H. R. 2617—1406 
(c) REPORT.—Not later than 180 days after the close of the 
public comment period for each public workshop convened under 
this section, the Secretary shall make available on the public 
website of the Food and Drug Administration a report on the 
topics discussed at such workshop. The report shall include a sum-
mary of topics and responses to any recommendations raised in 
such workshop. 
SEC. 3604. ANNUAL SUMMARY REPORT ON PROGRESS TO INCREASE 
DIVERSITY IN CLINICAL STUDIES. 
(a) IN GENERAL.—Beginning not later than 2 years after the 
date of enactment of this Act, and each year thereafter, the Sec-
retary shall submit to the Congress, and publish on the public 
website of the Food and Drug Administration, a report that— 
(1) summarizes, in aggregate, the diversity action plans 
received pursuant to section 505(z) or 520(g)(9) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 3601; and 
(2) contains information, in the aggregate, on— 
(A) for drugs, biological products, and devices approved, 
licensed, cleared, or classified under section 505, 515, 
510(k), or 513(f)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355; 360e; 360(k); and 360(f)(2)), or section 
351(a) of the Public Health Service Act (42 U.S.C. 262(a)), 
whether the clinical studies conducted with respect to such 
applications met the demographic subgroup enrollment 
goals from the diversity action plan submitted for such 
applications; and 
(B) the reasons provided, if any, for why enrollment 
goals from submitted diversity action plans were not met. 
(b) CONFIDENTIALITY.—Nothing in this section shall be con-
strued as authorizing the Secretary to disclose any information 
that is a trade secret or confidential information subject to section 
552(b)(4) of title 5, United States Code, or section 1905 of title 
18, United States Code. 
SEC. 3605. PUBLIC MEETING ON CLINICAL STUDY FLEXIBILITIES INITI-
ATED IN RESPONSE TO COVID–19 PANDEMIC. 
(a) IN GENERAL.—Not later than 180 days after the date on 
which the COVID–19 emergency period ends, the Secretary shall 
convene a public meeting to discuss the recommendations provided 
by the Food and Drug Administration during the COVID–19 emer-
gency period to mitigate disruption of clinical studies, including 
recommendations detailed in the guidance entitled ‘‘Conduct of Clin-
ical Trials of Medical Products During the COVID–19 Public Health 
Emergency, Guidance for Industry, Investigators, and Institutional 
Review Boards’’, as updated on August 8, 2021, and by any subse-
quent updates to such guidance. The Secretary shall invite to such 
meeting representatives from the pharmaceutical and medical 
device industries who sponsored clinical studies during the COVID– 
19 emergency period and organizations representing patients. 
(b) TOPICS.—Not later than 90 days after the date on which 
the public meeting under subsection (a) is convened, the Secretary 
shall make available on the public website of the Food and Drug 
Administration a report on the topics discussed at such meeting. 
Such topics shall include discussion of— 
(1) the actions sponsors took to utilize such recommenda-
tions and the frequency at which such recommendations were 
employed;
H. R. 2617—1407 
(2) the characteristics of the sponsors, studies, and patient 
populations impacted by such recommendations; 
(3) a consideration of how recommendations intended to 
mitigate disruption of clinical studies during the COVID–19 
emergency period, including any recommendations to consider 
decentralized clinical studies when appropriate, may have 
affected access to clinical studies for certain patient populations, 
especially unrepresented or underrepresented racial and ethnic 
minorities; and 
(4) recommendations for incorporating certain clinical study 
disruption mitigation recommendations into current or addi-
tional guidance to improve clinical study access and enrollment 
of diverse patient populations. 
(c) COVID–19 EMERGENCY PERIOD DEFINED.—In this section, 
the term ‘‘COVID–19 emergency period’’ has the meaning given 
the term ‘‘emergency period’’ in section 1135(g)(1)(B) of the Social 
Security Act (42 U.S.C. 1320b–5(g)(1)(B)). 
SEC. 3606. DECENTRALIZED CLINICAL STUDIES. 
(a) GUIDANCE.—The Secretary shall— 
(1) not later than 1 year after the date of enactment of 
this Act, issue or revise draft guidance that includes rec-
ommendations to clarify and advance the use of decentralized 
clinical studies to support the development of drugs and devices, 
including recommendations for how to advance the use of 
flexible and novel clinical trial designs and to help improve 
trial participant engagement, recruitment, enrollment, and 
retention of a meaningfully diverse clinical population, 
including with respect to race, ethnicity, age, sex, and 
geographic location, when appropriate; and 
(2) not later than 1 year after closing the comment period 
on such draft guidance, finalize such guidance. 
(b) CONTENT OF GUIDANCE.—The guidance under subsection 
(a) shall address the following: 
(1) Recommendations related to digital health technology 
or other assessment options, such as telehealth, local labora-
tories, local health care providers, or other options for remote 
data collection, could support decentralized clinical studies, 
including guidance on considerations for selecting technological 
platforms and mediums, data collection and use, data integrity 
and security, and communication to study participants through 
digital technology. 
(2) Recommendations for subject recruitment, retention, 
and engagement, including considerations for sponsors to mini-
mize or reduce burdens for clinical study participants through 
the use of digital health technology, telehealth, local health 
care providers and laboratories, health care provider home 
visits, direct-to-participant engagement, electronic informed 
consent, or other means, as appropriate. 
(3) Recommendations with respect to the evaluation of 
data collected within a decentralized clinical study setting. 
(4) Recommendations for methods of remote data collection, 
including clinical trial participant experience data, through the 
use of digital health technologies, telemedicine, local labora-
tories, local health care providers, or other options for data 
collection.
H. R. 2617—1408 
(5) Considerations for sponsors to minimize or reduce bur-
dens for clinical trial participants associated with participating 
in a clinical trial, such as the use of digital technologies, tele-
medicine, local laboratories, local health care providers, or other 
data collection or assessment options, health care provider home 
visits, direct-to-participant shipping of investigational drugs 
and devices, and electronic informed consent, as appropriate. 
(6) Recommendations regarding conducting decentralized 
clinical trials to facilitate and encourage meaningful diversity 
among clinical trial participants, including with respect to race, 
ethnicity, age, sex, and geographic location, as appropriate. 
(7) Recommendations for strategies and methods for 
recruiting, retaining, and engaging with clinical trial partici-
pants, including communication regarding the role of clinical 
trial participants and community partners to facilitate clinical 
trial recruitment and engagement, including with respect to 
diverse and underrepresented populations, as appropriate. 
(8) Considerations for review and oversight by sponsors 
and institutional review boards, including remote trial over-
sight. 
(9) Recommendations for decentralized clinical trial pro-
tocol designs and processes for evaluating such proposed clinical 
trial designs. 
(10) Recommendations related to digital health technology 
and other remote assessment tools that may support decentral-
ized clinical trials, including guidance on appropriate techno-
logical platforms and tools, data collection and use, data integ-
rity, and communication to clinical trial participants through 
such technology. 
(11) A description of the manner in which the Secretary 
will assess or evaluate data collected within a decentralized 
clinical trial to support the development of the drug or device, 
if the manner is different from that used for a nondecentralized 
trial. 
(12) Considerations for sponsors to validate digital tech-
nologies and establish appropriate clinical endpoints for use 
in decentralized trials. 
(13) Considerations for privacy and security of personally 
identifiable information of trial participants. 
(14) Considerations for conducting clinical trials using cen-
tralized 
approaches 
in 
conjunction 
with 
decentralized 
approaches. 
(c) DEFINITION.—In this section, the term ‘‘decentralized clinical 
study’’ means a clinical study in which some or all of the study- 
related activities occur at a location separate from the investigator’s 
location. 
SEC. 3607. MODERNIZING CLINICAL TRIALS. 
(a) CLARIFYING THE USE OF DIGITAL HEALTH TECHNOLOGIES 
IN CLINICAL TRIALS.— 
(1) IN
GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary shall issue or revise 
draft guidance regarding the appropriate use of digital health 
technologies in clinical trials to help improve recruitment for, 
retention in, participation in, and data collection during, clinical 
trials, and provide for novel clinical trial designs utilizing such 
technology for purposes of supporting the development of, and
H. R. 2617—1409 
review of applications for, drugs and devices. Not later than 
18 months after the public comment period on such draft guid-
ance ends, the Secretary shall issue a revised draft guidance 
or final guidance. 
(2) CONTENT.—The guidance described in paragraph (1) 
shall include— 
(A) recommendations for data collection methodologies 
by which sponsors may incorporate the use of digital health 
technologies in clinical trials to collect data remotely from 
trial participants; 
(B) considerations for privacy and security protections 
for data collected during a clinical trial, including— 
(i) recommendations for the protection of trial 
participant data that are collected or used in research 
using digital health technologies; 
(ii) compliance with the regulations promulgated 
under section 264(c) of the Health Insurance Port-
ability and Accountability Act of 1996 (42 U.S.C. 
1320d–2 note), subpart B of part 50 of title 21, Code 
of Federal Regulations, subpart C of part 56 of title 
21, Code of Federal Regulations, the Federal policy 
for the protection of human subjects under subpart 
A of part 46 of title 45, Code of Federal Regulations 
(commonly known as the ‘‘Common Rule’’), and part 
2 of title 42, Code of Federal Regulations (or any 
successor regulations); and 
(iii) recommendations for the protection of clinical 
trial participant data against cybersecurity threats, as 
applicable; 
(C) considerations on data collection methods to help 
increase recruitment of clinical trial participants and the 
level of participation of such participants, reduce burden 
on clinical trial participants, and optimize data quality; 
(D) recommendations for the use of electronic methods 
to obtain informed consent from clinical trial participants, 
taking into consideration applicable Federal law, including 
subpart B of part 50 of title 21, Code of Federal Regulations 
(or successor regulations), and, as appropriate, State law; 
(E) best practices for communication between sponsors 
and the Secretary on the development of data collection 
methods; 
(F) the appropriate format to submit such data to 
the Secretary; 
(G) a description of the manner in which the Secretary 
may assess or evaluate data collected through digital health 
technologies to support the development of the drug or 
device; 
(H) recommendations regarding the data and informa-
tion needed to demonstrate that a digital health technology 
is fit-for-purpose for a clinical trial, and a description of 
how the Secretary will evaluate such data and information; 
and 
(I) recommendations for increasing access to, and the 
use of, digital health technologies in clinical trials to facili-
tate the inclusion of diverse and underrepresented popu-
lations, as appropriate, including considerations for access