K-Soft

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:	K-Soft is a software driver used to adjust Ottobock`s Kenevo microprocessor-controlled prosthetic knees. Communication between the software and the prosthesis takes place via Bluetooth data transfer. Note: This software is included with the purchase of the hardware. There is no dedicated website for K-Soft that is maintained by the vendor. K-Soft stores data locally in a Microsoft Structured Query Language (SQL) Server database (standalone file) and the Ottobock Data Station, which stores patient information (first name, last name, and gender only), as well as `jobs` for the patient. A job contains the programming settings for a patient`s prosthetic device. All users can open the Data Station without a password. However, users are required to enter a username, 6 character unlock-Personal Identification Number (PIN), and a subsequent password to open a job. A PIN can only be obtained by certified clinicians who have passed the vendor`s online product training.
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 v22.7
Decision Date:	07/05/2022 at 15:15:25 UTC
Aliases:	Ottobock
Introduced By:	TRM Request
Vendor Name:	Ottobock

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
1.0	05/31/2015
1.2	08/31/2017
1.4	11/01/2018
1.6

Current Decision Matrix (06/28/2022)

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.

<Past

CY2023

CY2024

CY2025

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

1.0

Unapproved

1.2

Unapproved

1.4

Divest
[9, 11, 14, 15, 16, 17, 18, 19]

Divest
[9, 11, 14, 15, 16, 17, 18, 20]

Unapproved

1.6

Approved w/Constraints
[9, 11, 14, 15, 16, 17, 18, 19]

Approved w/Constraints
[9, 11, 14, 15, 16, 17, 18, 20]

Approved w/Constraints
[9, 11, 15, 16, 17, 18, 20, 21]

Decision Constraints


[1]	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 ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[2]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[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 ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[4]	This product includes a Bluetooth capability. If that capability is leveraged, the implementer must conform to the Bluetooth Standard. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[5]	Users must ensure that Microsoft .NET Framework, Microsoft Outlook, Microsoft Structured Query Language (SQL) Server and Microsoft Internet Explorer are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’)

[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 ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[7]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[8]	In cases where the technology is used for external connections, a full Enterprise Security Change Control Board (ESCCB) review is required in accordance VA Directive 6004 , VA Directive 6517, and VA Directive 6513. The local ISO can advise on the ESCCB review process.

[9]	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.

[10]	This product includes a Bluetooth capability. If that capability is leveraged, the implementer must conform to the Bluetooth Standard. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[11]	Users must ensure that Microsoft .NET Framework, Microsoft Outlook, Microsoft Structured Query Language (SQL) Server and Microsoft Internet Explorer (IE) are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must utilize approved internet browsers, as Microsoft Internet Explorer has reached End of Life status. See Category Tab for details.

[12]	Users should check with their supervisor, Information Security Office (ISO) or local OIT representative for permission to download and use this software. Downloaded software must always be scanned for viruses prior to installation to prevent adware or malware. Freeware may only be downloaded directly from the primary site that the creator of the software has advertised for public download and user or development community engagement. Users should note, any attempt by the installation process to install any additional, unrelated software is not approved and the user should take the proper steps to decline those installations.

[13]	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 ISO can provide assistance in reviewing the NIST vulnerabilities.

[14]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information System Security Officer (ISSO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[15]	In cases where the technology is used for external connections, a full Enterprise Security Change Control Board (ESCCB) review is required in accordance VA Directive 6004 , VA Directive 6517, and VA Directive 6513. The local ISSO (Information System Security Officer) can advise on the ESCCB review process.

[16]	This product includes a Bluetooth capability. If that capability is leveraged, the implementer must conform to the Bluetooth Standard. 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.

[17]	Users should check with their supervisor, Information System Security Officer (ISSO) or local OIT representative for permission to download and use this software. Downloaded software must always be scanned for viruses prior to installation to prevent adware or malware. Freeware may only be downloaded directly from the primary site that the creator of the software has advertised for public download and user or development community engagement. Users should note, any attempt by the installation process to install any additional, unrelated software is not approved and the user should take the proper steps to decline those installations.

[18]	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.

[19]	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.

[20]	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.

[21]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 or its successor to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 or 140-3 compliant full disk encryption (FOE) must be implemented on the storage device where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information System Security Officer (ISSO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP). By September 22, 2026, all FIPS 140-2 certificate validations will be placed on the Historical List, please refer to FIPS Transition Effort for further guidance and timeline of changes.

Note:

At the time of writing, version 1.6 is the most current version.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
Guideline	Release Notes \| System Requirements		This webpage outlines the system requirements for the K-Soft technology.

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	Rehabilitation Services

Operating Systems Supported by the Technology

Windows Client - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This is a mature technology.
There is no licensing fee associated with this technology.
This technology provides proprietary functionality for vendor`s associated hardware.
This technology may improve productivity for specific staff whose responsibilities include adjusting Ottobock`s Kenevo microprocessor-controlled prosthetic knees.
This is a well-documented technology.

Adoption Risks

The potential of vendor lock exists when utilizing proprietary vendor technology.
Microsoft Internet Explorer, a dependency of this technology, is in End of Life status and must no longer be used.
This technology is available as freeware. If commercial support is not purchased, the product will be without clearly defined support options which may result in suboptimal enterprise level support.
This technology can utilize Bluetooth technology.
This technology can integrate with and alter database technologies.
There are known Common Vulnerabilities and Exposures (CVEs) associated with this technology. Please see https://nvd.NIST.gov/vuln/search for more details.
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.

Architectural Benefits

This technology can use a VA-preferred database.

Architectural Risks

This technology is not portable as it runs only on Windows platforms.

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Decision Constraints

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Operating Systems Supported by the Technology

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