Commissioner of Social Security shall transmit an 
individual’s demographic data as collected under 
paragraph (1) to the Centers for Medicare & Med-
icaid Services. 
‘‘(7) ANALYSIS
AND
REPORTING
OF
DATA.— 
With respect to data transmitted under paragraph 
(5), the Administrator of the Centers for Medicare 
& Medicaid Services, in consultation with the Com-
missioner of Social Security shall— 
‘‘(A) require that such data be uniformly 
analyzed and that such analysis be reported at 
least annually to Congress; 
‘‘(B) incorporate such data in other anal-
ysis and reporting on health disparities and the 
provision of inequitable health care services by 
a health care provider, as appropriate; 
‘‘(C) make such data available to research-
ers, under the protections outlined in paragraph 
(7); 
‘‘(D) provide opportunities to individuals 
enrolled in Medicare to submit updated data; 
and 
‘‘(E) ensure that the provision of assist-
ance or benefits to an applicant is not denied 
or otherwise adversely affected because of the 
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failure of the applicant to provide any of the 
data collected under paragraph (1). 
‘‘(8) PROTECTION
OF
DATA.—The Commis-
sioner of Social Security shall ensure (through the 
promulgation of regulations or otherwise) that all 
data collected pursuant to subsection (a) is pro-
tected— 
‘‘(A) under the same privacy protections as 
the Secretary applies to health data under the 
regulations promulgated under section 264(c) of 
the Health Insurance Portability and Account-
ability Act of 1996 (relating to the privacy of 
individually identifiable health information and 
other protections); and 
‘‘(B) from all inappropriate internal use by 
any entity that collects, stores, or receives the 
data, including use of such data in determina-
tions of eligibility (or continued eligibility) in 
health plans, and from other inappropriate 
uses, as defined by the Secretary. 
‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to permit the use of information 
collected under this section in a manner that would ad-
versely affect any individual providing any such informa-
tion. 
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‘‘(c) TECHNICAL ASSISTANCE.—The Secretary of 
Health and Human Services may, either directly or by 
grant or contract, provide technical assistance to enable 
any entity to comply with the requirements of this section 
or with regulations implementing this section. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$500 million for 2022 and $100 million for each fiscal 
year thereafter.’’. 
SEC. 1004. REVISION OF HIPAA CLAIMS STANDARDS. 
(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall revise the regulations promulgated 
under part C of title XI of the Social Security Act (42 
U.S.C. 1320d et seq.) (relating to the collection of data 
on race, ethnicity, and primary language in a health-re-
lated transaction) to require— 
(1) the use, at a minimum, of standards for 
data collection on race, ethnicity, primary language, 
disability, sex, sexual orientation, gender identity, 
and socioeconomic status developed under section 
3101 of the Public Health Service Act (42 U.S.C. 
300kk); and 
(2) in consultation with the Office of the Na-
tional Coordinator for Health Information Tech-
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nology, the designation of the appropriate racial, 
ethnic, primary language, disability, sex, and other 
code sets as required for claims and enrollment data. 
(b) DISSEMINATION.—The Secretary of Health and 
Human Services shall disseminate the new standards de-
veloped under subsection (a) to all entities that are subject 
to the regulations described in such subsection and provide 
technical assistance with respect to the collection of the 
data involved. 
(c) COMPLIANCE.—The Secretary of Health and 
Human Services shall require that entities comply with the 
new standards developed under subsection (a) not later 
than 2 years after the final promulgation of such stand-
ards. 
SEC. 1005. NATIONAL CENTER FOR HEALTH STATISTICS. 
Section 306(n) of the Public Health Service Act (42 
U.S.C. 242k(n)) is amended— 
(1) in paragraph (1), by striking ‘‘2003’’ and 
inserting ‘‘2024’’; 
(2) in paragraph (2), in the first sentence, by 
striking ‘‘2003’’ and inserting ‘‘2024’’; and 
(3) in paragraph (3), by striking ‘‘2002’’ and 
inserting ‘‘2024’’. 
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SEC. 1006. DISPARITIES DATA COLLECTED BY THE FED-
ERAL GOVERNMENT. 
(a) REPOSITORY OF GOVERNMENT DATA.—The Sec-
retary of Health and Human Services, in coordination 
with the officials referenced in subsection (b), shall estab-
lish a centralized electronic repository of Government data 
on factors related to the health and well-being of the popu-
lation of the United States. 
(b) COLLECTION; SUBMISSION.—Not later than 180 
days after the date of enactment of this Act, and January 
31 of each year thereafter, each department, agency, and 
office of the Federal Government that has collected data 
on race, ethnicity, sex, primary language, sexual orienta-
tion, disability status, gender identity, age, or socio-
economic status during the preceding calendar year shall 
submit such data to the repository of Government data 
established under subsection (a). 
(c) ANALYSIS; PUBLIC AVAILABILITY; REPORTING.— 
Not later than April 30, 2021, and April 30 of each year 
thereafter, the Secretary of Health and Human Services, 
acting through the Assistant Secretary for Planning and 
Evaluation, the Assistant Secretary for Health, the Direc-
tor of the Agency for Healthcare Research and Quality, 
the Director of the National Center for Health Statistics, 
the Administrator of the Centers for Medicare & Medicaid 
Services, the Director of the National Institute on Minor-
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ity Health and Health Disparities, and the Deputy Assist-
ant Secretary for Minority Health, shall— 
(1) prepare and make available datasets for 
public use that relate to disparities in health status, 
health care access, health care quality, health out-
comes, public health, the provision of equitable 
health services, and other areas of health and well- 
being by factors that include race, ethnicity, sex, pri-
mary language, sexual orientation, disability status, 
gender identity, and socioeconomic status; 
(2) ensure that these datasets are publicly iden-
tified on the repository established under subsection 
(a) as ‘‘disparities’’ data; and 
(3) submit a report to the Congress on the 
availability and use of such data by public stake-
holders. 
SEC. 1007. DATA COLLECTION AND ANALYSIS GRANTS TO 
MINORITY-SERVING INSTITUTIONS. 
(a) AUTHORITY.—The Secretary of Health and 
Human Services, acting through the Director of the Na-
tional Institute on Minority Health and Health Disparities 
and the Deputy Assistant Secretary for Minority Health, 
shall award grants to eligible entities to access and analyze 
racial and ethnic data on disparities in health and health 
care, and where possible other data on disparities in health 
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and health care, to monitor and report on progress to re-
duce and eliminate disparities in health and health care. 
(b) ELIGIBLE ENTITY.—In this section, the term ‘‘el-
igible entity’’ means an entity that has an accredited pub-
lic health, health policy, or health services research pro-
gram and is any of the following: 
(1) A part B institution, as defined in section 
322 of the Higher Education Act of 1965 (20 
U.S.C. 1061). 
(2) A Hispanic-serving institution, as defined in 
section 502 of such Act (20 U.S.C. 1101a). 
(3) A Tribal College or University, as defined in 
section 316 of such Act (20 U.S.C. 1059c). 
(4) An Asian American and Native American 
Pacific Islander-serving institution, as defined in 
section 371(c) of such Act (20 U.S.C. 1067q(c)). 
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for fiscal years 2023 
through 2027. 
SEC. 1008. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
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ed by inserting after section 505G (21 U.S.C. 355h) the 
following: 
‘‘SEC. 505H. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
‘‘(a) PREAPPROVAL STUDIES.—If there is evidence of 
a racial or ethnic disparity in safety or effectiveness with 
respect to a drug or biological product, then— 
‘‘(1)(A) in the case of a drug, the investigations 
required under section 505(b)(1)(A) shall include 
adequate and well-controlled investigations of the 
disparity; or 
‘‘(B) in the case of a biological product, the evi-
dence required under section 351(a) of the Public 
Health Service Act for approval of a biologics license 
application for the biological product shall include 
adequate and well-controlled investigations of the 
disparity; and 
‘‘(2) if the investigations described in subpara-
graph (A) or (B) of paragraph (1) confirm that 
there is such a disparity, the labeling of the drug or 
biological product shall include appropriate informa-
tion about the disparity. 
‘‘(b) POSTMARKET STUDIES.— 
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‘‘(1) IN GENERAL.—If there is evidence of a ra-
cial or ethnic disparity in safety or effectiveness with 
respect to a drug for which there is an approved ap-
plication under section 505 of this Act or of a bio-
logical product for which there is an approved li-
cense under section 351 of the Public Health Service 
Act, the Secretary may by order require the holder 
of the approved application or license to conduct, by 
a date specified by the Secretary, postmarket studies 
to investigate the disparity. 
‘‘(2) LABELING.—If the Secretary determines 
that the postmarket studies confirm that there is a 
disparity described in paragraph (1), the labeling of 
the drug or biological product shall include appro-
priate information about the disparity. 
‘‘(3) STUDY DESIGN.—The Secretary may, in 
an order under paragraph (1), specify all aspects of 
the design of the postmarket studies required under 
such paragraph for a drug or biological product, in-
cluding the number of studies and study partici-
pants, and the other demographic characteristics of 
the study participants. 
‘‘(4) MODIFICATIONS OF STUDY DESIGN.—The 
Secretary may, by order and as necessary, modify 
any aspect of the design of a postmarket study re-
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quired in an order under paragraph (1) after issuing 
such order. 
‘‘(5) STUDY
RESULTS.—The results from a 
study required under paragraph (1) shall be sub-
mitted to the Secretary as a supplement to the drug 
application or biologics license application. 
‘‘(c) APPLICATIONS UNDER SECTION 505(j).— 
‘‘(1) IN GENERAL.—A drug for which an appli-
cation has been submitted or approved under section 
505(j) shall not be considered ineligible for approval 
under that section or misbranded under section 502 
on the basis that the labeling of the drug omits in-
formation relating to a disparity on the basis of ra-
cial or ethnic background as to the safety or effec-
tiveness of the drug, whether derived from investiga-
tions or studies required under this section or de-
rived from other sources, when the omitted informa-
tion is protected by patent or by exclusivity under 
section 505(j)(5)(F). 
‘‘(2) LABELING.—Notwithstanding paragraph 
(1), the Secretary may require that the labeling of 
a drug approved under section 505(j) that omits in-
formation relating to a disparity on the basis of ra-
cial or ethnic background as to the safety or effec-
tiveness of the drug include a statement of any ap-
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propriate contraindications, warnings, or precautions 
related to the disparity that the Secretary considers 
necessary. 
‘‘(d) DEFINITION.—In this section, the term ‘evi-
dence of a racial or ethnic disparity in safety or effective-
ness’, with respect to a drug or biological product, in-
cludes— 
‘‘(1) evidence that there is a disparity on the 
basis of racial or ethnic background as to safety or 
effectiveness of a drug or biological product in the 
same chemical class as the drug or biological prod-
uct; 
‘‘(2) evidence that there is a disparity on the 
basis of racial or ethnic background in the way the 
drug or biological product is metabolized; and 
‘‘(3) other evidence as the Secretary may deter-
mine appropriate.’’. 
(b) ENFORCEMENT.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(gg) If it is a drug and the holder of the approved 
application under section 505 or license under section 351 
of the Public Health Service Act for the drug has failed 
to complete the investigations or studies required under 
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section 505H, or comply with any other requirement of 
such section 505H.’’. 
(c) DRUG FEES.—Section 736(a)(1)(A)(ii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(a)(1)(A)(ii)) is amended by inserting after ‘‘are not 
required’’ the following: ‘‘, including postmarket studies 
required under section 505H’’. 
SEC. 1009. IMPROVING HEALTH DATA REGARDING NATIVE 
HAWAIIANS AND PACIFIC ISLANDERS. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317U the following: 
‘‘SEC. 317V. NATIVE HAWAIIAN AND PACIFIC ISLANDER 
HEALTH DATA. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) INSULAR AREA.—The term ‘insular area’ 
means Guam, the Commonwealth of Northern Mar-
iana Islands, American Samoa, the United States 
Virgin Islands, the Federated States of Micronesia, 
the Republic of Palau, or the Republic of the Mar-
shall Islands. 
‘‘(2) NATIVE HAWAIIANS AND PACIFIC ISLAND-
ERS (NHPI).—The term ‘Native Hawaiians and Pa-
cific Islanders’ or ‘NHPI’ means people having ori-
gins in any of the original peoples of American 
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Samoa, the Commonwealth of the Northern Mariana 
Islands, the Federated States of Micronesia, Guam, 
Hawaii, the Republic of the Marshall Islands, the 
Republic of Palau, or any other Pacific Island. 
‘‘(3) NHPI STAKEHOLDER GROUPS.—The term 
‘NHPI stakeholder group’ includes each of the fol-
lowing: 
‘‘(A) COMMUNITY
GROUP.—A group of 
NHPI who are organized at the community 
level, and may include a church group, social 
service group, national advocacy organization, 
or cultural group. 
‘‘(B) 
NONPROFIT, 
NONGOVERNMENTAL 
ORGANIZATION.—A group of NHPI with a dem-
onstrated history of addressing NHPI issues, 
including a NHPI coalition. 
‘‘(C) 
DESIGNATED
ORGANIZATION.—An 
entity established to represent NHPI popu-
lations and which has statutory responsibilities 
to provide, or has community support for pro-
viding, health care. 
‘‘(D) GOVERNMENT REPRESENTATIVES OF 
NHPI POPULATIONS.—Representatives from Ha-
waii, American Samoa, the Commonwealth of 
the Northern Mariana Islands, the Federated 
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States of Micronesia, Guam, the Republic of 
Palau, and the Republic of the Marshall Is-
lands. 
‘‘(b) PRELIMINARY HEALTH SURVEY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of NCHS, shall conduct a pre-
liminary health survey in order to identify the major 
areas and regions in the continental United States, 
Hawaii, American Samoa, the Commonwealth of the 
Northern Mariana Islands, the Federated States of 
Micronesia, Guam, the Republic of Palau, and the 
Republic of the Marshall Islands in which NHPI 
people reside. 
‘‘(2) CONTENTS.—The health survey described 
in paragraph (1) shall include health data and any 
other data the Secretary determines to be— 
‘‘(A) useful in determining health status 
and health care needs of NHPI populations; or 
‘‘(B) required for developing or imple-
menting the national strategy under subsection 
(c). 
‘‘(3) METHODOLOGY.—Methodology for the 
health survey described in paragraph (1), including 
plans for designing questions, implementation, sam-
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pling, and analysis, shall be developed in consulta-
tion with NHPI stakeholder groups. 
‘‘(4) TIMEFRAME.—The survey required under 
this subsection shall be completed not later than 18 
months after the date of enactment of the Health 
Equity and Accountability Act of 2022. 
‘‘(c) NATIONAL STRATEGY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the National Center for 
Health Statistics (referred to in this section as 
‘NCHS’) of the Centers for Disease Control and 
Prevention, and other agencies within the Depart-
ment of Health and Human Services as the Sec-
retary determines appropriate, shall develop and im-
plement a sustainable national strategy for identi-
fying and evaluating the health status and health 
care needs of NHPI populations living in the conti-
nental United States, Hawaii, American Samoa, the 
Commonwealth of the Northern Mariana Islands, 
the Federated States of Micronesia, Guam, the Re-
public of Palau, and the Republic of the Marshall Is-
lands. 
‘‘(2) CONSULTATION.—In developing and imple-
menting a national strategy, as described in para-
graph (1), not later than 180 days after the date of 
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enactment of the Health Equity and Accountability 
Act of 2022, the Secretary— 
‘‘(A) shall consult with representatives of 
NHPI stakeholder groups; and 
‘‘(B) may solicit the participation of rep-
resentatives from other Federal agencies. 
‘‘(d) PROGRESS REPORT.—Not later than 2 years 
after the date of enactment of the Health Equity and Ac-
countability Act of 2022, the Secretary shall submit to 
Congress a progress report, which shall include the na-
tional strategy described in subsection (c)(1). 
‘‘(e) STUDY AND REPORT BY THE HEALTH AND 
MEDICINE DIVISION.— 
‘‘(1) IN GENERAL.—The Secretary shall enter 
into an agreement with the Health and Medicine Di-
vision of the National Academies of Sciences, Engi-
neering, and Medicine to conduct a study, with input 
from stakeholders in insular areas, on each of the 
following: 
‘‘(A) The standards and definitions of 
health care applied to health care systems in in-
sular areas and the appropriateness of such 
standards and definitions. 
‘‘(B) The status and performance of health 
care systems in insular areas, evaluated based 
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