caused by artificial intelligence (AI). 
 Legislation on punitive damages for deepfake harms is required. As a civil liability, the victim's damages should be recognized not only for mental damages, but also for aggravated damages for monetary damages, if any. As such a legislative measure, so-called punitive damages should be introduced for malicious and deliberate use of artificial intelligence (AI) as a perpetrator. In the so-called risk liability of artificial intelligence (AI), the operator of artificial intelligence (AI), which has enormous profits through the operation of the risk source, will have to bear the risk liability as a no-fault liability. Korea's product liability law has embraced this principle of risk liability. In order for product liability law to apply to artificial intelligence (AI), there must be a defect in the artificial intelligence (AI) installed in the product.

Financial liability risks arising from the impact of economic actors on biodiversity

Financial liability risks arising from the impact of economic actors on biodiversity

О проблеме дисбаланса рисков ответственности и вознаграждения финансового управляющего по делам о несостоятельности (банкротстве) граждан

The article shows the problem of imbalance of high liability risks and the amount of remuneration of a financial receiver as a reason for refusal to get involved in personal bankruptcy cases. The author evaluates the explanation of the Supreme Court of the Russian Federation that a citizen may be released of any debts if no candidate to the receiver position is submitted to court. The paper points out that such explanation can be used in exceptional cases only.

Credit term structure and corporate indebtedness

At present, one of the major issues that seriously plague the high-quality development of the real economy globally is the current prevalence of high indebtedness and high leverage, as well as the financing problems of manufacturing enterprises. This paper empirically investigates the extent of the impact of bank credit term structure on corporate indebtedness and its mechanism using Chinese provincial panel data from 2003-2020 as the research sample. The results show that, firstly, long-term bank credit term structure can reduce corporate liabilities and mitigate corporate liability risks, and this result still holds after endogeneity analysis and robustness tests such as lagging credit term structure by one period, using instrumental variable method, and replacing explanatory variables. Second, income effect and innovation effect are two important mechanisms by which credit term structure affects corporate liabilities. Finally, the heterogeneity results show that the credit term structure of firms in the central and western regions has a more pronounced effect on corporate indebtedness than in the eastern regions. Therefore, this paper suggests optimizing the credit term structure, promoting the effective support of credit for the sustainable development of the real economy, taking full account of regional differences, and creating a more favorable environment for enterprise financing and development.

Permanence and Liability: Legal Considerations on the Integration of Carbon Dioxide Removal into the EU Emissions Trading System

AbstractThis article examines how carbon dioxide (CO2) removal credits can be integrated into the European Union (EU) Emissions Trading System (ETS), focusing on questions of permanence and climate liability. It identifies challenges within the integration process and analyzes approaches from practice and literature to cultivate learning. These approaches apply different strategies to address the issue of permanence, including temporary credit issuance, granting credits once a certain number of carbon tonne-years have been accumulated, or issuing credits at the beginning of the project period and relying on liability instead. Drawing from the findings of this research, the article presents legal considerations that may inform a proposal for an EU legislative act on the integration of carbon removal credits into the EU ETS. It suggests that only credits issued for permanent CO2 removal should be integrated to ensure the environmental integrity of the system. Furthermore, the liability of the project operator should transfer to the Member State under certain conditions to make liability risks more predictable.

Reuse of Orthopaedic Equipment: Barriers and Opportunities.

» Reuse of orthopaedic equipment is one of many potential ways to minimize the negative impact of used equipment on the environment, rising healthcare costs and disparities in access to surgical care.» Barriers to widespread adoption of reuse include concerns for patient safety, exposure to unknown liability risks, negative public perceptions, and logistical barriers such as limited availability of infrastructure and quality control metrics.» Some low- and middle-income countries have existing models of equipment reuse that can be adapted through reverse innovation to high-income countries such as the United States.» Further research should be conducted to examine the safety and efficacy of reusing various orthopaedic equipment, so that standardized guidelines for reuse can be established.

Off-label drugs in otolaryngological practice against the background of legal conditions of Polish legislation.

<b><br>Introduction:</b> 'Off-label drug use' refers to the administration of drugs for unapproved indications or age groups, a different dosage or other form of administration. Considering the legal issues, there clearly exists a need to implement rules that would regulate the use of pharmaceuticals outside the scope of a marketing authorisation. The brevity and diversity of Polish laws in the field of health care leads to many interpretative doubts associated with particular legal acts.</br> <b><br>Aim:</b> We aimed to present clinical examples from everyday practice of off-label drug use from the medical and legal perspectives, and to support it with relevant legal acts.</br> <b><br>Material and method:</b> Off-label drug use in various otolaryngology subspecialties - otology (mesna), laryngology (bevacizumab, cidofovir and botulinum toxin) and head and neck surgery (botulinum toxin) - are presented and discussed in detail.</br> <b><br>Results:</b> Fourteen Polish legal acts regarding off-label drug use and 4 from EU legislation are commented on. The algorithm of cascade of decision-making processes in off-label drug use is shown.</br> <b><br>Conclusions:</b> Off-label use of medicinal products is not prohibited in Poland or the EU; nevertheless, it is undeniable that the unclear legal situation regarding the use of medicinal products for nonregistered indications creates difficulties. To minimise a doctor's liability risk, obtaining the informed consent from the patient for such treatment is advisable.</br&gt.