Planmeca Romexis

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:	Planmeca Romexis is an imaging application intended for use in dental and medical care to display and visualize two- and three-dimensional (2D/3D) images from imaging devices, such as projection radiography and cone beam computed tomography (CBCT). Romexis is designed to retrieve, process, render, diagnose, review, store, print, and distribute images. Romexis stores patient and image data in a Microsoft Structured Query Language (SQL) Server database or Oracle database. Additionally, this product uses cloud services. Planmeca Romexis Cloud is a subscription-based service that can be used to transfer images and documents between Romexis users. 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 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 approved by the Mobile Technology and Endpoint Security Engineering Team: http://vaww.eie.va.gov/SysDesign/CS/MT/default.aspx.
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 v23.11
Decision Date:	11/09/2023 at 19:23:09 UTC
Aliases:	Planmeca Romexis Dental Imaging Software; Romexis
Introduced By:	SCCM
Vendor Name:	Planmeca

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
2.3	01/01/2011
3.6	06/01/2014
4.0	03/10/2015
4.5.x	03/10/2017
4.6.x
5.x
6.x

Current Decision Matrix (11/06/2023)

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.

<Past

CY2018

CY2019

CY2020

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

3.6

Approved w/Constraints
[7, 8, 10, 11]

Divest
[7, 8, 10, 11]

Divest
[7, 8, 10, 11, 12]

Unapproved

4.0

Approved w/Constraints
[7, 8, 10, 11]

Divest
[7, 8, 10, 11]

Divest
[7, 8, 10, 11, 12]

Divest
[7, 8, 10, 12, 13]

Unapproved

4.5.x

Approved w/Constraints
[7, 8, 10, 11]

Divest
[7, 8, 10, 11]

Divest
[7, 8, 10, 11, 12]

Divest
[7, 8, 10, 12, 13]

Unapproved

4.6.x

Unapproved

Approved w/Constraints
[7, 8, 10, 11]

Approved w/Constraints
[7, 8, 10, 11, 12]

Divest
[7, 8, 10, 11, 12]

Divest
[7, 8, 10, 12, 13]

Divest
[7, 8, 10, 13, 14]

5.x

Unapproved

Approved w/Constraints
[7, 8, 10, 11]

Approved w/Constraints
[7, 8, 10, 11, 12]

Approved w/Constraints
[7, 8, 10, 12, 13]

Divest
[7, 8, 10, 13, 14]

6.x

Unapproved

Approved w/Constraints
[7, 8, 10, 13, 14]

Decision Constraints


[1]	Only instances of this technology that have been deployed may continue to use this technology. No further expansion or use of this technology is permitted without a waiver from the Architecture and Engineering Review Board (AERB) and expressed authorization from the Assistant Secretary/Chief Information Officer or the Principal Deputy Assistant Secretary for the Office of Information and Technology.

[2]	Projects using this technology must meet Veterans Affairs (VA) Directive 6500 and implement Federal Information Processing Standards (FIPS 199) for all laptop devices and National Institute of Standards and Technology Special Publication 800-53 for all desktop devices when VA sensitive information is involved, or additional mitigating controls must be documented in an approved System Security Plan (SSP) to prevent potential disclosure of PII/PHI data. Additionally, projects which interface with external VA partner must have a Memorandum of Understanding and Interconnection Security Agreements (MOU/ISA) which detail the security requirements for users and systems that share information and resources outside of the VA production network. .

[3]	As of April 23, 2015, per the Deputy CIO of Architecture, Strategy and Design (ASD), all technologies in use by the VA require an assessment by the VA Section 508 office. Section 508 of the Rehabilitation Act Amendments of 1998 is a federal law that sets the guidelines for technology accessibility. A VA Section 508 assessment of this technology has not been completed at the time of publication. Therefore, as of April 23, 2015 only users of this technology who have deployed the technology to the production environment, or have project design and implementation plans approved, may continue to operate this technology. In the case of a project that has implemented, or been approved for a specific site or number of users, and that project needs to expand operations to other sites or to an increased user base, it may do so as long as the project stays on the existing version of the technology that was approved or implemented as of April 22, 2015. Use of this technology in all other cases is prohibited.

[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]	Due to potential information security risks, cloud based technologies may not be used without an Enterprise Security Change Control Board (ESCCB) approval. This body is in part responsible for ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[7]	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.

[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]	Due to potential information security risks, cloud based technologies may not be used without the approval of the VA Enterprise Cloud Services (ECS) Group. This body is in part responsible for ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[10]	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.

[11]	Due to potential information security risks, cloud based technologies may not be used without the approval of the Enterprise Cloud Solution Office (ECSO). This body is in part responsible for ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[12]	This technology must use the latest version of JRE (Java Runtime Environment) - Oracle.

[13]	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 with the Project Special Forces (SPF) team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[14]	This technology must use the latest version of JRE (Java Runtime Environment) - Oracle. Users must ensure that Microsoft Structured Query Language (SQL) Server and Oracle Database are implemented within VA-approved baselines.

Note:

At the time of writing, version 6.1.0 is the most current version released.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
There are no references identified for this entry.

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
Cephalometric Analysis (CEPH) Module	This module allows cephalometric analyses and superimpositions that can be composed of two-dimensional (2D) cephalometric images, facial photos, and dental images.
Clinic Module	The Clinic module allows time stamped recording and real-time monitoring and control of most activities performed using Planmeca Compact I, Planmeca Compact I Touch, Planmeca Sovereign and Planmeca Sovereign Classic dental units, Planmeca ProMax units, and Planmeca PlanMill 40 milling units. The features and gathered data can be used for remote assistance, service and maintenance, and preventive maintenance planning.
Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) Module	This allows users to work with digital impressions and restorations.
File Module	The File module manages patient information.
Implant Guide Module	The Implant Guide module enables users to design their own implant guide. The guide can then be printed from surgical guide material with any suitable three-dimensional (3D) printer.
Patients Module	The Patients module provides for the management of patients including searching, editing, assigning patients to a specific user, and inactivating patients.
Radiological Findings Module	The Radiological Findings module contains a findings list that is hierarchically categorized and can be freely edited. This module is designed for educational and radiology centers where uniformity of recordings is important.
Report Module	The Report module lists several processes of Planmeca Romexis as a report. These reports contain direct links to images and patients as well as the possibility to print the report.
Smile Design Module	The Smile Design module is an optional application for digital smile design. A patient smile image and intelligent tooth silhouettes are used to design a new smile for the patient.
Three-Dimensional (3D) Imaging Module	This is designed for capturing, processing, and storing images acquired with Planmeca ProMac 3D model units.
Three-Dimensional (3D) Implant Planning Module	This allows users to plan and verify implant placement using implant, abutment, and crown models from Planmeca Romexis libraries.
Three-Dimensional (3D) Ortho Studio Module	This is designed for the examination and analysis of digital dental models.
Two-Dimensional (2D) Imaging Module	This allows users to browse patient images as well as capture, process, store, import, and export radiographs and photos.

VA Categories View the VA Categorization Framework

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

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:

Java Runtime Environment (JRE) - Oracle - (required for some configurations)
Microsoft Structured Query Language (SQL) Server - (required for some configurations)
Oracle Database - (required for some configurations)

Comparable Technologies:

Companion Technologies/Supported Standards:

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 is a well-documented technology.
This technology may improve productivity for specific staff whose responsibilities include taking dental X-rays.

Adoption Risks

There is no indication based on available vendor documentation that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
Bitmap Image File (BMP), a supported standard of this technology, is divested at the time of writing.
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.
There are multiple other TRM-approved technologies that provide similar functionality.
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.
This technology relies on JRE (Java Runtime Environment) - Oracle, which has a rapid release and update schedule.

Architectural Benefits

This technology is portable as it runs on multiple TRM-approved operating systems.
This technology can use a VA-preferred database.

Architectural Risks

This technology has cloud-based functionality, which carries potential security risks.

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References

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Technologies/Standards Relationships

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Comparable Technologies:

Companion Technologies/Supported Standards:

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Architectural Risks

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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

Architectural Risks

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