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VA Technical Reference Model v 25.1

3Shape Implant Studio

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:	3Shape Implant Studio is a dental software application used for prosthetic implant planning and surgical guide design. This technology has the option to produce provisional dental components on the same day as planning. Patients are provided with customized tooth-supported or bone-supported surgical guides for less invasive surgeries. This technology can be used with the 3Shape TRIOS precision intraoral scanner hardware device, which scans dental impressions for digital implant treatment planning. 3Shape Implant Studio does not utilize a database.
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 v24.3
Decision Date:	03/07/2024 at 02:25:03 UTC
Introduced By:	TRM Request
Vendor Name:	3Shape

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
2.17.x
2.19.x	06/17/2019
2021.x
2022.x

Current Decision Matrix (03/01/2024)

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

CY2024

CY2025

CY2026

Future>

Release

2.17.x

Unapproved

Authorized w/ Constraints (POA&M)

Unapproved

Authorized w/ Constraints (POA&M)

2.19.x

DIVEST
[2, 5, 6, 7]

Authorized w/ Constraints (DIVEST)
[2, 5, 6, 7]

DIVEST
[2, 5, 6, 7]

Unapproved

Authorized w/ Constraints (POA&M)

2021.x

DIVEST
[2, 5, 6, 7]

Authorized w/ Constraints (DIVEST)
[2, 5, 6, 7]

DIVEST
[2, 5, 6, 7]

Unapproved

Authorized w/ Constraints (POA&M)

2022.x

Approved w/Constraints
[2, 5, 6, 7]

Authorized w/ Constraints
[2, 5, 6, 7]

Approved w/Constraints
[2, 5, 6, 7]

Authorized w/ Constraints
[2, 5, 6, 7]

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]	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.

[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]	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.

[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 ISSO (Information System Security Officer) to ensure compliance with both VA Handbook 6500 and VA Directive 6500.

[6]	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.

[7]	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 2022.1 is the most current version. Note: the vendor has changed the version schema for this technology.

Type	Name	Source	Description
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

Name	Description
No components have been identified for this entry.


Health Care Health Services	Dentistry

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 product may facilitate treatment plans by having patient information available at the point of care.
This is a well-documented technology.

Adoption Risks

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.
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.
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 Digital Imaging and Communications in Medicine (DICOM) options to reduce transcription errors.

Architectural Risks

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

- The information contained on this page is accurate as of the Decision Date (03/07/2024 at 02:25:03 UTC).

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VA Technical Reference Model v 25.1

General Information

Vendor Release Information

Current Decision Matrix (03/01/2024)

Decision Constraints

References

Technology Components

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Operating Systems Supported by the Technology

Technologies/Standards Relationships

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General Analysis

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Adoption Risks

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VA Technical Reference Model v 25.1

General Information

Vendor Release Information

Current Decision Matrix (03/01/2024)

Decision Constraints

References

Technology Components

VA Categories View the VA Categorization Framework

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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VA Categories

View the VA Categorization Framework