[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4544-4545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02519]
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NATIONAL SCIENCE FOUNDATION
Request for Information: Action on Interoperability of Medical
Devices, Data, and Platforms To Enhance Patient Care
AGENCY: Networking and Information Technology Research and Development
(NITRD) National Coordination Office (NCO), National Science
Foundation.
ACTION: Notice of request for information.
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SUMMARY: The NITRD Health Information Technology Research and
Development Interagency Working Group (HITRD IWG) requests input to
collect information on new approaches from industry, academia, and non-
governmental organizations, to solve the interoperability issues
between medical devices, data, and platforms.
DATES: Interested persons are invited to submit comments on or before
11:59 p.m. (ET) on March 15, 2019.
FOR FURTHER INFORMATION CONTACT: Alex Thai at (202) 459-9674 or [email protected], or by post mailing to 2415 Eisenhower Avenue,
Alexandria, VA 22314 USA. Individuals who use a telecommunications
device for the deaf (TDD) may call the Federal Information Relay
Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern
time, Monday through Friday.
ADDRESSES: Comments submitted in response to this notice may be sent by
any of the following methods:
Email: [email protected]. Email submissions should be machine-
readable and not be copy-protected. Submission should include ``RFI
Response: Action on Interoperability of Medical Devices, Data, and
Platforms to Enhance Patient Care'' in the subject line of the message.
Fax: (202) 459-9673, Attn: Alex Thai; or
Mail: Attn: Alex Thai, NCO, 2415 Eisenhower Avenue, Alexandria, VA
22314 USA.
SUPPLEMENTARY INFORMATION:
Purpose: There is ongoing recognition that medical device
interoperability is an issue and has a documented impact on patient
care and safety. These issues persist despite previous government
efforts by the Food and Drug Administration, the Department of Defense,
the Veterans Administration, the National Institute of Standards and
Technology, the National Institutes of Health, and the National Science
Foundation. The goal of this effort is to determine whether a vision of
sustained interoperability in the hospital and into the community is
feasible and, if so, what it will take to realize it. In addition, this
RFI looks to examine how users might leverage the existing tools and
processes for implementing this shared future vision. Please address
the following in your response.
(1) What is your vision for addressing interoperability issues
between medical devices, data, and platforms? How would this plan to
create interoperable systems address your key use cases and pain
points?
(2) Who are the relevant parties and their contributions to your
interoperability solution?
(3) What are the challenges and impediments to making
interoperability happen? How might these issues be addressed and by
whom?
(4) Is the federal vision for a medical device, data, and platform
interoperability end state outlined in this RFI viable? Please explain
why you have reached the conclusion that you have.
Instructions: Response to this RFI is voluntary. Each individual or
institution is requested to submit only one response. Submissions must
not exceed 20 pages in 12 point or larger font, with a page number
provided on each page. Responses should include the following: Name of
the individual(s) or organization(s) filing the comment; a description
of the individual(s) or organization(s) mission and/or expertise; non-
proprietary public-private partnership work within the past three years
with Federal, State, or local governments that is relevant to applied
research on interoperability on data, platforms, and medical devices;
and an Executive Summary for comments exceeding 15 pages.
Responses to this RFI may be posted online at http://www.nitrd.gov.
Please do not include any confidential, proprietary, or sensitive
information that you do not wish to be made public. Submissions are
subject to the Freedom of Information Act (FOIA).
In accordance with FAR 15.202(3), responses to this notice are not
offers and cannot be accepted by the Government to form a binding
contract. Responders are solely responsible for all expenses associated
with responding to this RFI.
Overview: Medical devices, electronic health records, and the data
generated and stored in these systems are essential to the practice and
advancement of modern medicine and healthcare. While healthcare systems
are rife with medical devices and the data they produce, to date, these
devices are not interoperable and cannot effectively interact with each
other and the broader healthcare ecosystem. With interoperability
[[Page 4545]]
between medical devices and systems enabled, new models for monitoring,
device interaction, and control--including the development of closed
loop, autonomous and semiautonomous systems--can be realized. These new
models will provide greater support for patient safety, decrease
medical errors, reduce provider burden, reduce practice variability
across healthcare facilities/geographic areas and, ultimately, will
enhance medical care quality and outcomes.
Future Vision: When people with serious injuries or illness are
hospitalized medical device additions and changes are automatically
recorded with no deficit in patient safety, loss in data fidelity, or
data security as the patient transitions across the continuum of care.
Additional medical devices can be added or removed as the patient's
status changes and details of these changes, calibration of the
instruments, and each equipment's unique device identifier [UDI] and
configuration settings are recorded and synchronized. If a piece of
equipment breaks, it can be switched seamlessly with a device from
another vendor. Data and settings from patient medical devices, such as
insulin pumps, are identified, integrated, and time synchronized, and
select data are included in the electronic health record. As autonomous
capabilities are added, real-time care is logged, and supervisory
control established to ensure the provision of real-time patient
monitoring and support. When providers are not available, or have
competing demands, medical devices will function in a closed loop,
autonomous manner with appropriate safety and control measures to
stabilize the patient. Data will flow through changes in equipment that
occur in moves from the emergency room, to the operating room, to the
intensive care unit, to a rehabilitation facility, and finally to the
home. This will allow for data and metadata to flow even as changes in
equipment are mapped to individual patient needs and environment. Each
change in equipment configuration will be noted in the supervisory
system/medical record and in the metadata (e.g., the UDI) generated by
the device. The resulting patient record from these systems will
include device data, metadata, and care documentation. These patient
records can be stored and analyzed using medical black box recorder-
equivalents to assess adverse events or examine unexpected positive
outcomes. This will also improve the consistency and quality of care;
create real-time automated care systems; create a learning health
system.
These types of records and the real-time systems interactions they
enable are widely used or are being actively developed in other
industries, such as the industrial controls and autonomous systems in
the automotive, aviation, and energy sectors. That is not the case for
healthcare. While there are many factors that may inhibit real-time
interaction in a medical setting, interoperability solutions that are
relevant for healthcare and patient safety need to be developed.
Seamlessly flowing, interoperable data from medical devices and
systems, when utilized effectively, could significantly enhance patient
outcomes, identify and reduce errors, enhance the efficiency of care
delivery, reduce development times and costs, improve standardization/
consistency of care delivery, and decrease healthcare provider burnout.
Next Steps: The Government anticipates hosting a conference in
June/July 2019 to allow for additional engagement. The results of the
conference discussion, in addition to the written responses to this
RFI, will be used to determine next steps in addressing federal efforts
in interoperability of data, platforms, and medical devices. This RFI
is solely issued to engage with interested parties to inform the
Government on developing a strategy for medical device, data, and
platform interoperability. The Government will not reimburse costs
associated with participating in the conference. The Government may
contact respondents regarding their submissions, such as to ask
questions, to learn more, or to notify them of further developments
related to the effort.
Submitted by the National Science Foundation in support of the
Networking and Information Technology Research and Development (NITRD)
National Coordination Office (NCO) on February 11, 2019.
Suzanne H. Plimpton,
Reports Clearance Officer, National Science Foundation.
[FR Doc. 2019-02519 Filed 2-14-19; 8:45 am]
BILLING CODE 7555-01-P