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VA Technical Reference Model v 24.11

Silhouette

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:	Silhouette is a wound imaging, three-dimensional (3D) measurement and documentation system providing wound information at the point-of-care and supporting the overall clinical management of wounds. This technology interfaces with the SilhouetteStar imaging device that communicates via Universal Serial Bus (USB) or Wi-Fi, and measures the area, depth, and volume of wounds and their healing progress. This software stores and manages wound informatics, and enables wound assessment activity to be monitored, providing instantly available wound information. Silhouette is also offered as a mobile solution. This technology stores data in a Microsoft Structured Query Language (SQL) Server database. This entry covers the Desktop Edition of this technology and not any mobile versions. Please note that the implementation of mobile technology applications that operate on Mobile Operating Systems must be reviewed and authorized by the Mobile Technology and Endpoint Security Engineering Team: https://dvagov.sharepoint.com/sites/OITMT/SitePages/MTHome.aspx The TRM decisions in this entry only apply to technologies and versions owned, operated, managed, patched, and version-controlled by VA. This includes technologies deployed as software installations on VMs within VA-controlled cloud environments (e.g. VA Enterprise Cloud (VAEC)). Cloud services provided by the VAEC, which are listed in the VAEC Service Catalog, and those controlled and managed by an external Cloud Service Provider (i.e. SaaS) are not in the purview of the TRM. For more information on the use of cloud services and cloud-based products within VA, including VA private clouds, please see the Enterprise Cloud Solutions Office (ECSO) Portal at: https://dvagov.sharepoint.com/sites/OITECSO
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 v24.4
Decision Date:	04/09/2024 at 11:55:14 UTC
Introduced By:	TRM Request
Vendor Name:	ARANZ Medical

Vendor Release Information

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

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Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
3.6	07/15/2014
3.14	04/11/2016
3.17	09/27/2016
3.18
3.20	09/01/2017
3.22
4.x

Current Decision Matrix (04/04/2024)

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 VAIT 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.

Legend:

White	Authorized: The technology/standard has been authorized for use.
Yellow	Authorized 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	Authorized w/ Constraints (POA&M): 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	Authorized w/ Constraints (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 unauthorized may be found on the Decision tab for the specific entry.
Black	Unauthorized: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Authorized w/ Constraints (PLANNING/EVALUATION): 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 authorized 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 authorized 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.

Any major.minor version that is not listed in the VA Decision Matrix is considered Authorized w/ Constraints (POA&M).

<Past

CY2023

CY2024

CY2025

Future>

Release

3.6

Unapproved

Authorized w/ Constraints (POA&M)

3.14

Unapproved

Authorized w/ Constraints (POA&M)

3.17

Unapproved

Authorized w/ Constraints (POA&M)

3.18

Unapproved

Authorized w/ Constraints (POA&M)

3.20

Unapproved

Authorized w/ Constraints (POA&M)

3.22

Approved w/Constraints
[6, 10, 11, 12]

DIVEST
[6, 11, 12, 13]

DIVEST
[6, 12, 13, 14]

DIVEST
[6, 13, 14, 15]

DIVEST
[6, 14, 15, 16, 17, 18]

Authorized w/ Constraints (DIVEST)
[6, 14, 15, 16, 17, 18]

Authorized w/ Constraints (POA&M)

4.x

Approved w/Constraints
[6, 10, 11, 12]

Approved w/Constraints
[6, 11, 12, 13]

Approved w/Constraints
[6, 12, 13, 14]

Approved w/Constraints
[6, 13, 14, 15]

Approved w/Constraints
[6, 14, 15, 16, 17, 18]

Authorized w/ Constraints
[6, 14, 15, 16, 17, 18]

Decision Constraints


[1]	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.

[2]	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.

[3]	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).

[4]	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).

[5]	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.

[6]	Technology must remain patched and operated in accordance with Federal and Department security policies and guidelines in order to mitigate known and future security vulnerabilities.

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

[8]	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).

[9]	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.

[10]	Users must ensure that Microsoft .NET Framework, Microsoft Internet Information Services (IIS), Microsoft Internet Explorer, Google Chrome, Firefox, and Microsoft Structured Query Language (SQL) Server are implemented with VA-authorized baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must Divest the use of Internet Explorer with this technology. Other authorized internet browsers are available. See Category Tab for details.

[11]	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.

[12]	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).

[13]	Users must ensure that Microsoft Internet Information Services (IIS), Google Chrome, Firefox, and Microsoft Structured Query Language (SQL) Server are implemented with VA-authorized baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must utilize authorized internet browsers, as Microsoft Internet Explorer has reached End of Life status. See Category Tab for details.

[14]	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.

[15]	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.

[16]	Users must ensure that Microsoft Internet Information Services (IIS), Microsoft Edge, Google Chrome, Firefox, and Microsoft Structured Query Language (SQL) Server are implemented with VA-authorized baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM. This technology requires using a Universal Service Bus (USB) technology to transfer data into the records. As such, proper precautions need to be taken to protect data.

[17]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request, visit the Product Marketplace. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[18]	The Federal Information Processing standards (FIPS) 140-2 certification status of this technology was not able to be verified. This technology will require a 3rd party FIPS 140-2 or 140-3 certified solution for any data containing PHI/PII or VA sensitive information, where applicable. More information regarding the Cryptographic Module Validation Program (CMVP) can be found on the NIST website.

Note:

At the time of writing, version 4.16.34.0 is the most current version.

A standard configuration of this technology was developed by the DDE team. At the time of writing, the standard version is 4.12.28.0, and version 4.16.34.0 is under testing and development for six weeks from 04/03/2024.

Type	Name	Source	Description
*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
Silhouette Protocol Engine	This module standardizes workflow in clinical practice or research projects. This rules engine can be customized according to the protocol of the clinical trial or desired procedure. The module can assist in ensuring data is collected consistently for all patients and for all centers. Clinical trial protocols can be automated using this module.
Silhouette Reports Module	This module is a wound information management module offering organizations intelligence based on aggregated patient data. This module is designed for clinical managers and administration staff. This optional addition to SilhouetteCentral provides an overview of important trends, key areas of focus and wound outcomes metrics. Template reports based on the most common clinical management wound oversight questions, and custom reports can also be created.
SilhouetteCentral	This module is a secure Internet-accessible database that stores and consolidates the information obtained from the organization`s SilhouetteStar and SilhouetteConnect devices.
SilhouetteConnect	This module manages three-dimensional wound measurement and documentation. Wound surface area, depth and volume data are captured, and images, graphs and statistics are automatically incorporated into the patient record, and immediately displayed on screen.
SilhouetteLink	This module is an integration engine that connects SilhouetteCentral to other health information systems such as Health Information Management systems and Electronic Medical Records systems and enables custom integrations.


Health Care Health Services	Primary Care
Health Care Administrative	Health Delivery Support
Information Management Technologies Business Intelligence and Data Warehouse Platforms	PoC Analytical Applications

General Analysis

Adoption Benefits

At the time of writing, no National Institute of Standards and Technology (NIST) vulnerabilities had been reported and no VA Cyber Security Operations Center (CSOC) bulletins had been issued for the latest versions of this technology.
This technology utilizes built-in Authentication and Authorization (A&A) capabilities.
The vendor asserts that this technology supports Health Insurance Portability and Accountability Act (HIPAA) regulations and protects patient security and confidentiality.
This technology has a comprehensive set of documentation.
This technology provides proprietary functionality for vendor`s associated hardware.

Adoption Risks

This technology can potentially use Secure Sockets Layer (SSL), an unapproved protocol.
There is no indication based on available vendor documentation that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
This technology involves the use Universal Serial Bus (USB) connections and proper security precautions must be taken when used.
This technology can integrate with and alter database technologies.
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.

Architectural Benefits

This technology supports Health Level Seven (HL7) and Digital Imaging and Communications in Medicine (DICOM) options to reduce transcription errors.
This technology is portable as it runs on multiple TRM-authorized operating systems.

Architectural Risks

This technology includes cloud-based functionality which has potential information security risks.

- The information contained on this page is accurate as of the Decision Date (04/09/2024 at 11:55:14 UTC).

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VA Technical Reference Model v 24.11

General Information

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Current Decision Matrix (04/04/2024)

Decision Constraints

References

Technology Components

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Operating Systems Supported by the Technology

Technologies/Standards Relationships

Runtime Dependencies:

Optional Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

Adoption Risks

Architectural Benefits

Architectural Risks

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