Eye Surface Profiler (ESP)

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 Eye Surface Profiler (ESP) is a non-invasive Profilometer intended to determine the shape of the human cornea, the limbus and large parts of the sclera by using images of the front surface of the human eye and Fourier Transform Profilometry. The ESP takes two photos of the surface of the cornea and sclera, using two illumination channels and a complementary metal oxide semiconductor (CMOS) camera channel, in one single shot that is taken in a few milliseconds. The software then calculates a three dimensional (3D) model of the anterior surface of the eye from which maps and parameters are calculated to assist in the evaluation of the shape of the cornea, limbus and sclera. This technology can integrate with a SQLite database that is integrated into the software.
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 v24.3
Decision Date:	03/27/2024 at 01:49:32 UTC
Introduced By:	TRM Request
Vendor Name:	Eaglet Eye

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
6.4.x

Current Decision Matrix (03/22/2024)

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.

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6.4.x

Unapproved

Approved w/Constraints
[1, 2, 3, 4, 5, 6, 7]

Decision Constraints


[1]	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.

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

[5]	In cases where the technology is used for external connections, a full Enterprise Security Change Control Board (ESCCB) review is required in accordance VA Directive 6004 , VA Directive 6517, and VA Directive 6513. The local ISSO (Information System Security Officer) can advise on the ESCCB review process.

[6]	If this technology is an FDA certified medical device or is categorized by the Department as a networked medical device then it must be isolated and protected in accordance with The Medical Device Isolation Architecture (MDIA) 2015 Guidance. This guideline stipulates that if the device meets ANY of the following criteria, then it must be isolated: If the device cannot have the VA standard desktop security suite loaded on it. This includes but is not limited to Anti-Virus, HIPS, USB Access controls, software/hardware inventory, automated software updates/patches and Group Policy Objects (GPOs) If the device is a Windows device and cannot be part of the domain If the device is not part of the regular IT patched management process Non Windows devices (UNIX, Linux, MAC/Apple, etc.) The criteria should be applied to both FDA certified and non-FDA certified devices which must maintain medical/clinical functionality. An example would be a PC that is not running the current supported operating system in order to manage medication-dispensing devices. While these may not be considered strictly medical devices, they are still vulnerable to attack and need to be protected. For guidance and assistance in security networked medical devices, please contact the Medical Device Isolation Architecture (MDIA) Working Group.

[7]	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.

Note:

At the time of writing, version 6.4.0 is the most current version.

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
SQLite Database	When installing the Eye Surface Profiler, this database is for new measurements that will automatically be saved. This is a managed component.

VA Categories View the VA Categorization Framework

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

Operating Systems Supported by the Technology

Windows Client - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

No runtime dependencies have been identified.

Comparable Technologies:

No comparable entries have been identified.

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.
The vendor asserts this technology supports Health Insurance Portability and Accountability Act (HIPAA) regulations and protects patient security and confidentiality.
At the time of writing, there are a limited number of TRM options providing this functionality. The addition of this technology will provide end users with multiple viable options.
This technology may improve productivity for specific staff whose responsibilities include optometry.

Adoption Risks

The potential of vendor lock exists when utilizing proprietary vendor technology.
The technology requires the purchase of licenses from vendor, which could potentially lead to vendor lock-in.
There is limited publicly available technical documentation for this technology.
This technology can integrate with and alter database technologies.
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.
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.
There is no indication based on either the vendor documentation or the Cryptographic Module Validation Program (CMVP) that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
This technology involves the use Universal Serial Bus (USB) connections and proper security precautions must be taken when used.
This technology may utilize external data connections.

Architectural Risks

This technology is not portable as it runs only on Windows platforms.
This technology does not use a VA-preferred database to store data.

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General Information

Vendor Release Information

Current Decision Matrix (03/22/2024)

Decision Constraints

References

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General Information

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Current Decision Matrix (03/22/2024)

Decision Constraints

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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

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Architectural Risks

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