The global health law trilogy: towards a safer, healthier, and fairer world.

Global health advocates often turn to medicine and science for solutions to enduring health risks, but law is also a powerful tool. No state acting alone can ward off health threats that span borders, requiring international solutions. A trilogy of global health law-the Framework Convention on Tobacco Control, International Health Regulations (2005), and Pandemic Influenza Preparedness Framework-strives for a safer, healthier, and fairer world. Yet, these international agreements are not well understood, and contain gaps in scope and enforceability. Moreover, major health concerns remain largely unregulated at the international level, such as non-communicable diseases, mental health, and injuries. Here, we offer reforms for this global health law trilogy.

Raising the Yellow Flag: State Variation in Quarantine Laws.

Quarantine is an important but often misused tool of public health. An effective quarantine requires a process that inspires trust in government, only punishes noncompliance, and promotes a culture of social responsibility. Accomplishing successful quarantine requires incentives and enabling factors, payments, job security, and a tiered enforcement plan. In this article, we examine the variation in state-level quarantine laws and assess the effectiveness of these laws and regulations. We find that most states allow for an individual to have a hearing (63%) and to have a voice in burial and cremation procedures (71%), yet are weak on all other individual rights measures. Only 20% of states have provisions to protect employment when an individual is under quarantine, and less than half have plans for safe and humane quarantines. Decision makers at the state and local levels must make a concerted effort to revise and update quarantine laws and regulations. Ideally, these laws and regulations should be harmonized so as to avoid confusion and disruption between states, and public health officials should work with populations to identify and address the factors that will support successful quarantines if they are ever required.

Funding Public Health Emergency Preparedness in the United States.

The historical precedents that support state and local leadership in preparedness for and response to disasters are in many ways at odds with the technical demands of preparedness and response for incidents affecting public health. New and revised laws and regulations, executive orders, policies, strategies, and plans developed in response to biological threats since 2001 address the role of the federal government in the response to public health emergencies. However, financial mechanisms for disaster response-especially those that wait for gubernatorial request before federal assistance can be provided-do not align with the need to prevent the spread of infectious agents or efficiently reduce the impact on public health. We review key US policies and funding mechanisms relevant to public health emergencies and clarify how policies, regulations, and resources affect coordinated responses.

Estimating the Size of the U.S. Population at Risk of Severe Adverse Events from Replicating Smallpox Vaccine.

OBJECTIVE: To quantify the population at risk of serious adverse reactions to replicating smallpox vaccine. DESIGN AND SAMPLE: Conditions known or suspected to carry risk were identified via Centers for Disease Control and Prevention planning documents, other federal publications, and peer-reviewed literature. Conditions identified were categorized as historically recognized risks or more recently recognized immunocompromised states that may pose risk. Major historical risk factors were as follows: eczema/atopic dermatitis, pregnancy, HIV, and primary immunodeficiency. More recently identified states were as follows: rheumatoid arthritis, inflammatory bowel disease, dialysis, bone marrow transplant recipients within 24 months post-transplant, solid-organ transplant recipients within 3 months post-transplant, age under 1 year, and systemic lupus erythematosus. MEASURES: The estimated prevalence or absolute number of affected individuals for each condition was ascertained from peer-reviewed studies, vital statistics, and registry databases. RESULTS: An estimated 48,121,280 to 50,028,045 individuals (15.2-15.8% of the U.S. population) are potentially contraindicated to replicating smallpox vaccine. This rises to 119,244,531 to 123,669,327 (37.4-38.8%) if household contacts are included. CONCLUSIONS: These figures are significant and larger than the only previously published study. Understanding this number allows for improved clinical utilization, equitable attention to the health needs of a vulnerable population, and strategic vaccine stockpiling.

Multifocal retinopathy in Dachshunds with CLN2 neuronal ceroid lipofuscinosis.

The CLN2 form of neuronal ceroid lipofuscinosis is an autosomal recessively inherited lysosomal storage disease that is characterized by progressive vision loss culminating in blindness, cognitive and motor decline, neurodegeneration, and premature death. CLN2 disease results from mutations in the gene that encodes the soluble lysosomal enzyme tripeptidyl peptidase-1. A null mutation in the TPP1 gene encoding this enzyme causes a CLN2-like disease in Dachshunds. Dachshunds that are homozygous for this mutation serve as a model for human CLN2 disease, exhibiting clinical signs and neuropathology similar to those of children with this disorder. Affected dogs reach end-stage terminal disease status at 10-11 months of age. In addition to retinal changes typical of CLN2 disease, a retinopathy consisting of multifocal, bullous retinal detachment lesions was identified in 65% of (TPP1-/-) dogs in an established research colony. These lesions did not occur in littermates that were heterozygous or homozygous for the normal TPP1 allele. Retinal changes and the functional effects of this multifocal retinopathy were examined objectively over time using ophthalmic examinations, fundus photography, electroretinography (ERG), quantitative pupillary light response (PLR) recording, fluorescein angiography, optical coherence tomography (OCT) and histopathology. The retinopathy consisted of progressive multifocal serous retinal detachments. The severity of the disease-related retinal thinning was no more serious in most detached areas than in adjacent areas of the retina that remained in close apposition to the retinal pigment epithelium. The retinopathy observed in these dogs was somewhat similar to canine multifocal retinopathy (CMR), a disease caused by a mutation of the bestrophin gene BEST1. ERG a-wave amplitudes were relatively preserved in the Dachshunds with CLN2 disease, whether or not they developed the multifocal retinopathy. The retinopathy also had minimal effects on the PLR. Histological evaluation indicated that the CLN2 disease-related retinal degeneration was not exacerbated in areas where the retina was detached except where the detached areas were very large. DNA sequence analysis ruled out a mutation in the BEST1 exons or splice junctions as a cause for the retinopathy. Perfect concordance between the TPP1 mutation and the retinopathy in the large number of dogs examined indicates that the retinopathy most likely occurs as a direct result of the TPP1 mutation. Therefore, inhibition of the development and progression of these lesions can be used as an indicator of the efficacy of therapeutic interventions currently under investigation for the treatment of CLN2 disease in the Dachshund model. In addition, these findings suggest that TPP1 mutations may underlie multifocal retinopathies of unknown cause in animals and humans.

Global approaches to tackling antimicrobial resistance: a comprehensive analysis of water, sanitation and hygiene policies.

BACKGROUND: Unsafe water, sanitation and hygiene (WASH) contributes to a high burden of disease and exacerbates factors that promote the development of antimicrobial resistance (AMR). Enforceable policies are foundational to curbing inappropriate use of antimicrobials and providing safe WASH. While many countries have established National Action Plans for AMR that include provisions for WASH, few have codified these plans into legally enforceable policy. Here, we provide a comprehensive map and describe the current regulatory environment for WASH. METHODS: We conducted a comprehensive analysis of the WASH-related policies in 193 countries. Policies were identified, collated, and categorised into a publicly available repository. RESULTS: A total of 672 policies met the criteria for inclusion in the dataset. No category of WASH-related policies had been adopted by all countries included in the study. Policy categories that were potentially more difficult to enforce in light of economic and governance limitations tended to be more prevalent and diverse, whereas policies in categories that were highly resource intensive and specific were less universal. Countries with gaps in policy categories also tended to be regionally clustered. While countries in the South Asian and European WHO regions had nearly universal policy coverage across all countries, the presence of policies was inconsistent across countries in the African and Eastern Mediterranean regions. CONCLUSION: While decision-makers should rely on knowing which policies work best to mitigate the burden of WASH-related disease and AMR development, they must first have a comprehensive understanding of the current regulatory environment. Researchers and decision-makers need to know which policies work best and under what circumstances. The global mapping of WASH policies, which may have implications for AMR development, serves as a foundation for future policy analysis for AMR.

Follow the money: a global analysis of funding dynamics for global health security.

Global financing for health security was dramatically impacted by COVID-19. Here, we provide an empirical analysis of how that funding changed. Using data from Global Health Security (GHS) Tracking (tracking.ghscosting.org), we analyzed disbursements of direct financial assistance for GHS from 2016 to 2022 to compare pre-pandemic funding (2016-2019) to post-pandemic funding (2020-2022) for preparedness and response during each of the seven World Health Organization-declared public health emergencies of international concern (PHEICs) from 2009 to 2022. Over $165B was disbursed for capacity-building and preparedness activities between January 2016 and December 2022, and over $76B was provided for PHEIC response. Preparedness funding remained evenly distributed since 2016 across regions, with the African region receiving about 70% of total preparedness funding. Indeed, how capacity-building and preparedness funding is distributed has changed remarkably little since 2016, despite unprecedented changes to the funding environment-including markedly increased spending-in response to COVID-19. This suggests we now have a unique opportunity to restructure how funds are tracked for accountability and assessing return on investment moving forward.

Digital health technology utilization is associated with enhanced patient perspectives of care.

BACKGROUND: Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores measure patient experience and perspectives on care. Novel health information technologies facilitate communication between patients and healthcare teams. Playback Health is a health information technology that incorporates multimedia for providers to communicate health information to patients, their support network, and their healthcare teams. We hypothesized implementing Playback Health may enhance patient perspectives on care. METHODS: HCAHPS scores were obtained retrospectively from a neurosurgical practice located in a metropolitan area between 2020 and 2022 for seven providers. Of these, four providers utilized Playback Health, and three did not. Individual providers' scores were compared between domains using two tailed t-tests at a significance level of p < 0.05. RESULTS: Playback Health use was associated with higher HCAHPS scores across varying domains from 2020 through 2022 as well as overall scores. In 2020, the mean overall score of HCAHPS users was higher than non-users (89.65 vs. 87.28, p = 0.0095). In 2021, again higher mean overall scores were observed in users as compared to non-users (89.11 vs. 87.79, p 0.0266). In 2022, Playback Health users maintained higher scores across communication domains and overall scores (p < 0.00001). Comparisons within domains between Playback Health users and non-users revealed no domains in which non-users had a significantly higher score than users. CONCLUSION: The addition of Playback Health multimedia health information technology was associated with improved patient satisfaction scores. When used as an adjunct to existing patient care, multimedia health information technologies may improve patient perceived care.

The World Health Organization's Disease Outbreak News: A retrospective database.

The World Health Organization (WHO) notifies the global community about disease outbreaks through the Disease Outbreak News (DON). These online reports tell important stories about both outbreaks themselves and the high-level decision making that governs information sharing during public health emergencies. However, they have been used only minimally in global health scholarship to date. Here, we collate all 2,789 of these reports from their first use through the start of the Covid-19 pandemic (January 1996 to December 2019), and develop an annotated database of the subjective and often inconsistent information they contain. We find that these reports are dominated by a mix of persistent worldwide threats (particularly influenza and cholera) and persistent epidemics (like Ebola virus disease in Africa or MERS-CoV in the Middle East), but also document important periods in history like the anthrax bioterrorist attacks at the turn of the century, the spread of chikungunya and Zika virus to the Americas, or even recent lapses in progress towards polio elimination. We present three simple vignettes that show how researchers can use these data to answer both qualitative and quantitative questions about global outbreak dynamics and public health response. However, we also find that the retrospective value of these reports is visibly limited by inconsistent reporting (e.g., of disease names, case totals, mortality, and actions taken to curtail spread). We conclude that sharing a transparent rubric for which outbreaks are considered reportable, and adopting more standardized formats for sharing epidemiological metadata, might help make the DON more useful to researchers and policymakers.

Open data for COVID-19 policy analysis and mapping.

As the COVID-19 pandemic unfolded in the spring of 2020, governments around the world began to implement policies to mitigate and manage the outbreak. Significant research efforts were deployed to track and analyse these policies in real-time to better inform the response. While much of the policy analysis focused narrowly on social distancing measures designed to slow the spread of disease, here, we present a dataset focused on capturing the breadth of policy types implemented by jurisdictions globally across the whole-of-government. COVID Analysis and Mapping of Policies (COVID AMP) includes nearly 50,000 policy measures from 150 countries, 124 intermediate areas, and 235 local areas between January 2020 and June 2022. With up to 40 structured and unstructured characteristics encoded per policy, as well as the original source and policy text, this dataset provides a uniquely broad capture of the governance strategies for pandemic response, serving as a critical data source for future work in legal epidemiology and political science.

Costing framework for International Health Regulations (2005).

The revised International Health Regulations (IHR [2005]) conferred new responsibilities on member states of the World Health Organization, requiring them to develop core capacities to detect, assess, report, and respond to public health emergencies. Many countries have not yet developed these capacities, and poor understanding of the associated costs have created a barrier to effectively marshaling assistance. To help national and international decision makers understand the inputs and associated costs of implementing the IHR (2005), we developed an IHR implementation strategy to serve as a framework for making preliminary estimates of fixed and operating costs associated with developing and sustaining IHR core capacities across an entire public health system. This tool lays the groundwork for modeling the costs of strengthening public health systems from the central to the peripheral level of an integrated health system, a key step in helping national health authorities define necessary actions and investments required for IHR compliance.

Investing in global health security: Estimating cost requirements for country-level capacity building.

The COVID-19 pandemic has highlighted critical gaps in global capacity to prevent, detect, and respond to infectious diseases. To effectively allocate investments that address these gaps, it is first necessary to quantify the extent of the need, evaluate the types of resources and activities that require additional support, and engage the global community in ongoing assessment, planning, and implementation. Which investments are needed, where, to strengthen health security? This work aims to estimate costs to strengthen country-level health security, globally and identify associated cost drivers. The cost of building public health capacity is estimated based on investments needed, per country, to progress towards the benchmarks identified by the World Health Organization's Joint External Evaluation (JEE). For each country, costs are estimated to progress to a score of "demonstrated capacity" (4) across indicators. Over five years, an estimated US$124 billion is needed to reach "demonstrated capacity" on each indicator of the JEE for each of the 196 States Parties to the International Health Regulations (IHR). Personnel costs, including skilled health, public health, and animal health workers, are the single most influential cost driver, comprising 66% of total costs. These findings, and the data generated by this effort, provide cost estimates to inform ongoing health security financing discussions at the global level. The results highlight the significant need for sustainable financing mechanisms for both workforce development and ongoing support for the health and public health workforce.

How are healthcare provider systems preparing for health emergency situations?

Natural disasters, disease outbreaks, famine, and human conflict have strained communities everywhere over the course of human existence. However, modern changes in climate, human mobility, and other factors have increased the global community's vulnerability to widespread emergencies. We are in the midst of a disruptive health event, with the COVID-19 pandemic testing our health provider systems globally. This study presents a qualitative analysis of published literature, obtained systematically, to examine approaches health providers are taking to prepare for and respond to mass casualty incidents around the globe. The research reveals emerging trends in the weaknesses of systems' disaster responses while highlighting proposed solutions, so that others may better prepare for future disasters. Additionally, the research examines gaps in the literature, to foster more targeted and actionable contributions to the literature.

Financial Assistance for Health Security: Effects of International Financial Assistance on Capacities for Preventing, Detecting, and Responding to Public Health Emergencies.

BACKGROUND: Health security funding is intended to improve capacities for preventing, detecting, and responding to public health emergencies. Recent years have witnessed substantial increases in the amounts of donor financial assistance to health security from countries, philanthropies, and other development partners. To date, no work has examined the effects of assistance on health security capacity development over time. This paper presents an analysis of the time-lagged effects of assistance for health security (AHS) on levels of capacity. METHODS: We collected publicly available health security assessment scores published between 2010 and 2019 and data relating to financial AHS. Using validated methods, we rescaled assessment scores on analogous scales to enable comparison and binned them in quartiles. We then used a distributed lag model (DLM) in a Bayesian ordinal regression framework to assess the effects of AHS on capacity development over time. RESULTS: Strong evidence exists for associations between financial assistance and select capacities on a variety of lagged time intervals. Financial assistance had positive effects on zoonotic disease capacities in the year it was disbursed, and positive effects on legislation, laboratory, workforce, and risk communication capacities one year after disbursal. Financial assistance had negative effects on laboratory and emergency response capacities two years after it was disbursed. Financial assistance did not have measurable effects on coordination, antimicrobial resistance (AMR), food safety, biosafety, surveillance, or response preparedness capacities over the timeframe considered. CONCLUSION: Financial AHS is associated with positive effects for several core health security capacities. However, for the majority of capacities, levels of funding were not significantly associated with capacity level, though we cannot fully exclude endogeneity. Future work should continue to investigate these relationships in different contexts and examine other factors that may contribute to capacity development.