Why the map exists
Although the U.S. had invested ~$700M in pathogen early warning in 2019 across different federal bodies, the COVID-19 pandemic caught us off guard. It wasn’t until well into the pandemic that reliable data on infection levels across the country became available.
Today, biosurveillance and early warning in the federal government remain fragmented across jurisdictions. We’ve created a comprehensive visual map of the entities that monitor biological threats across the U.S. federal government. The map is a tool to understand the fragmented landscape of federal biosurveillance and early warning efforts.
As the map makes clear, surveillance is distributed across a wide range of federal bodies, including key players like the Department of Health and Human Services (HHS), the Department of Defense (DoD), and the Department of Homeland Security (DHS), but also lesser-known efforts within the Department of Energy, the Postal Service, and Fish and Wildlife. Efforts are often siloed, leading to gaps, duplication, and uncoordinated response strategies. New stakeholders like the Advanced Research Projects Agency for Health (ARPA-H) are expected to become part of this ecosystem, further increasing the need for coordination.
Methodology and definitions
The map integrates data from multiple sources, including government agencies, non-profit reports, and international organizations, focusing solely on public programs. We’ve kept a low threshold for including government efforts and stakeholders, in order to reflect the current landscape as comprehensively as possible. We welcome feedback and additional suggestions via this feedback form.
The map will be updated periodically to maintain its status as a dynamic, interactive tool. Data collection for the first version ended in March 2024.
We’re using a color code key to delineate the functions of important nodes in the map. Since some programs fulfill several functions, we have categorized them according to their most important ones. Here are the descriptors and color code keys for the different nodes:
- Black: Policy & Coordination
- Entities that issue relevant policies, coordinate actors, and set strategic goals. Example: The White House Office of Pandemic Preparedness and Response Policy.
- Yellow: Data aggregation
- Organizations and systems that collect and synthesize data from various sources for analysis and dissemination. Example: The CDC’s SEDRIC: System for Enteric Disease Response, Investigation, and Coordination.
- Light blue: Implementation & Operation
- Entities that implement and operate biosurveillance and pathogen early warning, including fieldwork and the day-to-day management of surveillance activities. Example: GenomeTrakr Network created by the Food and Drug Administration (FDA).
- Purple: Research, Technology, and Innovation
- Initiatives focused on scientific and technological progress in pathogen detection and biosurveillance. Example: The National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative.
- Dark Blue: Regulation
- Regulatory bodies that set standards or guidelines. Example: National Institute of Standards and Technology (NIST).
- Red: Lab-based efforts & Forensics
- Laboratories and forensic units conducting pathogen analysis, genetic sequencing, and other diagnostic activities crucial for identifying and understanding infectious disease threats. Example: National Laboratories.
- Grey: Other
- Miscellaneous contributors that are not covered by the other categories. Example: The Defense Intelligence Agency.
The appendix explains how to use the map and includes both representative images and a list view of the map, for a quick overview of the departments involved.
The map includes efforts relevant to pathogen early warning, biosurveillance, and situational awareness — three interconnected yet distinct concepts in the realm of public health, health security, and biodefense:
- Biosurveillance encompasses the continuous gathering and communicating of data and information related to biological threats, including human, animal, plant, and environmental health. Biosurveillance tools are not only aimed at monitoring specific diseases but also assess the broader infectious disease landscape, including syndromic surveillance or event-based surveillance.
- Early warning for pathogens focuses on identifying and detecting emerging pathogens before they can lead to a widespread outbreak. Pathogen early warning monitors and analyzes data from various sources, such as laboratories, health care facilities, and the environment.
- Situational awareness focuses on understanding and interpreting an event in the context of its environment. It enables health officials, policymakers, and military personnel to make informed decisions about resource allocation, public health measures, and emergency response strategies.
Recommendations
Similar to how September 11th changed the U.S. conception of homeland security, the COVID-19 pandemic has changed our approach to pathogen early warning. In response to the pandemic, investments in early warning and biosurveillance occurred across the federal government. The CDC launched its Traveler-based Genomic Surveillance program; the National Wastewater Surveillance System was established; and HHS launched HHS Protect (now called the Response Ready Enterprise Data Integration platform), an operations platform for the whole-of-government response to COVID-19. Moreover, the Department of Defense conducted its first Biodefense Posture Review, prioritizing early warning capabilities to address the full spectrum of biological threats, and the National Biodefense Strategy named early warning as Goal 1.
Despite these advances, early warning and biosurveillance efforts remain fragmented across different government entities, and many initiatives focus on specific pathogens. This lack of integration and narrow focus limits the ability to detect and respond to a variety of outbreaks, especially those from unknown pathogens.
For an effective early warning system that encompasses all biological threats — whether accidental, engineered, or naturally occurring; novel, or known — four key capabilities are crucial:
- Identify: Quickly discover a biological incident is taking place.
- Detect: Determine the causative agent of a biological incident, such as a specific pathogen or toxin.
- Characterize: Analyze a pathogen to determine genetic similarities and immunological properties.
- Attribute: Determine the cause of a biological incident, such as whether a pathogen is engineered or naturally occurring.
To move away from the fragmented status quo to a comprehensive, agile, and integrated systems approach encompassing these four capabilities, we propose the following high-level recommendations:
- Prioritize Pathogen-Agnostic Capabilities:
- In order to detect novel infectious disease outbreaks, early warning systems need to incorporate pathogen-agnostic capabilities. These capabilities use advanced genomic sequencing and can detect all pathogens, including unknown ones. Currently, only a small fraction of government efforts are pathogen-agnostic, and while this fraction is evolving, increased investment in this area is needed to identify novel threats in a timely manner.
- Adopt a Layered Detection System:
- Historically, early warning systems have relied on syndromic surveillance, with astute doctors or public health officials noticing unusual clusters of infections. However, syndromic surveillance does not capture asymptomatic threats or identify the pathogen responsible.
- To ensure comprehensive detection and analysis of diverse biological threats, we cannot rely on a single data source or technology. While syndromic surveillance will continue to be an early warning layer, it should be complemented by clinical genomic data, environmental data from wastewater monitoring or aerosol detection, and input from the intelligence community, such as digital data.
- Furthermore, the many existing pathogen-specific efforts, like CDC’s CaliciNet for norovirus, should be complemented or replaced with capabilities that can identify multiple pathogens at once (multiplexed) and are not limited to known pathogens (pathogen-agnostic). Pathogen-specific systems cannot be leveraged effectively for early warning because they only confirm whether a single pathogen is present or not. Multiplexed diagnostics screen for several pathogens simultaneously, which is useful for monitoring pathogens that cause infections with common symptoms, like respiratory diseases. However, a comprehensive early warning system must incorporate pathogen-agnostic capabilities to be able to detect rare or new pathogens.
- Promote Integration and Interoperability:
- A layered system can help identify and detect credible signals by improving the signal-to-noise ratio, thereby enhancing situational awareness. But although the current biosurveillance landscape consists of different layers, they largely remain separated. For instance, the CDC has spread its biosurveillance efforts across several centers and offices and is currently reforming its Public Health Data Strategy to overcome challenges like the fact that ~70% of healthcare organizations are still using fax to send or receive care records.
- Across the federal enterprise, integrated and interoperable infrastructure is needed to promptly analyze and communicate biological incident data to key stakeholders, informing rapid decision-making and response at all levels of government. Integration within and between agencies can help identify both complementary and duplicative efforts. To aid in attribution, early warning data should also be integrated with signals from the intelligence community.
- A streamlined federal response framework is essential for effectively managing biological incidents across plant, animal, and human health. Coordination among key entities, such as HHS, DoD, DHS, the National Laboratories, and the Department of Agriculture, is vital for ensuring that responses are consistent and efficient, regardless of which agency first detects a biological threat.
- Create a National Plan for Bioattribution:
- The COVID-19 pandemic highlighted that the federal government not only seeks to detect a pathogen or toxin, but also to attribute the source — a process known as bioattribution. A key player in the federal bioattribution response is the National Biodefense Analysis and Countermeasures Center, which conducts forensic work to determine whether a pathogen is natural or engineered and assists federal law enforcement investigations.
- To keep up with advances in biotechnology, a whole-of-government approach is needed that can attribute any biological incident, including novel pathogens or those engineered to evade detection. However, a 2023 report by the Government Accountability Office points out that no articulated national strategy on bioattribution exists. The resulting lack of coordination between different federal efforts increases the risk of oversight and gaps in response efforts. The National Biodefense Strategy indicates several lead agencies for bioattribution, including DHS, HHS, the FBI, and the Department of the Interior. A clear national plan would clarify these roles, ensuring a coordinated approach across different aspects of bioattribution.
- Furthermore, a strategy should identify opportunities for routine bioattribution activities both across and within agencies, such as CDC routinely sharing biosurveillance data with the FBI or DHS. A strategy should also provide a timeline for piloting next-generation capabilities to characterize and attribute the full range of biological threats.
Appendix
Since the map is information-dense, we suggest zooming in on relevant agencies and hiding less relevant stakeholders. To do so, hover over the junction next to an agency’s name and click “collapse.”
The collapsed version looks like this:
Overview of the federal stakeholders involved
Exemplary efforts of various federal agencies
