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Understanding and Mitigating Health Inequities Eliminating racial health inequities requires a movement away from disparities as the focus of research and toward a research agenda centered on achie...

Background The US faces remarkable food and nutrition challenges. A new federal effort to strengthen and coordinate nutrition research could rapidly generate the evidence base needed to address these multiple national challenges. However, the relevant characteristics of such an effort have been uncertain. Objectives Our aim was to provide an objective, informative summary of 1) the mounting diet-related health burdens facing our nation and corresponding economic, health equity, national security, and sustainability implications; 2) the current federal nutrition research landscape and existing mechanisms for its coordination; 3) the opportunities for and potential impact of new fundamental, clinical, public health, food and agricultural, and translational scientific discoveries; and 4) the various options for further strengthening and coordinating federal nutrition research, including corresponding advantages, disadvantages, and potential executive and legislative considerations. Methods We reviewed government and other published documents on federal nutrition research; held various discussions with expert groups, advocacy organizations, and scientific societies; and held in-person or phone meetings with >50 federal staff in executive and legislative roles, as well as with a variety of other stakeholders in academic, industry, and nongovernment organizations. Results Stark national nutrition challenges were identified. More Americans are sick than are healthy, largely from rising diet-related illnesses. These conditions create tremendous strains on productivity, health care costs, health disparities, government budgets, US economic competitiveness, and military readiness. The coronavirus disease 2019 (COVID-19) outbreak has further laid bare these strains, including food insecurity, major diet-related comorbidities for poor outcomes from COVID-19 such as diabetes, hypertension, and obesity, and insufficient surveillance on and coordination of our food system. More than 10 federal departments and agencies currently invest in critical nutrition research, yet with relatively flat investments over several decades. Coordination also remains suboptimal, documented by multiple governmental reports over 50 years. Greater harmonization and expansion of federal investment in nutrition science, not a silo-ing or rearrangement of existing investments, has tremendous potential to generate new discoveries to improve and sustain the health of all Americans. Two identified key strategies to achieve this were as follows: 1) a new authority for robust cross-governmental coordination of nutrition research and other nutrition-related policy and 2) strengthened authority, investment, and coordination for nutrition research within the NIH. These strategies were found to be complementary, together catalyzing important new science, partnerships, coordination, and returns on investment. Additional complementary actions to accelerate federal nutrition research were identified at the USDA. Conclusions The need and opportunities for strengthened federal nutrition research are clear, with specific identified options to help create the new leadership, strategic planning, coordination, and investment the nation requires to address the multiple nutrition-related challenges and grasp the opportunities before us.

Introduction The new initiative by the Department of Health and Human Services (DHHS) aims to decrease new HIV infections in the U.S. by 75% within 5 years and 90% within 10 years. Our objective was to evaluate whether the U.S. military provides a good example of the benefits of such policies. Materials and methods We conducted an analysis of a cohort of 1,405 active duty military personnel with HIV enrolled in the Natural History Study who were diagnosed between 2003 and 2015 at six U.S. military medical centers. The study was approved by institutional review boards at the Uniformed Services University of the Health Sciences and each of the sites. We evaluated the impact of Department of Defense (DoD) HIV care policies, including screening, linkage to care, treatment eligibility, and combined antiretroviral therapy (cART) initiation on achieving viral suppression (VS) within 3 years of diagnosis. As a secondary outcome, we evaluated the DoD’s achievement of UNAIDS 90-90-90 targets. Results Nearly all (99%) were linked to care within 60 days. Among patients diagnosed in 2003–2009, 77.5% (95% confidence intervals (CI) 73.9–80.6%) became eligible for cART within 3 years of diagnosis, 70.6% (95% CI 66.6–74.1%) overall initiated cART, and 64.2% (95% CI 60.1–68.0%) overall achieved VS. Among patients diagnosed in 2010–2015, 98.7% (95% CI 96.7–99.5%) became eligible for cART within 3 years of diagnosis, 98.5% (95% CI 96.4–99.4%) overall initiated cART, and 89.8% (95% CI 86.0–92.5%) overall achieved VS. Conclusions U.S. military HIV policies have been highly successful in achieving VS goals, exceeding the UNAIDS 90-90-90 targets. In spite of limitations, including generalizability, this example demonstrates the feasibility of the DHHS initiative to decrease new infections through testing, early treatment, and retention in care.

To protect both patients and staff, healthcare personnel (HCP) were among the first groups in the United States recommended to receive the COVID-19 vaccine. We analyzed data reported to the U.S. Department of Health and Human Services (HHS) Unified Hospital Data Surveillance System on COVID-19 vaccination coverage among hospital-based HCP. After vaccine introduction in December 2020, COVID-19 vaccine coverage rose steadily through April 2021, but the rate of uptake has since slowed; as of September 15, 2021, among 3,357,348 HCP in 2,086 hospitals included in this analysis, 70.0% were fully vaccinated. Additional efforts are needed to improve COVID-19 vaccine coverage among HCP.

HIPAA at 25 — A Work in Progress HIPAA is best viewed as a framework of evolving regulation that’s revised periodically in response to demands of biomedical innovation and public health in the digi...

Venous thromboembolism (VTE) is an important cause of morbidity and mortality in the United States (US). The increasing rates of VTE in the US resulted in the surgeon general issuing a call to action to reduce VTE in 2008. The objective of our study was to analyze the national trends of inpatient VTE in the US from 2004 to 2013 (5 years before and after 2008). We used the dataset National Inpatient Sample, Healthcare Cost and Utilization Project and measured trends of inpatient VTE by annual % change using joinpoint regression software. From 2004 to 2013 the National Inpatient Sample contained data on 78 million hospitalizations (weighted n = 385 million). In these 1.6 million had a diagnosis of VTE (2.0%, weighted n = 7.7 million) including 1.2 million with deep venous thrombosis (DVT) (1.53%, weighted n = 5.9 million) and 588,878 with pulmonary embolism (PE) (0.74%, weighted n = 2.8 million). Joinpoint regression analysis showed that rates of DVT and PE are increasing consistently from 2004 to 2013(1.27% to 1.80% for DVT and 0.52% to 0.92% for PE). The increasing rates of DVT and PE were consistent in all subgroups except few exceptions. In conclusion inpatient VTE rates continue to rise even after 5 years from the surgeon general's a call to action except in certain high-risk patients. Further research is needed to curb the VTE in patients especially among those perceived to be at lower risk of VTE.

Context The objective of this systematic review was to update a prior review and summarize the evidence (newly identified and cumulative) on the impact of contraceptive counseling provided in clinical settings. Evidence acquisition Multiple databases, including PubMed, were searched during 2016–2017 for articles published from March 1, 2011, to November 30, 2016. Evidence synthesis The search strategy identified 24,953 articles; ten studies met inclusion criteria. Two of three new studies that examined contraceptive counseling interventions (i.e., enhanced models to standard of care) among adolescents and young adults found a statistically significant positive impact on at least one outcome of interest. Five of seven new studies that examined contraceptive counseling, in general, or specific counseling interventions or aspects of counseling (e.g., personalization) among adults or mixed populations (adults and adolescents) found a statistically significant positive impact on at least one outcome of interest. In combination with the initial review, six of nine studies among adolescents and young adults and 16 of 23 studies among adults or mixed populations found a statistically significant positive impact of counseling on at least one outcome of interest. Conclusions Overall, evidence supports the utility of contraceptive counseling, in general, and specific interventions or aspects of counseling. Promising components of contraceptive counseling were identified. The following would strengthen the evidence base: improved documentation of counseling content and processes, increased attention to the relationships between client experiences and behavioral outcomes, and examining the comparative effectiveness of different counseling approaches to identify those that are most effective. Theme information This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Context Educational interventions can help individuals increase their knowledge of available contraceptive methods, enabling them to make informed decisions and use contraception correctly. This review updates a previous review of contraceptive education. Evidence acquisition Multiple databases were searched for articles published March 2011–November 2016. Primary outcomes were knowledge, participation in and satisfaction/comfort with decision making, attitudes toward contraception, and selection of more effective methods. Secondary outcomes included contraceptive behaviors and pregnancy. Excluded articles described interventions that had no comparison group, could not be conducted feasibly in a clinic setting, or were conducted outside the U.S. or similar country. Evidence synthesis A total of 24,953 articles were identified. Combined with the original review, 37 articles met inclusion criteria and described 31 studies implementing a range of educational approaches (interactive tools, written materials, audio/videotapes, and text messages), with and without healthcare provider feedback, for a total of 36 independent interventions. Of the 31 interventions for which knowledge was assessed, 28 had a positive effect. Fewer were assessed for their effect on attitudes toward contraception, selection of more effective methods, contraceptive behaviors, or pregnancy—although increased knowledge was found to mediate additional outcomes (positive attitudes toward contraception and contraceptive continuation). Conclusions This systematic review is consistent with evidence from the broader healthcare field in suggesting that a range of interventions can increase knowledge. Future studies should assess what aspects are most effective, the benefits of including provider feedback, and the extent to which educational interventions can facilitate behavior change and attainment of reproductive health goals. Theme information This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Criticism of the Centers for Disease Control and Prevention (CDC) and its efforts to put forth recommendations and data based on core public health practice and principles is contrary to the realities of the work that the CDC has done on preparedness in past decades In 2001, the CDC funded a project intended to facilitate the development of an integrated national system of Academic Centers for Public Health Preparedness (CPHPs) to train frontline public health professionals who respond to bioterrorist incidents and other emerging infectious diseases Nineteen CPHPs were funded until the program was discontinued in August 2010 and replaced by 14 Preparedness and Emergency Response Learning Centers, whose funding ended in 2018 2 CPHPs worked to identify core principles for public health preparedness and response, strategies for local and state data collection, and curricula and best practices for educating the public health and first responder workforce

Essential but Undefined Safety-net hospitals provide essential care to patients regardless of their insurance coverage, financial circumstances, or immigration status, and they often operate with t...

Bridging the Gap at Warp Speed In addition to its goal of delivering safe and effective vaccines quickly, Operation Warp Speed aims to combat Covid-19 by improving the use of existing therapies and...

Policy Lessons from Our Covid Experience As the U.S. economy reopens, it’s important to assess how we can be better prepared to stave off such enormous economic losses during the next Covid-19 wave...

Background Healthcare systems and public health agencies use different methods to measure the impact of substance use (SU) on population health. We studied the ability of systems to accurately capture data on drug use-associated infective endocarditis (DUA-IE). Methods We conducted a retrospective analysis of patients with IE discharge diagnosis from an academic medical center, 2011–2017, comparing data from hospital Electronic Health Record (EHR) to State Uniform Hospital Discharge Data Set (UHDDS). To identify SU we developed a composite measure. Results EHR identified 472 IE discharges (430 of these were captured in UHDDS); 406 (86.0%) were correctly coded based on chart review. IE discharges increased from 57 to 92 (62%) from 2012 to 2017. Hospitalizations for the subset of DUA-IE identified by any measure of SU increased from 10 to 54 (440%). Discharge diagnosis coding identified 128 (60.7%) of total DUA-IE hospitalizations. The composite measure identified an additional 65 (30.8%) DUA-IE hospitalizations and chart review an additional 18 (8.5%). Conclusions The failure of discharge diagnosis coding to identify DUA-IE in 40% of hospitalizations demonstrates the need for better systems to capture the impact of SU. Collaborative data sharing could help improve surveillance responsiveness to address an emerging public health crises.

A foreshadowing of changes for other populations and nursing specialties?

Public health needs up-to-date information for surveillance and response. As healthcare application programming interfaces become widely available, a novel data gathering mechanism could provide public health with critical information in a timely fashion to respond to a fast-moving epidemic. In this article, we extrapolate from our experiences using a Fast Healthcare Interoperability Resource-based architecture for infectious disease surveillance for sexually transmitted diseases to its application to gather case information for an outbreak. One of the challenges with a fast-moving outbreak is to accurately assess its demand on healthcare resources, since information specific to comorbidities is often not available. These comorbidities are often associated with poor prognosis and higher resource utilization. If the comorbidity data and other clinical information were readily available to public health workers, they could better address community disruption and manage healthcare resources. The use of FHIR resources available through application programming and filtered through tools such as described herein will give public health the flexibility needed to investigate rapidly emerging disease while protecting patient privacy.

Donor lung allocation in the United States focuses on decreasing waitlist mortality and improving recipient outcomes. The implementation of allocation policy to match deceased donor lungs to waitlisted patients occurs through a unique partnership between government and private organizations, namely the Organ Procurement and Transplantation Network under the Department of Health and Human Services and the United Network for Organ Sharing. In 2005, the donor lung allocation algorithm shifted towards the prioritization of medical urgency of waitlisted patients instead of time accrued on the waitlist. This led to the Lung Allocation Score, which weighs over a dozen clinical variables to predict a one-year estimate of survival benefit, and is used to prioritize waitlisted patients. In 2017 the use of local allocation boundaries was eliminated in favor of a 250 nautical mile radius from the donor hospital as the first unit of distance used in allocation. The next upcoming iteration of donor allocation policy is expected to use a continuous distribution algorithm where all geographic boundaries are eliminated. There are additional opportunities to improve donor lung allocation, such as for patients with high antibody titers with access to a limited number of donors..

Recent coronavirus disease 2019 (COVID-19) events have presented challenges to health care systems worldwide. Air medical movement of individuals with potential infectious disease poses unique challenges and threats to crews and receiving personnel. The US Department of Health and Human Services air medical evacuation teams of the National Disaster Medical System directly supported 39 flights, moving over 2,000 individuals. Infection control precautions focused on source and engineering controls, personal protective equipment, safe work practices to limit contamination, and containment of the area of potential contamination. Source control to limit transmission distance was used by requiring all passengers to wear masks (surgical masks for persons under investigation and N95 for known positives). Engineering controls used plastic sheeting to segregate and treat patients who developed symptoms while airborne. Crews used Tyvek (Dupont Richmond, VA) suits with booties and a hood, a double layer of gloves, and either a powered air-purifying respirator or an N95 mask with a face shield. For those outside the 6-ft range, an N95 mask and gloves were worn. Safe work practices were used, which included mandatory aircraft surface decontamination, airflow exchanges, and designated lavatories. Although most patients transported were stable, to the best of our knowledge, this represents the largest repatriation of potentially contagious patients in history without infection of any transporting US Department of Health and Human Services air medical evacuation crews.

Current treatments for patients with HIV are not only effective at controlling viral replication but are also associated with a more favorable adverse reaction profile, may often be taken once daily, and are increasingly available in combination single-tablet regimens. This article provides an overview and prescribing considerations for several primary drugs currently recommended by the US Department of Health and Human Services.

Earlier this year, the U.S. Department of Health and Human Services announced its intent to strengthen enforcement of legal protections for health care providers' conscience rights. It proposed regulations that would give the DHHS Office of Civil Rights greater authority to ensure that recipients of federal funding comply with federal conscience laws. This recent development creates an opportunity for scholars and policy-makers to revisit the perennial debate about whether and how law should protect health care providers' rights of conscience. Arguments about who should be protected, what actions should be protected, and whether there should be any limitations on the exercise of conscience rights have brought us no closer to a resolution. However, there is one remaining avenue for analysis that has, surprisingly, received very little attention-the question of how providers are protected, and from what consequences. Existing U.S. conscience laws immunize health care providers from a wide range of adverse consequences-including civil liability, criminal prosecution, administrative penalties, adverse action by employers, and discrimination by private actors, among others. However, academic and public policy debates rarely acknowledge the breadth of these protections. It is essential to disentangle this network of possible protections.

This study uses Department of Health and Human Services data to analyze surveillance of electronic health records for patient safety issues to identify those with a potential for patient harm, and the frequency of these issues.

OBJECTIVE To analyze changes in intracytoplasmic sperm injection (ICSI) utilization, indications, and outcomes across U.S. regions. METHODS We conducted a retrospective cohort study. Data sets for 2000-2014 were obtained from the Centers for Disease Control and Prevention. Clinics with 100 or greater fresh, nondonor cycles were grouped by 10 nationally recognized Department of Health and Human Services (DHHS) regions and were compared for use of ICSI, frequency of male factor infertility, preimplantation genetic therapies, pregnancy, and live birth rates per cycle among fresh in vitro fertilization cycles in women younger than 35 years of age. RESULTS Nationwide ICSI utilization increased 52% (46.3±6.1% to 70.0±7.1%) from 2000 to 2014, whereas pregnancy and live birth rates per cycle modestly increased by 8.5% (39.2±3.8% to 42.5±2.5%) and 7.6% (34.4±3.6% to 37±2.6%), respectively, showing a positive correlation (r=0.78, P

According to Secretary Azar of Health and Human Services, implementing international reference pricing (IPI) in Medicare Part B will have minimal impacts. He has stated, "These savings, while substantial for American patients and taxpayers, cannot possibly pull out more than 1 percent of RD." As companies traditionally spend 20% of free cash flow on RD, we have measured the IPI impact according to industry standard metrics. The potential negative impacts of the international reference pricing plan, as it is currently structured, are numerous. Companies are likely to avoid developing Medicare Bart B physician-administered drugs in the future if it comes to fruition. Further, if distributing in any of the included countries in the benchmarking exercise that traditionally have prices far below that of the United States has the impact of creating lower US prices where the industry currently derives more than 80% of their global profit, companies will simply not seek market access in those benchmarked countries and patients in those countries will not receive the medicines they need. The idea that companies will be able to unilaterally raise prices in Europe defies logic and practice. Many countries in the EU have been threatening IP rights under the TRIPS clauses of the WTO for several years because of their belief that pharmaceutical pricing is unacceptably high right now, without the IPI. Harnessing real-world evidence would allow for increased competition by faster time to market. One wonders why an approach encompassing the improved time to market was not considered, as the reference pricing proposal as it stands now, ultimately, will reduce RD budgets, impair the overall investment climate, and deprive patients the new medicines.

Background Expert groups have recommended ongoing monitoring of the public health workforce to determine its ability to execute designated objectives. Resource- and time-intensive surveys have been a primary data source to monitor the workforce. We evaluated an administrative data source containing US Department of Health and Human Services (HHS) aggregate federal civil service workforce-related data to determine its potential as a workforce surveillance system for this component of the workforce. Methods We accessed FedScope, a publicly available online database containing federal administrative civilian HHS personnel data. Using established guidelines for evaluating surveillance systems and identified workforce characteristics, we evaluated FedScope attributes for workforce surveillance purposes. Results We determined FedScope to be a simple, highly accepted, flexible, stable, and timely system to support analyses of federal civil service workforce-related data. Data can be easily accessed, analyzed, and monitored for changes across years and draw conclusions about the workforce. FedScope data can be used to calculate demographics (eg, sex, race or ethnicity, age group, and education level), employment characteristics (ie, supervisory status, work schedule, and appointment type), retirement projections, and characterize the federal workforce into standard occupational categories. Conclusions This study indicates that an administrative data source containing HHS personnel data can function as a workforce surveillance system valuable to researchers, public health leaders, and decision makers interested in the federal civil service public health workforce. Using administrative data for workforce development is a model that can be applicable to federal and nonfederal public health agencies and ultimately support improvements in public health.

The new 2018 edition of the Physical Activity Guidelines for Americans (PAGA18) released by the U.S. Department of Health and Human Services [1] and directly informed by the 779-page 2018 Physical Activity Guidelines Advisory Committee Scientific Report [2] will undoubtedly change how we promote and research physical activity (PA). For the first time, PAGA18 include new insights on the role of a single session of PA for cognitive function and brain health, suggesting that the scientific evidence supporting PA benefits on cognitive function and brain health has matured. In addition, considering the difficulty in initiating and adhering to a long-term exercise program, cognitive function benefits from a single bout may provide a new approach to promote exercise for people who are not ready yet to adopt and adhere to an ongoing habitual exercise routine...

Toppling the Ethical Balance A new rule from the U.S. Department of Health and Human Services creates a wide-ranging right to refuse to provide health care services. If it goes into effect, patient...

“It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes

In early 2015, Sylvia Burwell, Secretary of the Department of Health and Human Services, described the federal administration's goals for delivery of health care in the United States. Prominently featured was a conversion from volume to value through the incorporation of Alternative Payment Models. The Department of Health and Human Services laid the framework, but recognized significant knowledge gaps in how providers and institutions would develop Alternative Payment Models. To that end, the Health Care Payment Learning and Action Network was conceived. On March 25, 2015, the Health Care Payment Learning and Action Network held its first meeting, which included a broad swath of industry participants. This collaboration was considered mission critical to achieving success in the goals of advancing Alternative Payment Models. This article highlights the Health Care Payment Learning and Action Network and the framework it is proposing for Alternative Payment Models that would have meaningful implications for radiologists.

Background Anecdotal evidence suggests that US practice patterns for ART differ by geographical region. The purpose of this study was to determine whether use of ICSI differs by region and to evaluate whether these rates are correlated with differences in live birth rates. Methods Public data for 2012 were obtained from the Centers for Disease Control and Prevention. Clinics with ≥100 fresh, non-donor cycles were grouped by 10 nationally recognized Department of Health & Human Services regions and 11 metropolitan Megaregions and were compared for use of ICSI, frequency of male factor infertility, and live birth rate in women

Background It is becoming increasingly common for individuals and organizations to use social media platforms such as Facebook. These are being used for a wide variety of purposes including disseminating, discussing and seeking health related information. U.S. Federal health agencies are leveraging these platforms to ‘engage’ social media users to read, spread, promote and encourage health related discussions. However, different agencies and their communications get varying levels of engagement. In this study we use statistical models to identify factors that associate with engagement. Methods We analyze over 45,000 Facebook posts from 72 Facebook accounts belonging to 24 health agencies. Account usage, user activity, sentiment and content of these posts are studied. We use the hurdle regression model to identify factors associated with the level of engagement and Cox proportional hazards model to identify factors associated with duration of engagement. Results In our analysis we find that agencies and accounts vary widely in their usage of social media and activity they generate. Statistical analysis shows, for instance, that Facebook posts with more visual cues such as photos or videos or those which express positive sentiment generate more engagement. We further find that posts on certain topics such as occupation or organizations negatively affect the duration of engagement. Conclusions We present the first comprehensive analyses of engagement with U.S. Federal health agencies on Facebook. In addition, we briefly compare and contrast findings from this study to our earlier study with similar focus but on Twitter to show the robustness of our methods.

Cybersecurity issues and their impact on compliance with the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act are becoming more of an enforcement focus for a variety of government agencies, including the US Department of Health and Human Services, the Federal Trade Commission, and the Department of Justice. In the case presented in this article, a nurse in a neurology practice opted to speak with a patient about human immunodeficiency virus testing procedures in a manner audible to others in the waiting room. Computer screens with patient information were visible to anyone approaching a desk, the staff had not been trained on cybersecurity issues, and malware infected the computers used in the practice. In light of these circumstances and the launch of Phase 2 of the HIPAA Audit Program by the US Department of Health and Human Services Office for Civil Rights, the neurology practice must consider the following questions. First, could the gaps in the technical, administrative, and physical requirements of HIPAA and the HITECH Act result in an adverse audit and penalties? Second, what course of action does the law mandate in response to a ransomware attack?

The secretary of the US Department of Health and Human Services in February 2016 recommended that X-linked adrenoleukodystrophy (X-ALD) be added to the recommended uniform screening panel for state newborn screening programs. This decision was informed by data presented on the accuracy of screening from New York, the only state that currently offers X-ALD newborn screening, and published and unpublished data showing health benefits of earlier treatment (hematopoietic stem cell transplantation and adrenal hormone replacement therapy) for the childhood cerebral form of X-ALD. X-ALD newborn screening also identifies individuals with later-onset disease, but poor genotype-phenotype correlation makes predicting health outcomes difficult and might increase the risk of unnecessary treatment. Few data are available regarding the harms of screening and presymptomatic identification. Significant challenges exist for implementing comprehensive X-ALD newborn screening, including incorporation of the test, coordinating follow-up diagnostic and treatment care, and coordination of extended family testing after case identification.Genet Med 19 1, 121-126.

The final rule for reporting clinical trial results has now been issued by the Department of Health and Human Services. It aims to increase accountability in the clinical research enterprise, making key information available to researchers, funders, and the public.

With the support of the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, PATH has contributed to the World Health Organization’s (WHO’s) Global Action Plan for Influenza Vaccines (GAP) by providing technical and clinical assistance to several developing country vaccine manufacturers (DCVMs). GAP builds regionally based independent and sustainable influenza vaccine production capacity to mitigate the overall global shortage of influenza vaccines. The program also ensures adequate influenza vaccine manufacturing capacity in the event of an influenza pandemic.Since 2009, PATH has worked closely with two DCVMs in Vietnam: the Institute of Vaccines and Medical Biologicals (IVAC) and VABIOTECH. Beginning in 2013, PATH also began working with Torlak Institute in Serbia; Instituto Butantan in Brazil; Serum Institute of India Private Ltd. in India; and Changchun BCHT Biotechnology Co. (BCHT) in China.The DCVMs supported under the GAP program all had existing influenza vaccine manufacturing capability and required technical support from PATH to improve vaccine yield, process efficiency, and product formulation. PATH has provided customized technical support for the manufacturing process to each DCVM based on their respective requirements.Additionally, PATH, working with BARDA and WHO, supported several DCVMs in the clinical development of influenza vaccine candidates progressing toward national licensure or WHO prequalification. As a result of the activities outlined in this review, several companies were able to make excellent progress in developing state-of-the-art manufacturing processes and completing early phase clinical trials. Licensure trials are currently ongoing or planned for several DCVMs.

Reform at Risk The Center for Medicare and Medicaid Innovation was meant to be the government’s innovation laboratory for health care. But HHS has quietly hobbled the agency, imperiling its ability...

Divisions, New and Old In creating a Conscience and Religious Freedom Division, leaders of the U.S. Department of Health and Human Services have framed “conscience” in a one-sided way, making it yet another issue dividing Americans largely along partisan lines.