[House Report 117-178]
[From the U.S. Government Publishing Office]


117th Congress   }                                      {      Report
                        HOUSE OF REPRESENTATIVES
 1st Session     }                                      {     117-178

======================================================================



 
         IMMUNIZATION INFRASTRUCTURE MODERNIZATION ACT OF 2021

                                _______
                                

 November 30, 2021.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 550]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 550) to amend the Public Health Service Act with 
respect to immunization system data modernization and 
expansion, and for other purposes, having considered the same, 
reports favorably thereon with an amendment and recommends that 
the bill as amended do pass.

                                CONTENTS

                                                                     Page
   I. Purpose and Summary.............................................  4
  II. Background and Need for the Legislation.........................  4
 III. Committee Hearings..............................................  6
  IV. Committee Consideration.........................................  6
   V. Committee Votes.................................................  7
  VI. Oversight Findings..............................................  7
 VII. New Budget Authority, Entitlement Authority, and Tax Expenditure  7
VIII. Congressional Budget Office Estimate............................  7
  IX. Federal Mandates Statement......................................  8
   X. Statement of General Performance Goals and Objectives...........  8
  XI. Duplication of Federal Programs.................................  8
 XII. Committee Cost Estimate.........................................  9
XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....  9
 XIV. Advisory Committee Statement....................................  9
  XV. Applicability to Legislative Branch.............................  9
 XVI. Section-by-Section Analysis of the Legislation..................  9
XVII. Changes in Existing Law Made by the Bill, as Reported..........  11

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Immunization Infrastructure 
Modernization Act of 2021''.

SEC. 2. IMMUNIZATION INFORMATION SYSTEM DATA MODERNIZATION 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 Department Capabilities.--
          ``(1) In general.--The Secretary shall--
                  ``(A) conduct activities (including with respect 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 territorial governments and 
                used by health care providers; and
                  ``(B) award grants or cooperative agreements to the 
                health departments, or such other governmental entities 
                as administer immunization information systems, of 
                State, local, Tribal, and territorial governments, for 
                the expansion, enhancement, and improvement of 
                immunization information systems to assist public 
                health departments in--
                          ``(i) assessing current data infrastructure 
                        capabilities and gaps among health care 
                        providers to improve and increase consistency 
                        in patient matching, data collection, 
                        reporting, bidirectional exchange, and analysis 
                        of immunization-related information;
                          ``(ii) providing for technical assistance and 
                        the efficient enrollment 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 populations;
                          ``(iii) improving secure data collection, 
                        transmission, bidirectional exchange, 
                        maintenance, and analysis of immunization 
                        information;
                          ``(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 multiple 
                                jurisdictions within a State, as 
                                appropriate; and
                                  ``(II) by simplifying and supporting 
                                electronic reporting by any health care 
                                provider;
                          ``(v) supporting the standardization of 
                        immunization information systems to accelerate 
                        interoperability with health information 
                        technology, including with health information 
                        technology certified under section 3001(c)(5) 
                        or with health information networks;
                          ``(vi) supporting adoption of the 
                        immunization information system functional 
                        standards of the Centers for Disease Control 
                        and Prevention and the maintenance of security 
                        standards to protect individually identifiable 
                        health information;
                          ``(vii) supporting and training immunization 
                        information system, data science, and 
                        informatics personnel;
                          ``(viii) supporting real-time immunization 
                        record data exchange and reporting, to support 
                        rapid identification of immunization coverage 
                        gaps;
                          ``(ix) improving completeness of data by 
                        facilitating the capability of immunization 
                        information systems to exchange data, directly 
                        or indirectly, with immunization information 
                        systems in other jurisdictions;
                          ``(x) enhancing the capabilities of 
                        immunization information systems to evaluate, 
                        forecast, and operationalize clinical decision 
                        support tools in alignment with the 
                        recommendations of the Advisory Committee on 
                        Immunization Practices as approved 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, 
                        consolidation, and access to accurate 
                        immunization information;
                          ``(xii) supporting the procurement and 
                        implementation of updated software, hardware, 
                        and cloud storage to adequately manage 
                        information volume and capabilities;
                          ``(xiii) supporting expansion of capabilities 
                        within immunization information systems for 
                        outbreak response;
                          ``(xiv) supporting activities within the 
                        applicable jurisdiction related to the 
                        management, distribution, and storage of 
                        vaccine doses and ancillary supplies;
                          ``(xv) developing information related to the 
                        use and importance of immunization record data 
                        and disseminating such information to health 
                        care providers and other persons authorized 
                        under State law to access such information, 
                        including payors and health care facilities; or
                          ``(xvi) supporting activities to improve the 
                        scheduling and administration of vaccinations.
          ``(2) Data standards.--In carrying out paragraph (1), the 
        Secretary shall--
                  ``(A) designate data and technology standards that 
                must be followed by governmental entities with respect 
                to use of immunization information 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 standards 
                        bodies; and
                  ``(B) support a means of independent verification of 
                the standards used in carrying out paragraph (1).
          ``(3) Public-private partnerships.--In carrying out paragraph 
        (1), the Secretary may develop and utilize contracts and 
        cooperative agreements for technical assistance, training, and 
        related implementation 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 standards 
        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 activities 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 
        require. Such application shall include information 
        describing--
                  ``(A) the activities that will be supported by the 
                grant or cooperative agreement; and
                  ``(B) how the modernization of the immunization 
                information systems involved will support or impact the 
                public health infrastructure of the health department, 
                including a description 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 section, 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 information systems 
        supported by the Centers for Disease Control and Prevention; 
        and
          ``(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 strategy and 
        implementation plan under subsection (c), the Secretary shall 
        consult with--
                  ``(A) health departments, or such other governmental 
                entities as administer immunization information 
                systems, of State, local, Tribal, and territorial 
                governments;
                  ``(B) professional medical, associations, public 
                health associations, and associations representing 
                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 
                appropriate.
          ``(2) Technical assistance.--In connection with consultation 
        under paragraph (1), the Secretary may--
                  ``(A) provide technical assistance, certification, 
                and training related to the exchange of information by 
                immunization information systems used by health care 
                and public health entities at the local, State, 
                Federal, Tribal, and territorial levels; and
                  ``(B) develop and utilize public-private partnerships 
                for implementation support applicable 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, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives 
that includes--
          ``(1) a description of any barriers to--
                  ``(A) public health authorities implementing 
                interoperable immunization information systems;
                  ``(B) the exchange of information pursuant to 
                immunization records; or
                  ``(C) reporting by any health care professional 
                authorized under State law, using such immunization 
                information systems, as appropriate, and pursuant to 
                State law; or
          ``(2) a description of barriers that hinder the effective 
        establishment of a network to support immunization 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 disparities and gaps in such 
        coverage and access for medically underserved, rural, and 
        frontier areas.
  ``(f) Definition.--In this section, the term `immunization 
information system' means a confidential, population-based, 
computerized database that records immunization doses administered by 
any health care provider to persons within the geographic area covered 
by that database.
  ``(g) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $400,000,000, to remain 
available until expended.''.

                         I. Purpose and Summary

    H.R. 550, the ``Immunization Infrastructure Modernization 
Act of 2021,'' authorizes the Secretary of Health and Human 
Services (the Secretary) to conduct activities, including 
designating data and technology standards, developing public-
private partnerships, and awarding grants or cooperative 
agreements to health departments, in order to expand, enhance, 
and improve immunization information systems (IIS).

                II. Background and Need for Legislation

    IIS are confidential, population-based, computerized 
databases that record all immunization doses administered by 
providers to persons within a certain geopolitical area.\1\ IIS 
are important tools in providing immunization care for patients 
by allowing providers to view a consolidated immunization 
history of a patient to determine appropriate vaccinations from 
childhood to adulthood, and often include features to 
automatically remind patients about vaccine schedules.\2\ On 
the population level, public health officials can review 
aggregate data in IIS to determine overall vaccination levels 
to better guide public health decisions.\3\
---------------------------------------------------------------------------
    \1\Centers for Disease Control and Prevention, About Immunization 
Information Systems (https://www.cdc.gov/vaccines/programs/iis/
about.html) (2021).
    \2\Lynn Gibbs Sharp, et al., Current Challenges and Future 
Possibilities for Immunization Information Systems, Academic Pediatrics 
(May 3, 2021).
    \3\Supra note 1.
---------------------------------------------------------------------------
    IIS were first developed in the early 1990s by local 
jurisdictions and private entities, with varying data and 
technology platforms.\4\ It was not until 2001 that the Centers 
for Disease Control and Prevention (CDC) published the first 
complete set of standards for IIS.\5\ These standards provided 
minimum recommended technical functions for all IIS, including 
allowing input of all personal data elements recommended by the 
National Vaccine Advisory Committee (NVAC), establishing a 
registry record for all newborn children in a jurisdiction 
within six weeks of birth, policies related to confidentiality 
and data security, and other important core functions.\6\ These 
standards have evolved since 2001, and now include functions 
related to resolving duplicate and incomplete patient records, 
digital security, encryption, uptime, and disaster recovery 
standards, and interoperability standards between data 
systems.\7\ Despite improvements to functional standards over 
the years, varying policies and interpretation, inconsistent 
and antiquated technology in state and local jurisdictions, 
incomplete provider participation, and less than full 
implementation of bidirectional data exchange have been cited 
by experts as challenges to improving data quality.\8\
---------------------------------------------------------------------------
    \4\Public Health Informatics Institute, IIS Technology Over Time: 
Impact and Changing Roles (available online at https://phii.org/sites/
default/files/iis_history_spotlight-_technology.pdf).
    \5\Centers for Disease Control and Prevention, IIS Minimum 
Functional Standards, 2001-2013 Historical Information (https://
www.cdc.gov/vaccines/programs/iis/func-stds-2001.html) (2012).
    \6\Id.
    \7\Centers for Disease Control and Prevention, Immunization 
Information Systems (IIS) Functional Standards, v.4.1 (https://
www.cdc.gov/vaccines/programs/iis/functional-standards/func-stds-v4-
1.html) (2020).
    \8\Supra note 2.
---------------------------------------------------------------------------
    H.R. 550 will improve immunization information data quality 
by providing grants to state and local public health 
departments to enhance these systems and requiring the 
Secretary to adopt data standards among grantees.
    Grants included in H.R. 550 will be used to assist public 
health departments in improving data quality by: assessing data 
infrastructure capabilities and gaps among health care 
providers to increase consistency in patient matching, data 
collection, reporting, bidirectional exchange of information, 
and information analysis; providing technical assistance to 
health providers and efficiently enrolling them; improving data 
collection, transmission, exchange, maintenance, and analysis; 
supporting standardization of IIS to accelerate 
interoperability, including with electronic health record 
systems; supporting training of IIS, data science, and 
informatics personnel; supporting procurement and 
implementation of software, hardware, and cloud storage; 
supporting activities to improve the scheduling of 
vaccinations; and other relevant activities. In carrying out 
the grant activities, the Secretary is authorized to develop 
and utilize contracts and cooperative agreements for technical 
assistance, training, and related implementation support.
    To improve data standards among state and local 
jurisdictions, H.R. 550 would require the Secretary to 
designate data and technology standards that must be followed 
by governmental entities as a condition of receiving grants, 
with priority given to data standards developed by consensus-
based organizations with input from the public and voluntary 
consensus-based standards bodies. The Secretary would also be 
required to support a means of independent verification of 
standards used in carrying out grant activities.
    The bill also requires the Secretary to submit to the 
Committee, within 90 days of enactment, a coordinated strategy 
and implementation plan for updating and improving IIS 
supported by CDC and carrying out the activities described in 
the bill. In developing the strategy and implementation plan, 
the Secretary is required to consult with health departments 
and other government entities that administer IIS, professional 
medical associations, public health associations, and 
associations representing pharmacists and pharmacies, community 
health centers, long-term care facilities, and other 
appropriate entities that provide immunizations, health 
information technology (IT) experts, and other public and 
private entities, as appropriate. The bill further directs the 
Secretary to provide to the Committee within a year of 
enactment a report describing any barriers to implementing 
interoperable IIS, exchange of information pursuant to 
immunization records, or reporting by health care providers. 
The report also must describe any barriers that hinder the 
effective establishment of a network to support immunization 
reporting or monitoring with a list of recommendations to 
address such barriers, and an assessment of immunization 
coverage and access to any disparities and gaps in coverage and 
access for medically underserved, rural, and frontier areas.
    H.R. 550 authorizes appropriations of $400,000,000 to carry 
out the activities described in the bill, to remain available 
until expended.

                        III. Committee Hearings

    For the purposes of section 3(c) of rule XIII of the Rules 
of the House of Representatives, the following hearing was used 
to develop or consider H.R. 550:
    The Subcommittee on Health held a legislative hearing on 
June 15, 2021 entitled ``Booster Shot: Enhancing Public Health 
through Vaccine Legislation.'' The Subcommittee received 
testimony from the following witnesses:
           Phyllis Arthur, Vice President, Infectious 
        Diseases and Emerging Science Policy, Biotechnology 
        Innovation Organization;
           Rebecca Coyle, Executive Director, American 
        Immunization Registry Association;
           Yvonne Maldonado, M.D., Chair, Committee on 
        Infectious Diseases, American Academy of Pediatrics; 
        and
           Lijen (L.J.) Tan, Ph.D., Chief Strategy 
        Officer, Immunization Action Coalition.

                      IV. Committee Consideration

    Representatives Ann Kuster (D-NH) and Larry Bucshon (R-IN) 
introduced H.R. 550, the ``Immunization Infrastructure 
Modernization Act of 2021,'' on January 28, 2021, and it was 
referred to the Committee on Energy and Commerce. Subsequently, 
on February 2, 2021, H.R. 550 was referred to the Subcommittee 
on Health. A legislative hearing was held on the bill on June 
15, 2021.
    On July 15, 2021, the Subcommittee on Health met in open 
markup session, pursuant to notice, to consider H.R. 550 and 18 
other bills. During consideration of the bill, a manager's 
amendment offered by Representative Bucshon was agreed to by a 
voice vote. Upon conclusion of consideration of the bill, the 
Subcommittee on Health agreed to report the bill favorably to 
the full Committee, amended, by a voice vote.
    On July 21, 2021, the full Committee met in open markup 
session, pursuant to notice, to consider H.R. 550 and 23 other 
bills. No amendments were offered to H.R. 550. Upon conclusion 
of consideration of the bill, the full Committee agreed to a 
motion on final passage offered by Representative Pallone (D-
NJ), Chairman of the Committee, to order H.R. 550 reported 
favorably to the House, as amended, by a voice vote.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were no record votes taken on H.R. 
550.

                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.

               VIII. Congressional Budget Office Estimate

                                     U.S. Congress,
                               Congressional Budget Office,
                                Washington, DC, September 21, 2021.
Hon. Frank Pallone, Jr.,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 550, the 
Immunization Infrastructure Modernization Act of 2021.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Sarah 
Sajewski.
            Sincerely,
                                         Phillip L. Swagel,
                                                          Director.
    Enclosure.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    H.R. 550 would authorize $400 million for the Secretary of 
Health and Human Services to improve and expand immunization 
information systems (IIS). The bill instructs the Secretary to 
award grants to state, local, tribal, and territorial public 
health departments for IIS improvements, to designate data and 
technology standards for IIS, and to submit a Congressional 
report.
    For this estimate, CBO assumes H.R. 550 will be enacted 
near the beginning of fiscal year 2022. Based on historical 
spending on similar activities, CBO estimates that implementing 
H.R. 550 would increase federal spending by $396 million over 
the 2022-2026 period, subject to the availability of 
appropriated funds.
    The CBO staff contact for this estimate is Sarah Sajewski. 
The estimate was reviewed by Leo Lex, Deputy Director of Budget 
Analysis.

                     IX. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

        X. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to improve 
data sharing and modernization of IIS through developing a plan 
and strategy to improve such systems, designating data and 
technology standards, and awarding grants to help departments 
to carry out activities necessary to improve IIS.

                  XI. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 550 is known to be duplicative of another Federal program, 
including any program that was included in a report to Congress 
pursuant to section 21 of Public Law 111-139 or the most recent 
Catalog of Federal Domestic Assistance.

                      XII. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

   XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 550 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                   XIV. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

          XVI. Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the Act may be cited as the 
``Immunization Infrastructure Modernization Act of 2021.''
    Sec. 2. Immunization Information System data modernization 
and expansion
    Section 2 amends the Public Health Service Act by creating 
a new Section 2824 to modernize and expand IIS infrastructure.
    Subsection (a) of Section 2824 requires the Secretary to 
conduct activities to expand, enhance, and improve IIS 
administered by health departments or other agencies of State, 
local, Tribal, and territorial governments and used by health 
care providers. Subsection (a) also requires the Secretary to 
award grants or cooperative agreements to health departments or 
other government entities to assist public health departments 
in: (1) assessing current data infrastructure capabilities and 
gaps among health care providers to improve and increase 
consistency in patient matching, data collection, reporting, 
bidirectional exchange, and analysis of immunization-related 
information; (2) providing technical assistance and training to 
health care providers; (3) improving secure data collection, 
transmission, bidirectional exchange, maintenance, and analysis 
of immunization information; (4) improving the secure 
bidirectional exchange of immunization record data among 
Federal, State, local, Tribal, and territorial governmental 
entities and non-governmental entities; (5) supporting the 
standardization of IIS to accelerate interoperability with 
health information technology (IT); (6) supporting adoption of 
CDC's functional IIS standards, and the maintenance of security 
standards to protect individually identifiable health 
information; (7) supporting and training IIS, data science, and 
informatics personnel; (8) supporting real-time immunization 
record data exchange and reporting to support rapid 
identification of immunization coverage gaps; (9) improving 
completeness of data by facilitating IIS to exchange data with 
IIS in other jurisdictions; (10) enhancing the capabilities of 
IIS to evaluate, forecast, and operationalize clinical decision 
support tools; (11) supporting the development and 
implementation of policies that facilitate complete population-
level capture, consolidation, and access to accurate 
immunization information; (12) supporting the procurement and 
implementation of software, hardware, and cloud storage; (13) 
strengthening outbreak response capabilities; (14) improving 
the management, distribution, and storage of vaccine doses and 
ancillary supplies; (15) developing and disseminating 
information related to the use and importance of immunization 
record data and disseminating it to health care providers and 
other relevant entities; and (16) supporting activities to 
improve the scheduling and administration of vaccinations.
    Section (a)(2) requires the Secretary to designate data and 
technology standards that must be followed by governmental 
entities with respect to the use of IIS as a condition of 
receiving an award, and prioritizes standards developed by 
consensus-based organizations with input from the public and 
voluntary consensus-based bodies. The Secretary is also 
required to support the independent verification of the adopted 
standards.
    Subsection (a)(3) authorizes the Secretary to develop and 
utilize contracts and cooperative agreements for technical 
assistance, training, and related implementation support.
    Subsection (b) prohibits the Secretary from issuing an 
award unless the applicant uses and agrees to use standards 
adopted by the Secretary under Section 3004 of the Public 
Health Service Act. Such prohibition can only be waived if the 
Secretary determines that grant activities cannot otherwise be 
carried out within the applicable jurisdiction. Subsection (b) 
also includes requirements related to the application for 
awards, such as a description of the activities to be carried 
out under the award, and how the activities will support or 
impact the public health department, and what gaps would 
remain.
    Subsection (c) requires the Secretary to submit, within 90 
days of enactment, a coordinated strategy and implementation 
plan to the House Committee on Energy and Commerce and the 
Senate Committee on Health, Education, Labor, and Pensions.
    Subsection (d) requires the Secretary, in developing the 
strategy and implementation plan described in subsection (c), 
to consult with health departments or other government entities 
that administer IIS; professional medical, public health, and 
pharmacist or pharmacy associations; community health centers, 
long-term care facilities, and other appropriate entities that 
provide immunizations; health IT experts; and other public or 
private entities, as appropriate. Subsection (d) also 
authorizes the Secretary to provide technical assistance, 
certification, and training related to IIS information exchange 
and develop public-private partnerships for implementation 
support.
    Subsection (e) requires the Secretary to submit, within one 
year of enactment, a report to the House Committee on Energy 
and Commerce and the Senate Committee on Health, Education, 
Labor, and Pensions that includes a description of barriers to 
the implementation of interoperable IIS, exchange of 
information, or health professionals reporting to an IIS; 
barriers that hinder the effective establishment of a network 
to support immunization reporting and monitoring and a list of 
recommendations to address such barriers; and an assessment of 
immunization coverage and access to immunizations services and 
any disparities and gaps in such coverage and access for 
medically underserved, rural, and frontier areas.
    Subsection (f) defines the term ``immunization information 
system.''
    Subsection (g) authorizes appropriations of $400,000,000 to 
carry out the section, to remain available until expended.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italics and existing law in which no change is 
proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT


   TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH 
EMERGENCIES

           *       *       *       *       *       *       *


Subtitle C--Strengthening Public Health Surveillance Systems

           *       *       *       *       *       *       *


SEC. 2824. IMMUNIZATION INFORMATION SYSTEM DATA MODERNIZATION AND 
                    EXPANSION.

  (a) Expanding CDC and Public Health Department 
Capabilities.--
          (1) In general.--The Secretary shall--
                  (A) conduct activities (including with 
                respect 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 territorial governments and 
                used by health care providers; and
                  (B) award grants or cooperative agreements to 
                the health departments, or such other 
                governmental entities as administer 
                immunization information systems, of State, 
                local, Tribal, and territorial governments, for 
                the expansion, enhancement, and improvement of 
                immunization information systems to assist 
                public health departments in--
                          (i) assessing current data 
                        infrastructure capabilities and gaps 
                        among health care providers to improve 
                        and increase consistency in patient 
                        matching, data collection, reporting, 
                        bidirectional exchange, and analysis of 
                        immunization-related information;
                          (ii) providing for technical 
                        assistance and the efficient enrollment 
                        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 populations;
                          (iii) improving secure data 
                        collection, transmission, bidirectional 
                        exchange, maintenance, and analysis of 
                        immunization information;
                          (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 multiple jurisdictions 
                                within a State, as appropriate; 
                                and
                                  (II) by simplifying and 
                                supporting electronic reporting 
                                by any health care provider;
                          (v) supporting the standardization of 
                        immunization information systems to 
                        accelerate interoperability with health 
                        information technology, including with 
                        health information technology certified 
                        under section 3001(c)(5) or with health 
                        information networks;
                          (vi) supporting adoption of the 
                        immunization information system 
                        functional standards of the Centers for 
                        Disease Control and Prevention and the 
                        maintenance of security standards to 
                        protect individually identifiable 
                        health information;
                          (vii) supporting and training 
                        immunization information system, data 
                        science, and informatics personnel;
                          (viii) supporting real-time 
                        immunization record data exchange and 
                        reporting, to support rapid 
                        identification of immunization coverage 
                        gaps;
                          (ix) improving completeness of data 
                        by facilitating the capability of 
                        immunization information systems to 
                        exchange data, directly or indirectly, 
                        with immunization information systems 
                        in other jurisdictions;
                          (x) enhancing the capabilities of 
                        immunization information systems to 
                        evaluate, forecast, and operationalize 
                        clinical decision support tools in 
                        alignment with the recommendations of 
                        the Advisory Committee on Immunization 
                        Practices as approved 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, consolidation, and access to 
                        accurate immunization information;
                          (xii) supporting the procurement and 
                        implementation of updated software, 
                        hardware, and cloud storage to 
                        adequately manage information volume 
                        and capabilities;
                          (xiii) supporting expansion of 
                        capabilities within immunization 
                        information systems for outbreak 
                        response;
                          (xiv) supporting activities within 
                        the applicable jurisdiction related to 
                        the management, distribution, and 
                        storage of vaccine doses and ancillary 
                        supplies;
                          (xv) developing information related 
                        to the use and importance of 
                        immunization record data and 
                        disseminating such information to 
                        health care providers and other persons 
                        authorized under State law to access 
                        such information, including payors and 
                        health care facilities; or
                          (xvi) supporting activities to 
                        improve the scheduling and 
                        administration of vaccinations.
          (2) Data standards.--In carrying out paragraph (1), 
        the Secretary shall--
                  (A) designate data and technology standards 
                that must be followed by governmental entities 
                with respect to use of immunization information 
                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 
                        standards bodies; and
                  (B) support a means of independent 
                verification of the standards used in carrying 
                out paragraph (1).
          (3) Public-private partnerships.--In carrying out 
        paragraph (1), the Secretary may develop and utilize 
        contracts and cooperative agreements for technical 
        assistance, training, and related implementation 
        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 standards 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 activities 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 require. Such 
        application shall include information describing--
                  (A) the activities that will be supported by 
                the grant or cooperative agreement; and
                  (B) how the modernization of the immunization 
                information systems involved will support or 
                impact the public health infrastructure of the 
                health department, including a description 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 section, 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 information 
        systems supported by the Centers for Disease Control 
        and Prevention; and
          (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 strategy and 
        implementation plan under subsection (c), the Secretary 
        shall consult with--
                  (A) health departments, or such other 
                governmental entities as administer 
                immunization information systems, of State, 
                local, Tribal, and territorial governments;
                  (B) professional medical, associations, 
                public health associations, and associations 
                representing 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 
                appropriate.
          (2) Technical assistance.--In connection with 
        consultation under paragraph (1), the Secretary may--
                  (A) provide technical assistance, 
                certification, and training related to the 
                exchange of information by immunization 
                information systems used by health care and 
                public health entities at the local, State, 
                Federal, Tribal, and territorial levels; and
                  (B) develop and utilize public-private 
                partnerships for implementation support 
                applicable 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, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and Commerce 
of the House of Representatives that includes--
          (1) a description of any barriers to--
                  (A) public health authorities implementing 
                interoperable immunization information systems;
                  (B) the exchange of information pursuant to 
                immunization records; or
                  (C) reporting by any health care professional 
                authorized under State law, using such 
                immunization information systems, as 
                appropriate, and pursuant to State law; or
          (2) a description of barriers that hinder the 
        effective establishment of a network to support 
        immunization 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 disparities and gaps 
        in such coverage and access for medically underserved, 
        rural, and frontier areas.
  (f) Definition.--In this section, the term ``immunization 
information system'' means a confidential, population-based, 
computerized database that records immunization doses 
administered by any health care provider to persons within the 
geographic area covered by that database.
  (g) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated $400,000,000, 
to remain available until expended.

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