Nerve Integrity Monitor (NIMs)

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website:	Go to site
Description:	Medtronic Nerve Integrity Monitor (NIMs) Response System is a technology that notifies users in real time of nerve conditions visually and audibly. This technology will increases operative efficiency and precision while reducing the risk of intraoperative nerve damage and the amount of time needed to identify motor nerves. This technology also assist surgeons to identify the site of nerve injury, helping to inform surgical decisions. This technology does not utilize a database. Note: This evaluation covers only the software associated with the hardware, and not the hardware itself.
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:	This technology has not been assessed by the Section 508 Office. The Implementer of this technology has the responsibility to ensure the version deployed is 508-compliant. Section 508 compliance may be reviewed by the Section 508 Office and appropriate remedial action required if necessary. For additional information or assistance regarding Section 508, please contact the Section 508 Office at Section508@va.gov.
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v23.3
Decision Date:	03/22/2023 at 14:22:26 UTC
Introduced By:	TRM Request
Vendor Name:	Medtronic

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Technology, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
3.x	06/23/2020

Current Decision Matrix (03/14/2023)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

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3.x

Approved w/Constraints
[1, 2, 4, 5, 6]

Decision Constraints


[1]	This technology involves the use Universal Serial Bus (USB) connections and proper security precautions must be taken when used. The Federal Processing Standards (FIPS) 140-2 certification status of this technology was not able to be verified. This technology must not be used to handle any data containing PHI/PII or VA sensitive information, unless FIPS 140-2 encryption can be enabled, or a 3rd party FIPS 140-2 certified solution can be deployed to protect it.

[2]	This technology has received one or more VA security bulletins that provide specific guidance on vulnerability patching and mitigation. It is the responsibility of VA system owners to ensure that the appropriate mitigations are taken to address all known and future discovered vulnerabilities with this product. See the Reference tab for more information on security bulletins related to this product.

[3]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with VA Handbook 6500.

[4]	Due to National Institute of Standards and Technology (NIST) identified security vulnerabilities, extra vigilance should be applied to ensure the versions remain properly patched to mitigate known and future vulnerabilities. The local ISSO (Information System Security Officer) can provide assistance in reviewing the NIST vulnerabilities.

[5]	If this technology is an FDA certified medical device or is categorized by the Department as a networked medical device then it must be isolated and protected in accordance with The Medical Device Isolation Architecture (MDIA) 2015 Guidance. This guideline stipulates that if the device meets ANY of the following criteria, then it must be isolated: If the device cannot have the VA standard desktop security suite loaded on it. This includes but is not limited to Anti-Virus, HIPS, USB Access controls, software/hardware inventory, automated software updates/patches and Group Policy Objects (GPOs) If the device is a Windows device and cannot be part of the domain If the device is not part of the regular IT patched management process Non Windows devices (UNIX, Linux, MAC/Apple, etc.) The criteria should be applied to both FDA certified and non-FDA certified devices which must maintain medical/clinical functionality. An example would be a PC that is not running the current supported operating system in order to manage medication-dispensing devices. While these may not be considered strictly medical devices, they are still vulnerable to attack and need to be protected. For guidance and assistance in security networked medical devices, please contact the Medical Device Isolation Architecture (MDIA) Working Group.

[6]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with both VA Handbook 6500 and VA Directive 6500.

Note:

At the time of writing, version 3.0 is the most current version, released 06/23/2020.

References

The following reference(s) are associated with this entry:
Type	Name	Description
Vendor Provided*	User Manual	This webpage is to the user manual to the most recent version.
Vendor Provided*	Nerve Integrity Monitor (NIMs) - Threat & Assessment Analysis Portal (TAAP) bulletin B-18-152	This document is VA Cybersecurity Operations Center (CSOC) Bulletin #B-18-152 that outlines a security vulnerability regarding this technology and steps to remedy the issue.
Vendor Provided*	Previous Versions Manual	This website links to the repository of user manuals for this technology.
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

Technology Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Name	Description
No components have been identified for this entry.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Health Care Health Services	Specialty Services
Health Care Health Services	Surgery

Operating Systems Supported by the Technology

macOS - Approved w/Constraints
Windows Client - Approved w/Constraints
Windows Server - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

No runtime dependencies have been identified.

Comparable Technologies:

No comparable entries have been identified.

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This technology may improve productivity for specific staff whose responsibilities include reducing the risk of intraoperative nerve damage and the amount of time needed to identify motor nerves.
At the time of writing, this technology provides functionality not available through other approved TRM options.

Adoption Risks

The potential of vendor lock exists when utilizing proprietary vendor technology.
There is limited publicly available technical documentation for this technology.
Due to the rapid release schedule of this technology, the VA may be unable to update to the most recent patch and may require a deployment model requiring the use of specific versions.
The potential exists to store Personally Identifiable Information (PII), Protected Health Information (PHI) and/or VA Sensitive data and proper security standards must be followed in these cases.
This technology involves the use Universal Serial Bus (USB) connections and proper security precautions must be taken when used.
There are Threat & Assessment Analysis Portal (TAAP) bulletins associated with this technology.
There are known Common Vulnerabilities and Exposures (CVEs) associated with this technology. Please see https://nvd.NIST.gov/vuln/search for more details.
There is no indication based on available vendor documentation that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.

Architectural Benefits

This technology is portable as it runs on multiple TRM-approved operating systems.

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Vendor Release Information

Current Decision Matrix (03/14/2023)

Decision Constraints

References

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VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (03/14/2023)

Decision Constraints

References

Technology Components

VA Categories View the VA Categorization Framework

Operating Systems Supported by the Technology

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

Adoption Risks

Architectural Benefits

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