ATO - Philips IntelliVue MX450 Vital Signs Monitors.pdf

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Attached to
USAFA - Philips Vital Signs Monitors (Brand Name)
Solicitation number
FA700025Q0136
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About this file

This document is a system details record for the Philips Healthcare IntelliVue Series Patient Monitors, registered in the Defense Health Agency (DHA) enterprise system. The system consists of multiple monitor models (MX series 40-850, MP series MP5/20/30/50/70/90, and X2/X3) intended for monitoring physiological parameters of patients in hospital environments. The monitors support TCP/IP but operate on an isolated Philips Intellivue patient network, with a real-time operating system (RTOS) that has a hardcoded configuration and does not support standard credentialed scanning protocols.

Key system details include an eMASS ID of 2928, authorization status of Approved (dated 8/29/2023 with an Authorization to Operate date of 8/29/2026), and deployment across multiple locations including military bases and hospitals in the United States, Guam, Japan, United Kingdom, and Korea. The system is classified as medical devices and equipment, processes and transmits electronic Protected Health Information (ePHI) without storing it, and is managed under the Cyber Logistics Center of Excellence (COE) with ongoing Risk Management Framework (RMF) efforts. The current system status indicates it is being maintained under CyberLOG Configuration Management guidance with no upcoming Plan of Action and Milestones (POA&Ms).

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PHILIPS HEALTHCARE INTELLIVUE SERIES PATIENT MONITORS VERSION

B/C/M/N/P.X_AI

SYSTEM DETAILS

eMASS ID† 2928

System Name† Philips Healthcare IntelliVue Series Patient Monitors Version B/C/M/N/P.x_AI

Acronym†ℹ️ IntelliVue Series

Version† B.0x/C.0x/M.0x/N.0x/P.0x

System Description† The Philips Intellivue family of monitors consist of the MX series (40, 100, 400, 450, 500, 550, 700, 750, 800, 850), MP series (MP5/20/30/50/70,90) and the X2 and X3. The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

The monitors are intended for use by trained healthcare professionals in a hospital environment. The MP30/MP50 monitors are additionally intended for use in transport situations within hospital environments. Only the MP5 monitor is for use during patient transport outside of the hospital environment The monitors does support TCP/IP but operate on a isolate non-routed Philips Intelllivue patient network. The real time operating system (RTOS) kernel has a hardcoded configuration and does not offer device or OS level interfaces for run-time configuration and management. The device therefore does not support credentialed scanning using any of the standard protocols typically found with mainstream Operating Systems (Ref: "Intellivue Series_2928_Scanning Memo_AI_21April23_V2") The primary hardware components are Intellivue monitors and the primary software is Philips Intellivue RTOS versions N.x, M.x, B.x, C.x, and P.x. The device does process and transmit ePHI but does not store ePHI on the device.

Vendor Philips Healthcare

Program or Site

System Type† Medical Devices and Equipment

Authorization Status† Approved

Authorization Date† 8/29/2023

ATD† 8/29/2026

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Site Functional:

CSTAR Team

Administrator

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Health Affairs DHA Chief of Staff Resources & Personnel Integration (J-1/8) Health Care Administration Support/CAE (J-4/6) DHA J-3/5/7 Services

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9/24/24, 9:47 AM System https://info.health.mil/apps/HIT/cstar/SitePages/System.aspx?IDX=10551 1/8 mailto:dha.jbcharleston.j-6.list.cstar@health.mil mailto:dha.jbcharleston.j-6.list.cstar@health.mil https://info.health.mil/agency/mhs https://info.health.mil/ https://info.health.mil/hco/pages/home.aspx https://info.health.mil/cos/Pages/RPIHome.aspx https://info.health.mil/HCA/Pages/Home.aspx https://info.health.mil/J-357/Pages/J-357.aspx https://info.health.mil/hit/508/Pages/Home.aspx

Registration Completion Date† 7/9/2020

Operational Status

DITPR† N/A - Medical Device are DHP Funded

PPSM† Umk24v06s

PII† Yes

PHI† Yes

PIA Required† Yes

PIA Date† 11/15/2023

PIA Status† Completed

PIA Expiration Date† 11/15/2026

Privacy Act System of Records Notice Required†

Yes

Privacy Threshold Analysis Completed†

No

Decommission Memo Status

MEDCOI Migration Status

Funding Received

Component

Organization† Cyber Logistics COE

Administrative Directorate / Agency / Service†

ADCS

Program Office† Cyber Logistics COE

Directorate / Region†

Division† ML Division

Branch† HTM Branch

Region

EaaS Subsystem

CATEGORIZATIONS

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SYSTEM POCS

AO+ℹ️

AODR+ℹ️

SCA+ℹ️

SCARℹ️

Event Lead Validatorℹ️

Event Analystℹ️

Commander / Hospital Commanderℹ️

System / Site CIOℹ️

Deputy CIOℹ️

System Owner/PMℹ️

ISSEℹ️

System IA POCℹ️

ISSMℹ️

ISSOℹ️

PCLO Analyst+ℹ️

PIA POC+ℹ️

DHA Records Managementℹ️

Market Place Leadℹ️

TAS Leadℹ️

D2D Trans Approval Gov Leadℹ️

ESABADℹ️

D2D Teamℹ️

SAVR Enterprise RMF Support Leadℹ️ SAVR Enterprise RMF Support Engineerℹ️

SAVR Enterprise RMF Support Backupℹ️

SAVR Analystℹ️

Thomas Flanders x

COL Joseph Hoffert x

Roberto Rojascorrea x

Jacob Belyna x

Leslie Bishop x

Gerardo Ramon x

Andrew Mcgraw x

Shannon Faye x

Jeremiah Bartlett x

Jeremiah Bartlett x

Crystal Delk x

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CHRIP Team Leadℹ️

CHRIP Coordinatorℹ️

CHRIP Enterprise Tools SMEℹ️

CHRIP Testing SMEℹ️

CHRIP Tool SMEℹ️

RMED Analystℹ️

Vendor POCℹ️

Network Engineerℹ️

HIPAA Privacy Officerℹ️

Facility Managerℹ️

PERSEC Officerℹ️

System Administrator Leadℹ️

CONTINUOUS MONITORING

Add Continuous Monitoring

AUTHENTICATION SECURITY PLAN

Link to view Authentication Security Plan data: ASP List

ADDITIONAL DETAILS

Network Authorized

Funding Received

Medical Specialty

Sizeℹ️ escID 20200710-072718

DAD IO/J-6 Request URL Link:

http://info.health.mil/apps/HIT/services/SitePages/escDispFor m.aspx?escID=15626

Label: http://info.health.mil/apps/HIT/services/SitePages/es

URL: http://info.health.mil/apps/HIT/services/SitePages/esc

Support Requested Assess & Incorporate

COAMS ID†

General Hospital x

Medium x

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System Registered in DITPR

DITPR Number used in all system documentation Existing Authorization

Baseline Location Recommendation†

NC - Camp Lejeune

Deployed Locations† FL - Jacksonville KOR - Osan MD - Bethesda ESP - Rota CO - Ft Carson ESP - NS Rota GA - Ft Eisenhower GUM - Andersen JPN - Misawa MD - Joint Base Andrews MO - Ft Leonard Wood NC - Ft Liberty NC - Seymour-Johnson AFB NV - Nellis AFB TN - Lovell Field CAP GBR - RAF Lakenheath TX - Ft Sam Houston SC - Beaufort GUM - Guam USNH VA - Portsmouth HI - Tripler AMC NC - Camp Lejeune NC - Cherrypoint

RegistrationType† Assess Only

HealthCare Market

Certified Market

CyberLog Workgroup

Cloud Computing† No

Cloud Type†

Other Service Models†

Milestone

Path Forward

Yes x

Direct Care x

2 x

ATO-C for IV&V x

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CONTRACT INFORMATION

ACN or Contract # No entries yet.

DEVICES

ITEM DETAILS

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Vendor Make Model Software Version Device Code Actions

Philips Healthcare Intellivue MP20 2.X 12636

Philips Healthcare Intellivue MP5 2.X 17588

Philips Healthcare Intellivue MP5SC 2.X 17588

Efforts Efforts Effort Type 2 Effort Status 1 Start Date Estimated Completio Active Conditions Comments PIA In Process 4/20/2023 11/9/2023 No

Services Service Status POD Start Date Estimated Completion

There are no items to show in this view of the "Services" list.

Conditions Condition Due Date Status Responsible POC Notes Make authorization documentation available to other components or Program Offices to utilize for reciprocity and reuse purposes as

1/15/2021 Complete Wilbourne, Jonathan C Mr CTR DHA CSD 59540

Active Archived All

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9/24/24, 9:47 AM System https://info.health.mil/apps/HIT/cstar/SitePages/System.aspx?IDX=10551 6/8 https://info.health.mil/apps/HIT/cstar/SitePages/Effort.aspx?IDX=10739 https://info.health.mil/apps/HIT/cstar/SitePages/System.aspx?IDX=10551 https://info.health.mil/apps/HIT/cstar/SitePages/System.aspx?IDX=10551 mandated by the DoD CIO's Cybersecurity Maintain and continue to update system information, artifacts, and risk information in eMASS.

1/15/2021 Complete Wilbourne, Jonathan C Mr CTR DHA CSD 59540

Ensure any significant/major change to the system will be reported to the SCA for evaluation.

1/15/2021 Complete Wilbourne, Jonathan C Mr CTR DHA CSD 59540

Ensure any change in support or architecture will be reported to the DHA SCA immediately.

1/15/2021 Complete Wilbourne, Jonathan C Mr CTR DHA CSD 59540

Follow the DHA Cybersecurity scorecard reporting as outlined in Scorecard flowchart.

1/15/2021 Complete Wilbourne, Jonathan C Mr CTR DHA CSD 59540

Follow the DHA IAVM/Issuances process. 1/15/2021 Complete Wilbourne, Jonathan C Mr CTR DHA CSD 59540

Report POA&M Status, through DHA CSD, to the DHA SCA via the DHA POAM monitor on a monthly basis.

1/15/2021 Complete Wilbourne, Jonathan C Mr CTR DHA CSD 59540

Complete, as necessary, a Privacy Impact Assessment (DD Form 2930) within 180 Days of authorization date.

2/13/2021 In Process Wilbourne, Jonathan C Mr CTR DHA CSD 59540

Ensure all assets are properly tag in ACAS, HBSS and CMRS within 30 days of

9/16/2020 In Process No POC Assigned

Updates new update Export Save Changes Undo Redo

Created System Status / Notes Applies To Created By 4/24/2024 This RMF effort is currently Transitioning ISSMs & ISSOs within

CyberLog. The Vendor POC is Stacie Brough, email:

Stacie.brough@hillrom.com, phone (315) 554-5912. This device is not scannable. Currently we are not waiting for the vendor to provide any items. We are not waiting for the MTF to provide any items. No vendor reoccurring meeting are currently scheduled.

J3 Cyberlog PO Edward Escobedo

4/15/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No upcoming POA&Ms or actions for this device.

J3 Cyberlog PO Eric Drynan

3/29/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No upcoming POA&Ms or actions for this device.

J3 Cyberlog PO Eric Drynan

3/15/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No upcoming POA&Ms or actions for this device.

J3 Cyberlog PO Eric Drynan

3/4/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No upcoming POAMs or actions for this device.

J3 Cyberlog PO Edward Escobedo

2/26/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No upcoming POAMs or actions for this device

J3 Cyberlog PO Edward Escobedo

2/9/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No J3 Cyberlog PO Edward Escobedo

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CONTACT US: Web & Mobile Technology PMO | No FEAR Act | Accessibility/Section 508

CONTACT GSC: 800-600-9332 or Visit the Global Service Center site here: https://gsc.health.mil/ Submit Service Request da i POAM ti f thi d i2/2/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No upcoming POAMs or actions for this device.

J3 Cyberlog PO Edward Escobedo

1/30/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No upcoming POAMs or actions for this device.

J3 Cyberlog PO Edward Escobedo

1/19/2024 NSTR. Device is being maintained under CyberLOG CM Guidance. No upcoming POAMs or actions for this device.

J3 Cyberlog PO Edward Escobedo

1/12/2024 Device is being maintained under CyberLOG CM Guidance. No upcoming POAMs or actions for this device.

J3 Cyberlog PO Edward Escobedo

1/4/2024 S stem transitioned to ne ISSO and POC information pdated on 4 J3 C berlog PO Da id Farris

HIT Portal Requests Title Status 1 Current Step Service Request Type Created 2

20240923-065043 Active 2 Assessment and Authorization

Application Assessment 9/23/2024

20230216-113618 Closed 7 Assessment and Authorization

Cost Estimate 2/16/2023

20200710-072718 Closed 7 Assessment and Authorization

Assess and Incorporate 7/10/2020

Issues Edit Issue Title Created Issue Notes Active Closed Date Status

Baseline Site 7/13/2020 Camp Lejeune true 11/23/2020 Completed

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| SERVICES | MILSUITE

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