Health STATISTICS Act of 2021
Bill: H.R.831 | Sponsor: Rep. Peters, Scott H. (D-CA)
Policy area: Health

Summary:
Health Standards To Advance Transparency, Integrity, Science, Technology Infrastructure, and Confidential Statistics Act of 2021 or the Health STATISTICS Act of 2021
This bill requires efforts to standardize reporting of public health data, including for COVID-19 (i.e., coronavirus disease 2019) data. It also expands access to federal databases for health research.
Specifically, the Centers for Disease Control and Prevention (CDC) must develop uniform standards for health departments and other entities that report public health data. The Department of Health and Human Services (HHS) may award grants to entities for adopting the uniform standards and otherwise improving their reporting capabilities.
Furthermore, the CDC must, in consultation with the National Institutes of Health, establish specific standards within 30 days for reporting COVID-19 data. HHS must also disseminate this data subject to privacy and other requirements.
Additionally, the Office of Management and Budget must issue guidance on federal health data collection that covers, for example, ensuring data quality and increasing access to health data for research.
The National Center for Health Statistics (NCHS) must carry out a demonstration program to expand an existing program that links different federal data sets for statistical public health research, including research on food insecurity, housing instability, and other social determinants of health. In particular, the program must link to the National Death Index, a database of death records maintained by the NCHS.
Finally, the bill requires the CDC to award grants to research entities and public health departments to increase their capacity for conducting statistical public health research.

To amend the Public Health Service Act to encourage the rapid 
    development of certain public health data standards, authorize 
   epidemiological surveillance grants, and authorize a data linkage 
             demonstration project, 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 ``Health Standards To Advance 
Transparency, Integrity, Science, Technology Infrastructure, and 
Confidential Statistics Act of 2021'' or the ``Health STATISTICS Act of 
2021''.

SEC. 2. IMPROVING PUBLIC HEALTH DATA.

    Title XXXI of the Public Health Service Act (42 U.S.C. 300kk) is 
amended--
            (1) by inserting before section 3101 the following subtitle 
        designation and heading:

                      ``Subtitle A--In General'';

                     and
            (2) by adding at the end the following new subtitle:

           ``Subtitle B--Public Health Common Data Standards

``SEC. 3111. TREATMENT OF PUBLIC HEALTH DATA.

    ``(a) Standardized Reporting.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall--
                    ``(A) adopt and update as necessary uniform 
                standards for State and local health departments to 
                report data to the Centers; and
                    ``(B) in adopting and updating standards under this 
                subsection, give deference to--
                            ``(i) corresponding standards developed by 
                        standards development organizations and 
                        voluntary consensus-based standards bodies; and
                            ``(ii) the recommendations of the working 
                        group established under paragraph (3).
            ``(2) Requirements.--The standards under paragraph (1) 
        shall--
                    ``(A) be consistent with--
                            ``(i) standards for the interoperability of 
                        health information technology under subtitle A;
                            ``(ii) Office of Management and Budget 
                        Circular A-119 (or any successor thereto);
                            ``(iii) Office of Management and Budget 
                        standards for race and ethnicity and other 
                        relevant measures; and
                            ``(iv) the data and technology standards 
                        designated under section 2823(a)(2); and
                    ``(B) provide for the use of interoperable systems, 
                consistent with the application programming interface 
                standards and associated implementation specifications 
                under section 170.215 of title 45 (or any successor 
                regulations).
            ``(3) Working group.--
                    ``(A) Establishment.--The Secretary shall establish 
                a technical working group (in this paragraph referred 
                to as the `working group') to make recommendations on 
                an ongoing basis and as needed to establish more 
                comprehensive common standards across appropriate 
                health care, public health, environmental, and public 
                assistance data systems.
                    ``(B) Duties.--In making the recommendations 
                required by subparagraph (A), the working group shall--
                            ``(i) coordinate, and consult with the 
                        Interagency Council on Statistical Policy 
                        established under section 3504 of title 44, 
                        United States Code, and any other relevant 
                        interagency or intra-agency committee;
                            ``(ii) include recommendations for--
                                    ``(I) efficiencies to reduce 
                                redundancy and the public reporting 
                                burden in Federal health data reporting 
                                requirements and data collections; and
                                    ``(II) methods to facilitate 
                                evidence-building through standardized 
                                local and State reporting and cross-
                                agency, linkable data sharing between 
                                and among local, State, and Federal 
                                agencies to collect, acquire, and 
                                compile complete statistics; and
                            ``(iii) build on existing efforts of public 
                        multistakeholder initiatives seeking to 
                        standardize key data elements necessary for 
                        documenting clinical and other activities 
                        related to the social determinants of health in 
                        order to improve interoperability, exchange, 
                        and use of social determinants of health data 
                        across the health and human services sectors.
                    ``(C) Additional consultation.--The working group 
                may consult with outside experts, including State, 
                local, Tribal, and territorial public health officials, 
                public health researchers, and health care providers 
                representing communities most affected by health 
                disparities.
                    ``(D) Timing.--Not later than 6 months after the 
                date of enactment of this subtitle, the working group 
                shall provide initial recommendations under subsection 
                (a) to the Secretary and the Director of the Centers 
                for Disease Control and Prevention.
                    ``(E) Composition.--
                            ``(i) In general.--The working group shall, 
                        at a minimum, include representation from--
                                    ``(I) all relevant Department of 
                                Health and Human Services units, 
                                including--
                                            ``(aa) the National Center 
                                        for Health Statistics;
                                            ``(bb) the Centers for 
                                        Disease Control and Prevention;
                                            ``(cc) the Office of the 
                                        Chief Technology Officer in the 
                                        Office of the Secretary;
                                            ``(dd) the Office of the 
                                        National Coordinator for Health 
                                        Information Technology; and
                                            ``(ee) the Health and Human 
                                        Services Data Council;
                                    ``(II) the Office of Information 
                                and Regulatory Affairs of the Office of 
                                Management and Budget;
                                    ``(III) the National Institute of 
                                Standards and Technology;
                                    ``(IV) the Veterans Health 
                                Administration;
                                    ``(V) the Military Health System; 
                                and
                                    ``(VI) the Indian Health Service.
                            ``(ii) Chair.--The chair of the working 
                        group shall be the Director of the National 
                        Center for Health Statistics (or the Director's 
                        designee).
    ``(b) Increasing Efficiency and Advancing Evidence Building.--
Consistent with the standards in effect under subsection (a), the Chief 
Statistician of the United States in the Office of Management and 
Budget, in accordance with section 3504(e) of title 44, United States 
Code, shall issue and update on an ongoing basis as needed, directives 
guiding Federal health data information collection to reduce public 
reporting burden, ensure information quality, improve use of 
determinants of health data, and enhance access to health data for 
evidence-building activities.
    ``(c) COVID-19 High-Priority Standards.--Not later than 30 days 
after the date of enactment of this subtitle, the Secretary, acting 
through the Director of the Centers for Disease Control and Prevention, 
and in consultation with the Director of the National Institutes of 
Health, shall--
            ``(1) establish standards under subsection (a) with respect 
        to COVID-19, including for genomic epidemiology, modeling 
        outbreak preparedness and response, therapeutic interventions, 
        treatment settings, and associated outcomes; and
            ``(2) in carrying out paragraph (1), adopt or build upon 
        existing standards.
    ``(d) Sharing Data Related to COVID-19.--Subject to applicable law 
on the privacy and confidentiality of individually identifiable 
information, the Secretary shall--
            ``(1) share real-time data related to COVID-19 data 
        collected by the Department of Health and Human Services with--
                    ``(A) the Centers for Disease Control and 
                Prevention; and
                    ``(B) Federal, State, and local public health 
                agencies outside of the Department of Health and Human 
                Services; and
            ``(2) make such data (including metadata as defined in 
        section 3502 of title 44, United States Code) publicly 
        available using standardized, machine-readable formats--
                    ``(A) on the website of the Department of Health 
                and Human Services; and
                    ``(B) in the Federal data catalogue maintained 
                under section 3511(c) of title 44, United States Code.

``SEC. 3112. EPIDEMIOLOGICAL SURVEILLANCE GRANTS.

    ``(a) Grant Authority.--The Secretary, in consultation with the 
Director of the National Center for Health Statistics, may award grants 
or cooperative agreements to public health reporting entities--
            ``(1) to establish protocols and acquire technologies to 
        implement the standards under section 3111 for reporting, 
        directly or indirectly, to the Federal Government, including 
        by--
                    ``(A) supporting expansion and modernization of 
                electronic case reporting, laboratory reporting, and 
                mortality reporting with an emphasis on modernizing and 
                linking, where appropriate, modularized medical 
                examiner and coroner case management systems, 
                electronic death registration systems, electronic 
                health records, and supporting laboratory systems to 
                improve data timeliness and quality;
                    ``(B) making data sharing with the National Center 
                for Health Statistics bidirectional, such that the data 
                received by the National Center for Health Statistics 
                is provided quickly back to State and local offices and 
                to Federal partners and in a form that is quickly 
                understandable and actionable;
                    ``(C) supporting survey activities to more broadly 
                measure health disparities at the national, State, and 
                local levels;
                    ``(D) improving interoperability standards and 
                implementation specifications for industry use to 
                fulfill specific clinical health information technology 
                interoperability needs;
                    ``(E) developing and implementing protections 
                required by subsection (b); and
                    ``(F) conducting real-world testing of data 
                important for forecasting to ensure viability, 
                scalability, and adaptability of data collection and 
                reporting activities; and
            ``(2) to carry out such reporting using such protocols and 
        technologies.
    ``(b) Adoption of Standards and Data Protections.--The Secretary 
may not award a grant or cooperative agreement under subsection (a) 
unless the applicant develops an implementation plan to develop and 
implement policies, practices, procedures, and controls related to--
            ``(1) improving data quality and reporting timeliness;
            ``(2) data security, in accordance with the most recent 
        versions of the Cybersecurity Framework and Privacy Framework 
        (or successor frameworks) of the National Institute of 
        Standards and Technology; and
            ``(3) confidentiality and privacy of any information that 
        pertains to an individual and from which, either alone or in 
        combination with other reasonably available information, the 
        individual's identity can be determined, including policies, 
        practices, procedures, and controls for--
                    ``(A) minimizing collection, processing, 
                maintenance, retention, and disclosure of such 
                information to what is necessary, proportionate, and 
                limited for a good faith public health purpose that is 
                clearly described and limited in an agreement between 
                the Federal Government and the recipient;
                    ``(B) prohibiting disclosure of such information to 
                persons, including government entities, absent legal 
                safeguards included in Federal or State laws or 
                regulations, for protecting the security and privacy of 
                such information; and
                    ``(C) making the data available to the National 
                Center for Health Statistics for statistical purposes 
                under subchapter III of chapter 35 of title 44, United 
                States Code.
    ``(c) COVID-19 Reporting.--The Secretary may not award a grant or 
cooperative agreement under subsection (a) unless the applicant 
agrees--
            ``(1) to use the grant for activities under subsection (a) 
        with respect to COVID-19, including with respect to--
                    ``(A) testing results data;
                    ``(B) testing results turnaround time;
                    ``(C) hospitalization and intensive care unit data;
                    ``(D) new infections among health care workers;
                    ``(E) new cases among quarantined contacts; and
                    ``(F) long-term care facilities, prisons, and other 
                congregate settings; and
            ``(2) in carrying out such activities, to disaggregate data 
        by age, sex, race, ethnicity, sexual orientation, gender 
        identity, and Zip Code, as appropriate and to the extent 
        possible.
    ``(d) Application.--A public health reporting entity applying for a 
grant or cooperative agreement under this section shall submit an 
application to the Secretary at such time and in such manner as the 
Secretary may require.
    ``(e) Definition.--In this section, the term `public health 
reporting entity' means any entity that reports data to the Centers for 
Disease Control and Prevention or another public health authority, 
including a State or local public health department, a public health 
laboratory, and a health care provider.

``SEC. 3113. EVIDENCE-BUILDING DEMONSTRATION PROGRAM.

    ``(a) In General.--The Secretary acting through the Director of the 
National Center for Health Statistics (in this section referred to as 
the `Secretary') shall expand the data linkage program of the 
Department of Health and Human Services consisting of Federal 
statistical and programmatic datasets from specified Federal entities, 
as authorized by subchapter III of chapter 35 of title 44, United 
States Code, for the purpose of facilitating statistical public health 
research on trends and patterns across specifically defined, 
statistically relevant populations, with a particular focus on linking 
social determinants of health data, including with respect to--
            ``(1) food insecurity;
            ``(2) housing instability;
            ``(3) transportation access;
            ``(4) safety;
            ``(5) social connection and isolation;
            ``(6) financial resource strain;
            ``(7) stress;
            ``(8) race and ethnicity; and
            ``(9) sexual orientation and gender identity.
    ``(b) Activities.--The activities of the demonstration program 
under this section shall include:
            ``(1) Assessing the availability of identified and 
        deidentified data sets held by Federal, State, local, and non-
        Federal entities that may be useful for research described in 
        subsection (a).
            ``(2) Using existing authorities and linkages of data in 
        accordance with subchapter III of chapter 35 of title 44, 
        United States Code, when relevant to request the submission of 
        datasets to the National Center for Health Statistics for 
        linking.
    ``(c) Limitation.--The Secretary shall limit access to data under 
the demonstration program under this section--
            ``(1) to Federal statistical agencies and qualified public 
        and private researchers, as determined by the Director of the 
        National Center for Health Statistics;
            ``(2) for a period to be specified by the Secretary; and
            ``(3) exclusively for the purpose described in subsection 
        (a).
    ``(d) Process for Making Data Available.--
            ``(1) In general.--Consistent with paragraph (2), the 
        Secretary shall establish a rigorous process for making data 
        available and usable pursuant to the demonstration program 
        under this section.
            ``(2) Requirements.--Before any data is made available 
        pursuant to the demonstration program under this section by an 
        entity described in subsection (b)(1) to another entity 
        described in subsection (b)(1)--
                    ``(A) the receiving entity shall submit to the 
                Director of the National Center for Health Statistics 
                an application for data for the purpose described in 
                subsection (a); and
                    ``(B) the Director shall approve or deny such 
                request in writing, including in the case of a denial 
                an explanation of the reasons for the denial.
    ``(e) Rulemaking.--
            ``(1) No delay on implementation.--The Secretary--
                    ``(A) shall begin implementation of the 
                demonstration program under this section upon the date 
                of enactment of this subtitle; and
                    ``(B) shall not delay such implementation for 
                purposes of promulgating the regulations required by 
                paragraph (2).
            ``(2) Promulgation.--The Secretary shall--
                    ``(A) issue regulations for carrying out this 
                section; and
                    ``(B) specify in such regulations the allowed and 
                disallowed purposes for sharing and linking data 
                through the program, including areas of potential 
                research.
    ``(f) Website.--The Secretary shall maintain a publicly accessible 
website--
            ``(1) providing information about a demonstration program 
        under this section;
            ``(2) facilitating stakeholder participation in such 
        demonstration program;
            ``(3) facilitating oversight of such demonstration program;
            ``(4) providing lists of datasets from Federal and non-
        Federal entities;
            ``(5) providing lists of identified and deidentified 
        datasets;
            ``(6) identifying linked datasets;
            ``(7) delineating a process to protect privacy and 
        confidentiality;
            ``(8) identifying sources of the datasets; and
            ``(9) delineating categories of personal data.
    ``(g) Program Requirements.--The demonstration program under this 
section shall be designed to--
            ``(1) support data matching services for agencies and 
        researchers using the National Death Index; and
            ``(2) facilitate collaboration with States and private 
        entities to examine, update, and modernize the fee structure of 
        the National Death Index to support a broad range of data 
        queries while assuring the continued support of the State 
        systems collecting and providing this information to the 
        National Death Index.
    ``(h) Contracted Entities.--
            ``(1) In general.--Subject to the availability of 
        appropriations, the Secretary may enter into contracts with 
        eligible entities, as appropriate, for infrastructure and 
        support services in carrying out the demonstration program 
        under this section.
            ``(2) Eligibility.--To be eligible for a contract under 
        paragraph (1), an entity shall--
                    ``(A) demonstrate core capabilities for data 
                sharing, data linkage, and compliance with subchapter 
                III of chapter 35 of title 44, United States Code; and
                    ``(B) adhere to security standards in accordance 
                with the Federal Risk and Authorization Management 
                Program (or any successor program).
    ``(i) Rule of Construction.--Nothing in this section shall be 
construed to authorize the availability or use of data for--
            ``(1) law enforcement; or
            ``(2) any determination of the eligibility of an individual 
        for any direct or indirect payment, benefit, or service.
    ``(j) Report to Congress.--Not later than 1 year after the date of 
enactment of this Act, and annually thereafter, the Secretary shall 
submit a report to the Congress on the implementation of this section, 
including--
            ``(1) identification of best States practices for--
                    ``(A) sharing data with, and reporting data to, the 
                National Death Index; and
                    ``(B) ensuring the quality of such data; and
            ``(2) recommendations to improve--
                    ``(A) such sharing and reporting; and
                    ``(B) access to the National Death Index by 
                researchers.

``SEC. 3114. BUILDING STATISTICAL PUBLIC HEALTH RESEARCH CAPACITY.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall provide financial 
assistance to research entities and public health departments to 
establish, expand, or enhance capacity for conducting statistical 
public health research--
            ``(1) in connection with the programs and activities under 
        this subtitle; and
            ``(2) in accordance with subchapter III of chapter 35 of 
        title 44, United States Code.
    ``(b) Capacity for Sharing and Linking.--The capacity referred to 
in subsection (a) may include sharing and linking information and 
accessing and utilizing linked health data files in accordance with 
established data use agreements with data holders (including electronic 
case reporting, electronic health records, and electronic test orders 
and results) with public health agencies and related systems, including 
the National Death Index, immunization information systems, syndromic 
surveillance systems, laboratory information management systems, 
electronic case reporting systems, medical examiner case management 
systems, and Patient Unified Look-up Systems for Emergencies.

``SEC. 3115. RULE OF CONSTRUCTION.

    ``Nothing in this subtitle shall be construed to supersede the 
authority of the Director of the Office of Management and Budget under 
title 44, United States Code, to determine and issue relevant standards 
for information management.

``SEC. 3116. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated--
            ``(1) to carry out this subtitle (other than section 3113), 
        $450,000,000, to remain available until expended; and
            ``(2) to carry out section 3113, $100,000,000 for the 
        period of fiscal years 2020 through 2025.''.
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