HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology (HHSAR Case 2023-001)

DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>48 CFR Parts 339 and 352</CFR> <RIN>RIN 0991-AC35</RIN> <SUBJECT>HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology (HHSAR Case 2023-001)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Department of Health and Human Services. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Health and Human Services (HHS) is proposing to amend and update its Health and Human Services Acquisition Regulation (HHSAR) to implement requirements to procure health information technology (health IT) that meets standards and implementation specifications (standards) adopted by the Office of the National Coordinator for Health Information Technology (ONC) in the following parts: Acquisition of Information Technology and Solicitation Provisions and Contract Clauses. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before October 8, 2024, to be considered in the formulation of the final rule. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit written comments in response to HHSAR Case 2023-001 through the Federal eRulemaking Portal at: <E T="03">https://www.regulations.gov</E> by searching for “HHSAR Case 2023-001”. Select the link “Comment Now” and follow the “Submit a comment” instructions. Please include your name, company name (if any), and indicate they are submitted in response to “RIN 0991-AC35—HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology (HHSAR Case 2023-001).” <E T="03">Warning:</E> Do not include any personally identifiable information or confidential business information that you do not want publicly disclosed. All comments may be posted on the internet and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to comments received. <E T="03">Inspection of Public Comments:</E> All comments received before the close of the comment period will be available for viewing by the public, including personally identifiable or confidential business information that is included in a comment. You may wish to consider limiting the amount of personal information that you provide in any voluntary public comment submission you make. HHS reserves the right to withhold information provided in comments from public viewing that it determines may have an adverse impact on an individual(s). For additional information, please read the Privacy Act notice that is available via the link in the footer of <E T="03">https://www.regulations.gov.</E> Follow the search instructions on that website to view the public comments. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Mr. Jarreau Vieira, Chief, Acquisition Rule-Making Branch, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Financial Resources, Office of Acquisition Policy, 200 Independence Avenue SW, Washington, DC 20201. Email: <E T="03">acquisition_policy@hhs.gov,</E> Telephone: (202) 731-4625. This is not a toll-free telephone number. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> <HD SOURCE="HD2">A. Authority</HD> This rulemaking is being taken under the authority of the Office of Federal Procurement Policy (OFPP) Act which provides the authority for an agency head to authorize the issuance of agency acquisition regulations that implement or supplement the Federal Acquisition Regulation (FAR). The OFPP Act, as codified in 41 U.S.C. 1702, provides the authority for the FAR and for the issuance of agency acquisition regulations consistent with the FAR. This authority ensures that Government procurements are handled fairly and consistently, that the Government receives overall best value, and that the Government and contractors both operate under a known set of rules. The Health and Human Services Acquisition Regulation (HHSAR) is set forth at Title 48 CFR, chapter 3, parts 301 through 370. Under this authority, we are seeking to implement a department-wide management policy issued by the Secretary of the Department of Health and Human Services (Secretary) in July 2022 (hereafter the “Secretary's July 2022 Memorandum”), that directed HHS agencies to align and coordinate health IT-related activities in support of HHS health IT and interoperability goals. This policy was supported by requirements in sections 13111 and 13112 of the Health Information Technology for Economic and Clinical Health Act (HITECH Act) (Pub. L. 111-5). <HD SOURCE="HD2">B. Genesis of Standards for Health Information Technology in the HHSAR</HD> The Secretary's July 2022 Memorandum recognized that HHS spending on health IT-related activities has grown dramatically in recent years, as various agencies have begun to leverage the large foundation of electronic health records put in place by the $40 billion invested as a result of the HITECH Act, as part of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5, Feb. 17, 2009), and the related clinical data and interoperability standards that HHS continues to promote. Advancing interoperability and the effective and appropriate use of health IT systems is a key HHS objective, and COVID-19 has further demonstrated the importance of interoperable data to improve the quality, safety, affordability, and efficiency of health care delivery; inform pandemic response; and identify and address disparities in care. As health IT-related activities begin to play an increasingly prominent role in programs across the Department, the Secretary's July 2022 Memorandum states that it is critical to ensure alignment of such activities to avoid the proliferation of ad-hoc health IT and data silos. These silos undercut the effectiveness and efficiency of the Department's policies and programs, are costly for Federal and state agencies and private sector partners to create and maintain, have no synergies across programs, and—due to lack of alignment across and within HHS agencies—impose significant burden on health care providers, technology developers, and other health care stakeholders. As part of the Secretary's July 2022 Memorandum, the Secretary directed HHS agencies, working with the Assistant Secretary for Financial Resources (ASFR), to develop standard language for use in grants, cooperative agreements, or contracts. The Secretary's July 2022 Memorandum further identified the general elements of this standard language, including that: recipients are expected to utilize health IT that meets standards adopted under Section 3004 of the Public Health Service Act (PHSA), if applicable, when the funding mechanism includes provisions requiring recipients to implement, acquire, or upgrade health IT; health care providers who have been eligible to participate in Center for Medicare & Medicaid Services's (CMS's) health IT-focused incentive programs can meet alignment requirements under this policy by using certified health IT which incorporates standards adopted under PHSA Section 3004; and, where there are no applicable standards adopted under PHSA Section 3004, recipients are encouraged to use other HHS-identified standards or non-proprietary, consensus-based standards developed by a national standard setting organization, such as those referenced in the Interoperability Standards Advisory, are recommended. We note that this regulation does not impact existing HHS authorities for standards adoption and note that HHS agencies are committed to working together to ensure that standards under such authorities are aligned to advance interoperability for a nationwide health IT infrastructure. Section 13111 of the HITECH Act requires agencies identified by the Director of the Office of Management and Budget (OMB), in consultation with the Secretary, when implementing, acquiring, or upgrading health IT systems used for the direct exchange of individually identifiable health information between agencies and with non-Federal entities, to utilize, where available, health IT systems and products that meet standards and implementation specifications adopted by ONC on behalf of the Secretary under section 3004 of the Public Health Service Act (PHSA). Section 13112 of the HITECH Act specifies that agencies, as defined in Executive Order 13410, shall require in contracts or agreements with health care providers, health plans, or health insurance issuers that as each provider, plan, or issuer implements, acquires, or upgrades health IT systems, it shall utilize, where available, health IT systems and products that meet standards and implementation specifications adopted under Section 3004 of the PHSA. On behalf of HHS, ONC adopts standards and implementation specifications under section 3004 of the PHSA in 45 CFR part 170, subpart B. Standards adopted under section 3004 are included in certification criteria for health IT in the ONC Health Information Technology Certification Program in 45 CFR part 170, subpart C. For more information on the ONC Certification Program, see <E T="03">https://www.healthit.gov/topic/certification-ehrs/certification-health-it.</E> Health care providers who have been eligible to participate in CMS's health IT-focused incentive programs under sections 4101, 4102, and 4201 of the HITECH Act have been incentivized to adopt health IT that meets certification criteria which incorporate standards in 45 CFR part 170, subpart B. Consistent with HHS policy, the proposals address use of certified health IT by these providers, where applicable. <HD SOURCE="HD2">C. Implementation Via Class Deviation (2023-01)</HD> On December 20, 2022, the HHS Senior Procurement Executive issued HHSAR Class Deviation (2023-01) from part 339, Acquisition of Information Technology; Standards for Health Information Te ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 54k characters. 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