Bidirectional legal socialization and the boundaries of law: The case of enclave communities' compliance with COVID-19 regulations.
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ABSTRACT:
SUBMITTER: Barak-Corren N
PROVIDER: S-EPMC8242847 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The past decade has seen a significant rise in research on high-consequence human and animal pathogens, many now known as "select agents." While physical security around these agents is tightly regulated, information security standards are still lagging. The understanding of the threats unique to the academic and research environment is still evolving, in part due to poor communication between the various stakeholders. Perhaps as a result, information security guidelines published by select agent regulators lack the critical details and directives needed to achieve even the lowest security level of the Federal Information Security Management Act (FISMA). While only government agencies are currently required to abide by the provisions of FISMA (unless specified as preconditions for obtaining government grants or contracts--still a relatively rare or narrowly scoped occurrence), the same strategies were recently recommended by executive order for others. We propose that information security guidelines for select agent research be updated to promulgate and detail FISMA standards and processes and that the latter be ultimately incorporated into select agent regulations. We also suggest that information security in academic and research institutions would greatly benefit from active efforts to improve communication among the biosecurity, security, and information technology communities, and from a secure venue for exchange of timely information on emerging threats and solutions in the research environment.
| S-EPMC4486445 | biostudies-literature
Project description:The study of network topology provides insight into the function and behavior of physical, social, and biological systems. A natural step towards discovering the organizing principles of these complex topologies is to identify a reduced network representation using cohesive subgroups or communities. This procedure often uncovers the underlying mechanisms governing the functional assembly of complex networks. A community is usually defined as a subgraph or a set of nodes that has more edges than would be expected from a simple, null distribution of edges over the graph. This view drives objective such as modularity. Another perspective, corresponding to objectives like conductance or density, is that communities are groups of nodes that have extremal properties with respect to the number of internal edges and cut edges. Here we show that identifying community boundaries rather than communities results in a more accurate decomposition of the network into informative components. We derive a network analog of Gauss's law that relates a measure of flux through a subgraph's boundary to the connectivity among the subgraph's nodes. Our Gauss's law for networks naturally characterizes a community as a subgraph with high flux through its boundary. Aggregating flux over these boundaries gives rise to a Laplacian and forms the basis of our "Laplacian modularity" quality function for community detection that is applicable to general network types. This technique allows us to determine communities that are both overlapping and hierarchically organized.
| S-EPMC6085300 | biostudies-literature
Project description:Hepatic encephalopathy, a form of brain dysfunction seen in the setting of liver insufficiency, negatively affects driving performance and so is both a patient and public safety issue. We aimed to review the motor vehicle codes in each Canadian province and territory relating to the reporting of patients with hepatic encephalopathy and to search a Canadian legal database for cases of motor vehicle collisions involving patients with hepatic encephalopathy. In this descriptive analysis, the transportation agencies of each Canadian province and territory were contacted via telephone and/or email between April and August 2017. Requirements of physicians to report medical conditions (including liver disease and hepatic encephalopathy) affecting a patient's fitness to drive were assessed. WestlawNext Canada was searched for any Canadian cases on hepatic encephalopathy and driving-related lawsuits from inception to Dec. 31, 2017. Reporting of medically unfit drivers is a requirement in all Canadian provinces and territories except Alberta, Quebec and Nova Scotia. Hepatic encephalopathy, cirrhosis and advanced liver disease were not specifically identified as reportable medical conditions in any province or territory. Our search did not identify any lawsuits involving a motor vehicle collision in Canada that were made either against physicians caring for patients with hepatic encephalopathy or against such patients themselves. Although hepatic encephalopathy has a substantial impact on driving performance, it is not specifically identified as a reportable medical condition in Canada. Increasing awareness of the potential impact of hepatic encephalopathy on safe driving for health care providers and the public is critical.
| S-EPMC6277253 | biostudies-other
Project description:BACKGROUND:Implementing an accredited quality and patient safety management system is inevitable for hospitals. Even in the case of an obligatory rule system, different approaches to implement such a system can be used: coercive (based on monitoring and threats of punishment) and catalytic (based on dialogue and suggestion). This study takes these different approaches as a starting point to explore whether and how implementation actions are linked to compliance. By doing so, this study aims to contribute to the knowledge on how to increase compliance with obligatory rules and regulations. METHODS:The internal audit system (the 'tracer system') of a large Dutch academic hospital is used as a case to investigate different implementation approaches and their effect on compliance. This case allowed us to use a multi-actor and multi-method approach for data collection. Internal audits (N?=?16) were observed, audit reports were analyzed, and semi-structured interviews were conducted with both the internal auditors (N?=?23) and the ward leaders (N?=?14) responsible for compliance. Framework analysis was used to analyze the data. RESULTS:Although all auditors use catalytic enforcement actions, these do not lead to (intended) compliance of all ward leaders. Rather, the catalytic actions contribute to (intended) compliance of ward leaders that are motivated, whereas they do not for the ward leaders that are not motivated. For the motivated ward leaders, catalytic enforcement actions contribute to (intended) compliance by increasing ward leaders' knowledge of the rules and how to comply with them. CONCLUSIONS:Our findings suggest that the effectiveness of implementation actions depends not only on the actions themselves, but also on the pre-existing motivation to comply. These findings imply that there is not one 'best' approach to the implementation of obligatory rules. Rather, the most effective approach depends on the willingness to comply with rules and regulations.
| S-EPMC5791382 | biostudies-literature
Project description:BACKGROUNDLaw purports to regulate end-of-life care but its role in decision-making by doctors is not clear. This paper, which is part of a three-year study into the role of law in medical practice at the end of life, investigates whether law affects doctors' decision-making. In particular, it considers whether the fact that the law differs across Australia's three largest states - New South Wales (NSW), Victoria and Queensland - leads to doctors making different decisions about withholding and withdrawing life-sustaining treatment from adults who lack capacity.METHODSA cross-sectional postal survey of the seven specialties most likely to be involved in end-of-life care in the acute setting was conducted between 18 July 2012 and 31 January 2013. The sample comprised all medical specialists in emergency medicine, geriatric medicine, intensive care, medical oncology, palliative medicine, renal medicine and respiratory medicine on the AMPCo Direct database in those three Australian states. The survey measured medical specialists' level of legal compliance, and reasons for their decisions, concerning the withholding or withdrawal of life-sustaining treatment. Multivariable logistic regression was used to examine predictors of legal compliance. Linear regression was used to examine associations between the decision about life-sustaining treatment and the relevance of factors involved in making these decisions, as well as state differences in these associations.RESULTSResponse rate was 32% (867/2702). A majority of respondents in each state said that they would provide treatment in a hypothetical scenario, despite an advance directive refusing it: 72% in NSW and Queensland; 63% in Victoria. After applying differences in state law, 72% of Queensland doctors answered in accordance with local law, compared with 37% in Victoria and 28% in NSW (p?<?0.001). Doctors reported broadly the same decision-making approach despite differences in local law.CONCLUSIONSLaw appears to play a limited role in medical decision-making at the end of life with doctors prioritising patient-related clinical and ethical considerations. Different legal frameworks in the three states examined did not lead to different decisions about providing treatment. More education is needed about law and its role in this area, particularly where law is inconsistent with traditional practice.
| S-EPMC5704501 | biostudies-literature
Project description:BackgroundThe use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance.MethodsTwenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes.ResultsThe major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size.ConclusionThe Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.
| S-EPMC1524757 | biostudies-literature
Project description:The term harassment is often used to refer two contexts, the workplace and school, but not the legal system itself. Long drawn-out litigation in the Family Law Courts often produces a surreptitious phenomenon of violence toward one of the litigating parties, who become victims of the legal system itself. The aim of this study was to determine whether legal harassment could be detected and measured in the Spanish Justice System using an innovative Legal Harassment Scale (LHS). This hypothesis was substantiated by the data obtained using a new 32-item psychometric instrument with a global index: the LHS, consisting of four factors: Direct Aggression, Procedural Harassment, Personal Contempt, and Manipulation of Reality. The estimated reliability and validity of the LHS was satisfactory, both in terms of the global score, and for each of the four factors distributed along the normal curve. The results of this study are discussed in terms of the limitations of the study and in relation to future lines of research aimed at ensuring that the legal system respects and safeguards the rights of the parties involved in litigation, and that no party falls victim to legal harassment.
| S-EPMC6345693 | biostudies-literature
Project description:AimsWe profile the lack of specific regulation for direct-to-patient postal supply (DTP) of clinical trial medications (investigational medicinal products, IMPs) calling for increased efficiency of patient-centred multi-country remote clinical trials.MethodsQuestionnaires emailed to 28 European Economic Area (EEA) Medical Product Licensing Authorities (MPLAs) and Swissmedic MPLA were analysed in 2019/2020. The questionnaire asked whether DTP of IMPs was legal, followed by comparative legal analysis profiling relevant national civil and criminal liability provisions in 30 European jurisdictions (including The Netherlands), finally summarising accessible COVID-19-related guidance in searches of 30 official MPLA websites in January 2021.ResultsTwenty MPLAs responded. Twelve consented to response publication in 2021. DTP was not widely authorised, though different phrases were used to explain this. Our legal review of national laws in 29 EEA jurisdictions and Switzerland did not identify any specific sanctions for DTP of IMPs; however, we identified potential national civil and criminal liability provisions. Switzerland provides legal clarity where DTP of IMPs is conditionally legal. MPLA webpage searches for COVID-19 guidance noted conditional acceptance by 19 MPLAs.ConclusionsSpecific national legislation authorising DTP of IMPs, defining IMP categories, and conditions permitting the postage and delivery by courier in an EEA-wide clinical trial, would support innovative patient-centred research for multi-country remote clinical trials. Despite it appearing more acceptable to do this between EU Member States, provided each EU MPLA and ethics board authorises it, temporary Covid-19 restrictions in national Good Clinical Practice (GCP) guidance discourages innovative research into the safety and effectiveness of clinical trial medications.
| S-EPMC9293225 | biostudies-literature
Project description:OBJECTIVE:The purpose of this study was to measure compliance with age and personal ID regulations by state-licensed recreational marijuana stores in two states. METHOD:Recreational marijuana stores (N = 175) in Colorado and Washington State were each visited twice by pseudo-buyer assessment teams in September 2016 to April 2017. The observer entered the store first, performed an environmental scan, and observed the buyer's purchase behavior. In both Washington State visits and in the first visit in Colorado, a young-adult buyer attempted to enter the store and purchase marijuana without showing a state-approved ID (i.e., valid driver's license). In the second Colorado visit, a buyer age 18-20 showed an underage driver's license and attempted to enter the store and purchase marijuana. RESULTS:All stores (100%) requested an ID. Stores refused buyers in 73.6% of visits at the entrance, 88.3% cumulative before the counter, and 92.6% by the time of a purchase attempt. Refusal was lower in Washington State (at entry, 53.1%; before the counter, 80.5%; and at purchase attempt, 86.6%) than in Colorado (at entry, 95.3%, p < .01; before the counter, 96.5%, p < .01; and at purchase attempt, 98.8%, p < .01), but it did not differ by buyer protocol (p > .05). CONCLUSIONS:Compliance with laws restricting marijuana sales to individuals 21 or older with a valid ID was high. Compliance in Washington State might be improved by having store personnel check IDs at the store entry. Although recreational stores may not be selling marijuana directly to youth, no information was collected on straw purchases.
| S-EPMC6900993 | biostudies-literature
Project description:ImportanceAlthough federal law has long promoted patients' access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process.ObjectiveTo evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access.Design, setting, and participantsA cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017 US News & World Report Best Hospitals National Rankings.ExposuresScripted interview with medical records departments in a single-blind, simulated patient experience.Main outcomes and measuresRequestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments.ResultsAmong the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for processing times.Conclusions and relevanceThe study revealed that there are discrepancies in the information provided to patients regarding the medical records release processes and noncompliance with federal and state regulations and recommendations. Policies focused on improving patient access may require stricter enforcement to ensure more transparent and less burdensome medical records request processes for patients.
| S-EPMC6324595 | biostudies-literature