Editor’s note: This story has been updated to reflect that HHS’ Office of the Assistant Secretary of Financial Resources proposed this rule. The proposal aims to advance interoperability standards.
The Department of Health and Human Services' technology office and financial resources office are acting on a July 2022 memorandum to align health information technology strategy, and investments, across the department.
The offices have developed standard language to align health data exchange standards for HHS grants, cooperative agreements, contracts and policy and regulatory actions.
As a part of the HHS Health IT Initiative, ASTP/ONC has also provided technical assistance to the Centers for Disease Control (CDC) and the Centers for Medicare and Medicaid Services (CMS) to align health IT standards.
HHS’ National Coordinator of Health IT Micky Tripathi published a blog post on Friday, Aug. 9 that emphasized the department’s commitment to advancing health information interoperability.
“By aligning on standards that enable interoperability, HHS is ensuring that federal investments do not contribute to the proliferation of proprietary modes of exchange and data silos that inhibit access, exchange, and use of data,” the blog post, co-authored with Lisa Molyneux, the acting Assistant Secretary for Financial Resources, says.
HHS’ Office of the Assistant Secretary of Financial Resources (ASFR) proposed a rule on Thursday to require HHS contractors to use health IT certified or accepted by the department.
The proposed rule would implement a July 2022 memorandum by the Secretary of HHS that requires HHS entities to coordinate health IT-related activities in services of HHS health IT and interoperability goals.
Providers, health plans, or health insurance issuers that contract with HHS would be required to adopt ONC standards if the contract involves implementing, acquiring, or upgrading health IT and the certified technology can support the work under the contract. Activities that are not directly related to implementing health IT would not be subject to the standards.
One organization’s analysis of the proposed rule obtained by Fierce Healthcare said the proposed rule covers contracts that make investments in the maintenance of health IT, use health IT for data management or support the piloting of new tools.
The proposed rule gives HHS contractors some leeway to choose their health IT systems. Contractors can either adopt ONC-certified health IT, use health IT that meets the standards of ONC or, if certified technology cannot support the work under the contract, the rule proposes that contractors use non proprietary standards and other specifications set out by consensus-based standards development organizations, such as Health Level Seven (HL7).
After initial regulatory analysis, experts are concerned that by requiring the use of ONC-certified technology or ONC approved standards that the office would be restricting the pace of innovation.
Experts are holding meetings to determine if the proposed rule would facilitate interoperability, as is its stated goal. Experts are also looking for clarity on how the proposed rule would apply to grants. Grant money is often used for exploring innovative solutions, and requiring the use of previously certified health IT may be counter to that aim.
Many organizations are already struggling to be able to implement certification requirements set out by ONC, especially because of the pace of regulation. For example, ONC released the HTI-1 final rule in December 2023, and it requires organizations to implement the United States Core of Data Interoperability version 3 by January 1, 2026.
Monday, August 12
The Department of Health and Human Services’ financial resources office dropped a new proposed rule on Thursday that would require healthcare entities that contract with the department to use HHS-adopted standards for data exchange.
The aim is to advance interoperability across intersecting health tech systems when a contract involves upgrading or implementing health IT.
The proposed rule is part of an HHS effort to align technology standards used by contracts that interact with health care systems, to the same standards used by hospitals and health care providers in those healthcare systems wherever feasible, according to department officials.
HHS’ Office of the Assistant Secretary of Financial Resources (ASFR) has been collaborating with the department’s health technology office to align health IT requirements for entities that enter into contracts with HHS since 2022 through the HHS Health IT Alignment Policy.
“Under Health IT Alignment Policy to date, ASTP and HHS partners have identified billions of dollars that impact health IT across HHS programs and activities,” Assistant Secretary of Technology Policy Micky Tripathi and Principal Deputy Assistant Secretary of Financial Resources Lisa Molyneux wrote in a blog post on August 9. “ASTP has supported HHS agencies with their programmatic goals by aligning health IT requirements across these investments.”
One group said the proposed rule could expand HHS’ purview over health technology beyond setting standards for electronic health records (EHRs) to include data systems used by public health entities and insurers’ information systems. The proposed rule could potentially impact the regulation of artificial intelligence and cybersecurity in healthcare, a source said.
HHS’ proposed rule, “Acquisition Regulation: Information Technology; Standards for Health Information Technology" proposes that health IT meet ONC standards requirements when: solicitations and contracts issued by or on behalf of HHS entities involve implementing, acquiring or upgrading health IT where individually identifiable health information (IIHI) is exchanged; and, health IT is used by healthcare providers, health plans, or health insurance issuers under HHS contracts.
The proposed rule would also include healthcare providers who have been eligible to participate in CMS’ health IT-focused incentive programs.
ASFR writes that the proposed rule will help standardize health IT and clarify when health information technology has to meet the requirements of HITECH.
“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,” the proposed rule says. “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 healthcare providers, technology developers, and other health care stakeholders.”
The Health Innovation Alliance promptly criticized the rule as an overreach of HHS’ authority. Executive Director of HIA Brett Meeks told Fierce Healthcare he is approaching the rule cautiously, and with an eye to the possibility that the rule could dramatically expand the scope of HHS purview.
Historically, ONC has only certified electronic health records. Meeks said the new rule could impact the technology that a broader swath of the healthcare industry is using, like public health data and health information systems.
Meeks said ASTP has made several shocking moves in recent weeks, like its massive reorganization that shifts its role within HHS.
“In the past few weeks, HHS’s IT office has given themselves a promotion and proposed to drastically expand their review of products used by the health care industry,” a statement by HIA says. “This morning, it announced the mandates of its proposals: all grantees or programs with a connection to HHS funding must use products the agency has approved.”
Stakeholders have 60 days to comment on the proposed rule.