such existing COVID–19 data collection activities 
and to advance policies to address social deter-
minants of health, including additional identifiers, 
such as those identified by the Commissioner, in-
cluding building on guidance existing on the date of 
enactment of this Act, for the collection of race and 
ethnicity data in clinical trials, as determined appro-
priate by the Secretary. 
(2) ADDITIONAL USE OF DATA.—The data col-
lected under paragraph (1) may be used to inform— 
(A) clinical trial recruitment; 
(B) resource allocations; 
(C) treatment strategies; and 
(D) other public health activities. 
(3) COLLECTION VIA GRANTS OR CONTRACTS.— 
(A) IN
GENERAL.—The Secretary may 
issue grants to, and enter into contracts with, 
States, local public health departments, or other 
entities supplying data to the Secretary as re-
quired under this subsection, to support the ac-
tivities under this subsection. 
(B) GUIDANCE FOR USE OF FUNDS.—In 
issuing grants or contracts under subparagraph 
(A), the Secretary may issue guidance regard-
ing best practices for collecting data pursuant 
VerDate Sep 11 2014 
01:56 Aug 14, 2021
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H5030.IH
H5030
kjohnson on DSK79L0C42PROD with BILLS
to paragraph (1) and track the performance of 
entities receiving grants or contracts. 
(4) USE AND DISCLOSURE FOR PUBLIC HEALTH 
ACTIVITIES.—The submission and use of data col-
lected pursuant to this subsection shall be consid-
ered a permitted disclosure and use for public health 
activities as set forth in section 164.512(b)(1)(i) of 
45, Code of Federal Regulations (or any successor 
regulations). 
(b) DATA COLLECTION REGARDING ENHANCED RISK 
FOR COVID–19.—The Secretary shall— 
(1) conduct a study on best practices for lab-
oratories that are subject to the reporting require-
ments under section 18115(a) of the Coronavirus 
Aid, Relief, and Economic Security Act (Public Law 
116–136) to aid such laboratories in collecting data 
elements related to enhanced risk for COVID–19, 
such as data, with respect to a patient, regarding in-
come, education, employment, disability, community 
resources, and social support; 
(2) consider which governmental entities (in-
cluding Federal, State, and local governmental enti-
ties) would be best suited to aiding in collecting such 
data elements in coordination with such laboratories; 
and 
VerDate Sep 11 2014 
01:56 Aug 14, 2021
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H5030.IH
H5030
kjohnson on DSK79L0C42PROD with BILLS
(3) issue guidance on such best practices. 
SEC. 5. CLARIFICATION THAT CERTAIN REMUNERATION 
RELATED TO PARTICIPATION IN CLINICAL 
TRIALS DOES NOT CONSTITUTE REMUNERA-
TION UNDER THE FEDERAL CIVIL MONEY 
PENALTIES LAW. 
(a) IN GENERAL.—Section 1128A(i)(6)(F) of the So-
cial Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amend-
ed by inserting ‘‘(including remuneration offered or trans-
ferred to an individual to promote the participation in an 
approved clinical trial, as defined in subsection (d) of the 
first section 2709 of the Public Health Service Act, that 
is registered with the database of clinical trials maintained 
by the National Library of Medicine (or any successor 
database), so long as such remuneration facilitates equi-
table inclusion of patients from all relevant demographic 
and socioeconomic populations and is related to patient 
participation in the approved clinical trial)’’ after ‘‘pro-
motes access to care’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to remuneration provided on or 
after the date of the enactment of this Act. 
SEC. 6. NATIONAL ACADEMY OF MEDICINE STUDY. 
(a) IN GENERAL.—The Secretary shall enter into an 
arrangement with the National Academy of Medicine 
VerDate Sep 11 2014 
01:56 Aug 14, 2021
Jkt 019200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H5030.IH
H5030
kjohnson on DSK79L0C42PROD with BILLS
under which the National Academy agrees to study and 
propose a design for a national interoperable data plat-
form to improve access to health data, and other relevant 
data needs, during public health emergencies. 
(b) REPORT.—The arrangement under subsection (a) 
shall provide for submission by the National Academy of 
Medicine to the Secretary and Congress, not later than 
120 days after the date of enactment of this Act, of a 
report on the results of the study under subsection (a) 
and the design proposed based on such study. 
Æ 
VerDate Sep 11 2014 
01:56 Aug 14, 2021
Jkt 019200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6301
E:\BILLS\H5030.IH
H5030
kjohnson on DSK79L0C42PROD with BILLS