IB 
Union Calendar No. 128 
117TH CONGRESS 
1ST SESSION 
H. R. 550 
[Report No. 117–178] 
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 
NOVEMBER 30, 2021 
Additional sponsors: Mr. BAIRD, Ms. WILLIAMS of Georgia, Mrs. DEMINGS, 
Ms. LOIS FRANKEL of Florida, Mr. BERA, Ms. UNDERWOOD, Mr. LEVIN 
of California, Ms. SEWELL, Ms. SCHRIER, Mr. MCKINLEY, Mr. 
FITZPATRICK, Mr. RUIZ, and Ms. CASTOR of Florida 
NOVEMBER 30, 2021 
Reported with an amendment; committed to the Committee of the Whole 
House on the State of the Union and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on January 28, 2021] 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6652
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
A BILL 
To amend the Public Health Service Act with respect to 
immunization system data modernization and expansion, 
and for other purposes. 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6652
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
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 Service 
Act (42 U.S.C. 300hh–31 et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 2824. IMMUNIZATION INFORMATION SYSTEM DATA 
MODERNIZATION AND EXPANSION. 
‘‘(a) EXPANDING CDC AND PUBLIC HEALTH DEPART-
MENT 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 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(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 entities 
and non-governmental entities, including 
by— 
‘‘(I) improving such exchange 
among public health officials in mul-
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 infor-
mation technology certified under section 
3001(c)(5) or with health information net-
works; 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(vi) supporting adoption of the im-
munization information system functional 
standards of the Centers for Disease Control 
and Prevention and the maintenance of se-
curity standards to protect individually 
identifiable health information; 
‘‘(vii) supporting and training immu-
nization information system, data science, 
and informatics personnel; 
‘‘(viii) supporting real-time immuni-
zation 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 Committee 
on Immunization Practices as approved by 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
the Director of the Centers for Disease Con-
trol 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 man-
age information volume and capabilities; 
‘‘(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; 
‘‘(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; or 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(xvi) supporting activities to improve 
the scheduling and administration of vac-
cinations. 
‘‘(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 enti-
ties 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— 
‘‘(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.— 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(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 standards 
adopted by the Secretary under section 3004. 
‘‘(2) WAIVER.—The Secretary may waive the re-
quirement 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 
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 immuni-
zation information systems involved will support 
or impact the public health infrastructure of the 
health department, including a description of re-
maining gaps, if any, and the actions needed to 
address such gaps. 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(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 Energy 
and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of 
the Senate a coordinated strategy and an accompanying 
implementation plan that identifies and demonstrates the 
measures the Secretary will utilize to— 
‘‘(1) update and improve immunization infor-
mation systems supported by the Centers for Disease 
Control and Prevention; and 
‘‘(2) carry out the activities described in this sec-
tion to support the expansion, enhancement, and im-
provement of State, local, Tribal, and territorial im-
munization information systems. 
‘‘(d) CONSULTATION; TECHNICAL ASSISTANCE.— 
‘‘(1) CONSULTATION.—In developing the strategy 
and implementation plan under subsection (c), the 
Secretary shall consult with— 
‘‘(A) health departments, or such other gov-
ernmental entities as administer immunization 
information systems, of State, local, Tribal, and 
territorial governments; 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(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 experts; 
and 
‘‘(E) other public or private entities, as ap-
propriate. 
‘‘(2) TECHNICAL
ASSISTANCE.—In connection 
with consultation under paragraph (1), the Secretary 
may— 
‘‘(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-
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Represent-
atives that includes— 
‘‘(1) a description of any barriers to— 
‘‘(A) public health authorities implementing 
interoperable immunization information sys-
tems; 
‘‘(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 
‘‘(2) a description of barriers that hinder the ef-
fective establishment of a network to support immuni-
zation 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 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
persons within the geographic area covered by that data-
base. 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$400,000,000, to remain available until expended.’’. 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6203
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS
Union Calendar No. 128 
117TH CONGRESS 
1ST SESSION 
H. R. 550 
[Report No. 117–178] 
A BILL 
To amend the Public Health Service Act with re-
spect to immunization system data modernization 
and expansion, and for other purposes. 
NOVEMBER 30, 2021 
Reported with an amendment; committed to the Com-
mittee of the Whole House on the State of the Union 
and ordered to be printed 
VerDate Sep 11 2014 
01:49 Dec 02, 2021
Jkt 029200
PO 00000
Frm 00014
Fmt 6651
Sfmt 6651
E:\BILLS\H550.RH
H550
pbinns on DSKJLVW7X2PROD with BILLS