Combating Extreme Heat with a National Moonshot

Extreme heat is the leading cause of weather-related deaths in the United States and has been for the past 30 years. Low-income communities and many other vulnerable populations are disproportionately affected by heat risk. As the climate continues to warm, the threat to public health will correspondingly increase. Through a presidential directive, the White House Climate Policy Office (WHCPO) should establish the National Moonshot to Combat Extreme Heat, an all-of-government program to harmonize and accelerate federal efforts to reduce heat risk and heat illness, save lives, and improve the cost-effectiveness of federal expenditures. 

The goals of the Moonshot are to:

  1. Reduce heat deaths by 20% by 2030, 40% by 2035, and 60% by 2050. 
  2. Build 150 heat-resilient communities by 2030 by facilitating access to funding and uplifting social infrastructure actions prioritizing at-risk, vulnerable populations.
  3. Increase visibility and awareness of federal efforts to protect residents from extreme heat. 

The Moonshot will be overseen by a new, high-level appointee at WHCPO to serve as the Executive Officer of the White House Interagency Work Group on Extreme Heat (WHIWG). 

Challenge and Opportunity

The threat to public health and safety from extreme heat is serious, expansive, and increasing as the planet continues to warm. According to Heat.gov, “Extreme heat has been the greatest weather-related cause of death in the U.S. for the past 30 years — more than hurricanes, tornadoes, flooding or extreme cold.” The number of deaths from extreme heat is difficult to accurately determine and is frequently undercounted. More recently, during the Heat Dome of 2021, the state of Washington reported 1,231 heat deaths in just one month. Further, heat-related illness includes a broad spectrum of diseases, from mild heat cramps to life-threatening heat stroke. Heat exposures have been linked to mental health illnesses and adverse birth outcomes, such as preterm births and low birth weights. Extreme heat disproportionately impacts marginalized people, including those that are low-income, BIPOC, seniors, veterans, children, the unhoused, and those with compromised health status, among others. All heat illnesses and deaths are considered preventable.

Extreme heat is an all-of-society problem that requires an all-of-government response. As the frequency, intensity, duration, and breadth of heat waves have increased dramatically over the past four years, officials and leaders at all levels have begun taking action. 

The federal government has launched new programs for addressing extreme heat over the last few years as heat waves have become a front-page issue. Recent programs initiated by the Biden Administration are providing a variety of resources and increasing awareness of this threat. Key examples are:

Actions are needed to remedy the deficit in attention to extreme heat by uplifting the role of extreme heat in the federal response to climate impacts and give greater emphasis to social infrastructure actions. 

Several bills to address extreme heat through federal legislation have been introduced in Congress, though none have advanced. Most notable are:

  1. S. 2645: Senator Edward Markey’s Preventing HEAT Illness and Deaths Act of 2023 would authorize NIHHIS to prescribe actions and provide funding. 
  2. HR 3965: Representative Ruben Gallego’s “Extreme Heat Emergency Act of 2023” would amend the Stafford Act by adding “extreme heat” as a natural disaster for which response aid is authorized.
  3. H.R. 2945: Representative Ruben Gallego’s Excess Urban Heat Mitigation Act of 2023” would require the Department of Housing and Urban Development (HUD) to establish a grant program to fund activities to mitigate or manage heat in urban areas. The Senate version of this bill, S. 1379, is led by Senator Sherrod Brown.

Even with this momentum, actions are dispersed across many departments and agencies. Plus, many local and state governments tend to apply for federal funding on a program-by-program, agency-by-agency basis and must navigate a complicated landscape with limited funding explicitly earmarked for heat resilience. Further, most “infrastructure” and capacity-building funding is based on mitigating or restoring economic loss of property, leading to financial relief that has gone primarily to built infrastructure and natural infrastructure projects. Communities need social infrastructure: social cohesion, policy and governance, public health, communications and alerts, planning, etc., to respond to extreme heat. This requires a pathway for communities to access funds to combat extreme heat in a comprehensive and coordinated way and bring social infrastructure actions up to a level equal to built and natural infrastructure interventions. 

There is a need to improve the coordination of heat actions across the federal government, align heat resilience activities with Justice40 mandates, and promote community-based interventions to reduce heat deaths. A National Moonshot to Combat Extreme Heat can do this by leveraging several new community-focused programs to accelerate the protection of at-risk populations from heat-related death and illness. The challenge, and therefore the opportunity, for the Moonshot is to identify, integrate, and accelerate existing resources in a human-centric framework to reduce preventable deaths, promote cool and healthy communities, and deliver value nationwide. 

Plan of Action 

The WHCPO should appoint a new Deputy Director for Heat to serve as the Executive Officer of the WHIWG and coordinate the National Moonshot to Combat Extreme Heat – an all-of-government program to accelerate federal actions to address extreme heat. The goals of the Moonshot are to:

  1. Reduce heat deaths by 20% by 2030, 40% by 2035, and 60% by 2050; 
  2. Build 150 heat-resilient communities by 2030 by facilitating access to funding and uplifting social infrastructure actions prioritizing at-risk, vulnerable populations. Social infrastructure encompasses a variety of actions in four categories: social cohesion, policy, communications, and planning.  Social infrastructure centers the needs of people in resilience.  This target aligns with the U.S. goal to reduce greenhouse gas emissions by 50% by 2030. 
  3. Improve visibility and awareness of federal efforts to protect residents from extreme heat.

The Moonshot will capitalize on existing policies, programs, and funding and establish a human-centric approach to climate resilience by uplifting extreme heat. The Moonshot will identify and evaluate existing federal activities and available funding, including funds from the Inflation Reduction Act (IRA) and the Bipartisan Infrastructure Law (BIL), as well as agency budgets, including Federal Emergency Management Agency’s funding for the Building Resilient Infrastructure and Communities (BRIC) and the Hazard Mitigation Grant Program (HMGP). The Moonshot will integrate actions among the many existing programs dispersed across the government into a well-coordinated, integrated inter-agency initiative that maximizes results and will support cool, safe, and healthy communities

Recommendation 1. Enhance the visibility, responsibility, and capacity of the WHIWG. 

Signaling high-level support through a presidential directive, the WHCPO should appoint a Deputy Director for Heat as the Executive Officer of the WHIWG to lead the Moonshot. Two additional staff positions will be established to support the assessment, stakeholder engagement, and planning processes. The WHIWG and the Deputy Director will design and implement the Moonshot working with the Department of Health and Human Services Office of Climate Change and Health Equity. A lead contact will be designated in each agency and department participating in the NIHHIS program. 

Recommendation 2. Assess and report current status. 

The Moonshot should identify, evaluate, and report on existing programs addressing heat across the federal government, including those recently launched by the White House, to establish a current baseline, identify gaps, and catalog opportunities for integration within the federal government. The Moonshot will generate a database of existing programs and a budget cross-cut analysis to identify current funding levels. The report will incorporate the NIHHIS Extreme Heat Strategy and identify existing funding opportunities, including those in the IRA, Bipartisan Infrastructure Law, and agency programs. The Moonshot will also work with CDC and NIHHIS to develop a method to identify heat deaths to establish a baseline for tracking progress on the goals. 

Recommendation 3. Build broad community support.

The Moonshot should convene conversations and conduct regional extreme heat workshops with state, local, and tribal government personnel; external experts and stakeholders; Justice40 community leaders; professional associations; private sector representatives; and philanthropies. Topics should span the spectrum of social infrastructure, including social cohesion, public health, insurance, infrastructure, communications, and more. Based on input, the Moonshot will establish an advisory committee of non-government participants and develop pathways to connect stakeholders with federal community-focused climate resilience programs, including the White House’s Justice 40 program, EPA’s Environmental Justice Thriving Communities Technical Assistance Centers Program, and the Department of Transportation’s Thriving Communities Network, and other relevant federal programs identified in Recommendation 2. The Moonshot would add extreme heat as a covered issue area in these programs.

Recommendation 4. Make a plan.

The Moonshot should expand upon the NIHHIS Extreme Heat Strategy and make a heat action plan uplifting human health and community access to harness the potential of federal heat programs. The plan would assign roles, responsibilities, and deadlines and establish a process to track and report progress annually. In addition, the Moonshot would expand the NCR Framework to include an implementation plan and establish a human-centric approach. The Moonshot will evaluate co-benefits from heat reduction strategies, including the role cool surfaces play in protecting public health while also decreasing smog, reducing energy use, and solar radiation management. And, consistent with the Biden Administration’s 2025 priorities, the Moonshot will support research and development on emerging technologies such as microfiber fabrics that keep people cool during heat waves, temperature-sensitive coatings, and high-albedo reflective materials that can reduce the need for mechanical air-conditioning. Innovation is especially needed related to resurfacing the nation’s aging roadways.

The Moonshot will also include a communications plan to increase awareness of federal programs and funding opportunities to combat extreme heat. This should all be in place in nine months to prepare for the FY 2026 budget. The NIHHIS and CDC will develop an enhanced method for improving the accuracy of tracking heat deaths. 

Recommendation 5. Connect with people and communities.

The Moonshot should emphasize social infrastructure projects and facilitate access to funding by establishing a centralized portal for comprehensive local heat action planning and programs. The Moonshot will help build cool, safe, healthy communities by integrating heat into federal climate equity programs and supporting local heat plans and projects that reflect community input and priorities. Local heat plans should be comprehensive and integrate a suite of actions that emphasize social infrastructure and include built infrastructure and natural infrastructure. 

Recommendation 6. Initiate all-of-government action.

The Moonshot will catalyze the implementation of the plan across the government, including all the agencies and departments identified in Recommendation 1. It will establish the grant portal to enhance access to federal resources for heat-related projects for state, local, tribal, and territorial governments, and community groups. It will launch a communications plan targeting press, social media, public employees at all levels of government, stakeholders, and more. 

Recommendation 7. Support legislation to secure long-term success 

In coordination with the White House Office of Legislative Affairs and Office of Management and Budget (OMB), the Moonshot should work with Congress to draft and support federal legislation and appropriations addressing extreme heat. Congressional authority is needed to firmly establish this human-centric approach to extreme heat. The Moonshot may recommend Congressional hearings on legislation or a Congressional commission to review the Administration’s work on heat. For example, the passage of S. 2645 would enshrine the position of NIHHIS in law. The Moonshot will help Congress fulfill its role in the all-of-government response and help empower local action. 

Costs

Using information gathered in Recommendation 2, the Moonshot will focus on capturing and directing existing federal funding, including from the IRA, BIL, agency budgets, and grant programs to uplift actions addressing extreme heat and implementing the Moonshot action plan. Initial costs should be minimal: $1 million to hire the Executive Director and two staff and to report on existing programs, funding, and agency budgets. The Moonshot will produce a budget cross-cut initially and annually thereafter and assemble a budget proposal for the WHIWG on Extreme Heat for the FY 2025 and FY 2026 budget.

The Moonshot recommendation is aligned with the OMB Budget Memo of August 17, 2023, which transmits Guidance for Research and Development Priorities for the FY 2025 Budget. The OMB priorities call for addressing climate change by protecting communities’ health and mitigating its health effects, especially for communities that experience these burdens disproportionately.

Conclusion

Extreme heat is a serious public health problem disproportionately impacting many vulnerable populations, and the threat is increasing tremendously. So far in winter 2023, more than 130 monthly high-temperature records were set across the U.S. 

The federal government has several programs addressing the threat of extreme heat in the U.S., and the WHIWG reflects the all-of-government approach needed to meet the threat. The next step is to capture the full potential of existing programs and funding by launching a focused and intensive National Moonshot to Combat Extreme Heat with quantitative goals to track and reduce heat deaths and build healthy communities. This  effort will enable state and local governments and communities, especially those disproportionately impacted by extreme heat, to more readily access federal funding to develop and implement comprehensive heat action plans. The Moonshot will reduce heat deaths, improve the quality of life in cities, and reduce economic productivity loss while increasing the visibility of federal leadership on this issue. 

With heat season 2024 beginning on April 29th, it’s essential to establish an all-of-government response to address extreme heat at all levels.

This idea of merit originated from our Extreme Heat Ideas Challenge. Scientific and technical experts across disciplines worked with FAS to develop potential solutions in various realms: infrastructure and the built environment, workforce safety and development, public health, food security and resilience, emergency planning and response, and data indices. Review ideas to combat extreme heat here.

Frequently Asked Questions
What entities are partners in NIHHIS?

Federal agencies involved in NIHHIS include: National Oceanic and Atmospheric Administration, Centers for Disease Control and Prevention, Administration for Community Living, Administration for Children and Families, Administration for Strategic Preparedness and Response, Environmental Protection Agency, Department of Housing and Urban Development, Federal Emergency Management Agency, Department of Defense, Department of Energy, Department of Transportation, National Institute for Occupational Safety and Health, Department of Veterans Affairs, US Census Bureau, Forest Service, National Park Service, Department of Health and Human Services, National Institute of Environmental Health Sciences, Occupational Safety and Health Administration, Substance Abuse and Mental Health Services Administration, and United States Agency for International Development.

Non-federal partners include, but are not limited to: CAPA Strategies, ESRI, Global Cool Cities Alliance, National League of Cities, and Global Heat Health Information Network.

Adopting Evidence-Based Heat Stress Management Strategies in the Workplace to Enhance Climate Equity

Millions of workers are subjected to the dangers of extreme heat that increase their risk of heat-related illnesses and fatalities. Due to personal, social, and workplace vulnerabilities, workers are at even greater risk, particularly women, people who are Black or Brown, those who facing low-income challenges, and those employed by small businesses. With no mandated federal heat stress standard, there is no federal mechanism to ensure the adoption of appropriate heat stress prevention strategies and emergency procedures to protect vulnerable workers. 

Now is an opportune time to introduce a federal program to champion climate equity and justice in the workplace by assisting employers’ implementation of evidence-based heat stress management strategies and heat illness emergency procedures, particularly targeting underserved working populations who labor in the heat. This program should be supported by the Occupational Safety and Health Administration (OSHA), along with university and nonprofit partners, and funded through a private or public partnership. This effort will act on the principles of employer social responsibility, best practice recognition, increased resource allocation to vulnerable working groups, third-party auditing, and a non-retaliation reporting mechanism. This policy action, across multiple stakeholders, will proactively address the challenges posed by extreme heat and work toward creating safer, more equitable working environments for all.

Challenge and Opportunity

The average global surface temperature in 2023 was 2.12ºF above the 20th century average, resulting in Earth’s warmest year on record. Extreme temperatures will continue to rise as the frequency, intensity, and duration of heat waves increase due to climate change. Climate change is a major public health priority that places workers who perform physical labor in the heat at higher risk, due to frequent prolonged, heavy physical exertion, layers of personal protective clothing, and exposure to environmental heat stress. This combination of factors exacerbates the level of heat stress placed on the body, leading to heat-related injuries, illnesses, and fatalities. While the Biden Administration has initiated federal action to establish a mandated heat standard, the bureaucratic process is slow, averaging around eight years. Congress is also working on addressing this issue through the consideration of a bill for the adoption of an emergency temporary standard. Although it offers a quicker solution, it has a limited life span of approximately six months. Moreover, in anticipation of mandating a federal heat stress standard, there is limited infrastructure to support the adoption of evidence-based heat stress management strategies to protect workers in high-temperature environments. The current enforcement solution, OSHA’s National Emphasis Program on outdoor and indoor heat hazards, has several limitations, include such as a vague definition of noncompliant following heat hazard inspection, and uses assessment tools such as Heat Index, which is not considered “best practice.” 

To address these limitations, key stakeholders from academic settings, large research institutes, and nonprofit organizations have developed evidence-based best practices to protect vulnerable workers from extreme heat. Unfortunately, there is no system in place to determine how well companies are prepared for extreme heat. The urgency of adopting evidence-based heat stress management strategies across industries cannot be overstated, as heat-related injuries and fatalities are entirely preventable with the implementation of appropriate prevention strategies and emergency procedures.

There is a critical opportunity to champion climate equity and justice to safeguard laborers from the dangers of extreme heat. Laborers from vulnerable demographics who engage in physical work in the heat are disproportionately affected and are often not protected under evidence-based heat stress management practices by their employers. Workers with personal (e.g., age, race/ethnicity, disease status) and social (e.g., employment type, income status) vulnerabilities are exploited by working in hot environments with limited heat stress prevention strategies available to them. This form of labor exploitation during periods of high heat exposure leaves millions of U.S. workers more vulnerable to preventable heat-related injuries and fatalities. 

Small businesses and other companies with limited resources are also less equipped to protect their workforce or have the means to ensure their employees are working in safe environments in the heat. To fortify workplace resilience against extreme heat and climate change, it is imperative to equitably distribute resources for enforcing evidence-based heat policies in workplaces. Organizations with employees exposed to high temperatures must be held accountable for the effective implementation of these policies. Additionally, vulnerable workers frequently refrain from reporting unsafe conditions due to the fear of employer retaliation. Advocacy efforts become even more challenging as language barriers, food insecurity, and poverty exacerbate already dire working conditions.

The present moment presents an opportune time to introduce a program supported by occupational health and safety federal agencies. As evidence-based best practices have been developed to protect workers from extreme heat, there is no system in place to protect vulnerable working populations, allocate resources, and keep companies accountable by assessing their current heat stress management practices. OSHA and the National Institute for Occupational Safety and Health (NIOSH) are key stakeholder organizations to initiate a federal response to address the lack of adoption of heat stress management policies. However, these entities often prioritize multiple projects simultaneously, are understaffed, and benefit from partnerships with universities and nonprofits. Therefore, a cooperative approach with governing like OSHA and universities/nonprofit organizations is the appropriate strategy to create a program that promotes the enforcement of evidence-based heat protection strategies (i.e., education, hydration, heat acclimatization, environmental monitoring, physiological monitoring) at the organizational level. This approach also provides under-resourced businesses with access to basic heat protection equipment and establishes a mechanism for employees to report unsafe working conditions without fear of retaliation. This program draws inspiration from the success of the Fair Food Program, a Corporate Social Responsibility model that promotes accountability among growers, buyers, and retailers. 

This comprehensive program will support all organizations that employ workers who perform physical work in the heat, such as construction, utilities, agriculture, oil, and gas. This program will facilitate employer accountability, social responsibility, increased resource allocation, third-party auditing, and a non-retaliation reporting system. 

Plan of Action

The development and implementation of this federal program, the Occupational Heat Resiliency Program (OHRP), will require a public-private partnership between OSHA, universities, and nonprofit partners. This partnership model draws inspiration from the successful collaborative partnerships between OSHA and other partners to protect the workforce against other occupational hazards. The OHRP will promote the adoption of evidence-based heat stress management practices by targeting employers with workplaces that experience high heat exposure and/or have a large population of laborers working in the heat who are classified as vulnerable workers. The establishment of OHRP will require funding through cooperative agreements, such as the OSHA Strategic Partnership Program (OSPP). To achieve the program’s objectives, both OSHA and its partners will commit their knowledge and resources to support the program.

The program will rely on the following principles to achieve this objective:

  1. Employer accountability and best practice recognition:
  1. Climate equity through increased resource allocation:
  1. Safer work environments through third-party auditing and a non-retaliation reporting system:

The program will be led by teams composed of OSHA representatives and university/nonprofit partners that will meet virtually regularly to ensure the goals of each principle are being met and to address any partnership issues that may arise.

Conclusion

The escalating challenges to the U.S. workforce posed by extreme heat demand proactive measures, necessitating collaboration among key government entities like OSHA alongside universities and nonprofit organizations. Currently, there is a glaring absence of mechanisms to safeguard workers who engage in physical work in the heat, particularly those from vulnerable demographics. 

To tackle this issue head-on, the establishment of OHRP funded through a private or public partnership is imperative. This initiative would champion climate equity in the workplace by expediting the adoption of evidence-based heat stress management strategies and emergency procedures. The program’s framework includes commitments from employers, recognition of best practices, increased resource allocation to vulnerable working groups, third-party auditing, and a non-retaliation mechanism. OHRP will have an immediate impact at both the federal and state level. Without the implementation of such a program, a significant portion of the U.S. workforce remains at risk of entirely preventable heat-related injuries, illnesses, and fatalities.

This idea of merit originated from our Extreme Heat Ideas Challenge. Scientific and technical experts across disciplines worked with FAS to develop potential solutions in various realms: infrastructure and the built environment, workforce safety and development, public health, food security and resilience, emergency planning and response, and data indices. Review ideas to combat extreme heat here.

Frequently Asked Questions
How does this proposal support the rule-making process for a heat stress standard and other federal extreme heat efforts?
Although federal action has begun to mobilize efforts to protect workers from extreme heat, the proposed federal and emergency heat stress standard will take several years to enforce and/or will contain limited details on the specific strategies to best protect workers. Evidence-based practices to best protect workers from extreme heat do exist—however, there is currently no system in place to ensure that employers implement them or protect vulnerable working populations. OHRP will accelerate the adoption of heat stress protection strategies, protect vulnerable working populations, and prepare companies for the future implementation of a federal or state heat standard. This will have an immediate impact at both the federal and state level as heat-related illnesses, injuries, and fatalities are entirely preventable with the implementation of evidence-based heat stress management strategies and emergency procedures.
How much would this proposal cost?

The program will require approximately $10 million for its initial three-year phase for startup, launch, and execution. A three-year projection is a conservative time based on the time frame for launching similar federal programs. The budget will be allocated to two areas:



  1. Time, labor, and travel costs for program management (~$8 million)

  2. Resource allocation for vulnerable working groups (i.e., small businesses, businesses with a high percentage of low-income workers) (~$2 million)


Following the three-year phase, approximately $1-2 million per year will be needed to reach more vulnerable working populations.

What accountability and evaluation measures will be included to ensure the program’s effectiveness?
The day-to-day operations will be run by executive teams led by the combined efforts of university and nonprofit partners and OSHA representatives. Each team will evaluate whether each principle is met and evaluate the program’s progress. The program will have clearly stated goals and will outline the roles and responsibilities of all personnel.

Improve Extreme Heat Monitoring by Launching Cross-Agency Temperature Network

Year after year, record-breaking air temperatures and heat waves are reported nationwide. In 2023, Death Valley, California experienced temperatures as high as 129°F — the highest recorded temperature on Earth for the month of June—and in July,  Southwest states experienced prolonged heat waves where temperatures did not drop below 90°F. This is especially worrisome as the frequency, intensity, and duration of rising temperatures are projected to increase, and the leading weather-related cause of death in the United States is heat. To address this growing threat, the Environmental Protection Agency (EPA) and the National Oceanic and Atmospheric Administration (NOAA) should combine and leverage their existing resources to develop extreme-heat monitoring networks that can capture spatiotemporal trends of heat and protect communities from heat-related hazards. 

Urban areas are particularly vulnerable to the effects of extreme heat due to the urban heat island (UHI) effect. However, UHIs are not uniform throughout a city, with some neighborhoods experiencing higher air temperatures than others. Further, communities with higher populations of Color and lower socioeconomic status disproportionately experience higher temperatures and are reported to have the highest increase in heat-related mortality. It is imperative for local government officials and city planners to understand who is most vulnerable to the impacts of extreme heat and how temperatures vary throughout a city to develop effective heat mitigation and response strategies. While the NOAA’s National Weather Service (NWS) stations provide hourly, standardized air measurements, their data do not capture intraurban variability.

Challenge and Opportunity

Heat has killed more than 11,000 Americans since 1979, yet an extreme heat monitoring network does not exist in the country. While NOAA NWS stations capture air temperatures at a central location within a city, they do not reveal how temperatures within a city vary. This missing information is necessary to create targeted, location-specific heat mitigation and response efforts.

Synergistic Environmental Hazards and Health Impacts

UHIs are metropolitan areas that experience higher temperatures than surrounding rural regions. The temperature differences can be attributed to many factors, including high impervious surface coverage, lack of vegetation and tree canopy, tall buildings, air pollution, and anthropogenic heat. UHIs are of significant concern as they contribute to higher daytime temperatures and reduce nighttime cooling, which in turn exacerbates heat-related deaths and illnesses in densely populated areas. Heat-related illnesses include heat exhaustion, cramps, edema, syncope, and stroke, among others. However, heat is not uniform throughout a city, and some neighborhoods experience warmer temperatures than others in part due to structural inequalities. Further, it has been found that, on average, People of Color and those living below the poverty line are disproportionately exposed to higher air temperatures and experience the highest increase in heat-related mortality. As temperatures continue to rise, it becomes more imperative for the federal government to protect vulnerable populations and communities from the impacts of extreme heat. This requires tools that can help guide heat mitigation strategies, such as the proposed interagency monitoring network. 

High air temperatures and extreme heat are also associated with poor air quality. As common pavement surfacing materials, like asphalt and concrete, absorb heat and energy from the sun during the day, the warm air at the surface rises with present air pollutants. High air temperatures and sunlight are also known to help catalyze the production of air pollutants such as ozone in the atmosphere and impact the movement of air and, therefore, the movement of air pollution. As a result, during extreme heat events, individuals are exposed to increased levels of harmful pollutants. Because poor air quality and extreme heat are directly related, the EPA should expand its air quality networks, which currently only detect pollutants and their sources, to include air temperature. Projections have determined extreme heat events and poor air quality days will increase due to climate change, with compounding detriments to human health

Furthermore, extreme heat is linked not only to poor air quality but also to wildfire smoke—and they are becoming increasingly concomitant. Projections report with very high confidence that warmer temperatures will lengthen the wildfire season and thus increase areas burned. Similar to extreme heat’s relationship with poor air quality, extreme heat and wildfire smoke have a synergistic effect in negatively impacting human health. Extreme heat and wildfire smoke can lead to cardiovascular and respiratory complications as well as dehydration and death. These climatic hazards have an even larger impact on environmental and human health when they occur together.

As the UHI effect is localized and its causes are well understood, urban cities are ideal locations to implement heat mitigation and adaptation strategies. To execute these plans equitably, it is critical to identify areas and communities that are most vulnerable and impacted by extreme heat events through an extreme heat monitoring network. The information collected from this network will also be valuable when planning strategies targeting poor air quality and wildfire smoke. The launch of an extreme heat monitoring network will have a considerable impact on protecting lives. 

Urban Heat Mapping Efforts

Both NOAA and EPA have existing programs that aim to map, reduce, or monitor UHIs throughout the country. These efforts may have the capacity to also implement the proposed heat monitoring network. 

Since 2017, NOAA has worked with the National Integrated Heat Health Information System (NIHHIS) and CAPA Strategies LLC to fund yearly UHI mapping campaign programs, which has been instrumental in highlighting the uneven distribution of heat throughout U.S. cities. These programs rely on community science volunteers who attach NOAA-funded sensors to their cars to collect air temperature, humidity, and time data. These campaigns, however, are currently only run during summer months, and not all major cities are mapped each year. NOAA’s NIHHIS has also created a Heat Vulnerability Mapping Tool, which impressively illustrates the relationship between social vulnerability and heat exposure. These maps, however, are not updated in real-time and do not display air temperature data. Another critical tool in mapping UHIs is NWS recently created HeatRisk prototype, which identifies risks of heat-related impacts in numerous parts of the country. This prototype also forecasts levels of heat concerns up to seven days into the future. However, HeatRisk does not yet provide forecasts for the entire country and uses NWS air temperature products, which do not capture intraurban variability. The EPA has a Heat Island Reduction program dedicated to working with community groups and local officials to find opportunities to mitigate UHIs and adopt projects to build heat-resilient communities. While this program aims to reduce and monitor UHIs, there are no explicit monitoring or mapping strategies in place. 

While the products and services of each agency have been instrumental in mapping UHIs throughout the country and in heat communication and mitigation efforts, consistent and real-time monitoring is required to execute extreme heat response plans in a timely fashion. Merging the resources of both agencies would provide the necessary foundation to design and implement a nationwide extreme heat monitoring network.

Plan of Action

Heat mitigation strategies are often city-wide. However, there are significant differences in heat exposure between neighborhoods. To create effective heat adaptation and mitigation strategies, it is critical to understand how and where temperatures vary throughout a city. Achieving this requires a cross-agency extreme heat monitoring network between federal agencies. 

The EPA and NOAA should sign a memorandum of agreement to improve air temperature monitoring nationwide. Following this, agencies should collaborate to create an extreme heat monitoring network that can capture the intraurban variability of air temperatures in major cities throughout the country.

Implementation and continued success require a number of actions from the EPA and NOAA. 

  1. EPA should expand its Heat Island Reduction program to include monitoring urban heat. The Inflation Reduction Act (IRA) provided the agency with $41.5 billion to fund new and existing programs, with $11 billion going toward clean air efforts. Currently, their noncompetitive and competitive air grants do not address extreme heat efforts. These funds could be used to place air temperature sensors in each census tract within cities to map real-time air temperatures with high spatial resolution.
  2. EPA should include air temperature monitoring in their monitoring deployments. Due to air quality tracking efforts mandated by the Clean Air Act, there are existing EPA air quality monitoring sites in cities throughout the country. Heat monitoring efforts could be tested by placing temperature sensors in the same locations.
  3. EPA and NOAA should help determine vulnerable communities most impacted by extreme heat. Utilizing EPA’s Environmental Justice Screening and Mapping (EJScreen) Tool and NIHHIS’s Heat Vulnerability Mapping Tool, EPA and NOAA could determine where to place air temperature monitors, as the largest burden due to extreme heat tends to occur in neighborhoods with the lowest economic status.
  4. NOAA should develop additional air temperature sensors. NOAA’s summer UHI campaign programs highlight the agency’s ability to create sensors that capture temperature data. Given their expertise in capturing meteorological conditions, NOAA should develop national air temperature sensors that can withstand various weather conditions.
  5. NOAA should build data infrastructure capable of supporting real-time monitoring. Through NIHHIS, the data obtained from the monitoring network could be updated in real-time and be publicly available. This data could also merge with the current vulnerability mapping tool and HeatRisk to examine extreme heat impacts at finer spatial scales. 

Successful implementation of these recommendations would result in a wealth of air temperature data, making it possible to monitor extreme heat at the neighborhood level in cities throughout the United States. These data can serve as a foundation for developing extreme heat forecasting models, which would enable governing bodies to develop and execute response plans in a timely fashion. In addition, the publicly available data from these monitoring networks will allow local, state, and tribal officials, as well as academic and non-academic researchers, to better understand the disproportionate impacts of extreme heat. This insight can support the development of targeted, location-specific mitigation and response efforts.

Conclusion

As temperatures continue to rise in the United States, so do the risks of heat-related hazards, morbidity, and mortality. This is especially true for urban cities, where the effects of extreme heat are most prevalent. A cross-agency extreme-heat monitoring network can support the development of equitable heat mitigation and disaster preparedness efforts in major cities throughout the country.

This idea of merit originated from our Extreme Heat Ideas Challenge. Scientific and technical experts across disciplines worked with FAS to develop potential solutions in various realms: infrastructure and the built environment, workforce safety and development, public health, food security and resilience, emergency planning and response, and data indices. Review ideas to combat extreme heat here.

Frequently Asked Questions
How are urban heat islands formed?
Cities often have less vegetation and tree canopy cover than surrounding rural areas, which decreases cooling and evaporation. Tall buildings and ones that are close together reduce wind speed, trapping heat within a city. Buildings, as well as roads, streets, and sidewalks, are very good at absorbing and storing heat from the sun. Additionally, air pollution and heat from cars, buildings, and space heating absorb heat that is trying to escape from the city.
What is the difference between urban heat islands and heat waves?

Urban heat islands are urbanized regions experiencing higher temperatures compared to nearby rural areas. Heat waves—also known as extreme heat events—are persistent periods of unusually hot weather lasting more than two days. Research has found, however, that urban heat islands and heat waves have a synergistic relationship.

How many people die due to heat in the United States?

Nationwide, more than 1,300 annual deaths are estimated to be attributable to extreme heat. This number is likely an undercount, as medical records do not regularly include the impact of heat when describing the cause of death.

What can communities do to combat rising temperatures?
Cities can create more green spaces and plant more trees to increase evapotranspiration rates and provide shade. Installing cool or green roofs can reduce the amount of heat buildings store throughout the day. Altering roads, streets, or sidewalks with cool pavements may also reduce the amount of stored heat and provide less heat stress to pedestrians. Walking and biking instead of using an automobile, when possible, would reduce the amount of pollution introduced into the air, which could not only combat rising temperatures but also improve air quality.

Addressing the National Challenges of Extreme Heat by Modernizing Preparedness Approaches at Administration for Strategic Preparedness and Response

In the United States, almost one in four Americans are vulnerable to the growing threat of extreme heat. In fact, extreme heat kills more people on average every year than any other extreme weather event. Yet scientists believe these numbers still largely underestimate the true number of heat-related deaths by up to 50-fold, suggesting tens of thousands of Americans could be dying each year from heat-related exposure. Climate change further drives the risk of extreme heat, with a hundred million Americans exposed to dangerous temperatures each summer and projections showing these numbers to further increase.

The Administration for Strategic Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) can and should play a leadership role in supporting State, Local, Tribal, and Territorial (SLTT) preparedness and response to extreme heat. Just as ASPR serves as the Sector Risk Management Agency for healthcare and Public Health (HPH) cybersecurity, ASPR is uniquely positioned to lead the federal response to extreme heat due to the distinct and disproportionate impacts of extreme heat on the medical and public health sector. As leader, ASPR would support the integration of extreme heat into healthcare preparedness and response programs, participate in an interagency workgroup to develop critical healthcare impact-based forecasts, and implement lessons learned from similar efforts to develop effective hurricane responses. This is critical for ASPR to meet its mandate in a rapidly warming world, will save thousands of American lives, and stand as a testament to U.S. innovation and resolve.

Challenge and Opportunity

Across the U.S., more communities are facing the deadly impacts of extreme heat. Local responses are often disorganized and reactive, resulting in excessive preventable injuries and deaths. Hospitals are overwhelmed, emergency services are stretched thin, and the most vulnerable suffer. Combined with potential power outages, heat waves could create catastrophic impacts, including unparalleled patient surge and mass casualty crises that would overwhelm local and state resources. Unlike other extreme weather hazards, the impacts of extreme heat are disproportionately felt by HPH organizations and agencies, a clear indicator that ASPR should play a leadership role in supporting SLTTs to ensure regional healthcare readiness, sharing of critical impact-forecast data, and effective response coordination.

On June 23, 2021, the Seattle-based National Weather Service (NWS) office alerted Washington State response agencies about a large record-breaking heat dome forecasted to impact the region. With three days until the start of the heat dome and five days until its peak, there was ample time to prepare. However, with Washington being largely unaccustomed to extreme heat —and lacking plans, an understanding of the potential impacts, and technical assistance or resource support from the federal government — SLTTs were left to fend for themselves. The results were catastrophic: more lives were lost than any other extreme weather event in the state’s history.

ASPR, with minimal additional funding from Congress, should act to better support SLTT-level healthcare and public health organizations and agencies by supporting the development of data-driven decision-making tools, heat-integrated preparedness programs, and response systems ready to pre-deploy when extreme heat threatens to overwhelm SLTT HPH resources.

Heat Impact Forecasts and Response Triggers

A major operational barrier to extreme heat response planning is a lack of data-driven decision-making resources, such as impact-based forecasts. Traditional forecasts for heat waves often focus on temperature and humidity, but do little to provide necessary information for SLTTs and national agencies to understand community risk and anticipated impacts on the HPH sectors.

Similar to ongoing efforts to move beyond traditional hurricane forecasts (wind speed, pressure, location) and toward impact-based warnings for jurisdictions and communities, the Centers for Disease Control and Prevention (CDC) and the NWS collaboratively developed the HeatRisk prototype to provide risk-focused information. Even with the tool still in the development phase and only providing forecasts for half of the continental United States, HeatRisk has already been integrated into SLTT response plans. This demonstrates a significant need to complete and expand this tool to support SLTT and federal response decision-making.

ASPR is uniquely positioned to advance this initiative by integrating healthcare data to develop impact-based forecasts that provide anticipated public health and healthcare surge information. Instead of only forecasting the level of risk posed to the public, a HeatRisk HPH platform could provide critical estimates of healthcare service demand due the extreme heat. This information would be vital to identify evidence-based thresholds that could trigger pre-event coordination, technical assistance, and activation of federal resources from ASPR and FEMA. 

Heat-Prepared Medical and Public Health Response System

Extreme temperature exposure can take just hours to days to be deadly, while federal responses often take days to weeks to organize and deploy, so saving lives during an extreme heat event that overwhelms local and state HPH resources requires rapid pre-deployment of federal assets based on extreme heat forecast data. To date, there is no plan for or example of this occurring, even when thousands of Americans are dying each year from extreme heat.

Clear legal guidelines allow ASPR to pre-deploy response personnel and supplies without a disaster declaration. Section 301, 311, 2812 of the Public Health Services Act authorizes the HHS secretary to provide public health service personnel, equipment, medical supplies, and other assistance to states and local jurisdictions to prevent or respond to any health emergency, with or without a public health emergency declaration. In addition, there are many examples of ASPR pre-deploying assets in anticipation of extreme weather hazards such as Hurricane Ian in 2022, which included the pre-deployment of Health and Medical Task Force teams, Incident Management Teams, and caches of medical supplies. 

ASPR has a mission responsibility to support SLTTs before and during an overwhelming heat emergency with technical assistance and resources – such as personnel and critical medical supplies. This will require modernizing the National Disaster Medical System (NDMS) and U.S. Public Health Service (USPHS) Commissioned Corps to meet the current and future threat landscape of extreme heat, development of heat-specific response standards and training, and integration of forecast-based pre-deployment and technical assistance into regional SLTT preparedness activities. 

Additionally, heat response standards and training could support SLTT Medical Reserve Corps (MRC) volunteer heat-response capabilities through an already existing ASPR and the National Association of County and City Health Officials collaboration, which provides MRC deployment training and readiness guides. This technical support would help meet the growing demand for MRC volunteers in local extreme heat responses.

Heat-Prepared Healthcare Systems

Healthcare systems are often caught off guard by extreme heat events due to a lack of hazard analysis and preparedness. ASPR is critical in supporting healthcare readiness via the Hospital Preparedness Program (HPP), which provides funding through grants and cooperative agreements to support local healthcare capacity, system readiness, and coordination in response to medical surge events.

There is a significant opportunity to integrate heat-specific programmatic requirements into HPP, such as requiring heat-specific hazard and vulnerability analyses and preparedness activities, which would ensure health systems are aware and prepared. Additionally, advancements in medical surge coordination, such as regional and state medical operations coordination cells (MOCC), developed or refined during the pandemic and utilized during periods of extreme heat, should be funded through HPP to ensure patient and resource coordination capabilities are developed, utilized, have appropriate authority, and are financially sustained. 

Heat-Health Response Excellence Centers

ASPR has created and funded several medical-academic centers that provide technical assistance, training, exercises, and assessments specific to unique hazards and demographics. These include two Pediatric Disaster Care Centers of Excellence and the National Emerging Special Pathogens Training & Education Center. With adequate congressional funding, ASPR should establish two national Heat-Health Response Excellence Centers that support SLTTs and ASPR in identifying preparedness and response best practices; developing heat-specific federal response standards and training; understanding regional heat impact characteristics and supporting HeatRisk data integration; connecting HPH response planners with leading national heat research and subject matter experts; and leveraging ASPR TRACIE, ASPR Project ECHO, and the National Integrated Heat Health Information Network (NIHHIS) to capture and disseminate best practices and ongoing engagement.

Plan of Action

To ensure ASPR is able to advance SLTT HPH extreme heat readiness and can effectively support jurisdictions responding to a heat-related health emergencies, the following actions should be taken.

Recommendation 1. Develop heat impact-based forecasts 

  1. ASPR collaborates closely with CDC and NWS to support the expansion of the HeatRisk prototype to include HPH sector risk analysis (using ASPR-controlled healthcare data), and is socialized/integrated in SLTT heat response plans. 
  2. Identify specific NDMS forecast thresholds to trigger support for SLTTs, such as prepositioning of personnel, resources, and provision of technical assistance. 
  3. One-time funds of $10 million to increase HeatRisk scope and impact-based forecast planning that would include:
    1. Staff support to appropriately integrate ASPR healthcare data
    2. Cross-agency integration of HeatRisk data to identify activation thresholds
    3. Outreach and promotion for SLTT awareness and planning
  4. Recurring $3 million to ensure ongoing HeatRisk refinement (incorporating new data), ASPR healthcare data integration, and ongoing assistance to SLTTs to support heat response planning.

Recommendation 2. Leverage HPP to advance healthcare readiness

  1. Require HPP recipients to integrate extreme heat in the required coalition-led hazard and vulnerability assessments (HVA). This should include connections with local or regional climate projection subject matter experts.
  2. Require healthcare coalitions to develop a coalition heat response plan, similar to existing requirements for hazard-specific response plans, such as the radiation emergency surge annex requirement.
  3. Require healthcare coalitions to use extreme heat as a Medical Response and Surge Exercise scenario once in each cooperative agreement, or more frequently based on HVA and priorities.
  4. Streamline MOCC-capability funding through HPP, require all HPP recipients to establish patient and resource transfer coordination capabilities, and institute clear transfer authority. 50% increase in annual funding per recipient, or $120 million based on 2023 funding.
    1. Current funding mechanisms for MOCCs are convoluted, tied to expiring COVID funding or reallocating funds from various response funds. A clear, streamlined approach will ensure sustainability and readiness.
    2. MOCC funding should be periodically reassessed based on innovative best practices and changes in the local and national threat landscape. For example, MOCCs may be critical during non-emergency protracted hospital strain and should be funded appropriately.
  5. Ensure healthcare coalitions engage outpatient healthcare, long-term care, and federally qualified health centers and their respective regional or state associations.

Recommendation 3. Establish technical assistance resources

  1. Fund and establish two regional Heat-Health Response Excellence Centers at two academic institutions that will provide technical expertise and guidance to federal agencies and SLTTs on heat preparedness and response best practices, regional heat characteristics, and connect SLTTs with heat subject matter experts.
  2. Develop heat-specific response guidance—examples could include heat-sensitive pharmaceutical guidance, heat-associated mass casualty triage, and critical resources for extreme heat-related patient surges. 
  3. Allocate $6 million in annual funds based on existing ASPR-funded Pediatric Disaster Care Centers of Excellence

Recommendation 4. Modernize NDMS and USPHS for extreme heat

  1. Work with Heat-Health Response Excellence Centers to develop heat-specific response standards and training. Integrate them into current NDMS modernization efforts, starting with Disaster Medical Assistant Teams.
  2. Update NDMS response plans to align with forecast-based response triggers. Integrate these plans into ongoing regional exercises that include HPP recipients. 
  3. One-time funds: $17 million based on 2020 CARES Act for USPHS training.

Cost Estimates

This proposal would require a first-year cost of $153 million and future annual costs of $129 million. The economic justification to fund these efforts is apparent. The sharp increase in billion-dollar extreme weather disasters in the U. S., the growing awareness of the impact of extreme heat on human health (and associated medical expenses), and mitigation research showing that every dollar in prevention saves up to $15 in response and recovery expenses should incentivize Congress to fully fund this proposal. 

Conclusion

Increasing risks associated with extreme heat in the United States signal an urgent need to enhance national preparedness and response strategies. ASPR is ideally suited to lead in supporting SLTTs in their preparedness and response. ASPR can accomplish this through low-cost measures that develop critical decision-making tools and better integrate extreme heat into existing programs, funding mechanisms, and medical and public health deployment systems.

Frequently Asked Questions
Why should ASPR be in a leadership role?

Extreme heat events are unique compared to other extreme weather events. The impacts more closely resemble those of a rapid epidemic, with often geographically dispersed direct impacts to human health resulting in significant surges of patients into emergency departments. While heat-related impacts to infrastructure do occur, and require coordination with local, state, and federal emergency management, ASPR is ideally situated to support the frontlines of a heat emergency with existing programs and response systems, such as HPP, and HPH technical assistance, coordination, and resources.

How are so many people dying of heat with so little public attention?

Sociologist Eric Klinenberg characterizes heat as a “silent and invisible killer of silenced and invisible people,” highlighting the many, often intersecting health inequities that drive heat morbidity and mortality. In the U.S., the socially isolated, elderly, disabled, and unhoused make up the majority of heat-related deaths. Tragically, these deaths rarely garner media attention. Additionally, heat affects the human body in a variety of often under-recognized ways, resulting in underreporting on medical records. Lastly, aggregate surveillance data from heat events is often slow to come out or not analyzed at all. The combination of these factors results in significant undercounting of heat deaths—and a public that largely underestimates their risk to this growing threat.

How does extreme heat impact healthcare and public health?

Direct health impacts (e.g., heat stress, heat stroke, heat-associated cardiac and respiratory events) increase demand for emergency healthcare services, which can result in significant patient surges to emergency departments. This can increase 9-1-1 wait times and pre-hospital wall times. Indirect health impacts, such increases in drownings, auto accidents, burns, domestic violence, and overdoses, further stress an already-overwhelmed healthcare service. High temperatures can affect medical equipment, staff safety, productivity, and burnout. As extreme heat exposure increases in frequency, severity, and duration, the risk of a catastrophic heat event that results in tens of thousands of deaths increases, demanding urgent action.

Moving the Nation: The Role of Federal Policy in Promoting Physical Activity

Physical activity is one of the most powerful tools for promoting health and wellbeing. Movement is not only medicine—effective at treating a range of physical and mental health conditions—but it is also preventive medicine, because movement reduces the risk for many conditions ranging from cancer and heart disease to depression and Alzheimer’s disease. But rates of physical inactivity and sedentary behavior have remained high in the U.S. and worldwide for decades.

Engagement in physical activity is impacted by myriad factors that can be viewed from a social ecological perspective. This model views health and health behavior within the context of a complex interplay between different levels of influence, including individual, interpersonal, institutional, community, and policy levels. When it comes to healthy behavior such as physical activity, sustainable change is considered most likely when these levels of influence are aligned to support change. Every level of influence on physical activity within a social-ecological framework is directly or indirectly affected by federal policy, suggesting physical activity policy has the potential to bring about substantial changes in the physical activity habits of Americans. 

Every level of influence on physical activity within a social-ecological framework is directly or indirectly affected by federal policy, suggesting physical activity policy has the potential to bring about substantial changes in the physical activity habits of Americans.
FIGURE 1. Adapted from Heise, L., Elisberg, M., & Gottemoeller, M. (1999)

Why are federal physical activity policies needed?

Physical inactivity is recognized as a public health issue, having widespread impacts on health, longevity, and even the economy. Similar to other public health issues over past decades such as sanitation and tobacco use, federal policies may be the best way to coordinate large-scale changes involving cooperation between diverse sectors, including health care, transportation, environment, education, workplace, and urban planning. An active society requires the infrastructure, environment, and resources that promote physical activity. Federal policies can meet those needs by improving access, providing funding, establishing regulations, and developing programs to empower all Americans to move more. Policies also play an important role in removing barriers to physical activity, such as financial constraints and lack of safe spaces to move, that contribute to health disparities. With such a variety of factors impacting active lifestyles, physical activity policies must have inter-agency involvement to be effective.

What physical activity initiatives exist currently?

Analysis of publicly available information revealed that there are a variety of initiatives currently in place at the federal level, across several departments and agencies, aimed at increasing physical activity levels in the U.S. Information about each initiative was evaluated for their correspondence with levels of the social-ecological model, as summarized in the table. Note that it is possible the search that was conducted did not identify every relevant effort, thus there could be additional initiatives that are not included below.

Given the large number of groups with the shared goal of increasing physical activity in the nation, a memorandum of understanding (MOU) may help to promote coordination of goals and implementation strategies.

FIGURE 2. Agency roles
Department or AgencyExisting or Potential Role
Administration for Children and Families (ACF)ACF’s strategic goals include taking a “preventative and proactive approach to ensuring child, youth, family, and individual well-being.” Physical activity is a powerful preventative and proactive approach.
Administration for Community Living (ACL)ACL’s Health, Wellness, and Nutrition program addresses behavioral health, prevention of injuries and illness, and chronic disease self-management for aging and disability populations, all of which relate to physical activity, though physical activity is not directly addressed in the program’s goals.
Agency for Healthcare Research and Quality (AHRQ)AHRQ moves scientific evidence into practice to help healthcare systems and professionals deliver care that is high quality, safe, accessible, equitable, and affordable, and works to ensure that the scientific evidence is understood and used. AHRQ provides support to the U.S. Preventive Services Task Force (USPSTF), which makes recommendations about clinical preventive services including physical activity.
Centers for Disease Control and Prevention (CDC)The CDC conducts research and provides health information to tackle health problems causing death and disability for Americans, put science into action to prevent disease, and promote healthy and safe behaviors, communities and environment. The CDC has several programs focused on physical activity, partnering with other government agencies and departments as well as other organizations, including the Active People, Healthy Nation program and funding initiatives such as the State Physical Activity and Nutrition Program (SPAN 2023), which supports state-level programs to implement evidence-based strategies to address health disparities related to poor nutrition, physical inactivity, and/or obesity.
Centers for Medicare and Medicaid (CMS)CMS’ Behavioral Health Strategy is aimed at increasing access to equitable and high-quality behavioral health services and improving outcomes for people covered by Medicare, Medicaid and private health insurance. CMS could play an important role in providing access to gym memberships and exercise prescriptions for both intervention and prevention. Currently, gym memberships or fitness programs may be included in the extra coverage offered by Medicare Advantage Plans depending on the person’s location. Less commonly, coverage is provided by Medicare Supplement (Medigap) plans. For Medicaid, some states cover gym memberships as part of weight loss initiatives or partner with YMCAs or other community organizations to run health programs.
Council on Environmental Quality (CEQ) and Environmental Protection Agency (EPA)CEQ and EPA coordinate federal environmental activities and the development of environmental policy, which has a reciprocal beneficial relationship with physical activity. For example, to reduce emission and energy use, climate change policies have been introduced to encourage cycling, walking and other forms of sustainable, active transport. Parks and other green spaces that sequester carbon dioxide also provide space for people to be active. Policies that reduce air pollution help to reduce a barrier to exercising outside.
Department of Agriculture (USDA)The USDA’s strategic priorities include addressing climate change via climate smart agriculture, forestry, and clean energy. Climate, clean air, and spaces for outdoor recreation and camping such as forests are all related to physical activity. The USDA works with the Bureau of Land Management, National Park Service, and others to increase physical activity on federal land (hiking, rafting, biking, etc.), and also provides funding for urban forestry, which promotes physical activity in urban areas.
Department of Education (DE)The DE sets guidelines for physical education in schools and has provided funding for research on physical activity in schools, such as the Carol M. White Physical Education Program, which awarded grants from 2001-2015 to Local Education Agencies (LEAs) and community-based organizations (CBOs) to initiate, expand, or enhance physical education programs. The DE could also designate physical education as a core subject and ensure that physical activity is not assigned or withheld as punishment.
Department of Housing and Urban Development (HUD)HUD has an important role in community building and infrastructure. The built environment can support physical activity (e.g., by providing safe spaces for movement). For example, HUD’s Office of Community Planning and Development develops communities by promoting decent housing, suitable living environments, and expanded economic opportunities for low- and moderate-income people. Research shows that receiving HUD housing assistance is associated with higher physical activity levels in low-income Americans. HUD is also involved in the climate action plan.
Department of the Interior (DOI)The DOI manages public lands and minerals, national parks, and wildlife refuges. Within the DOI, the Bureau of Land Management and National Park Service maximize land use, including recreational activities that involve physical activity in outdoor spaces. The National Park Service promotes health and wellness through the Healthy Parks Healthy People initiative, which involves a collaboration with partners and interdisciplinary teams in the sectors of public health, medicine, conservation, and recreation to put a spotlight on the role of parks as social determinant of health.
Department of Transportation (DOT)The DOT promotes physical activity in the public sector through building and maintaining sidewalks or trails, as well as connecting them; reducing car dependency; provide increased opportunities for walking and bicycling; encouraging the creation and implementation of policies to support alternate modes of transportation; providing direct investments to supportive infrastructure such as bicycle lanes, greenways, multi use paths, sidewalks and trails; reducing distances between key destinations and providing and improving bicycle and pedestrian facilities; and installing streetlights. For example, the Safe Routes to School Programs, which promotes safe ways for youth to walk or bike to and from school through the funding of infrastructure (e.g., sidewalks) and educational programs, grew out of these federal funding programs. The DOT and its partner agencies also work to address air and noise pollution and reduce greenhouse gas emissions, to improve opportunities for safe, active, multimodal transportation and reduce dependence on vehicles, such as the Clean Air Act and the Congestion Mitigation and Air Quality Improvement (CMAQ) Program.
Department of Veterans Affairs (VA)The VA’s Veterans Health Administration is America’s largest integrated health care system. Their National Center for Health Promotion and Disease Prevention includes talking to one’s doctor about physical activity as one of their recommended preventive services. The integrated nature of medical care through the VA would promote the implementation of exercise prescriptions to a large and vulnerable population and could serve as a model for more widespread implementation.
Health Resources and Services Administration (HRSA)HRSA offers programs to improve access to health care for people who are uninsured, isolated, or medically vulnerable, and funds grants and cooperative agreements related to its mission. Funding related to physical activity is directly related to its strategic goal to “Take actionable steps to achieve health equity and improve public health.”
National Institutes of Health (NIH)As the federal government’s medical research agency, NIH supports physical activity related research in its intramural laboratories and through research funding to scientists at other organizations. Requests for applications (RFAs) and Notices of Special Interest (NOSIs) for exercise-focused research grants can promote continued research on the impacts of physical activity on health.
Office of Minority Health (OMH)The OMH promotes the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities. Prevention through physical activity and nutrition is one of OMH’s focus areas, as are clinical conditions including diabetes and hypertension that can be prevented or treated with physical activity.
Office of Personnel Management (OPM)One role of OPM, which oversees human resources for federal employees, is to help federal agencies integrate prevention strategies into their workplace through worksite health and wellness programs and organizational and employee benefits. Examples include encouraging employees to use flexible work schedules (non-duty time) to participate in health promotion activities, allowing employees to request annual leave, leave without pay, or sick leave (as appropriate) to participate in health promotion programs, and providing short periods of excused absence for health promotion programs and activities officially sponsored and administered by the agency.

The work of several agencies and departments within the federal government relates to physical activity promotion. Current initiatives are in place, but there are also opportunities for additional efforts that could further the goal of creating a more active nation.

FIGURE 3. Agency interactions
Department, Agency, or DivisionIndividualInterpersonalOrganizationalCommunityPolicy
Administration for Children and Families (ACF)XX
Administration for Community Living (ACL)XX
Agency for Healthcare Research and Quality (AHRQ)XXX
Centers for Disease Control and Prevention (CDC)XX
Centers for Medicare and Medicaid (CMS)XX
Council on Environmental Quality (CEQ)XX
Department of Agriculture (USDA)XX
Department of Education (DE)XX
Department of Housing and Urban Development (HUD)XX
Department of the Interior (DOI)XX
Department of Transportation (DOT)XX
Department of Veterans Affairs (VA)X
Environmental Protection Agency (EPA)XX
Health Resources and Services Administration (HRSA)XX
National Institutes of Health (NIH)XX
Office of Minority Health (OMH)XXX
Office of Personnel Management (OPM)XX

These and other federal departments and agencies can coordinate action with state and local partners, for example in healthcare, business and industry, education, mass media, and faith-based settings, to implement physical activity policies. 

The CDC’s Active People, Healthy Nation initiative provides an example of this approach. This campaign, launched in 2020, has the goal of helping 27 million Americans become more physically active by 2027. By taking action steps focused on program delivery, partnership engagement, communication, training, and continuous monitoring and evaluation, the campaign seeks to help communities implement evidence-based strategies across sectors and settings to provide equitable and inclusive access to safe spaces for physical activity. According to our analysis, the strategies of the Active People, Healthy Nation initiative are aligned with the social-ecological model. The Physical Activity Policy Research and Evaluation Network, a research partner of the Active People, Healthy Nation initiative, provides an example of coordinating with partners in other sectors to promote physical activity. Through collaboration across sectors, the network brings together diverse partners to put into practice research on environments that maximize physical activity. The network includes work groups focused on equity and inclusion, parks and green space, rural active living, school wellness, transportation policy and planning, and business/industry.

The Biden-Harris Administration National Strategy on Hunger, Nutrition, and Health, announced in September 2022, also includes strategies that are consistent with a social-ecological model. The strategy outlines steps toward the goal of ending hunger and increasing healthy eating and physical activity by 2030 so that fewer Americans will experience diet-related diseases. Pillar 4 of the strategy is to “make it easier for people to be more physically active—in part by ensuring that everyone has access to safe places to be active—increase awareness of the benefits of physical activity, and conduct research on and measure physical activity.” The strategy specifies goals such as building environments that promote physical activity (e.g., connecting people to parks; promoting active transportation and land use policies to support physical activity) and includes a call to action for a whole-of-society response involving the private sector, state, local, and territory governments, schools, and workplaces.

The Congressional Physical Activity Caucus has been active in introducing legislation that can help realize the goals of the current physical activity initiatives. For example, in February 2023, Sen. Sherrod Brown (D-OH), co-chair of the Caucus, introduced the Promoting Physical Activity for Americans Act, a bill that would require the Department of Health and Human Services to continue issuing evidence-based physical-activity guidelines and detailed reports at least every 10 years, including recommendations for population subgroups (e.g., children or individuals with disabilities). In addition, members of the Caucus, along with other members of congress, reintroduced the bipartisan, bicameral Personal Health Investment Today (PHIT) Act in March 2023. This legislation seeks to encourage physical activity by allowing Americans to use a portion of the money saved in their pre-tax health savings account (HSA) and flexible spending account (FSA) toward qualified sports and fitness purchases, such as gym memberships, fitness equipment, physical exercise or activity programs and youth sports league fees. The bill would also allow a medical care tax deduction for up to $1,000 ($2,000 for a joint return or a head of household) of qualified sports and fitness expenses per year.

What progress has been made?

There are signs that some of the national campaigns are leading to changes at other levels of society. For example, 46 cities, towns, and states have passed an Active People, Healthy Nation Proclamation as of September 2023. According to the State Routes Partnership, which develops “report cards” for states based on their policies supporting walking, bicycling, and active kids and communities, many states have shown movement in their policies between 2020 and 2022, such as implementing new policies to support walking and biking and increasing state funding for active transportation. However, more time is needed to determine the extent to which recent initiatives are helping to create a more active country, since most were initiated in the past two or three years. Predating the current initiatives, the overall physical activity level of Americans increased from 2008 to 2018, but there has been little change since that time, and only about one-quarter of adults meet the physical activity guidelines established by the CDC.

Clearly, there is a critical need for concerted effort to implement the strategies outlined in current physical activity initiatives so that national policies have the intended impacts on communities and on individuals. Leveraging provisions in existing legislation related to the social-ecological model of physical activity promotion will also help with implementation. For example, title III-D of the Older Americans Act supports healthy lifestyles and promotes healthy behaviors amongst older adults (age 60 and older), providing funding for evidence-based programs that have been proven to improve health and well-being and reduce disease and injury. Physical activity programs are prime candidates for such funding. In addition, programs under the 2021 Bipartisan Infrastructure Law and the 2022 Inflation Reduction Act are helping to change the current car-dependent transportation network, providing healthier and more sustainable transportation options, including walking, biking, and using public transportation, and are providing investments in environmental programs to improve public health and reduce pollution. For example, states can use funds from the Highway Safety Improvement Program for bicycle and pedestrian highway safety improvement projects, and funding is available through the Carbon Reduction Program for programs that help reduce dependence on single-occupancy vehicles, such as public transportation projects and the construction, planning, and design of facilities for pedestrians, bicyclists, and other non-motorized forms of transportation.

Partnering with non-governmental groups working towards common goals, such as the Physical Activity Alliance, can also help with implementation. The Alliance’s National Physical Activity Plan is based on the socio-ecological model and includes recommendations for evidence-based actions for 10 societal sectors at the national, state, local and institutional levels, with a focus on making change at the community level. The plan shares many priorities with those of the Active People, Healthy Nation initiative, while also introducing new goals, such as establishing a CDC Office of Physical Activity and Health. 

With coordinated action based on established public health models, such as the social-ecological framework, federal policies can be successfully implemented to make the systemic changes that are needed to create a more active nation.


The work for this blog was undertaken before Dr. Dotson joined the Agency for Healthcare Research and Quality (AHRQ). Dr. Dotson is solely responsible for this blog post’s contents, findings, and conclusions, which do not necessarily represent the views of AHRQ. Readers should not interpret any statement as an official position of AHRQ or of the U.S. Department of Health and Human Services.

Establishing an AI Center of Excellence to Address Maternal Health Disparities

Summary

Maternal mortality is a crisis in the United States. Yet more than 60% of maternal deaths are preventable—with the right evidence-based interventions. Data is a powerful tool for uncovering best care practices. While healthcare data, including maternal health data, has been generated at a massive scale by the widespread adoption and use of Electronic Health Records (EHR), much of this data remains unstandardized and unanalyzed. Further, while many federal datasets related to maternal health are openly available through initiatives set forth in the Open Government National Action Plan, there is no central coordinating body charged with analyzing this breadth of data. Advancing data harmonization, research, and analysis are foundational elements of the Biden Administration’s Blueprint for Addressing the Maternal Health Crisis. As a data-driven technology, artificial intelligence (AI) has great potential to support maternal health research efforts. Examples of promising applications of AI include using electronic health data to predict whether expectant mothers are at risk of difficulty during delivery. However, further research is needed to understand how to effectively implement this technology in a way that promotes transparency, safety, and equity. The Biden-Harris Administration should establish an AI Center of Excellence to bring together data sources and then analyze, diagnose, and address maternal health disparities, all while demonstrating trustworthy and responsible AI principles.  

Challenge and Opportunity

Maternal deaths currently average around 700 per year, and severe maternal morbidity-related conditions impact upward of 60,000 women annually. Stark maternal health disparities persist in the United States, and pregnancy outcomes are subject to substantial racial/ethnic disparities, including maternal morbidity and mortality. According to the Centers for Disease Control and Prevention (CDC), “Black women are three times more likely to die from a pregnancy-related cause than White women.” Research is ongoing to specifically identify the root causes, which include socioeconomic factors such as insurance status, access to healthcare services, and risks associated with social determinants of health. For example, maternity care deserts exist in counties throughout the country where maternal health services are substantially limited or not available, impacting an estimated 2.2 million women of child-bearing age.

Many federal, public, and private datasets exist to understand the conditions that impact pregnant people, the quality of the care they receive, and ultimate care outcomes. For example, the CDC collects abundant data on maternal health, including the Pregnancy Mortality Surveillance System (PMSS) and the National Vital Statistics System (NVSS). Many of these datasets, however, have yet to be analyzed at scale or linked to other federal or privately held data sources in a comprehensive way. More broadly, an estimated 30% of the data generated globally is produced by the healthcare industry. AI is uniquely designed for data management, including cataloging, classification, and data integration. AI will play a pivotal role in the federal government’s ability to process an unprecedented volume of data to generate evidence-based recommendations to improve maternal health outcomes. 

Applications of AI have rapidly proliferated throughout the healthcare sector due to their potential to reduce healthcare expenditures and improve patient outcomes (Figure 1). Several applications of this technology exist across the maternal health continuum and are shown in the figure below. For example, evidence suggests that AI can help clinicians identify more than 70% of at-risk moms during the first trimester by analyzing patient data and identifying patterns associated with poor health outcomes. Based on its findings, AI can provide recommendations for which patients will most likely be at-risk for pregnancy challenges before they occur. Research has also demonstrated the use of AI in fetal health monitoring

Figure 1: Areas Where Artificial Intelligence and Machine Learning Is Used for Women’s Reproductive Health

Yet for all of AI’s potential, there is a significant dearth of consumer and medical provider understanding of how these algorithms work. Policy analysts argue that “algorithmic discrimination” and feedback loops in algorithms—which may exacerbate algorithmic bias—are potential risks of using AI in healthcare outside of the confines of an ethical framework. In response, certain federal entities such as the Department of Defense, the Office of the Director of National Intelligence, the National Institute for Standards and Technology, and the U.S. Department of Health and Human Services have published and adopted guidelines for implementing data privacy practices and building public trust of AI. Further, past Day One authors have proposed the establishment of testbeds for government-procured AI models to provide services to U.S. citizens. This is critical for enhancing the safety and reliability of AI systems while reducing the risk of perpetuating existing structural inequities. 

It is vital to demonstrate safe, trustworthy uses of AI and measure the efficacy of these best practices through applications of AI to real-world societal challenges. For example, potential use cases of AI for maternal health include a social determinants of health [SDoH] extractor, which combines AI with clinical notes to more effectively identify SDoH information and analyze its potential role in health inequities. A center dedicated to ethically developing AI for maternal health would allow for the development of evidence-based guidelines for broader AI implementation across healthcare systems throughout the country. Lessons learned from this effort will contribute to the knowledge base around ethical AI and enable development of AI solutions for health disparities more broadly. 

Plan of Action

To meet the calls for advancing data collection, standardization, transparency, research, and analysis to address the maternal health crisis, the Biden-Harris Administration should establish an AI Center of Excellence for maternal health. The AI Center of Excellence for Maternal Health will bring together data sources, then analyze, diagnose, and address maternal health disparities, all while demonstrating trustworthy and responsible AI principles. The Center should be created within the Department of Health and Human Services (HHS) and work closely with relevant offices throughout HHS and beyond, including the HHS Office of the Chief Artificial Intelligence Officer (OCAIO), the National Institutes of Health (NIH) IMPROVE initiative, the CDC, the Veterans Health Administration (VHA), and the National Institute for Standards and Technology (NIST). The Center should offer competitive salaries to recruit the best and brightest talent in AI, human-centered design, biostatistics, and human-computer interaction.

The first priority should be to work with all agencies tasked by the White House Blueprint for Addressing the Maternal Health Crisis to collect and evaluate data. This includes privately held EHR data that is made available through the Qualified Health Information Network (QHIN) and federal data from the CDC, Centers for Medicare and Medicaid (CMS), Office of Personnel Management (OPM), Healthcare Resources and Services Agency (HRSA), NIH, United States Department of Agriculture (USDA), Housing and Urban Development (HUD), the Veterans Health Administration, and Environmental Protection Agency (EPA), all of which contain datasets relevant to maternal health at different stages of the reproductive health journey from Figure 1. The Center should serve as a data clearing and cleaning shop, preparing these datasets using best practices for data management, preparation, and labeling.

The second priority should be to evaluate existing datasets to establish high-priority, high-impact applications of AI-enabled research for improving clinical care guidelines and tools for maternal healthcare providers. These AI demonstrations should be aligned with the White House’s Action Plan and be focused on implementing best practices for AI development, such as the AI Risk Management Framework developed by NIST. The following examples demonstrate how AI might help address maternal health disparities, based on priority areas informed by clinicians in the field:   

  1. AI implementation should be explored for analysis of electronic health records from the VHA and QHIN to predict patients who have a higher risk of pregnancy and/or delivery complications. 
  2. Drawing on the robust data collection and patient surveillance capabilities of the VHA and HRSA, AI should be explored for the deployment of digital tools to help monitor patients during pregnancy to ensure adequate and consistent use of prenatal care.  
  3. Using VHA data and QHIN data, AI should be explored in supporting patient monitoring in instances of patient referrals and/or transfers to hospitals that are appropriately equipped to serve high-risk patients, following guidelines provided by the American College of Obstetricians and Gynecologists.
  4. Data on housing from HUD, rural development from the USDA, environmental health from the EPA, and social determinants of health research from the CDC should be connected to risk factors for maternal mortality in the academic literature to create an AI-powered risk algorithm.
  5. Understand the power of payment models operated by CMS and OPM for novel strategies to enhance maternal health outcomes and reduce maternal deaths.

The final priority should be direct translation of the findings from AI to federal policymaking around reducing maternal health disparities as well as ethical development of AI tools. Research findings for both aspects of this interdisciplinary initiative should be framed using Living Evidence models that help ensure that research-derived evidence and guidance remain current.

The Center should be able to meet the following objectives within the first year after creation to further the case for future federal funding and creation of more AI Centers of Excellence for healthcare:

  1. Conduct a study on the use cases uncovered for AI to help address maternal health disparities explored through the various demonstration projects.
  2. Publish a report of study findings, which should be submitted to Congress with recommendations to help inform funding priorities for subsequent research activities.
  3. Make study findings available to the public to help build public trust in AI.

Successful piloting of the Center could be made possible by passage of an equivalent bill to S.893 in the current Congress. This is a critical first step in supporting this work. In March 2021, the S.893—Tech to Save Moms Act was introduced in the Senate to fund research conducted by National Academies of Sciences, Engineering, and Medicine to understand the role of AI in maternal care delivery and its impact on bias in maternal health. Passage of an equivalent bill into law would enable the National Academies of Sciences, Engineering, and Medicine to conduct research in parallel with HHS to generate more findings and to broaden potential impact.

Conclusion

The United States has the highest rate of maternal health disparities among all developed countries. Yet more than 60% of pregnancy-related deaths are preventable, highlighting a critical opportunity to uncover the factors impeding more equitable health outcomes for the nation as a whole. Legislative support for research to understand AI’s role in addressing maternal health disparities will affirm the nation’s commitment to ensuring that we are prepared to thrive in a 21st century influenced and shaped by next-generation technologies such as artificial intelligence.

A Bipartisan Health Agenda to Unite America: Innovative Ideas to Strengthen American Wellbeing

As the COVID-19 pandemic has clearly shown – American health is crucial to the health of our nation. Yet American health is under threat from all angles, from escalating chronic deadly diseases like cancer to rising mental health challenges and the growing overdose epidemic. All of these threats contribute to the United States ranking 31st in life expectancy at birth, one of the lowest in the developed world, despite having the highest health spending per capita.

At the State of the Union, the Biden Administration presented a bipartisan platform dedicated to securing the health and wellbeing of the American people, from our Veterans to our youth. An agenda is a first step – unified action on public health comes next. Evidence-based science policy can bring us closer to a healthier future. Since 2020, policy entrepreneurs have developed innovative implementation-ready policy proposals through the Day One Project (D1P) to tackle some of the biggest societal problems. Here are a few that speak to the current moment:

To combat cancer…

With the median monthly cost of cancer drugs topping $10,000, many families cannot afford the costs of caring for their loved ones. Yet, there are 1,100 FDA-approved off-patent generics that could be used for treating cancer, at a fraction of the cost. Congress should appropriate $100 million into Phase III clinical trials of off-patent generics for treating a variety of cancers. This funding can go towards the National Cancer Institute and be implemented through an open-source pharmaceutical R&D framework through accelerated progress towards accessible and affordable cures.

Environmental hazards are a growing driver of cancers, and disproportionately impact rural and disadvantaged communities. Air pollution has been linked to lung cancer, the most deadly cancer for both men and women in the US. An interagency collaboration led by National Oceanic and Atmospheric Administration and leveraging funds from the Inflation Reduction Act could deploy a network on low-cost, real-time, ground-based sensors in all 300 US cities with a population above 100,000 to track particulate matter rates. Connecting this data to relevant providers in these cities, such as federally-qualified community health centers, could inform physicians of high-risk sites to target early screening interventions. Further, materials composing American homes, from housing materials to pipe materials, and even water running in the faucets, have been identified as possible sources of carcinogens. The Biden Administration should launch the President’s Task Force on Healthy Housing and Water for Cancer Prevention to coordinate research, develop the statistical database, and prepare for regulatory actions.

Finally, innovations in primary care can also catch cancer at earlier stages in disease progression. Yet, many rural and disadvantaged communities lack access to primary care. The NIH’s $23 million investment investigating telehealth for cancer care will develop the best care strategies – but labor-market, technical, financial/regulatory barriers, and data barriers will remain for scaling to the broad population. The Biden Administration and Congress will need to collaborate to unlock barriers to delivering healthcare services directly to the American home, through reforming licensure, expanding broadband access, investing in new mobile healthcare devices, expanding Medicare and Medicaid reimbursements, and ensuring data interoperability.

To strengthen mental health…

Digital mental health technologies have enormous potential to combat the growing mental health crisis, as evidenced by the Administration’s plan on mental health research and development. Yet more work remains to build a national infrastructure for successful implementation of digital mental health services. The vast majority of digital mental health technologies are unregulated, as existing FDA standards fail to cover these emerging technologies because many do not make treatment claims. Congress should authorize Health and Human Services (HHS) to develop standards for digital mental health products to ensure clinical effectiveness, data safety, and mitigate risk. Technologies that meet these standards should then be reimbursable through Medicare and Medicaid, which will require further congressional action. Finally, the Substance Abuse and Mental Health Services Administration (SAMHSA) should create a National Center for Digital Mental Health to maintain a database of approved digital products, provide training to providers, and ensure compliance of developers with national standards.

Knowing that tech platforms can be harmful to the youth’s wellbeing, the Congress and the Administration can take several steps to protect children’s privacy. Congress can expand the technological expertise at the Department of Education (ED) to protect children’s privacy and security in schools as well as appropriate $160 million funding to the Federal Trade Commission (FTC) to expand Children’s Online Protection Privacy Act (COPPA) enforcement and further investigate technology companies extracting children’s data. The Administration can commission a task force to identify ways to protect children’s data through existing legislation such as the Family Educational Rights and Privacy Act and COPPA.

To tackle the opioid crisis…

The opioid crisis is claiming thousands of lives every year, and there is bipartisan consensus on action. The Centers for Medicare and Medicaid (CMS) has sought strategies to prevent opioid use disorders – which will require reforms to the insurance reimbursement model which less generously covers preventative services. The Biden Administration should pilot a multidisciplinary study group to implement payment for prevention, using opioid use disorders as the test case. Following the guidance of the study group, CMS should provide guidelines to contracts between states and managed care organizations (MCOs) and between MCOs and providers and provide necessary technical assistance to implement these guidelines.

To deliver on care for Veterans…

Five million veterans live in rural areas, and of those, 45% lack access to reliable broadband internet, reducing access to vital health services. To ensure Veterans remain connected to healthcare services wherever they are, the Veterans Health Administration (VHA) should partner with the Postal Service and/or Department of Agriculture to pilot telehealth hubs in rural communities using existing FY23 appropriations for telehealth. An initial focus of care delivery could be on digital mental health and suicide prevention. Going forward, care delivery innovations like this one, if successful, can inspire new policies for the broader population, if the VHA’s health policy mission is expanded. VHA should be added to strategic interagency health policy coalitions such as the ACA interagency working group on healthcare quality and Healthy People 2030 to share data, develop innovative projects, and evaluate progress.

There’s more work to be done to build a healthier future for all Americans – these ideas can be jumping off points for Executive and Congressional action. FAS will continue to develop and surface evidence-based policies that can make a difference, and submissions to the Day One project are always welcome.

118th Congress: Bioeconomy & Health Security

For the United States, the economic, societal, and national security benefits of the life sciences are vast. The U.S. bioeconomy – the part of the economy driven by the life sciences and biotech, and enabled by engineering, computing, and information science – is valued at over $950 billion. Life sciences research leads to cleaner crops through pollution-free fertilizers, and access to life-saving vaccines, like those mRNA vaccines that helped counter the devastating impacts of COVID-19. And industries built on the life sciences create good-paying jobs across the country.

The 118th Congress can adopt policy to help drive U.S. biotech and biomanufacturing to grow regional prosperity, deliver on conservation goals, and improve U.S. competitiveness and resilience. Here are some ideas.

Advancing the U.S. Bioeconomy to Create Jobs and Bolster Competitiveness. Many provisions in the bipartisan CHIPS and Science Act are intended to enable the bioeconomy. Implementation should focus on three areas: cutting-edge R&D, fundamental and publicly available tools, and biomanufacturing. To further support fundamental research, Congress could direct the National Institutes of Health (NIH) to aim to maximize returns on its massive R&D budget by piloting novel funding mechanisms with evaluation through randomized control trials, funding more high-risk high-reward research, and dedicating more funding to early-career researchers. Congress could also establish a Plant Genome Research Institute (PGRI) that would drive plant genomics research and centralize federal government activities, helping to promote crop innovation and enable a diversified, localized, and resilient food system. And to ensure all Americans benefit fully, actions should be taken to address bias in medical technology at the development, testing and regulation, and market-deployment and evaluation phases.

To promote U.S. bioindustrial manufacturing scale-up and commercialization, Congress could authorize a Bio for America Program Office at the National Institute of Standards and Technology. With appropriations, the office would house a suite of initiatives:

Importantly, Congress can help prepare and invite more Americans into skilled jobs that support the bioeconomy, building a better future for Americans in all 50 states – including people of color, people with disabilities, and people from economically disadvantaged backgrounds – by funding modernized biology education, establishing world-class entrepreneurial hubs for biotechnology in non-traditional regions of the country, and supporting equitable access to industry-recognized certificates and work-based training.

Biotech can also be leveraged to fast-track our nation’s capability to deliver on conservation goals, remediate contaminated habitats, and detect dangerous environmental toxins and pathogens. To that end, Congress could establish a national center to achieve several important goals:

Safeguarding Americans Against Biological Threats. The human and economic toll of COVID-19 has shown the need to be better prepared for future pandemics and epidemics. And yet, there is currently little to no economic incentive for pharmaceutical companies to engage in vaccine research for infectious diseases that have not, and yet could, cause a pandemic. To address this market failure, the U.S. should incentivize vaccine development for priority emerging infectious diseases through federal financing. Specifically, Congress should authorize and appropriate $10 billion to the Biomedical Advanced Research and Development Authority (BARDA) over 10 years to create an investment fund that would:

Masks, especially high quality respirators, are disease-agnostic tools that can help reduce infections from respiratory diseases like the flu virus and RSV. In turn, this can reduce the burden on doctors and hospitals, and avoid additional healthcare. To that end, the mail delivery system used to distribute COVID-19 diagnostic tests should be augmented by the addition of a masks via mail program. The COVID-19 test mailing program should be restarted and expanded to include an option for ordering one box of 10 free N95 masks every quarter, for those Americans who wish to participate. Additionally, rotating face-mask inventory from the Strategic National Stockpile in a “first in, first out” method will prevent masks from being stored past their recommended shelf life, and promote continual replenishment of the U.S.’s stockpile. The recent National Strategy for a Resilient Public Health Supply Chain, as well as the bipartisan PPE in America Act (H.R.1436) and the bipartisan PREVENT Pandemics Act (S.3799), all advocate for a rotating stock system; however, steps must be taken to better operationalize its implementation and instate a timeline. Congress should authorize the Administration for Strategic Preparedness and Response to grant the HHS Coordination Operations and Response Element key management and distribution responsibilities for critical diagnostic and preventative measures like tests and masks.

The impact of the COVID-19 pandemic was significantly worsened by the presence of diseases that persist at relatively stable case numbers within a particular region. Additional infections paired with COVID-19 infections can lead to lower survival rates and longer hospital stays, creating a drain on resources as well as higher morbidity and mortality effects. Congress should thus authorize an initiative within the Centers for Disease Control and Prevention that enhances the reporting and tracking of regional diseases and helps reduce the data gap that prevents actions and responses to countering circulating diseases. The initiative could be incorporated into S. 3814, the bipartisan Modernizing Biosurveillance Capabilities and Epidemic Forecasting Act.

Finally, the bipartisan Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) will expire in 2023. This law contains several integral provisions for national health security, public health preparedness, biosurveillance, and emergency medical countermeasures, as well as authorizations for BARDA and the Assistant Secretary for Preparedness and Response (ASPR). Congress should re-authorize PAHPAIA, as it forms the bedrock of America’s pandemic preparedness architecture, and consider expanding its purview to address aspects of other U.S. challenges such as wildfires and antimicrobial resistance.

Appropriations Recommendations

Bioeconomy in CHIPS and Science. There are many provisions critical to the U.S. bioeconomy in the CHIPS and Science Law, which Congress should ensure receive robust appropriations. These include:

Congress should provide robust appropriations to all activities, as close to the CHIPS authorizations as possible, to ensure a dynamic and innovative bioeconomy sector.

Bioproduct Pilot Program. The National Institute of Food and Agriculture’s (NIFA) Bioproduct Pilot Program (created in the Infrastructure Investment and Jobs Act, Sec. 70501) is intended to increase economic activity in rural areas of the U.S. while also lowering commercialization risks associated with bringing biobased products to market. The program aims to study the benefits of using materials derived from covered agricultural commodities for manufacture of construction and consumer products. The program’s work also enables the development of a more circular economy, where finite resources are not just extracted and consumed but also regenerated in a sustainable manner. Adopting a more circular economy ensures that wealth and other economic benefits in the form of jobs and other opportunities are created, and stay in, rural communities, while learnings can be shared throughout the U.S. innovation ecosystem.

A total of up to $5 million is available for the program for each of FY 2022 and FY 2023. The availability of funds for the program should be extended through FY 2028, with yearly increases to a level above $5 million per year according to the requests of NIFA/the program team.

Scaling and Regionalizing Networked Bioindustrial Manufacturing. The 2023 NDAA (Division A, Section 215) directs the Secretary of Defense to establish and expand a network of manufacturing innovation institutes and intermediate scale facilities for R&D, piloting, and scaling of innovative bioindustrial manufacturing processes and products. Support for these activities is critical to ensure the industrial base can leverage bioindustrial manufacturing processes for the production of chemicals, materials, and other products necessary to support national security and secure fragile supply chains. Congress should provide $500 million in appropriations across national security bioeconomy activities including $300 million for biomanufacturing innovation institutes, in accord with the NDAA.

Countering Global Malnutrition to Enhance U.S. Security. Due to the COVID-19 pandemic, environmental impacts, and conflicts like the war in Ukraine, global rates of malnutrition are at eight percent and are forecast to become even worse. Providing life-saving treatment around the world serves a core American value of humanitarianism, and a priority for U.S. national security – the newly released National Security Strategy dedicates an entire section to food insecurity.

In 2021 legislation, Congress directed USAID to advance programs to prevent and treat malnutrition around the world and develop a Global Nutrition Coordination Plan. That legislation also directed USAID to create the Nutrition Leadership Council, which can help elevate nutrition programs across U.S. global health interventions and foster collaboration with other sectors, development agencies, partner governments, and local actors. These are important steps to create a centralized food security program with harmonized funding – a system to deploy a more effective response to end global malnutrition and improve U.S. national security.

Congress should work with the Administration to begin scaling up global malnutrition assistance in FY 2024, in accord with the 2021 legislation.

Supporting the U.S. Emergency Response Workforce. The National Disaster Medical System (NDMS) is an integral part of the United States’ pandemic and hazards preparedness and response infrastructure. NDMS has a unique ability to coordinate and deliver emergency medical services to both federal and state, local, tribal, or territorial (SLTT) agencies. During the COVID-19 pandemic, NDMS deployed all across the country to provide training, medical care, coordinate medical supply delivery, and ensure effective communication. Additional appropriations would go toward hiring more personnel and bolstering in-person activities in the wake of COVID-19. Congress should ensure NDMS is funded up to FY 2024 request levels.

Return to introduction

An Overdue Fix: Racial Bias and Pulse Oximeters

The invention of pulse oximeters in the 1980s reshaped healthcare. While tracking blood oxygen content (commonly recognized as the “fifth vital sign”) once required a painful blood draw and time-delayed analysis, pulse oximeters deliver nearly instantaneous data by simply sending a pulse of light through the skin. Today, pulse oximeters today are ubiquitous: built into smartwatches, purchased at pharmacies for home health monitoring, and used by clinicians to inform treatment of everything from asthma to heart failure to COVID-19. Emerging algorithms are even incorporating pulse ox data to predict future illness.

There is a huge caveat. Pulse oximeters are medically transformative, but racially biased. The devices work less accurately on dark-skinned populations because melanin, the chemical which gives skin pigment, interferes with light-based pulse ox measurements. This means that dark-skinned individuals can exhibit normal pulse ox readings, but be suffering from hypoxemia or other critical conditions.

But because regulations to this day do not require diversity in medical device evaluation, many pulse ox manufacturers don’t test their devices on diverse populations. And because the Food and Drug Administration (FDA) has created streamlined pathways to approve new medical devices based on technology that is “substantially similar” to already-approved technology, the racial bias embedded in ‘80s-era pulse ox technology continues to pervade pulse oximeters on the market today.

COVID-19 illustrated, in devastating fashion, the consequences of this problem. Embedded bias in pulse oximeters demonstrably worsened outcomes for patient populations already disproportionately impacted by COVID-19. Studies show, for instance, that Black COVID-19 patients have been 29% less likely to receive supplemental oxygen on time and three times as likely to suffer occult hypoxemia during the pandemic. 

Similar inequities persist across the health-innovation ecosystem. Women suffer from lack of sex-aware prescription drug dosages. Minorities increasingly suffer from biased health risk-assessment algorithms. Children and those with varying body types suffer from medical equipment not built for their physical characteristics. Across the board, inequities create greater risks of morbidity and mortality and contribute to ballooning national healthcare costs. 

This need not be the status quo. If health stakeholders—including patient advocates, medtech companies, clinicians, researchers, and policymakers—collectively commit to systematic evaluation and remediation of bias in health technology, change is possible.

An excellent example is eGFR algorithms. These algorithms, used to assess kidney functionality, previously used faulty “correction factors” to account for patient race. But this correction did not actually correlate with biological realities—and instead of treating patients more effectively, it increased disparities in care. Motivated by the data, advocacy and industry organizations issued broad recommendations to avoid using the eGFR calculation. Hospitals and medical systems listened, dropping eGFR from practice, and the National Institutes of Health (NIH) is now committing funding to investigate alternative calculations.

We as a society must continue to root out bias in health technology, from development to testing to deployment.

When we develop new medical tools, we should consider all the populations who could ultimately need them. 

When we test tools, we should rigorously evaluate outcomes across subgroup populations, looking for groups that might fare better or worse from its use in care. 

And when we deploy technologies, we need to be ready to track the outcomes of their use at scale.

Engineers, researchers, and clinicians can support these goals by designing medical devices with equity in mind. The UK just launched its evidence-gathering process on equity in medical devices, looking into the impacts of bias and ways to build more equitable solutions. The FDA’s meeting reviewing the evidence on pulse oximetry is a start to auditing technologies for their performance on different populations. 

Advocacy organizations can support these goals by providing input to ongoing policy processes. The Federation of American Scientists (FAS), alongside the University of Maryland Medical System, submitted a public comment to the FDA to call for regulations that will encourage the development of low-bias and bias-free tools. FAS is also convening a Forum on Bias in Pulse Oximetry to examine the consequences of bias, build an evidence base for bias-free pulse oximetry, and look ahead to approaches to build more equitable devices. 

“Do no harm”, a central oath in medicine, is becoming exceedingly difficult in our technological age. Yet, with an evidence-based approach that ensures technologies equitably serve all groups in a population and works to correct them when they do not, we can come closer to achieving this age-old goal.

Pandemic Readiness Requires Bold Federal Financing for Vaccines

Summary

Most people will experience a severe pandemic within their lifetime, and the world remains dangerously unprepared. In fact, scientists predict a nearly 50% chance––the same probability as flipping heads or tails on a coin––that we will endure another COVID-19-level pandemic within the next 25 years. Shifting America’s pandemic response capability from reactive to proactive is, therefore, urgent. Failure to do so risks the country’s welfare. 

Getting ahead of the next pandemic is impossible without government financing. Vaccine production is costly, and these expenses will hinder industries from preemptively developing the tools needed to halt disease transmission. For example, the total expected revenues over a 20-year vaccine patent lifecycle would cover just half of the upfront research and development (R&D) costs. 

However, research suggests that a portfolio-based approach to vaccine development —  especially now with new, broadly applicable mRNA technology — dramatically increases the returns on investment while also guarding against an estimated 31 of the next 45 epidemic outbreaks. With lessons learned from Operation Warp Speed, Congress can deploy this approach by (i) authorizing and appropriating $10 billion to the Biomedical Advanced Research and Development Authority (BARDA) (ii) developing a vaccine portfolio for 10 emerging infectious diseases (EIDs), and (iii) a White House Office of Science and Technology Policy (OSTP)-led interagency effort focused on scaling up production of priority vaccines. 

Challenge & Opportunity 

The COVID-19 pandemic continues to wreak havoc across the world, with an ongoing total cost of $16 trillion and more than 6 million dead. Three conditions increase the likelihood that we will experience another pandemic that is just as disastrous: 

  1. New outbreaks of infectious diseases––like ––are emerging due to population growth, increased zoonotic transmission from animals, habitat loss, climate change, and more. Over 1.6 million yet-to-be-discovered, human-infecting viral species are thought to exist in mammals and birds.
  2. More laboratories are handling dangerous pathogens around the world, which increases the likelihood of an accidental contagion release.
  3. It is easier than ever to purchase biotechnologies once reserved only for scientists. Consequently, malign actors now have more resources to develop a human-engineered bioweapon. 

The United States and the rest of the world are still woefully unprepared for future pandemic or epidemic threats. The lack of progress is largely due to little to no vaccine development for these six EIDs, all of which have pandemic potential

Failure to produce and supply vaccines doses to Americans could undermine the U.S. government’s response to a vaccine crisis. This is illustrated in the recent monkeypox response. The federal government invested in a new monkeypox vaccine with a significantly longer shelf life. While focused on this effort, it failed to replace its existing vaccine stockpile as it expired, leaving the American population woefully unprepared during the recent monkeypox outbreak. 

An immediate national strategy is needed to course correct, the beginnings of which are articulated in the recent plan for American Pandemic Preparedness: Transforming our Capabilities. These overarching concerns were also echoed in a bipartisan letter from the Senate Health, Education, Labor, and Pensions and Armed Services Committees, urging the Biden Administration to re-establish a “2.0” version of Operation Warp Speed (OWS)––the government’s prior effort to accelerate COVID-19 vaccine production. 

The President’s recent FY23 Budget advocates for a historic pandemic preparedness investment. The plan allocates nearly $40 billion to the Department of Health and Human Services Assistant Secretary for Preparedness and Response to “invest in advanced development and manufacturing of countermeasures for high priority threats and viral families, including vaccines, therapeutics, diagnostics, and personal protective equipment.” BARDA also declared the need to prepare prototype vaccines for virus families with pandemic potential and has included such investments in its most recent strategic plan. And, the recent  calls for increased “piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice.”

Robust federal investment in America’s vaccine industry is especially needed since––as demonstrated by COVID-19––industries garner minimal profit from vaccine development before or during a widespread outbreak. A recent study predicted that in the unlikely scenario where 10 million vaccines are manufactured during a crisis response, pharmaceutical companies can expect to recoup only half of the upfront R&D costs. The same research states that “new drug development has become slower, more expensive, and less likely to succeed” because:

With clinical costs accounting for 96% of total investment, companies have a weak financial justification for investing in risky vaccine research. 

To minimize these uncertainties and improve investment returns for vaccine and therapeutic production, the federal government should embrace two key lessons from OWS: 

  1. Guaranteed government demand enables the pursuit of innovative, speedy, and effective vaccine R&D. OWS selected companies pursuing different scientific methods to develop a vaccine, each of which possessed breakthrough potential. Moderna and Pfizer/BioNTech utilized mRNA, AstraZeneca and Janssen worked with replication-defective live vectors, and Novavax and Sanofi/GSK utilized a recombinant protein. Merck is working on a live attenuated virus that may be given orally. By frequently evaluating vaccine candidates, scientists ensured that only the most promising contenders continued to subsequent regulatory phases. This workflow dramatically expedited vaccine development. Relatedly, companies were able to invest in large-scale vaccine manufacturing during clinical trials thanks to government financial support. They not only received guaranteed investment installments, but also advanced commitments to purchase vaccines. This significantly decreased the financial risk and saved tremendous amounts of time and resources. 
  2. Public-private partnerships utilize incentives and rewards to foster highly effective and dynamic teams. OWS created a “unique distribution of responsibilities … based upon core competencies rather than on political or financial considerations.” The interests of eight pharmaceutical companies were aligned based on the potential to receive an upfront commitment from the federal government to bulk purchase vaccines. Such approaches are critical to ensuring vaccine R&D not only happens in an efficient, coordinated manner but also that such R&D yields production at scale. Moreover, it enabled a suite of approaches to vaccine development rather than one method, raising the overall probability of developing a successful vaccine. 

Repeating these lessons in subsequent EID vaccine developments would generate both significant returns on investment and benefits to society. 

Plan of Action

By incentivizing vaccine development for priority EIDs, the federal government can preemptively solve market failures without picking winners or losers. 

First, Congress should authorize and appropriate $10 billion to BARDA over 10 years to create a Dynamic Vaccine Development Fund. This fund would build on BARDA’s unique competencies as an engagement platform with the private sector. would allow for new developments to emerge 

It would also enact the following strategies, gleaned from all of which were proven to be effective in OWS: 

As illustrated by its successful history, BARDA is well-positioned to manage a large-scale vaccine initiative. Last year, BARDA announced the first venture capital partnership with the Global Health Investment Corporation to “allow direct linkage with the investment community and establish sustained and long-term efforts to identify, nurture, and commercialize technologies that aid the U.S. in responding effectively to future health security threats.” During the COVID-19 pandemic, BARDA and Janssen shared the R&D costs to help move Janssen’s investigational novel coronavirus vaccine into clinical evaluation—a collaboration supported by their previous successes on the Ebola vaccine. The Government Accountability Office reported that BARDA had also supported scaled production by identifying additional manufacturing partners. This partnership record shows that BARDA not only knows how to manage global health projects to completion but also is particularly adept at interfacing with the private sector. As such, it stands out as an ideal manager for the Dynamic Vaccine Development Fund.

With $10 billion, this Fund could not only support the vaccine economy, but also save millions of lives and trillions of dollars. Although the price tag is admittedly hefty, it is reasonable. After all, OWS had a price tag of $12+ billion––a small investment compared to the $16+ trillion cost of COVID-19. As seen in OWS, the long-term benefits of upfront, robust financing are even more impactful. One back-of-the-envelope calculation suggests immense economic returns for the Fund: 

A $10 billion down payment would allow the Fund to excel in its normal operations (see bulleted list above) and support up to 120 vaccine candidates. OWS also spawned more than just new breakthrough R&D in the use of mRNA vaccine models. It also led to a health and biotechnology innovation windfall

“Now that we know that mRNA vaccines work, there is no reason we could not start the process of developing those for the top 20 most likely pandemic pathogen prototypes” 

Dr. Francis Collins, former director of the National Institutes of Health

Ten billion dollars would ensure the Fund’s impact could be similarly force-multiplied by private sector partnerships. There would be  more time available and more opportunity for creative partnerships with the private sector. The Fund’s purpose is to lower financial risks and attract large amounts of capital from the bond market, whose size outweighs the venture capital, public equity, or private equity markets. Indeed, there has been growing interest in the application of social bonds to pandemic preparedness as a unique instrument for rapidly frontloading resources from capital markets. Though this Fund will assume a different form, the International Finance Facility for Immunisation represents a proof of concept for coordinating  philanthropic foundations, governments, and supranational organizations for the purpose of “raising money more quickly.” With seed capital, this Fund could provide a strong signal — and perhaps an anchor for coordination — to debt capital markets to make issuances for vaccines. To this end, the targeted critical mass of $10 billion is estimated to generate both tremendous societal value by preventing future epidemic outbreaks as well as producing positive returns for investors. 

Second, in executing Fund activities, BARDA should leverage investment strategies––such as milestone-based payments––to incentivize maximum vaccine innovation. When combatting EIDs, the U.S. will need as many vaccine options as possible. To facilitate this outcome, vaccine manufacturers should be rewarded for producing multiple kinds of vaccines at the same time. For example, BARDA might support the development of vaccines for a given EID by funding progress for four novel methods (e.g., mRNA, recombinant protein, gene-therapy, and live attenuated, orally-administered vaccines).  

Furthermore, these rewards should come regularly during major events––or “milestones”––during development. Initial-stage milestones include vaccine candidates that protect an animal model against disease; later-stage milestones include human clinical trials. This financing model would provide companies with clear, short-term targets, reducing uncertainty and rewarding progress dynamically. Additionally, it would support the recent executive order, which calls for “increasing piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice.”

BARDA could expand the milestone-based financing mechanism further by employing early-stage challenges. In this scenario, it would only fund the first two of three candidates that successfully complete small-scale clinical trials. The final milestone stage––which should only be offered to a limited number of candidates––should provide an advanced market commitment to house complete vaccines within U.S. storage facilities, based on the interagency effort (described in the paragraph below). The selections process would retain sufficient competition throughout the development process, while ensuring a sustainable method for scaling up certain vaccines based on mission priorities.

Third, to support Fund activities towards late-stage clinical trials, the White House Office of Science and Technology Policy (OSTP) should coordinate a larger-scale interagency effort leveraging advanced market commitments, prize challenges, and other innovative procurement techniques. OSTP should be a coordinator across federal agencies that address pandemic preparedness, which might include: the Department of Defense, BARDA, the U.S. Agency for International Development, the National Institute of Allergy and Infectious Diseases, the Federal Emergency Management Agency, and the Development Finance Corporation. In doing so, the OSTP can (i) consolidate investments for particular vaccine candidates, and (ii) utilize networks and incentive strategies across the U.S. government to secure vaccines. Separately––and based on urgent priorities shared by agencies––OSTP should work closely with the Food and Drug Administration (FDA) to explore opportunities for pre-approval of vaccines as they develop through the trial phase. 

Conclusion

Vaccines are among the most powerful tools for fighting pandemics. Unfortunately, bringing vaccines to market at scale is challenging. However, Operation Warp Speed (OWS) established a new precedent for tackling vaccine innovation market failures, laying the groundwork for a new era of industrial strategy. Congress should take advantage and supercharge U.S. pandemic preparedness by enabling the Biomedical Advanced Research and Development Authority (BARDA) to build a Dynamic Vaccine Development Fund. Embracing lessons learned from OWS, the Fund would incentivize companies to create vaccines for the six emerging infectious diseases most likely to cause the next pandemic.

Frequently Asked Questions
If it takes so long to approve a new vaccine, why should we invest in developing vaccines ahead of time?

The regulatory process for approving vaccines is even more reason to develop them ahead of time—before they are needed, rather than after an outbreak. Having access to an effective vaccine even days sooner can save thousands of lives due to the exponential rate of growth of all infectious diseases. Moreover, the FDA approval process—especially its Emergency Use Authorization Program—is extremely efficient, and is not the bottleneck for vaccine development. The main delay involved in vaccine development is the time it takes to conduct randomized clinical trials. Unfortunately, there are no shortcuts to this process if we want to ensure that vaccines are safe and effective. That is why we need to develop vaccines before pandemics occur. The idea here is simply to develop the minimum viable product of vaccines for priority EIDs that positions these vaccines to rapidly scale in the event of a pandemic.

Has this large-scale, multi-use investment program been deployed elsewhere?

Yes, there are several examples of vaccine initiatives using this strategy. To list a few:



  1. The Coalition for Epidemic Preparedness Innovations (CEPI) has a “megafund” vaccine portfolio (i.e., they have 32 vaccine candidates as of April 2022). This portfolio spans 13 different therapeutic mechanisms and five different stages of clinical development, from preclinical to “Emergency Use Listing” by the World Health Organization. 

  2. BridgeBioRoivant Sciences have used portfolio-based approaches for drug development.

  3. The National Brain Tumor Society is also leveraging this approach to finance novel drug candidates that can treat glioblastoma.

Where and how would you safely store a large vaccine stockpile? When we tried this before, didn’t 20 million doses of monkeypox vaccines expire?

Ideally, vaccines in the final milestone stage would be stored in the United States and in line with new CDC guidance in the Vaccine Storage and Handling toolkit. This prevents the scenario where vaccines are held up in transit due to complex international negotiations and, potentially, expire during the lengthy proceedings. This exact scenario occurred when the 300,000 doses of monkeypox vaccine held in a Denmark-based facility were slowly and inconsistently onshored back to the U.S. 


In addition, vaccines that are financed through the Fund would not always be final products. Instead, they would potentially be at varying stages of development thanks to the milestone-based payment strategy and frequent progress reviews. This would make it easier for the federal government to closely coordinate vaccine development with manufacturing professionals and rapidly increase vaccine production if necessary. The strategy offered in this memo lowers the risk of a similar situation occurring again.


We recommend that the executive order on biomanufacturing continue exploring this issue and investigate ways to securely store completed vaccines. The Government Accountability Office, for example, recently suggested several promising and discrete changes to update the requirements and operations of the Strategic National Stockpile.

Why did you select these six emerging infectious diseases?

This list was derived from justifications listed on CEPI’s website, linked here

Why not develop a vaccine against all potential viral threats?

There are simply too many infectious diseases in nature, and most of are too rare to pose a significant threat. It would be scientifically and financially impractical––and unnecessary––to develop vaccines against all of them. However, we can greatly increase our readiness by widening our scope and developing a library of prototyped vaccines based on the 25 viral families (as called for by CEPI). Doing so would allow us to respond quickly against even unlikely pandemic scenarios.

Combating Bias in Medical Innovation

There is a crisis within healthcare technology research and development, wherein historically marginalized groups are under-researched in preclinical studiesunder-represented in clinical trialsmisunderstood by clinical practitioners, and harmed by biased medical technology. These issues in turn contribute to costly disparities in healthcare outcomes, leading to losses of $93 billion a year in excess medical-care costs, $42 billion a year in lost productivity, and $175 billion a year due to premature deaths. COVID-19 put these disparities into especially sharp focus. In December 2020, pulse oximeters, critical for healthcare monitoring during the pandemic, were shown to be much less accurate in patients with darker skin, thereby putting those patients at a greater risk of organ damage. The Food and Drug Administration (FDA) responded by issuing a safety communication, but not with any changes to regulation of pulse oximeters. 

Especially for an administration that has embedded equity throughout its policy agenda, this situation is unacceptable. The Biden-Harris Administration must act to address bias in medical technology at the development, testing and regulation, and market-deployment and evaluation phases. This will require coordinated effort across multiple agencies. In the development phase, science-funding agencies should crack down on federally funded studies that do not conduct mandatory subgroup analysis for diverse populations. Funding agencies should also expand funding for under-resourced research areas. In the testing and regulation phase, the FDA should raise the threshold for evaluation of medical technologies, make diversity requirements binding, and expand data-auditing processes. In the market-deployment and evaluation phases, the FDA should strengthen reporting mechanisms for adverse outcomes, the Federal Trade Commission (FTC) should require impact assessments of deployed technologies, and the Agency for Healthcare Research and Quality (AHRQ) should identify technologies that could address healthcare disparities.

Challenge and Opportunity

Bias is regrettably endemic in medical innovation. Drugs are incorrectly dosed to people assigned female at birth due to historical exclusion of women from clinical trials. Medical algorithms make healthcare decisions based on biased health dataclinically disputed race-based corrections, and/or model choices that exacerbate healthcare disparitiesMuch medical equipment is not accessible, thus violating the Americans with Disabilities Act. Biased studies, technology, and equipment inevitably produce disparate outcomes in U.S. healthcare.

The problem of bias in medical innovation manifests in multiple ways: cutting across technological sectors in clinical trials, pervading the commercialization pipeline, and impeding equitable access to critical healthcare advances.

Bias in medical innovation cuts across technology sectors

The 1993 National Institutes of Health (NIH) Revitalization Act required federally funded clinical studies to (i) include women and racial minorities as participants, and (ii) break down results by sex and race or ethnicity. Yet a 2019 study found that only 13.4% of NIH-funded trials performed the mandatory subgroup analysis. Moreover, the increasing share of industry-funded studies are not subject to Revitalization Act mandates — they are only governed by non-binding FDA recommendations for clinical-trial diversity. These studies frequently fail to report differences in outcomes by patient population as a result. The resulting disparities in clinical-trial representation are stark: African Americans represent 12% of the U.S. population but only 5% of clinical-trial participants, Hispanics make up 16% of the population but only 1% of clinical trial participants, and sex distribution in some trials is 67% male. Finally, many medical technologies approved prior to 1993 have not been reassessed for potential bias. One outcome of such inequitable representation is evident in drug dosing protocols: sex-aware prescribing guidelines exist for only a third of all drugs.

Bias in U.S. medical innovation — perpetuated by weak or weakly enforced federal regulations — extends beyond clinical trials. As explained below, bias pervades medical algorithms, medical devices, and the pharmaceutical sector as well. 

Algorithms

Regulation of medical algorithms varies based on end application, as defined in the 21st Century Cures Act. Only algorithms that (i) acquire and analyze medical data and (ii) could have adverse outcomes are subject to FDA regulation. Thus, clinical decision-support software is not regulated even though these technologies make important clinical decisions in 90% of U.S. hospitals

Even when a medical algorithm is regulated, regulation may occur through relatively permissive de novo pathways and 510(k) pathways. A de novo pathway is used for novel devices determined to be low to moderate risk, and thus subject to a lower burden of proof with respect to safety and equity. A 510(k) pathway can be used to approve a medical device exhibiting “substantial equivalence” to a previously approved device, i.e., it has the same intended use and/or same technological features. Different technical features can be approved so long as there are not questions raised around safety and effectiveness.

Medical devices approved through de novo pathways can be used as predicates for approval of devices through 510(k) pathways. Moreover, a device approved through a 510(k) pathway can remain on the market even if its predicate device was recalled. Widespread use of 510(k) approval pathways has generated a “collapsing building” phenomenon, wherein many technologies currently in use are based on failed predecessors. Indeed, 97% of devices recalled between 2008 to 2017 were approved via 510(k) clearance. 

Even more alarming is evidence showing that machine learning can further entrench medical inequities. Because machine learning medical algorithms are powered by data from past medical decision-making, which is rife with human error, these algorithms can perpetuate racial, gender, and economic bias. Even algorithms demonstrated to be unbiased at the time of approval can evolve in biased ways over time, with little to no oversight from the FDA. As technological innovation progresses, an intentional focus on this problem will be required.

Finally, there is not a list of approved medical algorithms on the market, making it difficult for researchers to assess them for bias.

Medical devices

Currently, the Medical Device User Fee Act requires the FDA to consider the least burdensome appropriate means for manufacturers to demonstrate the effectiveness of a medical device or to demonstrate a device’s substantial equivalence. This requirement was reinforced by the 21st Century Cures Act, which also designated a category for “breakthrough devices” subject to far less-stringent data requirements. Such legislation shifts the burden of clinical data collection to physicians and researchers, who might discover bias years after FDA approval. This legislation also makes it difficult to require assessments on the differential impacts of technology.

Like medical algorithms, many medical devices are approved through 510(k) exemptions or de novopathways. The FDA has taken steps since 2018 to increase requirements for 510(k) approval and ensure that Class III (high-risk) medical devices are subject to rigorous pre-market approval, but problems posed by equivalence and limited diversity requirements remain. 

Pharmaceuticals

The 1993 Revitalization Act strictly governs clinical trials for pharmaceuticals and does not make recommendations for adequate sex or genetic diversity in preclinical research. The results are that a disproportionately high number of male animals are used in research and that only 5% of cell lines used for pharmaceutical research are of African descent. Programs like All of Us, an effort to build diverse health databases through data collection, are promising steps towards improving equity and representation in pharmaceutical research and development (R&D). But stronger enforcement is needed to ensure that preclinical data (which informs function in clinical trials) reflects the diversity of our nation. 

Bias in medical innovation exists throughout the commercialization pipeline

Bias occurs not only in multiple medical innovation sectors, but also across the development, testing and regulation, and market-deployment and evaluation phases of the medical innovation pipeline. This can be understood through the example of pulse oximeters.

Development

Pulse oximetry was developed by Biox and given FDA approval in 1980. The technology works by shining a light through the skin and measuring the difference in light absorbance to estimate arterial oxygen saturation. Melanin absorbs visual and infrared light and will interfere at all wavelengths. No algorithm has yet been developed to account for melanin attenuation. Hence pulse oximeter calibration data does not accurately reflect Black patients.

Testing and regulation

The first pulse oximeter was approved by the FDA at a time when clinical trials did not require gender and racial diversity. Thus, the foundational, 1980s-era pulse oximeter technology upon which subsequent 510(k) clearance for pulse oximeters has been granted is one that was tested almost exclusively on white, male patient populations.

With the 510(k) clearance, only 10 people are required in a study of any new pulse oximeter’s efficacy. The FDA states that pulse oximetry study populations should have a range of skin pigmentations and must include at least two darkly pigmented individuals or 15% of the participant pool, whichever is larger. But the FDA does not provide an objective standard for “darkly pigmented”. Moreover, this requirement (i) does not have the statistical power necessary to detect differences between demographic groups, and (i) does not represent the composition of the U.S. population. Finally, FDA guidance is silent on how pulse oximetry technology should be calibrated — it does not, for instance, specifically recommend studies on melanin interference.

Market deployment and evaluation

To clinical practitioners, pulse oximeters are a metaphorical “black box”, with oxygenation calculations hidden by proprietary algorithms. When errors or biases occur in oximeter data (if they are even noticed), the practitioner may blame the patient for their lifestyle rather than the technology used for assessment. This in turn leads to worse clinical outcomes for patients with darker skin tones, as they are at greater risk of becoming sicker before receiving care. The problem is exacerbated by the fact that clinicians who use oximeter technology for the first time (as was the case during COVID-19) generally are not trained to spot factors that cause inaccurate measurements. This leads to underreporting of adverse events to the FDA — which is already a problem due to the voluntary nature of adverse-event reporting. When problems are ultimately identified during market deployment and evaluation of a given technology, government can be slow to respond. The pulse oximeter’s limitations in monitoring oxygenation levels across diverse skin tones was identified as early as the 1990s. 31 years later, despite repeated follow-up studies indicating biases, no manufacturer has incorporated skin-tone-adjusted calibration algorithms into pulse oximeters. It required the large Sjoding study, and the media coverage it garnered, for the FDA to issue a safety communication. Even then, the safety communication has not been followed with any additional regulatory action. 

Inequitable access to medical innovation represents a form of bias

Americans face wildly different levels of access to new medical innovations. As many new innovations have high cost points, these devices exist outside the price range of many smaller healthcare institutions and/or federally funded healthcare services, including Veterans Affairs, health centers, and the Indian Health Service. Emerging care-delivery strategies might not be covered by Medicare and Medicaid, meaning that patients under those systems cannot access the most cutting-edge treatments. Finally, the shift to digital health in response to COVID-19 has compromised access to healthcare in rural communities without reliable broadband access. 

Finally, the Advanced Research Projects Agency for Health (ARPA-H) has a commitment to have all programs and projects consider equity in their design. To fulfill ARPA-H’s commitment, there is a need for action across the federal government to ensure that medical technologies are developed fairly, tested with rigor, deployed safely, and made affordable and accessible to everyone.

Plan of Action

The Biden-Harris Administration should launch “Healthcare Technology for All Americans” (HTAA), a government-wide initiative to address systemic inequities in U.S. healthcare wrought by biased medical technology. Through a comprehensive approach that addresses bias in all medical sectors, at all stages of the commercialization pipeline, and in all geographies, the initiative will strive to ensure unbiased, equitable care delivery across the entire medical-innovation ecosystem. HTAA should be a joint mandate of Health and Human Services (HHS) and the Office of Science Technology and Policy (OSTP) to work with federal agencies on priorities of health equity, and initiative leadership should sit at both HHS and OSTP. 

This initiative will require involvement of multiple federal agencies, as summarized in the table below. Additional detail is provided in the subsequent sections describing how the federal government can mitigate bias in the development phase; testing, regulation, and approval phases; and market deployment and evaluation phases.

Three guiding principles should underlie the initiative:

  1. Equity should drive action. Actions should seek to improve the health of those who have been historically excluded from medical research and development. We should design standards that repair past exclusion and prevent future exclusion. 
  2. Coordination and cooperation are necessary. The executive and legislative branches must collaborate to address the full scope of the problem of bias in medical technology, from federal processes to new regulations. Legislative leadership should task the Government Accountability Office (GAO) to engage in ongoing assessment of progress towards the goal of achieving equity in medical innovation.
  3. Transparent, evidence-based decision making is paramount. There is abundant peer-reviewed literature that examines bias in drugs, devices, and algorithms used in healthcare settings — this literature should form the basis of an equity-driven approach to medical innovation. Gaps in evidence should be focused on through deployed research funding. Moreover, as algorithms become ubiquitous in medicine, every effort should be made to ensure that these algorithms are trained on representative data of those experiencing a given healthcare condition.

Addressing bias at the development phase

The following actions should be taken to address bias in medical technology at the innovation phase:

Addressing bias at the testing, regulation, and approval phases

The following actions should be taken to address bias in medical innovation at the testing, regulation, and approval phases:

Addressing bias at the market deployment and evaluation phases 

A comprehensive road map is needed

In January 2021, Senators Elizabeth Warren, Cory Booker, and Ron Wyden called for an FDA review of pulse oximetry measurements and their skin tone bias, citing the lack of understanding about clinical outcomes of this bias in their call to action. The GAO should go a step beyond this call to action and conduct a comprehensive investigation of “black box” medical technologies utilizing algorithms that are not transparent to end users, medical providers, and patients. The investigation should inform a national strategic plan for equity and inclusion in medical innovation that relies heavily on algorithmic decision-making. The plan should include identification of noteworthy medical algorithms exacerbating inequities, creation of enforceable regulatory standards, development of new sources of research funding to address knowledge gaps, development of enforcement mechanisms for bias reporting, and ongoing assessment of equity goals.

Timeline for action

Realizing HTAA will require mobilization of federal funding, introduction of regulation and legislation, and coordination of stakeholders from federal agencies, industry, healthcare providers, and researchers around a common goal of mitigating bias in medical technology. Such an initiative will be a multi-year undertaking and require funding to enact R&D expenditures, expand data capacity, assess enforcement impacts, create educational materials, and deploy personnel to staff all the above.

Near-term steps that can be taken to launch HTAA include issuing a public request for information, gathering stakeholders, engaging the public and relevant communities in conversation, and preparing a report outlining the roadmap to accomplishing the policies outlined in this memo. 

Conclusion

Medical innovation is central to the delivery of high-quality healthcare in the United States. Ensuring equitable healthcare for all Americans requires ensuring that medical innovation is equitable across all sectors, phases, and geographies. Through a bold and comprehensive initiative, the Biden-Harris Administration can ensure that our nation continues leading the world in medical innovation while crafting a future where healthcare delivery works for all.

Frequently Asked Questions
1. How will the success of HTAA be evaluated?

HTAA will be successful when medical policies, projects, and technologies yield equitable health care access, treatment, and outcomes. For instance, success would yield the following outcomes:



  1. Representation in preclinical and clinical research equivalent to the incidence of a studied condition in the general population.

  2. Research on a disease condition funded equally per affected patient.

  3. Existence of data for all populations facing a given disease condition.

  4. Medical algorithms that have equal efficacy across subgroup populations.

  5. Technologies that work equally well in testing as they do when deployed to the market.

  6. Healthcare technologies made available and affordable to all care facilities.

2. Why does this memo propose an expansive multi-agency effort instead of just targeting the FDA?

Regulation alone cannot close the disparity gap. There are notable gaps in preclinical and clinical research data for women, people of color, and other historically marginalized groups that need to be filled. There are also historical biases encoded in AI/ML decision-making algorithms that need to be studied and rectified. In addition, the FDA’s role is to serve as a safety check on new technologies — the agency has limited oversight over technologies once they are out on the market due to the voluntary nature of adverse reporting mechanisms. This means that agencies like the FTC and CMS need to be mobilized to audit high-risk technologies once they reach the market. Eliminating bias in medical technology is only possible through coordination and cooperation of federal agencies with each other as well as with partners in the medical device industry, the pharmaceutical industry, academic research, and medical care delivery.

3. Why is ARPA-H critical to this effort?

Working together to address the enormous challenge of bias in medical innovation will require communication, coordination, and collaboration. ARPA-H provides the essential platform for these three tasks. As an agency bridging academic research and industry, ARPA-H will focus on developing technologies that address some of the greatest healthcare challenges facing Americans, including inequities existing in healthcare. By committing to consider equity in every project, ARPA-H provides the basis for practice of technological development that is inclusive, responsible, and accountable. ARPA-H’s deep relationships with industry will spur medical device companies to align with ARPA-H’s processes.

4. Why create a new initiative when we have standing offices like the Office of Minority Health (OMH) focused on health equity?

Offices like the OMH do necessary work in identifying disparities in care and pointing out solutions. For example, the call for digital infrastructure improvements to improve care access for vulnerable populations has been echoed by OMH. But these offices lack the ability to operationalize multi-agency collaborations needed to address cross-cutting challenges related to medical bias. A new initiative led by the White House      in close partnership with HHS leadership is needed to ensure that the broad scope of the plan outlined in this memo is actualized.

5. What challenges might the administration encounter from industry in launching this initiative?

A significant focus of the medical device and pharmaceutical industries is reducing      the time to market for new medical devices and drugs. Imposing additional requirements for subgroup analysis and equitable use as part of the approval process could work against this objective. On the other hand, ensuring equitable use during the development and approval stages of commercialization will ultimately be less costly than dealing with a future recall or a loss of Medicare or Medicaid eligibility if inequitable outcomes are discovered. FAR regulation can also be employed to incentivize companies to adhere to equity standards in order to receive federal contracts.

6. How can the Administration build the bipartisan support necessary to secure the funding for this initiative?

Healthcare disparities exist in every state in America and are costing billions a year in economic growth. Some of the most vulnerable people live in rural areas, where they are less likely to receive high-quality care because costs of new medical technologies are too high for the federally qualified health centers that serve one in five rural residents as well as rural hospitals. Furthermore, during continued use, a biased device creates adverse healthcare outcomes that cost taxpayers money. A technology functioning poorly due to bias can be expensive to replace. It is economically imperative to ensure technology works as expected, as it leads to more effective healthcare and thus healthier people.

Eliminating Childhood Lead Poisoning Worldwide

An estimated 815 million children (one in three) around the globe have dangerous levels of lead in their bloodstream, levels high enough to cause irreversible brain damage and impose severe health, economic, and societal consequences. 96% of these children live in low- and middle-income countries (LMICs), where collectively only about $6–10 million from non-governmental organizations is available each year to address the problem. To help eliminate childhood lead poisoning worldwide, the U.S. Federal Government should (1) add blood lead level (BLL) testing to the USAID-led Demographic and Health Survey Program, (2) create a Grand Challenge for Development to end childhood lead poisoning, and (3) push forward a global treaty on lead control.

Challenge and Opportunity

Lead is a potent toxin that causes irreversible harm to children’s brains and vital organs. Elevated body lead levels result in reduced intelligence, lower educational attainment, behavioral disorders, violent crime, reduced lifetime earnings, anemia, kidney disease, and cardiovascular disease. Impacts of lead on cognitive development are estimated to cause nearly $1 trillion of income loss in LMICs annually. Adverse health effects related to lead poisoning account for 1% of the global disease burden, causing 1 million deaths annually and substantial disability.

This enormous burden of lead poisoning in LMICs is preventable. It results from a combination of sources of exposure, some of the most important being:

These sources of lead exposure have been effectively regulated in the United States and other high-income countries, which have seen average blood lead levels in their populations decline dramatically over the last 40 years. To achieve the same success, LMICs will need to prioritize policies such as:

LMICs generally face three major barriers to implementing such policies:

  1. Lack of data on blood lead levels and on the scale and severity of lead poisoning. Most LMICs have no studies measuring blood lead levels. Policymakers are therefore unaware of the extent of the problem and hence unlikely to act in response. 
  2. Lack of data on which sources of lead exposure are the biggest local contributors. Causes of lead poisoning vary spatially, but the vast majority of LMICs have not conducted source-apportionment studies. This makes it difficult to prioritize the most impactful policies. 
  3. Limited access to equipment needed to detect lead in paint, spices, water, other sources, or the environment. Without needed detection capabilities, regulators cannot investigate the lead content of potential sources, nor can they monitor and enforce regulation of known sources. 

These barriers are relatively simple to overcome, and when they are overcome do indeed result in action. As an example, at least 20 LMICs introduced legally binding lead paint regulation after the Global Alliance to Eliminate Lead Paint and its partners helped those countries confirm that lead paint was an important source of lead poisoning. Moreover, addressing childhood lead poisoning is in line with the priorities of the Biden Administration and the U.S. Agency for International Development (USAID). The Administration has already proposed an ambitious $15 billion plan to address childhood lead poisoning in the United States by eliminating lead pipes and service lines. By contributing to global elimination efforts (for only a fraction of what it will cost to solve the problem domestically), the Administration can multiply its impact on reducing childhood lead poisoning. Doing so would also advance USAID’s mission of “advanc[ing] a free, peaceful, and prosperous world”, since a reduction in childhood lead poisoning worldwide would improve health, strengthen economies, and prevent crime and conflict.

Plan of Action

Lead poisoning, from a variety of sources, affects one in three children worldwide. This is an unacceptable situation that demands action. The United States should adopt a three-part roadmap to help LMICs implement and enforce policies needed to achieve global elimination of childhood lead poisoning. 

Recommendation 1. Add blood lead level (BLL) testing to the USAID-led Demographic and Health Survey. 

USAID, through its Demographic and Health Survey (DHS), is in an ideal position to address the first barrier that LMICs face to implementing anti-lead poisoning policies: lack of data and awareness. The DHS collects, analyzes, and disseminates accurate and representative data on health in over 90 countries. Including BLL testing in the DHS would:

As such, USAID should add BLL testing of children into the DHS Biomarker Questionnaire for all host countries. This could be done in DHS revision for Phase 9, beginning in 2023. Including BLL testing in the DHS is also the first step to addressing the second barrier that LMICs face: lack of data on sources of lead exposure. BLL data collected through the DHS would reveal which countries and populations have the greatest lead burdens. These data can be leveraged by researchers, governments, and NGOs to investigate key sources of lead exposure.

BLL testing of children is feasible to carry out in the context of the DHS. It was successfully piloted in 1998 and 2002 via the DHS presence in India and Uzbekistan, but not rolled out further. Testing can be carried out using finger-stick capillary sampling and portable analyzers, so venipuncture and laboratory analysis are not required. Further, such testing can be carried out by health technicians who are already trained in capillary blood testing of children for anemia as part of the DHS. The testing can be conducted while questionnaires are administered, and results and any follow-up actions can be shared with the parent/guardian immediately. Alternatively, laboratory lead tests can be added onto sample analysis if blood draws are already being taken. Costs are low in both cases, estimated at around $10 per test. 

Recommendation 2. Create a Grand Challenge for Development to end childhood lead poisoning.

Childhood lead poisoning in LMICs is dramatically neglected relative to the scale of the problem. Though childhood lead poisoning costs LMICs nearly $1 trillion annually and accounts for 1% of the global disease burden, only about $6–10 million per year is dedicated to addressing the problem. A USAID-led Grand Challenge for Development to end childhood lead poisoning would mobilize governments, companies, and foundations around generating and implementing solutions. In particular, the Challenge should encourage solutions to the second and third barriers presented above: lack of data on sources of lead exposure and limited detection capacity. 

Recommendation 3. Push forward a global treaty on lead control.

A global push is needed to put childhood lead poisoning on the radar of decision-makers across the world and spur implementation and enforcement of policies to address the issue. The Biden Administration should lead an international conference to develop a global treaty on lead control. Such a treaty would set safe standards for lead in a variety of products (building on the Global Alliance to Eliminate Lead Paint’s toolkit for establishing lead-paint laws) and recommend regulatory measures to control sources of lead exposure. The success of the UN’s Partnership for Clean Fuels and Vehicles in bringing about global elimination of leaded gasoline illustrates that international political will to act can indeed be generated around lead pollution. 

Conclusion

By implementing this three-part roadmap the Biden administration and USAID can make a historic and catalytic contribution towards global elimination of lead poisoning. There is true urgency; the problem becomes harder to solve each year as more lead enters the environment where it will remain a source of exposure for decades to come.  Acting now will improve the health, wellbeing and potential of hundreds of millions of children. 

Frequently Asked Questions
How do we know that childhood lead poisoning is a global problem if there is very little data on it?

Though relatively little investigation has been done on childhood lead poisoning in LMICs, the studies that do exist have consistently shown very high levels of lead poisoning. A recent systematic reviewidentified studies of background levels of childhood lead exposure in 34 LMICs. According to the review, “[o]f the 1.3 billion children (aged 0–14 years) living in the 34 LMICs with acceptable data on background blood lead levels in children, approximately 632 million…were estimated to have a level exceeding the CDC [Centers for Disease Control and Prevention] reference value of 5 μg/dL, and 413 million…were estimated to exceed the previous reference value of 10 μg/dL.” Data collected by the Institute of Health Metrics and Evaluation and analyzed in a joint UNICEF/Pure Earth report published in 2020 similarly concluded that dangerously elevated BLLs affect over 800 million children worldwide.

Why are levels of lead poisoning so high in LMICs and what are the sources?

Major sources of lead poisoning in LMICs include paint, spices, cookware, pottery, pipes, cosmetics, toys, unsafe lead-acid battery recycling, unsafe e-waste recycling, and poorly controlled mining and smelting operations. High-income countries like the United States have relatively low levels of lead poisoning due to strong regulations around these sources of lead poisoning. Most high-income countries have, for instance, banned lead in gasoline and paint, set enforceable standards around the lead content of water, and imposed strong regulations around food adulteration. As a result, median BLLs in high-income countries have declined dramatically (in the United States, from 15ug/dL in the 1970s to <1µg/dL today). LMICs generally lack many of these effective controls around lead exposure and therefore have very high levels of childhood lead poisoning.

What policies and interventions need to be in place in LMICs to eliminate childhood lead poisoning?

The most important thing that can be done to tackle the scourge of childhood lead poisoning is to impose source controls that prevent lead from entering the environment or consumer products. Though the relative contributions of different sources to childhood lead poisoning differ by country, effective policies and interventions tend to include:



  • Regulations limiting the lead content of paint available on the market.



  • Regulation of lead-acid battery and e-waste recycling practices.



  • Inclusion of lead parameters in national drinking-water-quality standards.



  • Regulation of the use of lead compounds in other locally important sources, such as spices, ceramics, cookware, toys, and cosmetics. 


To enforce these policies, LMICs need testing capacity sufficient to monitor lead levels in potential exposure sources and in the environment. LMICs also need BLL monitoring to track the impact of policies and interventions. Fully eliminating childhood lead poisoning will ultimately involve abatement: i.e., removing lead already in the environment, such as by taking off lead paint already on walls and by replacing lead pipes. However, these interventions are extremely costly, with much lower impact per dollar than preventing lead from entering the environment in the first place.

Why is global childhood lead poisoning such a neglected issue despite its enormous scale?

An extreme lack of awareness, lack of data, and lack of advocacy around childhood lead poisoning in LMICs has created a vicious cycle of inattention. A large part of the problem is that lead poisoning is invisible. Unlike a disease like malaria, which causes characteristic cyclical fevers that indicate their cause, the effects of lead poisoning are more difficult to trace back.