MAESTRO System Software

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 MAESTRO System Software provides a way for users to program MED-EL cochlear implants from the MAX Programing Interface. This technology is designed to simplify the fitting process of the cochlear implants with a variety of features and designs that are specifically created for the convenience of the patient. Additionally, this technology transfers data by connecting to a Personal Computer (PC) via Universal Serial Bus (USB). All data generated with MAESTRO are saved in an encrypted database that contains patient data and administrative data. This technology is compatible with SQLite and Microsoft Structured Query Language (SQL) Server. SQLite is a single-file database (.db3) optimized for use on a local drive on the computer and is recommended if only one computer uses the database. Microsoft SQL Server is optimized for networking and is recommended if several computers use the same database. Please note that there is no specific product page for this technology and thus the vendor webpage is used in its place.
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:	Section 508 does not apply. This product is considered Medical Technology as defined by the VA in the Medical Device Isolation Architecture (MDIA). 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 v23.9
Decision Date:	09/21/2023 at 12:07:38 UTC
Introduced By:	TRM Request
Vendor Name:	MED-EL

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
6.x	01/30/2015
7.x	09/29/2017
8.x
9.x
10.x	01/28/2022

Current Decision Matrix (09/19/2023)

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

6.x

Unapproved

7.x

Unapproved

8.x

Divest
[8, 10, 11, 12, 13]

Unapproved

9.x

Approved w/Constraints
[8, 10, 11, 12, 13]

Approved w/Constraints
[3, 11, 13, 14]

Approved w/Constraints
[3, 13, 14, 15]

Approved w/Constraints
[3, 14, 15, 16]

10.x

Unapproved

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]	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]	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]	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 Structured Query Language (SQL) Server and Microsoft .NET Framework 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 Microsoft Structured Query Language (SQL) Server and Microsoft .NET Framework are implemented with VA-approved baselines.

[9]	Due to National Institute of Standards and Technology (NIST) identified security vulnerabilities, extra vigilance should be applied to ensure the versions remain properly patched to mitigate known and future vulnerabilities. The local ISO can provide assistance in reviewing the NIST vulnerabilities.

[10]	This technology has received one or more VA security bulletins that provide specific guidance on vulnerability patching and mitigation. It is the responsibility of VA system owners to ensure that the appropriate mitigations are taken to address all known and future discovered vulnerabilities with this product. See the Reference tab for more information on security bulletins related to this product.

[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 VA Handbook 6500.

[12]	Due to National Institute of Standards and Technology (NIST) identified security vulnerabilities, extra vigilance should be applied to ensure the versions remain properly patched to mitigate known and future vulnerabilities. The local ISSO (Information System Security Officer) can provide assistance in reviewing the NIST vulnerabilities.

[13]	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).

[14]	Users must ensure that Microsoft Structured Query Language (SQL) Server is implemented with VA-approved baselines.

[15]	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.

[16]	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 10.0 is the most current version, released 01/28/2022.

A standard configuration of this technology was developed by the DDE team. At the time of writing, the baseline version is 9.0.5.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description

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
No components have been identified for this entry.

VA Categories View the VA Categorization Framework

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

Operating Systems Supported by the Technology

Windows Client - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This technology may create efficiencies for clinicians working with patients who have hearing loss.
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 role-based authentication and authorization capabilities.
This technology includes data logging capabilities that provide detailed information on usage behavior, including usage time and volume range of each selectable program, which enables fitting maps to be tailored to a user`s individual needs.
This technology has the ability to perform bilateral fittings without the need for two programming interfaces.

Adoption Risks

There is no indication based on available vendor documentation that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
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.
The potential for vendor lock-in exists due to this software`s sole compatibility with proprietary vendor-supplied equipment.
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 can use a VA-preferred database.

Architectural Risks

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

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Current Decision Matrix (09/19/2023)

Decision Constraints

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Current Decision Matrix (09/19/2023)

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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

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Architectural Benefits

Architectural Risks

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