Title: Immunization Infrastructure Modernization Act of 2021
Policy area: Health

Summary:
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)]

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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.''.
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