OCRTME Graduate Medical Education Information Management System Security Clauses.docx

Security and Privacy Language for Information and Information Technology Procurements Effective Date: Wednesday, March 3, 2021 Policy ID: HHS-OCIO-OIS-2021-03-001

I. Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

i. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

ii. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/NIH policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

· Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

· Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

· Availability, which means ensuring timely and reliable access to and use of information.

ii. Categorize all information owned and/or collected/managed on behalf of HHS/NIH and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories. Based on information provided by the ISSO, CISO, NIH SOP, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

· Confidentiality: [ ] Low [x] Moderate [ ] High

· Integrity: [ ] Low [ ] Moderate [x] High

· Availability: [ ] Low [x] Moderate [ ] High

· Overall Impact Level: [ ] Low [ ] Moderate [x] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of HHS/NIH regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/NIH Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or HHS/NIH security and/or privacy officials.

c. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." 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.

d. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

e. 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).

f. Contract Documentation. The Contractor must use provided templates, policies, forms and other NIH agency documents to comply with contract deliverables as appropriate.

g. Standard for Encryption

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

ii. 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 current FIPS 140 validation certificate from the NIST CMVP.

iii. 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).

h. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the NIH non-disclosure agreement. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

2. 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 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 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)."

b. In the event of a suspected or confirmed incident or breach, the Contractor (and/or 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 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.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT), COR, CO, NIH SOP (or his or her designee), and other stakeholders, 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 Clinical Center 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, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.

3. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor must follow the HHS EPLC framework and methodology or in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO within NIH before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or NIH policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the NIH Contractor Employee Separation Checklist when an employee terminates work under this contract within [specific timeframe determined by department] days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

4. Records Management and Retention

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS Policy for Records Management and NIH policies, and must not dispose of any records unless authorized by HHS/NIH.

b. In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with HHS/NIH policies.

II. Requirements for Procurements Involving Privacy Act Records Privacy Act It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records about individuals from which records are retrieved by name or other identifying particular.

The System of Records Notice that is applicable to this contract is: [department inserts name/number if one exists. If there is no SORN, indicate that a new or revised SORN will be developed].

The system of records design, development, or operation work the Contractor is to perform is: [department inserts description of design, development, and/or operation work; see definitions in the FAR at 24.101 - Definitions].

The disposition to be made of the Privacy Act records upon completion of contract performance is: [department inserts records disposition instructions the contractor and any subcontractor must follow upon completion of contract performance].

I. Procurements Involving Government Information Processed on GOCO or COCO Systems

1. Security Requirements for GOCO and COCO Resources

a. Federal Policies. The Contractor (and/or any subcontractor) must comply with applicable federal laws and HHS policies that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P), Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, latest revision, Security and Privacy Controls for Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and Departmental policies.

NIH/CC acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

i. Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, must meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, HHS ISCM Strategy, and HHS IS2P.

ii. Configuration Management - Use available SCAP-compliant automated tools as per NIST IR 7511 and HHS Minimum Security Configurations Standards Guidance to scan all IT assets, including but not limited to: computers, servers, routers, databases, operating systems, application, etc., that store and process government information. Provide scan reports to HHS/NIH/CC upon request. Contractor must maintain a capability to provide security configuration compliance information for 100% of its IT assets using SCAP-compliant automated tools.

iii. Vulnerability Management - Contractors must actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS Policy for Vulnerability Management. Automated tools must be compliant with NIST-specified SCAP standards for vulnerability identification and management. The contractor must maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency.

iv. Patching and Vulnerability Remediation - Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and agency specified timeframes [insert specific timeframe].

v. Secure Coding - Follow the HHS Policy for Software Development Secure Coding Practices and secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

vi. Boundary Protection - The contractor must ensure that government information, other than unrestricted information, being transmitted from federal government entities to external entities is routed through a Trusted Internet Connection (TIC).

b. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) must afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

i. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract.

The Government includes but is not limited to the U.S. Department of Justice, U.S. Government Accountability Office, and the HHS Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

ii. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity. It includes timely and complete production of requested data, metadata, information, and records relevant to any inspection, audit, investigation, or review, and making employees of the contractor available for interview by inspectors, auditors, and investigators upon request. Full cooperation also includes allowing the Government to make reproductions or copies of information and equipment, including, if necessary, collecting a machine or system image capture.

Segregate Government protected information and metadata on the handling of Government protected information from other information. Commingling of information is prohibited. Inspectors, auditors, and investigators will not be precluded from having access to the sought information if sought information is commingled with other information.

Cooperate with inspections, audits, investigations, and reviews.

c. Rights to Data. All contracts that require data to be produced, furnished, acquired, or used in meeting contract performance requirements, must contain terms that delineate the respective rights and obligations of the Government and the contractor regarding the use, reproduction, and disclosure of that data. Data rights clauses do not specify the type, quantity or quality of data that is to be delivered, but only the respective rights of the Government and the contractor regarding the use, disclosure, or reproduction of the data. Accordingly, the contract must specify the data to be delivered.

d. Information and Communications Technology (ICT) Cybersecurity Supply Chain Risk Management (C-SCRM) requirements. The Contractor (and/or any subcontractor) must secure their ICT supply chain in compliance with HHS Policy for Cyber Supply Chain Risk Management and Public Law 115-232 § 889. At a minimum, they must implement the following:

i. Develop rules for suppliers' development methods, techniques, or practices;

ii. Use of secondary market components;

iii. Prohibit counterfeit products;

iv. Dispose and/or retain elements such as components, data, or intellectual property securely;

v. Ensure adequate supply of components;

vi. Require external providers handling federal information or operating systems on behalf of the federal government to meet the same security and privacy requirements as federal agencies;

vii. Require external providers to express security and privacy requirements (including the controls for systems processing, storing, or transmitting federal information) in contracts or other formal agreements;

viii. Establish Service Level Agreements (SLAs), patching vehicles and disclosure requirements in the case of a security incident or new vulnerability being discovered; and

ix. Ensure that the supplier applies same contractual requirements to any sub-contractors/suppliers that they involve in the provision of the product or service to the customer; and

x. Prohibit the use of covered telecommunications and video surveillance equipment or services.

II. Contracts Involving Cloud Services

1. HHS FedRAMP Privacy and Security Requirements

The Contractor (and/or any subcontractor) must be responsible for the following privacy and security requirements:

a. FedRAMP Compliant ATO. Comply with FedRAMP Assessment and Authorization (A&A) requirements and ensure the information system/service under this contract has a valid FedRAMP compliant (approved) authority to operate (ATO) in accordance with Federal Information Processing Standard (FIPS) Publication 199 defined security categorization. If a FedRAMP compliant ATO has not been granted, the Contractor must submit a plan to obtain a FedRAMP compliant ATO.

i. Implement applicable FedRAMP baseline controls commensurate with the agency-defined security categorization and the applicable FedRAMP security control baseline (www.FedRAMP.gov). The HHS Information Security and Privacy Policy (IS2P) and HHS Cloud Computing and Federal Risk and Authorization Management Program (FedRAMP) Guidance further define the baseline policies as well as roles and responsibilities. The Contractor must also implement a set of additional controls identified by the agency when applicable.

ii. A security control assessment must be conducted by a FedRAMP third-party assessment organization (3PAO) for the initial ATO and annually thereafter or whenever there is a significant change to the system's security posture in accordance with the FedRAMP Continuous Monitoring Plan.

b. Data Jurisdiction. The contractor must store all information within the security authorization boundary, data at rest or data backup, within the Continental United States (CONUS).

c. Service Level Agreements. Add when applicable The Contractor must understand the terms of the service agreements that define the legal relationships between cloud customers and cloud providers and work with NIH/CC to develop and maintain an SLA.

d. Interconnection Agreements/Memorandum of Agreements. Add when applicable The Contractor must establish and maintain Interconnection Agreements and or Memorandum of Agreements/Understanding in accordance with HHS/NIH/CC policies.

2. Protection of Information in a Cloud Environment

a. If contractor (and/or any subcontractor) personnel must remove any information from the primary work area, they must protect it to the same extent they would the proprietary data and/or company trade secrets and in accordance with HHS/NIH/CC policies https://www.hhs.gov/web/governance/digital-strategy/it-policy- archive/index.html.

b. HHS will retain unrestricted rights to federal data handled under this contract. Specifically, HHS retains ownership of any user created/loaded data and applications collected, maintained, used, or operated on behalf of HHS and hosted on contractor's infrastructure, as well as maintains the right to request full copies of these at any time. If requested, data must be available to HHS within one (1) business day from request date or within the timeframe specified otherwise. In addition, the data must be provided at no additional cost to HHS.

c. The Contractor (and/or any subcontractor) must ensure that the facilities that house the network infrastructure are physically and logically secure in accordance with FedRAMP requirements and HHS policies.

d. The contractor must support a system of records in accordance with NARA-approved records schedule(s) and protection requirements for federal agencies to manage their electronic records in accordance with 36 CFR § 1236.20 & 1236.22 (ref. a), including but not limited to the following:

i. Maintenance of links between records and metadata, and

ii. Categorization of records to manage retention and disposal, either through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules.

e. The disposition of all HHS data must be at the written direction of HHS/NIH/CC. This may include documents returned to HHS control; destroyed; or held as specified until otherwise directed. Items returned to the Government must be hand carried or sent by certified mail to the COR.

i. If the system involves the design, development, or operation of a system of records on individuals, the Contractor must comply with the Privacy Act requirements.

3. Assessment and Authorization (A&A) Process

a. The Contractor (and/or any subcontractor) must comply with HHS and FedRAMP requirements as mandated by federal laws, regulations, and HHS policies, including making available any documentation, physical access, and logical access needed to support the A&A requirement. The level of effort for the A&A is based on the system's FIPS 199 security categorization and HHS/NIH/CC security policies.

i. In addition to the FedRAMP compliant ATO, the contractor must complete and maintain an agency A&A package to obtain agency ATO prior to system deployment/service implementation. The agency ATO must be approved by the NIH/CC authorizing official (AO) prior to implementation of system and/or service being acquired.

ii. CSP systems categorized as Federal Information Processing Standards (FIPS) 199 high must leverage a FedRAMP accredited third-party assessment organization (3PAO); moderate impact CSP systems must make a best effort to use a FedRAMP accredited 3PAO but should not use self-assessment. CSP systems categorized as FIPS 199 low impact may leverage a non-accredited, independent assessor.

iii. For all acquired cloud services, the A&A package must contain documentation. Following the initial ATO, the Contractor must review and maintain the ATO in accordance with HHS/NIH/CC policies. [NIH/CC CISO must also specify whether the contractor should use the FedRAMP templates (http://www.fedramp.gov/) or NIH/CC templates and include specific deliverables timelines].

b. HHS reserves the right to perform penetration testing (pen testing) on all systems operated on behalf of agency. If HHS exercises this right, the Contractor (and/or any subcontractor) must allow HHS employees (and/or designated third parties) to conduct Security Assessment activities to include control reviews in accordance with HHS requirements. Review activities include, but are not limited to, scanning operating systems, web applications, wireless scanning; network device scanning to include routers, switches, and firewall, and IDS/IPS; databases and other applicable systems, including general support structure, that support the processing, transportation, storage, or security of Government information for vulnerabilities.

c. The Contractor must identify any gaps between required FedRAMP Security Control Baseline/Continuous Monitoring controls and the contractor's implementation status as documented in the Security Assessment Report and related Continuous Monitoring artifacts. In addition, the contractor must document and track all gaps for mitigation in a Plan of Action and Milestones (POA&M) document. Depending on the severity of the risks, HHS may require remediation at the contractor's expense, before HHS issues an ATO.

d. The Contractor (and/or any subcontractor) must mitigate security risks for which they are responsible, including those identified during A&A and continuous monitoring activities. All vulnerabilities and findings must be remediated, in accordance with timelines specified in the HHS POA&M Standard, from discovery:

(1) critical vulnerabilities no later than fifteen (15) days and (2) high within thirty (30) days (3) medium within ninety (90) days and (4) low vulnerabilities no later than three hundred and sixty (360) days. In the event a vulnerability or other risk finding cannot be mitigated within the prescribed timelines above, they must be added to the designated POA&M and mitigated within the newly designated timelines. HHS will determine the risk rating of vulnerabilities using FedRAMP baselines.

e. Revocation of a Cloud Service. HHS/ NIH/CC have the right to take action in response to the CSP's lack of compliance and/or increased level of risk. In the event the CSP fails to meet HHS and FedRAMP security and privacy requirements and/or there is an incident involving sensitive information, HHS and/or NIH/CC may suspend or revoke an existing agency ATO (either in part or in whole) and/or cease operations. If an ATO is suspended or revoked in accordance with this provision, the CO and/or COR may direct the CSP to take additional security measures to secure sensitive information. These measures may include restricting access to sensitive information on the Contractor information system under this contract. Restricting access may include disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls.

4. Reporting and Continuous Monitoring

a. Following the initial ATOs, the Contractor (and/or any subcontractor) must perform the minimum ongoing continuous monitoring activities specified below, submit required deliverables by the specified due dates, and meet with the system/service owner and other relevant stakeholders to discuss the ongoing continuous monitoring activities, findings, and other relevant matters. The CSP will work with the agency to schedule ongoing continuous monitoring activities.

b. At a minimum, the Contractor must provide the following artifacts/deliverables on a monthly basis:

i. Operating system, database, Web application, and network vulnerability scan results;

ii. Updated POA&Ms;

iii. Any updated authorization package documentation as required by the annual attestation/assessment/review or as requested by the NIH/CC System Owner or AO, and;

iv. Any configuration changes to the system and/or system components or CSP's cloud environment that may impact HHS/NIH/CC's security posture. Changes to the configuration of the system, its components, or environment that may impact the security posture of the system under this contract must be approved by the agency.

5. Configuration Baseline

a. The contractor must certify that applications are fully functional and operate correctly as intended on systems using HHS Minimum Security Configurations Standards Guidance. The standard installation, operation, maintenance, updates, and/or patching of software must not alter the configuration settings from the approved HHS/NIH/CC configuration baseline.

b. The contractor must use Security Content Automation Protocol (SCAP) validated tools with configuration baseline scanner capability to certify their products operate correctly with HHS and NIST defined configurations and do not alter these settings.

6. Incident Reporting

Note to Requiring Activity Representative: Include Incident Response language from Appendix B:

Standards

a. The Contractor (and/or any subcontractor) must provide an Incident and Breach Response Plan (IRP) in accordance with HHS/NIH/CC, OMB, and US-CERT requirements and obtain approval from the NIH/CC. In addition, the Contractor must follow the incident response and US-CERT reporting guidance contained in the FedRAMP Incident Communications.

b. The Contractor (and/or any subcontractor) must implement a program of inspection to safeguard against threats and hazards to the security, confidentiality, integrity, and availability of federal data, afford HHS access to its facilities, installations, technical capabilities, operations, documentation, records, and databases within 72 hours of notification. The program of inspection must include, but is not limited to:

i. Conduct authenticated and unauthenticated operating system/network/database/Web application vulnerability scans. Automated scans can be performed by HHS/NIH/CC personnel, or agents acting on behalf of HHS/NIH/CC, using agency-operated equipment and/or specified tools. The Contractor may choose to run its own automated scans or audits, provided the scanning tools and configuration settings are compliant with NIST Security Content Automation Protocol (SCAP) standards and have been approved by the agency. The agency may request the Contractor's scanning results and, at the agency discretion, accept those in lieu of agency performed vulnerability scans.

ii. In the event an incident involving sensitive information occurs, cooperate on all required activities determined by the agency to ensure an effective incident or breach response and provide all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. In addition, the Contractor must follow the agency reporting procedures and document the steps it takes to contain and eradicate the incident, recover from the incident, and provide a post-incident report that includes at a minimum the following:

Company and point of contact name;

Contract information;

Impact classifications/threat vector;

Type of information compromised;

A summary of lessons learned; and

Explanation of the mitigation steps of exploited vulnerabilities to prevent similar incidents in the future.

7. Media Transport

a. The Contractor and its employees must be accountable and document all activities associated with the transport of government information, devices, and media transported outside controlled areas and/or facilities. These include information stored on digital and non-digital media (e.g., CD-ROM, tapes, etc.), mobile/portable devices (e.g., USB flash drives, external hard drives, and SD cards).

b. All information, devices and media must be encrypted with HHS-approved encryption mechanisms to protect the confidentiality, integrity, and availability of all government information transported outside of controlled facilities.

8. Boundary Protection: Trusted Internet Connections (TIC)

a. The contractor must ensure that government information, other than unrestricted information, being transmitted from federal government entities to external entities using cloud services is inspected by Trusted Internet Connection (TIC) processes that are in compliance with the requirements of the Office of Management and Budget (OMB) Memorandum (M) 19-26: Update to the TIC Initiative, TIC 3.0.

b. The contractor must route all external connections through a TIC.

c. Non-Repudiation. The contractor must provide a system that implements encryption with current FIPS 140 validation certificate from the NIST CMVP that provides for origin authentication, data integrity, and signer non-repudiation.

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