[Federal Register Volume 81, Number 15 (Monday, January 25, 2016)]
[Notices]
[Pages 4016-4018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01344]


-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

[Docket No.: 151217999-5999-01]
RIN 0693-XC058


National Cybersecurity Center of Excellence (NCCoE) Wireless 
Medical Infusion Pumps Use Case for the Health Care Sector

AGENCY: National Institute of Standards and Technology, Department of 
Commerce.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institute of Standards and Technology (NIST) 
invites organizations to provide products and technical expertise to 
support and demonstrate security platforms for the Wireless Medical 
Infusion Pumps use case for the health care sector. This notice is the 
initial step for the National Cybersecurity Center of Excellence 
(NCCoE) in collaborating with technology companies to address 
cybersecurity challenges identified under the Health Care Sector 
program. Participation in the use case is open to all interested 
organizations.

DATES: Interested parties must contact NIST to request a letter of 
interest template to be completed and submitted to NIST. Letters of 
interest will be accepted on a first come, first served basis. 
Collaborative activities will commence as soon as enough completed and 
signed letters of interest have been returned to address all the 
necessary components and capabilities, but no earlier than February 24, 
2016. When the use case has been completed, NIST will post a notice on 
the NCCoE Health Care Sector program Web site at https://nccoe.nist.gov/projects/use_cases/health_it announcing the completion 
of the use case and informing the public that it will no longer accept 
letters of interest for this use case.

ADDRESSES: The NCCoE is located at 9700 Great Seneca Highway, 
Rockville, MD 20850. Letters of interest must be submitted to 
[email protected]; or via hardcopy to National Institute of Standards 
and Technology, NCCoE; 100 Bureau Drive, MS 2002, Gaithersburg, MD, 
20899. Organizations whose letters of interest are accepted in 
accordance with the process set forth in the SUPPLEMENTARY INFORMATION 
section of

[[Page 4017]]

this notice will be asked to sign a Cooperative Research and 
Development Agreement (CRADA) with NIST. A CRADA template can be found 
at: https://nccoe.nist.gov/library/nccoe-consortium-crada-example.

FOR FURTHER INFORMATION CONTACT: Gavin O'Brien via email at 
[email protected]; by telephone 240-314-6815; or by mail to National 
Institute of Standards and Technology, NCCoE; 100 Bureau Drive, MS 
2002, Gaithersburg, MD, 20899. Additional details about the NCCoE 
Health Care Sector program are available at https://nccoe.nist.gov/projects/use_cases/health_it.

SUPPLEMENTARY INFORMATION: 
    Background: The NCCoE, part of NIST, is a public-private 
collaboration for accelerating the widespread adoption of integrated 
cybersecurity tools and technologies. The NCCoE brings together experts 
from industry, government, and academia under one roof to develop 
practical, interoperable cybersecurity approaches that address the 
real-world needs of complex Information Technology (IT) systems. By 
accelerating dissemination and use of these integrated tools and 
technologies for protecting IT assets, the NCCoE will enhance trust in 
U.S. IT communications, data, and storage systems; reduce risk for 
companies and individuals using IT systems; and encourage development 
of innovative, job-creating cybersecurity products and services.
    Process: NIST is soliciting responses from all sources of relevant 
security capabilities (see below) to enter into a Cooperative Research 
and Development Agreement (CRADA) to provide products and technical 
expertise to support and demonstrate security platforms for the 
Wireless Medical Infusion Pumps use case for the health care sector. 
The full use case can be viewed at: https://nccoe.nist.gov/projects/use_cases/health_it.
    Interested parties should contact NIST using the information 
provided in the FOR FURTHER INFORMATION CONTACT section of this notice. 
NIST will then provide each interested party with a letter of interest 
template, which the party must complete, certify that it is accurate, 
and submit to NIST. NIST will contact interested parties if there are 
questions regarding the responsiveness of the letters of interest to 
the use case objective or requirements identified below. NIST will 
select participants who have submitted complete letters of interest on 
a first come, first served basis within each category of product 
components or capabilities listed below up to the number of 
participants in each category necessary to carry out this use case. 
However, there may be continuing opportunity to participate even after 
initial activity commences. Selected participants will be required to 
enter into a consortium CRADA with NIST (for reference, see ADDRESSES 
section above). NIST published a notice in the Federal Register on 
October 19, 2012 (77 FR 64314) inviting U.S. companies to enter into 
National Cybersecurity Excellence Partnerships (NCEPs) in furtherance 
of the NCCoE. For this demonstration project, NCEP partners will not be 
given priority for participation.
    Use Case Objective: In the past, medical devices were standalone 
instruments that interacted only with the patient. Today, medical 
devices have operating systems and communication hardware that allow 
them to connect to networks and other devices. While this technology 
has created more powerful tools and improved health care, it has led to 
additional risks in safety and security.
    The goal of this use case is to help health care providers secure 
their medical devices on an enterprise network, with a specific focus 
on wireless infusion pumps.\1\ This use case begins the process to 
identify the actors interacting with infusion pumps, define the 
interactions between the actors and the system, perform a risk 
assessment, identify applicable mitigating security technologies, and 
provide an example implementation.
---------------------------------------------------------------------------

    \1\ For purposes of this notice, NIST is adopting the definition 
of external infusion pumps provided on the Food and Drug 
Administration (FDA) Protecting and Promoting Your Health Web site 
as: ``Medical devices that deliver fluids, including nutrients and 
medications such as antibiotics, chemotherapy drugs, and pain 
relievers, into a patient's body in controlled amounts. Many types 
of pumps, including large volume, patient-controlled analgesia, 
elastomeric, syringe, enteral, and insulin pumps, are used worldwide 
in health care facilities such as hospitals, and in the home.'' 
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/.
---------------------------------------------------------------------------

    Clinicians and patients rely on infusion pumps for safe and 
accurate administration of fluids and medications. However, the FDA has 
identified problems that can compromise the safe use of external 
infusion pumps. These issues can lead to over or under-infusion, missed 
treatments, or delayed therapy.
    The publication of the use case is merely the beginning of a 
process that will identify research participants and components of a 
laboratory environment to identify, evaluate and test relevant security 
tools and controls. The approach may include: risk assessment and 
analysis, logical design, build development, test & evaluation and 
security control mapping. The output of the process will be the 
publication of a multi-part Practice Guide to assist the community in 
evaluating the security environment surrounding their infusion pumps 
deployed in a clinical setting.
    A detailed description of the Wireless Medical Infusion Pumps use 
case is available at https://nccoe.nist.gov/projects/use_cases/health_it
    Requirements: Each responding organization's letter of interest 
should identify which security platform component(s) or capability(ies) 
it is offering. Letters of interest should not include company 
proprietary information, and all components and capabilities must be 
commercially available. Components are listed in section two of the 
Wireless Medical Infusion Pumps use case (for reference, please see the 
link in the PROCESS section above) and include, but are not limited to:

1. Wireless infusion pump
2. Pump server
3. Network
4. Alarm manager
5. Electronic medication administration record (eMAR)
6. Point of care medication system
7. In hospital pharmacy system
8. Computerized physician order entry (CPOE)
9. IT security system
10. Network security system
11. Credentialing/credentialing server
12. Asset management and monitoring systems

Each responding organization's letter of interest should identify how 
their products address one or more of the following desired solution 
characteristics in the Security Control Map section of the Wireless 
Medical Infusion Pumps use case (for reference, please see the link in 
the PROCESS section above):

1. Automatic logoff
2. Audit controls
3. Authorization
4. Configuration of security features
5. Cybersecurity product upgrades
6. Data backup and disaster recovery
7. Emergency access
8. Health data de-identification
9. Health data integrity and authenticity
10. Malware detection/protection
11. Node authentication
12. Person authentication
13. Physical locks and devices
14. Security guides
15. System and application hardening
16. Third-party components in product lifecycle roadmaps
17. Health data storage confidentiality

[[Page 4018]]

18. Transmission confidentiality
19. Transmission integrity

Responding organizations need to understand and, in their letters of 
interest, commit to provide:
    1. Access for all participants' project teams to component 
interfaces and the organization's experts necessary to make functional 
connections among security platform components.
    2. Support for development and demonstration of the Wireless 
Medical Infusion Pump capability in NCCoE facilities which will be 
conducted in a manner consistent with Federal requirements (e.g., FIPS 
200, FIPS 201, SP 800-53, and SP 800-63).
    Additional details about the Wireless Medical Infusion Pumps use 
case for the Health care sector are available at https://nccoe.nist.gov/projects/use_cases/health_it. NIST cannot guarantee that 
all of the products proposed by respondents will be used in the 
demonstration. Each prospective participant will be expected to work 
collaboratively with NIST staff and other project participants under 
the terms of the consortium CRADA in the development of the Wireless 
Medical Infusion Pump capability. Prospective participants' 
contribution to the collaborative effort will include assistance in 
establishing the necessary interface functionality, connection and set-
up capabilities and procedures, demonstration harnesses, environmental 
and safety conditions for use, integrated platform user instructions, 
and demonstration plans and scripts necessary to demonstrate the 
desired capabilities. Each participant will train NIST personnel, as 
necessary, to operate its product in capability demonstrations to the 
health care community. Following successful demonstrations, NIST will 
publish a description of the security platform and its performance 
characteristics sufficient to permit other organizations to develop and 
deploy security platforms that meet the security objectives of the 
Wireless Medical Infusion Pumps use case. These descriptions will be 
public information.
    Under the terms of the consortium CRADA, NIST will support 
development of interfaces among participants' products by providing IT 
infrastructure, laboratory facilities, office facilities, collaboration 
facilities, and staff support to component composition, security 
platform documentation, and demonstration activities.
    The dates of the demonstration of the Wireless Medical Infusion 
Pump capability will be announced on the NCCoE Web site at least two 
weeks in advance at https://nccoe.nist.gov/. The expected outcome of 
the demonstration is to improve wireless medical infusion pumps across 
an entire health care sector enterprise. Participating organizations 
will gain from the knowledge that their products are interoperable with 
other participants' offerings.
    For additional information on the NCCoE governance, business 
processes, and NCCoE operational structure, visit the NCCoE Web site 
https://nccoe.nist.gov/.

Richard Cavanagh,
Acting Associate Director for Laboratory Programs.
[FR Doc. 2016-01344 Filed 1-22-16; 8:45 am]
BILLING CODE 3510-13-P