[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8080 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 8080
To amend the Public Health Service Act to encourage the development of
certain public health data standards, authorize epidemiological
surveillance grants, and authorize a data linkage demonstration
project, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 21, 2020
Mr. Peters (for himself, Ms. Eshoo, Mrs. McBath, and Mr. Fitzpatrick)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to encourage the 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 2020'' or the ``Health STATISTICS Act of
2020''.
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
``(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 permanent 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 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 up-to-date 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;
``(B) making data sharing with the National Center
for Health Statistics bidirectional;
``(C) improving interoperability standards and
implementation specifications for industry use to
fulfill specific clinical health information technology
interoperability needs;
``(D) developing and implementing protections
required by subsection (b); and
``(E) conducting real-world testing of data sharing
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, 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; and
``(7) stress.
``(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 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
nonfederal 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.
``(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.''.
<all>
Health STATISTICS Act of 2020
#8080 | HR Congress #116
Policy Area: Health
Subjects: Advisory bodiesCardiovascular and respiratory healthCensus and government statisticsComputer security and identity theftCongressional oversightDepartment of Health and Human ServicesEmergency medical services and trauma careExecutive agency funding and structureGovernment information and archivesHealth information and medical recordsHealth programs administration and fundingHealth technology, devices, suppliesInfectious and parasitic diseasesIntergovernmental relationsMedical researchMedical tests and diagnostic methodsResearch administration and fundingRight of privacyState and local government operations
Last Action: Referred to the House Committee on Energy and Commerce. (8/21/2020)
Bill Text Source: Congress.gov
Summary and Impacts
Original Text