Att_06_IT Security and Privacy Clauses.pdf

Attachment 6

NIH ICO Information Security & Privacy Certification Checklist for Procurements (V2 Aug 2026) FORM Part D Attachment (V1 Aug 2026) Page 1 of 58

IT Security and Privacy Clauses

ARTICLE H.56.3. NOTIFICATION OF SYSTEM OF RECORDS NOTICE, HHSAR 352.224-70 (FEB 2024)

(DEVIATION).

(a) This contract provides for the design, development, or operation of a system of records about individuals from which information about an individual is retrieved by the individual’s name or by some other identifying particular assigned to the individual.

(b) The System of Records Notice(s) (SORN(s)) that is applicable to this contract is: SORN 09- 25-0200, 09-25-0099, and 09-25-0216. If there is no SORN, indicate that a new or revised SORN will be developed].

(c) The System of Records design, development, or operation work the Contractor is to perform is: contractor personnel may access and handle participant-level clinical research information, including demographic, clinical and medical, genetic and genomic, laboratory, study, and safety-related data, as applicable to the supported protocols.

(d) The disposition to be made of the Privacy Act records upon completion of contract performance is as follows: Cut off annually at termination of project/program or when no longer needed for scientific reference, whichever is longer. Destroy seven (7) years after cutoff.

(e) Subcontract flow down. The Contractor is required to include this clause in all subcontracts at any tier performing work under the prime contract involving design, development, or operation work involving a System of Records.

(End of clause).

NOTE: The SORN describing the types of information contained in the records, the legal authority for collecting and maintaining the records, how the records are used within HHS, and the purposes (referred to as "routine uses") for which HHS may disclose the records to non-HHS parties without the individual record subject's consent is found at: https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html.

ARTICLE H.56.4. INFORMATION AND INFORMATION SYSTEMS SECURITY, HHSAR 352.204-71 (FEB 2024)

(a) Definitions. As used in this clause—

Breach means the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where— https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html

FORM Part D Attachment (V1 Aug 2026) Page 2 of 58

(1) A person other than an authorized user accesses or potentially accesses personally identifiable information, or

(2) An authorized user accesses personally identifiable information for an other than authorized purpose.

Business associate (see 45 CFR 160.103), except as provided in paragraph (2) of this definition, business associate means, with respect to a covered entity, a person who -

(1) On behalf of such covered entity or of an organized health care arrangement (as defined in this clause) in which the covered entity participates, but other than in the capacity of a member of the workforce of such covered entity or arrangement, creates, receives, maintains, or transmits protected health information for a function or activity regulated by this contract or agreement, including claims processing or administration, data analysis, processing or administration, utilization review, quality assurance, patient safety activities listed at 42 CFR 3.20, billing, benefit management, practice management, and repricing; or

(2) Provides, other than in the capacity of a member of the workforce of such covered entity, legal, actuarial, accounting, consulting, data aggregation (as defined in 45 CFR section 164.501), management, administrative, accreditation, or financial services to or for such covered entity, or to or for an organized health care arrangement in which the covered entity participates, where the provision of the service involves the disclosure of protected health information from such covered entity or arrangement, or from another business associate of such covered entity or arrangement, to the person.

(3) A covered entity may be a business associate of another covered entity.

(4) Business associate includes the following:

(i) A Health Information Organization, E-prescribing Gateway, or other person that provides data transmission services with respect to protected health information to a covered entity and that requires access on a routine basis to such protected health information.

(ii) A person that offers a personal health record to one or more individuals on behalf of a covered entity.

(iii) A subcontractor that creates, receives, maintains, or transmits protected health information on behalf of the business associate.

(5) Business associate does not include:

(i) A health care provider, with respect to disclosures by a covered entity to the health care provider concerning the treatment of the individual.

https://www.ecfr.gov/current/title-42/section-3.20 https://www.ecfr.gov/current/title-45/section-164.501 https://www.ecfr.gov/current/title-45/section-164.501

FORM Part D Attachment (V1 Aug 2026) Page 3 of 58

(ii) A plan sponsor, with respect to disclosures by a group health plan (or by a health insurance issuer or HMO with respect to a group health plan) to the plan sponsor, to the extent that the requirements of 45 CFR 164.504(f) apply and are met.

(iii) A government agency, with respect to determining eligibility for, or enrollment in, a government health plan that provides public benefits and is administered by another government agency, or collecting protected health information for such purposes, to the extent such activities are authorized by law.

(iv) A covered entity participating in an organized health care arrangement that performs a function or activity as described by paragraph (1)(i) of this definition for or on behalf of such organized health care arrangement, or that provides a service as described in paragraph (1)(ii) of this definition to or for such organized health care arrangement by virtue of such activities or services.

Business associate agreement means the agreement, or other arrangement, as dictated by the HIPAA Privacy Rule (45 CFR 160), between an HHS covered entity and a business associate, which must be entered into in addition to the underlying contract for services and before any disclosure (see 45 CFR 160.103) of PHI can be made to the business associate, in order for the business associate to perform certain functions or activities on behalf of an HHS entity.

Controlled unclassified information (CUI) means information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.

Healthcare component means a component or combination of components of a hybrid entity designated by the hybrid entity in accordance with 45 CFR 164.105(a)(2)(iii)(D) (see 45 CFR 164.103). The Secretary of HHS has designated HHS as a covered entity (further designated as a “hybrid entity”), and has also designated four HHS divisions as healthcare components under HIPAA, including

(1) The Centers for Medicare and Medicaid Services (CMS), insofar as it operates the fee-for-service Medicare program;

(2) The Program Support Center (PSC), Division of Commissioned Personnel, insofar as it operates a health plan for Commissioned Corps officers;

(3) The World Trade Center (WTC) Health Program; and,

(4) The Indian Health Service (IHS), insofar as it operates a health plan and a program providing healthcare that uses electronic transactions.

HHS Information Technology General Rules of Behavior means a set of HHS rules that https://www.ecfr.gov/current/title-45/section-164.504#p-164.504(f)

FORM Part D Attachment (V1 Aug 2026) Page 4 of 58 describes the responsibilities and expected behavior of users of HHS information or information systems.

HHS sensitive information means all HHS data, on any storage media or in any form or format, which requires confidentiality, integrity, and availability protection due to the risk of harm that could result to interests of HHS, other agencies or entities, or individuals from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes—

(1) Information where the improper use or disclosure could adversely affect the ability of HHS to accomplish its mission, i.e., HHS proprietary information;

(2) Records about individuals requiring protection under laws and regulations such as the E-Government Act, Privacy Act and the HIPAA Privacy Rule, or based on a data use agreement or a promise or assurance of confidentiality; and

(3) Information that would be exempt from disclosure if requested under the

Freedom of Information Act. Examples of HHS sensitive information include—

(i) Individually-identifiable medical, benefits, and personnel information;

(ii) Financial, budgetary, research, quality assurance, confidential commercial, critical infrastructure, security-sensitive, procurement-sensitive, investigatory, and law enforcement information;

(iii) Controlled unclassified information;

(iv) Information that would be confidential and privileged in litigation such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney-client privilege; and

(v) Other information which, if released, could result in a violation of law or agreement, could cause harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of Federal programs.

HIPAA Rules means the Privacy, Security, Breach Notification, and Enforcement Rules at 45

CFR Part 160 and part 164.

Incident means an occurrence that (A) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information systems; or (B) constitutes a violation or imminent threat of violation of law, security policies, security

FORM Part D Attachment (V1 Aug 2026) Page 5 of 58 procedures, or acceptable policies.

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information.

Information system security plan means a formal document that provides an overview of the security requirements for an information system or an information security program and describes the security controls in place or planned for meeting those requirements.

Information technology (see FAR 2.101) also means Information and Communication Technology (ICT).

Information technology-related contracts means those contracts that include services (including support services), and related resources for information technology.

Organized health care arrangement (see 45 CFR 160.103) means:

(1) A clinically integrated care setting in which individuals typically receive health care from more than one health care provider;

(2) An organized system of health care in which more than one covered entity participates and in which the participating covered entities:

(i) Hold themselves out to the public as participating in a joint arrangement;

and

(ii) Participate in joint activities that include at least one of the following:

(A) Utilization review, in which health care decisions by participating covered entities are reviewed by other participating covered entities or by a third party on their behalf;

(B) Quality assessment and improvement activities, in which treatment provided by participating covered entities is assessed by other participating covered entities or by a third party on their behalf; or

(C) Payment activities, if the financial risk for delivering health care is shared, in part or in whole, by participating covered entities through the joint arrangement and if protected health information created or received by a covered entity is reviewed by other participating covered entities or by a third party on their behalf for the purpose of administering the sharing of financial risk.

(3) A group health plan and a health insurance issuer or HMO with respect to such

FORM Part D Attachment (V1 Aug 2026) Page 6 of 58 group health plan, but only with respect to protected health information created or received by such health insurance issuer or HMO that relates to individuals who are or who have been participants or beneficiaries in such group health plan;

(4) A group health plan and one or more other group health plans each of which are maintained by the same plan sponsor; or

(5) The group health plans described in paragraph (4) of this definition and health insurance issuers or HMOs with respect to such group health plans, but only with respect to protected health information created or received by such health insurance issuers or HMOs that relates to individuals who are or have been participants or beneficiaries in any of such group health plans.

Privacy officer means the HHS official(s) with responsibility for implementing and oversight of privacy related policies and practices that impact a given HHS acquisition.

(b) General. Contractors, subcontractors, their employees, third-parties, and business associates with access to HHS information, information systems, or information technology (IT) or providing and accessing IT-related goods and services, shall adhere to the HHS Cybersecurity Program and the directives and handbooks, complete HHS security training prior to accessing HHS information (including HHS sensitive information and information systems security and privacy) and on an annual basis thereafter, as well as those set forth in the contract specifications, statement of work, or performance work statement. These include, but are not limited to, HHS Personnel Security and Suitability Program, which establishes HHS procedures, responsibilities, and processes for complying with current Federal law, Executive Orders, policies, regulations, standards, and guidance for protecting HHS information, information systems (see 302.101, Definitions) security and privacy, and adhering to personnel security requirements when accessing HHS information or information systems.

(c) Access to HHS information and HHS information systems.

(1) Contractors are limited in their request for logical or physical access to HHS information or HHS information systems for their employees, subcontractors, third parties and business associates to the extent necessary to perform the services or provide the goods as specified in the contracts, agreements, task, delivery, or purchase orders.

(2) All Contractors, subcontractors, third parties, and business associates working with HHS information are subject to the same investigative requirements as those of HHS appointees or employees who have access to the same types of information. The level and process of background security investigations for Contractors to access HHS information and HHS information systems shall be in accordance with HHS Personnel Security and Suitability Program.

FORM Part D Attachment (V1 Aug 2026) Page 7 of 58

(3) Contractors, subcontractors, third parties, and business associates who require access to national security programs must have a valid security clearance.

(4) The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be –

(i) Marked appropriately;

(ii) Disclosed to authorized personnel on a need-to-know basis;

(iii) Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

(iv) Returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

(5) HIPAA business associate agreements. Under the HIPAA Privacy and Security Rules (see 45 CFR 164), pursuant to 45 CFR 164.502(e)(1), a covered entity may disclose protected health information to a business associate and may allow a business associate to create, receive, maintain, or transmit protected health information on its behalf, if the covered entity obtains satisfactory assurance that the business associate will appropriately safeguard the information. A covered entity is not required to obtain such satisfactory assurances from a business associate that is a subcontractor of a covered entity’s business associate.

Additionally, a business associate may disclose protected health information to a business associate that is a subcontractor and may allow the subcontractor to create, receive, maintain, or transmit protected health information on its behalf, if the business associate obtains satisfactory assurances, in accordance with 45 CFR 164.504(e)(1)(i), that the subcontractor will appropriately safeguard the information. The satisfactory assurances required by 45 CFR 45 CFR 164.504(e)(1) of this section shall be documented through a written contract or other written agreement or arrangement with the business associate that meets the applicable requirements of 45 CFR 164.504(e). The contracts shall also include breach reporting policies and procedures for suspected or confirmed breaches of protected health information. The contract shall impose a duty to cooperate with the healthcare component and/or HHS breach investigation and response and must require all https://www.ecfr.gov/current/title-45/section-164.504#p-164.504(e)(1)(i) https://www.ecfr.gov/current/title-45/section-164.504#p-164.504(e)

FORM Part D Attachment (V1 Aug 2026) Page 8 of 58 subcontractors to comply with the same HIPAA Rules requirements as a condition of receiving government data.

(i) Contractors or entities required to execute business associate agreements for contracts and other agreements become HHS business associates. Business associate agreements are issued by HHS or may be issued by other HHS programs in support of HHS.

The HIPAA Privacy Rule requires HHS to execute compliant business associate agreements with persons or entities that create, receive, maintain, or transmit HHS PHI or that will store, generate, access, exchange, process, or utilize such PHI in order to perform certain activities, functions or services to, for, or on behalf of HHS. There may be other HHS components or staff offices which also provide certain services and support to HHS and must receive PHI in order to do so. If these components award contracts or enter into other agreements, purchase/delivery orders, modifications and issue governmentwide purchase card transactions to help in the delivery of these services to HHS, they will also fall within the requirement to obtain a satisfactory assurance from these contractors by executing a business associate agreements.

(ii) Business associate agreement flow down to subcontractors. A prime contractor required to execute a business associate agreement shall also obtain a satisfactory assurance, in the form of a business associate agreement, of its subcontractors who will also create, receive, maintain, or transmit PHI or that will store, generate, access, exchange, process, or utilize such PHI will comply with HIPAA Rules requirements to the same degree as the Contractor. A contractor employing a subcontractor who creates, receives, maintains, or transmits PHI or that will store, generate, access, exchange, process, or utilize such PHI under a contract or agreement is required to execute a business associate agreement with each of its subcontractors which also obligates the subcontractor (i.e., also a business associate) to provide the same protections and safeguards and agree to the same disclosure restrictions to PHI that is required of the covered entity and the prime contractor.

(d) Contractor operations required to be in United States. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practicable. If such services are proposed to be performed outside the continental United States, and are not otherwise disallowed by other Federal law, regulations or policy, or other HHS policy or other mandates as stated in the contract, specifications, statement of work or performance work statement (including applicable business associate agreements), the Contractor/subcontractor must state in its proposal where all non-U.S. services are provided.

At a minimum, the Contractor/subcontractor must include a detailed Information System Security Plan, for review and approval by the Contracting Officer, specifically to address mitigation of the resulting problems of communication, control, and data protection.

(e) Roster of employees. Contractors and subcontractors shall provide a roster containing the name, position, e-mail address, phone number, and responsibilities of each employee, including subcontractors, performing work under the contract to develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to Contracting Officer within 15 Calendar days stated number of days from the

FORM Part D Attachment (V1 Aug 2026) Page 9 of 58 effective date of the contract. Revisions to the roster as a result of staffing changes must be submitted within the number of days of the change provided by the Contracting Officer. The Contracting Officer, or the Contracting Officer’s Representative (COR), will notify the Contractor of the appropriate level of investigation required for each staff member based on the information provided on the roster. If an employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level.

(f) Contractor/subcontractor employee reassignment and termination notification.

Contractors and subcontractors shall provide written notification to the Contracting Officer and COR immediately, and not later than four (4) hours, when an employee working on an HHS information system or with access to HHS information is reassigned or leaves the Contractor or subcontractor's employment on the cognizant HHS contract. The Contracting Officer and COR must also be notified immediately by the Contractor or subcontractor prior to an unfriendly termination.

(g) Non-disclosure agreement. The Contractor and subcontractors shall submit completed non-disclosure agreements, as provided by the Contracting Officer, for each employee having access to non-public government information under this contract. The non-disclosure agreements shall be submitted to the Contracting Officer prior to the performance of work.

(h) HHS information custodial requirements. (1) Release, publication, and use of data.

Information made available to a Contractor or subcontractor by HHS for the performance or administration of a contract or information developed by the Contractor/subcontractor in performance or administration of a contract shall be used only for the stated contract purpose and shall not be used in any other way without HHS prior written approval. This clause expressly limits the Contractor’s/subcontractor's rights to use data as described in 52.227-14, Rights in Data—General, paragraph (d).

(2) Media sanitization. HHS information shall not be co-mingled with any other data on the Contractors/subcontractor’s information systems or media storage systems in order to ensure federal and HHS requirements related to data protection, information segregation, classification requirements, and media sanitization can be met (see HHS Cybersecurity Program). HHS reserves the right to conduct scheduled or unscheduled on-site inspections, assessments, or audits of Contractor and subcontractor IT resources, information systems and assets to ensure data security and privacy controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with Federal and HHS requirements. The Contractor and subcontractor will provide all necessary access and support to HHS and/or GAO staff during periodic control assessments or audits.

(3) Data retention, destruction and contractor self-certification. The Contactor and its subcontractors are responsible for collecting and destroying any HHS data provided, created, or stored under the terms of this contract, to a point where HHS data or materials are no longer readable or reconstructable to any degree, in accordance with NIST SP 800-88, Guidelines for Media Sanitization, or subsequent directive. Prior to termination or completion https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/information-security-privacy-program/index.html https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/information-security-privacy-program/index.html

FORM Part D Attachment (V1 Aug 2026) Page 10 of 58 of this contract, the Contractor/subcontractor must provide its plan for destruction or return of all HHS data in its possession accordance with contract requirements or Contracting Officer instructions for disposition, including compliance with National Institute of Standards and Technology (NIST) SP 800-88, Guidelines for Media Sanitization, for the purposes of media sanitization on all IT equipment. The Contractor must certify in writing to the Contracting Officer within 30 days of termination of the contract that the data destruction requirements in this paragraph have been met.

(4) Return of HHS data and information. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to the HHS (as stipulated by the Contracting Officer or the COR) or the Contractor/subcontractor must hold it until otherwise directed. Items returned will be hand carried, securely mailed, emailed, or securely electronically transmitted to the Contracting Officer or to the address as provided in the contract or by the assigned COR, and/or accompanying business associate agreement.

Depending on the method of return, Contractor/subcontractor must store, transport, or transmit HHS sensitive information, when permitted by the contract using HHS-approved encryption tools that are, at a minimum, validated under Federal Information Processing Standards (FIPS) 140-3 (or its successor). If mailed, Contractor/subcontractor must send via a trackable method (USPS, UPS, Federal Express, etc.) and immediately provide the Contracting Officer with the tracking information. No information, data, documentary material, records or equipment will be destroyed unless done in accordance with the terms of this contract and the HHS Agency Records Control Schedules (2019).

(5) Use of HHS data and information. The Contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of HHS information only in compliance with the terms of the contract and applicable Federal and HHS information confidentiality and security laws, regulations, and policies. If Federal or HHS information confidentiality and security laws, regulations, and policies become applicable to the HHS information or information systems after execution of the contract, or if the 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 for this contract as a result of any updates, if required.

(6) Copying HHS data or information. The Contractor/subcontractor shall not make copies of HHS information except as authorized and necessary to perform the terms of the contract 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.

(7) Violation of information custodial requirements. If HHS determines that the

Contractor has violated any of HHS information confidentiality, privacy, or security provisions, it shall be sufficient grounds for HHS to withhold payment to the Contractor or third-party or https://www.archives.gov/records-mgmt/rcs/schedules/index.html?dir=/departments/department-of-health-and-human-services

FORM Part D Attachment (V1 Aug 2026) Page 11 of 58 terminate the contract for default in accordance with FAR part 49 or terminate for cause in accordance with FAR 12.403.

(8) Encryption. The Contractor/subcontractor must store, transport, or transmit

HHS sensitive information, when permitted by the contract, using cryptography, HHS encryption policies, and HHS-approved encryption tools that are, at a minimum, validated under FIPS 140-3 (or its successor).

(9) Firewall and web services security controls. The Contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed HHS minimum requirements. HHS Configuration Standards Guidelines are available upon request.

(10) Disclosure of HHS data and information. Except for uses and disclosures of

HHS information authorized in a cognizant contract for performance of the contract, the Contractor/subcontractor may use and disclose HHS information only in two other situations:

(i) subject to paragraph 10 of this section, in response to a court order from a court of competent jurisdiction, or (ii) with HHS prior written approval. The Contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, HHS information and information systems to the Contracting Officer for response. If the Contractor/subcontractor is in receipt of a court order or other request or believes it has a legal requirement to disclose HHS information, that Contractor/subcontractor shall immediately refer such court order or other request to the Contracting Officer for response. If the Contractor or subcontractor discloses information on behalf of HHS, the Contractor and/or subcontractor must maintain an accounting of disclosures. Accounting of Disclosures documentation maintained by the Contractor/subcontractor will include the name of the individual to whom the information pertains, the date of each disclosure, the nature or description of the information disclosed, a brief statement of the purpose of each disclosure or, in lieu of such statement, a copy of a written request for a disclosure, and the name and address of the person or agency to whom the disclosure was made. The Contractor/subcontractor will provide its Accounting of Disclosures upon request and within 15 calendar days to the assigned COR and Privacy Officer. Accounting of disclosures should be provided electronically via encrypted email to the COR and designated HHS facility Privacy Officer as provided in the contract, business associate agreement, or by the Contracting Officer. If providing the Accounting of disclosures electronically cannot be done securely, the Contractor/subcontractor will provide copies via trackable methods (UPS, USPS, Federal Express, etc.) immediately, providing the designated COR and Privacy Officer with the tracking information.

(11) Compliance with privacy statutes and applicable regulations. The

Contractor/subcontractor shall not disclose HHS information protected by any of HHS privacy statutes or applicable regulations including, but not limited to, the Privacy Act of 1974 or the HIPAA Rules. If the Contractor/subcontractor is in receipt of a court order or other requests for HHS information or has questions if it can disclose information protected under the above-mentioned confidentiality statutes because it is required by law, that

FORM Part D Attachment (V1 Aug 2026) Page 12 of 58

Contractor/subcontractor shall immediately refer such court order or other request to the Contracting Officer for response.

(i) Compliance with identification policies. Contractors shall comply with the Homeland

Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; HHS Policy for Information Security and Privacy Protection (IS2P) Control Catalog, and Executive Order 13467, Part 1, section 1.2.

(j) Report of known or suspected incident or breach. The Contractor, subcontractor, third-party affiliate or business associate, and its employees shall notify HHS immediately via the Contracting Officer and the COR or within one (1) hour of a known or suspected incident or breach. The initial notification may first be made verbally but must be followed up in writing within one (1) hour. Report all actual or suspected incident and breach information to the Contracting Officer and the COR as identified in the contract or as directed in the contract, within one hour of discovery or suspicion.

(1) Such issues shall be remediated as quickly as is practical, but in no event longer than 30 calendar days. The Contractor shall notify the Contracting Officer in writing.

(2) When the security fixes involve installing third party patched (e.g., Microsoft OS patches or Adobe Acrobat), the Contractor will provide written notice to HHS that the patch has been validated as not affecting the systems within 10 working days. When the Contractor is responsible for operations or maintenance of the systems, they shall apply the security fixes within 30 calendar days.

(3) All other vulnerabilities shall be remediated in a timely manner based on risk, in accordance with the timelines specified in the HHS Policy for Vulnerability Management, and the HHS Standard for Plan of Action and Milestones (POAM) Management and Reporting.

Contractors shall notify the Contracting Officer, and COR within 2 business days after remediation of the identified vulnerability. Exceptions to this paragraph (e.g., for the convenience of HHS) must be requested by the Contractor through the COR and shall only be granted with approval of the Contracting Officer and the Office of the Chief Information Officer (OCIO). These exceptions will be tracked by the Contractor in concert with the Government in accordance with HHS Policy for IT Procurements–Security and Privacy Language.

(k) Incident and breach investigation. (1) The Contractor/ subcontractor shall immediately notify the Contracting Officer and COR for the contract of any known or suspected incident or breach (see definitions, paragraph (a)), or any other unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/subcontractor has access.

FORM Part D Attachment (V1 Aug 2026) Page 13 of 58

(2) To the extent known by the Contractor/subcontractor, the Contractor/ subcontractor’s notice to HHS shall identify the information involved, an estimate of the number of potentially impacted individuals, the circumstances surrounding the incident (including to whom, how, when, and where the HHS information or assets were placed at risk or compromised), and any other information that the Contractor/subcontractor considers relevant.

(3) With respect to unsecured protected health information, the business associate is deemed to have discovered an incident as defined above when the business associate either knew, or by exercising reasonable diligence should have been known to an employee of the business associate. Upon discovery, the business associate must notify HHS of the incident immediately within one hour of discovery or suspicion as agreed to in the business associate agreement.

(4) 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. The Contractor, its employees, and its subcontractors and their employees shall cooperate with HHS 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 HHS in any civil litigation to recover HHS 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.

(l) Incident and breach notification requirements. (1) The Contractor/subcontractor shall provide notice to HHS of an incident as set forth in the incident and breach investigation section of this clause. The Contractor shall fully cooperate with HHS or third-party entity performing an independent risk analysis on behalf of HHS. Failure to cooperate may be deemed a material incident or breach and grounds for contract termination.

(2) The Contractor/subcontractor shall fully cooperate with the HHS Computer Security Incident Response Center (CSIRC), HHS Breach Response Team, Operating Divisions (OPDIVs), Staff Divisions (STAFFDIVs), other stakeholders or any Government agency conducting an analysis regarding any notice of an incident or breach, potential incident or breach, or incident which may require the Contractor to provide information to the Government or third-party performing a risk analysis for HHS, and shall address all relevant information concerning the incident or breach, including the following:

(i) Nature of the event (loss, theft, unauthorized access).

(ii) Description of the event, including:

(A) Date of occurrence.

(B) Date of incident or breach detection.

FORM Part D Attachment (V1 Aug 2026) Page 14 of 58

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

(D) Number of individuals affected or potentially affected.

(E) Names of individuals or groups affected or potentially affected.

(F) 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.

(G) Amount of time the data has been out of HHS control.

(H) The likelihood that the sensitive information will or has been compromised

(made accessible to and usable by unauthorized persons).

(I) Known misuses of data containing sensitive information, if any.

(J) Assessment of the potential harm to the affected individuals.

(K) Incident or breach analysis as outlined in the HHS Breach Response Policy and

Plan, as appropriate.

(L) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive information that may have been compromised.

(M) Steps taken in response to mitigate or prevent a repetition of the incident.

(m) Training. (1) All Contractor employees and subcontractor employees requiring access to HHS information or HHS information systems shall complete the following before being granted access to HHS information and its systems:

(i) On an annual basis, successfully complete the HHS Privacy and Information Security Awareness and HHS Information Security Rules of Behavior training.

(ii) On an annual basis, sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the HHS Information Security Rules of Behavior, relating to access to HHS information and information systems.

(iii) Successfully complete any additional cyber security or privacy training, as required for HHS personnel with equivalent information system access.

FORM Part D Attachment (V1 Aug 2026) Page 15 of 58

(2) The Contractor shall provide to the Contracting Officer and/or the COR a copy of the training certificates and affirmation that HHS Information Security Rules of Behavior signed by each applicable employee have been completed and submitted within five (5) days of the initiation of the contract and annually thereafter, as required.

(3) Failure to complete the mandatory annual training and acknowledgement of the HHS Information Security Rules of Behavior, 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.

(n) Subcontract flow down. The Contractor shall include the substance of this clause, including this paragraph (k), in subcontracts, third-party agreements, and business associate agreements, of any amount and in which subcontractor employees, third-party servicers/employees, and business associates will perform functions where they will have access to HHS information (including HHS sensitive information), information systems, information technology (IT) or providing and accessing information technology-related contract services, support services, and related resources (see HHSAR 302.101 definition of information technology-related contracts.)

SUPPLEMENT TO HHSAR 352.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2024) (DEVIATION).

CONFIDENTIALITY AND NONDISCLOSURE OF INFORMATION

Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor.

Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information must be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

i.18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

ii.18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and iii.44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Each Contractor (and/or any subcontractor) employee who may have access to non-public information under this contract must sign the form, "Commitment to Protect Non-Public

FORM Part D Attachment (V1 Aug 2026) Page 16 of 58

Information - Contractor Agreement" located at: https://ocio.nih.gov/sites/external/files/2024- 01/Nondisclosure04082020.pdf. A copy of each signed and witnessed nondisclosure agreement shall be submitted to the Contracting Officer and/or COR prior to performing any work on the contract.

STANDARD FOR ENCRYPTION

The Contractor (and/or any subcontractor) must:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with encryption solution that is validated with FIPS 140 (in accordance with HHSAR 352.204-71(h)(8)) validation certificate from the NIST CMVP.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 (in accordance with HHSAR 352.204-71(h)(8)) validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR within 15 days of the validation.

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/.

Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

INCIDENT RESPONSE

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/NIH IRT teams (the NIH IRT is known as NIH Threat Mitigation and Incident Response (TMIR)) within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system;

or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on https://ocio.nih.gov/sites/external/files/2024-01/Nondisclosure04082020.pdf https://ocio.nih.gov/sites/external/files/2024-01/Nondisclosure04082020.pdf http://csrc.nist.gov/publications/

FORM Part D Attachment (V1 Aug 2026) Page 17 of 58 the HHS breach response process, please see the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

Alert NIH CIO, CISO, TMIR and IC CIO, ISSO, System Owner, and incident response personnel when the following indications of compromise or potential compromise occur:

• Internal traffic that indicates the presence of malicious code within an information system or propagating among system components

• Attack signatures (a characteristic byte pattern used in malicious code or an indicator, or set of indicators, that allows the identification of malicious network activities)

• Signaling to an external information system

• Localized, targeted, and network-wide events

Note: The above list is a minimum set of compromises or potential compromises and may be expanded to include IC-specific items relevant to their missions.

b. In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) must:

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 (in accordance with HHSAR 352.204-71(h)(8)) validation certificate from the NIST

CMVP.

ii. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor must send NIH approved notifications to affected individuals in accordance with https://wiki.ocio.nih.gov/wiki/index.php/US- CERT_Federal_Incident_Notification_Guidelines.

iii. Report all suspected and confirmed information security and privacy incidents and breaches via the Contracting Officer and COR to the NIH Threat Mitigation and Incident Response (TMIR) via the NIH Incident Response Team (IRT) Portal (email:

IRT@mail.nih.gov), including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable NIH and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

Not include any sensitive information in the subject or body of any reporting e-mail;

and

Encrypt sensitive information in attachments to email, media, etc.

iv. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally

Identifiable Information, and HHS/NIH and NIH privacy breach response policies when handling PII breaches.

v. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, https://wiki.ocio.nih.gov/wiki/index.php/US-CERT_Federal_Incident_Notification_Guidelines…