National Cybersecurity Center of Excellence (NCCoE) Wireless Medical Infusion Pumps Use Case for the Health Care Sector, 4016-4018 [2016-01344]

Download as PDF 4016 Notices Federal Register Vol. 81, No. 15 Monday, January 25, 2016 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF COMMERCE Bureau of Industry and Security Proposed Information Collection; Comment Request; National Security and Critical Technology Assessments of the U.S. Industrial Base Bureau of Industry and Security, Commerce. ACTION: Notice. AGENCY: The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. DATES: Written comments must be submitted on or before March 25, 2016. ADDRESSES: Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at JJessup@doc.gov). FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection instrument and instructions should be directed to Mark Crace, BIS ICB Liaison, (202) 482–8093, Mark.Crace@ bis.doc.gov. The link below clarifies the policies and procedures of the Bureau of Industry and Security (BIS) for conducting surveys to obtain information in order to perform industry studies assessing the U.S. industrial base to support the national defense pursuant to the Defense Production Act of 1950, as amended. https:// www.federalregister.gov/articles/2015/ 07/15/2015-17388/us-industrial-basesurveys-pursuant-to-the-defenseproduction-act-of-1950 SUPPLEMENTARY INFORMATION: asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 13:09 Jan 22, 2016 Jkt 238001 I. Abstract The Department of Commerce, in coordination with the Department of Defense and other Federal agencies, conducts survey assessments of U.S. industrial base sectors deemed critical to U.S. national security. The information gathered is necessary to determine the health and competitiveness as well as the needs of these critical market segments in order to maintain a strong U.S. industrial base. II. Method of Collection Submitted electronically. III. Data OMB Control Number: 0694–0119. Form Number(s): N/A. Type of Review: Regular submission extension. Affected Public: Business or other forprofit organizations. Estimated Number of Respondents: 28,000. Estimated Time per Response: 8 to 14 hours per response. Estimated Total Annual Burden Hours: 308,000 hours. Estimated Total Annual Cost to Public: $0. IV. Request for Comments Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record. Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer. [FR Doc. 2016–01338 Filed 1–22–16; 8:45 am] BILLING CODE 3510–33–P PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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 National Institute of Standards and Technology, Department of Commerce. ACTION: Notice. AGENCY: 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 HIT_NCCoE@nist.gov; 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 SUMMARY: E:\FR\FM\25JAN1.SGM 25JAN1 Federal Register / Vol. 81, No. 15 / Monday, January 25, 2016 / Notices 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/nccoeconsortium-crada-example. FOR FURTHER INFORMATION CONTACT: Gavin O’Brien via email at HIT_ NCCoE@nist.gov; 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 13:09 Jan 22, 2016 Jkt 238001 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. 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 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/GeneralHospital DevicesandSupplies/InfusionPumps/. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 4017 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 E:\FR\FM\25JAN1.SGM 25JAN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 4018 Federal Register / Vol. 81, No. 15 / Monday, January 25, 2016 / Notices 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 VerDate Sep<11>2014 13:09 Jan 22, 2016 Jkt 238001 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 DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648–XE370 Fisheries of the Exclusive Economic Zone off Alaska; Application for an Exempted Fishing Permit National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice; receipt of application for exempted fishing permit. AGENCY: This notice announces receipt of an exempted fishing permit (EFP) application from the Alaska Seafood Cooperative (AKSC) and co-applicants. If granted, this EFP would allow the applicants to remove halibut from a trawl codend on the deck, and release those fish back to the water in a timely manner to increase survivability. These halibut would be sampled by NMFStrained observers for length and physical condition using standard International Pacific Halibut Commission (IPHC) halibut mortality assessment methods. The objectives of the EFP application are to (1) test methods for sorting halibut on deck for suitability as an allowable fish handling mode for the non-pollock catcher/ processor trawl fisheries (Amendment 80, community development quota (CDQ), and trawl limited access) in the Bering Sea and Aleutian Islands under an eventual regulated program; (2) simplify and improve on elements that worked under a 2015 deck sorting EFP project; and (3) address challenges and issues that arose in the 2015 EFP. This experiment has the potential to promote the objectives of the Magnuson-Stevens SUMMARY: PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 Fishery Conservation and Management Act and the Northern Pacific Halibut Act. DATES: Comments on this EFP application must be submitted to NMFS on or before February 9, 2016. The North Pacific Fishery Management Council (Council) will consider the application at its meeting from February 1, 2016, through February 9, 2016, in Portland, OR. ADDRESSES: The Council meeting will be held at the Benson Hotel, 309 SW Broadway, Portland, OR 97205. The agenda for the Council meeting is available at http://www.npfmc.org. You may submit comments on this document, identified by NOAA–NMFS– 2015–0162, by any of the following methods: • Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/ #!docketDetail;D=NOAA-NMFS-20150162, click the ‘‘Comment Now!’’ icon, complete the required fields, and enter or attach your comments. • Mail: Submit written comments to Glenn Merrill, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS, Attn: Ellen Sebastian. Mail comments to P.O. Box 21668, Juneau, AK 99802–1668. Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address) submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter ‘‘N/A’’ in the required fields if you wish to remain anonymous). Electronic copies of the EFP application and the basis for a categorical exclusion under the National Environmental Policy Act are available from the Alaska Region, NMFS Web site at http://alaskafisheries.noaa.gov/. The June 2014 IPHC Report is available from the Council Web site at http://www.npfmc.org. FOR FURTHER INFORMATION CONTACT: Julie Scheurer, 907–586–7111. SUPPLEMENTARY INFORMATION: NMFS manages the domestic groundfish fisheries in the Bering Sea and Aleutian Islands management area (BSAI) under the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP), which the Council prepared E:\FR\FM\25JAN1.SGM 25JAN1

Agencies

[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 
HIT_NCCoE@nist.gov; 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 
HIT_NCCoE@nist.gov; 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