Attachment 1 - CCN NG Dental Clauses and Provisions.docx

36C10X23R0007 Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

In accordance with FAR 52.243-1, the Government reserves the right to unilaterally make changes to this contract without requiring the Contractor’s concurrence. If the Contractor believes the change warrants an equitable adjustment to the contract price, schedule, or other terms, the Contractor shall submit a complete Request for Equitable Adjustment to the Contracting Officer within 30 calendar days from the implementation date of the new or modified requirement.

B.2 PRICE SCHEDULE

RESERVED

B.3 TUNGSTEN ELECTRONIC INVOICE SUBMISSION

RESERVED

B.4 INTEGRATED PRODUCT TEAMS

In order to address evolving technologies or new healthcare services, the Government may develop requirement and program changes that will result in contract, task order, and CCN Contractor Manual modifications or updates through the use of Integrated Product Teams (IPTs) staffed by Government and Contractor personnel. The Government will not establish IPTs for all contract changes but generally will establish them to address system-wide issues impacting all CCN Next Generation contracts. The IPT process required in this section will begin on the date the CO notifies the Contractor in writing of the Government’s intent to establish an IPT. Within 14 days after receiving such written notification, the Contractor shall identify the appropriate personnel (as agreed to by the CO and the Contractor) to serve on the IPT to develop and/or improve the technical, business, and implementation approach to any proposed CCN program or contract change.

The Contractor shall participate in all required IPT meetings, as determined by the Government designated team lead, regardless of the mode of meeting (in person or via teleconference, video-teleconference, or another electronic conference mode). The frequency and scheduling of such meetings will vary depending on the topic. The Contractor shall participate with the Government team in the entire process from concept development through establishment of the final requirement. The IPT process required in this section may include developing the Government’s budgetary cost estimates, identifying requirements, developing associated rough order of magnitude cost estimates, and preparing the final specification/statement of work. The IPT process will not include post-change order activities, such as implementation/ coordination meetings and definitization efforts, the costs of which will be allocable to the change order itself.

The Government will have sole discretion to decide to implement an IPT’s recommendation based on designed outcomes and budgetary cost estimates. The Contractor shall partner with the Government to make best efforts to pre-review any proposed contract modifications and CCN Contractor Manual changes to ensure that the Government’s implementation of such changes does not significantly deviate from the Government’s designed outcomes and budgetary cost estimates for the project.

Unless otherwise determined, on a case-by-case basis, by the Government, the IPT process shall occur as follows:

1. Establish IPT membership

a. Establish full-team and component teams (e.g. technical, cost)

b. Establish Government-only and Contractor-only teams that allow for issues to be raised on a non-attribution basis

2. IPT Kick-off Meeting

a. Review IPT Objectives and resource demands required to support the technical and time needs of the IPT

b. Identify Key Milestones and ITP Deliverables

c. Establish IPT Schedule, to include meeting cadence, dates, and times for the full team, component teams, Government-only team(s), and Contractor-only team(s)

d. Discuss method(s) of communication and exchange of information and documentation

3. Meet and work in accordance with the IPT Schedule to develop the necessary IPT Deliverables. As determined by the Government, such documents may include but are not limited to:

a. Work Breakdown Structure (WBS)

b. Performance Work Statement (PWS)

c. Attachments to PWS

d. Rough Order of Magnitude (ROM)

e. Basis of Estimate (BOE)

4. CCRB review and concurrence of IPT Deliverables

5. Revise/update as necessary based on feedback from CCRB

6. Submit finalized IPT Deliverables to Strategic Acquisition Center (SAC) for processing

B.5 CONTRACT MODIFICATION

The Contractor shall partner with the Government to make best efforts to pre-review any proposed contract modifications stemming from policy, rule, regulatory, statutory, and CCN Contractor Manual changes to ensure that the Government’s implementation of such changes does not significantly deviate from the Government’s designed outcomes and budgetary cost estimates for CCN and VHA.

Submission Deadlines: The Contractor shall submit all proposals, including but not limited to technical, cost, and management proposals, by the deadlines specified in the contract schedule or as otherwise directed by the Contracting Officer.

1. Notification of Submission: The Contractor shall provide written notification to the Contracting Officer confirming the submission of proposals no later than one (1) business day following the submission.

2. Extension Requests: The Contractor may request an extension of the proposal submission deadline. Such requests shall be submitted in writing to the Contracting Officer no less than 3 business days prior to the original submission deadline. The Contracting Officer may, at their discretion, grant or deny the request for an extension.

3. Mitigating Circumstances: In the event of unforeseen circumstances beyond the control of the Contractor, which prevent timely submission, the Contractor shall notify the Contracting Officer immediately and provide documentation supporting the delay. The Contracting Officer will assess the situation and may provide an extension.

4. Records of Submission: The Contractor is required to maintain accurate records of all proposal submissions, including dates and times, and provide such records to the Contracting Officer upon request.

5. Consequences of Late Submission: Failure to submit proposals by the specified deadlines, without an approved extension from the Contracting Officer, may result in the following:

a) Performance Evaluation: Late submissions may negatively impact the Contractor’s performance evaluation and future contract opportunities with the VA.

b) Termination for Default: Repeated failure to submit proposals timely may result in termination of the contract for default in accordance with the contract's termination provisions.

B.6 SAC 18-01-SAC SERVICE LEVEL AGREEMENT FEE

RESERVED

B.7 SAC IT CONTRACT SECURITY

GENERAL

The Community Care Network Next Gen (CCN NG) Contractor will require direct access to VA information or VA systems to meet the requirements of the CCN contract. The CCN Contractor will need to send and receive data to VA internal systems. VA and its partners must exchange data using a standardized format such as HL7, EDI, and consider FHIR as it becomes standardized in the industry. The HL7 FHIR standard allows health apps (like HSRM) to leverage data from any EHR in a standard format. The Contractors shall educate providers to have a FHIR interface as a solution to return information back to VA. VA also encourages implementation of Trusted Exchange Framework and Common Agreement (TEFCA) or SMART on FHIR.

VA will legally disclose a copy of the required sensitive Government Furnished Information to the CCN Contractor under the authority of the Privacy Act System of Records “Non-VA Care (Fee) Records-VA”, 23VA10B3 Routine Use 10 ( 80 FR 146, July 30, 2015), Privacy Act System of Records “Patient Medical Records-VA”, 24VA10P2 Routine Use 43 (79 FR 157, August 14, 2014), 38 U.S.C. 5701, HIPAA Privacy Rule provision 45 CFR § 164.506(c) and The Veterans Choice Program Improvement Act, Public Law 115 26 and 38 U.S.C. 7332(b)(2)(H). The data will be sent via Federal Information Processing Standards (FIPS) 140-2 (or successor) validated encryption transmission. The CCN Contractor will receive, retain and then maintain the data copy and return to VA the agreed upon information. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

B.7.1 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

The Contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employer. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

B.7.2 INFORMATION CUSTODIAL LANGUAGE

Information made available to the Contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1.)

VA information should not be co-mingled with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, the contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 calendar days of termination of the contract.

The Contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The Contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

If VA determines that the Contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions be taken in accordance with VHA Handbook 1600.05, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

The Contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer to all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

Notwithstanding the provision above, the Contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that Contractor/ subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

B.7.3 INFORMATION SECURITY

The CCN Contractor shall send and receive sensitive data to and from VA using NIST FIPS 140-2 validated encryption. The CCN Contractor shall attest to protect Government Furnished Information in accordance with the HIPAA Security Rules. In addition, the CCN Contractor shall enforce the privacy and security provisions of HIPAA through the Health Information Technology for Economic and Clinical Health Act [footnoteRef:1] or HITECH Act that incentivizes the meaningful use of EHRs, complies with privacy rule standards, and the new Breach Notification Rule. [1: Health Information Technology for Economic and Clinical Health (HITECH) Act, Pub. L.111-5, 123 Stat. 226,260 (2009), codified at 42 U.S.C. 17932.]

If an Electronic Healthcare Network Accreditation Commission (EHNAC) certification has been obtained, provide the assigned certification number. If a Federal Government Authority to Operate (ATO) has been obtained within the past three years, provide a copy of the ATO obtained, and the agency issuing the ATO). If the CCN Contractor has neither of these, the Contractor must provide a synopsis of their network security controls environment as part of their proposal. Upon contract award the CCN Contractor shall complete a Contractor Security Control Assessment (CSCA) within 30 calendar days of contract award and on a yearly basis thereafter to VA’s COR. The Contractor shall cooperate and assist in a government-sponsored security controls assessment, including those initiated by the Office of Inspector General. The Government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

B.7.4 INFORMATION SYSTEM DESIGN AND DEVELOPMENT

Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program, and the TIC Reference Architecture). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6508, Implementation of Privacy Threshold Analysis and VA Privacy Impact Assessment.

The Contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 11 configured to operate on Windows 7 and future versions, as required.

The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

The Contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. The contractor/subcontractor agrees to:

· Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

· The Systems of Records (SOR)

· The design, development, or operation work that the contractor/subcontractor is to perform Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

“System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

The Contractor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

The Contractor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 5 working days.

When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 10 working days.

All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 calendar days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

B.7.5 INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, Contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation. For Cloud Services hosting, the Contractor shall also ensure compliance with the Federal Risk and Authorization Management Program (FedRAMP).

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Assessment, Authorization and Continuous Monitoring of VA Information Systems and/or the VA OCS Certification Program Office. Government owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The Contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA Contracting Officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The Contractor/subcontractor shall conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or Contractor/subcontractor-owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 calendar days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

1. Vendor must accept the system without the drive

2. VA’s initial medical device purchase includes a spare drive which must be installed in place of

3. the original drive at time of turn-in; or

4. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

5. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then:

The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

B.7.6 SECURITY INCIDENT INVESTIGATION

The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

B.7.7 LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access)

(2) Description of the event, including:

(a) date of occurrence

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code

(3) Number of individuals affected or potentially affected

(4) Names of individuals or groups affected or potentially affected

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text

(6) Amount of time the data has been out of VA control

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons)

(8) Known misuses of data containing sensitive personal information, if any

(9) Assessment of the potential harm to the affected individuals

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3

(3) relevant credit bureau reports;

(4) Data breach analysis;

(5) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(6) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(7) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

B.7.8 DATA RIGHTS

1. The VA Data Repository Schema, the MVI Identity Management Data along with a copy of individually identifiable health information or personal health information of Veterans (hereinafter collectively known as “Government Furnished Information”) will be delivered to the Contractor in order for the Contractor to administer the services set forth in this contract. The CCN Contractor will own the copy it receives from VA of the individually identifiable health information or personal health information of Veterans.

2. Government Furnished Information modified, updated, revised or changed in any manner by the Contractor during performance of the contract is technical data as that term is used in FAR 52.227-14, Rights in Data—General (May 2014) and VA shall receive unlimited rights to all such data.

3. All data, and any and all data elements, first produced by the Contractor during performance of this contract that is contained in the Contractor’s data reports, VA Data Repository, and in the Contractor’s Interactive Dashboard shall be deemed technical data as that term is defined in FAR 52.227-14, Rights in Data—General (May 2014) and VA shall receive unlimited rights to all such data. With respect to Contractor’s provider reimbursement rates, in the event the Contractor notifies VA in writing of the proprietary nature of the rates, VA agrees that it will not disclose such rates outside the Federal Government in connection with a competitive acquisition for same or similar services to the CCN.

4. During the period of performance of the contract, VA shall have unlimited rights and access to both Government Furnished Information and any and all technical data produced by the Contractor.

5. At the conclusion of the contract, Contractor shall deliver to VA in a format acceptable and approved by VA all data, including but not limited to the Government Furnished Information and technical data, entered into and processed by the Contractor in performance of this Contract in order that such data can be used, stored, and/or maintained by the Government. The parties agree that the technical data generated, stored, and processed by the Contactor pursuant to this Contract may contain both Sensitive Information and identifiable health information or personal health information of Veterans such that the disclosure thereof would violate the right of privacy or publicity of the individual to whom the information relates or the right of privacy and publicity of VA. Accordingly, the Contractor relinquishes its reservation of rights set forth in FAR 52.227-14 (b) (2) for all technical data delivered to the Contracting Officer at the conclusion of this contract.

6. The Contracting Officer will be the sole authorized official to release, in writing, any VA Government Furnished Information, technical data or any other written or printed materials pertaining to the solicitation (resulting award) maintained and provided by Contractor pursuant to the requirements of the contract. The Contractor will not release any such information.

B.7.9 SECURITY CONTROLS COMPLIANCE TESTING---N/A

B.7.10 TRAINING

a. All Contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

1. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, updated version located at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4848, relating to access to VA information and information systems

2. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training (TMS #10176)

3. Successfully complete the appropriate VA privacy training and annually complete required privacy training

4. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] The Contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 2 working days of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

B.7.11 SYSTEM SECURITY GOVERNANCE

The Contractor is required to achieve and maintain a FedRamp rating as directed by VA and governed by the FedRamp.gov program. This rating must apply to any and all interfaces or data repositories maintaining or displaying health care PHI, PII, or financial information.

B.7.12 ENTERPRISE AND IT FRAMEWORK

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OI&T Technical Reference Model (One-VA TRM). One-VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. One-VA TRM includes the Standards Profile and Product List that collectively serves as a VA technology roadmap. Architecture, Strategy, and Design (ASD) has overall responsibility for the One-VA TRM. The Contractor shall ensure Commercial Off-The-Shelf (COTS) product(s), software configuration and customization, and/or new software are PIV-enabled by accepting HSPD-12 PIV credentials using VA Enterprise Technical Architecture (ETA), http://www.ea.oit.va.gov/VA_EA/VAEA_TechnicalArchitecture.asp, and VA Identity and Access Management (IAM) approved enterprise design and integration patterns, http://www.techstrategies.oit.va.gov/enterprise_dp.asp. The Contractor shall ensure all Contractor delivered applications and systems are compliant with VA Identity Management Policy (VAIQ# 7011145), Continued Implementation of Homeland Security Presidential Directive 12 (VAIQ#7100147), and VA IAM enterprise identity management requirements (IAM Identity Management Business Requirements Guidance document), located at https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514. The Contractor shall ensure all Contractor delivered applications and systems provide user authentication services compliant with NIST Special Publication 800-63, VA Handbook 6500 Appendix F, “VA System Security Controls”, and VA IAM enterprise requirements for direct, assertion-based authentication, and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of Personal Identity Verification (PIV) and/or Common Access Card (CAC), as determined by the business need.

B.8 DEFINITIONS

RESERVED

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SECTION C - CONTRACT CLAUSES

C.1 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (NOV 2021)

(a) Definitions. As used in this clause— Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information…