Intesys Clinical Suite (ICS)

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:	Intesys Clinical Suite (ICS) is a collection of fully-integrated software applications. ICS provides physicians access to vital signs and waveforms data from any location on the hospital network and is designed to improve efficiency, functionality, and flow of patient cardiac information. The ICS software applications connect with Spacelabs monitoring devices on the network using Transmission Control Protocol (TCP)/Internet Protocol (IP). The Smart Disclosure application stores patient physiological data and patient demographics in a Microsoft Structured Query Language (SQL) Server database, which resides on VA servers. Various interface applications connect to the database and provide data on their interfaces. Data encryption is 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 v22.11
Decision Date:	11/04/2022 at 01:37:19 UTC
Aliases:	Intesys Clinical Suite (ICS) G2; ICS G2; SpaceLabs
Introduced By:	TRM Request
Vendor Name:	Spacelabs Healthcare

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
4.3.x	11/01/2013
5.x.x	06/12/2015

Current Decision Matrix (10/20/2022)

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

CY2023

CY2024

CY2025

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

4.3.x

Unapproved

5.x.x

Approved w/Constraints
[3, 9, 10, 11]

Approved w/Constraints
[3, 9, 11, 12]

Approved w/Constraints
[3, 9, 12, 13]

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 must ensure that Microsoft .NET Framework and Microsoft Structured Query Language (SQL) Server are implemented with VA-approved baselines. Security Engineering (SE) conducted a pre-assessment and security requirements verification of ICS. It is advised that if this product is used within the VA that the following constraints be applied: Ensure that the underlying infrastructure such as Operating System (OS), Web Server or a third party FIPS 140-2 cryptographic module can protect the security of the application when it processes, stores or transmits VA sensitive information. Vendor or third-party support at an enterprise level should be acquired for these software applications to be deployed on the VA network if needed.

[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]	Users must ensure that Microsoft Structured Query Language (SQL) Server is implemented with VA-approved baselines. Security Engineering (SE) conducted a pre-assessment and security requirements verification of ICS. It is advised that if this product is used within the VA that the following constraints be applied: Ensure that the underlying infrastructure such as Operating System (OS), Web Server or a third party FIPS 140-2 cryptographic module can protect the security of the application when it processes, stores or transmits VA sensitive information. Vendor or third-party support at an enterprise level should be acquired for these software applications to be deployed on the VA network if needed.

[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]	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 5.5.0 is the most current version, released 01/11/2019.

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
12-Lead Electrocardiogram (ECG) Interface	The 12-Lead Electrocardiogram (ECG) Interface is designed to provide a means to export 12-lead ECG reports and waveform data to an external system 12-lead database that is part of the hospital`s information system.
Admission-Discharge-Transfer (ADT) Interface (HL7 Inbound)	The ADT Interface (HL7 Inbound) is designed to provide a means for external systems to input, in Health Level Seven (HL7) format, patient demographic data obtained from the hospital`s information system into Spacelabs Intesys Clinical Suite (ICS).
Clinical Access	Clinical Access provides a remote view of patient clinical history stored on the ICS database. The Clinical Access client extracts data from the ICS database and presents retrospective vitals, waveforms, and alarms on a Windows workstation. The following applications comprise Clinical Access: Smart Disclosure, Vital Signs Viewer, Custom Trends, and Print Manager.
Custom Trends	Custom Trends is indicated for use in clinical situations where there is a need for retrospective review of physiological trends and the user desires one or more customized views of the trend data.
Enterprise Network Interface (ENI)	The Enterprise Network Interface is designed to provide historical information regarding past patient alarm events. The information is not provided in real time and is not intended as a basis for diagnosis, clinical decisions, or active patient monitoring. ENI is intended to transfer data to other vendors` information systems using an industry standard data exchange protocol, such as Extensible Markup Language (XML) or HL7.
Intesys Clinical Suite (ICS) Core Services	Core Services is designed to provide the underlying database functionality, utilities, and security that support the overall Intesys Clinical Suite of applications. The Core Services include the Monitor Loader feature that provides the interface between the ICS database and the networked Spacelabs patient monitors.
Print Manager	Print Manager is designed to provide the user with the ability to initiate printing waveforms and data to a networked printer from Spacelabs Healthcare bedside monitors connected to the Spacelabs Patient monitoring network interfaced to the Clinical Access workstation and associated database. Print Manager is indicated for use in clinical situations where there is a need to print information from a Spacelabs patient monitor to a network page printer. It is also indicated in those situations where review or printing of print jobs previously initiated at a patient monitor is desired.
Smart Disclosure System	The Smart Disclosure System collects patient waveforms, alarms, vital signs, and 12-lead reports. This application provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view.
Vital Signs Interface (HL7 Outbound)	The Vital Signs Interface (HL7 Outbound) is designed to provide a means for Spacelabs Intesys Clinical Suite to output vital signs data in HL7 format to the hospital`s information system.
Vital Signs Viewer	Vital Signs Viewer is designed to provide users a means to remotely view patient information and waveforms with associated numeric data obtained from Spacelabs Healthcare patient monitors.

VA Categories View the VA Categorization Framework

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

Operating Systems Supported by the Technology

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

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This is a mature technology.
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.

Adoption Risks

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.
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.
This technology can integrate with and alter database technologies.
This technology has the potential to store, collect, or transmit Personally Identifiable Information (PII)/Protected Health Information (PHI); however, the vendor states that: “Intesys Clinical Suite (ICS) uses a gateway cryptographic module for establishing the Virtual Private Network tunnel. The certificate number for this module is FIPS #2820. The ICS software runs on the Windows software platform, which is FIPS 140-2 compliant”.
There is limited publicly available technical information such as implementation guides for these software applications. The VA may require support for these software applications to be used on the VA enterprise.

Architectural Benefits

This technology is compatible with virtual machines, therefore consistent with the enterprise Server Virtualize First Policy (VAIQ 7266972 08-27-2012).
This technology can use a VA-preferred database.
This technology has the ability to integrate with several Electronic Medical Record (EMR) systems via Health Level Seven (HL7) protocol. Additionally, data can be exported into various cardiology data management systems.

Architectural Risks

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

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