Immunization Infrastructure Modernization Act of 2021
This bill directs the Department of Health and Human Services (HHS) to take actions to improve data sharing and other aspects of immunization information systems. These are confidential, population-based databases that maintain a record of vaccine administrations.
Specifically, HHS must
As a condition of receiving the grants, recipients must use the designated standards. However, HHS may waive this condition in some circumstances.
HHS must also report to Congress on these activities.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 550 Introduced in House (IH)]
<DOC>
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 Representatives of the
United States of America in Congress assembled,
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. 2823. 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 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 as defined in section
160.103 of title 45, Code of Federal
Regulations (or any successor regulations);
``(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; and
``(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.
``(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.''.
<all>
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Sponsor introductory remarks on measure. (CR H393)
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-178.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-178.
Placed on the Union Calendar, Calendar No. 128.
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
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Considered under suspension of the rules. (consideration: CR H6684-6687)
DEBATE - The House proceeded with forty minutes of debate on H.R. 550.
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
Considered as unfinished business. (consideration: CR H6698-6699)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 294 - 130 (Roll no. 388).(text: CR H6684-6685)
Roll Call #388 (House)On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 294 - 130 (Roll no. 388). (text: CR H6684-6685)
Roll Call #388 (House)Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.