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 HHS’s 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 GAO’s 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;
CDC’s Emergency Operations Center;
FDA’s 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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