B.01. Solicitation W81K00-21-Q-0259 Attachment 5-HBSS Waiver Template.pdf
PDF 104 KB Posted
- Attached to
- Microwave Ablation System - WBAMC Federal contract opportunity
- Solicitation number
- W81K0021Q0259
- Issued by
- Department of the Army Medical Command
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Solicitation W81K00-21-Q-0259 Amendment 0001.pdf | ||
| Solicitation W81K00-21-Q-0259 Microwave Ablation.pdf | ||
| B.01. Combined Synopsis and Solicitation W81K0021Q0259 Cover Page.pdf | ||
| B.01. Solicitation W81K00-21-Q-0259 Attachment 1-Medical Device Risk Assessment Questionnaire ~.docx | DOCX document |
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Text version
HBSS Waiver Request
DATE:
All fields or sections are required to be filled out/completed before request is reviewed.
Per USCYBERCOM OPORD 16-0080, FRAGO 1, waiver requests must be submitted for approval for systems or networks that cannot be modified to use Endpoint Security tools or any of its components due to exemption criteria listed in Section 3.C.3.D of this OPORD. Waiver requests must be sent to the Combatant Command, Service, Agency or Field Activity (CC/S/A/FA) J3 (or equivalent Operations Leadership) for review and approval prior to submitting to USCYBERCOM. The CC/S/A/FA J3 will ensure the appropriate Authorizing Official (AO) has approved the request, and will forward the request and exempted system's ATO on to USCYBERCOM.
CC/S/A/FA (i.e. CENTCOM, Navy, DFAS, etc.)
Sub Organization Point of Contact Information:
Full Name Job Title and Grade/Rank Office Symbol/Department Phone Number (DSN & COMM) E-mail Address (SIPR/NIPR)
Organization requiring waiver or exemption
HBSS module(s) or directive(s) requiring waiver:
ACCM DCM HIPS PA Rollup
Event Feed OAM RSD Other_______ (Anti-Virus is required)
Total number of hosts affected by waiver: Unclassified: Classified:
Certification and Accreditation expiration date for affected systems or network: Unclassified: Classified:
Ensure the following are attached/included:
(ensure documents are correctly classified and handled)
Host/Network technical information (e.g. Network diagrams, IP ranges, computer names) Plan Of Action and Milestones
Waiver Request Submission Information
(1) Identify system, or network, that is not capable of supporting Endpoint Security tools / HBSS as directed (i.e., System Name and brief description):
(2) Identify the Endpoint Security tools / HBSS modules which cannot be installed or supported as directed (e.g. HIPS 8 Patch 4, RSD 4.7.2, ePO 4.6.8) including specific module versions:
(3) Identify the reason(s) why specified system or network is not capable of supporting Endpoint Security tools / HBSS directives (i.e., technical, resource, capability, and/or time constraints):
(4) Provide any supporting data and test results that show Endpoint Security / HBSS modules or directives cannot be supported:
(5) Mission Impact if waiver is not approved:
(6) Other mitigation techniques that will be put in place in the interim to protect the system, or network, in question:
(7) A Plan of Action and Milestones (POA&M) are required for waivers with expected completion dates. If no POA&M is included, provide justification for why the use of Endpoint Security tools / HBSS is infeasible.
Approval Signatures
CC/S/A/FA J3
(Full Name, Grade/Rank, Title)
CC/S/A/FA J3 Signature (manual or digital)
CC/S/A/FA Authorizing Official (Full Name, Grade/Rank, Title)
CC/S/A/FA Authorizing Official's Signature
(manual or digital)
| DATE YYYYMMMDD: |
| CCSAFA ie CENTCOM Navy DFAS etc: Defense Health Agency |
| Sub Organization: RHC-C |
| Point of Contact Information: |
| Full Name: |
| Job Title and GradeRank: |
| Office SymbolDepartment: |
| Phone Number DSN COMM: |
| Email Address SIPRNIPR: |
| Organization requiring waiver or exemption: |
| Other: |
| Unclassified: |
| Classified: 0 |
| Unclassified_2: |
| Classified_2: |
| 1 Identify system or network that is HBSS compatible but is not capable of supporting HBSS as directed eg Windows 7 64bit Red Hat Enterprise Linux 6xetcRow1: |
| 2 Identify the HBSS modules which cannot be installed or supported as directed eg HIPS 8 Patch 4 RSD 472 ePO 468 including specific module versionsRow1: |
| 3 Identify the reasons why specified system or network is not capable of supporting HBSS directives ie technical resource capability andor time constraintsRow1: |
| 4 Provide any supporting data and test results that show HBSS modules or directives cannot be supportedRow1: |
| 5 Mission Impact if waiver is not approvedRow1: |
| 6 Other mitigation techniques that will be put in place in the interim to protect the system or network in questionRow1: There are numerous mitigations in place to minimize threats and potential negative impacts to the facility and DoD networks. The device has a limited number of ports, protocols and services which are supported which significantly reduces possible threat vectors. The device is located in Treatment Rooms and Intensive Care units which must first be accessed in order to exploit this particular device. Physical and Logical Isolation within the DHA network supports a Defense in Depth strategy which also mitigates this vulnerability. |
| 7 A Plan of Action and Milestones POAM are required for waivers with expected completion dates If no POAM is included provide justification for why the use of HBSS is infeasibleRow1: This is a COTS 510k certified medical device. Implementation of HBSS technologies are not feasible due to the sensitive nature of the device design. It would require complete re-engineering by the vendor and potentially a complete recertification by the FDA to ensure that there are no negative effects on clinical efficacy. Additionally, the substantial re-engineering effort required for this commercially viable COTS device would be financially prohibitive for the vendor. |
| Check Box1: Yes |
| Check Box2: Yes |
| Check Box3: Yes |
| Check Box4: Yes |
| Check Box5: Yes |
| Check Box6: Yes |
| Check Box7: Yes |
| Check Box8: Yes |
| Check Box9: Yes |
| CCSAFA Operations Authority Full Name GradeRank Title CCSAFA Operations Authority Signature manual or digital: THOMAS G. HINES, Civ, DOD, Authorizing Official, Director Engineering and Technology Transformation, J6, DHA |
| CCSAFA DAA Full Name GradeRank Title CCSAFA DAA Signature manual or digital: JEFFREY A. EYINK, Civ, DOD, Security Controls Assessor, Chief, Assessment and Authorization Branch, J6, DHA |
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