The Key to Enabling Biosurveillance Is Cooperative Technology Development

Abstract

The world population will continue to face biological threats, whether they are naturally occurring or intentional events. The speed with which diseases can emerge and spread presents serious challenges, because the impact on public health, the economy, and development can be huge. The U.S. government recognizes that global public health can also have an impact on national security. This global perspective manifests itself in U.S. policy documents that clearly articulate the importance of biosurveillance in providing early warning, detection, and situational awareness of infectious disease threats in order to mount a rapid response and save lives. In this commentary, we suggest that early recognition of infectious disease threats, whether naturally occurring or man-made, requires a globally distributed array of interoperable hardware and software fielded in sufficient numbers to create a network of linked collection nodes. We argue that achievement of this end state will require a degree of cooperation that does not exist at this time—either across the U.S. federal government or among our global partners. Successful fielding of a family of interoperable technologies will require interagency research, development, and purchase (“acquisition”) of biosurveillance systems through cooperative ventures that likely will involve our strategic allies and public-private partnerships. To this end, we propose leveraging an existing federal interagency group to integrate the acquisition of technologies to enable global biosurveillance.

U.S. policy recognizes the importance of global public health to maintaining national security interests at home and military force posture abroad. A rapidly evolving pandemic influenza or the tainting of regional food supply chains, for example, could quickly incapacitate a forward deployed military airfield by rendering its pilots unable to fly. Such threats are insidious in their speed and impact, and they are no less effective than a direct military assault on our infrastructure. The awareness of this global threat has manifested itself in formal U.S. policy documents that have contributed (and continue to contribute) to shifts in federal department and agency missions and budget priorities that clearly recognize the validity of biosurveillance in the early recognition of infectious disease threats. The earlier in the disease outbreak cycle one can predict a threat, the more quickly response assets can be mobilized. Response is most efficient when it is initiated at the earliest possible juncture.

In calling for this national capability, Homeland Security Presidential Directive 21 (HSPD-21) discusses certain aspects related to the personnel, training, equipment, and systems needed.¹ For example, among the elements it describes as necessary for a robust and integrated national capability are enhanced clinician awareness, stronger laboratory diagnostic capabilities, integrated biosurveillance data, and an epidemiologic surveillance system with sufficient flexibility to tailor analyses to new syndromes and emerging diseases. The capability to carry out any broad emergency management mission—like biosurveillance—consists of (a) planning, (b) organization and leadership, (c) personnel, (d) equipment and systems, (e) training, and (f ) measurement and monitoring.² Hence, by deploying greater numbers of interoperable detection systems, staffed by properly trained personnel and linked into a global communication network, we could more efficiently respond to the early notification of emerging public health threats.

During a recent meeting in New Mexico on biosurveillance detection hardware and diagnostic systems,³ the question was raised about what game-changing, revolutionary technology would need to be developed in order to enable fulfillment of the global biosurveillance mission. We put forward the suggestion that much of the foundational basic research critical to in vitro identification and diagnostics already exists to enable the mission. The primary issue is that the foundational research has yet to be integrated into commercially available systems that are interoperable, affordable, or distributed globally in sufficient numbers to have broad impact. In our opinion, the real game-changing event will be the willingness of the global community to agree on where gaps in basic research exist, to jointly invest in an array of technologies to enable global biosurveillance, and to agree on policy and standards of information sharing. The global community must act quickly to augment existing World Health Organization regulations and International Health Regulations to maximize our ability to share limited resources and jointly select specific technologies in order to enable the revolutionary change that is needed to make a global biosurveillance effort successful.

There are many aspects to this complex problem, and we recognize that it would be impossible to tackle a discussion on the full scope of challenges in a single commentary. Instead, we hope to focus on one aspect of the topic: fielding interoperable hardware that could complement and benefit medical and public health communities. We focus on how the public health community can coordinate investments in improved, cost-effective technologies that will enable rapid early recognition of infectious disease threats that could affect U.S. interests at home and abroad. We discuss the cost-benefits of shared investments and suggest that a joint requirements building process be established to feed into a formal interagency research, development, and purchasing process. We propose modification of the successful CBRN Medical Countermeasures (MCM) Portfolio Initiative (“Integrated Portfolio”), which is currently a Department of Health and Human Services (HHS) and Department of Defense (DoD) partnership. We propose expansion of this group's scope beyond acquisition of MCMs to include integrated acquisition of technologies to enable global biosurveillance. In addition, we propose expanding the group's membership to include additional federal partners relevant to the expanded scope. This group could coordinate with other overarching efforts that are linked to the development of a national biosurveillance research and development (R&D) strategy. We discuss how this pathway will benefit the U.S. biosurveillance effort, why it is better than other alternatives, and what steps would need to occur to make such an effort successful.

Background

HSPD-21, Public Health and Medical Preparedness,¹ identified biosurveillance* as a critical component of public health and medical preparedness, along with countermeasure distribution, mass casualty care, and community resilience, all as they relate to human health. HSPD-21 mandated a nationwide, robust, integrated biosurveillance capability, as well as the establishment of a federal advisory committee under the Secretary of HHS. Although HSPD-21 noted the importance of a coordinated biosurveillance system that provides a common operating picture by integration of human health, animal health, and agricultural, meteorological, environmental, and intelligence data, it covered only human health surveillance in its implementing actions and suggested connection to international surveillance data only where applicable.

There are numerous federal departments and agencies that, either by statute or as a result of a presidential directive, oversee programmatic roles in biosurveillance.⁴ While remarkable progress has been made, the challenge has been to ensure that biosurveillance efforts (a) are coordinated and integrated across national and international systems, as well as among federal, state, local, and tribal governments and the private sector; (b) take into account the relative effects of biological threats in all sectors, whether environmental, vector, plant, animal, or human health; and (c) support a framework for conducting an appropriate and timely response across federal and, most important, state and local assets, including government and the private sector.

Through implementation of HSPD-21, as well as HSPD-9, Defense of United States Agriculture and Food,⁵ and HSPD-10, Biodefense for the 21st Century,⁶ among other strategic documents, the United States has made significant progress in biosurveillance and in planning responses to biological threats. Some accomplishments are:

• Publication of the National Health Security Strategy (NHSS) by HHS in 2009⁷ and its implementation plan;⁸

• Establishment of a Biosurveillance Coordination (BC)⁹ unit in the Centers for Disease Control and Prevention (CDC) and subsequent publication of the National Biosurveillance Strategy for Human Health (NBSHH) in 2008 (revised in February 2010¹⁰) and its implementation plan;¹¹

• Establishment of the National Biosurveillance Integration System (NBIS) by the Department of Homeland Security (DHS);

• Establishment of the National Animal Health Surveillance System (NAHSS)¹² by the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS);

• Establishment of the National Biosurveillance Advisory Subcommittee (NBAS), a federal advisory committee under the CDC's Biosurveillance Coordination unit; and

• Establishment of the Integrated Consortium of Laboratory Networks (ICLN).¹³

To improve global capabilities and manage the risks from naturally occurring and deliberately introduced diseases, the White House issued the National Strategy for Countering Biological Threats¹⁴ in November 2009. It calls for the development of “a strategy for advancing situational awareness and a plan that identifies key elements of information to be shared, critical sensitivities to be protected, and a framework for enabling information exchange.”¹⁴^(p12) This directive is repeated in the National Health Security Strategy and further defines situational awareness as capturing information related to health threats and response resources; this information informs and improves prevention, protection, response, and recovery operations and, ultimately, health outcomes.

A number of reports in the past several years have highlighted the successes of the federal government in initiating efforts toward a coordinated biosurveillance system, but these reports have also pointed out shortcomings in the current model—specifically, the lack of a responsible authority in the federal government to coordinate all biosurveillance efforts and the lack of a national biosurveillance strategy to guide such efforts. In June 2010, the Government Accountability Office (GAO) called for the development of such a strategy.² As it relates to investments, the GAO implied that a strategy document would provide a foundation for determining investment priorities to guide the entire interagency and intergovernmental biosurveillance enterprise.²^(p33)

Similarly, in its 2009 report, the National Biosurveillance Advisory Subcommittee offered the following recommendations related to technology investments for biosurveillance:

• Government investments in electronic health records and electronic laboratory data should be leveraged to improve how they serve biosurveillance and public health missions.

• The federal government must make strategic investments in new technologies (e.g., genomics, supply chain management, visualizations, display dashboards) to strengthen U.S. biosurveillance capabilities.¹⁵^(p2)

Although the need for a national biosurveillance strategy is clear, any overarching strategy in the area of biosurveillance will require an array of capabilities to enable its success. It will need to be complemented with a research and development strategy and an implementing roadmap to guide investment in science and technology (S&T) in order to establish the foundation on which to build a successful biosurveillance enterprise. Required capabilities may include predictive modeling, detection, threat characterization, diagnostics, integration software, leveraging electronic health records, and communications tools. Innovative research solutions such as technical hardware, interoperability, and new computational tools are not a means to an end; rather, they buttress a biosurveillance roadmap and enhance the ability to rapidly articulate relevant disease outbreak indications and streamline the process of gathering health information. Such a roadmap should identify current capabilities and gaps across all sectors of the operational community and should devise a plan to develop technologies to meet gaps. The roadmap should also identify funding gaps.

It is therefore critical that we establish a strategic vision for a national biosurveillance enterprise with state-of-the-art technologies that will enable a level of confidence that threats to public health, whether deliberate or naturally occurring, will be identified early, communicated rapidly, and responded to in a coordinated fashion.

Recommendations

Strategic investments in new technologies represent an opportunity to realize significant gains in our ability to achieve the goals articulated in HSPD-21. Toward this end, we recommend augmenting the Integrated Portfolio with a focus area on biosurveillance and expanding membership to include DHS, EPA, and USDA. Within the Integrated Portfolio, a biosurveillance action group should be assigned to implement the NBAS 2009 recommendation to establish an interagency committee to “define the strategic goals and priorities of federal investments in biosurveillance activities and technologies, and implement a plan to achieve, fund and periodically assess progress toward these goals.”¹⁵^(p2) Specific tasks would include:

1. Developing a biosurveillance R&D roadmap, with an emphasis on technologies that are flexible, adaptable, and enable prediction and early warning of health threats;

2. Proposing an interagency requirements building process to inform a formal set of biosurveillance requirements that will support the R&D roadmap and interagency acquisition;

3. Developing an acquisition strategy that maximally leverages joint investment and cooperative ventures to field an interoperable integrated biosurveillance family of systems; and

4. Conducting an assessment of current data standards, data use policies, and conformance and testing standards, which currently present barriers to data sharing and interoperability, and establishing a roadmap to integrate biosurveillance data with critical interagency nodes (eg, NBIC/NBIS and ICLN).

Expand the Integrated Portfolio

Created in 2008, the Integrated Portfolio works to produce an integrated, end-to-end national portfolio for acquisition of MCMs against chemical, biological, radiological, and nuclear (CBRN) threats, thereby capitalizing on investments and maximizing preparedness for the nation. The group is the result of the convergence of military (DoD) and civilian (HHS) CBRN MCM requirements post-9/11 that has allowed for the development of a detailed roadmap of current vaccine and therapeutic efforts in the U.S.'s R&D pipeline. This effort supports the MCM planning and alignment called for in HSPD-18¹⁶ and the vertical and horizontal coordination echoed in HSPD-21. The Integrated Portfolio optimizes the allocation of resources for MCM R&D and related infrastructure in alignment with requirements and priorities established by the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and the DoD Joint Requirements Office for CBRN Defense. To that end, the Integrated Portfolio provides a comprehensive view of DoD and HHS efforts to develop CBRN MCMs and to deliver analyses and recommendations to the PHEMCE Executive Committee and DoD Senior Leadership at the deputy assistant secretary level. To institutionalize the Integrated Portfolio for CBRN MCMs, the working group formed a Portfolio Advisory Committee (PAC) composed of government organizations, at the action officer level, that fund and manage CBRN MCM R&D programs.†

The activities of the PAC work to enhance intra- and interdepartmental collaboration in CBRN MCM development, establish a shared understanding of each individual agency's programmatic requirements, and develop an integrated set of goals. While the PAC has encountered challenges in bringing together complex programs from multiple agencies, the group has been successful in enhancing communication, coordinating product development efforts, and aligning product development, regulatory, and scientific resources with respect to prioritized programs within the MCM portfolio. Currently, the PAC does not address nonmedical or nonpharmaceutical countermeasures (eg, environmental detection or medical equipment such as diagnostic devices).

With proper resourcing and prioritization, we propose that a segment of the biosurveillance mission could be undertaken by the PAC. In order for this to be successful, the scope and membership of the Integrated Portfolio will need to be expanded. The scope of the group would need to be augmented to encompass investments in detection and diagnostic hardware and technology. While we recognize the tangible value of this effort to the biosurveillance mission, it is not envisioned that the group will engage in coordination activities on efforts such as biosurveillance data fusion tools and information technology (IT) systems, which are best handled by other ongoing efforts throughout the interagency community. Membership would also need to be expanded to include federal departments and agencies relevant to the expanded scope and to include those with equities in homeland and national security and human and animal health. We believe that this approach will work because the Integrated Portfolio charter is established, has been socialized with senior executive and congressional leaders, and is currently one of the major established efforts that will not require the development or formation of another large, bureaucratic agency. Many departments and agencies already participate in the interagency process; therefore, this proposal can blend this enhanced effort in the current integrated structure.

Both DoD and HHS, through the Integrated Portfolio, have harmonized a common set of technology readiness levels to define research pipeline and candidate maturity. Program officers from both departments have established focused networks with colleagues in other agencies. MCM development “projects in common” have been identified and further coordinated between DoD and HHS and across HHS. This has led to approaches to portfolio integration that are being implemented (eg, cost sharing, knowledge sharing, program sharing) with established memoranda of understanding that were developed between agencies to facilitate cooperation.¹⁷ A variety of working groups will be needed to tackle the full scope of integration and coordination activities, such as groups focused on tracking emerging technologies, consensus performance standards, and testing and evaluation criteria. Further, most work associated with this effort is anticipated to be done at working group and executive committee levels, with only crosscutting, strategic issues being raised to the senior leader level for decision or adjudication.

Develop an R&D Roadmap

National coordination and joint investment in detection and diagnostic hardware and associated technologies will speed proliferation of a variety of biosurveillance tools that are compatible with interoperable equipment and work in concert to drive down global prices by amortization of R&D costs, production costs, and regulatory clearance investments. The R&D roadmap should be built with overarching guidance from a national biosurveillance R&D strategy. The national R&D strategy should be published as a separate document from a national biosurveillance strategy in order to recognize the unique and vital nature of harmonized federal interagency technology investments, which are a key determinant of a successful biosurveillance strategy.

To build the national R&D roadmap for biosurveillance, it will be critical to have a mature process to determine joint capability gaps and generate joint requirements. The DoD's requirement-building process provides an effective way to translate the needs of a diverse operational community into a formal acquisition and fielding effort. Other federal departments and agencies, to include HHS and DHS, have recognized the need for formal requirements-building processes and are implementing them, but at this time the DoD's is the most mature and may serve as a model. We suggest that the interagency community set in motion a process to craft a set of joint requirements documents that capture the full spectrum of needs. These joint interagency requirements documents would be linked to the R&D roadmap if they were to serve as a foundation for the development of detailed requirements specific to an agency's mission set.

Acquisition Strategy for Interoperable Integrated Systems

In order for the federal community to agree on joint acquisition, testing, and fielding of biosurveillance hardware, it must have effective integration of its programs and a willingness to realign multiyear funding streams toward mutually agreeable objectives in support of a broad national mission. The current interagency community is not yet focused on the establishment of interoperable detection hardware or on the creation of common test and evaluation panels. There are no insurmountable obstacles that prevent the community from aligning itself toward these goals. What is necessary is a collective agreement that such efforts are a national priority for the WMD and public health communities. Therefore, if we agree on the importance of fielding technology that addresses our joint biosurveillance needs without fundamentally altering the ability of components to address their respective needs, we must recognize that significant federal department and agency authority must be granted to those entities assigned the task of prioritizing programs and shifting budgets.

In our opinion, an analysis of the technology necessary to adequately respond to and fulfill the biosurveillance mission will ultimately drive the end user community toward the development of more than a single hardware and software solution. No single piece of technology is going to do everything needed to detect or allow a clinician to confirm the presence of the full range of microbial threats having the potential to have a significant impact on the global public health community. Detection and diagnostic platforms will need to be flexible and adaptable, depending on specific mission requirements and whether the sample source is environmental, vector, plant, animal, human, or meteorological. Integrating data from numerous disparate sources is crucial to gaining a common operating picture and for early visibility into developing public health threats.

Technology is evolving at an unprecedented rate, as is the threat. The technology refresh rate of U.S. investments will need to keep pace with that of industry in order to take advantage of incremental capability gains. To achieve this, the acquisition process must be tailored to enable the quick insertion of rapidly maturing technologies having the potential to buttress biosurveillance capabilities. Furthermore, technologies must be amenable to filling the needs of a dynamic mission space and readily tailored to meet the numerous challenges posed by emerging and reemerging threats. Even if we are able to achieve true early warning, we will likely only reduce the impact of, rather than completely prevent, the spread of contagious infectious diseases.

In the case of the 2009 H1N1 pandemic, existing diagnostic assays needed to be reconfigured to detect the new variant. These assays were used to confirm suspect cases and track the spread of the disease throughout our populations. Having an agile and flexible response capability enabled public health officials to maintain situational awareness throughout the pandemic. Marrying early detection with an integrated and coordinated response plan is crucial, because without response the early detection and tracking of an emerging illness is merely a quantification of misery.

The cornerstones of this agile capability are open architecture hardware and software systems that enable the development of assays and source code by multiple entities other than the system developer (much akin to smartphone and tablets applications). Ongoing efforts to scan the horizon of CBRN hardware and software^18,19 allow us to see that we face an array of between 6 and 8 systems that will be needed to perform the mission. They range from simple (possibly disposable or single-use devices) up to high-end analytical devices capable of analyzing emerging threats at the DNA, protein, or atomic level.

Some discussions have discussed high technology and low technology equipment, but this generalization is not necessarily the best way to differentiate the kinds of hardware we may need for pushing out to remote locations where emerging infectious diseases are likely to be detected earlier. In selecting fieldable hardware it is better to differentiate by referencing a piece of hardware as being low resource intensive instead of having low technology. A consensus observation arose at the Global Biosurveillance: Enabling Science and Technology conference convened January 2011³ that is summarized in the following statement:

A cellular phone has some pretty high technology widgits inside of it, but it is really quite easy to use in the forest jungles. It doesn't require many consumables or perishable components on a regular basis. So if one were to resource a remote laboratory with a piece of diagnostic hardware, we don't necessarily need to shy away from high technology solutions unless they are also highly resource intensive.

In considering technologies for biosurveillance another question we should consider is: Can we apply emerging technologies in a manner that will provide decision makers the information needed to accurately assess the risks posed by specific threats? Responsibility for the prediction of a bio-attack resides largely in the intelligence community and will continue to be a critical component of our capability. Understanding human behavior or political instability that increases the risk of a malicious biological attack is a daunting task, but the reward for allocating biosecurity resources or alerting health community preparedness cannot be overstated. Substantial research on terrorist trends and methods that lead to behavior signatures or modeling the potential political instability in high-risk regions of the world is aiding the predictive capability for future bioterrorist attacks.^20,21 The Defense Advanced Research Projects Agency (DARPA) is performing leading-edge research on how technology enables military commanders to identify the countries that are likely to become more or less unstable in the future.²²

Research into the predictability of bio-nature, unlike a bio-attack, is much more challenging, involving the variable complexities of biological ecosystem phenomena and how these ecosystems contribute to disease dynamics. Although researchers are investigating remote sensing and geospatial and temporal technologies, and they are gaining increased knowledge of the molecular and cellular characteristics of disease transmission in converging vector-animal-human populations, much more innovation is needed to institute future capabilities in predicting naturally emerging disease.

The world population is expected to increase to 9 billion by 2050; human borders and ecological boundaries are shrinking. We are seeing vector distribution in different ways that promote new disease in naive ecosystems.^23,24 Emerging infectious diseases are increasing, and the majority of emerging zoonotic diseases that lead to human disease are derived from wildlife.^25,26 Understanding these relationships has important implications for predicting future outbreaks.

The Defense Department has a keen interest in global biosurveillance and protecting U.S. military personnel and their dependents and in building partner capacity against the impact of endemic and pandemic disease. U.S. military personnel are deployed in areas where endemic disease poses a force health protection risk.²⁷ Researchers from the U.S. government, nongovernment organizations, academia, and industry are working together to study ecologies and disease and to build warning systems to catch disease on the verge of epidemics. Defense Department laboratories were the first to identify H1N1—imagine a world where H1N1 was predicted before the first patient encounter ever occurred.

Although no empirical proof exists, the ability to develop and deliver diagnostic assays and medical countermeasures proactively rather than reactively may potentially alter the course of disease and improve morbidity and mortality. Laboratory data can provide evidence for the introduction of new vaccines, updating of existing vaccine composition, and guidelines on treatment and prevention policies and protocols at national and regional levels.²⁸ Furthermore, investing in predictive warning tools to respond to emerging pathogens and ultimately save lives is a global responsibility that could result in a profound leap ahead in biosafety and biosecurity for all of mankind.

Cracking the prediction code for a bio-attack or natural biological epidemics using interdisciplinary resources will vastly improve response and mitigate the consequences of disease. However, if biosurveillance is going to be truly successful, a national strategy that fosters cooperation at all levels of government and outside of government must lead the way. Without top-level guidance, we will continue to invest in happenstance science and technology without a cohesive national capability.

Interagency Barriers to Data Sharing

The 2008 report from the Project on National Security Reform, Forging a New Shield,²⁹ notes: “In the absence of effective integrating mechanisms and delegated authority, the interagency system is generally incapable of producing integrated policies.”²⁹^(p214) To address the difficulties of banding together hardware acquisition programs on a national and possibly global scale, the federal government will need to conduct a complete assessment of department and agency barriers to interoperability and data and information sharing. To enable a national biosurveillance strategy, and during the consideration of joint acquisition of interoperation technologies to enable biosurveillance, sharing of sensitive information among federal departments and agencies, as well as state, local, tribal, academic, and industrial partners, will have to be assessed. Development of interoperable technologies will serve no purpose if barriers to data sharing cannot be overcome.

Summary

We have put forward the supposition that the success of a global biosurveillance mission requires fielding sufficient numbers of interoperable detection and diagnostic devices in the global landscape. The acquisition of these families of systems must be augmented by standards in communication, testing, and logistical support in order to drive costs down to affordable levels. To capitalize on existing and planned federal investments that cut across multiple departments and agencies, we propose modifying the Integrated Portfolio Charter, which describes the national biodefense MCM R&D portfolio, to include the EPA, USDA, and DHS and to encompass detection and diagnostic equipment in addition to vaccines and therapeutics.

We also considered the establishment of a fresh interagency portfolio advisory committee, but this option would be more time-consuming. Since much of the expertise already exists in the Portfolio Advisory Committee, a new effort would be largely duplicative. Furthermore, the proposed framework will need to be aligned with the National Science and Technology Council's ongoing effort to craft a national R&D strategy on biosurveillance, which, when finished, will encompass a broader scope of activities to include predictive modeling, data fusion tools, and IT systems.

An expanded Integrated Portfolio endeavor will provide the ability to evaluate portfolio probability of success and articulate the required investment, identify portfolio gaps and overlaps, develop recommendations for the portfolio (“implementation planning”), implement joint portfolio oversight, enhance intra- and interdepartmental collaboration, and build a portfolio plan into budget planning. Once a codified U.S. government charter is developed and agreed to, then joint efforts through focused reviews of the integrated federal department and agency pipelines will culminate in an annual analysis of the entire biosurveillance R&D portfolio to inform all department and agency budget processes.

Clearly, there are many critical questions that must be answered by the global community over the next few years as we move toward an effective biosurveillance effort. Within U.S. agencies, we have questions about roles and responsibilities, funding, information sharing, and more. At the end of the day, there are smaller subsets of questions that are omnipresent, and those revolve around the S&T that must be deployed to gather the data that support an early warning and rapid response system. In short, whoever is in charge, wherever the funding comes from, no matter how we integrate the metadata into a coherent picture, the nation must cooperatively invest in interoperable hardware and software technologies that enable global biosurveillance architecture, along with the personnel resources and training to support these technologies.

Footnotes

*

In HSPD-21, the term biosurveillance was defined as “the process of active data-gathering with appropriate analysis and interpretation of biosphere data that might relate to disease activity and threats to human or animal health – whether infectious, toxic, metabolic, or otherwise, and regardless of intentional or natural origin – in order to achieve early warning of health threats, early detection of health events, and overall situational awareness of disease activity.”¹

†

All agencies that develop and procure MCMs in HHS (NIAID, BARDA, FDA, ASPR) and in DoD (DTRA/JSTO, JPEO-CBD/JPM-CBMS, Health Affairs, Joint Requirements Office, MRMC, DARPA).

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