This is the accessible text file for GAO report number GAO-11-99 
entitled 'Public Health Information Technology: Additional Strategic 
Planning Needed to Guide HHS's Efforts to Establish Electronic 
Situational Awareness Capabilities' which was released on December 17, 
2010. 

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United States Government Accountability Office: 
GAO: 

Report to Congressional Committees: 

December 2010: 

Public Health Information Technology: 

Additional Strategic Planning Needed to Guide HHS's Efforts to 
Establish Electronic Situational Awareness Capabilities: 

GAO-11-99: 

GAO Highlights: 

Highlights of GAO-11-99, a report to congressional committees. 

Why GAO Did This Study: 

A catastrophic public health event could threaten our national 
security and cause hundreds of thousands of casualties. Recognizing 
the need for efficient sharing of real-time information to help 
prevent devastating consequences of public health emergencies, 
Congress included in the Pandemic and All-Hazards Preparedness Act in 
December 2006 a mandate for the Secretary of the Department of Health 
and Human Services (HHS), in collaboration with state, local, and 
tribal public health officials, to develop and deliver to Congress a 
strategic plan for the establishment and evaluation of an electronic 
nationwide public health situational awareness capability. 

Pursuant to requirements of the act, GAO reviewed HHSs plans for and 
status of efforts to implement these capabilities, described 
collaborative efforts to establish a network, and determined grants 
authorized by the act and awarded to public health entities. GAO 
assessed relevant strategic planning documents and interviewed HHS 
officials and public health stakeholders. 

What GAO Found: 

HHS did not develop and deliver to congressional committees a 
strategic plan that demonstrated the steps to be taken toward the 
establishment and evaluation of an electronic public health 
situational awareness network, as required by PAHPA. While multiple 
offices within HHS have developed related strategies that could 
contribute to a comprehensive strategic plan for an electronic public 
health information network to enhance situational awareness, these 
strategies were not developed for this purpose. Instead, the offices 
developed the strategies to address their specific goals, objectives, 
and priorities and to meet requirements of executive and statutory 
authorities that mandated the development of strategies for nationwide 
health information exchange, coordinated biosurveillance, and health 
security. However, HHS has not defined a comprehensive strategic plan 
that identifies goals, objectives, activities, and priorities and that 
integrates related strategies to achieve the unified electronic 
nationwide situational awareness capability required by PAHPA. 

The department has developed and implemented information technology 
systems intended to enable electronic information sharing to support 
early detection of and response to public health emergencies; however, 
these systems were not developed as part of a comprehensive, 
coordinated strategic plan as required by PAHPA. Instead, they were 
developed to support ongoing public health activities over the past 
decade, such as disease and syndromic surveillance. Without the 
guidance and direction that would be provided by an overall strategic 
plan that defines requirements for establishing and evaluating the 
capabilities of existing and planned information systems, HHS cannot 
be assured that its resources are being effectively used to develop 
and implement systems that are able to collect, analyze, and share the 
information needed to fulfill requirements for an electronic 
nationwide public health situational awareness capability. 

HHS has engaged in collaborative efforts to improve information 
technology capabilities to share situational awareness information. 
For example, HHS has collaborated with public and private health care 
partners to establish standards, services, and policies that support 
the electronic exchange of interoperable health care and public health 
data to support electronic sharing of information for biosurveillance 
purposes. The department has also awarded funds through cooperative 
agreement programs to state and local public health entities intended 
to improve capabilities to detect public health emergencies and to 
identify emergency response resources. 

Although the act authorized the use of funds for the award of grants 
to states to establish statewide or regional public health situational 
awareness systems, to date, Congress has not appropriated funds 
pursuant to the authorization. 

What GAO Recommends: 

GAO is recommending that HHS develop and implement a strategic plan to 
guide and integrate efforts to establish electronic situational 
awareness capabilities. In written comments on a draft of the report, 
HHS neither agreed nor disagreed with GAOs recommendation, but stated 
that a complete strategy would be developed. 

View [hyperlink, http://www.gao.gov/products/GAO-11-99] or key 
components. For more information, contact Valerie C. Melvin at (202) 
512-6304 or melvinv@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

HHS Has Not Defined a Strategic Plan or Fully Established a Network as 
Required by PAHPA, but Has Developed Related Strategies and Systems: 

HHS Has Taken Steps to Collaborate with State and Local Entities: 

HHS Has Not Awarded Grants to States for Improved Information Systems 
to Enhance Nationwide Situational Awareness: 

Conclusions: 

Recommendation for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: HHS's Key Information Technology Initiatives: 

Appendix III: HHS's Key Cooperative Agreement Programs: 

Appendix IV: Comments from the Department of Health and Human Services: 

Appendix V: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Summary of Requirements Defined by PAHPA Section 202: 

Table 2: Key HHS Information Technology Systems Used to Enhance 
Situational Awareness: 

Table 3: Key HHS Cooperative Agreement Programs Funding Enhanced State 
and Local Public Health Situational Awareness through Information 
Technology Systems: 

Figures: 

Figure 1: Roles of Federal, State, and Local Public Health Entities in 
a Public Health Emergency: 

Figure 2: Emergency Response Partners: 

Abbreviations: 

ASPR: Assistant Secretary for Preparedness and Response: 

CDC: Centers for Disease Control and Prevention: 

DHS: Department of Homeland Security: 

eLEXNET: Electronic Laboratory Exchange Network: 

EWIDS: Early Warning Infectious Disease Surveillance: 

FDA: Food and Drug Administration: 

HAvBED: Hospital Available Beds for Emergencies and Disasters: 

HHS: Department of Health and Human Services: 

NEDSS: National Electronic Disease Surveillance System: 

NHIN: Nationwide Health Information Network: 

ONC: Office of the National Coordinator for Health Information 
Technology: 

PAHPA: Pandemic and All-Hazards Preparedness Act: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

December 17, 2010: 

Congressional Committees: 

A catastrophic public health event--such as a widespread disease 
outbreak--could threaten our national security, weaken our economy, 
cause hundreds of thousands of casualties, and damage public morale 
and confidence. Recent events, such as the Deepwater Horizon drilling 
rig explosion and the H1N1 influenza outbreak, draw attention to the 
need for public health officials to have access to real-time 
information about emerging threats to enhance their awareness of 
situations and enable them to make responsible and timely decisions. 

Public health situational awareness is the knowledge of key components 
needed to prepare for and respond to disease outbreaks and other 
public health emergencies. These components include, but are not 
limited to, health-related events, critical response resources, 
medical care capacity, environmental threats, public awareness, and 
preparedness status across the many public health jurisdictions in the 
country. Creating and maintaining situational awareness involves an 
active, continuous, and timely data-oriented loop that enhances public 
health officials' ability to make decisions that lead to successful 
mitigation of emerging threats, better use of resources in preparing 
for and responding to emergencies, and better health outcomes for the 
population. The use of information technology to collect and share 
this information electronically among public health entities can aid 
in creating the situational awareness needed to enable early detection 
of and effective response to emerging events. 

The Pandemic and All-Hazards Preparedness Act (PAHPA)[Footnote 1] of 
2006 mandated actions by the Secretary of the Department of Health and 
Human Services (HHS) for improvements in public health emergency 
preparedness and response. Within this act, Congress recognized the 
need for efficient sharing of real-time information to help prevent 
potentially devastating consequences that could result from public 
health emergencies. To address this need, PAHPA required the Secretary 
of HHS, in collaboration with state, local, and tribal public health 
officials, to develop an overall strategic plan for and undertake the 
establishment of a near real-time electronic nationwide public health 
situational awareness capability through an interoperable network of 
systems. The systems are to collect, store, and analyze public health 
data and share the information needed to enhance early detection of 
and rapid response to potential catastrophic infectious disease 
outbreaks and other public health emergencies originating domestically 
or abroad. The act established within HHS the position of the 
Assistant Secretary for Preparedness and Response to, among other 
things, serve as the principal advisor to the Secretary on all matters 
related to federal public health and medical preparedness and response 
for public health emergencies.[Footnote 2] 

PAHPA also required us to evaluate and report on activities conducted 
by HHS to implement such a network. Accordingly, we studied HHS's 
efforts to meet the requirements of PAHPA. As agreed with your 
offices, our specific objectives were to (1) determine HHS's plans for 
and status of implementing the network; (2) describe HHS's efforts to 
collaborate with state, local, and tribal public health officials to 
achieve a nationwide situational awareness capability; and (3) 
determine how HHS uses grants authorized by PAHPA to enhance states' 
ability to establish coordinated public health situational awareness 
systems. 

To accomplish the objectives, we reviewed relevant program 
documentation and interviewed appropriate agency officials. 
Specifically, to determine HHS's plans for implementing a nationwide 
situational awareness network, we assessed the requirements defined by 
PAHPA and identified strategic planning documents and status reports 
of relevant public health information technology initiatives. We 
evaluated these documents to determine whether they met criteria 
established by PAHPA and effective strategic planning practices. To 
determine HHS's status in implementing the network, we discussed with 
agency officials key information technology initiatives that addressed 
elements of an electronic situational awareness capability defined by 
the act. To describe efforts to collaborate with state, local, and 
tribal public health officials, we collected and reviewed documents 
and artifacts from stakeholder collaborations, such as minutes from 
meetings between HHS and public health stakeholders, materials used to 
solicit input from conference attendees, and presentations on the 
results of information technology initiatives funded through 
cooperative agreements between HHS and regional, state, and local 
public health entities. We also interviewed agency officials and 
stakeholders identified through research of public health information 
technology programs and from our previous work on the use of 
information technology to support public health emergency preparedness 
and response. To determine the use of grants for establishing 
coordinated public health situational awareness systems, we held 
discussions with department officials about the award of grant funds 
authorized by PAHPA Section 202. 

We conducted this performance audit at the headquarters of HHS in 
Washington, D.C., and its agencies--the Food and Drug Administration 
and the Indian Health Service, both in Washington, D.C., and the 
Centers for Disease Control and Prevention in Atlanta, Georgia--from 
November 2009 through December 2010 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. Detailed information about 
our objectives, scope, and methodology can be found in appendix I. 

Background: 

Responsibilities for detecting and responding to public health 
emergencies are dispersed among federal, state, and local public 
health entities throughout the country. As such, it is important that 
these entities share information about emerging events, such as 
disease outbreaks or environmental hazards, to enable decision making 
by public health officials as they prepare for and respond to 
emergencies. The use of information technology can enable the many 
public health officials involved in emergency preparedness and 
response to more efficiently share information on a near real-time 
basis. 

Roles of Federal, State, and Local Public Health Officials in 
Detecting and Responding to Emergencies: 

Public health functions in the United States--such as disease 
detection, vaccinations, clinical lab testing, and emergency 
preparedness and response--are conducted by public health officials 
from 59 state and territorial health departments; more than 3,000 
county, city, and tribal health departments; more than 180,000 public 
and private clinical laboratories; and multiple federal agencies, 
including the Department of Homeland Security (DHS) and HHS's Centers 
for Disease Control and Prevention (CDC) and the Food and Drug 
Administration (FDA). 

Initial detection of and response to a public health emergency is 
generally a local responsibility that could involve multiple 
jurisdictions in a region, with states providing additional support 
when needed. Since clinicians at the local level are most likely to be 
the first ones to detect an incident, they and local public health 
officials are expected to report incidents or symptoms of diseases to 
the state health department and other designated parties. States 
provide supporting personnel, financial resources, laboratory 
capacity, and other assistance to local responders when needed. When 
an incident occurs that exceeds or is anticipated to exceed state, 
local, or tribal resources, state governors may request the federal 
government to provide resources to assist the state in its response 
efforts. For incidents involving primarily federal jurisdiction or 
authorities (e.g., on a military base, federal facility, or federal 
lands), federal departments or agencies may be the first responders 
and first line of defense in coordinating activities with state, 
local, and tribal partners. The federal government also maintains 
working relationships with private health care entities, such as 
hospitals and clinical laboratories, and nongovernment organizations, 
such as the Red Cross. 

Because of the many participants involved, the identification and 
management of public health emergencies calls for effective 
communication and collaboration across all levels of government and 
the public health community, and for sharing information to create and 
maintain the situational awareness essential to effectively prepare 
for, respond to, and manage public health emergencies. However, 
sharing information across public health jurisdictions can be 
challenging because of the need for rapid and comprehensive 
distribution of alerts and information to public health workers across 
multiple jurisdictions and organizations, while at the same time 
respecting the autonomous authority of each agency to control the flow 
of information within its jurisdiction of responsibility and among its 
workforce. The ability to share information electronically is further 
challenged by the wide variety of public health entities' 
technological capabilities and implementation of nonstandard systems 
and software that are unable to exchange and share data. 

Figure 1 provides a simplified view of the roles of local, state, and 
federal entities in public health emergencies. 

Figure 1: Roles of Federal, State, and Local Public Health Entities in 
a Public Health Emergency: 

[Refer to PDF for image: illustration] 

Local level (private and public): 

Public health emergency: 

Victims seek medical care: from: 
Public clinics[A]: Testing and treatment; 
Physicians[A]: Testing and treatment; 
Public and private hospitals[A]: Testing and treatment. 

Medical laboratory: Testing: 

Local public health department: Epidemiologic services; Laboratory 
services. 

Local emergency management agency: Planning and support. 

State level: 

State public health department: Epidemiologic services; Laboratory 
services; Advice on diagnosis and treatment; Other support. 

State emergency management agency: Planning and coordination efforts. 

Civil support teams: Assistance and advice. 

Governor: Leadership. 

Federal level: 

Department of Health and Human Services: Office of the Assistant 
Secretary for Preparedness and Response: 
* Coordination of response; 
* HHS Command Center. 

Department of Health and Human Services: Food and Drug Administration: 
* Coordination of response; 
* Emergency Operations Center; 
* FDA regulated product surveillance. 

Department of Health and Human Services: Centers for Disease Control 
and Prevention: 
* Disease and outbreak surveillance; 
* Testing and advice; 
* Communications and alerts; 
* Emergency Operations Center. 

Other federal agencies: 

Department of Defense: 
* Detection of biological agents; 
* Disease and outbreak surveillance. 

Department of Energy: 
* Detection of biological agents; 
* Disease and outbreak surveillance; 
* Simulation and modeling tools. 

Department of Homeland Security: 
* Emergency management. 

U.S. Department of Agriculture: 
* Domestic and imported food safety surveillance; 
* Communications regarding animal disease outbreaks and contamination. 

Environmental Protection Agency: 
* Drinking water safety monitoring. 

Veterans Affairs: 
* Disease and pathogen surveillance. 

Source: GAO based on research of HHS and other data. 

[A] Health care providers can also contact state entities directly. 

[End of figure] 

HHS, primarily through the activities of CDC, collects health data 
from state and local health departments and analyzes the data using 
information technology to detect biological events, such as disease 
outbreaks.[Footnote 3] In addition, FDA conducts surveillance of food- 
borne illnesses and adverse drug events. When an event is detected, 
states may provide HHS regional emergency coordinators access to 
state, local, and tribal data within their jurisdictions. 

HHS serves as the federal focal point for coordinating response 
support for public health and medical services, which is 1 of 15 
emergency support functions defined by DHS's Federal Emergency 
Management Agency.[Footnote 4] The department coordinates national 
emergency response efforts for public health emergencies primarily 
through the Secretary's Operations Center, which is a 24-hour-a-day, 7-
day-a-week emergency operations center that collects and analyzes data 
from other federal emergency centers, such as CDC's and FDA's 
emergency operations centers. The Secretary's Operations Center shares 
information with other federal agencies that have responsibility for 
public health and other emergency support functions, such as DHS and 
the Departments of Agriculture and Transportation; the World Health 
Organization; and state and local entities through HHS's Regional 
Emergency Coordinators. The regional coordinators maintain daily 
contact with public health entities in their designated regions and 
communicate regularly by telephone and e-mail. 

Figure 2 presents a simplified illustration of the relationships and 
information sharing among the Secretary's Operations Center and its 
partners in emergency response. 

Figure 2: Emergency Response Partners: 

[Refer to PDF for image: illustration] 

HHS Secretary's Operations Center: 
Partners: 
Emergency support function partners; 
World Health Organization and international partners; 
CDCs Emergency Operations Center; 
FDAs Emergency Operations Center; 
DHS; 
HHS Regional Emergency Coordinators; 
HHS operating and staff divisions. 

Source: GAO presentation of HHS information. 

[End of figure] 

Use of Information Technology in Supporting Situational Awareness: 

Information technology plays an essential role in providing data 
needed by public health entities to enhance situational awareness of 
emergencies and potential emergencies. For more than a decade, 
federal, state, and local public health organizations, private 
companies, and academic institutions have been developing systems for 
collecting and analyzing electronic surveillance data from sources 
such as hospital emergency departments, clinical laboratories, and 
pharmacies. These systems support emergency preparedness by providing 
near real-time information needed to detect disease outbreaks and 
other public health emergencies. For example, electronic 
biosurveillance[Footnote 5] systems collect and provide data such as 
lab test results and complaints from emergency department patients to 
public health officials. These surveillance techniques are employed 
not only to detect initial signs of emerging threats but also to track 
the spread of syndromes, diseases, and other biological events 
throughout the duration of public health emergencies. Additionally, 
geographic information systems and mapping tools that support 
emergency response to events are useful to public health officials, as 
these tools provide visual and quantitative data such as maps of 
available hospital facilities and bed capacity, the location of 
electrical grids, and regional population information during a disease 
outbreak or other public health emergency. 

HHS's Use of Information Systems to Prepare For and Respond to Public 
Health Events: 

Recent domestic public health events provide examples of HHS's use of 
information systems and tools in preparation for and response to 
emerging public health events. During the Deepwater Horizon oil spill 
in 2010, CDC, in coordination with state and local health departments, 
conducted surveillance for related health effects across the five 
states bordering the Gulf of Mexico. As part of this effort, CDC used 
BioSense, a syndromic surveillance system, and the National Poison 
Data System to maintain a situational awareness of more than 20 health 
conditions related to the eyes, skin, and respiratory, cardiovascular, 
gastrointestinal, and neurological systems in states affected by the 
spill. Further, the Secretary's Operations Center at HHS employed 
geographic information systems and Internet-based mapping tools to 
track the spread of the oil and manage response efforts during this 
event. 

Information technology also played a role in providing situational 
awareness for the early detection of influenza-like illnesses during 
the 2009-2010 H1N1 influenza outbreak. During this outbreak, CDC, in 
partnership with the Public Health Informatics Institute[Footnote 6] 
and the International Society for Disease Surveillance,[Footnote 7] 
used another surveillance system called Distribute to collect, 
analyze, and share surveillance information from local emergency 
departments' surveillance systems throughout the affected areas and 
across multiple public health jurisdictions. Additionally, during the 
public health emergency that occurred as a result of the earthquake in 
Haiti, CDC used Internet-based mapping tools to identify available 
medical facilities and open transportation routes for delivering 
medical supplies. 

State, Local, and Federal Tribal Public Health Entities' Use of 
Information Technology to Share Information: 

State, local, and tribal public health entities have implemented and 
used information systems and tools for more than a decade to help 
personnel conduct jurisdictional syndromic and disease surveillance, 
public health reporting, and emergency response operations. Many of 
these systems were developed locally or were acquired from commercial, 
government, or academic sources.[Footnote 8] Additionally, public 
health personnel with the Indian Health Service track syndromes and 
diseases of tribal populations using the service's medical facilities 
by extracting, aggregating, and analyzing medical data from its 
electronic health records system. The Indian Health Service 
demonstrated this capability during the 2009 H1N1 outbreak. 

HHS Regional Emergency Coordinators with whom we spoke described the 
use of information technology by state and local entities to support 
event detection and emergency response operations in their 
jurisdiction. They described variations in the use of these systems 
and in state and local health entities' information technology 
infrastructures and capabilities to collect, transmit, and receive 
electronic data.[Footnote 9] The regional coordinators stated that 
some local health departments lack the resources and technology to 
develop and implement electronic data collection and analysis systems, 
or to electronically share information with HHS. On the other hand, 
they described some states, such as New York and New Jersey, which 
have implemented robust public health surveillance and reporting 
systems and sophisticated tools for supporting emergency response. 

While some state and local public health officials are able to view in 
near real-time the graphs and charts produced by CDC's biosurveillance 
systems, such as BioSense and Distribute, they are not currently able 
to view information that the HHS emergency operations centers produce 
in near real-time. According to HHS officials, the department is not 
able to share much of the information across all public health 
jurisdictions in part because of data ownership and governance issues, 
but they are working towards making the data that are shareable more 
easily accessible to state and local entities. Additionally, according 
to HHS officials and public health stakeholders with whom we spoke, 
electronic data collection, analysis, and sharing capabilities of many 
state and local public health departments are limited by challenges 
such as lack of infrastructure, funding, and personnel resources. HHS 
officials further stated that, even in cases where state and local 
public health entities have implemented information systems that 
support response operations, data and interoperability standards have 
not been defined to allow electronic transmission from state and local 
systems into the Secretary's Operations Center's systems and tools 
used during response operations; as a result, public health officials 
experience lost time and increased workloads associated with the need 
to duplicate data entry efforts. 

PAHPA's Requirements for Electronic Public Health Situational 
Awareness Capabilities: 

In December 2006, PAHPA established within HHS the Office of the 
Assistant Secretary for Preparedness and Response (ASPR). Among other 
things, the act required the Assistant Secretary to serve as the 
principal advisor to the Secretary on all matters related to federal 
public health and medical preparedness and response for public health 
emergencies, and to coordinate with state, local, and tribal public 
health officials to ensure effective integration of federal public 
health and medical assets during public health emergencies. Records 
from a November 2007 PAHPA stakeholders' meeting conducted by 
officials from ASPR, the Office of the National Coordinator for Health 
Information Technology (ONC), and CDC highlighted requirements for HHS 
to establish a near real-time electronic nationwide public health 
situational awareness capability in accordance with Section 202 of the 
act. (Table 1 summarizes the requirements of the act.) PAHPA 
authorized the use of grants for purposes of meeting this mandate 
through fiscal year 2011 (i.e., September 30, 2011).[Footnote 10] To 
date, no appropriations have been made pursuant to the authorization. 

Table 1: Summary of Requirements Defined by PAHPA Section 202: 

Requirement: Strategic plan; 
Description: 
* Submit a strategic plan that demonstrates the steps the Secretary 
will undertake to develop, implement, and evaluate the network no 
later than 180 days after December 19, 2006 (i.e., June 16, 2007). 

Requirement: Electronic situational awareness network; 
Description: 
* Establish by December 19, 2008, in collaboration with state, tribal, 
and local health officials, a near real-time electronic nationwide 
public health situational awareness network of systems to share data 
and information to enhance early detection of, rapid response to, and 
management of potentially catastrophic infectious disease outbreaks 
and other public health emergencies that originate domestically or 
abroad; 
* The network is to include data transmitted in a standardized format 
from state, local, and tribal public health entities, including: 
- public health laboratories; 
- federal health agencies; 
- zoonotic disease monitoring systems; 
- public and private sector health care entities, hospitals, 
pharmacies, poison control centers, and clinical labs to the extent 
practicable and provided that such data are voluntarily provided 
simultaneously to HHS and to state, local, and tribal public health 
agencies; and; 
- other sources as the Secretary deems appropriate; 
* The Secretary was further required to use interoperability standards 
determined through a joint public and private sector process and to 
define minimal data elements for the network. 

Requirement: Collaborative efforts; 
Description: 
* Collaborate with state, local, and tribal public health officials to 
establish the network; integrate and build on existing capabilities to 
ensure simultaneous sharing of data from the network with state, 
local, and tribal public health agencies; and develop procedures and 
standards for the collection, analysis, and interpretation of data 
collected and reported to the network. 

Requirement: Grants; 
Description: 
* The Secretary was authorized, but not required, to award grants to 
states or consortia of states to establish or operate a coordinated 
statewide or regional public health situational awareness system; 
* Any state or consortium of states that received an award was 
required to establish, enhance, or operate a coordinated public health 
situational awareness system for both regional and statewide early 
detection of, response to, and management of public health emergencies. 

Source: GAO analysis of PAHPA Section 202. 

[End of table] 

Our Previous Studies Highlighted the Need for Coordination and 
Definition of National Strategic Plans for Biosurveillance and Public 
Health Information Technology Capabilities: 

Prior to the enactment of PAHPA, we issued reports on the need for HHS 
to develop strategies and plans for coordinating public health 
information technology initiatives among federal, state, and local 
public health entities. In these reports, we noted a need for 
definitions of data and interoperability standards to better enable 
the analysis of data and the sharing of information needed to support 
public health emergency preparedness and response. For example, in 
2003, we studied federal agencies' efforts to develop and implement 
information technology to support public health emergency preparedness 
and response.[Footnote 11] We noted that information technology could 
more effectively facilitate emergency response if standards were 
defined and implemented to allow systems to be interoperable. We also 
noted that an underlying challenge for establishing and implementing 
such standards is the lack of an overall strategy guiding information 
technology initiatives. We recommended that the Secretary of HHS, in 
coordination with other key stakeholders--such as the Secretaries of 
Defense, Homeland Security, and Veterans Affairs--establish a national 
information technology strategy for public health preparedness and 
response. HHS, through activities initiated by ONC, has activities 
underway to implement this recommendation to define interoperability 
standards and address other concerns, such as privacy, as part of its 
efforts to advance the nationwide implementation of health care 
information technology. 

Also, in a June 2005 report,[Footnote 12] we described the reported 
progress of federal agencies on major public health information 
technology initiatives including one broad initiative at CDC--the 
Public Health Information Network--that is intended to provide the 
nation with integrated public health information systems to support 
activities such as disease detection, tracking, outbreak management, 
and exchange of laboratory information. As a result of our study, we 
recommended that the Secretary of HHS ensure that the federal 
initiatives were (1) aligned with the national health information 
technology strategy, the federal health architecture, and other 
ongoing public health information technology initiatives, and (2) 
coordinated with state and local public health initiatives and ensure 
federal actions to encourage the development, adoption, and 
implementation of health care data and communication standards across 
the health care industry to address interoperability challenges 
associated with the exchange of public health information. The 
department addressed our recommendations by including public health 
strategies within its overall strategy for nationwide health 
information technology, including state and local entities, in 
initiatives to improve the exchange of clinical and public health 
data, and awarding a contract for harmonization of standards across 
the public and private health care sectors. 

Further, in 2004 as part of our reporting related to homeland 
security, we identified a set of desirable characteristics for 
effective strategies to aid the entities responsible in further 
developing and implementing seven national strategies related to 
homeland security and combating terrorism.[Footnote 13] Among the 
characteristics we identified were: (1) goals, objectives, activities, 
and priorities; (2) performance measures; (3) costs and benefits; (4) 
identification of resources; and (5) integration of related strategies. 

In November 2008, we reported on our study of CDC's BioSense program. 
We found that state and local public health entities with whom we 
spoke considered costs and benefits of electronic syndromic 
surveillance systems difficult to track since syndromic surveillance 
activities are only one component of a wide range of emergency 
response activities, including identifying available hospital beds. 
Additionally, we reported that CDC had not identified annual and long-
term cost and time line estimates and performance measures for 
implementation of its redesigned BioSense program.[Footnote 14] We 
recommended that the Director of CDC develop reliable cost and time 
line estimates for implementing the BioSense program, and, with 
stakeholder input, develop outcome-based performance measures. HHS 
welcomed the recommendations discussed in our report and has taken 
steps to implement them. Specifically, CDC has initiated activities to 
define reliable cost and time line estimates and has worked with a 
panel of state and local stakeholders to define performance measures 
that are focused on the intended results of the program. However, as 
of December 2010 the recommendations had not yet been fully addressed. 

In a related report issued in December 2009,[Footnote 15] we noted 
that DHS's National Biosurveillance Integration Center was not fully 
equipped to carry out its mission because it lacked key resources--
such as data and personnel--from its partner agencies. We recommended 
that the Director of the center finalize a strategy for more 
effectively collaborating with current and potential members of the 
center's National Biosurveillance Information System by (1) clearly 
defining the center's mission and purpose, along with the value of 
National Biosurveillance Information System membership for each 
agency; (2) addressing challenges to sharing data and personnel, 
including clearly and properly defining roles and responsibilities in 
accordance with the unique skills and assets of each agency; and (3) 
developing and achieving buy-in for joint strategies, procedures, and 
policies for working across agency boundaries. We also recommended 
that the Director establish and use performance measures to monitor 
and evaluate the effectiveness of collaboration with current and 
potential National Biosurveillance Information System partners. DHS 
generally concurred with our findings and recommendations and stated 
that the National Biosurveillance Information Center would work to 
develop a collaboration strategy to clarify the mission, roles, and 
responsibilities of all National Biosurveillance Information System 
partners. 

Most recently, we reported that, while national biodefense strategies 
have been developed to address biological threats such as pandemic 
influenza, there is neither a comprehensive national strategy nor a 
focal point with the authority and resources to guide the effort to 
develop a national biosurveillance capability. We also reported that 
limited information is available to develop a reliable assessment of 
the costs and benefits of a national biosurveillance capability. In 
our June 2010 report,[Footnote 16] we recommended that the Homeland 
Security Council direct the National Security Staff to, in 
coordination with relevant federal agencies, (1) establish the 
appropriate leadership mechanism to provide a focal point with 
authority and accountability for developing a national biosurveillance 
capability and (2) charge this focal point with the responsibility for 
developing, in conjunction with relevant federal agencies, a national 
biosurveillance strategy. Officials from HHS, DHS, and the Departments 
of Agriculture and Defense stated that having a focal point would help 
coordinate federal efforts to develop a national biosurveillance 
capability. In particular, DHS noted that it is important to develop a 
strategy that encompasses all biological domains. 

HHS Has Not Defined a Strategic Plan or Fully Established a Network as 
Required by PAHPA, but Has Developed Related Strategies and Systems: 

PAHPA mandated that the Secretary of HHS develop and submit to the 
appropriate committees of Congress by June 16, 2007, a strategic plan 
that described the steps the department would take to develop, 
implement, and evaluate an electronic network of interoperable systems 
for the simultaneous sharing of information needed to enhance 
situational awareness at the federal, state, local, and tribal levels 
of public health. The act required the department to establish such a 
network by December 19, 2008. 

HHS did not develop and submit to congressional committees the 
strategic plan required by PAHPA, although it has developed related 
strategies that could contribute to a comprehensive strategic plan for 
an electronic public health information network to enhance situational 
awareness. These related strategies were developed by different 
offices within HHS--such as ONC, CDC, and ASPR--to address goals, 
objectives, and priorities established by their offices[Footnote 17] 
and to meet specific requirements of executive and statutory 
authorities for the development of strategies for nationwide health 
information exchange, coordinated biosurveillance, and health 
security. However, HHS has not defined a comprehensive strategic plan 
that identifies goals, objectives, activities, priorities, and 
performance measures, and that integrates related strategies to 
achieve the unified electronic nationwide situational awareness 
capability required by PAHPA. 

Additionally, the department has developed and implemented information 
technology systems intended to enable electronic information sharing 
to support early detection of and response to public health 
emergencies. However, these systems were not developed as part of a 
comprehensive, coordinated strategic plan as required by PAHPA. 
Instead, they were developed to support ongoing public health 
activities over the past decade, such as disease and syndromic 
surveillance. Without the guidance and direction that would be 
provided by an overall strategic plan that defines requirements for 
establishing and evaluating the capabilities of existing and planned 
information systems, the department cannot be assured that its 
resources are being used to develop and implement systems that are 
able to collect, analyze, and share the information needed to fulfill 
requirements for an electronic nationwide public health situational 
awareness capability. 

HHS Has Not Developed a Strategic Plan for Establishing an Electronic 
Network to Support Nationwide Public Health Situational Awareness: 

PAHPA required HHS to develop a strategic plan that demonstrated steps 
the department would take to develop and implement an electronic 
network for public health situational awareness. The act further 
stated that the plan was to define steps for evaluating network 
capabilities. It also established criteria for evaluating the extent 
to which the network met requirements of the act, such as the 
integration of data from various sources and the implementation of 
interoperability standards. 

HHS did not develop and deliver to congressional committees a 
strategic plan as required by PAHPA. HHS officials stated that when 
PAHPA was enacted in December 2006, the Assistant Secretary for 
Preparedness and Response and the Director of CDC interpreted the 
PAHPA language describing situational awareness to mean the knowledge 
obtained from biosurveillance activities. These officials stated that, 
as a result of this understanding, a policy decision was made by ASPR 
and CDC in early 2007 that CDC would serve as the lead for PAHPA-
related biosurveillance activities and that a nationwide 
biosurveillance strategy that was expected to be developed by CDC 
would satisfy the PAHPA strategic plan requirement. However, CDC did 
not develop and HHS did not deliver such a plan to congressional 
committees, as required by PAHPA. 

Although a comprehensive strategic plan for an electronic situational 
awareness network of systems has not yet been developed, CDC, ASPR, 
and ONC have individually taken steps to define strategies that 
identify certain objectives, goals, priorities, and activities related 
to the development of electronic networks and systems intended to 
support event detection and emergency response. For example: 

* In June 2008, ONC released the ONC-Coordinated Federal Health IT 
Strategic Plan,[Footnote 18] which defines strategies, objectives, 
goals, and measures for the implementation of the Nationwide Health 
Information Network (NHIN), an HHS initiative intended to define 
standards, policies, and procedures for enabling the secure exchange 
of interoperable health care and public health information over the 
Internet. In addition to establishing goals and objectives for the 
exchange of clinical health information, this strategy also defines 
population health-oriented goals. For example, the Federal Health IT 
Strategic Plan identifies an objective and supporting strategies for 
enabling the secure exchange of interoperable health information for 
population health purposes, including public health emergency 
preparedness and response. However, this strategy was developed to 
coordinate federal health information technology initiatives focused 
on sharing electronic health data collected from health care providers 
(e.g., hospitals and physicians) and was not intended to address the 
exchange of data between public health entities. 

* In December 2008, CDC's Biosurveillance Coordination unit released 
the initial version of the National Biosurveillance Strategy for Human 
Health,[Footnote 19] which defines goals to support integrated 
biosurveillance information as a priority. The strategy states that 
health information exchange, enabled by the NHIN, is a foundation for 
a nationwide exchange of biosurveillance data. It also emphasizes the 
need for data and interoperability standards to enable systems to 
share information across jurisdictions, disciplines, and domains 
related to human health, such as veterinary, environmental, food, and 
agricultural. Version 2.0 of the strategy, which was released in 
February 2010, defines an activity that is intended to identify and 
compile a registry of existing biosurveillance systems in use by 
federal, state, and local public health entities. While this strategy 
addresses the need for improved electronic exchange of biosurveillance 
data to enhance public health emergency preparedness and response 
capabilities of federal, state, and local public health entities, it 
does not address another key component of situational awareness--i.e., 
the knowledge of resources available for emergency response operations. 

* In December 2009, HHS published the National Health Security 
Strategy and a companion implementation plan to meet another PAHPA 
requirement.[Footnote 20] In this strategy, the department defined 
situational awareness more broadly than the knowledge provided by 
biosurveillance activities to include, among other things, knowledge 
of operational resources needed to respond to public health 
emergencies. According to HHS officials with ASPR, the health security 
strategy represents current HHS policy defining situational awareness, 
which is consistent with PAHPA. This strategy includes an objective to 
"ensure situational awareness" and emphasizes the need to improve the 
efficiency, accuracy, interoperability, and usability of information 
systems to enhance situational awareness. However, the strategy does 
not identify goals, objectives, or priorities for developing and 
implementing a network of information systems for situational 
awareness, nor does it identify steps for evaluating such a network. 
According to ASPR officials, the implementation plan for the health 
security strategy is being revised. They stated that they expect a new 
version will be released in 2011. 

As HHS broadened the scope and definition of public health situational 
awareness to encompass knowledge of emerging events and emergency 
response resources, the department did not develop an overall 
strategic plan for the establishment and evaluation of an electronic 
nationwide public health situational awareness network that addressed 
this scope. Until HHS develops a strategic plan that identifies goals, 
objectives, activities, and priorities that integrate related 
strategies to achieve the unified electronic nationwide situational 
awareness capability required by PAHPA, the department will not be 
able to provide the guidance needed to help ensure that the various 
offices across HHS coordinate their strategic planning efforts to meet 
the PAHPA mandate. 

HHS Has Taken Steps to Implement Systems and Tools that Support Event 
Detection and Emergency Response, but They Do Not Fully Address 
Objectives of PAHPA: 

PAHPA describes data and other technical requirements for establishing 
and evaluating a public health situational awareness network that was 
to be completed by December 19, 2008. Specifically, the act required 
HHS to build on existing systems to establish a near real-time 
electronic nationwide public health situational awareness capability 
through an interoperable network of systems. The act identified the 
sources of data to be collected, analyzed, and shared among the 
systems, such as state, local, and tribal public health entities; 
federal health agencies; zoonotic disease monitoring systems;[Footnote 
21] poison control centers; and clinical laboratories. The act further 
required HHS to use interoperability standards determined through a 
joint public and private sector process and to define minimal data 
elements for the network of systems. The electronic capability 
described by PAHPA was to support simultaneous sharing of data among 
federal, state, local, and tribal public health entities. 

CDC, ASPR, and ONC officials described more than 25 ongoing 
information technology initiatives that, in their view, contribute to 
the department's efforts to enable electronic information sharing to 
support situational awareness for early event detection and emergency 
response. Some of them address certain criteria for systems defined by 
the PAHPA mandate, such as requirements for data sources, 
interoperability standards, and minimal data elements for an 
electronic public health situational awareness network. Among the 
ongoing initiatives, the officials described the following: 

* HHS officials identified key information technology systems and 
tools that support early event detection through the analysis of 
electronic data collected from sources specified by PAHPA. 
Biosurveillance systems, such as BioSense and Distribute, collect, 
analyze, and share data from sources such as state and local public 
health departments, public health laboratories, and health care 
facilities. These systems are intended to enhance public health 
entities' ability to detect disease outbreaks and other public health 
emergencies by enabling simultaneous sharing of information produced 
by the systems. In addition, officials with the FDA stated that they 
use a Web-based system called the Electronic Laboratory Exchange 
Network (eLEXNET) to collect, analyze, and share electronic food 
safety laboratory data among federal, state, and local agencies to 
help detect potential for outbreaks of foodborne illnesses. 

* ONC officials described initiatives to define interoperability 
standards and identify minimal data elements for the electronic 
exchange of biosurveillance information through electronic health 
records. CDC, through the Public Health Information Network 
initiative, identified interoperability standards and developed 
messaging software that allow public health entities to securely send 
and receive encrypted public health information, including disease and 
syndromic surveillance data, over the Internet. 

* HHS emergency response officials who operate and manage the 
Secretary's Operations Center identified systems and tools that are 
crucial to the department's ability to support response operations in 
public health emergencies, such as MedMap, a system that allows users 
to identify the status of a health event and future areas of concern. 
ASPR developed and maintains the Information Management Plan, which is 
intended to define the data needed, along with methods and processes 
for collecting and managing information, to support situational 
awareness and decision making during emergency response to public 
health events. 

See table 2 in appendix II for additional details about the key event 
detection and emergency response information systems identified by HHS 
officials. 

While the systems that HHS officials described collect and analyze 
data from many of the sources required by PAHPA and while HHS has 
recently taken some steps to define data elements and standards to 
support sharing of biosurveillance information throughout the public 
health community, these activities were initiated to collect, analyze, 
and share data to support specific public health functions, such as 
biosurveillance and hospital capacity planning. Department officials 
stated that HHS does not view a situational awareness network or 
system as being one comprehensive system, but rather an integrated 
collection of systems and networks. These officials further stated 
that the information systems and networks they described comprise a 
network that makes up an electronic situational awareness capability. 

Nonetheless, while these systems and tools enhance the nation's 
ability to detect and respond to public health emergencies, they were 
developed and implemented without the guidance and direction that 
would be provided by an overall strategic plan that defines 
requirements for establishing and evaluating the capabilities of 
existing and planned information systems. Lacking such a plan, HHS 
cannot be assured that its resources are being used to develop and 
implement systems that are able to collect, analyze, and share the 
information needed to fulfill requirements for an electronic 
nationwide public health situational awareness capability. 

HHS Has Taken Steps to Collaborate with State and Local Entities: 

PAHPA required the Secretary of HHS to collaborate with state, local, 
and tribal public health officials in establishing an electronic 
information-sharing network which builds on existing capabilities to 
ensure simultaneous sharing of data with state, local, and tribal 
public health agencies. The act required collaborative efforts to 
develop procedures and standards for the collection, analysis, and 
interpretation of data collected and reported to the network. 

Department officials have engaged in certain collaborative efforts 
with stakeholders to define components of an electronic information-
sharing network. Additionally, the department has awarded funds 
through cooperative agreement programs to engage state and local 
public health officials in collaborative efforts to improve 
information sharing for enhanced situational awareness. 

ONC, CDC, and ASPR Have Engaged in Collaborations with Public Health 
Partners to Define Information Technology Standards and Data 
Requirements: 

Since its establishment in 2004, ONC has engaged in collaborations 
with public and private health care partners to establish standards, 
services, and policies that support the electronic exchange of 
interoperable health care and public health data as part of the NHIN 
initiative. Through these collaborative efforts, the office defined 
minimal data elements that must be included in electronic health 
records to support electronic sharing of information for 
biosurveillance purposes, along with interoperability standards to 
enable sharing of electronic health and public health 
information.[Footnote 22] Additionally, HHS's requirements for 
demonstrating meaningful use of electronic health records by providers 
include the ability to report syndromic surveillance data to state and 
local public health entities.[Footnote 23] CDC officials stated that 
they are working with ONC and other public health stakeholders, 
including the International Society for Disease Surveillance, to 
define data requirements for situational awareness as part of future 
meaningful use criteria. 

CDC officials have also taken steps to improve collaborative efforts 
with public health stakeholders in biosurveillance and other public 
health information technology initiatives. For example, they 
contracted with state and regional health information exchanges to 
integrate and build on the exchanges' existing capabilities to collect 
and share data using the BioSense system. Additionally, through a 
partnership with other public and private entities (the International 
Society for Disease Surveillance and the Public Health Informatics 
Institute), the agency created a data format, the Geocoded 
Interoperable Population Summary Exchange, to facilitate the 
electronic exchange of syndromic surveillance data among public health 
entities using the Distribute system.[Footnote 24] In September 2010, 
as part of ongoing efforts initiated during the H1N1 outbreak 
response, CDC officials established a community forum on its BioSense 
Redesign Collaboration Web site to obtain input from and provide 
updated information to public health surveillance stakeholders 
regarding the ongoing redesign of the BioSense program, including the 
area of situational awareness.[Footnote 25] Public health 
stakeholders, such as the Council of State and Territorial 
Epidemiologists and the Public Health Informatics Institute, agreed 
that CDC has improved efforts to collaborate on information technology 
initiatives to support early event detection. 

ASPR officials stated that they work with state and local public 
health emergency response partners to develop information collection 
plans for the Secretary's Operations Center. These plans identify the 
data elements needed to assess potential threats (such as the spread 
of disease outbreaks or natural disasters), the source of each data 
element, and mechanisms for sharing data between the Secretary's 
Operations Center and other public health entities to enhance 
situational awareness. For example, the information collection plan 
for response to the spread of influenza-like illness identifies 
information requirements for measuring the impact of the illness, such 
as school absenteeism or closure, and for identifying the capacity to 
meet needs during medical surges, such as availability of ventilators 
or pharmaceuticals. 

HHS Has Established Cooperative Agreement Programs Intended to Improve 
State and Local Public Health Entities' Information Systems: 

Under authorities other than PAHPA, HHS initiated additional 
activities to collaborate with public health stakeholders through 
cooperative agreement programs intended to support the development and 
implementation of information systems to collect, analyze, and share 
data for enhanced situational awareness. For example, according to 
HHS, the Public Health Emergency Preparedness Cooperative Agreement 
program, the Regional Surveillance Collaboratives program, and the 
Hospital Preparedness Program were designed to, among other things, 
award funds to regional, state, and local public health entities for 
implementation of information systems to improve syndromic 
surveillance and emergency response operations.[Footnote 26] 

* The Public Health Emergency Preparedness program awards funds to 
state and local public health jurisdictions. Awardees are required to 
use the funds for, among other things, improving capabilities to 
prepare for and respond to bioterrorism, outbreaks of infectious 
diseases, and other public health threats and emergencies. North 
Carolina public health officials stated that they used funds from this 
program to enhance the capabilities of an existing Web-based syndromic 
surveillance system called NC DETECT, which collects poison control 
and school absenteeism data and data describing patients' complaints 
from all the state's hospital emergency departments. The system was 
enhanced to transmit these data to CDC's BioSense system. 

* The Regional Surveillance Collaboratives program awards funds to 
states and consortia of states to promote collaboration, planning, and 
use of standards to allow for effective surveillance and exchange of 
data using existing technologies. The collaboratives are intended to 
bring together resources from multiple jurisdictions to enhance 
overall public health surveillance and situational awareness. 
According to officials with the Missouri Regional Collaborative, as a 
result of the funds and support provided through this program, 
Missouri and Kansas built on their existing technologies to implement 
features that enabled them to share syndromic surveillance data. They 
also stated that they used these funds to integrate state surveillance 
data into Johns Hopkins University's surveillance system and into 
CDC's BioSense system. 

* The Hospital Preparedness Program funds activities of states, 
territories, and localities intended to improve preparedness planning 
for disease outbreaks and other public health emergencies. Program 
guidance for fiscal year 2010 states that funds are to be used by 
awardees to, among other things: 

- enhance or maintain the ability of health care systems to adequately 
prepare for increased numbers of patients in the event of a public 
health emergency; 

- engage with other responders through interoperable communication 
systems; 

- track bed and resource availability through electronic systems; 

- develop systems to facilitate the use of volunteers in local, 
territorial, and federal emergency response;[Footnote 27] and: 

- coordinate regional emergency response exercises. 

More than 30 state and local public health entities reported that they 
have implemented, refined, or maintained National Hospital Available 
Beds for Emergencies and Disasters (HAvBED) capabilities using funds 
from this program. In one case, a county health department revised 
HAvBED reporting schedules from four times a month to daily in order 
to meet reporting needs during the H1N1 outbreak. 

Cooperative agreement awardees with whom we spoke stated that the 
funds available through these programs have supported their ability to 
enhance nationwide public health situational awareness by improving 
the capabilities of existing information systems that support public 
health officials' collection, analysis, and sharing of information. 
According to a public health official participating in CDC's Regional 
Collaborative with Missouri and Kansas, funds awarded through the 
program facilitated the implementation of technologies that met the 
unique needs of states that were at different levels of technical 
capacity. Additionally, public health officials from North Carolina 
indicated that funds provided by the Public Health Emergency 
Preparedness Cooperative Agreement contributed to the implementation 
of technologies that provide statewide early event detection and 
timely public health surveillance information to public health 
officials and hospital users. 

More detailed information about these and other key cooperative 
agreements administered by ASPR and CDC can be found in appendix III. 

HHS Has Not Awarded Grants to States for Improved Information Systems 
to Enhance Nationwide Situational Awareness: 

PAHPA states that the Secretary of HHS may award grants to states or 
consortia of states to enhance their ability to establish or operate 
public health situational awareness systems for regional or statewide 
early detection of, response to, and management of public health 
emergencies. The act authorized the use of funds for this purpose 
through September 30, 2011. 

To date, Congress has not appropriated funds pursuant to the 
authorization. HHS officials with ASPR stated that if funds are 
appropriated for grant awards under the mandate, they will administer 
them. 

Conclusions: 

HHS did not develop and deliver to congressional committees the 
situational awareness strategic plan required by PAHPA. While ONC, 
CDC, and ASPR have developed other related strategies and information 
systems intended to address the need for improvements in health 
information exchange and information technology to support early event 
detection and emergency response operations, the department has not 
yet developed and implemented a strategic plan for the development, 
implementation, and evaluation of an electronic public health 
situational awareness network as required by PAHPA. Without such a 
plan, HHS has not established overall goals, objectives, priorities, 
and activities to guide and integrate related efforts, nor has it 
defined steps and performance measures for evaluating the 
effectiveness of existing and ongoing information technology 
initiatives toward establishing an information-sharing network of 
interoperable systems. 

HHS's current efforts to revise its related strategies provide an 
opportunity for the department to define and implement a comprehensive 
strategic plan that integrates the goals, objectives, and priorities 
for electronic health information exchange, biosurveillance 
capabilities, and national health security into an overall strategic 
plan for electronic situational awareness capabilities. This strategic 
plan would also define steps and performance measures for evaluating 
the outcomes of the department's various efforts related to electronic 
public health situational awareness capabilities. Until HHS develops 
and implements such a strategic plan, the department cannot ensure 
that its efforts to develop and implement systems that support public 
health emergency preparedness and response fulfill the PAHPA mandate 
and meet goals and objectives for enhanced nationwide public health 
situational awareness through electronic information-sharing systems. 

Recommendation for Executive Action: 

To address the requirements of PAHPA, we recommend that the Secretary 
of HHS direct the Assistant Secretary for Preparedness and Response to 
immediately lead efforts, in collaboration with other federal, state, 
local, and tribal public health officials, to develop and implement an 
overall strategic plan for establishing and evaluating an electronic 
network of systems that meets the information-sharing requirements for 
enhanced nationwide public health situational awareness defined by the 
act. The strategy should: 

* define specific goals, objectives, priorities, and activities for 
establishing the network; 

* identify steps and performance measures for evaluating capabilities 
of existing and planned information systems to establish the network; 
and: 

* integrate elements of related strategies to achieve unified 
electronic public health situational awareness capabilities defined by 
PAHPA. 

Agency Comments and Our Evaluation: 

HHS's Assistant Secretary for Legislation provided written comments on 
a draft of this report. In the comments, the department neither agreed 
nor disagreed with our recommendations. HHS described strategies and 
existing resources it has utilized to support improvements for 
situational awareness at the state, local, tribal, and territorial 
levels. Further, the department believed that its efforts are 
consistent with direction provided in the Pandemic and All-Hazards 
Preparedness Act. Nonetheless, HHS stated that a complete strategy for 
health and public health situational awareness will be developed and 
incorporated into the Biennial Implementation Plan for the National 
Health Security Strategy which will identify actions to be 
accomplished in the next 2 years. The department added that it intends 
to release this first biennial plan in early 2011. As discussed in our 
report, developing a strategic plan that integrates the goals, 
objectives, and priorities of related strategies will be essential to 
ensuring success of the department's efforts to support and enhance 
nationwide public health situational awareness. 

HHS's comments are reproduced in appendix IV of this report. In 
addition, the department provided technical comments which we have 
incorporated as appropriate. 

We are sending copies of this report to the Secretary of HHS and 
interested congressional committees. In addition, the report will be 
available at no charge on the GAO Web site at [hyperlink, 
http://www.gao.gov]. 

If you have any questions on matters discussed in this report, please 
contact me at (202) 512-6304 or at melvinv@gao.gov. Contact points for 
our offices of Congressional Relations and Public Affairs may be found 
on the last page of this report. Other contacts and key contributors 
to this report are listed in appendix V. 

Signed by: 

Valerie C. Melvin: 
Director, Information Management and Human Capital Issues: 

List of Congressional Committees: 

The Honorable Tom Harkin: 
Chairman: 
Committee on Health, Education, Labor, and Pensions: 
United States Senate: 

The Honorable Michael B. Enzi: 
Ranking Member: 
Committee on Health, Education, Labor, and Pensions: 
United States Senate: 

The Honorable Joseph I. Lieberman: 
Chairman: 
Committee on Homeland Security and Governmental Affairs: 
United States Senate: 

The Honorable Susan M. Collins: 
Ranking Member: 
Committee on Homeland Security and Governmental Affairs: 
United States Senate: 

The Honorable Henry A. Waxman: 
Chairman: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Joe Barton: 
Ranking Member: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Edolphus Towns: 
Chairman: 
Committee on Oversight and Government Reform: 
House of Representatives: 

The Honorable Darrell Issa: 
Ranking Member: 
Committee on Oversight and Government Reform: 
House of Representatives: 

[End of section] 

Appendix I: Objectives, Scope, and Methodology: 

The objectives of our review were to (1) determine the Department of 
Health and Human Services' (HHS) plans for and status of implementing 
an electronic nationwide public health situational awareness network; 
(2) describe HHS's efforts to collaborate with state, local, and 
tribal public health officials to achieve a nationwide situational 
awareness capability; and (3) determine how HHS uses grants authorized 
by the Pandemic and All-Hazards Preparedness Act (PAHPA), Section 202, 
to enhance states' ability to establish coordinated public health 
situational awareness systems. 

To determine HHS's plans for and status of the establishment of an 
electronic network to enhance nationwide public health situational 
awareness, we reviewed Section 202 of PAHPA to identify requirements 
for an electronic situational awareness network as defined by the act. 
We collected and analyzed agency documentation regarding program 
planning and management activities, such as strategic and information 
management plans, and descriptions of current uses and outcomes of 
systems and tools used by the department to collect, analyze, and 
share information to enhance nationwide, state, and local public 
health situational awareness. We reviewed strategic planning documents 
related to the implementation of information technology to enhance 
public health situational awareness including the Centers for Disease 
Control and Prevention's (CDC) 2010 National Biosurveillance Strategy 
for Human Health; the Office of the National Coordinator for Health 
Information Technology's (ONC) ONC-coordinated Federal Health IT 
Strategic Plan, 2008-2012; HHS's Assistant Secretary for Preparedness 
and Response's (ASPR) 2009 National Health Security Strategy and 
Interim Implementation Guide; and ASPR's 2007 Information Management 
Plan. 

In addition, we identified key information systems used by HHS to 
support early event detection and emergency response operations by 
reviewing HHS planning documents and prior GAO reports and by having 
discussions with officials from ASPR, ONC, the Food and Drug 
Administration, the Indian Health Service, and CDC's Office of 
Surveillance, Epidemiology, and Laboratory Services, Emergency 
Operation's Center, and the Center for Global Health. We also visited 
HHS's Secretary's Operations Center and CDC's Emergency Operations 
Center to discuss and observe the use of key systems and tools that 
support detection of and response to public health emergencies. Within 
CDC's Office of Surveillance, Epidemiology, and Laboratory Services, 
we held more detailed discussions with officials in the Public Health 
Informatics and Technology Program Office and Biosurveillance 
Coordination regarding the status of and plans for information 
technology initiatives to support early detection of disease outbreaks 
and other public health emergencies, including the definition and 
implementation of data and interoperability standards within such a 
network. To supplement this information, we attended presentations on 
the status of and plans for CDC's biosurveillance initiatives, such as 
the BioSense and Distribute systems. From the information we gathered, 
we developed a table of HHS's key information technology initiatives 
intended to enhance early detection of and response to public health 
emergencies. 

To describe HHS's efforts to collaborate with state, local, and tribal 
public health officials, we reviewed Section 202, Title II, of PAHPA 
to determine requirements for HHS to collaborate with stakeholders on 
the establishment of an electronic situational awareness capability. 
We collected and analyzed documentation including cooperative 
agreements between HHS and state and local partners, and artifacts 
from stakeholders' participation at conferences related to nationwide 
biosurveillance activities. We discussed with officials from the Food 
and Drug Administration, CDC, and ASPR, including officials involved 
with HHS's Secretary's Operation Center and CDC's Emergency Operations 
Center, their efforts to collaborate with public health officials. To 
supplement our discussions with HHS officials, we met with 
representatives from four public health organizations to obtain their 
views on the department's efforts to collaborate on implementation of 
information systems for event detection and emergency and on the 
department's efforts to establish an electronic network for sharing 
information to enhance public health situational awareness. 
Specifically, we held discussions with officials from the National 
Association of City and County Health Officials, Association of State 
and Territorial Health Organizations, Council of State and Territorial 
Epidemiologists, and Public Health Informatics Institute. We selected 
these organizations through research of public health information 
technology programs and from our previous work on the use of 
information technology to support public health emergency preparedness 
and response. In addition, we interviewed representatives of the 
National Association of State Chief Information Officers who are 
involved in state public health information technology initiatives. We 
also interviewed state and local public health officials participating 
in CDC's demonstration projects with health information exchanges in 
New York, Washington state, and Indiana, and in other regional 
collaborative efforts with South Carolina, Missouri, Kansas, the 
University of Pittsburgh, and John Hopkins University. To describe 
further the extent to which HHS collaborates with the tribal 
community, we interviewed public health and information technology 
officials with the Indian Health Service. 

To determine the extent to which HHS provided funds through grants 
authorized by PAHPA to enhance states' ability to establish 
coordinated public health situational awareness systems, we held 
discussions with HHS officials. These officials stated that no grants 
had been established or awarded under authorization of the act. For 
each of the objectives, we assessed the reliability of the data we 
analyzed by reviewing existing documentation related to the data 
sources and interviewing knowledgeable agency officials about the data 
we used. We found the data sufficiently reliable for the purposes of 
this review. 

We conducted this performance audit from November 2009 through 
December 2010 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. 

[End of section] 

Appendix II: HHS's Key Information Technology Initiatives: 

Table 2 describes key information technology initiatives to develop 
and implement systems intended to enhance capabilities to detect and 
respond to disease outbreaks and other public health emergencies. 

Table 2: Key HHS Information Technology Systems Used to Enhance 
Situational Awareness: 

CDC systems: 

BioSense: 
Status: system is operational and is undergoing revision to collect 
data from existing automated surveillance systems operated by state 
and local health departments rather than from hospitals. CDC officials 
expect revised program plans to be in place by late 2011; 
FY 2009 costs: $27,656,000; 
Note: This only includes the program funds for BioSense; 
Description: National program to improve capabilities for early event 
detection, monitoring, and real-time situational awareness through 
access to specific health care data from participating organizations; 
Users: Public health staff at state and local health departments, CDC 
program staff, CDC's Emergency Operations Center, International 
Society for Disease Surveillance, VA's Office of Public Health and 
Environmental Hazards, and VA's Infectious Disease Program Office; 
Data providers: 640 acute-care hospitals; 1,300 Department of Defense 
and Department of Veterans Affairs hospitals and health care 
facilities; 2 large national commercial laboratories; and a national 
retail pharmacy database representing 27,000 retail pharmacies (as of 
September 2010). 

Distribute: 
Status: system is operational; 
FY 2009 costs: $1,480,000; 
Description: A collaborative surveillance activity that aggregates 
information from hospital emergency department syndromic surveillance 
systems operated by state and local health departments and merges 
those data with other existing surveillance systems to enhance 
situational awareness of geographic and age-specific patterns of 
influenza-like illness; 
Users: CDC, state, and local public health officials; 
Data providers: 41 local or state public health departments (as of 
September 2010). 

Health Alert Network: 
Status: system is operational; 
FY 2009 costs: $341,000; 
Description: A nationwide system serving as a platform for the 
distribution of health alerts, dissemination of prevention guidelines 
and other information, distance learning, national disease 
surveillance, and electronic laboratory reporting, as well as for 
CDC's bioterrorism and related initiatives to strengthen preparedness 
at the local and state levels; 
Users: State public health officials from 50 states, 3 large city 
health departments, 3 county health departments, 8 territories, the 
District of Columbia, and multiple health organizations and major 
hospital networks; 
Data providers: CDC, local, state, and federal health authorities 
access and share disease reports, response plans, and CDC diagnostic 
and treatment guidelines. 

Epidemic Information Exchange: 
Status: system is operational; 
FY 2009 costs: $2,008,000; 
Description: A system for the secure exchange of epidemiologic data, 
including provisional or secure-but-not-classified information 
regarding outbreaks and other emergent public health events, among 
public health officials at the local, state, and federal levels; 
Users: Approximately 5,000public health officials, including CDC 
epidemiologists and program staff, state and territorial health 
officers, state and territorial epidemiologists, and other state and 
local officials; 
Data providers: CDC epidemiologists, state epidemiologists, poison 
control center directors, local health officers, and other public 
health professionals. 

Laboratory Response Network: 
Status: system is operational; 
FY 2009 costs: $7,594,000; 
Description: An integrated network of 165 public health and clinical 
laboratories that provide laboratory diagnostics and have a 
disseminated testing capability for public health preparedness and 
response; 
Users: State and local public health officials; 
Data providers: 165 public health and clinical laboratories. 

National Electronic Disease Surveillance System Base System: 
Status: system is operational; 
FY 2009 costs: $4,022,000; 
Note: Not an actual "surveillance system," it is a secure Internet-
based infrastructure for public health surveillance data exchange; 
Description: An integrated electronic disease surveillance system 
application that includes the capability to receive standards-based 
electronic records. The system provides public health jurisdictions 
with a reference implementation of National Electronic Disease 
Surveillance System/National Notifiable Diseases Surveillance System 
policy and standards consistent with the Nationwide Health Information 
Network and CDC's Public Health Information Network; 
Users: 16 state health departments; 
Data providers: State and local health departments and providers. 

National Notifiable Diseases Surveillance System: 
Status: system is operational; 
FY 2009 costs: $1,800,000; 
Description: A system that enables CDC to collect and publish data 
concerning nationally notifiable diseases; 
Users: State and local public health officials and CDC officials; 
Data providers: Public health officials in 50 states, 5 territories, 
the District of Columbia, and New York City. 

Border Infectious Disease Surveillance Project: 
Status: system is operational; 
FY 2009 costs: $728,000; 
Description: An early warning and active syndromic illness and disease 
monitoring network operating in the U.S.-Mexico border region that 
targets approximately 12 million people; 
Users: State and local public health epidemiologists at the U.S.-
Mexico border; 
Data providers: Data are contributed by local, state, and federal 
public health officials from the United States and Mexico. 

National Molecular Subtyping Network for Foodborne Disease 
Surveillance: 
Status: system is operational; 
FY 2009 costs: $4,400,000; 
Description: An early warning system for outbreaks of food-borne 
diseases; 
Users: State public health laboratories in all 50 states as well as 
other city, county, agricultural, and federal food safety laboratories; 
Data providers: Public health labs. 

Outbreak Management System: 
Status: system is operational; 
FY 2009 costs: $419,000; 
Description: A system that enables rapid, coordinated detection and 
response to multistate outbreaks of food-borne illness to promote more 
comprehensive outbreak surveillance; 
Users: CDC, Food and Drug Administration (FDA), and Department of 
Agriculture public health and food safety officials and state and 
local health departments; 
Data providers: Local, state and federal officials with responsibility 
for investigating and reporting food-borne, waterborne, and other 
enteric diseases outbreaks. 

Arboviral Surveillance System: 
Status: system is operational; 
FY 2009 costs: $12,700,000; 
Description: An Internet-based national arboviral surveillance system 
developed by state health departments and CDC in 2000 to assist states 
in tracking West Nile and other mosquito-borne viruses; 
Users: State and local public health officials and CDC officials, with 
distribution to the general public via CDC's Web site; 
Data providers: Public health departments in all states and three 
local districts (New York City, Washington D.C., and Puerto Rico). 

National Poison Data System: 
Status: system is operational; 
FY 2009 costs: $2,000,000; 
Description: A database that holds more than 50 million poison 
exposure case records; 
Users: Information from the National Poison Data System is available 
to the general public; 
Data providers: General public via case phone calls into poison 
centers across the country. 

National Toxic Substance Incidents Program: 
Status: system is operational; 
FY 2009 costs: $495,000; 
Description: National database of toxic substance incidents. Currently 
seven states contribute data to the system. Activities include 
national database, surveillance, and response teams; 
Users: CDC, state, and local public health officials, other federal 
agencies; 
Data providers: State health departments and affiliated agencies. 

Indian Health Service System: 

Resource and Patient Management System: 
Status: system is operational; 
FY 2009 costs: not available; 
Description: An automated system for managing clinical and 
administrative information in health care facilities that serves as a 
mechanism to provide near real-time health and public health data to 
the tribal community. A specific use of the overall system is to 
aggregate data for national public health surveillance for influenza 
and other reportable conditions in tribal areas; 
Users: Indian Health System federal and tribal hospitals, health 
centers and stations, and urban Indian health projects; 
Data providers: Indian Health Service federal sites, through tribally 
contracted and operated health programs, and urban Indian health 
projects. 

FDA Systems: 

Electronic Laboratory Exchange Network: 
Status: system is operational; 
FY 2009 costs: $1,097,000; 
Description: A Web-based system for real-time sharing of food safety 
laboratory data among federal, state, and local agencies; 
Users: 1,800 users including 203 participating labs; 
Data providers: Public health and agricultural food safety officials. 

Emergency Operations Network Incident Management System: 
Status: system is operational; 
FY 2009 costs: $2,046,000; 
Description: The central hub for exchanging and relaying all incident-
related information within the FDA. The Emergency Operations Network 
Incident Management System includes the central data repository for 
reports to the Reportable Food Registry, where industry is required to 
submit notification when there is a reasonable probability their human 
or animal food product could cause illness or injury; 
Users: FDA; 
Data providers: Systems such as the Electronic Laboratory Exchange 
Network and the Epidemic Electronic Exchange, FDA laboratories, and 
investigators and external agencies. 

International Food Safety Authorities Network: 
Status: system is operational; 
FY 2009 costs: funding provided by the World Health Organization; 
Description: A system that monitors potential international food 
safety-related events in addition to receiving information through 
International Food Safety Authorities Network emergency contact points; 
Users: 177 member states and the Food and Drug Administration; 
Data providers: Member states. 

National Consumer Complaint System: 
Status: system is operational; 
FY 2009 costs: not available; 
Description: A system used to collect and analyze complaints from 
consumers about FDA-regulated products; 
Users: Consumer complaint coordinators at FDA headquarters and 
regional offices; 
Data providers: Consumers of FDA-regulated products. 

MedWatch: 
Status: system is operational; 
FY 2009 costs: not available; 
Description: A system that provides important and timely clinical 
information about safety issues involving medical products, including 
prescription and over-the-counter drugs, biologics, medical and 
radiation-emitting devices, and special nutritional products; 
Users: General public, healthcare professionals, and consumers; 
Data providers: Healthcare professionals and consumers. 

ASPR Systems: 

Hospital Available Beds for Emergencies and Disasters: 
Status: system is operational; 
FY 2009 costs: $12,000,000; 
Description: A Web system that provides a centralized, national view 
of bed availability for supporting a medical response to a federal 
emergency, disaster, or disaster training event; 
Users: HHS Secretary's Operation Center and CDC's Emergency Operation 
Center as well as public health responders; 
Data providers: Civilian, Department of Defense, and Department of 
Veterans Affairs hospitals, mental health institutions, and nursing 
homes. 

WebEOC: 
Status: system is operational; 
FY 2009 costs: $15,400; 
Description: A commercial off-the-shelf emergency operations center 
crisis information management system; 
Users: HHS Secretary's Operation Center and CDC Emergency Operations 
Center and the FDA Emergency Operations Center; 
Data providers: HHS's federal, state, and local health partners and 
Geospatial Information System data. 

MedMap: 
Status: system is operational; 
FY 2009 costs: $499,700; 
Description: MedMap is a Web-based application that allows the user to 
become aware of the current status of a health event from the field 
and identify future areas of concern or gaps; 
Users: HHS Secretary's Operation Center Federal health responders, 
including HHS's regional emergency coordinators; 
Data providers: Emergency Support Function-8 partners, the U.S. Census 
Bureau, commercial health and medical data repositories, and open 
source news pushes (free and commercial). 

Geospatial Information System: 
Status: system is operational; 
FY 2009 costs: $110,700; 
Description: Computer hardware, software, geographic data, and 
processes designed to capture, store, update, manipulate, analyze, and 
display all forms of geographically referenced data; 
Users: HHS Secretary's Operation Center, Federal and state health 
departments, and FDA Emergency Operations Center; 
Data providers: Geospatial Information System technology--
Environmental Systems Research Institute geographical information 
systems software. 

Electronic Medical Record: 
Status: system is operational; 
FY 2009 costs: $1,877,000; 
Description: A disaster response system that supports operational 
decision making with near real-time injury and illness data and 
supports patient care documentation and the exchange of that 
information over the Nationwide Health Information Network; 
Users: HHS Secretary's Operation Center and hospital, doctors, and 
clinics; 
Data providers: Hospitals, doctors, and clinics. 

The Joint Patient Assessment and Tracking System: 
Status: system is operational; 
FY 2009 costs: $283,000; 
Description: A system that provides a means of tracking patients as 
they move through the National Disaster Medical System; 
Users: HHS Secretary's Operation Center and HHS staff, contractors, 
and other authorized users; 
Data providers: HHS; 
Departments of Defense, Veterans Affairs, and Homeland Security; 
and 72 federal coordination centers. 

Source: HHS officials. 

[End of table] 

[End of section] 

Appendix III: HHS's Key Cooperative Agreement Programs: 

Table 3 describes key cooperative agreement programs identified by HHS 
that provide funds for collaborations between HHS and state and local 
public health entities to support development of information systems 
to enhance public health situational awareness. 

Table 3: Key HHS Cooperative Agreement Programs Funding Enhanced State 
and Local Public Health Situational Awareness through Information 
Technology Systems: 

CDC-administered programs: 

Program and funding mechanism: Early Warning Infectious Disease 
Surveillance (EWIDS)[B]; 
Funding authorized through CDC Public Health Emergency Preparedness 
Cooperative Agreement Program, Announcement AA154 from 2003-2009. In 
fiscal year 2010, EWIDS funding was issued by ASPR to CDC under 
authorization from the Consolidated Appropriations Act 2010 (P. L. 111-
117), through an Intra-Departmental Delegation of Authority rather 
than the CDC Public Health Emergency Preparedness authorization; 
Approximate total amount awarded: $38.7 million; 
Description: HHS created the EWIDS program in fiscal year 2003. The 
U.S. Border States EWIDS program exclusively focuses on building the 
capacity of public health systems of all 20 U.S. border states, 
including Alaska. The purpose of the program is to provide cross-
border early warning of infectious diseases by enhancing surveillance 
capabilities and prompt sharing of findings of concern among U.S. 
states, Mexican states, and Canadian provinces along local and tribal 
jurisdictions adjacent to or straddling the U.S. international 
boundary to the north and south; 
Awardees[A]: 20 states. 

Program and funding mechanism: The Public Health Emergency 
Preparedness Cooperative Agreement; 
Funding authorized through CDC Public Health Emergency Preparedness 
Cooperative Agreement Program, Announcement AA154; 
Approximate total amount awarded: $7 billion; 
Description: Congress authorized funding for the Public Health 
Emergency Preparedness Cooperative Agreement in 2002 to support all-
hazards preparedness nationwide. The program provides funds to support 
development and maintenance of critical public health preparedness and 
response capacities and capabilities, including implementation of 
interoperable systems consistent with Public Health Information 
Network standards; 
Awardees[A]: 62 states, territories, and localities. 

Program and funding mechanism: Epidemiology and Laboratory Capacity 
for Infectious Diseases--NEDSS; 
Funding authorized through CDC Epidemiology and Laboratory Capacity 
for Infectious Diseases Program under Announcements CDC-RFA-CI04-040; 
CI07-701 and CI07-702; 
Approximate total amount awarded: $102.1 million; 
Description: This program was originated in 2001 to promote the use of 
data and information system standards to advance the development of 
efficient, integrated, and interoperable surveillance systems at 
federal, state, and local levels. NEDSS is a major component of the 
Public Health Information Network. This broad initiative is designed 
to detect outbreaks rapidly and to monitor the health of the nation, 
facilitate the electronic transfer of appropriate information from 
clinical information systems in the health care system to public 
health departments, reduce provider burden in the provision of 
information, and enhance both the timeliness and quality of 
information provided; 
Awardees[A]: 50 states, 5 localities, and 1 territory. 

Program and funding mechanism: Epidemiology and Laboratory Capacity 
for Infectious Diseases--BioSense; 
Funding authorized through CDC Epidemiology and Laboratory Capacity 
for Infectious Diseases Program under Announcements CDC-RFA-CI04-040; 
Approximate total amount awarded: $462,000; 
Description: This program was started in 2010 to support early event 
detection and timely public health surveillance using a variety of 
secondary data sources, such as hospital emergency departments; 
Awardees[A]: North Carolina. 

Program and funding mechanism: Epidemiology and Laboratory Capacity 
for Infectious Diseases--Infrastructure and Interoperability Support 
for Public Health Laboratories; 
Funding authorized by the American Recovery and Reinvestment Act 
through Epidemiology and Laboratory Capacity for Infectious Diseases 
Program under Announcements CDC-RFA-CI10-1007ARRA10; 
Approximate total amount awarded: $5 million; 
Description: This program began in 2010 to enhance and advance 
infrastructure and interoperability support for public health 
laboratories to satisfy Stage 1 meaningful use criteria for reporting 
to public health agencies; 
Awardees[A]: 8 states and 2 localities. 

Program and funding mechanism: Epidemiology and Laboratory Capacity 
for Infectious Diseases--Building and Strengthening Epidemiology, 
Laboratory, and Health Information Systems Capacity in State and Local 
Health Departments; 
Funding authorized by the Patient Protection and Affordable Care Act 
through Epidemiology and Laboratory Capacity for Infectious Diseases 
Program under Announcement CDC-RFA-C110-1012; 
Approximate total amount awarded: $22.74 million total; (including 
$9.1 million for health information systems and $13.56 million for 
epidemiology and laboratory capacity, which includes $2.65 million of 
BioSense funding); 
Description: This program began in 2010 to invest in public health's 
capacity to participate in modern health information exchange through 
support of Laboratory Information Management Systems, electronic 
laboratory-based reporting; supporting public health capacity to 
participate in "meaningful use" of electronic health records. While 
the Epidemiology and Laboratory Capacity for Infectious Diseases has 
supported NEDSS activities over the years, the laboratory Patient 
Protection and Affordable Care Act funding is more clearly focused on 
an important area for health reform--public health's participation in 
meaningful use as electronic health records evolve; 
Awardees[A]: 49 states and 5 localities. 

Program and funding mechanism: CDC Regional Surveillance 
Collaboratives Program; 
Funded through Announcement-CDC RFS HK08-802; 
Approximate total amount awarded: $1 million; 
Description: The CDC Regional Surveillance Collaboratives program 
started in June 2008. The program provides funds to demonstrate and 
evaluate earlier detection of potential outbreaks and enhanced 
situational awareness by exchanging cross-jurisdiction summary data 
from existing surveillance systems; 
Awardees[A]: Missouri Department of Health and Senior Services, Johns 
Hopkins University, South Carolina Department of Health and 
Environmental Control, and the University of Pittsburgh. 

ASPR-administered program: 

Program and funding mechanism: Hospital Preparedness Program; 
Funded through a Continuation Cooperative Agreement and the 
Consolidated Appropriations Act in fiscal year 2010 Announcement-HHS-
2009-ASPR-SA-0901; 
Approximate total amount awarded: $3.6 billion; 
Description: The program has provided all-hazard preparedness funding 
to 62 awardees since fiscal year 2002 to increase the capacities and 
capabilities of health care systems, including the Hospital Available 
Beds for Emergencies and Disasters system; to improve surge capacity; 
and enhance community and hospital preparedness for public health 
emergencies and mass casualty events; 
Awardees[A]: 62 states, territories, and localities. 

Source: HHS officials. 

[A] All awardees received funds in 2009, with the exception of 
awardees for the Epidemiology and Laboratory Capacity programs that 
originated in 2010. 

[B] EWIDS is a joint collaboration between HHS-ASPR and CDC's Office 
of Public Health and Preparedness Response. CDC manages the 
programmatic distribution and implementation of EWIDS funds through a 
supplement to Public Health Emergency Preparedness cooperative 
agreements with the states. ASPR leads policy development for border 
and trans-border activities and program management with partner 
countries in Canada and Mexico. 

[End of table] 

[End of section] 

Appendix IV: Comments from the Department of Health and Human Services: 

Department Of Health And Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

December 14, 2010: 

Valerie C. Melvin: 
Director, Information Management and Human Capital Issues: 
U.S. Government Accountability Office: 
441 G Street N.W. 
Washington, DC 20548: 

Dear Ms. Melvin: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) report entitled: "Public Health Information Technology: 
Additional Strategic Planning Needed to Guide HHS's Efforts to 
Establish Electronic Situational Awareness Capabilities" (GAO-11-99). 

The Department appreciates the opportunity to review this 
correspondence before its publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

[End of letter] 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office's (GAO) Draft Report Entitled, 
"Public Health Information Technology: Additional Strategic Planning 
Needed To Guide HHS's Efforts To Establish Electronic Situational 
Awareness Capabilities (GA0-11-99). 

The Department appreciates the opportunity to review and continent on 
this draft report before its publication. We have carefully reviewed 
the report and are pleased that GAO recognizes the significant efforts 
of HHS to build electronic public health information systems and 
networks for situational awareness. These efforts are consistent with 
direction provided in the Pandemic and All-Hazards Preparedness Act 
(PAHPA) through the development of the National Health Security 
Strategy (NHSS). 

In 2009, HHS published the first National Health Security Strategy 
which identifies 10 strategic objectives with the overall aim to 
minimize the health consequences associated with significant health 
incidents. Recognizing the critical importance to the goals of the 
NHSS, "Ensuring Situational Awareness" was included as a stand-alone 
objective. Perceptions and definitions of situational awareness have 
continued to evolve in the context of health incidents, moving from an 
initial focus on biomedical surveillance to a much broader context. We 
now recognize that operational situational awareness represents a 
range of systems and technologies and captures information related to 
health threats and biomedical surveillance, as well as health system 
and response resources thereby informing and improving prevention, 
protection, response, and recovery operations and, ultimately, health 
outcomes. 

Consistent with the strategic direction established in the NHSS, HHS 
has developed and released several strategies to improve electronic 
situational awareness capabilities. The Centers for Disease Control 
and Prevention (CDC) lead the development of the National 
Biosurveillance Strategy for Human Health (NBSFE1), a comprehensive, 
national strategy for improving health-related situational awareness 
through biosurveillance that elaborates strategic goals and objectives 
for advancing the Nation's biosurveillance capabilities. The 
establishment of a national biosurveillance system represents an ideAl 
capability in the domain of public health situational awareness. The 
NHS Office of the National Coordinator for Health Information 
Technology (ONC) led the development of ONC-Coordinated Federal Health 
IT Strategic Plan. This strategic plan identifies protocols for 
exchanging health information via information technology which is 
essential for advancing health-related electronic situational 
awareness systems and networks. 

GAO notes in the report that Section 202 of PAHPA ("Using Information 
Technology to Improve Situational Awareness in Health Emergencies") 
provides HHS with authorities to award grants to enhance health-
related situational awareness under section 319D of the Public Health 
Service (PHS) Act, but to date, Congress-has not appropriated funds 
pursuant to the authorization. In the absence of funding, HI-IS has 
moved forward with new strategies and systems as well as utilizing 
existing resources to Support improvements for situational awareness 
at the State level. 

HHS leverages the Hospital Preparedness Program (HPP) and the Public 
Health Emergency Preparedness (PREP) cooperative agreements to improve 
situational awareness for States, localities, as well as tribal and 
territorial jurisdictions. Through these cooperative agreements, HHS 
supports grantees to improve situational awareness including a 
national capability to address a surge of patients during a mass 
casualty event. In addition, HHS has created innovative partnerships 
to improve situational awareness. For example, during the 2009 HIN I 
influenza pandemic, HHS partnered with the National Association of 
County and City Health Officials (NACCHO) to create a sentinel network 
of local health departments that could provide situational awareness 
of pharmaceutical uptake and non-pharmaceutical intervention 
activities at the local level. HHS and the Federal Emergency 
Management Agency (FEMA) have partnered with Gulf Coast officials to 
assess hospital and nursing home vulnerabilities and capabilities to 
withstand an emergency incident such as a hurricane. These assessments 
provide situational awareness about what resources may need to be 
brought to bear during an incident to supplement hospital and nursing 
home capabilities and what actions can be taken before an incident to 
reduce these vulnerabilities. 

The NHSS reflects a roadmap and common vision for how the nation will 
achieve national health security including ensuring situational 
awareness; through implementation of the NHSS, HHS will be identifying 
gaps and determining what is required in the development of a more 
comprehensive plan and strategy. HHS's efforts in the past two years 
are important components of a comprehensive approach and demonstrate 
progress toward the goals of the NHSS. Development of a complete 
strategy for health and public health situational awareness will be 
incorporated into the Biennial Implementation Plan for the NHSS which 
will identify actions to be accomplished in the next 2 years. This 
first NHSS Biennial Implementation Plan will be released in early 2011. 

[End of section] 

Appendix V: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Valerie C. Melvin, (202) 512-6304 or melvinv@gao.gov: 

Staff Acknowledgments: 

In addition to the contact named above, Teresa F. Tucker (assistant 
director), Michael A. Alexander, Tonia B. Brown, Neil J. Doherty, 
Nancy Glover, Franklin D. Jackson, Lee A. McCracken, Dana R. Pon, and 
Adam Vodraska made key contributions to this report. 

[End of section] 

Footnotes: 

[1] Pub. L. No. 109-417 (Dec. 19, 2006). 

[2] 42 U.S.C. 300hh-10(b)(1). 

[3] Health data collected by public health entities for purposes of 
syndromic and disease surveillance are generally "deidentified"--i.e., 
aggregated statistical data is stripped of individual identifiers. 
Under the Health Insurance Portability and Accountability Act Privacy 
Rule, these deidentified data, unless reidentified, are not 
individually identifiable health information and, as such, the data 
are not covered by the protections for that information defined by the 
rule (45 C.F.R.  164.502(d), 164.512, 164.514). 

[4] The Federal Emergency Management Agency coordinates response 
support from across federal government and nongovernment organizations 
by calling up, as needed, 1 or more of 15 emergency support functions. 
Each of these functions has a lead coordinator and primary and support 
agencies. The mission of the emergency support functions and 
respective coordinators and agencies is to provide the greatest 
possible access to capabilities of the federal government irrespective 
of the agency having those capabilities. The emergency support 
functions also assist in functional areas including transportation, 
communications, public works and engineering, firefighting, mass care, 
housing, human services, public health and medical services, search 
and rescue, agriculture, natural resources, and energy. 

[5] Biosurveillance is a concept that emerged in response to increased 
concern about biological threats from infectious diseases and 
bioterrorism. Biosurveillance contributes to situational awareness for 
a response that gives decision makers and the public accurate 
information about how to prevent, manage, or mitigate the potentially 
catastrophic consequences of an event. A subset of biosurveillance, 
syndromic surveillance is a technique that uses health-related data to 
identify patterns of disease symptoms prior to the diagnosis of a 
specific disease. Effective use of this technique can provide 
information that enhances situational awareness and enables early 
detection of a disease outbreak. 

[6] The Public Health Informatics Institute, located in Decatur, 
Georgia, is a program of the Task Force for Global Health, a nonprofit 
organization. The institute brings together public health 
professionals to facilitate their understanding of information needs 
and to define solutions for their informatics challenges. 

[7] The International Society of Disease Surveillance is a nonprofit 
professional society founded in 2005 and is administratively supported 
by Tufts Health Care Institute located in Boston, Massachusetts. The 
mission of the society is to improve population health by advancing 
the field of disease surveillance. 

[8] In an earlier report, we described syndromic surveillance systems 
in use by hospitals and state and local health departments throughout 
the country, including locally developed systems and systems available 
from the Department of Defense and the University of Pittsburgh. See 
GAO, Health Information Technology: More Detailed Plans Needed for the 
Centers for Disease Control and Prevention's Redesigned BioSense 
Program, [hyperlink, http://www.gao.gov/products/GAO-09-100] 
(Washington, D.C.: Nov. 20, 2008). 

[9] The emergency coordinators' descriptions were consistent with 
findings of our earlier study, [hyperlink, 
http://www.gao.gov/products/GAO-09-100]. 

[10] HHS officials noted that statutory authorities and directives 
other than those provided by PAHPA identify roles and responsibilities 
of other federal agencies, such as DHS and the Departments of 
Transportation and Agriculture, that also support public health 
situational awareness. However, these statutes are related primarily 
to biosurveillance activities, which do not meet the broader 
definition of situational awareness established by HHS. Further, the 
mandate for HHS to establish electronic network capabilities for 
enhanced situational awareness is unique to PAHPA. We describe 
relevant laws and directives in our June 2010 report, Biosurveillance: 
Efforts to Develop a National Biosurveillance Capability Need a 
National Strategy and a Designated Leader, [hyperlink, 
http://www.gao.gov/products/GAO-10-645] (Washington, D.C.: June 30, 
2010). 

[11] GAO, Bioterrorism: Information Technology Strategy Could 
Strengthen Federal Agencies' Abilities to Respond to Public Health 
Emergencies, [hyperlink, http://www.gao.gov/products/GAO-03-139] 
(Washington, D.C.: May 30, 2003). 

[12] GAO, Information Technology: Federal Agencies Face Challenges in 
Implementing Initiatives to Improve Public Health Infrastructure, 
[hyperlink, http://www.gao.gov/products/GAO-05-308] (Washington, D.C.: 
June 10, 2005). 

[13] GAO, Combating Terrorism: Evaluation of Selected Characteristics 
in National Strategies Related to Terrorism, [hyperlink, 
http://www.gao.gov/products/GAO-04-408T] (Washington, D.C.: Feb. 3, 
2004). 

[14] [hyperlink, http://www.gao.gov/products/GAO-09-100]. 

[15] GAO, Biosurveillance: Developing a Collaboration Strategy Is 
Essential to Fostering Interagency Data and Resource Sharing, 
[hyperlink, http://www.gao.gov/products/GAO-10-171] (Washington, D.C.: 
Dec. 18, 2009). 

[16] [hyperlink, http://www.gao.gov/products/GAO-10-645]. 

[17] According to HHS, the National Biosurveillance Strategy for Human 
Health reflects goals, objectives, and priorities established through 
a CDC-led collaboration with federal, state, local, and other health 
partners to reflect both CDC's and its partners' needs. 

[18] ONC, ONC-Coordinated Federal Health IT Strategic Plan 2008-2012 
(Washington, D.C., June 2008). ONC's health information technology 
strategy was developed and maintained to meet requirements of an April 
2004 Presidential Executive Order (E.O. 13335). According to HHS 
officials, ONC is revising the 2008 plan and expects to publish the 
revision by the end of 2010. 

[19] HHS, CDC, Office of Public Health Preparedness and Response, 
Biosurveillance Coordination Unit, National Biosurveillance Strategy 
for Human Health, Version 1.0 (Atlanta, Ga., December 2008). This 
strategy was developed to meet requirements of the Homeland Security 
Presidential Directive 21, Public Health and Medical Preparedness, 
which was issued in October 2007. 

[20] HHS, National Health Security Strategy of the United States of 
America and Interim Implementation Guide for the National Health 
Security Strategy of the United States of America (Washington, D.C., 
December 2009). This strategy was developed to meet other requirements 
of PAHPA, such as for HHS to identify processes for achieving the 
preparedness goals described in the act, evaluate the progress made by 
federal, state, local, and tribal entities toward levels of 
preparedness established by the act, and include a national strategy 
for establishing an effective and prepared public health workforce. 

[21] Diseases transmitted between people and animals are called 
zoonotic diseases. Examples of zoonotic diseases include mad cow 
disease, West Nile virus, and H1N1 influenza. 

[22] The data elements and standards established to date were defined 
by the Health Information Technology Standards Panel and the American 
Health Information Community, which are committees made up of 
representatives from the public and private health sectors, 
established by ONC to support NHIN initiatives. 

[23] Within the American Recovery and Reinvestment Act of 2009, the 
Health Information Technology for Economic and Clinical Health Act 
authorized incentive payments to Medicare and Medicaid providers that 
meaningfully use electronic health records in their practices. 42 
U.S.C.  1395w-4(o), 1395ww(n), 1396b(t). To demonstrate "meaningful 
use" providers must meet specific criteria defined by HHS in three 
phases. Phase I requirements were finalized in July 2010 and phase II 
requirements are planned to be announced in 2012. 

[24] This format included the minimal data elements for conducting 
biosurveillance defined by ONC and its partners--the Health 
Information Technology Standards Panel and the America Health 
Information Community, which are public-private partnerships 
established by HHS to provide consultation and technical support to 
ONC as it defines specifications for the NHIN. AHIC has been replaced 
by other committees formed by the Health Information Technology for 
Economic and Clinical Health Act. 

[25] The BioSense Redesign Collaboration Web site address is 
[hyperlink, https://sites.google.com/site/biosenseredesign/]. 

[26] The Federal Grant and Cooperative Agreement Act of 1977, 31 
U.S.C. 6305, defines the cooperative agreement as similar to a grant 
in that a thing of value is transferred to a recipient to carry out a 
public purpose. However, a cooperative agreement is used whenever 
substantial federal involvement with the recipient during performance 
is anticipated. The difference between grants and cooperative 
agreements is the degree of federal programmatic involvement rather 
than the type of administrative requirements imposed. 

[27] According to ASPR, development of systems within the Emergency 
System for Advance Registration of Volunteer Health Professionals 
network is funded through the program. The purpose of the program is 
to establish a single national interoperable network of state-based 
programs to effectively facilitate the use of volunteers in local, 
territorial, and federal emergency responses. All awardees under the 
Hospital Preparedness Program are required to meet and maintain all 
Emergency System for Advance Registration of Volunteer Health 
Professionals electronic system, operational, evaluation, and 
reporting compliance requirements. 

[End of section] 

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