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VA Technical Reference Model v 24.11

Genie Medical

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:	The Genie Medical software programs the Ponto bone anchored hearing aid, ConnectClip, and Oticon Opn (Open) hearing aid processors. This technology allows the audiologist to program the output of these devices according to the individual`s hearing loss with in-situ audiometry. Genie Medical provides a pediatric fitting mode that provides professionals a centralized way to view and change children`s hearing aid settings. This technology can use a proprietary Genie Medical BAHS (BrainHearing) database to store data. This method is optional and is not included in all editions; users may also store data on local storage devices if necessary. Genie Medical differs from the Genie and Genie 2 software, which is also produced by the vendor. This technology is available in multiple editions that the vendor dictates with versioning. These editions provide proprietary functionality for different releases of the vendor`s associated hardware. Please note that there is no specific product page for this technology and thus the webpage for the hearing device this software supports is used in its place (Ponto hearing aid). This technology does not use a database to store data.
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 been assessed by the Section 508 Office and found non-conformant. 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. Please see reference tab for more information concerning product versions.
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v23.10
Decision Date:	10/28/2023 at 03:30:53 UTC
Introduced By:	TRM Request
Vendor Name:	Oticon 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
2016.x	11/30/2016
2019.x	10/01/2018
2021.x	02/01/2021
2022.x	03/21/2022
2023.x	08/18/2023

Current Decision Matrix (10/20/2023)

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 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

2016.x

DIVEST
[3, 9, 11]

Authorized w/ Constraints (DIVEST)
[3, 9, 11]

Authorized w/ Constraints (POA&M)

2019.x

Unapproved

Authorized w/ Constraints (POA&M)

2021.x

DIVEST
[3, 9, 11]

Authorized w/ Constraints (DIVEST)
[3, 9, 11]

Authorized w/ Constraints (POA&M)

2022.x

Approved w/Constraints
[3, 9, 11]

Authorized w/ Constraints
[3, 9, 11]

2023.x

Approved w/Constraints
[3, 9, 11]

Authorized w/ Constraints
[3, 9, 11]

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]	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.

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

[5]	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).

[6]	Users should check with their supervisor, Information Security Office (ISO) or local OIT representative for permission to download and use this software. Downloaded software must always be scanned for viruses prior to installation to prevent adware or malware. Freeware may only be downloaded directly from the primary site that the creator of the software has advertised for public download and user or development community engagement. Users should note, any attempt by the installation process to install any additional, unrelated software is not authorized and the user should take the proper steps to decline those installations.

[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]	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.

[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]	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.

Note:

At the time of writing, versions 2022.1 and 2023.1 are the most current versions, released 03/31/2022 and 08/18/2023, respectively.

Type	Name	Source	Description
Vendor Provided*	Genie Medical Installation Guide	Vendor - Oticon	This link provides the installation guide for the 2019.1 version of this technology. Per the vendor, more up-to-date installation guides are not available at this time except with universal serial bus (USB) or compact disc (CD) installations.
Vendor Provided*	Opn Technology	Publicly Available	This site provides features and benefits for this technology.
*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	Rehabilitation Services

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 provides proprietary functionality for vendor`s associated hardware.
This technology may improve productivity for specific staff whose responsibilities include hearing aid adjustment, fitting, and management.

Adoption Risks

This technology involves the use Universal Serial Bus (USB) connections and proper security precautions must be taken when used.
There is no indication based on available vendor documentation that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
There is limited publicly available technical documentation for this technology.
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.
The potential of vendor lock exists when utilizing proprietary vendor technology.
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 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 (10/28/2023 at 03:30:53 UTC).

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VA Technical Reference Model v 24.11

General Information

Vendor Release Information

Current Decision Matrix (10/20/2023)

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 Risks

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VA Technical Reference Model v 24.11

General Information

Vendor Release Information

Current Decision Matrix (10/20/2023)

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 Risks

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VA Categories

View the VA Categorization Framework