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VA Technical Reference Model v 24.7

CareLink Pro

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:	CareLink Pro is a diabetes therapy management system. CareLink Pro allows users to acquire, store, and report patient treatment and diagnostic data. Used in conjunction with Medtronic devices, this technology can be utilized to access pump, meter, and sensor-based glucose data. This system consists of an application that allows clinicians to manage patients and generate reports, and a client uploader that lets the user upload device data into the system. Data is transferred from glucose meter devices via Universal Serial Bus (USB) cable. This technology stores data in an Oracle database. Data flows from the patient`s insulin pump to the CareLink system servers via a CareLink application, and after processing, portable document format (PDF) reports are returned back to the CareLink web application. The system does not store any information locally. The TRM decisions in this entry only apply to technologies and versions owned, operated, managed, patched, and version-controlled by VA. This includes technologies deployed as software installations on VMs within VA-controlled cloud environments (e.g. VA Enterprise Cloud (VAEC)). Cloud services provided by the VAEC, which are listed in the VAEC Service Catalog, and those controlled and managed by an external Cloud Service Provider (i.e. SaaS) are not in the purview of the TRM. For more information on the use of cloud services and cloud-based products within VA, including VA private clouds, please see the Enterprise Cloud Solutions Office (ECSO) Portal at: https://dvagov.sharepoint.com/sites/OITECSO
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 v22.12
Decision Date:	12/07/2022 at 20:44:55 UTC
Aliases:	Medtronic CareLink Pro
Introduced By:	SCCM
Vendor Name:	Medtronic MiniMed

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
2.8
3	03/13/2012
3.1
3.2
3.3
3.4	11/01/2013
3.6
5.x	10/31/2016

Current Decision Matrix (12/05/2022)

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

CY2022

CY2023

CY2024

Future>

Release

2.8

Unapproved

3.1

Unapproved

3.2

Unapproved

3.3

Unapproved

3.4

Unapproved

3.6

Unapproved

Approved w/Constraints
[14, 16, 19, 20, 21]

Approved w/Constraints
[20, 21, 22, 23, 24]

Approved w/Constraints
[20, 21, 22, 23, 25]

Approved w/Constraints
[21, 22, 23, 25, 26]

5.x

Approved w/Constraints
[3, 14, 16, 17, 18, 19]

Approved w/Constraints
[3, 14, 16, 18, 19, 20]

Approved w/Constraints
[14, 16, 19, 20, 21]

Approved w/Constraints
[20, 21, 22, 23, 24]

Approved w/Constraints
[20, 21, 22, 23, 25]

Approved w/Constraints
[21, 22, 23, 25, 26]

Decision Constraints


[1]	Projects using this technology must comply with VA Directive 6512, Secure Wireless Technology. Federal Information Processing Standards (FIPS 140-2) certified encryption must be used to encrypt data in transit if PII/PHI, or Veteran Affairs (VA) sensitive information is involved or additional mitigating controls must be documented in an approved System Security Plan (SSP). VA users must ensure that VA sensitive data is properly protected in accordance to VA 6500 and the Federal Information Security Management Act (FISMA).

[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]	Due to potential information security risks, cloud based technologies may not be used without an Enterprise Security Change Control Board (ESCCB) approval. This body is in part responsible for ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[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]	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 ISO can advise on the ESCCB review process.

[9]	Due to potential information security risks, cloud based technologies may not be used without the approval of the VA Enterprise Cloud Services (ECS) Group. This body is in part responsible for ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[10]	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 ISO can advise on the ESCCB review process.

[11]	Due to potential information security risks, cloud based technologies may not be used without the approval of the Enterprise Cloud Solution Office (ECSO). This body is in part responsible for ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[12]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request with the Project Special Forces (SPF) team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[13]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request with the Project Special Forces (SPF) team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

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

[15]	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).

[16]	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 ISO can advise on the ESCCB review process.

[17]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request with the Project Special Forces (PSF) team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[18]	Users must ensure that Microsoft Internet Explorer (IE), Adobe Acrobat, Google Chrome and Oracle Database are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must Divest the use of Internet Explorer with this technology. Other approved internet browsers are available. See Category Tab for details. 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.

[19]	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.

[20]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request with the VA OIT Product Engineering team, please use their online form. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

[21]	Users must ensure that Adobe Acrobat, and Oracle Database 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. 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.

[22]	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.

[23]	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.

[24]	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.

[25]	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.

[26]	Due to potential information security risks for cloud-based technologies, users should coordinate closely with their facility ISSO for guidance and assistance on cloud products. If further guidance is needed contact the Enterprise Cloud Solution Office (ECSO), which is the body responsible for new software development in and migration of existing systems to the VA Enterprise Cloud (VAEC) and ensuring organizational information, Personally Identifiable Information (PII), Protected Health Information (PHI), and VA sensitive data are not compromised within the VAEC. For information about Software as a Service (SaaS) products or to submit a SaaS product request, visit the Product Marketplace. (Ref: VA Directive 6004, VA Directive 6517, VA Directive 6513 and VA Directive 6102).

Note:

At the time of writing, version 5.1 is the most current version released.

The following reference(s) are associated with this entry:
Type	Name	Source	Description
There are no references identified for this entry.

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
CareLink Device Uploader	CareLink Device Uploader is used for uploading device data. Users will need to download and perform a onetime install of the CareLink Device Uploader Client software which is supported on a Mac and Personal Computer (PC). When trying to access the upload functionality, the system will prompt for the uploader download if it detects it is not installed in the system. The user can download and run the installer from the link provided by the system. The installer requires local administrator privileges to install and has to be done on all computers where the clinic plans to upload devices. The user will be notified of any updates to the uploader if available.
CareLink Web App	The CareLink Web App contains the health care provider (HCP) facing webpages. Various clinic-based functionalities of the system are accessible through the app that runs in supported web browsers on Personal Computers (PC). The module is a single page app that works on the client browser communicating with the services at the server required for performing various business operations. The web app and the services are secured with Secure Hypertext Transfer Protocol (S-HTTP) and authenticated by the user name and password supplied by the HCP user at log on.
Oracle Database	Oracle Database is a vendor managed component of this technology.


Information Management Technologies Business Intelligence and Data Warehouse Platforms	Data Analytics (Statistical Analysis, Prediction, and Modeling)
Information Management Technologies Business Intelligence and Data Warehouse Platforms	PoC Analytical Applications
Health Care Health Services	Medicine Services

- The information contained on this page is accurate as of the Decision Date (12/07/2022 at 20:44:55 UTC).

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VA Technical Reference Model v 24.7

General Information

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Current Decision Matrix (12/05/2022)

Decision Constraints

References

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VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (12/05/2022)

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

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