On August 9, the Department of Health and Human Services (HHS) published a proposed rule that seeks to amend and update the Health and Human Services Acquisition Regulation (HHSAR) to align health IT procurement requirements. The rule mandates that health IT procured by HHS meet certain "standards and implementation specifications adopted by the Office of the National Coordinator for Health Information Technology."
This move comes after the issuance of a 2022 HHS-wide plan to advance interoperability through departmental activities. The hope is that increased interoperability will allow HHS to leverage data available in electronic health records to enhance federal activities, and greater consistency in health IT activities will lower costs and increase the effectiveness of agency programs.
2022 Plan
In the summer of 2022, HHS announced a plan to proactively align "health IT activities across the department to ensure that [HHS is] operating as efficiently and cohesively as possible." Specifically, Secretary Becerra directed the Office of the National Coordinator (ONC) for Health Information Technology to 1) "incorporat[e] standard health IT requirements language in all applicable HHS funding programs, contracts, and policies; and 2) provid[e] direct ONC assistance to HHS agencies to maximize the use of HHS-approved standards and authorities."
Proposed Rule
The issuance of the proposed rule is a key part of realizing the objectives of the 2022 HHS Health IT Alignment Policy as it seeks to "establish and oversee a consistent HHS-wide approach to ensure that health IT requirements in grants, cooperative agreements, contracts and policy and regulatory actions align with HHS-adopted data standards," according to Micky Tripathi, Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology.
Notably, the proposed rule adds a new subpart to HHSAR Part 339, which implements the requirements of the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HITECH Act requires agencies identified by the Director of the Office of Management and Budget (OMB) to use health IT systems that meet certain standards and specifications 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.
The HITECH Act also mandates that "agencies 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 certain standards and implementation specifications. The specific standards and specifications can be found in 45 CFR part 170, subpart B.
The proposed rule would prohibit HHS from entering into any contract involving health IT "used for the direct exchange of individually identifiable health information between agencies and with non-Federal entities unless an offeror/quoter/contractor shall utilize health IT that" does either of the following:
- Meets certain standards and implementation specifications adopted in 45 CFR part 170, subpart B.
- Is certified under the ONC Health Information Technology Certification Program, when the contractor is an eligible professional in an ambulatory setting or a hospital or implementing, acquiring, or upgrading technology to be used by an eligible professional in an ambulatory setting, or hospital.
In addition, the proposed rule would "prohibit contracting officers from awarding a contract if a contractor is a health care provider, health plan, or health insurance issuer, for any work performed under the contract that involves implementing, acquiring or upgrading health IT, unless the offeror/quoter/contractor agrees that it will utilize health IT that complies with the aforementioned requirements."
In the event that health IT cannot meet the required standards and implementation specifications because those standards cannot support the work specified in the contract, the proposed rule encourages contractors to use health IT that "meets non-proprietary standards and implementation specifications developed by consensus-based standards development organizations." Contractors can look to the ONC Interoperability Standards Advisory for guidance as to those standards.
Conclusion
HHS has long understood the value of having accessible, interoperable health data to improve the effectiveness and efficiency of the department and the advancement of positive health outcomes around the world. The proposed rule is HHS's latest effort to realize the value of its data. With these new standards, HHS data will help improve the quality, safety and affordability of healthcare delivery, identify and address disparities in care, and even inform responses to future pandemics.
Comments on the proposed rule are due by October 8, 2024.
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