Sol_Doc_75F40124R00003_Attachment 6 - HHS FAR Class Deviation 2023-01.pdf

Class Deviation to the

Department of Health and Human Services Acquisition Regulation

Part 339

HHSAR Text Baseline is 48 CFR chapter 3 dated May 24, 2022.

Changes to baseline shown as [bolded, bracketed additions] and strikethrough deletions.

HHSAR text unchanged shown as asterisks.

[PART 339—ACQUISITION OF INFORMATION TECHNOLOGY (DEVIATION)

Subpart 339.70 – Standards for Health Information Technology (DEVIATION)

339.7000 Scope of subpart. (DEVIATION)

(a) This subpart implements standards for health information technology (health IT) pursuant to the Health Information Technology for Economic and Clinical Health Act

(“HITECH Act”), Pub. L. 111-5, Title XIII, sections 13111 and 13112.

(b) This subpart provides policies and procedures for solicitations and contracts that involve implementing, acquiring, or upgrading health IT used—

(1) For the direct exchange of individually identifiable health information between agencies and with non-Federal entities; and

(2) By health care providers, health plans, or health insurance issuers.

339.7001 Definitions. (DEVIATION)

As used in this subpart—

Health information technology (health IT) means hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information. (42 U.S.C.

300jj)

Individually identifiable health information means information that is a subset of health information, including demographic information collected from an individual, and:

(1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and

(2) Relates to the past, present, or future physical or mental health condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and

(i) That identifies the individual; or

(ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual. (42 U.S.C. 300jj, 1320d)

ONC Health Information Technology Certification Program means the certification program administered by the HHS Office of the National Coordinator for Health

Information Technology (ONC) using a third-party conformity assessment program for health IT. Certification criteria for the Program, which incorporate standards and implementation specifications in 45 CFR part 170 subpart B, are found in 45 CFR part

170, subpart C.

339.7002 Policy—standards for health information technology. (DEVIATION)

(a) Pursuant to the HITECH Act, Pub. L. 111-5, Title XIII, sections 13111 and 13112, health IT procured by or on behalf of HHS entities, or when contracting with health care providers, health plans, or health insurance issuers that are implementing, acquiring, or upgrading health IT, shall meet standards and implementation specifications adopted in 45

CFR part 170, subpart B, if applicable.

(b) Contracting officers shall not award a contract unless the offeror/contractor agrees that—

(1) For work performed under the contract that involves implementing, acquiring, or upgrading health IT used for the direct exchange of individually identifiable health information between agencies and with non-Federal entities the contractor will utilize health IT that—

(i) Meets standards and implementation specifications adopted in 45 CFR part

170, subpart B, if such standards and implementation specifications can support work performed under the contract; and

(ii) Is certified under the ONC Health Information Technology Certification

Program, if certified technology can support work performed under the contract (see certification criteria in 45 CFR part 170, subpart C), when the contractor is an eligible professional in an ambulatory setting, or a hospital, eligible under sections 4101, 4102, and

4201 of the HITECH Act, or when the contractor is implementing, acquiring, or upgrading technology to be used by an eligible professional in an ambulatory setting, or hospital, eligible under sections 4101, 4102, and 4201 of the HITECH Act.

(2) If the contractor is a health care provider, health plan, or health insurance issuer, or is establishing an agreement with a health care provider, health plan, or health insurance issuer, for work performed under the contract that involves implementing, acquiring, or upgrading health IT, the contractor will utilize health IT that—

(i) Meets standards and implementation specifications adopted in 45 CFR part

170, subpart B, if such standards and implementation specifications can support work performed under the contract; and

(ii) Is certified under the ONC Health Information Technology Certification

Program, if certified technology can support work performed under the contract (see certification criteria in 45 CFR part 170, subpart C), when the contractor is an eligible professional in an ambulatory setting, or a hospital, eligible under sections 4101, 4102, and

4201 of the HITECH Act, or when the contractor is implementing, acquiring, or upgrading technology to be used by an eligible professional in an ambulatory setting, or hospital, eligible under sections 4101, 4102, and 4201 of the HITECH Act.

(c) If standards and implementation specifications adopted in 45 CFR part 170, subpart B, cannot support the work as specified in the contract, the contractor is encouraged to use health IT that meets non-proprietary standards and implementation specifications developed by consensus-based standards development organizations. This may include standards identified in the ONC Interoperability Standards Advisory, available at https://www.healthit.gov/isa/.

339.7003 Contract clause. (DEVIATION)

The contracting officer shall insert the clause at 352.239-70, Standards for Health

Information Technology, in solicitations and contracts issued by or on behalf of HHS entities that involve implementing, acquiring, or upgrading health IT used —

(a) For the direct exchange of individually identifiable health information between agencies and with non-Federal entities; or

(b) By health care providers, health plans, or health insurance issuers.

https://www.healthit.gov/isa/

PART 352—SOLICITATION PROVISIONS AND CONTRACT CLAUSES

Subpart 352.2—Text of Provisions and Clauses

[352.239-70 Standards for Health Information Technology. (DEVIATION)

As prescribed in 339.7003, insert the following clause:

STANDARDS FOR HEALTH INFORMATION TECHNOLOGY

(DEC 2022) (DEVIATION)

(a) Definitions. As used in this clause—

Health information technology (health IT) means hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information. (42 U.S.C.

300jj)

Individually identifiable health information means information that is a subset of health information, including demographic information collected from an individual, and:

(1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and

(2) Relates to the past, present, or future physical or mental health condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and

(i) That identifies the individual; or

(ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual. (42 U.S.C. 300jj, 1320d)

ONC Health Information Technology Certification Program means the certification program administered by the HHS Office of the National Coordinator for Health

Information Technology (ONC) using a third-party conformity assessment program for health IT. Certification criteria for the Program, which incorporate standards and implementation specifications in 45 CFR part 170 subpart B, are found in 45 CFR part

170, subpart C.

(b) Pursuant to the Health Information Technology for Economic and Clinical

Health Act (HITECH Act), Pub. L. 111-5, Title XIII, sections 13111 and 13112, by submission of an offer and execution of a contract, the Contractor agrees that—

(1) For any work performed under the contract that involves implementing, acquiring, or upgrading health IT used for the direct exchange of individually identifiable health information between agencies and with non-Federal entities, the Contractor will utilize health IT that—

(i) Meets standards and implementation specifications adopted in 45 CFR part 170, subpart B, if such standards and implementation specifications can support the work performed under the contract; and

(ii) Is certified under the ONC Health Information Technology Certification

Program, if certified technology can support the work performed under the contract (see certification criteria in 45 CFR part 170, subpart C), when the Contractor is an eligible professional in an ambulatory setting, or a hospital, eligible under sections 4101, 4102 and

4201 of the HITECH Act, or when the Contractor is implementing, acquiring or upgrading technology to be used by an eligible professional in an ambulatory setting, or a hospital, eligible under sections 4101, 4102 and 4201 of the HITECH Act.

(2) If the Contractor is a health care provider, health plan, or health insurance issuer, or is establishing an agreement with a health care provider, health plan, or health insurance issuer, for work performed under the contract that involves implementing, acquiring, or upgrading health IT, the Contractor will utilize health IT that—

(i) Meets standards and implementation specifications adopted in 45 CFR part 170, subpart B, if such standards and implementation specifications can support the work performed under the contract; and

(ii) Is certified under the ONC Health Information Technology Certification

Program, if certified technology can support the work performed under the contract (see certification criteria in 45 CFR part 170, subpart C), when the Contractor is an eligible professional in an ambulatory setting, or a hospital, eligible under sections 4101, 4102 and

4201 of the HITECH Act, or when the Contractor is implementing, acquiring or upgrading technology to be used by an eligible professional in an ambulatory setting, or a hospital, eligible under sections 4101, 4102 and 4201 of the HITECH Act.

(c) If standards and implementation specifications adopted in 45 CFR part 170, subpart B, cannot support the work as specified in the contract, the Contractor is encouraged to use health IT that meets non-proprietary standards and implementation specifications developed by consensus-based standards development organizations. This may include standards identified in the ONC Interoperability Standards Advisory, available at https://www.healthit.gov/isa/.

(End of clause)] https://www.healthit.gov/isa/

Changes to HHSAR PGI Due to HHSAR Part 339 Class Deviation

Changes to baseline shown as [bolded, bracketed additions] and strikethrough deletions.

HHS Acquisition PGI text unchanged shown as ***** asterisks.

[PGI Subpart 339.70 – Standards for Health Information Technology

339.7002 Policy— standards for health information technology.

Contracting officers and requiring activities—

(a) Should consult with the Office of the National Coordinator for Health Information

Technology (ONC) if they have questions regarding the use of the clause at 352.239-70, Standards for Health Information Technology. Contracting officers and requiring activities can email onchealthitalignment@hhs.gov with questions;

(b) May access educational materials and resources regarding available standards and certification criteria can support health care activities are available from ONC at https://www.healthit.gov/topic/hhs-health-it-alignment-policy; and

(c) May access the ONC Certified Health IT Product List at https://chpl.healthit.gov/ to validate certified health IT has been tested and certified by the ONC Health Information

Technology Certification Program.

mailto:onchealthitalignment@hhs.gov https://www.healthit.gov/topic/hhs-health-it-alignment-policy https://chpl.healthit.gov/