Biosurveillance: Challenges and Options for the National Biosurveillance Integration Center

A biological event, such as a naturally occurring pandemic or a terrorist attack with a weapon of mass destruction, could have catastrophic consequences for the nation. This potential threat underscores the importance of a national biosurveillance capability—that is, the ability to detect biological events of national significance to provide early warning and information to guide public health and emergency response. The 9/11 Commission Act of 2007 addresses this capability, in part, by creating NBIC within the Department of Homeland Security (DHS); it was tasked with integrating information from human health, animal, plant, food, and environmental monitoring systems across the federal government, to improve the likelihood of identifying a biological event at an earlier stage. In recent years, NBIC's budget has ranged from $10 million to $13 million annually.

GAO was asked to evaluate NBIC. This report discusses the (1) extent to which NBIC is implementing its roles as a biosurveillance integrator, and (2) options for improving such integration. To conduct this work, GAO reviewed NBIC products and activities; conducted interviews and surveyed 19 federal partners, 11 of which have key roles in biosurveillance; interviewed NBIC officials; and analyzed the 9/11 Commission Act, NBIC Strategic Plan , and National Strategy for Biosurveillance .

The National Biosurveillance Integration Center (NBIC) has activities that support its integration mission, but faces challenges that limit its ability to enhance the national biosurveillance capability. In the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Commission Act) and NBIC Strategic Plan , GAO identified three roles that NBIC must fulfill to meet its biosurveillance integration mission. The following describes actions and challenges in each role:

Analyzer: NBIC is to use technology and subject matter expertise, including using analytical tools, to meaningfully connect disparate datasets and information for earlier warning and better situational awareness of biological events. GAO found that NBIC produces reports on biological events using open-source data, but faces challenges obtaining data and creating meaningful new information. For example, most of the federal partners with key roles in biosurveillance (8 of 11) stated that NBIC's products help their agencies identify biological events to little or no extent, generally because they already obtain such information directly from other federal partners more quickly. In addition, data that could help to identify and characterize a biological event may not exist or are not in a usable form. Further, few federal partners (5 of 19) reported that they share the data they do have with NBIC, citing legal and regulatory restrictions, among other reasons..

Coordinator: NBIC is to bring together partners across the federal biosurveillance community to enhance understanding of biological events. NBIC has developed procedures and activities to coordinate with partners, such as daily and biweekly calls, but faces challenges related to the limited partner participation in the center's activities, lack of partner personnel detailed to NBIC, and competing structures for convening federal partners. For example, although NBIC would like to obtain liaisons from each of its federal partners, only 3 of 19 partners provided NBIC with dedicated liaisons.

Innovator: NBIC is to facilitate the development of new tools to address gaps in biosurveillance integration. GAO found that NBIC has efforts underway to develop some tools, such as pilot projects examining the use of social media data to identify health trends, but faces challenges prioritizing developmental efforts. For example, partners noted limitations in NBIC's ability to address gaps, like limited resources and the difficulty in prioritizing the center's innovation efforts because its partners have diverse needs.

GAO identified various options that could address these challenges, ranging from strengthening the center's ability to implement its current roles to repealing NBIC's statute. GAO also identified potential benefits and limitations with each option. For example, one option would be to provide NBIC with additional authorities to obtain data to better develop meaningful information; however this may also require additional investments. Another option is to not pursue national biosurveillance integration through NBIC and to consider designating one of the other federal partners with key roles in biosurveillance as the federal integrator. The options identified are not exhaustive, and some could be implemented together or in part. GAO did not evaluate the financial implications of each option, but acknowledges some options may require additional investment or shifting of resources or priorities to result in significant long lasting change.

GAO is not making recommendations. GAO provided this draft to DHS and its federal partners who provided technical comments which were incorporated, as applicable.

A biological event, such as a naturally occurring pandemic or a terrorist  attack with a weapon of mass destruction, could have catastrophic  consequences for the nation. Although Ebola did not cause many U.S.  casualties, the outbreak in West Africa from 2013 through 2015  underscored the importance of developing and maintaining a national  biosurveillance capability—that is, the ability to detect biological events of  national significance with the aim of providing early warning and better  information to guide public health and other types of emergency  response. Further, because the data needed to detect an emerging  infectious disease or bioterrorism threat may come from a variety of  sources, the ability to share and analyze data from multiple sources may  help officials better collaborate to analyze data and quickly recognize the  nature of a disease event and its scope.

The Implementing Recommendations of the 9/11 Commission Act of  2007 (9/11 Commission Act) established the National Biosurveillance  Integration Center (NBIC) within the Department of Homeland Security  (DHS); it was specifically tasked with integrating and analyzing  information from human health, animal, plant, food, and environmental  monitoring systems across the federal government and supporting the  interagency biosurveillance community. In analyzing this act, as well as  the August 2012 NBIC Strategic Plan, we identified three general roles  that NBIC, as a federal-level biosurveillance integrator, must carry out to  achieve the duties and outcomes described by NBIC’s authorizing  legislation: (1) Analyzer, (2) Coordinator, and (3) Innovator.

As an Analyzer, NBIC is to use technological tools and subject matter  expertise to develop shared situational awareness by creating  meaningful new insights from disparate datasets and information that  could not be gleaned in isolation.

As a Coordinator, NBIC is to bring together multi-disciplinary partners  across interagency organizations to enhance understanding of new or  potential biological events, such as through the collaborative  development of products and services.

As an Innovator, NBIC is to facilitate the development of new tools,  technology, and approaches to address gaps in biosurveillance  integration.

In December 2009, we reported that NBIC was not fully equipped to carry  out its mission because it lacked key resources—data and personnel— from its partner agencies, which may have been at least partially the  result of collaboration challenges it faced. For example, some partners  reported that they did not trust NBIC to use their information and  resources appropriately, while others were not convinced of the value that  working with NBIC provided because NBIC’s mission was not clearly  articulated. In order to help NBIC enhance and sustain collaboration,  including the provision of data, personnel, and other resources, we  recommended that NBIC develop a strategy for addressing barriers to  collaboration and develop accountability mechanisms to monitor these  efforts. As previously noted, in August 2012, NBIC issued the NBIC  Strategic Plan, which is intended to provide NBIC’s strategic vision, clarify  the center’s mission and purpose, articulate the value that NBIC seeks to  provide to its partners, and lay the groundwork for setting interagency  roles, responsibilities, and procedures. Further, in November 2014, NBIC  completed its first biannual NBIC Federal Stakeholder Survey, which  NBIC uses to assess the usefulness of its products and activities and to  determine what improvements should be made on the basis of those  results. We believe these actions addressed the recommendations in our  prior report.

You expressed interest in determining what progress NBIC has made in  contributing to the national biosurveillance capability. This report’s  objectives are:  1.  To what extent is NBIC implementing its roles as a biosurveillance  integrator?  2.  What are options for improving federal biosurveillance integration, and  what are their benefits and limitations?

To determine the extent to which NBIC is implementing its role as a  biosurveillance integrator, we conducted structured interviews with 19  federal departments and their component agencies across 13 of the 14  departments and agencies that compose the National Biosurveillance  Integration System (NBIS)—the federal partners that NBIC is responsible  for coordinating because they have missions and resources that can  contribute to earlier detection and shared situational awareness for  biological events of national significance. Although NBIC has interaction  with other stakeholders, we selected these 19 federal agencies based on  their biosurveillance roles and responsibilities and because they were  federal departments or components within federal departments that have  signed the NBIC Advisory Board charter—signifying their participation in  the NBIS. Prior to conducting our structured interviews, we provided a  list of these agencies to NBIC and senior NBIC officials agreed that the  agencies we identified represented the partners with which the center had  the most interaction and collaboration. We discussed with these NBIS  partners the extent to which NBIC has enhanced the national  biosurveillance capability by carrying out its national integrator roles and  any challenges the center has faced in doing so, including the extent to  which NBIC’s products and activities enhance the agency’s situational  awareness of biological events. Within these agencies, we interviewed  officials who serve on NBIC’s Advisory Board or its Interagency Working  Group, as well as other relevant officials that regularly interact with NBIC,  review the center’s products, or participate in the center’s activities. As  part of this review, we did not interview or survey NBIC’s nonfederal  stakeholders, such as state, local, tribal, or territorial agencies.

We also conducted a Web-based survey of the 19 agencies to identify the  federal agencies from which they obtain information that contributes to  their agency’s situational awareness of biological events, the methods  through which they share information from NBIC, and the extent to which  they participate in NBIC activities. We obtained a 100 percent response  rate on this survey.  In the survey, we asked each agency whether it  obtains information from each of the other agencies in our population, as  well as which types of information it obtains from them (perception-,  comprehension-, or projection-related information). We performed a  network analysis of these survey data, which is a quantitative and  graphical technique for identifying the underlying patterns in a complex  system of relationships among entities of interest. Additional information  on our survey methodology can be found in Appendix II.

Further, we reviewed NBIC products, such as its daily Monitoring List e- mail and Biosurveillance Event Reports, and observed some NBIC  activities, such as its daily and bi-weekly calls. We reviewed key  documents that guide NBIC’s activities and products, such as the August  2012 NBIC Strategic Plan, the July 2012 National Strategy for  Biosurveillance, and the White House’s Office of Science and Technology  Policy’s June 2013 National Biosurveillance Science and Technology  Roadmap (S&T Roadmap). We also reviewed other relevant documents,  such as NBIC’s Advisory Board’s charter, standard operating procedures  for the center’s activities and protocols, memorandums of understanding  and interagency agreements between NBIC and its federal partners, the  results of NBIC’s Federal Stakeholder Survey, and evaluations of NBIC’s  pilot projects. We also interviewed NBIC officials to obtain their opinions  on the extent to which NBIC is implementing its roles as a biosurveillance  integrator and enhancing the national biosurveillance capability.

To identify options for improving federal biosurveillance integration, as  well as their benefits and limitations, we examined the 9/11 Commission  Act to identify tasks and responsibilities that NBIC, as a federal-level  biosurveillance integrator, is to carry out. We analyzed documents that  identify potential gaps and needs in biosurveillance integration, including  the National Strategy for Biosurveillance and the S&T Roadmap. We also  obtained information from our structured interviews with NBIC’s federal  partners on their views about what else, if anything, the center could be  doing to better enhance the national biosurveillance capability. Given the  challenges described by NBIC’s federal partners, we identified options for  policy or structural changes. Although these options are not exhaustive,  they represent a range of potential actions that could be taken to better  fulfill the biosurveillance integration mission described in the 9/11  Commission Act.

We conducted this performance audit from July 2014 to September 2015  in accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

According to the July 2012 National Strategy for Biosurveillance,  biosurveillance is the ongoing process of gathering, integrating,  interpreting, and communicating essential information related to all- hazards threats or disease activity affecting human, animal, or plant  health, for the purpose of (1) achieving early detection and warning, (2)  contributing to overall situational awareness of the health aspects of the  incident, and (3) enabling better decision making at all levels. As defined  in the NBIC Strategic Plan, biosurveillance integration is combining  biosurveillance information from different sources and domains (e.g.,  human, animal, and plant health; food and environmental safety and  security; and homeland security) to provide partners and stakeholders  with a synthesized view of the information, and what it could mean. The  goal is to create new meaning—that is, to provide insights that cannot be  gleaned in isolation, leading to earlier warning of emerging events and  shared situational awareness.

Example of a biological event monitored  by the National Biosurveillance Integration  Center:   Middle East respiratory syndrome coronavirus  (MERS-CoV)  Since first recognized in September 2012 in  Saudi Arabia, MERS-CoV has been detected  in nearly 30 countries, including the United  States. As of July 2015, there have been  more than 1,300 confirmed cases and over  500 deaths, the vast majority of which have  been in Saudi Arabia. Two cases have been  detected in the United States from patients  who had recently travelled to Saudi Arabia.   MERS-CoV is characterized as a potentially  severe respiratory illness and symptoms may  include fever, cough, shortness of breath,  congestion of the nose and throat, and  diarrhea. Camels are considered the likely  source for human infections. As of June 2015,  human-to-human transmission has been  limited and the risk of infection to travelers  visiting the Arabian Peninsula is considered to  be low. made in a shared risk environment that considers all domains. According  to the NBIC Strategic Plan, shared situational awareness across the  biosurveillance community is achieved cooperatively by entities that  integrate mission essential, overlapping portions of their individual  situational awareness for a unified purpose, leading to a common picture  or understanding of potential and ongoing biological events. Further, the  plan notes that shared situational awareness of the broader biological  domain may provide insights that cannot be gleaned in isolation, and thus  enhance the likelihood of identifying an event earlier and with more  certainty.

The importance of biosurveillance integration has also been described by  key national planning documents. In July 2012, the White House issued  the National Strategy for Biosurveillance, which describes the U.S.  government’s approach to strengthening biosurveillance. Although the  strategy does not specifically identify roles for NBIC, it does emphasize  the need for integration across disparate information sources, including  data derived from intelligence, law enforcement, environmental, plant,  animal, and other relevant areas. In June 2013, the White House’s Office  of Science and Technology Policy issued the S&T Roadmap. Building  upon the National Strategy for Biosurveillance, the Roadmap identifies  biosurveillance capability needs and key research and development  priorities, including those related to integration. For example, the roadmap  proposes the development of a national, interagency biosurveillance data- sharing framework that integrates data and information from disparate  sources, as well as the development of tools that enhance the efficient  manipulation of large data sets, including social media.

NBIC’s Roles, Responsibilities, and Governance

As shown in table 2, the 9/11 Commission Act outlines certain  requirements for NBIC. Drawing upon these requirements as well as the  July 2012 NBIC Strategic Plan, we identified three main roles that NBIC,  as a federal-level biosurveillance integrator, must carry out to achieve the  duties and outcomes described by NBIC’s authorizing legislation. Senior  NBIC officials agreed that these three roles are consistent with the  center’s responsibilities. These roles are not mutually exclusive and can  reinforce one other. For example, NBIC’s efforts as an Innovator might  result in the in the development of data that could enhance its role as an  Analyzer by providing the center with another dataset to review.

Example of a biological event monitored  by the National Biosurveillance Integration  Center:   Ebola virus disease (EVD)  Since late 2013, the World Health  Organization (WHO) has reported a  cumulative over 27,000 suspected, probable,  and confirmed cases of EVD and over 11,000  related deaths as of June 2015.The vast  majority of cases have been in West Africa,  but there have also been cases in the United  States. Eleven cases of EVD have been  treated in the U.S., of which 9 recovered and  2 patients died. Of the 11 cases, 9 were  presumed to have been contracted in West  Africa and 2 were presumed to have been  contracted at a Texas hospital by nurses  treating an infected patient.   EVD symptoms typically develop 2 to 21 days  after exposure to Ebola virus. Symptoms  include fever, headache, joint and muscle  aches, impaired liver and kidney function,  stomach pain, and death. Although the WHO  has classified the West African EVD epidemic  as a Public Health Emergency of International  Concern, the outbreak is considered to be  unlikely to significantly affect U.S. public  health.

Example of a biological event monitored  by the National Biosurveillance Integration  Center:   Measles in the United States  From December 2014 through February 2015,  state and local health departments reported  171 measles cases across 20 states and the  District of Columbia. Most of these cases had  been associated with an ongoing outbreak  associated with Disneyland theme parks in  California.   Measles is a highly contagious viral illness  that can spread rapidly in communities without  proper vaccination. Symptoms include high  fever, cough, runny nose, watery eyes, rash,  and death. Measles was officially declared  eliminated in the U.S. in 2000 and cases in  the U.S. have primarily the result of  international travel to countries experiencing  outbreaks. Outbreaks in the U.S. have  persisted mainly due to the increase in  unvaccinated people.

DHS to assist in achieving NBIC goals. The board is to meet at least  twice a year and is to be chaired by DHS’s Chief Medical Officer, with a  cochair that is to be rotated annually among the federal partners by a  majority vote. The NBIC Advisory Board members are to provide formal  recommendations to the Advisory Board Chair and Cochair on: (1)  identifying, prioritizing, and addressing NBIC and other appropriate  operational and programmatic needs; (2) reviewing draft guidance and  other supporting documents related to national biosurveillance strategy  and policy, as appropriate; and (3) improving communications and  collaboration among local, state, tribal, territorial, and federal interagency  partners. The NBIC Interagency Working Group is to provide support and  respond to taskings from the Advisory Board to assist in addressing NBIC  operational, programmatic, and scientific issues. The working group is to  consist of senior-level federal officials from NBIS member departments  and agencies and the Executive Office of the President who are  authorized to make recommendations on behalf of their organizations.  Each agency is to have at least one working group member, but can have  more based on the relevance to their missions of the topics to be covered  by the working group or subworking groups. The working group is to meet  as needed, but generally more frequently than the Advisory Board,  according to NBIC officials.

The NBIS is a consortium of federal partners that was established to  rapidly identify and monitor biological events of national concern and to  collect; analyze; and share human, animal, plant, food, and environmental  biosurveillance information with NBIC. The NBIS community predated  the enactment of the 9/11 Commission Act. Beginning in 2004, DHS  coordinated the NBIS community and developed an information  technology (IT) system to integrate other agencies’ biosurveillance  information, an effort that was moved among several DHS directorates,  including DHS’s Science and Technology Directorate. In 2007, DHS  created the Office of Health Affairs, headed by the DHS Chief Medical  Officer, to lead DHS’s biodefense activities and provide timely incident- specific guidance for the medical consequences of disasters. At that time,  DHS placed the responsibility for coordinating the NBIS in the Office of  Health Affairs. Shortly after that, the 9/11 Commission Act created NBIC  and gave it responsibility for coordinating the NBIS. NBIC has remained  in the Office of Health Affairs since that time.

Example of a biological event monitored  by the National Biosurveillance Integration  Center:   Porcine epidemic diarrhea virus (PEDv)  Since Spring 2013, there have been 11,364  confirmed samples of PEDv from 35 states as  of April 2015. As a result, 5 countries and the  European Union issued trade restrictions  against U.S. swine imports, some of which  have since lifted those restrictions. Hog and  pig farming is a multi-billion dollar industry.  However, despite earlier predictions, the  economic decline due to PEDv has not been  as drastic as predicted.  PEDv is a highly infectious virus specific to  swine and does not affect humans or other  species. Symptoms in pigs include diarrhea,  vomiting, and anorexia, and is particularly  deadly to young pigs. In June 2014, the U.S.  Department of Agriculture issued a Federal  Order requiring mandatory reporting of all  novel swine enteric coronavirus diseases,  including PEDv.

Commission Act outlines a number of responsibilities for member  agencies. For example, the member agencies are to use their best  efforts to integrate biosurveillance information into NBIC and connect their  biosurveillance data systems to the NBIC data system under mutually  agreed protocols. Further, per the act, member agencies are to provide  personnel to NBIC under an interagency personnel agreement and  consider the qualifications of such personnel necessary to provide  human, animal, and environmental data analysis and interpretation  support to NBIC.

We surveyed and interviewed officials from 19 federal departments and  their component agencies across 13 of the 14 departments and agencies  that compose the NBIS. On the basis of their roles and responsibilities  related to biosurveillance, we categorized the NBIS partners agencies  into three groups:

Primary biosurveillance agencies: Primary biosurveillance agencies  have major biosurveillance mission responsibilities that include  collecting or analyzing biosurveillance information for the purposes of  detecting, monitoring, or responding to biological events. These  agencies generate information and develop subject matter expertise  in pursuit of their missions that is directly relevant to disease detection  and monitoring. In addition, they consume information from multiple  sources—including nonfederal sources—to help achieve their  missions. Examples of primary biosurveillance agencies include  HHS’s Centers for Disease Control and Prevention (CDC) and  USDA’s Animal and Plant Health Inspection Service (APHIS). Eleven  of the 19 NBIS partners we interviewed and surveyed are primary  biosurveillance agencies.

Support biosurveillance agencies: Support biosurveillance  agencies do not have missions that directly involve disease detection  and monitoring; however, they collect data and information or have  subject matter expertise that may be useful to efforts to detect,  monitor, or respond to biological events. For example, the Department  of Commerce’s National Oceanic and Atmospheric Agency collects  meteorological data that may be used by NBIC to help inform the  officials about progression of an outbreak based on weather patterns.  Five of the 19 NBIS partners we interviewed and surveyed are  support biosurveillance agencies.

Biosurveillance information consumers: Biosurveillance  information consumers generally do not have missions that directly  involve disease detection and monitoring and generally do not  produce information that is useful for biosurveillance. However, they  consume such information because biological events can affect their  main mission and they may have a particular role to play in  responding to an event. For example, officials from DOT stated that  their department consumes biosurveillance information because  biological events can affect the national transportation system and  transporting people and items through a contaminated area can  further exacerbate a biological event. Three of the 19 NBIS partners  we interviewed and surveyed are biosurveillance information  consumers.

Figure 1 and appendix I describe the missions and biosurveillance  responsibilities of the 19 NBIS partners we interviewed and surveyed.

Click on highlighted departments or agencies for more information. Click    to close. For a printer-friendly version, see app. I.

Primary biosurveillance agencies: Have major biosurveillance mission responsibilities that include collecting or  analyzing biosurveillance information for the purposes of detecting, monitoring, or responding to biological events.

Support biosurveillance agencies: Do not have missions that directly involve disease detection and monitoring;  however, they collect data and information or have subject matter expertise that may be useful to efforts to detect,  monitor, or respond to biological events.

Biosurveillance information consumers: Generally do not produce information that is useful for biosurveillance,  but consume such information because biological events can affect their main mission and they may have a  particular role to play in responding to an event.

To fulfill its Analyzer role, NBIC develops a variety of products to enable  early warning and enhance situational awareness of biological events, but  the center faces challenges related to its ability to develop products that  contribute meaningful information and has difficulty obtaining  biosurveillance data.

NBIC’s Analyzer Role Products and Activities

NBIC’s efforts to fulfill its Analyzer role include a variety of products and  activities designed to enable early warning and shared situational  awareness. As part of its daily analytic process, NBIC analysts review two  main types of information: (1) open source, such as media reports,  foreign, national, state, and local government agency websites, and  industry and professional association reports and websites, and (2)  partner-provided. First, to identify relevant open-source information, NBIC  uses both automated and manual methods. For example, in addition to  conducting manual searches of media, NBIC analysts also access  commercial open source data feeds such as HealthMap and DOD’s  National Center for Medical Intelligence’s (NCMI) Arkham data feeds,  which provide open-source information in more than 80 languages that   are translated automatically into English. Second, NBIC also relies on  finished analytical products from NBIS partners, which may be obtained  directly from partners or are available publically on agency websites.  These products are usually received or obtained as written reports that  represent the agency’s analysis and interpretation of the raw data that it  collects on a routine basis or for a specific event. NBIC analysts may also  make requests for information to NBIS partners for additional information.

24 hours a day: Department of  Homeland Security’s Office of Health  Affairs Watch Desk evaluates open- source biosurveillance information using  a variety of tools and sources, which will  inform the development of future  products. NBIC analysts review watch  desk information and reports from  federal partners to identify items of  potential significance.  Late morning: Analysts conduct a daily  internal NBIC discussion to determine  items of significance and decide  additional actions that are required.  Afternoon: The Daily Biosurveillance  Review is distributed to internal  recipients including agency liaisons, and  serves as a tool that generates a record  of what was known, at what time, and  from what source.    Late afternoon: Monitoring List is  distributed via e-mail to federal partners  and other domestic and international  stakeholders to update them on items  being monitored, as well as other reports  published by NBIC.

NBIC produces a variety of regular products to enable early warning and  enhance situational awareness, including its daily Monitoring List,  Biosurveillance Event Reports, and Special Event Reports, as well as by  responding to requests for information from its partners. NBIC’s  Monitoring List is a daily e-mail that contains brief summaries on acute,  ongoing biological events of concern or interest to the NBIS partners.  Biosurveillance Event Reports provide additional detail on specific events.  For example, throughout 2015, NBIC produced such reports on the  Middle East respiratory syndrome coronavirus, highly pathogenic avian  influenza, Ebola virus disease, measles, and porcine epidemic diarrhea  virus, among others. NBIC has also produced Special Event Reports at  the request of state and local authorities in advance of mass gathering  events, such as the Super Bowl and the Little League World Series. NBIC  also responds to requests for information from the NBIS partners and  other stakeholders.

According to agency officials we spoke with and strategic documents we  reviewed, NBIC faces challenges in implementing its Analyzer role,  including its limited ability to develop products that contribute meaningful  information to its partners and difficulty obtaining biosurveillance data.

Products That Provide New Meaningful Information  Primary biosurveillance agencies generally reported that NBIC’s products  do not provide them with meaningful information because those products  contain information that they either already generate themselves or could  obtain directly from other NBIS partners more quickly. As illustrated in  figure 2, during our structured interviews, 8 of 11 primary biosurveillance  agencies reported that NBIC products and activities help their agency  identify potential or ongoing biological events (i.e., perception) to little or  no extent. For example, officials from 2 of these agencies stated that  much of the information in NBIC’s products related to their respective  domains do not inform their biosurveillance activities because this  information generally originates from reports that their agencies release  publically. partners reported that NBIC’s products contain much information of which  they are already aware or could access regardless of their participation  with NBIC. For example, as illustrated by figure 3, EPA officials reported  that their agency obtains information that enhances all three elements of  situational awareness from seven agencies, including APHIS, CDC, and  NBIC, among others. Further, EPA officials reported that they obtain  information that enhances their comprehension and projection of  biological events from DOI’s Office of Emergency Management and  NCMI.

NBIC Monitoring List: a daily e-mail to  inform partners of new and ongoing  events that NBIC is currently monitoring.  These emails are sent to (1) federal; (2)  state, local, tribal, and territorial; and (3)

Biosurveillance Event Report: a more  detailed report focused on a specific  event. These reports provide basic event  details (e.g., pathogen, location, affected  populations, and event progression) and  describe interagency actions, among  other things. These reports are  distributed via e-mail as well as the  Homeland Security Information Network,  among others.  Special Event Report: a report  requested by government partners, such  as state and local governments, to  provide a public health assessment for a  selected event.   Requests for Information:  biosurveillance information collection and  gathering technique through analyst-to- analyst communications that can be  submitted through the Department of  Homeland Security’s National  Operations Center, e-mail, phone calls,  or a biosurveillance information-sharing  portal known as Wildfire.

Move mouse over agency names to show the sources from which that agency obtains biosurveillance information. The size of the circle for an  NBIS partner reflects the number of times other primary and support biosurveillance agencies identified that agency as an information source that  enhances situational awareness of a biological event. For a printer-friendly version, see app. II.

However, agencies with more limited roles in biosurveillance, such as the  biosurveillance support agencies and information consumers, had more  favorable views on NBIC’s products and activities. For example, as also  illustrated by figure 2, 5 of the 8 biosurveillance support agencies and  information consumers stated that NBIC’s products and activities help  their agencies identify potential or ongoing biological events (i.e.,  perception) to a moderate extent. Officials from some of these agencies  reported that they leveraged NBIC products because their own agencies  lacked time, capacity, or the infrastructure to regularly review disparate  sets of information across multiple agencies and domains. For example,  officials from a support biosurveillance agency reported that because the  agency did not have the capacity to review all of the relevant  biosurveillance information that it collected, NBIC’s products filled a  critical information gap in its intelligence. Some NBIS partners suggested  that NBIC’s reports might be useful for state and local entities that might  not have access to the same breadth of information or the capacity to  integrate biosurveillance information themselves.

Further, as illustrated by figure 4, 5 of the 8 biosurveillance support  agencies and information consumers stated that NBIC’s products and  activities help their agencies understand the nature and scope of  emerging biological events (i.e., comprehension) to a great or moderate  extent. Officials from these agencies generally stated that NBIC’s  products were easy to understand and provided useful context for events  outside their scope of expertise. For example, officials from a support  biosurveillance agency praised one of NBIC’s Biosurveillance Event  Reports on the recent outbreak of highly pathogenic avian influenza,  which included information from CDC, APHIS, and USDA’s Food Safety  and Inspection Service (FSIS) on how the disease will affect the food  chain, if it could cross to the human population, and what information is  known locally.

Regardless of their role in biosurveillance, partners noted that NBIC’s  products and activities do not generally contribute new meaning or  analysis—that is, insights that cannot be gleaned in isolation. For  example, as shown in figure 5, 10 NBIS partners stated that NBIC’s  products and activities enhance their agencies’ ability to carry out their  biosurveillance roles and responsibilities to little or no extent, 4 responded  to a moderate extent, and 5 responded that they did not have a basis to  judge. Generally, partners that responded to little or no extent noted that  NBIC products and activities do not, for example, identify trends and  patterns or describe potential impacts of a biological event. For example,  officials from a primary biosurveillance agency stated that NBIC’s  products and activities do not “connect the dots” between dissimilar  information, provide novel synthesis of information, or recommend  possible courses of action.

Further, as shown in figure 6, 11 of the 19 NBIS partners stated that  NBIC’s products and activities help their agencies understand how  emerging and ongoing biological events are likely to progress into the  near future (i.e., projection) to little or no extent. Officials noted that  forecasting and projection are inherently difficult, but suggested that NBIC  could develop other kinds of analysis that would be useful for the  projection element of situational awareness. For example, officials from a  primary biosurveillance agency suggested that NBIC could integrate more  data and information from other DHS components into its reports, which  would help to provide a homeland security perspective on biological  events. Officials from another agency stated that NBIC could combine  information across multiple domains on a local disease outbreak with  known travel and weather patterns to predict how a disease might spread.

NBIC officials stated that the center is working to improve its products and  its ability to contextualize the information it collects from open sources,  and has sought partner input to do so. For example, beginning in late  June 2015, partly on the basis of feedback the center received from its  November 2014 Federal Stakeholder Survey, NBIC modified its daily  Monitoring List to include an up-front summary that identifies the status of  ongoing biological events as worsening, improving, unchanged, or  undetermined. During our interviews with the NBIS partners, several  agency officials suggested that the center make a similar change to this  product because it would help them to more quickly scan the report to  determine which events might be worth further examination. Although we  are not able to analyze the effect this change had on partner views  because the change took place after our interviews, it appears to be a  positive step in response to one issue that partners raised. Further, NBIC  officials noted that the center is also working to better integrate forecasts  and projections into its products and activities. Specifically, NBIC is  participating in a working group led by the Office of Science and  Technology Policy to support the priorities articulated in the S&T  Roadmap by developing a common interagency vision for specific federal  capabilities and practical next steps leading to the application of reliable  infectious disease forecasting models in decision-making processes.

Data that NBIC could use to identify and characterize a biological event of  national concern using statistical and analytical tools, as called for in the  9/11 Commission Act, are limited. Apart from searches of global news  reports and other publically available reports generated by NBIS partners,  NBIC has been unable to secure streams of raw data from multiple  domains across the biosurveillance enterprise that would lend themselves  to near-time quantitative analysis that could reveal unusual patterns and  trends. NBIC acknowledged in its strategic plan that the data required to  carry out its mission as envisioned in the 9/11 Commission Act either do  not exist or are subject to a variety of information sharing challenges that  make a large information technology-centered solution less feasible than  originally imagined.

NBIC and NBIS partners noted that there were several kinds of data that  could be useful for this kind of biosurveillance integration, but these data  may not exist or may not be in a usable form. For example, EPA officials  stated that under the existing statutory framework, the federal  government does not collect real-time data on water quality and  contamination from drinking water utilities. Instead, water systems report  violations of drinking water standards to EPA on a quarterly basis. In  addition, officials from CBP and DOI’s U.S. Geological Survey (USGS)  reported that there is a significant gap in the availability of animal health  data, particularly data on wildlife disease, which makes it difficult to fully  understand the dynamics of zoonotic diseases. NBIC officials also noted  that other kinds of data are maintained in formats that make them difficult  to analyze, such as paper health records. Further, the S&T Roadmap  noted that many livestock health records are held by private industry and  are not broadly accessible or standardized in a manner that would make  such data usable.

In our survey, few—5 of 19—NBIS partners reported that they shared raw  data with NBIC, and during structured interviews NBIS partners discussed  a variety of challenges they faced in sharing certain data with NBIC.  Some agencies are reluctant to share their data with NBIC because they  are unsure how the information will be used. For example, officials from a  primary biosurveillance agency stated that the agency does not share  some data with NBIC because sharing such information too broadly might  have substantial implications on agricultural trade or public perception of  safety. Further, officials from another primary biosurveillance agency  noted that there is sometimes reticence to share information and data  with components of DHS because, given the department’s roles in law  enforcement and national security, the information might be shared  outside of the health security community in a way that lacks appropriate  context and perspective.

Other agencies stated that they are unable to share data for regulatory or  legal reasons, or because appropriately protecting the data would take  too long. For example, officials from HHS’s Food and Drug Administration  (FDA) stated that their agency is unable to share some of its data on food  and drug contamination because this information is confidential  commercial information that FDA is restricted from sharing outside the  agency. According to CDC officials, their agency receives electronic data  from state, territorial, local, and tribal sources for a variety of programs  and purposes that are covered by data use agreements that do not allow  CDC to share the data outside the terms of those agreements and as  allowed or required by applicable federal laws, such as the Privacy Act of  1974 and the Freedom of Information Act. Pursuant to federal law and  the terms of these agreements, CDC may share aggregated information  as long as it protects an individual’s privacy. However, according to CDC  officials, some of these data cannot be shared without extensive, time- consuming work to appropriately redact the data to ensure that individuals  may not be identified and that privacy is protected, which results in the  release of the data being postponed to the point that the data are no  longer actionable. Further, officials from VA noted that the Health  Insurance Portability and Accountability Act of 1996 and its implementing  regulations also restrict their ability to share some data because it  requires appropriate safeguards to protect the privacy of personal health  information, and sets limits and conditions on the uses and disclosures  that may be made of such information without patient authorization.

Concerns over data are a long-standing issue with NBIC and the federal  biosurveillance integration mission. We have previously reported that  scant availability of data throughout the federal government, a lack of  trust, and partners’ concerns over sharing sensitive information with NBIC  were major barriers in NBIC’s ability to obtain the data and other  information that it needed to support data integration. NBIC officials  recognize that these barriers inhibit the ability of their partners to share  some data with the center, but noted that they are trying to work with  some of their partners to address these issues. For example, NBIC is  currently developing a project with VA to determine how the center can  use VA’s data for biosurveillance purposes while ensuring that sensitive  data are properly managed.

NBIC Has Developed Procedures to Coordinate with Biosurveillance Partners, but Faces Limited Participation and Provision of Partner Personnel

To fulfill its Coordinator role, NBIC has established procedures that occur  daily, weekly, and as emerging or significant biological event occur, but  the center faces challenges related to participation of NBIS partners in the  center’s activities, the provision of partner personnel to NBIC, and  competing structures for convening NBIS partners.

NBIC’s Coordinator Role Products and Activities

Biweekly Calls: Until recently NBIC hosted a Weekly Reporting Call  to present and discuss the most significant biosurveillance events  from the previous week. In response to feedback the center received  from its November 2014 Federal Stakeholder Survey, NBIC changed  the format of the weekly call in January 2015 to a biweekly call with a  rotating responsibility among the NBIS partners to provide a featured  speaker on a relevant issue, as well as an opportunity to pose  questions to NBIC and the other partners on ongoing or potential  biological events.

National Biosurveillance Integration  System (NBIS) Protocol: a mechanism  that brings federal partners together on a  short-notice teleconference to provide  information sharing on an emerging or  significant biological event.   Daily Analysts’ Call: a daily  teleconference in which NBIC analysts  and other participants discuss newly  identified potential and active hazards.  Bi-weekly Reporting Call:  NBIC hosts  the Interagency Biosurveillance  Presentation Series bi-weekly via  teleconference with NBIS Partners  presenting and discussing  biosurveillance project findings of  interest. interagency information-sharing portal— housed within the National Center for  Medical Intelligence—through which  participating entities can request  information among a trusted subset of  interagency subject matter experts within  the federal biosurveillance community.   Jointly Developed Products: NBIC  brings together its multidisciplinary  partners to develop joint products that  enhance understanding of new or  potential biological events. multidisciplinary partners to develop joint products that enhance  understanding of new or potential biological events. For example,  NBIC coordinated with APHIS to facilitate a study by DHS’s Homeland  Infrastructure Threat and Analysis Center that modeled the potential  biological and economic impacts of the Kudzu bug, a pest that  presents a potential risk to the U.S. soybean crop if pesticide  applications failed. NBIC has also developed joint classified  intelligence products developed by DHS’s Office of Intelligence and  Analysis by, for example, describing the scope and context of a  biological agent in these products.

According to agency officials we spoke with and strategic documents we  reviewed, NBIC faces challenges that affect its ability to implement its  Coordinator role, including the limited participation of NBIS partners in  NBIC activities, limited provision of partner personnel to NBIC, and  competing structures for convening NBIS partners.

Although NBIC has implemented its Coordinator role through a variety of  interactions and procedures, partner participation in key NBIC activities  has generally been limited. For example, as shown in figure 7, about half  of the NBIS partners reported in our survey that they regularly  participated in NBIC’s Weekly Reporting Calls (9 of 19) during the time  period between August 2012 and December 2014, and even fewer  reported regularly participating in the Daily Analyst Calls (2 of 19). Some  of the agencies that reported not regularly participating in the daily and  weekly calls are primary biosurveillance agencies that are generally  considered to be among the lead generators of biosurveillance  information in their respective domains. Officials from one of these  agencies noted that much of the information presented during the daily  and weekly calls was already provided in the daily Monitoring List e-mail,  and therefore provided relatively little new information.

The National Strategy for Biosurveillance notes that in a reduced  resources environment, it is important to pursue activities that add value  for all participants, and officials across the NBIS noted that the  modification to the weekly call was a positive step. For example, officials  from a primary biosurveillance agency stated that the change provided  them with an opportunity to advertise the services their agency provides.  Officials from another primary biosurveillance agency noted that the new  presentation-focused format is more likely to benefit all partners across  the NBIS. NBIC officials stated that they plan to request feedback from  the partners in the future on the new format of these calls to determine  what, if any, additional changes are needed.

Limited Provision of Partner Personnel  Another challenge faced by NBIC concerns its ability to obtain personnel  from its partners as originally envisioned in the 9/11 Commission Act.  NBIC officials told us that effective biosurveillance depends on subject  matter experts to interpret events and place them in context. Although all  of the NBIS partners provide key points of contact for NBIC, few (3 of 19)  partners currently provide a dedicated liaison as of July 2015. Officials  across the NBIS partners provided various reasons for why their agencies  did not provide a liaison. For example, officials from one primary  biosurveillance agency stated that for their agency, and likely other  agencies as well, it is difficult to provide personnel to NBIC on a full- or  part-time basis because of their own resource constraints. Further,  officials from a support biosurveillance agency noted that the lack of  clarity about NBIC’s value to its partners is a barrier to providing the  center with detailees.

In order to obtain more personnel from its partners, NBIC has agreed to  partially fund some of the liaisons. For example, according to NBIC  officials, the center already funds liaisons from VA, DOI, and USDA’s  APHIS and is working to establish a liaison with CDC. .According to  NBIC, liaisons have provided great benefit to the center such as by  providing special knowledge of their agency’s roles and areas of  responsibility and providing NBIC with the critical ability to reach-back into  their respective agency or department. According to the officials, NBIC  would like to more fully leverage the capabilities of its partners and obtain  a liaison from each NBIS partner; however, budget constraints currently  prohibit NBIC from obtaining fully funded liaisons from each partner.

Competing Structures for Convening Partners  Federal partners noted that they were unclear about the differences  between two of the major structures used for convening federal  stakeholders to discuss emerging biological events. The NBIS Protocol,  as previously identified, is managed by NBIC, while the other, the  Biological Assessment Threat Response (BATR) Protocol, is managed by  the White House’s National Security Council Staff. According to the NBIC  Strategic Plan, the BATR Protocol is a national-level interagency  consultation process with mid-to-high level decision makers that is  designed to achieve coordinated action and desired outcomes to prevent,  protect from, and respond to high-consequence bioterrorism and  biosecurity threats. According to NBIC, each of the protocols is  designed to serve a different purpose for a different set of participants  according to their respective roles in the recognition of, and response to,  a biological event. The NBIS Protocol is a mechanism to bring together  federal analysts and operators for information sharing early in a biological  event’s discovery and development phase; whereas the BATR Protocol is  designed to enable the most senior level of federal leadership to achieve  situational awareness to effectively coordinate available resources for  incident response. However, although we did not ask a specific question  about the two protocols in our structured interviews, about a quarter of the  NBIS partners (5 of 19) we interviewed were unclear about the  differences between the two protocols. For example, in structured  interviews, officials from two of the agencies noted that the protocols  appeared to serve the same purpose or were attended by the same  officials.

NBIC Has Efforts Under Way to Develop New Biosurveillance Tools, but Faces Challenges Prioritizing Development Efforts in a Limited Resource Environment

To fulfill its Innovator role, NBIC has funded several pilot projects, sought  new data sources, and made efforts to enhance its IT system, but faces  challenges related to its limited resources and the varying needs of its  partners.

NBIC’s Innovator Role Products and Activities

rapid characterization and mitigation of disease outbreaks. The resulting  product, which was completed in October 2014, provides biosurveillance  analysts with procedures for selecting and applying uncertainty methods  as well as a standardized format for reporting information.

National Collaborative for Bio- Preparedness (NCB-Prepared): a pilot  project sponsored by NBIC and the  University of North Carolina at Chapel  Hill, among others. According to NBIC, a  September 2014 prototype was capable  of real-time analysis of health data in a  geographic format, enabling users to  search data, for example, on clinical  symptoms and text within health records,  using data from Emergency Medical  Services, 911 phone calls, and Poison  Control Centers. According to NBIC, this  pilot program is intended to be offered to  state and local governments and the  private sector.   Social Media pilot projects: NBIC has  conducted several pilot projects to  examine the extent that social media can  augment existing biosurveillance  detection and analysis. The pilot projects  assessed the feasibility of using  commercial and government off-the-shelf  systems to aggregate social media  information for biosurveillance. The most  recent pilot, initiated in fiscal year 2012,  funds the Department of Defense’s  Naval Surface Warfare Center to  develop analytical techniques to improve  the use of social media data for  biosurveillance. NBIC plans to conclude  the project at the end of fiscal year 2015,  and transition the project’s algorithms for  operational use.

The 2012 NBIC Strategic Plan also identified a number of pilot projects  designed to assess the extent to which such projects could be adopted  full-scale. According to the plan, each pilot project is intended to improve  collaboration or information sharing. According to NBIC, these pilots are  routinely assessed and evaluated to determine what is most helpful and  effective, and those that prove successful will be integrated into normal  operations, while those that are not will be discontinued. For example,  NBIC has jointly funded the National Collaborative for Bio-Preparedness  pilot project to develop a comprehensive, state-level system to analyze  public health trends and detect emerging biological incidents by using  data analytics and anomaly algorithms. Further, NBIC has also funded  three pilot projects examining the feasibility of using open-source data  from various social media applications in order to identify possible health  trends. NBIC has completed two of these pilots and one is ongoing.

NBIC has been seeking new sources of data and information in order to  fulfill its mission for early warning and shared situational awareness of  acute biological events, including data and information from other DHS  components and NBIS partners, as well as classified information. First, in  September 2013, NBIC analyzed the usefulness of department-wide  absenteeism data from DHS’s Office of the Chief Human Capital Officer,  which could be an indicator of an emerging epidemic. Based on an  analysis of 20 months of DHS workforce data from 2012 and 2013, the  study concluded that absenteeism data could be a useful component in  biosurveillance, as understanding differences between normal leave  behavior and expected rises in leave behavior during peak flu seasons  would help in establishing baseline values for comparison. In August  2014, NBIC, working with DHS’s Science and Technology Directorate and  Lawrence Livermore National Laboratory, evaluated the usefulness of  DHS components’ data systems as potential biosurveillance data  sources. The assessment identified two Customs and Border Protection  (CBP) databases as the most useful to NBIC’s mission, and in June 2014,  NBIC funded a part-time liaison to CBP’s Office of Intelligence to  determine the extent to which NBIC can use CBP databases for  biosurveillance purposes. Second, NBIC has also sought to obtain new  sources of data from NBIS partners and other stakeholders. For example,  as of July 2011, VA has provided NBIC a liaison to, among other  responsibilities, identify ways NBIC can use VA’s patient healthcare  information to support its early detection and situational awareness  mission. Finally, according to NBIC officials, the center has enhanced its  process for analyzing intelligence information and reviews various  intelligence sources to supplement, corroborate, or provide additional  context to the biosurveillance items identified through other sources. For  example, an NBIC intelligence analyst reviews all source intelligence  information to identify potential topics of interest, such as indications of  novel infectious disease or terrorism, and if necessary, reaches back to  partners in the intelligence community for further information.

NBIC officials noted that the center’s recent focus is on building its  internal IT infrastructure, rather than pilot projects. For example, through  its current Biofeeds project with the Pacific Northwest National  Laboratory, NBIC is seeking to build a visual and text analytics capability  that to enable the center to more effectively and efficiently identify  relevant information in open source data. Officials also noted that NBIC is  partnering with the Defense Threat Reduction Agency on the  Biosurveillance Ecosystem project to build a collaborative analytic  workbench for the center. Further, officials stated that NBIC has obtained  an IT program manager as a detailee from the Transportation Security  Administration to help build the center’s internal IT program.

According to agency officials we spoke with and strategic documents we  reviewed, NBIC faces challenges that affect its ability to implement its  Innovator role, including its limited resources and the varying needs of  partners.

Although we did not ask a specific question about resource limitations,  officials from 9 of the 19 NBIS partners identified it as a challenge NBIC  faces in developing new biosurveillance tools and technology. From fiscal  year 2012 through 2015, NBIC’s budget ranged from $10 million to $13  million annually. Officials from 2 primary biosurveillance agencies noted  that NBIC’s budget limits its ability to enhance its existing technology  systems to invest in innovations such as disease event modeling. Further,  officials from 3 primary biosurveillance agencies more generally  expressed concerns regarding the imbalance between the size and  nature of NBIC’s mission, including its role as an innovator, and the  resources that it had available to achieve it. NBIC officials stated they  have never requested a budget increase, because their larger DHS office,  the Office of Health Affairs, has experienced budget reductions, and an  increase for NBIC would require a decrease for another program.  However, NBIC officials noted that they would likely use any increase in  its budget to help develop more analytical tools for itself and its partners.

Related to its limited resources, NBIC also faces challenges prioritizing its  innovation efforts because its partners have diverse, and sometimes  conflicting, needs. The S&T Roadmap noted that active collaboration for  biosurveillance presents challenges because stakeholders have varying  missions and roles. As previously noted, NBIC asked its partners to  identify existing capability gaps. The 13 submissions covered a wide  variety of biosurveillance issues and domains, such as wildlife disease  surveillance, integration of pharmacy data, and analysis of Medicare  claims data. However, although NBIC asked partners to prioritize the 13  submissions identified as existing capability gaps, the proposal that was  selected had been ranked third by the partners, and officials from a  primary biosurveillance agency stated that it was unclear why the higher  ranking proposals were not selected. Further, officials from a primary  biosurveillance agency suggested that NBIC conduct its own needs  analysis to determine what tools and technology NBIC could invest in.  NBIC officials noted that the third ranked proposal was selected because  it was the highest ranked proposal that was “shovel ready”, thereby  allowing funding to be applied when funding was available, whereas the  top two proposals were not. According to NBIC officials, future  investments will be informed by the S&T Roadmap.

Biosurveillance Partners Expressed Skepticism about the Feasibility of NBIC’s Mission

Although 13 of the 19 NBIS partners stated in our structured interviews  that the concept of having a federal entity whose mission is to serve as  the integrator of national biosurveillance information across agencies and  disease domains is very or moderately important, some also expressed  doubts about the feasibility and practicality of this mission. Specifically,  although we did not specifically ask a question about the practicality of  NBIC’s mission, about a third of the NBIS partners (7 of 19) expressed  skepticism and doubts about the feasibility of NBIC’s mission, including  whether federal integration of biosurveillance information could actually  achieve early warning and situational awareness of biological events.  Among the specific reasons officials cited for the skepticism was their  uncertainty that the current model of biosurveillance integration was the  most effective investment for strengthening the national biosurveillance  capability. For example, officials from one agency noted that while the  concept makes sense intuitively, there is no reliable evidence, such as a  peer-reviewed study, that has confirmed the viability of the concept, nor  has there been a large-scale biological threat that has been detected  through integration; moreover, such a system—by virtue of its being  federally-based—would lack timely detection and response capabilities  because events occur at the local level. Officials from another agency  questioned the feasibility of NBIC’s mission because the data and  technology that are currently available do not provide for the accurate  projection of biological events or facilitate the provision of early warning.  Additionally, an NBIC official told us that the ability to achieve early  detection of emerging events—especially unexpected or novel events—is  dubious because most of the tools and techniques used in surveillance  rely on contrasting current conditions with known baseline trends and  patterns, but as an event emerges, surveillance practitioners are not  necessarily going to be focused on those patterns and trends until  something prompts their attention. Moreover, when a biological event is  novel, its patterns and trends are not yet known.

We have previously reported on skepticism on the part of some of the  NBIS partners regarding the value of the federal biosurveillance mission  as well as NBIC’s role in that mission. In our 2009 report, most of the  NBIS partners we interviewed at that time expressed uncertainty about  the value of participating in the NBIS or confusion about the purpose of  NBIC’s mission. For example, officials from 1 of the partners stated that  it was unsure whether NBIC contributed anything to the federal  biosurveillance community that other agencies were not already  accomplishing in the course of carrying out their biosurveillance-relevant  missions. We, the NBIS partners, and other major stakeholders in the  biosurveillance community acknowledge that no single problem limits  NBIC’s mission to integrate biosurveillance data. Rather, over the years,  several long-standing problems have combined to inhibit the achievement  of this mission as envisioned in the 9/11 Commission Act. Most notably,  to operationalize the federal biosurveillance integration concept requires  the simultaneous sharing and consideration of information from vastly  disparate domains, including health, law enforcement, intelligence, and  international partners. However, as noted in the S&T Roadmap, the  sharing of this information is limited and is often not possible.

There Are a Range of Options for Addressing Biosurveillance Integration Challenges, and Each Has Associated Benefits and Limitations

The challenges previously described illustrate that NBIC faces significant  obstacles in implementing its roles as a biosurveillance integrator as  originally described in the 9/11 Commission Act. Below, we discuss  options for policy or structural changes that could help better fulfill the  biosurveillance integration mission. We identified these options and their  benefits and limitations, on the basis of the roles of a federal-level  biosurveillance integrator we identified in the 9/11 Commission Act,  NBIC’s strategic plan, and the perspectives of the NBIS partners obtained  during our structured interviews. These options are not exhaustive, and  some options could be implemented together or in part. In developing  these options, we did not evaluate the financial implications of  implementing each option, to the extent it is knowable, but we  acknowledge they are likely to result in an increase, decrease, or shifting  of funding based on the changes described.

Option 1: Reinforce NBIC’s Analyzer Role

Developing meaningful information not otherwise available: This  option would address some of the challenges NBIC faces in  implementing its Analyzer role, such as access to data from the NBIS  partners, and would better position the center to develop meaningful  information that could not be gleaned in isolation, potentially leading  to earlier warning of emerging events and shared situational  awareness.

Capitalize on new data sources and analysis techniques:  Focusing on providing the resources, infrastructure, and frameworks  for data sharing may provide the foundation to capitalize on future  advancements in data analytics, including big data analysis and  electronic health records, to mine data for emerging patterns.

Uncertain need: The probability that a disease event with significant  national consequences occurring in such a way that it would be  detected more quickly by overlaying various data streams and  applying statistical and analytical tools to them is not known.

Uncertain data availability: There may not be a significant amount of  meaningful data available that is not already being provided to  facilitate advanced analytical techniques. For example, although  partners identified other potential data sources that could contribute to  a more robust integration tool, such as water contamination and  wildlife disease data, it is unknown whether such data could be  collected and managed to make a meaningful contribution, and if they  could, at what cost.

Unproven concept: Even with access to more data, it is unclear  whether a federal biosurveillance integrator would be able to identify  patterns or connections that would lead to earlier warning of emerging  events or reduce the time it takes to discover, prevent, or respond to a  potentially catastrophic event, or that it would merit the associated  costs. Finding patterns and trends without knowing specifically what to  look for is challenging, and about a third of the NBIS partners (7 of 19)  expressed skepticism and doubts about the feasibility of NBIC’s  mission, including whether federal integration of biosurveillance  information could actually achieve early warning and situational  awareness of biological events.

Unknown impact of earlier detection: If NBIC were able to discern  signals that gave warning of an emerging event, there is no guarantee  that it would significantly decrease the amount of time it would take  federal partners to confirm the warning and implement response  actions.

Increased costs: Creating the enterprise architecture both within  NBIC and across the NBIS that would facilitate transfer and computer- aided analysis of data would likely require a significant investment in  technology, as well as skilled personnel with data analytic, legal, and  regulatory expertise. Although we have not specifically assessed the  costs of these options, such costs, at least in the near term, would  likely exceed NBIC’s current annual budget.

Option 2: Strengthen NBIC’s Coordinator Role

Clear leadership: This option would create clear leadership across  the interagency for developing and implementing biosurveillance  policy in general and in response to specific biological events, which  may also encourage partners to more fully participate in NBIC  activities, such as regularly attending NBIC’s Daily Analysts’ and Bi- weekly Reporting calls.

Better institutional connection: NBIC officials have stated that the  current liaisons have provided great benefit to the center. Ongoing  interaction among more dedicated liaisons from various agencies may  strengthen biosurveillance subject matter expertise and could  enhance communication across all the agencies.

Routine, institutionalized channels to monitor for emerging  trends and patterns: Clarifying the federal integrator’s role in  routinely convening and drawing on the analytical capacity of the  various pockets of federal expertise across the NBIS could enhance  the ability of NBIC to go beyond daily surveillance and monitoring  activities to recognize connections and generate meaningful insights  that may not be gleaned in isolation.

Enhanced accountability for implementing the National Strategy  for Biosurveillance: Formally vesting a federal entity with  responsibility for leadership of the national biosurveillance enterprise  would fill a longstanding need to institutionalize and create  accountability for common goals and deliberate, results-driven, risk- based investment across the enterprise. Because the mission  responsibilities and resources needed to develop a national  biosurveillance capability are dispersed across a number of federal  agencies, efforts could benefit from a focal point to provide sustained  leadership that helps direct interagency efforts to invest in and  implement new and existing programs in a way that ensures  generation of meaningful data with the potential to discover emerging  biological events with potentially catastrophic consequences.

Role conflict: Some of these responsibilities overlap with  responsibilities that have historically been the purview of the National  Security Council Staff, and legislative direction to assume these  responsibilities could create more role conflict and confusion unless  authority, roles, and responsibilities were very clearly designated.

Authority and legitimacy: It may be difficult for an agency at NBIC’s  level to successfully influence decision making across the  interagency. For example, discussions we had with some NBIS  partners demonstrated that both DHS and NBIC have encountered  and may continue to encounter issues with perceived legitimacy in the  health security arena.

New tools and technology: NBIC could foster the development of  tools and technology that benefit multiple federal partners and other  members of the NBIS (e.g., state and local health agencies), thus  enhancing the overall national biosurveillance capability. For example,  the 2013 S&T Roadmap identified the need to strengthen detection by  developing new modeling and ecological forecasting approaches that  could enhance current ways of predicting disease outbreaks and  determining likely impacts when a threat is detected. Specifically, this  should be accomplished by developing methods that integrate  traditional monitoring (i.e., pathogen, environmental, and health) with  background data (i.e., meteorological and population dynamics).

Coordinate research and development efforts: The S&T Roadmap  notes that there are dozens, and possibly hundreds, of biosurveillance  initiatives and pilot projects that have been implemented at local,  state, regional, and national levels, NBIC would be well positioned to  help coordinate and deconflict biosurveillance research and  development across the interagency, which would help to avoid any  unnecessary duplication, overlap, and fragmentation of effort. Further,  the S&T Roadmap identifies 14 research priorities, many of which  would benefit from coordination across the federal government, as  well as with state, local, and private entities. For example, one of the  research priorities is to develop multilateral communication  mechanisms among the various levels of government and the private  sector to enable timely decision making. Effectively addressing such a  research priority would likely require the collaboration of multiple  federal and nonfederal partners, including HHS, USDA, and DHS, as  well as healthcare providers and international partners, among others.

Increased costs: Although we have not specifically assessed the  costs associated with the options, supporting the development of new  tools and technology would likely exceed NBIC’s current annual  budget.

More research and development expertise: Although NBIC has  engaged in some pilot projects that develop tools and technology, a  national integrator that focuses on innovation would likely need to  acquire more expertise in research and development.

Significant restructuring: In comparison with its other roles, NBIC’s  role as an Innovator is the least well defined in the 9/11 Commission  Act, and NBIS partners noted that the center’s current budget limits its  ability to fulfill this role. Focusing attention on this role may represent  a significant mission shift from the status quo, and may require very  different sets of resources and procedures.

Option 4: Continue to Execute the 2012 NBIC Strategic Plan

NBIC has made progress and may continue to do so: Although  most (10 of 19) federal partners stated that NBIC has limited impact  on their ability to carry out their biosurveillance roles and  responsibilities, 12 of 19 NBIS partners interviewed noted that NBIC  has made improvements in its products, outreach, coordination, and  other activities. Further, in recent years, NBIC has been able to  obtain or partially fund liaisons from other agencies. Establishing itself  as a trusted and effective federal integrator with limited direct authority  is a difficult task, and the center and its NBIS partners may merely  need more time to evolve their roles and relationships to realize the  full potential of the current NBIC as the federal biosurveillance  integrator.

Some agencies currently find value in NBIC’s products: Agencies  with more limited roles in biosurveillance, such as biosurveillance  support agencies and information consumers, generally stated that  they like NBIC’s products because their own agencies do not have  enough resources to review biosurveillance information across  multiple agencies and domains. Further, NBIC officials noted that the  center’s products benefit some of their nonfederal stakeholders that  have limited resources for biosurveillance, such as state, local, tribal,  and territorial agencies. For example, as of July 2015, NBIC’s daily  Monitoring List e-mail is distributed to 338 individuals representing  state, local, tribal, and territorial entities, including state departments  of health and agriculture, fusion centers, and police departments.

Data challenges: NBIC will likely continue to face challenges in  obtaining all the biosurveillance data it needs to effectively apply  statistical and analytical tools to identify and characterize biological  events of national concern in as close to real time as practicable, per  requirements in the 9/11 Commission Act.

Partners remain skeptical of NBIC’s value: NBIC has implemented  our recommendation to create a strategy, in partnership with the NBIS  agencies, that better defines its mission and focus on other  collaborative practices. Nevertheless, NBIS partners remain skeptical  of NBIC’s value. As previously shown in figure 5, few of the NBIS  partners (4 of 19) we interviewed stated that NBIC’s products and  activities enhanced their agency’s ability to carry out their  biosurveillance roles and responsibilities. Further, as illustrated in  figure 8, 8 of 19 NBIS partners we interviewed stated that NBIC is  achieving its mission to little or no extent. It is unclear whether  additional time or what additional actions will improve partners’  experience with NBIC’s overall value to the national biosurveillance  capability.

Cost savings: Given that most federal partners stated that they  integrate some biosurveillance information themselves and that NBIC  has limited impact on their ability to carry out their biosurveillance  roles and responsibilities, the cost of operating NBIC may not be  worth its benefits.

Officials report that a federal integrator is important: Although  federal partners generally thought that NBIC’s products and activities  did not provide meaningful new information, they largely thought that  the concept of having a federal entity to integrate biosurveillance  information across the federal government was important. Specifically,  in our structured interviews, 13 of the 19 NBIS partners stated that the  concept of having a federal entity whose mission is to serve as the  integrator of national biosurveillance information across agencies and  disease domains is very or moderately important.

Potential loss of investment: As previously noted, 13 of 19 NBIS  partners stated that NBIC has made improvements in its products,  outreach, coordination, and other activities. Defunding NBIC could  create a loss of investment, institutional learning, and progress made  toward developing a federal biosurveillance integrator, which may  need more time to evolve to become effective.

Another integrator may experience similar challenges: Even if  one of the other primary biosurveillance agencies were designated as  the federal biosurveillance integrator, that entity may still find it difficult  to overcome organizational boundaries and engender agency  cooperation, given that multiple agencies have key biosurveillance  responsibilities.

We provided a draft of this report for review and comment to DHS and the  13 other departments and agencies that compose the NBIS—the  Departments of Agriculture, Commerce, Defense, Energy, Health and  Human Services, Interior, Justice, State, Transportation, and Veterans  Affairs, as well as EPA, ODNI, and USPS. DHS provided written  comments on September 16, 2015, which are summarized below and  presented in their entirety in appendix III of this report. DHS, EPA, USPS,  and the Departments of Agriculture, Interior, Health and Human Services,  and Veteran’s Affairs provided technical comments, which we considered  and incorporated, where appropriate. The ODNI and the Departments of  Commerce, Defense, Energy, Justice, State, and Transportation did not  comment.

DHS expressed appreciation for our recognition of its progress fulfilling  our prior recommendations, which were designed to enhance interagency  collaboration. DHS also acknowledged the array of challenges detailed in  this report, and noted some actions it is undertaking to try to address  them. DHS noted that the report does not include nonfederal  biosurveillance stakeholders in its scope, and posits that these  stakeholders may find value in NBIC’s current products. Although we  cannot comment on the extent to which these nonfederal stakeholders  value NBIC’s current products, we have previously reported on the  important role that nonfederal partners in the biosurveillance enterprise,  particularly because most of the resources necessary to generate  biosurveillance information are outside of the federal government. The  federal departments and agencies with primary biosurveillance roles, as  outlined in this report, have a variety of relationships and agreements with  nonfederal partners to facilitate partnership and information sharing. We  note that NBIC’s authorizing legislation calls for NBIC to work with state  and local entities in coordination with, and through when possible, its  federal partners and these existing relationships.

We are sending copies of this report to the Departments of Agriculture,  Commerce, Defense, Energy, Health and Human Services, Homeland  Security, the Interior, Justice, State, Transportation, and Veterans Affairs;  the Environmental Protection Agency; the United States Postal Service;  and the Office of the Director of National Intelligence. In addition, the  report is available at no charge on the GAO website at  http://www.gao.gov.

If you or your staff have any questions about this report please contact  me at (404) 679-1875 or curriec@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this product  are listed in appendix IV.

Appendix I: Biosurveillance Responsibilities of the National Biosurveillance Integration System Partners

We surveyed and interviewed officials from 19 federal departments and  their component agencies across 13 of the 14 departments and agencies  that compose the National Biosurveillance Integration System (NBIS).  We refer to these 19 agencies as NBIS-partner agencies, and we  categorized these into three groups:

Primary biosurveillance agencies: Have major biosurveillance mission  responsibilities that include collecting or analyzing biosurveillance  information for the purposes of detecting, monitoring, or responding to  biological events.

Support biosurveillance agencies: Do not have missions that directly  involve disease detection and monitoring; however, they collect data  and information or have subject matter expertise that may be useful to  efforts to detect, monitor, or respond to biological events.

Biosurveillance information consumers: Generally do not produce  information that is useful for biosurveillance, but consume such  information because biological events can affect their main mission  and they may have a particular role to play in responding to an event.

We developed these categories based on each partner’s roles and  responsibilities related to biosurveillance. Table 3 includes brief  summaries of the NBIS partners, including agency type, mission,  domains, and biosurveillance responsibilities.

Appendix II: Biosurveillance Agencies’ Sources for Information that Enhances Situational Awareness of Biological Events

We conducted a Web-based survey of the 19 National Biosurveillance  Integration System (NBIS) partners to identify the federal agencies from  which they obtain information that contributes to their agency’s situational  awareness of biological events.

Because this was not a sample survey, it has no sampling errors.  However, the practical difficulties of conducting any survey can introduce  errors, commonly referred to as nonsampling errors. We took steps in  developing the questionnaire, collecting the data, and analyzing them to  minimize such nonsampling errors. We conducted pretests with 3  agencies to help ensure that the questions were clear and unbiased, and  that the questionnaire did not place an undue burden on respondents. An  independent reviewer within GAO also reviewed a draft of the  questionnaire prior to its administration. We made appropriate revisions to  the content and format of the survey questionnaire based on the pretests  and independent review. The survey was administered on the Internet  from March 25, 2013, to May 15, 2013. To increase the response rate, we  followed up with emails and personal phone calls to the experts to  encourage participation in our survey. We received responses from all 19  agencies in our population (100 percent response rate). Based on  comments we received from two agencies, we also conducted two follow- up phone calls with officials at these agencies who responded to our  survey to verify their answers to survey questions about the federal  agencies from which their agency obtains information that contributes to  their agency’s situational awareness of biological events. We made  appropriate changes to the responses recorded on these officials’  questionnaires to reflect the clarifications made during these phone calls.  When we analyzed the data, an independent analyst verified all  programs. Because this was a Web-based survey, respondents entered  their answers directly into the electronic questionnaire, eliminating the  need to key data into a database, minimizing error.

In the survey, we asked each agency whether it obtains information from  each of the other agencies in our population, as well as which types of  information it obtains from them (perception-, comprehension-, or  projection-related information). For the purposes of this report, we use the  definition of situational awareness that the NBIC Strategic Plan uses in  the articulation of its mission. The definition has its basis in the work of  Mica Endsley, who described situational awareness as having three  elements: (1) perception that a situation has occurred, (2) comprehension  of the situation’s meaning, and (3) projection of the event’s likely course  in the near future. We performed a network analysis of these survey  data, which is a quantitative and graphical technique for identifying the  underlying patterns in a complex system of relationships among entities  of interest. Figure 9 illustrates the agency sources from which the primary  and support biosurveillance agencies in our survey obtain data that  enhances their situational awareness of biological events. For example,  officials from the Environmental Protection Agency (EPA) reported that  their agency obtains information that enhances all three elements of  situational awareness from seven agencies, including the Animal and  Plant Health Inspection Service, Centers for Disease Control and  Prevention, and National Biosurveillance Integration Center, among  others. Further, EPA officials reported that they obtain information that  enhances their comprehension and projection of biological events from  the Department of the Interior’s Office of Emergency Management and  the National Center for Medical Intelligence.

Appendix III: Comments from the Department of Homeland Security

Appendix IV: GAO Contacts and Staff Acknowledgments

In addition to the contact named above, Kathryn Godfrey (Assistant  Director), Andrew Brown, David Dornisch, Lorraine Ettaro, Eric Hauswirth,  R. Denton Herring, Tracey King, Erin O’Brien, Lerone Reid, John Vocino,  Brian Wanlass, and Christopher Yun made key contributions to this  report.

Question: How should NBIC use the tools available to them to best understand the data they have?

Answer: Analyzer: NBIC is to use technology and subject matter expertise, including using analytical tools, to meaningfully connect disparate datasets and information for earlier warning and better situational awareness of biological events.

Question: According to GAO, which aspects of the NBIC's data analysis process have the most room for improvement?

Answer: GAO found that NBIC produces reports on biological events using open-source data, but faces challenges obtaining data and creating meaningful new information.

Question: To what extent is NBIC's role redundant?

Answer: For example, most of the federal partners with key roles in biosurveillance (8 of 11) stated that NBIC's products help their agencies identify biological events to little or no extent, generally because they already obtain such information directly from other federal partners more quickly.

Question: Why is the NBIC's data analysis program unable to provide other agencies with expanded information about biological events?

Answer: In addition, data that could help to identify and characterize a biological event may not exist or are not in a usable form.

Question: To what extent could other federal agencies be a reliable source to expand the data available to the NBIC?

Answer: Further, few federal partners (5 of 19) reported that they share the data they do have with NBIC, citing legal and regulatory restrictions, among other reasons..

Background
Interagency Biosurveillance Community

Background
Interagency Biosurveillance Community
NBIC’s Challenges as an Analyzer

Question: How can NBIC collaborate with other agencies to better analyze biological events?

Answer: Coordinator: NBIC is to bring together partners across the federal biosurveillance community to enhance understanding of biological events.

Question: To what extent has the NBIC been successful in collaborating with partners?

Answer: NBIC has developed procedures and activities to coordinate with partners, such as daily and biweekly calls, but faces challenges related to the limited partner participation in the center's activities, lack of partner personnel detailed to NBIC, and competing structures for convening federal partners.

Question: What would NBIC like to obtain from its federal partners?

Answer: For example, although NBIC would like to obtain liaisons from each of its federal partners, only 3 of 19 partners provided NBIC with dedicated liaisons.

NBIC Has Developed Procedures to Coordinate with Biosurveillance Partners, but Faces Limited Participation and Provision of Partner Personnel

NBIC’s Coordinator Role Products and Activities

Question: How is NBIC addressing gaps in biosurveillance integration?

Answer: Innovator: NBIC is to facilitate the development of new tools to address gaps in biosurveillance integration.

Question: How has the NBIC started to address development of these tools?

Answer: GAO found that NBIC has efforts underway to develop some tools, such as pilot projects examining the use of social media data to identify health trends, but faces challenges prioritizing developmental efforts.

Question: How are the efforts to develop new tools limited?

Answer: For example, partners noted limitations in NBIC's ability to address gaps, like limited resources and the difficulty in prioritizing the center's innovation efforts because its partners have diverse needs.

NBIC Has Efforts Under Way to Develop New Biosurveillance Tools, but Faces Challenges Prioritizing Development Efforts in a Limited Resource Environment

NBIC’s Innovator Role Products and Activities

Question: How could challenges facing the NBIC be addressed?

Answer: GAO identified various options that could address these challenges, ranging from strengthening the center's ability to implement its current roles to repealing NBIC's statute.

Question: How did GAO analyze these options to determine which would best suit the NBIC?

Answer: GAO also identified potential benefits and limitations with each option.

Question: How do the options differ from each other?

Answer: For example, one option would be to provide NBIC with additional authorities to obtain data to better develop meaningful information; however this may also require additional investments. Another option is to not pursue national biosurveillance integration through NBIC and to consider designating one of the other federal partners with key roles in biosurveillance as the federal integrator.

Question: How could further analysis of these options be beneficial?

Answer: The options identified are not exhaustive, and some could be implemented together or in part.

Question: To what extent would the various options fiscally affect the nation?

Answer: GAO did not evaluate the financial implications of each option, but acknowledges some options may require additional investment or shifting of resources or priorities to result in significant long lasting change.

Biosurveillance Partners Expressed Skepticism about the Feasibility of NBIC’s Mission

There Are a Range of Options for Addressing Biosurveillance Integration Challenges, and Each Has Associated Benefits and Limitations

Option 1: Reinforce NBIC’s Analyzer Role

Appendix II: Biosurveillance Agencies’ Sources for Information that Enhances Situational Awareness of Biological Events

Question: To what extent could a biological event threaten the nation?

Answer: A biological event, such as a naturally occurring pandemic or a terrorist attack with a weapon of mass destruction, could have catastrophic consequences for the nation.

Question: How could a national biosurveillance capability mitigate this threat?

Answer: This potential threat underscores the importance of a national biosurveillance capability—that is, the ability to detect biological events of national significance to provide early warning and information to guide public health and emergency response.

Question: How did the 9/11 Commission Act of 2007 address this threat?

Answer: The 9/11 Commission Act of 2007 addresses this capability, in part, by creating NBIC within the Department of Homeland Security (DHS); it was tasked with integrating information from human health, animal, plant, food, and environmental monitoring systems across the federal government, to improve the likelihood of identifying a biological event at an earlier stage.

Question: How much funding does the NBIC receive annually?

Answer: In recent years, NBIC's budget has ranged from $10 million to $13 million annually.

NBIC’s Roles, Responsibilities, and Governance

Question: How have the successes and shortcomings of the NBIC been evaluated?

Answer: GAO was asked to evaluate NBIC.

Question: Which facets of the NBIC's work were evaluated?

Answer: This report discusses the (1) extent to which NBIC is implementing its roles as a biosurveillance integrator, and (2) options for improving such integration.

Question: How did GAO gather data about the NBIC'?

Answer: To conduct this work, GAO reviewed NBIC products and activities; conducted interviews and surveyed 19 federal partners, 11 of which have key roles in biosurveillance; interviewed NBIC officials; and analyzed the 9/11 Commission Act, NBIC Strategic Plan , and National Strategy for Biosurveillance .

NBIC’s Analyzer Role Products and Activities