I 
117TH CONGRESS 
1ST SESSION 
H. R. 550 
To amend the Public Health Service Act with respect to immunization system 
data modernization and expansion, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 28, 2021 
Ms. KUSTER (for herself and Mr. BUCSHON) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act with respect to 
immunization system data modernization and expansion, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Immunization Infra-
structure Modernization Act of 2021’’. 
SEC. 2. IMMUNIZATION INFORMATION SYSTEM DATA MOD-
ERNIZATION AND EXPANSION. 
Subtitle C of title XXVIII of the Public Health Serv-
ice Act (42 U.S.C. 300hh–31 et seq.) is amended by add-
ing at the end the following: 
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‘‘SEC. 2823. IMMUNIZATION INFORMATION SYSTEM DATA 
MODERNIZATION AND EXPANSION. 
‘‘(a) EXPANDING CDC AND PUBLIC HEALTH DE-
PARTMENT CAPABILITIES.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) conduct activities (including with re-
spect to interoperability, population reporting, 
and bidirectional reporting) to expand, enhance, 
and improve immunization information systems 
that are administered by health departments or 
other agencies of State, local, Tribal, and terri-
torial governments and used by health care pro-
viders; and 
‘‘(B) award grants or cooperative agree-
ments to the health departments, or such other 
governmental entities as administer immuniza-
tion information systems, of State, local, Tribal, 
and territorial governments, for the expansion, 
enhancement, and improvement of immuniza-
tion information systems to assist public health 
departments in— 
‘‘(i) assessing current data infrastruc-
ture capabilities and gaps among health 
care providers to improve and increase 
consistency in patient matching, data col-
lection, reporting, bidirectional exchange, 
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and analysis of immunization-related infor-
mation; 
‘‘(ii) providing for the efficient enroll-
ment and training of health care providers, 
including at pharmacies and other settings 
where immunizations are being provided, 
such as long-term care facilities, specialty 
health care providers, community health 
centers, Federally qualified health centers, 
rural health centers, organizations serving 
adults 65 and older, and organizations 
serving homeless and incarcerated popu-
lations; 
‘‘(iii) improving secure data collection, 
transmission, bidirectional exchange, main-
tenance, and analysis of immunization in-
formation; 
‘‘(iv) 
improving 
the 
secure 
bidirectional exchange of immunization 
record data among Federal, State, local, 
Tribal, and territorial governmental enti-
ties and non-governmental entities, includ-
ing by— 
‘‘(I) improving such exchange 
among public health officials in mul-
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tiple jurisdictions within a State, as 
appropriate; and 
‘‘(II) by simplifying and sup-
porting electronic reporting by any 
health care provider; 
‘‘(v) supporting the standardization of 
immunization information systems to accel-
erate interoperability with health informa-
tion technology, including with health in-
formation technology certified under sec-
tion 3001(c)(5) or with health information 
networks; 
‘‘(vi) supporting adoption of the im-
munization information system functional 
standards of the Centers for Disease Con-
trol and Prevention and the maintenance 
of security standards to protect individ-
ually identifiable health information as de-
fined in section 160.103 of title 45, Code 
of Federal Regulations (or any successor 
regulations); 
‘‘(vii) supporting and training immu-
nization information system, data science, 
and informatics personnel; 
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‘‘(viii) supporting real-time immuniza-
tion record data exchange and reporting, 
to support rapid identification of immuni-
zation coverage gaps; 
‘‘(ix) improving completeness of data 
by facilitating the capability of immuniza-
tion information systems to exchange data, 
directly or indirectly, with immunization 
information systems in other jurisdictions; 
‘‘(x) enhancing the capabilities of im-
munization information systems to evalu-
ate, forecast, and operationalize clinical de-
cision support tools in alignment with the 
recommendations of the Advisory Com-
mittee on Immunization Practices as ap-
proved by the Director of the Centers for 
Disease Control and Prevention; 
‘‘(xi) supporting the development and 
implementation of policies that facilitate 
complete population-level capture, consoli-
dation, and access to accurate immuniza-
tion information; 
‘‘(xii) supporting the procurement and 
implementation of updated software, hard-
ware, and cloud storage to adequately 
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manage information volume and capabili-
ties; 
‘‘(xiii) supporting expansion of capa-
bilities within immunization information 
systems for outbreak response; 
‘‘(xiv) supporting activities within the 
applicable jurisdiction related to the man-
agement, distribution, and storage of vac-
cine doses and ancillary supplies; and 
‘‘(xv) developing information related 
to the use and importance of immunization 
record data and disseminating such infor-
mation to health care providers and other 
persons authorized under State law to ac-
cess such information, including payors 
and health care facilities. 
‘‘(2) DATA STANDARDS.—In carrying out para-
graph (1), the Secretary shall— 
‘‘(A) designate data and technology stand-
ards that must be followed by governmental en-
tities with respect to use of immunization infor-
mation systems as a condition of receiving an 
award under this section, with priority given to 
standards developed by— 
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‘‘(i) 
consensus-based 
organizations 
with input from the public; and 
‘‘(ii) voluntary consensus-based stand-
ards bodies; and 
‘‘(B) support a means of independent 
verification of the standards used in carrying 
out paragraph (1). 
‘‘(3) PUBLIC-PRIVATE PARTNERSHIPS.—In car-
rying out paragraph (1), the Secretary may develop 
and utilize contracts and cooperative agreements for 
technical assistance, training, and related implemen-
tation support. 
‘‘(b) REQUIREMENTS.— 
‘‘(1) 
HEALTH
INFORMATION
TECHNOLOGY 
STANDARDS.—The Secretary may not award a grant 
or cooperative agreement under subsection (a)(1)(B) 
unless the applicant uses and agrees to use stand-
ards adopted by the Secretary under section 3004. 
‘‘(2) WAIVER.—The Secretary may waive the 
requirement under paragraph (1) with respect to an 
applicant if the Secretary determines that the activi-
ties under subsection (a)(1)(B) cannot otherwise be 
carried out within the applicable jurisdiction. 
‘‘(3) APPLICATION.—A State, local, Tribal, or 
territorial health department applying for a grant or 
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cooperative agreement under subsection (a)(1)(B) 
shall submit an application to the Secretary at such 
time and in such manner as the Secretary may re-
quire. Such application shall include information de-
scribing— 
‘‘(A) the activities that will be supported 
by the grant or cooperative agreement; and 
‘‘(B) how the modernization of the immu-
nization information systems involved will sup-
port or impact the public health infrastructure 
of the health department, including a descrip-
tion of remaining gaps, if any, and the actions 
needed to address such gaps. 
‘‘(c) STRATEGY AND IMPLEMENTATION PLAN.—Not 
later than 90 days after the date of enactment of this sec-
tion, the Secretary shall submit to the Committee on En-
ergy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate a coordinated strategy and an accom-
panying implementation plan that identifies and dem-
onstrates the measures the Secretary will utilize to— 
‘‘(1) update and improve immunization infor-
mation systems supported by the Centers for Dis-
ease Control and Prevention; and 
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‘‘(2) carry out the activities described in this 
section to support the expansion, enhancement, and 
improvement of State, local, Tribal, and territorial 
immunization information systems. 
‘‘(d) CONSULTATION; TECHNICAL ASSISTANCE.— 
‘‘(1) CONSULTATION.—In developing the strat-
egy and implementation plan under subsection (c), 
the Secretary shall consult with— 
‘‘(A) health departments, or such other 
governmental entities as administer immuniza-
tion information systems, of State, local, Tribal, 
and territorial governments; 
‘‘(B) professional medical, associations, 
public health associations, and associations rep-
resenting pharmacists and pharmacies; 
‘‘(C) community health centers, long-term 
care facilities, and other appropriate entities 
that provide immunizations; 
‘‘(D) health information technology ex-
perts; and 
‘‘(E) other public or private entities, as ap-
propriate. 
‘‘(2) TECHNICAL
ASSISTANCE.—In connection 
with consultation under paragraph (1), the Secretary 
may— 
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‘‘(A) provide technical assistance, certifi-
cation, and training related to the exchange of 
information by immunization information sys-
tems used by health care and public health enti-
ties at the local, State, Federal, Tribal, and ter-
ritorial levels; and 
‘‘(B) develop and utilize public-private 
partnerships for implementation support appli-
cable to this section. 
‘‘(e) REPORT TO CONGRESS.—Not later than 1 year 
after the date of enactment of this section, the Secretary 
shall submit a report to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives that includes— 
‘‘(1) a description of any barriers to— 
‘‘(A) public health authorities imple-
menting interoperable immunization informa-
tion systems; 
‘‘(B) the exchange of information pursuant 
to immunization records; or 
‘‘(C) reporting by any health care profes-
sional authorized under State law, using such 
immunization information systems, as appro-
priate, and pursuant to State law; or 
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‘‘(2) a description of barriers that hinder the 
effective establishment of a network to support im-
munization reporting and monitoring, including a 
list of recommendations to address such barriers; 
and 
‘‘(3) an assessment of immunization coverage 
and access to immunizations services and any dis-
parities and gaps in such coverage and access for 
medically underserved, rural, and frontier areas. 
‘‘(f) DEFINITION.—In this section, the term ‘immuni-
zation information system’ means a confidential, popu-
lation-based, computerized database that records immuni-
zation doses administered by any health care provider to 
persons within the geographic area covered by that data-
base. 
‘‘(g) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $400,000,000, to remain available until ex-
pended.’’. 
Æ 
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