Dyna Computer Aided Detection (CAD)

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:	Dyna Computer Aided Detection (CAD) is a breast and prostate imaging workflow software. As a software component to the DynaCAD Workstation, DynaCAD employs a post-processing engine that generates Multi-Planar Reformatted (MPR) and Maximum Intensity Projection (MIP) images. The data processed can be viewed on the DynaCAD Workstation (two 20-inch flat panel monitors that provide a workspace for viewing image data within a patient exam), or can be automatically forwarded to a Picture Archiving and Communication System (PACS). Additionally, users can modify segments of an image view to see information such as volume analysis, lesion composition statistics, histograms, and a three-dimensional (3D) rendered morphological overview. The client is the same regardless of whether Dyna Computer Aided Detection is used for breast or prostate. The licensing determines whether the client can process breast, prostate, or both. DynaCAD software is hosted on VA premises and stores Protected Health Information (PHI) in a Microsoft Structured Query Language (SQL) Server database. This data can be sent to a PACS. This technology connects to PACS and Magnetic Resonance Imaging (MRI) scanners via a Transmission Control Protocol (TCP) connection using Microsoft Internet Information Services (IIS). The MRI scanner sends breast studies to the DynaCAD unit, which processes and organizes them in a computer-aided detection layout. Radiology staff read the studies in the unit`s viewer and take result captures. These captures are sent back to PACS for permanent storage. The vendor does not support the encryption of personal data (including Digital Imaging and Communications in Medicine (DICOM) data) for transmission or storage (internally or on removable media). Additionally, the vendor does not support de-identification of DICOM data for export functionality.
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 v23.4
Decision Date:	04/04/2023 at 02:07:14 UTC
Aliases:	Dyna Computer Aided Detection (CAD) Breast/Prostate
Introduced By:	TRM Request
Vendor Name:	Invivo

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
3.3	03/03/2015
3.5	02/26/2017
4.x	04/05/2018
5.x

Current Decision Matrix (03/27/2023)

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

CY2023

CY2024

CY2025

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

3.3

Unapproved

3.5

Unapproved

4.x

Divest
[6, 9, 10, 11]

Divest
[6, 10, 11, 12, 13]

Divest
[6, 11, 12, 13, 14]

Unapproved

5.x

Approved w/Constraints
[6, 9, 10, 11]

Approved w/Constraints
[6, 10, 11, 12, 13]

Approved w/Constraints
[6, 11, 12, 13, 14]

Approved w/Constraints
[6, 12, 13, 14, 15]

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

[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]	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.

[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]	Users must ensure that Microsoft .NET Framework, Google Chrome, Microsoft Structured Query Language (SQL) Server, and Microsoft Internet Information Services (IIS) 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.

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

[11]	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).

[12]	Users must ensure thatMicrosoft Structured Query Language (SQL) Server and Microsoft Internet Information Services (IIS) 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.

[13]	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.

[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.

Note:

At the time of writing, version 5.0 is the most current version released.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
Vendor Provided*	Technical Datasheet		This webpage documents the system requirements for the 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
Magnetic Resonance (MR) Analysis Server	The Magnetic Resonance (MR) Analysis Server includes the DynaCAD Breast MR Analysis modules. These modules are intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source Magnetic Resonance Images (MRI`s).
Viewer Workstation	The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of generated datasets. Additionally, the workstation incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, three-dimensional visualization of an image series, and Digital Imaging and Communications in Medicine (DICOM) reporting, among other capabilities.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Collaboration and Electronic Workplace Productivity Software	Health Care
Health Care Health Services	Imaging

Operating Systems Supported by the Technology

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

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

The technology has a comprehensive set of documentation.
This technology may improve productivity for specific staff whose responsibilities include medical imaging.
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 supports several industry standard file formats.

Adoption Risks

Microsoft Internet Explorer, a dependency of this technology, is in End of Life status and must no longer be used.
There is no indication based on available vendor documentation that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
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.
A potential for vendor lock-in exists when utilizing this proprietary vendor technology due to its reliance on Invivo core components.
There are other approved solutions that provide similar functionality available on the TRM. The use of several similar solutions may increase organization requirements for support and maintenance.
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.

Architectural Benefits

This technology can use a VA-preferred database.
This technology is compatible with virtual machines, therefore consistent with the enterprise Server Virtualize First Policy (VAIQ 7266972 08-27-2012).

Architectural Risks

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

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