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Notice2023-21239

Request for Information (RFI): Inviting Comments and Suggestions on Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) Including Electronic Health Records, for National Institutes of Health (NIH) Supported Biomedical and Behavioral Research

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Published
September 28, 2023

Issuing agencies

Health and Human Services DepartmentNational Institutes of Health

Abstract

The purpose of this National Institutes of Health (NIH) Request for Information (RFI) is to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research.

Full Text

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<title>Federal Register, Volume 88 Issue 187 (Thursday, September 28, 2023)</title>
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[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66860-66861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21239]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information (RFI): Inviting Comments and Suggestions 
on Opportunities and Challenges for the Collection, Use, and Sharing of 
Real-World Data (RWD) Including Electronic Health Records, for National 
Institutes of Health (NIH) Supported Biomedical and Behavioral Research

AGENCY: National Institutes of Health, HHS.

ACTION: Request for information.

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SUMMARY: The purpose of this National Institutes of Health (NIH) 
Request for Information (RFI) is to solicit public comments on the use 
of Real-World Data (RWD), including Electronic Health Records, for 
Biomedical and Behavioral Research.

DATES: The NIH RFI is open for public comment. To assure consideration, 
your response must be received by December 14, 2023, 11:59 p.m. (ET).

ADDRESSES: All comments must be submitted electronically on the 
submission website at <a href="https://datascience.nih.gov/rfi-rwd">https://datascience.nih.gov/rfi-rwd</a>.
    Responses must be received by 11:59:59 p.m. (ET) on December 14, 
2023.
    Responses to this RFI are voluntary and may be submitted 
anonymously. You may voluntarily include your name and contact 
information with your response. If you choose to provide NIH with this 
information, NIH will not share your name and contact information 
outside of NIH unless required by law.
    Other than your name and contact information, please do not include 
any personally identifiable information or any information that you do 
not wish to make public. Proprietary, classified, confidential, or 
sensitive information should not be included in your response. The 
Government will use the information submitted in response to this RFI 
at its discretion. Other than your name and contact information, the 
Government reserves the right to use any submitted information on 
public websites, in reports, in summaries of the state of the science, 
in any possible resultant solicitation(s), grant(s), or cooperative 
agreement(s), or in the development of future funding opportunity 
announcements. This RFI is for informational and planning purposes only 
and is not a solicitation for applications or an obligation on the part 
of the Government to provide support for any ideas identified in 
response to it. Please note that the Government will not pay for the 
preparation of any information submitted or for use of that 
information.
    We look forward to your input and hope that you will share this RFI 
opportunity with your colleagues.

FOR FURTHER INFORMATION CONTACT: Questions about this request for 
information should be directed to Dr. Susan Gregurick, 301-435-1923, 
<a href="/cdn-cgi/l/email-protection#376560731a45515e77585319595e5f19505841"><span class="__cf_email__" data-cfemail="4b191c0f66392d220b242f65252223652c243d">[email&#160;protected]</span></a>, National Institutes of Health, Office of Data 
Science Strategy, 9000 Rockville Pike, Bethesda, Maryland 20892.

SUPPLEMENTARY INFORMATION: The National Institutes of Health (NIH) is 
requesting public comment on the use of Real World Data (RWD) for NIH 
supported biomedical and behavioral research, including opportunities 
for leveraging the benefits of RWD and strategies for responsible use. 
NIH also seeks to better understand community perspectives on the 
potential value and constraints--including scientific, administrative, 
legal, business, and bioethical--for the greater use of RWD in NIH-
sponsored biomedical and behavioral research. This request for 
information (RFI) is in accordance with 42 U.S.C. 281 as amended.

Background

    Researchers are increasingly using data collected in real-world 
settings to augment traditional research studies, as well as develop 
more effective treatments and interventions for patients. These ``real-
world data (RWD)'', defined by the U.S. Food and Drug Administration, 
are data relating to patient health status and/or the delivery of 
health care routinely collected from a variety of sources. Examples of 
RWD include data derived from electronic health records, medical claims 
data, data from product or disease registries, and data gathered from 
other sources (such as digital health technologies) that can inform on 
health status. While these data hold tremendous promise for biomedical 
and behavioral research, they can be collected from a variety of 
sources through multiple mechanisms, creating challenges for 
researchers and questions for those whose data are being shared.
    Importantly, NIH is committed to ensuring participant privacy and 
autonomy are protected in all NIH-supported research. As NIH 
establishes health-related research data platforms that include access 
to RWD, NIH continues to prioritize maximizing data access while 
upholding participant preferences regarding the collection and use of 
their data. Most recently, through the Advisory Committee to the NIH 
Director, (<a href="https://www.acd.od.nih.gov/index.html">https://www.acd.od.nih.gov/index.html</a>), NIH staff met with 
stakeholders to better understand their perspectives on benefits and 
risks of combining and using human datasets, particularly from 
disparate sources (e.g., research and non-research settings) and how 
their data should be used in biomedical and behavioral research. NIH 
will continue working to incorporate these perspectives in its research 
studies to build trust and honor participant preferences. Input 
requested on this RFI will be used to inform NIH's continuing 
development of guidance on the use of RWD for research and assist in 
the planning for appropriate mechanisms and programs for research with 
RWD.

Information Requested

    NIH is requesting public comment on the use of RWD for NIH-
supported biomedical and behavioral research, including opportunities 
for leveraging the benefits of RWD and strategies for its responsible 
use. NIH also seeks to better understand community perspectives on the 
potential value and constraints--including scientific, administrative, 
legal, business, and bioethical--for the increased use of RWD in 
biomedical and behavioral research.
    Response to this RFI is voluntary and may be submitted anonymously. 
Respondents are free to address any or all topics listed below, as well 
as other relevant topics, for NIH's consideration.
    1. Scientific value and quality considerations for collection, use, 
and sharing of RWD in biomedical and behavioral research. NIH seeks 
broad input on how RWD is acquired and used in NIH-funded research, the 
demonstrated and anticipated value of RWD in research, and 
opportunities and challenges related to data standards and quality, 
representativeness, and potential biases for using RWD in research. 
Additionally, NIH is seeking information on:
    (a) Biomedical and behavioral research questions that could be 
investigated using RWD, including novel unanticipated insights that 
have been enabled by using RWD in research.
    (b) Barriers to using RWD in research, such as bias, 
underrepresentation of populations in data, and technical

[[Page 66861]]

issues of data harmonization and linkage.
    2. Using RWD as part of the scientific paradigm, including open 
science, scientific rigor and reproducibility, and team science. NIH 
seeks broad input on the opportunities and challenges related to using 
RWD as part of the scientific process.
    (a) Approaches or methods for using RWD in collaborative teams and 
ensuring reproducibility.
    (b) How do researchers assess the validation and verification of 
RWD data that is used in research.
    (c) Appropriate open science practices and use of the FAIR 
principles (<a href="https://www.nature.com/articles/sdata201618">https://www.nature.com/articles/sdata201618</a>) for research 
using RWD and approaches for maximizing appropriate data sharing when 
expected by the NIH Policy for Data Management and Sharing (<a href="https://sharing.nih.gov/data-management-and-sharing-policy">https://sharing.nih.gov/data-management-and-sharing-policy</a>) or other policies.
    3. Administrative and logistical considerations for collecting, 
using, and sharing RWD for biomedical and behavioral research. NIH 
seeks broad input on the opportunities and challenges related to the 
process of acquiring, using, and making RWD available for biomedical 
and behavioral research, including:
    (a) Pros and cons of various approaches for obtaining RWD through 
algorithms, purchasing RWD through trusted parties, accessing RWD 
through secure enclaves, etc.
    (b) Considerations regarding licensing, costs, third party 
involvement, and restrictions for data use and sharing.
    (c) Availability/utility of emerging de-identification technologies 
and data storage/sharing considerations.
    4. Ethical considerations for using RWD for biomedical and 
behavioral research. NIH seeks broad input on the opportunities and 
challenges related to potential bioethical issues regarding the 
collection, use, and sharing of RWD, including:
    (a) Strategies for protecting participant privacy and autonomy.
    (b) Potential re-identification risks for RWD, including the 
technical feasibility of re-identifying linked data and the possibility 
of anonymity for patients, research participants, and their families.
    (c) Ethical implications of data as a ``commodity'', in terms of 
buying and selling personal health data.
    This RFI is for planning purposes only and should not be construed 
as a solicitation for applications or proposals, or as an obligation in 
any way on the part of the United States Government. The Government 
will not pay for the preparation of any information submitted or for 
the Government's use. Additionally, the Government cannot guarantee the 
confidentiality of the information provided.

    Dated: September 21, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-21239 Filed 9-27-23; 8:45 am]
BILLING CODE 4140-01-P


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