Electronic Health Reporter

By Leigh Burchell, vice chair, EHR Association Information Blocking Compliance Task Force.

The HTI-5 proposed rule, Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity, includes several significant updates to information blocking compliance provisions. The proposed changes raised red flags because they increase compliance challenges rather than providing the simplification, guidance, and education needed to cut through the complexity of current policy.

The EHR Association, which represents nearly 30 health IT developer companies whose technologies support the vast majority of hospitals and ambulatory providers across the US, has several additional overarching concerns, including ASTP/ONC’s overstated predictions about the burden-reduction outcomes of its proposed changes and its underestimation of the true economic impact of both the current and proposed information blocking policy. The reality is that the proposed changes will increase the administrative burden on software developers and other stakeholders who interact with our community as they determine the best path forward for accessing, exchanging, and using information, and the agency should have conducted and included an economic impact analysis of the implementation costs that will be borne by the industry if the proposed changes are finalized.

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. Thomas Keane, the National Coordinator for Health IT, has repeatedly emphasized since then 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.

Exacerbating the Already-Complex Infeasibility Exception

Among the proposed changes to the Infeasibility Exception are the removal of the “third party seeking modification use” condition and an increase in the number of alternative manners required before an actor can claim the Manner Exception is exhausted.

Most developers rarely use the Infeasibility Exception, 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 be more helpful for the industry to 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 connectivity request, reacting to the original manner requested, and then possibly assessing and negotiating up to three alternative manners cannot be completed within that timeframe. For many health IT developers, especially smaller vendors, the volume of requests alone makes this impossible. We have long recommended amending the regulation to require that the 10-day clock begin after negotiations conclude, not upon receipt of the request.

A Shift Toward Ambiguity in Manner Exception Exhausted

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 implies that all write APIs or filters are inherently analogous, which notably oversimplifies the diversity of technical implementations across the industry.

This ambiguity complicates both compliance and enforcement. OIG and private litigants increasingly cite information blocking exceptions in disputes. Subjective terminology raises the stakes for everyone, particularly in private litigation, where judges frequently lack the requisite technical knowledge to assess the situation accurately. That is why we recommend retaining the current “same” standard.

Putting Innovation at Risk

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 technical pilot projects, custom development for healthcare organizations, and early-stage innovation — precisely the activities that advance interoperability. If a single-pilot implementation sets a precedent for all future requesters, developers could be far less willing to experiment.

We strongly recommend to ONC that the Manner Exception Exhausted condition be retained and improved by both clarifying expectations for negotiation and setting more realistic timelines.

New Manner Exception 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 u 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 r 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.
• Flexibility for custom work is eliminated. Removing paragraph (a)(2) from the Manner Requested Condition and forcing all arrangements into the Fees and Licensing Exceptions would undermine the fundamental purpose of the Manner Exception. Custom integrations often require custom pricing. Restricting that flexibility would discourage innovation, limit vendors’ flexibility to meet clients’ unique requests, and reduce the availability of unique, mutually beneficial exchange arrangements.

Burden Estimates: A Missing Piece of the Regulatory Puzzle

Our assessment is that the information blocking elements of HTI-5 are, in fact, the opposite of deregulatory, given the burden they would impose. 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.

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. We suggest that the proposals specific to information blocking not be finalized without additional rulemaking proposals that include economic impact assessments, provide an opportunity for industry input, and verify the accuracy of that analysis.

The EHR Association suggests that the information blocking sections of the HTI-5 NPRM require significant rework to achieve 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.