The Office of the National Coordinator for Health Information Technology’s latest proposed rule, HTI-5, has drawn sharp criticism from health IT developers. They argue the changes to information blocking compliance will increase complexity rather than simplify it.
The rule, titled Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity, aims to streamline health data exchange. Instead, it has raised concerns about heightened administrative burdens and unclear requirements.
Developers warn of unintended consequences
The Electronic Health Record Association represents nearly 30 health IT companies serving most U.S. hospitals and ambulatory providers. The group contends the proposed changes underestimate the economic and operational impact on software developers and other stakeholders.
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In its analysis, the association stated the adjustments will increase the administrative burden as developers determine how to access, exchange, and use information. It also noted ONC did not include an economic impact analysis of implementation costs the industry would face if the rule is finalized.
ONC leadership has shifted enforcement by linking certification status to information blocking behavior. Dr. Thomas Keane, the National Coordinator for Health IT, has emphasized that certification nonconformity will be a key enforcement tool. Developers say this raises the stakes without addressing underlying policy flaws.
Infeasibility exception becomes harder to use
One of the most contentious changes involves the Infeasibility Exception, which allows actors to deny data access requests if fulfilling them is impractical. The proposed rule removes the “third party seeking modification use” condition and increases the number of alternative methods required before claiming the Manner Exception is exhausted.
Developers say the 10-business-day response window is unrealistic. Scoping a connectivity request, negotiating alternatives, and assessing technical feasibility often take longer, particularly for smaller vendors handling high volumes of requests. The EHR Association has recommended the 10-day clock start only after negotiations conclude, not upon receipt of the request.
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The rule replaces the requirement to offer the “same” access with an “analogous” one, introducing ambiguity. What qualifies as analogous in one system may not in another, complicating compliance.
New definitions create confusion
HTI-5 attempts to clarify the Manner Exception by introducing new requirements around fair market value, contracts of adhesion, and general market value. Developers argue these changes add confusion instead of resolving it.
The rule also conflicts with existing ONC requirements. While the agency mandates standardized, publicly posted API terms and pricing, HTI-5 suggests such terms could be considered contracts of adhesion. This leaves developers caught between contradictory expectations.
Removing flexibility for custom work further complicates matters. The proposed changes would push all arrangements into the Fees and Licensing Exceptions, undermining the Manner Exception’s original purpose. Custom integrations often require custom pricing, and restricting that flexibility could discourage vendors from meeting unique client needs.
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Missing economic impact analysis raises concerns
The EHR Association argues the information blocking provisions in HTI-5 are not deregulatory, given the new burdens they impose. Despite introducing negotiation expectations and interpretive standards, ONC provided no economic impact analysis in the proposal.
The lack of these estimates is particularly concerning for small developers. They may not have the resources to comply with the new requirements. The association recommends the information blocking sections not be finalized without additional rulemaking that includes economic assessments and industry input.
“We strongly support a regulatory framework that encourages innovation and interoperability,” the EHR Association said. “But the current proposals fall short.”
