I 117th CONGRESS 1st Session H. R. 550 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.

1. Short title This Act may be cited as the Immunization Infrastructure Modernization Act of 2021 . 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: 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. .