The Department of Health and Human Services’ technology office dropped a new proposed rule on Thursday that would require healthcare entities that contract with HHS to use government-certified health information technology.
One group said the proposed rule could expand ASTP/ONC’s scope 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.
The Office of the Assistant Secretary of Technology Policy’s 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’s health IT-focused incentive programs.
ASTP/ONC writes that 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 ASTP/ONC’s 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 ASTP purview.
The proposed rule says that healthcare providers, health plans and insurers that contract with HHS may be required to use ONC-certified technology. 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.
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