[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