By the EHR Association Information Blocking Compliance Task Force

This is the first installment of a multi-part blog series on the EHR Association’s analysis of the HTI-5 proposed rule.

The HTI-5 proposed rule, Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity, significantly updates information blocking compliance provisions. The proposed changes raised red flags for the EHR Association because they do not provide the simplification, guidance, and education needed to cut through the complexity of current policy. In fact, they increase the complexity and challenges of compliance.

Also among our overarching concerns are ASTP/ONC’s apparent overstatement of the burden-reduction outcomes of its proposed changes and its underestimation of the true economic impact of both the current information blocking policy and the proposed changes, as implied by the agency’s failure to provide an estimate of the implementation costs borne by the industry. The reality is that the proposed changes will increase the administrative burden on software developers and other stakeholders who interact with our community in the process of determining the best path forward for information access, exchange, and use. 

In the months prior to the proposed rule’s issuance, ONC leadership made it clear that information blocking enforcement was entering a new era. Dr. Tom Keane, the National Coordinator for Health IT, has repeatedly emphasized that certification status and information blocking behavior are linked and that certification nonconformity will be a powerful enforcement tool. 

As EHR developers, we support the intent of the information blocking prohibition: seamless information sharing and nationwide interoperability. However, ONC’s policy is not achieving that intention. 

Our analysis of HTI-5’s information blocking proposals identified new ambiguities, administrative requirements, and risks for developers and providers. In addition, the HTI-5 proposed rule downplayed the operational and economic impact for covered actors.

Our analysis of HTI-5’s information blocking proposals identified new ambiguities, administrative requirements, and risks for developers and providers. In addition, the HTI-5 proposed rule downplayed the operational and economic impact for covered actors.

Infeasibility: A Complex Exception Made Harder

HTI-5 proposes several changes to the Infeasibility Exception, including removing the “third party seeking modification use” condition and increasing the number of alternative manners required before an actor can claim the Manner Exception is exhausted.

Most developers rarely use the Infeasibility Exception today, yet HTI-5 explicitly implies misuse. Rather than conclude that their policy is overly complex and difficult for even sophisticated actors to understand, ONC’s language in the proposed rule was inflammatory. Real-world examples would help the industry understand how regulators interpret the exception and better allow stakeholders to react accurately and specifically.

The proposal also overlooks the fundamental operational reality that — as the EHR Association has noted since the infeasibility exception was initially proposed — the 10-business-day response window is simply unworkable. Understanding and scoping a request, reacting to the original manner requested, and then possibly assessing and negotiating up to three alternative manners simply cannot be completed in that timeframe. For many health IT developers, especially smaller vendors, the volume of requests alone makes this impossible. As such, we have long recommended that the regulation be adjusted to require starting the 10-day clock after negotiations conclude, not upon receipt of the request.

Analogous vs. Same: A Shift Toward Ambiguity

HTI-5 would replace Manner Exception Exhausted wording that actors offer the “same” access, exchange, or use with an “analogous” one. While seemingly minor, this change introduces significant ambiguity. What is “analogous” in one system architecture may not be in another. ONC’s own example, implying that all write APIs or filters are inherently analogous, notably oversimplifies the diversity of technical implementations across the industry.

This ambiguity doesn’t just complicate compliance; it complicates enforcement. OIG and private litigants increasingly cite information blocking exceptions in disputes. Subjective terminology raises the stakes for everyone (and particularly in private litigation, where judges frequently lack the requisite technical knowledge), which is why we recommend retaining the current “same” standard.

Innovation at Risk: Pilots, Custom Work, and Standards

HTI-5 also proposes that if any entity receives a requested manner of access, exchange, or use, the Manner Exception Exhausted cannot apply. This would discourage pilots, custom development, and early-stage innovation, which are precisely the activities that help advance interoperability. If a single-pilot implementation sets a precedent for all future requesters, developers will be far less willing to experiment.

We strongly recommended to ONC, in our response to the HTI-5 proposal, that the Manner Exception Exhausted condition be retained and improved by clarifying expectations for negotiation and setting more realistic timelines.

We strongly recommended to ONC, in our response to the HTI-5 proposal, that the Manner Exception Exhausted condition be retained and improved by clarifying expectations for negotiation and setting more realistic timelines.

Manner Exception: New Definitions, Burdens, and Conflicts

HTI-5 attempts to clarify the Manner Exception by introducing new requirements around market rate, contracts of adhesion, and general market value. Unfortunately, these changes create more confusion than clarity and risk slowing processes specific to innovation and contracting.

• Fair Market Value (FMV) Requirements Are Unworkable. Defining “market rate” as Stark Law FMV would require developers to obtain formal valuations for potentially every product, module, or custom integration. ONC did not estimate the costs of this often lengthy process, but they would be substantial and would slow innovation, including emerging AI-driven capabilities.
• Contract-of-Adhesion Language Conflicts with Other ONC Rules. ONC requires standardized, publicly posted API terms and pricing. Yet HTI-5 suggests that standardized terms may be considered contracts of adhesion. Developers cannot be simultaneously required to publish consistent terms and penalized for using them.
• Eliminating Flexibility for Custom Work. Removing paragraph (a)(2) from the Manner Requested Condition and forcing all arrangements into the Fees and Licensing Exceptions would undermine the very purpose of the Manner Exception. Custom integrations often require custom pricing. Restricting that flexibility would discourage innovation, limit vendor flexibility to meet unique requests from clients, and reduce the availability of unique, mutually beneficial exchange arrangements.

Burden Estimates: A Missing Piece of the Regulatory Puzzle

Despite introducing the possibility of new negotiation expectations, valuation requirements, and interpretive standards, ONC provided no economic impact analysis for these proposals in the HTI-5 NPRM. The absence of these estimates is especially concerning, given the disproportionate impact on small developers and the cascading compliance obligations for both providers and third-party partners. Our assessment is that the information blocking elements of HTI-5 are, in fact, the opposite of deregulatory, given the burden they would impose.

Accurate burden estimates must include:

• Expected volume of Manner Exception negotiations
• Time and staffing required for multi-step negotiations
• Costs of FMV valuations
• Impact on innovation, especially AI and custom integrations

Without this analysis, HTI-5 proposals cannot reasonably be considered deregulatory, and we suggest that the proposals specific to information blocking not be finalized without additional rulemaking proposals that do include economic impact assessments.

The EHR Association suggests that the information blocking sections of the HTI-5 NPRM need significant rework for greater clarity, practicality, and accuracy before any related concepts are finalized. We strongly support a regulatory framework that encourages, rather than constrains, innovation and interoperability, but the current proposals are not yet there.

Subsequent installments of this blog series will examine certification aspects of the HTI-5 proposed rule from the EHR Association perspective.