PraediGene

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:	PraediGene is a laboratory workflow application designed to allow users to electronically enter and track various medical lab tests. In addition to these core capabilities, PraediGene contains advanced computational biology features and interfaces with Electronic Health Record (EHR) systems. This software stores data in a Structured Query Language (SQL) database. PraediGene has plugins for Oracle, Microsoft SQL Server, and SQLite databases. The PraediGene platform fully supports encryption during all phases of over-the-wire data transmission as well as storage. The PraediGene user interface sends web service requests of a Secure Sockets Layer (SSL) connection and the web services handle saving data to the database. The vendor asserts that Federal Information Processing Standards (FIPS) 140-2 disk encryption is supported. Other database provider encryption protocols can also be supported.
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 v24.2
Decision Date:	02/23/2024 at 02:53:38 UTC
Introduced By:	TRM Request
Vendor Name:	Bitscopic Inc.

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
2.9
3.3	08/05/2016
3.6
3.11
4.4	02/24/2019
5.0	09/01/2021

Current Decision Matrix (02/14/2024)

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 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

CY2024

CY2025

CY2026

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

2.9

Unapproved

3.3

Unapproved

3.6

Unapproved

3.11

Unapproved

4.4

Unapproved

5.0

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

Decision Constraints


[1]	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).

[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]	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 Internet Explorer (IE), Microsoft Internet Information Services (IIS), Microsoft Structured Query Language (SQL) Server, and Oracle Database 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]	Users must ensure that Apache Tomcat, Firefox, Google Chrome, Microsoft Internet Explorer (IE), Microsoft Internet Information Services (IIS), Microsoft Structured Query Language (SQL) Server and Oracle Database are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) This technology must use the latest TRM-approved version of Java Development Kit (JDK) - Oracle. Users must Divest the use of Internet Explorer with this technology. Other approved internet browsers are available. See Category Tab for details. Users must not utilize Secure Sockets Layer (SSL) as it is, at the time of writing, unapproved in the TRM. Users must ensure that when using Microsoft .NET Core that approved versions are utilized.

[9]	Users must ensure that Apache Tomcat, Firefox, Google Chrome, Microsoft Internet Explorer (IE), Microsoft Internet Information Services (IIS), Microsoft Structured Query Language (SQL) Server and Oracle Database are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) This technology must use the latest TRM-approved version of Java Development Kit (JDK) - Oracle. This technology must use the latest TRM-approved version of Microsoft .NET Core. Users must Divest the use of Internet Explorer with this technology. Other approved internet browsers are available. See Category Tab for details. Users must not utilize Secure Sockets Layer (SSL) as it is, at the time of writing, unapproved in the TRM.

[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]	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.

[13]	Users must ensure that Apache Tomcat, Firefox, Google Chrome, Microsoft Edge, Microsoft Internet Information Services (IIS), Microsoft Structured Query Language (SQL) Server and Oracle Database are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) This technology must use the latest TRM-approved version of Java Development Kit (JDK) - Oracle. Users must not utilize Secure Sockets Layer (SSL) as it is, at the time of writing, unapproved in the TRM.

[14]	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.

[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 09/01/2021.

References

The following reference(s) are associated with this entry:
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
Emerging Pathogens	The PraediGene Emerging Pathogens Module is an optional module seamlessly integrated with PraediGene Laboratory Workflow Tool. Once entered into the PraediGene Emerging Pathogen Module, work items are immediately available to all users for tracking, DNA analysis, report generation, and generic workflow activities. The DNA analysis features automatically predict and report resistance mutations given the organism’s genetic sequence. To ease reporting and transcription requirements, it is also able to generate “EHR friendly” input
PraediVault (Biorepository Module)	PraediVault connects biobanking systems to hospital system infrastructure to enable rapid, accurate and secure expansion of the biobank.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Health Care Administrative	Health Delivery Support
Health Care Health Services	Pathology and Laboratory Medicine Services

Operating Systems Supported by the Technology

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

Technologies/Standards Relationships

Runtime Dependencies:

Apache Tomcat
Codename: The Bridge
Docmosis-Java
Hortonworks Data Platform (HDP)
JDK - Oracle Java Standard Edition (SE) Development Kit
Microsoft .NET
Microsoft Edge. - (required for some configurations)
Microsoft Internet Information Services (IIS)
Microsoft Structured Query Language (SQL) Server - (required for some configurations)
Oracle Database - (required for some configurations)
SQLite - (required for some configurations)

Comparable Technologies:

PraediCare

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 technology can be used for tracking, DNA analysis, report generation, and generic workflow activities. In addition, the DNA analysis features automatically predict and report resistance mutations given the organism`s genetic sequence.

Adoption Risks

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 is a limited amount of publicly-available technical documentation for this product.
This technology relies on Java Development Kit (JDK) - Oracle, which has a rapid release and update schedule.
This technology can potentially use Secure Sockets Layer (SSL), an unapproved protocol.
This technology can integrate with and alter database technologies.
There is no indication based on available vendor documentation that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.

Architectural Benefits

This technology can use a VA-preferred database.
This technology is compatible with multiple other Technical Reference Model (TRM) technologies and standards used by the organization.
This technology can integrate with multiple VA-supported databases and Veterans Health Information Systems and Technology Architecture (VistA).

Architectural Risks

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

Inside VA

Budget and Performance

Inside the Media Room

National Observances

Special Events

VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (02/14/2024)

Decision Constraints

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

CONNECT

VA HOME

QUICK LIST

RESOURCES

ADMINISTRATION

VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (02/14/2024)

Decision Constraints

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

EMAIL UPDATES