CHPL SOW_7571TE26Q00034.pdf

ONC Certified Health IT Product List (CHPL) Development, Maintenance, and Improvement

Attachment A Statement of Work (SOW)

Date: June 4, 2026

SECTION B – SUPPLIES/SERVICES AND PRICE/COSTS

B.1 BRIEF DESCRIPTION OF SERVICES

Obtain the services and personnel required to support the continued maintenance, development, and improvement of the currently deployed ONC Certified Health IT Product List (ONC CHPL).

This will in turn support the ONC’s overall program goals outlined in the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.

B.2 TYPE OF CONTRACT

The contract type awarded is a Firm – Fixed Price Contract.

B.3 SEVERABLE SERVICES

The services acquired under this contract are severable services. Funds are only available for use for the contract line item (CLIN) to which they are obligated. Unused funds from one CLIN may not rollover for use in other periods.

B.4 CONSIDERATION AND PAYMENT

In consideration of satisfactory performance of the work as described throughout this contract, the Contractor shall be paid a fixed price for each CLIN (if exercised). If the options are exercised, funding will be obligated by modification to the contract.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

TITLE: ONC Certified Health IT Product List (CHPL) Development, Maintenance, and Improvement

C.1 BACKGROUND

The Office of the National Coordinator for Health Information Technology (ONC) is continuing its efforts to facilitate and expand the secure, electronic movement, and use of health information among organizations according to nationally recognized standards. The ONC Health IT Certification Program’s (Certification Program) original purpose was to establish and execute a process for certifying Health Information Technology (Health IT), including Electronic Health Records (EHRs) that can be purchased by providers to help them become meaningful users and eligible for incentives offered by the Centers for Medicare and Medicaid Services (CMS). The Program has evolved and now also supports health IT adoption, interoperability, and care quality improvement initiatives.

The ONC Certified Health IT Product List (ONC CHPL) was established to be the sole source of information regarding products successfully tested and certified through the Certification Program. Beginning with the ONC Temporary Certification Program, continuing through the release of the 2015 Edition Cures Update in the Certification Program, and its recent update with HIT1, the ONC CHPL is the destination for certified health information technology information.

The ONC CHPL was previously referred to as the “open data” CHPL, but it will be referred to as the ONC CHPL here. Earlier versions of the ONC CHPL, which are no longer operating, will be referred to as the legacy CHPL (i.e., not “open data” CHPL).

The ONC CHPL has served two main purposes since its creation:

1. Listing all technology which has successfully been tested and certified through the ONC Health IT Certification program, and

2. Providing stakeholders with a mechanism to create a Center for Medicare and Medicaid Electronic Health Record Certification ID (CMS EHR Certification ID) for use in the Medicare and Medicaid EHR Incentive Programs (now known as the Promoting Interoperability Programs) and successor programs.

The Certification Program helps to ensure that health IT conforms to the standards and certification criteria adopted by the Secretary of Health and Human Services. It was established to develop and oversee national programs for the certification of health information technology by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.

The HITECH Act of 2009 states that the National Coordinator shall perform duties in a manner consistent with the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information and that:

1. Ensures that each patient’s health information is secure and protected, in accordance with applicable law;

2. Improves health care quality, reduces medical errors, reduces health disparities, and advances the delivery of patient-centered medical care;

3. Reduces health care costs, resulting from inefficiency, medical errors, inappropriate care, duplicative care and incomplete information;

4. Provides appropriate information to help guide medical decisions at the time and place of care;

5. Ensures the inclusion of meaningful public input in such development of such infrastructure;

6. Improves the coordination of care and information among hospitals, laboratories, physician offices, and other entities through an effective infrastructure for the secure and authorized exchange of health care information;

7. Improves public health activities and facilitates the early identification and rapid response to public health threats and emergencies, including bio-terror events and infectious disease outbreaks;

8. Facilitates health and clinical research and health care quality;

9. Promotes early detection, prevention and management of chronic diseases;

10. Promotes a more effective marketplace, greater competition, greater systems analysis, increased consumer choice, and improved outcomes in healthcare services; and

11. Improves efforts to reduce health disparities.

The HITECH Act also includes consideration for other areas including “the appropriate uses of a nationwide health information infrastructure” including for the purposes of:

1. The collection of quality data and public reporting;

2. Bio surveillance and public health;

3. Medical and clinical research; and

4. Drug safety.

Additionally, the testing and certification of Health IT under the Certification Program is conducted against the criteria and standards adopted by the Secretary as described in the following rulemaking documents:

• Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency Interim Final Rule;

• 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule;

• ONC Health IT Certification Program, Enhanced Oversight and Accountability Final Rule;

• 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Final Rule;

• 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange;

• Cures Act Final Rule, TEFCA, Common Agreement 2.0, and HTI-1; and

• Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology, Final Rule.

C.2 PURPOSE

The purpose of this contract is to obtain the services and personnel required to support the continued maintenance, development, and improvement of the ONC Certified Health IT Product List (ONC CHPL), which is a key component of the ONC Health IT Certification Program’s operations. This will in turn support the ONC’s overall program goals outlined in the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.

C.3 SCOPE

In support of the ONC CHPL, the Contractor shall:

1. Maintain and update the currently deployed infrastructure and database;

2. Develop and implement improvements to the API (Application Programming Interface) connectivity for all stakeholders;

3. Maintain and modify ONC CHPL widget(s);

4. Create refinements and improvements to certified product upload and certified product display on the ONC CHPL page;

5. Provide on-demand access as well as reporting capabilities for data analytics on customer use and listed products;

6. Provide updates and modifications required by current rulemaking documents or upcoming rulemaking processes; and;

7. Maintain, develop and improve CMS widget.

Provide project management services to ensure that the project requirements are delivered on schedule.

The Contractor shall review all applicable health IT certification, certification body, and testing lab reporting requirements set forth by current or upcoming ONC Health IT rulemaking and regulatory guidance to provide assistance in an operational role in the requirements gathering/planning, execution, maintenance, and management of the ONC CHPL.

C.4 STATEMENT OF WORK (MANDATORY TASKS ARE FOR BASE AND ALL

OPTION PERIODS)

The Contractor shall furnish all of the necessary personnel, materials, services, facilities, (except as otherwise specified herein), and otherwise do all the things necessary for or incident to the performance of the work as set forth below:

C.4.1 Mandatory Task 1 – Task Order Management

C.4.1.1 Subtask 1 – Management Plan and Project Work Plan

The Contractor shall develop a comprehensive work plan that includes: 1) a management plan and 2) a project work plan.

Management Plan The Contractor shall prepare a Task Order Management Plan describing the technical approach, organizational resources, and structure. Also included should be a detailed project schedule, identifying all tasks and deliverables to be performed, durations for each task, principal schedule milestones, and overall time of completion, staffing plan, and management controls to be employed to meet the cost, performance, and schedule requirements for execution of all tasks throughout the task order execution.

The Contractor shall coordinate organizational requirements, manage projects and schedules, and report progress/issues on an ongoing basis to Contracting Officer Representative (COR).

The Contractor shall provide centralized administrative, clerical, and other related functions.

Project Work Plan The Contractor shall submit a draft project work plan within three (3) weeks of contract award for the review and approval of the COR. The work plan shall reflect preliminary discussions and decisions reached during the post-award meeting. The work plan shall include, at a minimum, a communication plan to include outreach and updates to all key stakeholders and a chart with the timeframe for draft and final deliverables with specific dates identified. The work plan will also include description of the proposed process and strategy to execute all tasks.

The Contractor shall modify the draft work plan in accordance with comments provided by the COR. The revised work plan is due no later than two (2) weeks after receiving comments from the COR and shall be considered final upon approval by the COR. The Contractor shall manage the work according to the work plan approved by COR.

C.4.1.2 Subtask 2 – Reports

Technical Status Reports The Contractor shall electronically submit technical status reports to the COR, on a weekly and monthly basis, which address the following:

• Weekly: Describe progress against the Project Work Plan, including upcoming milestones; potential risks to their achievement and proposed mitigation strategies;

planned activities for the coming week; contractor progress on any requirements analyses;

highlights of any dependencies related to the government’s upcoming responsibilities;

and an estimate of the tools and/or resources needed in the coming week to accomplish Work Plan objectives.

o Weekly reports should be delivered to the COR by the third business day of the week.

• Monthly: Describe project highlights; narrative summary of the month’s activities;

roadblocks and issues; year-to-date personnel hours by labor category; planned productions and goals; and status meeting reports.

o Monthly reports should be delivered to the COR on the tenth day after the end of the prior month.

Data Reports and Briefings As needed, the Contractor shall assist the COR at the COR’s direction in developing reports, briefings, and other data analyses in response to requests from internal/external entities. The reports shall include, at a minimum but not limited to, details and statistics related to certified products and certification status; statistics on API usage and connectivity; reporting related to ONC – Authorized Testing Lab (ONC-ATL) and ONC-Authorized Certification Body (ONC- ACB) activities; and reporting on connectivity and validation from external stakeholders.

C.4.1.3 Subtask 3 – Virtual Meetings

Post-Award Meeting Within two (2) weeks of the contract award date the Contractor shall meet with the COR and other ONC staff to discuss the objectives of the contract and any related project issues.

Collaboration Meetings The Contractor shall participate in meetings and related activities which will be designated by and at the direction of the COR, including routine and ad hoc meetings with ONC-ACBs, ONC- ATLs, CMS, and other stakeholders as required by the COR.

Weekly Update Meetings The Contractor shall meet with the COR each week to discuss the current status of the ONC CHPL including, but not limited to, recently completed work toward the Project Plan, upcoming work, government dependencies, and any changes to prioritization of work toward the Project Plan.

C.4.2 Mandatory Task 2 – ONC CHPL Development, Maintenance, and Updates

The ONC CHPL is an online database hosted through http://chpl.healthit.gov and serves as the sole source of information regarding products that were successfully tested and certified through the ONC Health IT Certification program.

The Technical Requirements for the ONC CHPL include:

o Data-model layer:

PostgreSQL v15: database program that stores the business data of the ONC

CHPL, as well as all audit information, and a few other elements that support management and maintenance of ONC CHPL o Application layer:

Java v17: the programming language nearly all of the application layer is written in http://chpl.healthit.gov/

Java Spring v6.2: framework for Java that gives access to a lot of configurations and supports best programming practices

FF4J: package that allows development of features that can be toggled on/off at will. Necessary for when various features need to be built well in advance of when they can be deployed

Quartz: system tool that supports configured jobs and processes. Used to schedule and send dozens of reports daily

Datadog: logging integration tool that's also used to monitor all of the URLs in the CHPL data for reliability and uptime

Swagger / OpenAPI: package that is used to generate API documentation to be displayed to the public, in order to support external users' access to the API

Tomcat: software package that hosts and runs the application code Amazon Cognito: user authentication and authorization tool. Also necessary for Single-Sign-On (SSO) and integration with other ASTP/ONC projects Microsoft Azure with Microsoft Graph: combination of packages that provide services to send email Redis: software tool that supports server-side caching of data, enabling improved performance and stability Jira: integration with an external service to ingest and display Direct Reviews o User interface layer:

Apache: system software that serves all of the UI files, and routes external API calls to the internal API AngularJS v1.8.3: Single Page Application (SPA) framework that was originally used to develop the UI, but now needs to be replaced React v17: new SPA framework that is replacing AngularJS. Both SPA frameworks need to run at the same time, on the same page Bootstrap v2: original user interface package that supports consistent user display and experience. Also deprecated, and needs to be replaced MaterialUI v4: replacement user interface for Bootstrap that is more usable with ReactJS Formik v2: package to support form entry, and data validation JSPDF v2: tool that generates PDFs on the fly for a variety of purposes PowerBI: modern business intelligence tool that pulls data from the API, transforms it in various ways, and outputs dozens of charts and graphs that are then displayed on the UI

Google Analytics: user analysis tool to generate information on user activity for later interpretation

In support of the development and maintenance of the ONC CHPL, the Contractor shall:

a. Assist in the back-end development and maintenance by:

Operations and Maintenance

• Supporting the ONC CHPL database on an online platform that is available through the healthit.gov infrastructure hosted by ONC in a service-level agreement (SLA) with

TISTA or other service providers, ensuring that the site maintains consistent accessibility to meet usage needs.

• Continuing maintenance of the open and accessible database, which can be queried through an open web service by both human and computer data calls (JSON (JavaScript Object Notation) and XML (Extensible Markup Language)). In addition, API access will allow for on-demand queries, which can be named and modified to get specific information requests.

• Maintaining and updating the open list of available APIs used to access the database by external stakeholders, which will be modified and customized as requested.

• Ensuring continued operation of direct access for ONC-ACBs to access the database in order to conduct Certified Health IT product information upload / modification on demand, along with data integrity checks for submitted products, and implement minor updates as needed to maintain this objective.

Development

• Continuing development on the database framework(s) to support currently included data elements required for the 2015 Certification Edition, HTI-1, along with historical data on all 2011 and 2014 Edition Certified products, and future rulemaking changes required— all with different reporting/presentation requirements.

• Continuing development of the open and accessible database, which can be queried through an open web service by both human and computer data calls (JSON (JavaScript Object Notation) and XML (Extensible Markup Language)) to support improved functionality and any new features and content added to the ONC CHPL under this contract.

• Developing the API on demand when required. An extensive list of currently developed and available API endpoints must be made accessible through the ONC CHPL website by the Contractor as well.

• Developing new features as needed to improve direct access for ONC-ACBs to access the database in order to conduct Certified Health IT product information upload / modification on demand, along with data integrity checks for submitted products.

• Developing new public search functions as needed to improve access and usability of data for the general public.

• Identifying and implementing structural improvements to improve ONC CHPL performance for both front-end and back-end use.

b. Assist in the front-end development and maintenance by:

• Ensuring that search results, page contents, and downloadable files are accessible, accurate, and updated at a schedule that is determined by the management plan and is altered as needed in consultation with the COR.

• Continuing development and improvement of the user interface for ONC CHPL (specifically geared towards fast efficient search and query results allowing for display of certification details in a minimal format if necessary), including such interface content as:

o Shortcut pages to pre-sorted content;

o Data analytics/chart pages;

o CHPL API documentation and list of API endpoints;

o Download pages;

o Reporting modules;

o Certified product details pages; and o Any additional content required under current rulemaking documents or upcoming rulemaking processes.

• Continuing development and maintenance on the ONC CHPL Compare Products Tool.

c. Maintain data integrity and information security by:

• Providing a plan to ensure data loaded into the ONC CHPL is accurate and secure and protected.

• Providing secure user access accounts to the ONC CHPL backend for various stakeholder groups including, but not limited to, ONC-ACBs, ATLs, CMS stakeholders, and ONC staff.

• Providing complete audit capability on data stored in systems, to allow for quality control and adherence to ONC-ACB principles of proper conduct.

d. Participate in customer service and support management / stakeholder engagement by:

• Providing support for ONC CHPL system interfaces and website to stakeholders and the general public.

• Assisting the COR in providing support for questions submitted from stakeholders and general public via additional technical details and guidance when available.

• Collaborating with stakeholder groups including, but not limited to, ONC, the Centers for Medicare and Medicaid Services (CMS), ONC-ACBs, ONC-ATLs, US State representatives, and Health IT Vendors/Developers to ensure the ONC CHPL is operating and meeting stakeholder expectations.

e. Align and update the ONC CHPL in accordance with current and future rulemaking activities put forward by ASTP/ONC, the CMS, and the Department of Health and Human Services (HHS) by:

• Updating the website display, product upload requirements, product upload and download templates, detailed product display pages, and changes to ONC CHPL widget(s) as regulatory requirements mandate.

• Verifying and validating that reporting requirements and product modifications are in alignment with updated rulemaking changes.

• Maintaining a comprehensive record of all previous data elements when rulemaking changes requires the update, modification, or removal of previous elements.

• Providing assistance to the COR in ensuring rulemaking updates are in alignment with program requirements and processes via detailed reviews and validation of ONC CHPL processes.

C.4.3 Mandatory Task 3– ONC CHPL Specific Development Items

The contractor shall complete the following specific ONC CHPL development items:

• Conduct a public usage and usability analysis by developing and implementing a plan for using multiple techniques to elicit public user feedback on the ONC CHPL interface to identify and prioritize areas for improvement.

• Improve the front-end UI to align with user feedback and usage metrics, as well as the newly redesigned back-end UI as needed, with a focus on, but not limited to, enhanced public access to ONC CHPL data and front-end functions.

• Enhance ONC CHPL guidance for all user roles to allow for more user-friendly, accessible, and streamlined guidance by improving user documentation in addition to identifying other methods, such as integrating specialized features to the front-end and back-end UI.

C.4.4 Optional Task 1 – ONC CHPL CMS Widget Maintenance, Development, and Improvement

The ONC CHPL CMS widget generates and stores CMS EHR Certification IDs used for participation in CMS and other EHR (Electronic Health Record) incentive programs. This function was previously developed as an integral part of the legacy CHPL (not “open data” CHPL). The CHPL CMS widget was deployed in Summer 2016, and ONC continues to maintain, develop, and improve on the widget.

In an effort to support current and future requirements for CMS EHR Incentive (now Promoting Interoperability) programs, the contractor shall:

• Provide support and continued development for ONC CHPL CMS widget for the continued creation, storage and reference of CMS EHR Certification IDs created and used in the CMS EHR Incentive (now Promoting Interoperability) programs.

• Provide updates to ONC CHPL CMS widget based on new or updated definitions of Certified Health IT detailed in CMS or ONC rulemaking.

• Maintain programmatic alignment with numerous CMS programs, which require creation of CMS EHR Certification ID for program participation.

• Support on-demand queries from CMS and States to provide electronic and automated verification and validation of submitted CMS EHR Certification IDs by program participants.

• Support on-demand queries from other interested parties, including auditors or others, to verify and validate previously submitted CMS EHR Certification IDs for use in CMS EHR Incentive (now Promoting Interoperability) programs through electronic access.

• Provide system account access for individual states to perform verification and validation actions and functions with the ONC CHPL CMS widget.

• Provide comprehensive listing of ONC CHPL CMS widget system API endpoints for stakeholder validation processes.

C.5 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/ONC 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.

Categorize all information owned and/or collected/managed on behalf of HHS/ONC 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, ONC 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: [ X ] Low [ ] Moderate [ ] High

• Integrity: [ ] Low [ X ] Moderate [ ] High

• Availability: [ X ] Low [ ] Moderate [ ] High

ii. 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/ONC regardless of location or purpose.

iii. 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).

iv. Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/ONC Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf 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/ONC security and/or privacy officials.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/ONC privacy policies, and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, HHS uses a privacy analysis process to assess the risks associated with HHS's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how HHS collects, disseminates, maintains, or disposes of the public's PII.

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

e. 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.

f. 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.

g. 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 ONC policies. Unauthorized disclosure of information will be subject to the HHS/ONC 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).

h. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with OMB Memorandum M-21-07, Completing the Transition to Internet Protocol Version 6 (1Pv6) available at https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf.

i. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf they identify prohibited ICT products and/or services are used during the contract performance.

j. Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

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

l. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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 ONC 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).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. 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.

m. 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 a 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. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable http://csrc.nist.gov/publications/

HHS/ONC Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with HHS policy.

A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual ONC Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

4. 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)/ONC 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 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 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 ONC approved notifications to affected individuals.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the ONC Incident Response Team (IRT), COR, CO, ONC 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 ONC 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/ONC and ONC 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.

5. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: [SELECT: Non-sensitive (NS)/Low Risk; Noncritical-Sensitive (NCS)/Moderate Risk; Critical-Sensitive (CS)/High Risk; Special-Sensitive (SS)/High Risk; Moderate Risk (MR); High Risk (HR) or NCS/High Risk]

6. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees must comply with 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; and Executive Order 13467, Part 1 §1.2.

7. Roster

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO. Any revisions to the roster as a result of staffing changes must be submitted.

The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level.

8. 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 and 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 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 ONC policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the ONC Contractor Employee Separation Checklist when an employee terminates work under this contract within 5-days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. 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 ONC policies and must not dispose of any records unless authorized by HHS/ONC.

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/ONC policies.

10. High Value Asset (HVA)

If a system is identified as HVA,[23] the contractor must comply with the HHS Policy for the High Value Asset (HVA) Program and the DHS HVA Control Overlay[24] in addition to the above requirements.

C.6 Security Requirements for GOCO and COCO Resources

1. 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), [enter applicable OpDiv policy if any]; 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.

2. Assessment and Authorization (A&A). A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) 6 months.