HHS Guidelines for Ensuring and Maximizing
the Quality, Objectivity, Utility, and Integrity
of Information Disseminated to the Public
Part I: HHS Overview
[ Full Table of Contents ]
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Summary of HHS Agency Guidelines
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OMB Guidelines
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HHS Responsibilities
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Framework for HHS Guidelines
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Purpose
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Definitions
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Scope and Applicability of the Guidelines
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Overview of HHS Information Dissemination and Quality
Assurance
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The HHS Mission
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Categories of Information Disseminated
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Types of Dissemination Mechanisms
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Overview of Quality Assurance Policies and Practices in
HHS
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HHS Information Quality Goals
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Influential Scientific, Financial and Statistical
Information
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Health, Safety, and Environmental Information
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Urgent Public Health and Safety Information
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Overview of Agency Complaint Procedures
The U.S. Department of Health and Human Services (HHS) developed these guidelines
to implement Office of Management and Budget (OMB) January 2002 requirement
that all federal agencies issue guidelines for ensuring the quality of the
information that they disseminate to the public. The Department of Health
and Human Services is the United States government's principal agency for
protecting the health of all Americans and providing essential human services,
especially to those who are least able to help themselves. The Department
includes more than 300 programs, covering a wide spectrum of activities.
In the course of carrying out program missions, agencies and staff offices
within HHS disseminate a wide variety of information to the public, ranging
from research and statistical reports to authoritative health and medical
information. Many of these information dissemination activities and products
rank among the highest quality scientific, statistical and programmatic
information among federal agencies, and in many cases set the national and
international standard for quality.
HHS is committed to disseminating information that meets the standards of
quality set forth in OMB and in the guidelines discussed in this document.
It is HHS's goal to ensure and maximize the quality, objectivity, utility,
and integrity of information that it disseminates to the public. We strive
to provide information that is accurate, reliable, clear, complete, unbiased,
and useful. We are committed to integrating the principle of information
quality into every phase of information development, including creation,
collection, maintenance, and dissemination. The guidelines that follow describe
the quality assurance policies and practices that support information
dissemination activities in HHS.
Following an overview of the OMB Guidelines and HHS guidelines, the quality
assurance policies of each of the major operating agencies and staff offices
of HHS are described. Each set of agency guidelines includes a description
of a) the mission of the agency, b) the scope and applicability of the guidelines
within the agency, c) the types of information that the agency disseminates,
d) the dissemination methods employed by the agency, e) the policies, standards
and practices that the agency employs to ensure the quality of the information
it disseminates, and f) an administrative mechanism and contact points for
each agency so that individuals may seek correction of any information that
is believed not to meet the OMB, HHS, or agency-specific guidelines along
with an administrative appeals process.
[ Go to Contents ]
On September 28, 2001, and as amended on February 22, 2002, OMB issued final
Guidelines to implement section 515 of the Treasury and General Government
Appropriations Act for Fiscal Year 2001 (Public Law 106-554). The statute
directs OMB to "issue government wide guidelines that provide policy and
procedural guidance to federal agencies for ensuring and maximizing the quality,
objectivity, utility, and integrity of information (including statistical
information) disseminated by federal agencies." By October 1, 2002, agencies
must issue their own implementing guidelines. The guidelines only apply to
information that is disseminated on or after October 1, 2002. The administrative
mechanism for correction applies to information that the agency disseminates
on or after October 1, 2002, regardless of when the agency first disseminated
the information.
In general, the OMB Guidelines require agencies to adopt a basic standard
of quality as a performance goal and take appropriate steps to incorporate
information quality criteria into agency information dissemination practices.
Quality is to be ensured and established at levels appropriate to the nature
and timeliness of the information to be disseminated, and specific standards
may be adopted that are appropriate to the various categories of information
that is disseminated. Agencies are to develop a process for reviewing the
quality of information before it is disseminated. Further, information quality
is to be treated as an integral step in every aspect of the information
development process.
In issuing the Guidelines, OMB outlined several guiding principles. First,
OMB designed the Guidelines to apply to a wide variety of government
dissemination activities that may range in importance and scope. OMB also
designed the Guidelines to be generic enough to fit all media, whether printed
or electronic. OMB specifically sought to avoid the problems inherent in
developing detailed, prescriptive, "one size fits all" guidelines that would
artificially require all types of dissemination activities to be treated
in the same manner. Second, OMB designed the Guidelines so that agencies
will meet basic information quality standards. The Guidelines recognize that
some government information may need to meet higher or more specific standards
than others, depending on their purpose and scope. The more important the
information, the higher the quality standards to which it might be held,
for example, "influential scientific, financial or statistical information"
described below. At the same time, OMB recognizes that information quality
comes at a cost. Accordingly, agencies are encouraged to weigh the costs
and benefits of higher information quality in the development of information,
and the level of quality to which it will be held.
Third, OMB designed the Guidelines so that agencies can apply them in a common
sense, workable manner. OMB expects agencies to use existing processes rather
than create new and potentially duplicative or contradictory processes. Finally,
OMB recognizes that the Guidelines cannot be implemented in the same way
by all agencies. While the implementation may differ, the essence of the
Guidelines will apply. The agencies must make their methods transparent by
providing documentation, ensure quality by reviewing the underlying methods
used, by consulting as needed with both experts and users, and by keeping
users notified about corrections and revisions. These underlying principles
apply equally well across the diversity of HHS agencies and information
dissemination activities, and they have been adopted in the approach to the
HHS Guidelines described below.
[ Go to Contents ]
In accordance with the OMB Guidelines, agencies subject to the Paperwork
Reduction Act (44USC 3502(1)) are required to:
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Issue their own information quality guidelines ensuring and maximizing the
quality, objectivity, utility, and integrity of information (including
statistical information) disseminated by the agency not later than one year
after the issuance of the OMB Guidelines;
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Establish administrative mechanisms allowing affected persons to seek and
obtain correction of information maintained and disseminated by the agency
that does not comply with the guidelines. Agencies also are to specify
appropriate time periods for agency decisions on whether and how to correct
the information, and are to notify the affected persons of the action taken.
If the person who requested the correction does not agree with the agency's
decision (including the corrective action, if any), that person may file
for reconsideration within the agency. The agency is to establish an
administrative appeal process to review the initial decision, and specify
appropriate time limits in which to resolve such requests for reconsideration.
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Report periodically to the OMB Director on the number and nature of complaints
received by the agency regarding the accuracy of information disseminated
by the agency and how such complaints were resolved by the agency.
The HHS guidelines described in this plan incorporate the underlying principles
that OMB used in designing their government-wide guidelines. First, the HHS
guidelines apply to a wide range of government information dissemination
activities across HHS and are generic enough to fit all types of media, including
print, electronic, and other forms within HHS. Second, the HHS guidelines
are intended to assure that all the information that is disseminated meets
a basic level of quality and that more important information meets a more
rigorous quality standard. Third, the HHS guidelines explicitly recognize
the very different types of information that various HHS agencies disseminate
depending on their missions, including the need for flexibility in implementation
and avoidance of a "one size fits all" approach. Fourth, the statement of
HHS information quality policies and procedures are issued in the form of
guidelines and not a regulation.
HHS itself encompasses a broad and diverse range of health and human services
programs which, while unified in their pursuit of broad goals, are themselves
very diverse, encompassing the nation's largest health insurance plan, the
nation's preeminent biomedical research agency, as well as most of the nation's
federal capacity for public health protection and preparedness and income
assistance to needy families. Accordingly, the HHS approach to implementation
of the OMB Guidelines is designed to allow HHS agencies and offices to use
existing agency quality assurance mechanisms, and apply the guidelines in
a flexible manner that recognizes the mission of the agency, the wide range
of data that is disseminated and the frequent reliance on third party sources.
[ Go to Contents ]
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Purpose
These Guidelines describe the policies and procedures that HHS agencies employ
to ensure the quality of the information they disseminate and the administrative
complaint mechanisms that HHS agencies make available to the public. The
Guidelines provide policy and procedural guidance to HHS staff and are intended
to inform the public about agency quality assurance policies and procedures.
HHS views the guidelines as an evolving document and process. HHS will
continually review the performance of the guidelines in the context of agency
statutes and missions and will make revisions to the guidelines as necessary.
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Definitions
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"Quality" is an encompassing term comprising utility, objectivity, and Integrity.
Therefore, the Guidelines sometimes refer to these four statutory terms,
collectively, as "quality."
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"Utility" refers to the usefulness of the information to its intended users,
including the public. In assessing the usefulness of information that the
agency disseminates to the public, the agency needs to consider the uses
of the information not only from the perspective of the agency but also from
the perspective of the public. As a result, when transparency of information
is relevant for assessing the information's usefulness from the public's
perspective, the agency must take care to ensure that transparency has been
addressed in its review of the information.
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"Objectivity" involves two distinct elements, presentation and substance.
"Objectivity" includes whether disseminated information is being presented
in an accurate, clear, complete, and unbiased manner. This involves whether
the information is presented within a proper context. Sometimes, in disseminating
certain types of information to the public, other information must also be
disseminated in order to ensure an accurate, clear, complete, and unbiased
presentation. Also, the agency needs to identify the sources of the disseminated
information (to the extent possible, consistent with confidentiality protections)
and, in a scientific, financial, or statistical context, the supporting data
and models, so that the public can assess for itself whether there may be
some reason to question the objectivity of the sources. Where appropriate,
data should have full, accurate, transparent documentation, and error sources
affecting data quality should be identified and disclosed to users.
In addition, "objectivity" involves a focus on ensuring accurate, reliable,
and unbiased information. In a scientific, financial or statistical context,
the original and supporting data shall be generated, and the analytic results
shall be developed, using sound statistical and research methods.
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If data and analytic results have been subjected to formal, independent,
external peer review, the information may generally be presumed to be of
acceptable objectivity. However, this presumption is rebuttable based on
a persuasive showing by the petitioner in a particular instance. If
agency-sponsored peer review is employed to help satisfy the objectivity
standard, the review process employed shall meet the general criteria for
competent and credible peer review recommended by OMB-OIRA to the President's
Management Council (9/20/01)
(www.whitehouse.gov/omb/inforeg/oira_review-process.html),
namely, that (a) peer reviewers be selected primarily on the basis of necessary
technical expertise, (b) peer reviewers be expected to disclose to agencies
prior technical/policy positions they may have taken on the issues at hand,
(c) peer reviewers be expected to disclose agencies their sources of personal
and institutional funding (private or public sector), and (d) peer reviews
be conducted in an open and rigorous manner.
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If an agency is responsible for disseminating influential scientific, financial,
or statistical information, agency guidelines shall include a high degree
of transparency about the data and methods to facilitate the reproducibility
of such information by qualified third parties.
Original and supporting data must be subject to commonly accepted scientific,
financial, and statistical standards related thereto. However, agency guidelines
shall not require that all disseminated data be subjected to a reproducibility
requirement. Agencies may identify, in consultation with the relevant scientific
and technical communities, those particular types of data that can practicably
be subjected to a reproducibility requirement, given ethical, feasibility,
or confidentiality constraints. It is understood that reproducibility of
data is an indication of transparency about research design and methods and
thus a replication exercise (i.e., a new experiment, test, or sample) shall
not be required prior to each dissemination.
With regard to analytic results, agency guidelines shall generally require
sufficient transparency about data and methods that an independent reanalysis
could be undertaken by a qualified member of the public. These transparency
standards apply to agency analysis of data from a single study as well as
to analyses that combine information from multiple studies.
Making the data and methods publicly available will assist in determining
whether analytic results are reproducible. However, the objectivity standard
does not override other compelling interests such as privacy, trade secrets,
intellectual property, and other confidentiality protections.
In situations where public access to data and methods will not occur due
to other compelling interests, agencies shall apply especially rigorous
robustness checks to analytic results and document what checks were undertaken.
However, agency guidelines, in all cases, shall require a disclosure of the
specific data sources that have been used and the specific quantitative methods
and assumptions that have been employed. Each agency is authorized to define
the type of robustness checks, and level of detail for documentation thereof,
in ways appropriate for it given the nature and multiplicity of issues for
which the agency is responsible.
With regard to analysis of risks to human health, safety and the environment
maintained or disseminated by the agencies, agencies shall either adopt or
adapt the quality principles applied by Congress to risk information used
and disseminated pursuant to the Safe Drinking Water Act Amendments of 1996
(42 U.S.C. 300g-1(b)(3)(A) & (B)). Agencies responsible for dissemination
of vital health and medical information shall interpret the reproducibility
and peer-review standards in a manner appropriate to assuring the timely
flow of vital information from agencies to medical providers, patients, health
agencies, and the public. Information quality standards may be waived temporarily
by agencies under urgent situations (e.g., imminent threats to public health
or homeland security) in accordance with the latitude specified in
agency-specific guidelines.
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"Integrity" refers to the security of information protection
of the information from unauthorized access or revision, to ensure that the
information is not compromised through corruption or falsification.
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"Information" means any communication or representation of knowledge such
as facts or data, in any medium or form, including textual, numerical, graphic,
cartographic, narrative, or audiovisual forms. This definition includes
information that an agency disseminates from a web page, but does not include
the provision of hyperlinks to information that others disseminate. This
definition does not include opinions, where the agency's presentation makes
it clear that what is being offered is someone's opinion rather than fact
or the agency's views.
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"Government information" means information created, collected, processed,
disseminated, or disposed of by or for the Federal Government.
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"Information dissemination product" means any book, paper, map, machine-readable
material, audiovisual production, or other documentary material, regardless
of physical form or characteristic, an agency disseminates to the public.
This definition includes any electronic document, CD-ROM, or web page.
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"Dissemination" means agency initiated or sponsored distribution of information
to the public (see 5 C.F.R. 1320.3(d) (definition of "Conduct or Sponsor").
Dissemination does not include distribution intended to be limited to government
employees or agency contractors or grantees; intra- or inter-agency use or
sharing of government information; and responses to request for agency records
under the Freedom of Information Act, the Privacy Act, the Federal Advisory
Committee Act or other similar law. This definition also does not include
distribution limited to correspondence with individuals or persons, archival
records, public filings, subpoenas or adjudicative processes.
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"Influential," when used in the phrase "influential scientific, financial,
or statistical information," means that the agency can reasonably determine
that dissemination of the information will have or does have a clear and
substantial impact on important public policies or important private sector
decisions. Each agency is authorized to define "influential" in ways appropriate
for it given the nature and multiplicity of issues for which the agency is
responsible.
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"Reproducibility" means that the information is capable of being substantially
reproduced, subject to an acceptable degree of imprecision. For information
judged to have more (less) important impacts, the degree of imprecision that
is tolerated is reduced (increased). If agencies apply the reproducibility
test to specific types of original or supporting data, the associated guidelines
shall provide relevant definitions of reproducibility (e.g., standards for
replication of laboratory data). With respect to analytic results, "capable
of being substantially reproduced" means that independent analysis of the
original or supporting data using identical methods would generate similar
analytic results, subject to an acceptable degree of imprecision or error.
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Scope and Applicability of the Guidelines
The HHS guidelines described in this implementation plan apply to substantive
information dissemination activities that are initiated or sponsored by HHS
agencies. The pre-dissemination review described in the guidelines only applies
to information that is disseminated on or after October 1, 2002. The
administrative mechanism for correction applies to information that the agency
disseminates on or after October 1, 2002, regardless of when the agency first
disseminated the information. The guidelines do not apply to the large proportion
of extramural scientific research activity supported by HHS whose dissemination
is the sole responsibility of the academic researcher rather than HHS. The
guidelines do apply to the dissemination of information by federal intramural
researchers if the dissemination is agency-initiated or sponsored. Otherwise,
appropriate disclaimers are to be included in the report or speech to distinguish
the research from agency views and positions. The guidelines do not apply
to distribution of information limited to correspondence with individuals
or persons, press releases that support the announcement or give public notice
of information that the agency disseminates elsewhere, archival material,
public filings, subpoenas or adjudicative processes. Nor do they apply to
opinions, when the agency's presentation makes clear that what is disseminated
is someone's opinion rather than fact or agency views.
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Overview of HHS Information Dissemination and Quality
Assurance
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The HHS Mission
The Department of Health and Human Services is the United States government's
principal agency for protecting the health of all Americans and providing
essential human services, especially to those who are least able to help
themselves. The Department includes more than 300 programs, covering a wide
spectrum of activities. Program responsibilities include:
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Ensuring a safe and healthy America
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Conducting and supporting medical and social science research
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Preventing outbreaks of infectious diseases
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Assuring the safety of foods and drugs
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Administering the Medicare and Medicaid programs
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Providing financial assistance for low income families
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Improving maternal and child health
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Administering the Head Start program
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Preventing child abuse and domestic violence
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Providing assistance to States for substance abuse treatment and prevention
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Providing services for older Americans
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Assuring comprehensive health services for Native Americans
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Categories of Information Disseminated
The development and dissemination of timely and high quality data and information
is a critical component of the missions of many HHS programs, as well as
those of HHS partners in the health and human services communities. As a
result, HHS plays a major role in information dissemination, as a producer
and user of high quality data and information, as a collaborator with partners
in the health and human services communities, and as a national leader in
health and human services information policy.
In carrying out their diverse statutes and missions, HHS agencies develop
and support the dissemination of the following types of substantive information:
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Scientific research studies (the results of biomedical, behavioral, services
research and social science research)
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Statistical and analytic studies (the results of surveys, statistical systems
as well as analytical and modeling studies and public use data files
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Programmatic, administrative and regulatory information, including program
evaluations
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Authoritative health, medical and human services information aimed at consumers
and health and human services professionals
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Public health surveillance, epidemiology and risk assessment studies and
information
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Types of Dissemination Mechanisms
HHS agencies disseminate information through a wide range of methods and
print and electronic media. These include publication in peer reviewed
literature, published reports, periodicals, newsletters, brochures,
clearinghouses, websites, CD-ROM and other electronic media.
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Overview of Quality Assurance Policies and Practices
in HHS
Depending upon their specific statutes and missions and the nature of the
information they disseminate to the public, HHS agencies currently use a
variety of quality assurance methods and procedures. These methods and procedures
are designed to maximize the quality of HHS information, including the
objectivity, utility, and integrity.
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Objectivity involves a focus on ensuring that information is
accurate, reliable and unbiased and that information products are presented
in an accurate, clear, complete and unbiased manner. Objectivity is achieved
by using reliable data sources and sound analytical techniques, and carefully
reviewing information products prepared by qualified people using proven
methods.
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Utility involves the usefulness of the information to its intended
users. Utility is achieved by staying informed of information needs and
developing new data, and information products where appropriate. Based on
internal analyses of information requirements, convening and attending
conferences, working with advisory committees and stakeholders, sponsoring
outreach activities, and where appropriate, testing publications with targeted
audiences to ensure relevance, clarity, and comprehensiveness, HHS agencies
keeps abreast of information needs.
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Integrity refers to the security of information from unauthorized
access or revision to ensure that the information is not compromised through
corruption or falsification. HHS agencies have in place rigorous controls
to ensure the integrity of its administrative information. Three distinct
objectives are pursued in protecting the integrity of information: ensuring
that there is no deliberate or accidental improper disclosure of sensitive
automated information; protecting against deliberate or accidental corruption
of automated information; and protecting against deliberate or accidental
actions that cause automated information resources to be unavailable to users
when needed. Information is accorded protection against disclosure, alteration,
loss, or destruction based on the degree of sensitivity.
In addition, HHS agencies use appropriate safeguards to protect data from
improper disclosure by backing up critical data periodically, and, if a security
incident occurs, by following proper incident response procedures. Managers
are responsible for ensuring that employees, both Government and contractors,
observe all security requirements, and that employees receive appropriate
security training. HHS also is instituting an enterprise-wide structured
management control review process that applies throughout the system life
cycle. As part of this process, risk analyses are conducted to establish
a balance between an acceptable level of risk and the costs associated with
safeguards.
In addition, HHS is subject to a number of statutory requirements that protect
the sensitive information it gathers and maintains on individuals. Among
these are:
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Health Insurance Portability and Accountability Act of 1996
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Privacy Act of 1974
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Computer Security Act of 1987
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Office of Management and Budget (OMB) Circulars A-123, A-127, and A-130
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Government Information Security Reform Act
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Federal Managers' Financial Integrity Act (FMFIA) of 1982
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HHS Information Quality Goals
The development of data and information within HHS is generally undertaken
within the context of two overarching goals:
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attention to information quality as a total and continuing process, and
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commitment to making data and information supported with public funds available
to the public, consistent with confidentiality concerns and resource
availability.
Further, when HHS agencies prepare a Paperwork Reduction Act (PRA) clearance
submission, they strive to engage in a data development effort that will
result in information that will be collected maintained, and used in a way
that is consistent with OMB, HHS, and agency-specific information quality
guidelines. As a general policy, HHS views data and information quality as
a continuing process that begins at the inception of the information development
process with project conceptualization and carries through all phases of
data planning, design and execution, including information dissemination
activities. Further, HHS agencies that support or sponsor research and
statistical activities are encouraged to not only describe the methods and
data sources in a clear and transparent manner in the reports they release,
but also to make the data used for the report available to the public through
public use data files, restricted access research files, research data centers,
data archives and other mechanisms consistent with confidentiality, legal
and proprietary restrictions.
In addition, HHS agencies review the quality (including the objectivity,
utility, and integrity) of information before it is disseminated and treat
information quality as integral to every step of the development of information,
including its creation, collection, maintenance and dissemination. The quality
assurance processes that are used to ensure the quality of specific categories
of information are described below.
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Research and scientific studies disseminated by HHS are subject
to an external, objective peer review process at both the inception stage
and the pre-dissemination stage as a part of the publication process in peer
reviewed journals. In addition, the quality of all of the intramural research
programs of HHS agencies is continually reviewed and monitored by advisory
committees and boards of scientific advisors. In accordance with widely accepted
scientific research practice in the U.S., research reports disseminated by
HHS agencies describe the methods, data sources, analytical techniques, measures,
assumptions and limitations of the research, so that the study could be
substantially reproduced. If original data are employed, it is the policy
of HHS to make every effort to make the data available to the public in
de-identified form consistent with confidentiality requirements, proprietary
restrictions and resource availability.
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Statistical activities of HHS agencies are based on reliable
data sources and are carried out in accordance with modern statistical theory
and practice, including scientific sampling, statistical inference and analytical
techniques and practices. All statistical programs employ or have access
to experts in statistics and research design. HHS houses the National Center
for Health Statistics, the federal government's designated general purpose
statistical agency for health statistics, as well as programmatic and special
purpose statistical activities. All proposals for original data collection
activities in HHS undergo a rigorous and exacting review process in connection
with the Paperwork Reduction Act, which also provides opportunity for public
comment in the design of the information collection. Frequent meetings with
user groups are common, and individual surveys and statistical systems often
employ project specific technical advisory groups. Substantive reports from
HHS statistical activities undergo a quality review process within their
organizations before they are released, including expert review by supervisors,
internal peer review by qualified scientists and statisticians, and in some
cases external peer review as well as expert review by other offices prior
to dissemination.
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Programmatic and administrative information A
significant amount of substantive information is disseminated by HHS agencies
in connection with and as a byproduct of the administration of programs.
Often the programmatic and administrative information disseminated is obtained
from third parties, such as States, grantees, health plan contractors or
intermediaries, or community-based organizations. In their stewardship function,
agencies often collect, compile, standardize, analyze and disseminate such
programmatic information. While the reliance on third parties places limits
on the federal quality assurance authorities, a variety of techniques are
employed to promote the accuracy, completeness and timeliness of the information.
These include use of generally accepted accounting and financial management
procedures and principles, internal controls, legal certifications and assurances
on the part of the organizations supplying the information, audited financial
reports and statements, as well as sample audits and site visits, and checks
for completeness and consistency with trends and external controls. Programmatic
reports are typically subject to supervisory review before release.
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Program evaluation studies are often undertaken by HHS agencies
to assess program functioning and identify opportunities for improvement.
Agencies employ quality assurance procedures in the choice and development
of evaluation projects. Proposals for evaluation activities in HHS agencies
are usually reviewed by agency management for suitability, utility and
methodology in accordance with sound evaluation design and standards of
evaluation practice. Many evaluation projects have specific technical advisory
committees that oversee the design and conduct of the evaluation in accordance
with standard evaluation theory and practice, and they often provide an expert
review of the final report. Results of evaluation activities are released
to the public only after agency management has completed a review of the
quality, accuracy and completeness of the report.
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Regulatory information A variety of information
is used in support of regulatory development and decision-making. Regulatory
activity undertaken by HHS agencies closely tracks statutory authorities
and program responsibilities. Scientific, financial, and statistical information
used in support of regulatory decision-making is subject to a quality review
process within the agency involving appropriate experts depending upon the
nature of the information. In addition, all significant proposed regulations
are reviewed by OMB prior to issuance for public comment, and all proposed
regulatory actions provide for extensive public comment.
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Authoritative health, scientific and consumer
information Several HHS agencies develop and disseminate
authoritative health and human services information intended for consumers
and the professional community. In some instances, the agency simply provides
a link to information developed by other authoritative organizations. In
other instances, the agency develops its own consumer and professional practice
information. In the latter case, the information is reviewed for scientific
and medical accuracy and completeness by experts within the agency before
it is disseminated. In a number of instances the information also is reviewed
by scientific and medical advisory bodies before dissemination as well, depending
on the nature of the information.
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Public health surveillance and epidemiological
information Several HHS agencies compile, analyze and
disseminate information from public health surveillance systems and
epidemiological activities. In many surveillance systems, the primary information
is developed by State and local government agencies, clinical laboratories
and other health care entities and reported to CDC for national aggregation
and analysis. Data quality is assured through use of reliable data sources,
appropriate statistical techniques, agreement on national reporting standards,
quality control procedures, standard case definitions and reports, adherence
to professional practices and standards for public health reporting in the
U.S., and frequent consultation with the user community. Before such information
is disseminated, it is reviewed for medical, scientific and public health
accuracy, soundness and utility by agency experts. Comment and feedback is
encouraged on such information, and HHS agencies work closely with the relevant
professional and public health organizations.
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Influential Scientific, Financial, and Statistical
Information
From time to time, HHS agencies disseminate influential scientific, financial
and statistical information as defined in the OMB Guidelines. In such instances,
care is taken to ensure that the information is substantially reproducible
and replicable. This goal is accomplished by using reliable data sources
and sound analytical techniques, and by employing a high degree of transparency
about the data, sources, methods, measures, assumptions and limitations used
to develop the information in order to facilitate reproducibility by qualified
third parties. In the case of original or supporting data, most major
epidemiological and statistical activities sponsored by HHS agencies have
well developed public use data dissemination programs that make much of the
data available to the public in standardized, de-identified micro-data files.
Because of confidentiality, ethical and feasibility constraints and legal
obligations to third parties supplying the information, there may be instances
where original or supporting data may not be available to the public, but
HHS agencies typically will work with qualified third parties to facilitate
understanding, and transparency in data sources and methods will be emphasized
in the report or in reference documents. In the case of analytical studies,
HHS agencies will make provisions for sufficient transparency about data
and methods so that an independent reanalysis could be undertaken by a qualified
member of the public.
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Health, Safety, and Environmental
Information
Several HHS agencies have science-based missions and use such information
in decision making. These agencies adapt the quality standards discussed
in the Safe Drinking Water Act Amendments of 1996 (SDWA) (42 U.S.C.
300g-1(b)(3)(A) and (B)). The adaptation involves the commitment of these
agencies to use: a.) the best available science and supporting studies conducted
in accordance with sound and objective scientific practices, including peer
reviewed studies when available and b.) data collected by accepted methods
(if reliability of the method and the nature of the decision justify use
of the data.) Additional detail relating to the standards employed by individual
agencies is described in Part II, the individual agency section of these
guidelines.
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Urgent Public Health and Safety Information
Several HHS agencies are responsible for dissemination of authoritative health,
medical and safety information on a real time basis in order to protect the
health of the public against urgent and emerging threats. Accordingly, nothing
in these guidelines relating to reproducibility or peer review shall be construed
to limit or delay the timely flow of vital information from agencies to medical
providers, patients, health agencies, and the public. HHS reserves the right
to waive information quality standards temporarily for agencies addressing
urgent situations (e.g., imminent threats to public health or homeland security)
in accordance with the latitude described in both the OMB and agency specific
guidelines.
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The OMB Guidelines require all agencies to establish administrative mechanisms
allowing affected persons to seek and obtain correction of information
disseminated by the agency that does not comply with OMB, HHS or agency-specific
guidelines. Agencies also are to specify appropriate time periods for agency
decisions on whether and how to correct the information, and are to notify
the affected persons of the action taken. If the person who requested the
correction does not agree with the agency's decision (including the corrective
action, if any), that person may file for reconsideration within the agency.
The agency is to establish an administrative appeal process to review the
initial decision, and specify appropriate time limits in which to resolve
such requests for reconsideration. The agency need not respond substantively
to information not covered by the guidelines or to frivolous or repetitive
requests for correction.
Requests for correction of information quality pursuant to Section 515 are
to be directed to the respective agency. A common format for complaints has
been developed across HHS. The approach is described below. To accompany
the actual implementation of the Guidelines in October 2002, HHS has created
a department-wide website describing in user friendly terms the procedures
and contact persons for submitting requests for corrections. The web site
can be accessed at
www.hhs.gov/infoquality.
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Responsibility of the Complainant
In general, to seek an information quality request for correction of information
disseminated by any HHS agency, individuals should follow the procedures
described below. Requests for correction that are specific and provide evidence
to support the need for correction will enable the agency to provide a
satisfactory response. Complainants should be aware that they bear the "burden
of proof" with respect to the necessity for correction as well as with respect
to the type of correction they seek.
A complaint or request for correction of information must be in written hard
copy or electronic form, be sent to the agency designated address by mail
or electronic-mail (e-mail); and state that an information quality request
for correction is being submitted. In terms of content, the complaint letter
must contain:
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a detailed description of the specific material that needs to be corrected
including where the material is located, i.e. the publication title, date,
and publication number, if any, or the website and web page address (url),
or the speech title, presenter, date and place of delivery;
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the specific reasons for believing the information does not comply with OMB,
HHS, or agency-specific guidelines and is in error and supporting documentation,
if any;
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the specific recommendations for correcting the information;
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a description of how the person submitting the complaint is affected by the
information error; and
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the name, mailing address, telephone number, e-mail address, and organizational
affiliation, if any, of the individual making the complaint.
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Responsibility of the Agency
Based on a review of the information provided, the agency will determine
whether a correction is warranted and if, so what action to take. The agency
will respond to the requestor by letter or e-mail. The agency's response
will explain the findings of the review and the actions that the agency will
take, if any. The response will consider the nature and timeliness of the
information involved and such factors as the significance of the correction
on the use of the information, the magnitude of the correction and the resource
requirements for the correction. The response will describe how the complainant
may request reconsideration. The agency will respond to all requests for
correction within 60 calendar days of receipt. If the request requires more
than 60 calendar days to resolve, the agency will inform the complainant
that more time is required and indicate the reason why and an estimated decision
date.
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Appeals for Reconsideration
If the individual submitting the complaint does not agree with the agency's
decision (including the corrective action), the complainant may send a written
hard copy or electronic request for reconsideration within 30 days of receipt
of the agency's decision. The appeal shall state the reasons why the agency
response is insufficient or inadequate. Complainants shall attach a copy
of their original request and the agency response to it, clearly mark the
appeal with the words, "Information Quality Appeal," and send the appeal
to the specific agency appeals address.
The agency official who handles the original complaint will not have
responsibility for resolving the appeal. The agency will respond to all requests
for appeals within 60 calendar days of receipt. If the request requires more
than 60 calendar days to resolve, the agency will inform the complainant
that more time is required and indicate the reason why and an estimated decision
date.
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Rulemakings and Other Public Comment Procedures
Existing public comment procedures for rule-makings and other formal agency
actions already provide well established procedural safeguards that allow
affected persons to raise information quality issues on a timely basis.
Accordingly, agencies will use these existing procedures to respond to
information quality complaints that arise in this process.
In cases where the agency disseminates a study, analysis, or other information
prior to the final agency action or information product, requests for correction
will be considered prior to the final agency action or information product
in those cases where in the agency's judgment issuing an earlier response
would not unduly delay issuance of the agency action or information product
and the complainant has shown a reasonable likelihood of suffering actual
harm from the agency's dissemination if the agency does not resolve the complaint
prior to the final agency action or information product.
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Last revised: December 13, 2006