FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States.

Diagnosing infectious diseases significantly influences patient care, aiding in outbreak identification, response, and public health monitoring. However, the range of FDA-approved molecular tests remains notably limited, especially concerning neglected tropical diseases (NTDs). Drawing upon our experience as one of the largest healthcare networks in the greater New York metropolitan area, this viewpoint manuscript aims to spotlight the existing diagnostic landscape and unmet clinical needs for 4 emerging NTDs increasingly prevalent in the United States, additionally, it delves into the possible adverse effects of the FDA's Proposed Rule on Laboratory-Developed Tests for these clinical conditions and the broader spectrum of NTDs.

Certificate of Need Laws in Health Care: Past, Present, and Future.

Certificate of need (CON) laws limit the supply of health care services in about two-thirds of U.S. states. The regulations require those who wish to offer new services or expand existing services to first prove to a regulator that the care is needed. While advocates for the regulation have offered several rationales for its continuance, the balance of evidence suggests that the rules protect incumbent providers from competition at the expense of patients, payors, and would-be competitors. In this article, I review the history of CON laws in health care, summarize the large literature evaluating them, and briefly sketch options for reform.JEL Classification: I11, I18, H75.

Prevention of infective endocarditis in at-risk patients: how should dentists proceed in 2024?

National Institute for Health and Care Excellence (NICE) guidelines are ambiguous over the need for patients at increased risk of infective endocarditis (IE) to receive antibiotic prophylaxis (AP) prior to invasive dental procedures (IDPs), and this has caused confusion for patients and dentists alike. Moreover, the current law on consent requires clinicians to ensure that patients are made aware of any material risk they might be exposed to by any proposed dental treatment and what can be done to ameliorate this risk, so that the patient can decide for themselves how they wish to proceed. The aim of this article is to provide dentists with the latest information on the IE-risk posed by IDPs to different patient populations (the general population and those defined as being at moderate or high risk of IE), and data on the effectiveness of AP in reducing the IE risk in these populations. This provides the information dentists need to facilitate the informed consent discussions they are legally required to have with patients at increased risk of IE about the risks posed by IDPs and how this can be minimised. The article also provides practical information and advice for dentists on how to manage patients at increased IE risk who present for dental treatment.

[On-line pornography and minors. Diagnosis, challenges and proposals]. / Pornografía on-line y menores. Diagnóstico, desafíos y propuestas.

The consumption of pornography over the Internet by minors has been increasing exponentially in recent years. The use of digital technologies and the ease of access to these contents are causes that explain this event. Simultaneously, there is concern about the increase in sexual violence, associated with discriminatory behavior, despite the efforts of laws and programs that promote sexual reproductive health (SRH) and the principle of equality. From a bioethical point of view, it is urgent to address this issue, which affects the physical and psychological health of minors and their affective-sexual education. The study addresses whether it is possible to relate the consumption of online pornography by minors and sexual violence. To do this, legal sources, reports from associations, audiovisual councils and scientific studies are consulted. In all of them, the relationship between the consumption of online pornography by adolescents and risky behavior in emotional-sexual matters and gender inequality is evident. In the legal and fiscal sphere, it is alerted to the damage that is occurring and points out the need to propose lines of action that reverse this situation. We propose measures to technically regulate access to content. These measures are based on the precautionary principle, a tool that has been applied in fields such as health and the environment. More studies and political actions are needed to make the Internet a safe place for minors.

Tobacco policies and changes in the tendency of smoking cessation in cigarette users in Chile: a longitudinal cross-sectional study.

OBJECTIVE: To assess the impact of tobacco control regulations and policy implementation on smoking cessation tendencies in cigarette users born between 1982 and 1991 in Chile. DESIGN: Longitudinal cross-sectional study. SETTING: National level. PARTICIPANTS: Data from the National Survey of Drug Consumption (Service of Prevention and Rehabilitation for Drug and Alcohol Consumption). A pseudo-cohort of smokers born between 1982 and 1991 (N=17 905) was tracked from 2002 to 2016. PRIMARY AND SECONDARY OUTCOMES MEASURES: Primary outcome was the tendency to cease smoking conceptualised as the report of using cigarettes 1 month or more ago relative to using cigarettes in the last 30 days. The main exposure variable was the Tobacco Policy Index-tracking tobacco policy changes over time. Logistic regression, controlling for various factors, was applied. RESULTS: Models suggested a 14% increase in the smoking cessation tendency of individuals using cigarettes 1 month or more ago relative to those using cigarettes in the last 30 days (OR 1.14, CI 95% CI 1.10 to 1.19) for each point increment in the Tobacco Policy index. CONCLUSIONS: Our study contributes to documenting a positive impact of the implementation of interventions considered in the MPOWER strategy in the progression of smoking cessation tendencies in smokers born between 1982 and 1991 in Chile.

Community Engagement, Jurisdictional Experience, and Previous Tobacco-Related Ordinances in Neighboring Communities as Drivers of Flavored Tobacco Bans in Los Angeles County.

We examined whether a community engagement approach and jurisdictional attributes were associated with local action to restrict the sale of flavored tobacco products in Los Angeles County during 2019-2022. We estimated crude and adjusted risk ratios to examine these associations. Jurisdictions that used an active community engagement approach to adopt a flavored tobacco ban ordinance, those with previous experience adopting other tobacco-related ordinances, and those located next to communities that have an existing tobacco retail license ordinance were more likely than jurisdictions without these attributes to adopt a new ordinance to restrict the sale of flavored tobacco products. Efforts to adopt such an ordinance were generally more successful in jurisdictions where community members were engaged and policy makers were familiar with the adoption of public health ordinances.

The development of a road safety policy index and its application in evaluating the effects of road safety policy.

The paper presents an exploratory study of a road safety policy index developed for Norway. The index consists of ten road safety measures for which data on their use from 1980 to 2021 are available. The ten measures were combined into an index which had an initial value of 50 in 1980 and increased to a value of 185 in 2021. To assess the application of the index in evaluating the effects of road safety policy, negative binomial regression models and multivariate time series models were developed for traffic fatalities, fatalities and serious injuries, and all injuries. The coefficient for the policy index was negative, indicating the road safety policy has contributed to reducing the number of fatalities and injuries. The size of this contribution can be estimated by means of at least three estimators that do not always produce identical values. There is little doubt about the sign of the relationship: a stronger road safety policy (as indicated by index values) is associated with a larger decline in fatalities and injuries. A precise quantification is, however, not possible. Different estimators of effect, all of which can be regarded as plausible, yield different results.

The effect of following best practice reporting recommendations on legal and community evaluations of forensic examiners reports.

Commentators have recommended that forensic scientists' reports contain various disclosures to facilitate comprehension. However, little research has explored whether following best practice recommendations for disclosure impacts on receivers' impressions of the evidence. We examined whether forensic science reports that are more compliant with these best practice recommendations reduced overvaluing of the evidence and sensitized legal and community decision-makers to evidence quality. Across three experiments, 240 legal practitioners/trainees and 566 community decision-makers were presented with a fingerprint or footwear report that was either compliant or non-compliant with best practice recommendations. Participants were then asked to make evaluations and decisions based on the report. We found mixed effects of report compliance. Report compliance affected community participant's evaluations of the persuasiveness of the evidence but had limited impact on the judgments of legal practitioners/trainees. When presented with compliant reports, we found that community participants regarded unknown reliability evidence as less reliable and less persuasive than high reliability evidence, suggesting disclosures helped reduce overvaluing of the evidence and create sensitivity to differences in evidence quality. These results suggest compliance with reporting recommendations does affect community impressions, while only minimally influencing legal impressions of forensic science evidence. The costs and/or benefits of this outcome require further examination.

When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

Interpreting results, impacts and implications from WHO FCTC tobacco control investment cases in 21 low-income and middle-income countries.

BACKGROUND: Tobacco control investment cases analyse the health and socioeconomic costs of tobacco use and the benefits that can be achieved from implementing measures outlined in the WHO Framework Convention on Tobacco Control (WHO FCTC). They are intended to provide policy-makers and other stakeholders with country-level evidence that is relevant, useful and responsive to national priorities and policy context. METHODS: This paper synthesises findings from investment cases conducted in Armenia, Cabo Verde, Cambodia, Chad, Colombia, Costa Rica, El Salvador, Eswatini, Georgia, Ghana, Jordan, Laos, Madagascar, Myanmar, Nepal, Samoa, Sierra Leone, Sri Lanka, Suriname, Tunisia and Zambia. We examine annual socioeconomic costs associated with tobacco use, focusing on smoking-related healthcare expenditures, the value of lives lost due to tobacco-related mortality and workplace productivity losses due to smoking. We explore potential benefits associated with WHO FCTC tobacco demand-reduction measures. RESULTS: Tobacco use results in average annual socioeconomic losses of US$95 million, US$610 million and US$1.6 billion among the low-income (n=3), lower-middle-income (n=12) and upper-middle-income countries (n=6) included in this analysis, respectively. These losses are equal to 1.1%, 1.8% and 2.9% of average annual national gross domestic product, respectively. Implementation and enforcement of WHO FCTC tobacco demand-reduction measures would lead to reduced tobacco use, fewer tobacco-related deaths and reduced socioeconomic losses. CONCLUSIONS: WHO FCTC tobacco control measures would provide a positive return on investment in every country analysed.

Advancing progress on tobacco control in low-income and middle-income countries through economic analysis.

BACKGROUND: More than 80% of the world's 1.3 billion tobacco users live in low-income and middle-income countries (LMICs), where progress to address tobacco and its harms has been slow. The perception that tobacco control detracts from economic priorities has impeded progress. The Secretariat of the WHO Framework Convention on Tobacco Control (FCTC) is leading the FCTC 2030 project, which includes technical assistance to LMICs to analyse the economic costs of tobacco use and the benefits of tobacco control. METHODS: The Secretariat of the WHO FCTC, United Nations Development Programme and WHO supported 21 LMICs between 2017 and 2022 to complete national investment cases to guide country implementation of the WHO FCTC, with analytical support provided by RTI International. These country-level cases combine customised estimates of tobacco's economic impact with qualitative analysis of socio-political factors influencing tobacco control. This paper overviews the approach, observed tobacco control advancements and learnings from 21 countries: Armenia, Cabo Verde, Cambodia, Chad, Colombia, Costa Rica, El Salvador, Eswatini, Georgia, Ghana, Jordan, Laos, Madagascar, Myanmar, Nepal, Samoa, Sierra Leone, Sri Lanka, Suriname, Tunisia and Zambia. RESULTS: Tobacco control advancements in line with investment case findings and recommendations have been observed in 17 of the 21 countries, and many have improved collaboration and policy coherence between health and economic stakeholders. CONCLUSIONS: Tobacco control must be seen as more than a health concern. Tobacco control leads to economic benefits and contributes to sustainable development. National investment cases can support country ownership and leadership to advance tobacco control.

An Anticipatory Approach to Ethico-Legal Implications of Future Neurotechnology.

This paper provides a justificatory rationale for recommending the inclusion of imagined future use cases in neurotechnology development processes, specifically for legal and policy ends. Including detailed imaginative engagement with future applications of neurotechnology can serve to connect ethical, legal, and policy issues potentially arising from the translation of brain stimulation research to the public consumer domain. Futurist scholars have for some time recommended approaches that merge creative arts with scientific development in order to theorise possible futures toward which current trends in technology development might be steered. Taking a creative, imaginative approach like this in the neurotechnology context can help move development processes beyond considerations of device functioning, safety, and compliance with existing regulation, and into an active engagement with potential future dynamics brought about by the emergence of the neurotechnology itself. Imagined scenarios can engage with potential consumer uses of devices that might come to challenge legal or policy contexts. An anticipatory, creative approach can imagine what such uses might consist in, and what they might imply. Justifying this approach also prompts a co-responsibility perspective for policymaking in technology contexts. Overall, this furnishes a mode of neurotechnology's emergence that can avoid crises of confidence in terms of ethico-legal issues, and promote policy responses balanced between knowledge, values, protected innovation potential, and regulatory safeguards.