USCDI, Bulk Data Exports & EHI Exports: Solid Concepts Requiring Standardization and Maturity

By Hans Buitendijk, Chair, EHR Association Privacy & Consent Task Force

The EHR Association has previously written about our belief that smart deregulation, a core policy priority of the current administration, can eliminate outdated or redundant regulatory requirements that are of limited value to patients, providers, and developers. By focusing on policies that drive improvements in standardized interoperability and health data exchange, regulatory agencies will better support the industry’s ability to deliver safe, effective, and innovative technology solutions without slowing forward momentum or devaluing existing investments.

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EHR Association Statement on HTI-2 Final Rule

Following is the statement from the EHR Association on the Dec. 11, 2024 publication by ASTP/ONC of the Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (HTI-2) Final Rule, which will publish in the Federal Register on Dec. 16, 2024. The scaled-based rule finalizes certain proposals related to the Trusted Exchange Framework and Common Agreement (TEFCA). It also amends the information blocking regulations by including definitions related to the TEFCA Manner Exception and implements provisions to support the reliability, privacy, security, and trust within TEFCA.

“This first rule finalizing parts of the HTI-2 proposals was released on December 11, 2024, and the focus on TEFCA allows ASTP to solidify pillars of that program that outgoing leadership wants to leave as a legacy. We expect the remaining components of the HTI-2 proposed rule to be split into multiple other final rules. In doing so, the EHR Association hopes that ASTP/ONC will prioritize the necessary additional technical corrections specific to health IT vendors, the most urgent of which relate to Insights Measures. As currently drafted, the Insights Measures are likely to produce data of questionable value – something we have been stressing to ASTP since publication of the HTI-1 proposed rule in 2023. As we inch closer to the January 1, 2026, start date, the uncertainty of finalized measurements creates challenges. We hope that future rules finalizing HTI-2 proposals will include helpful and necessary clarifications.”

HTI-2: Immature Standards and Lopsided Mandates

By Danielle Friend (Epic), Chair, Standards & Interoperability Workgroup, and John Stamm (Epic), Vice Chair, Public Health Workgroup

Previous installments of this 3-part blog series on the EHR Association’s top concerns with HTI-2 focused on the overarching issues and specific issues with the complex web of proposed changes to Insights Measures. Our full comments to ASTP are available on our website.

Along with unrealistic compliance timeframes and out-of-sync cross-agency requirements, ASTP’s Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule creates substantial compliance burdens for providers, the EHR developers that support them, and public health agencies (PHAs) due to the laundry list of premature and/or unnecessary and lopsided requirements.

Three areas where these issues are quite prominent are HTI-2’s proposed requirements pertaining to standards, electronic prior authorization (ePA), and public health reporting.

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ASTP’s HTI-2 Proposes Concerning Changes to Insights Measures

By Greg Thole (Oracle), Chair, EHR Association Certification Workgroup

In the previous installment of our blog series dissecting the EHR Association’s raft of concerns with ASTP’s Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, we focused on the overarching issues. In this blog, we take a deep dive into the complex web of proposed changes to Insights measures that present specific challenges for certified health IT developers and indirect impacts for the providers that use their solutions. (Our full comments to ASTP are available on our website.)

Insights is a Condition and Maintenance of Certification requirement introduced via statutory directive in the 21st Century Cures Act, which tasked ASTP with creating an EHR reporting program for certified health IT developers. By its nature, Insights poses a difficult value proposition for developers, as it requires the commitment of development time and resources to efforts that do not directly benefit providers. 

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Huge Scope, Not Enough Time: Concerns with ASTP’s HTI-2 Proposed Rule

By Stephanie Jamison (Greenway Health), Chair, and Leigh Burchell (Altera Digital Health), Vice Chair, EHR Association Executive Committee

In the months leading up to ASTP’s July 2024 release of the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, the EHR Association and other health IT stakeholder organizations braced themselves for what was certain to be a massive policy proposal. Those fears were quickly realized when the overwhelming scope of proposed new and expanded software requirements in the 1067-page HTI-2 NPRM was revealed. 

Following our in-depth analysis of HTI-2 and the process of drafting comments, the Association has identified concerns related to public health, standards, Insights measures, and electronic prior authorization requirements within the proposed rule, all of which will be discussed in greater detail in the subsequent blogs in this HTI-2 series. Additionally, there are several overarching issues we believe need to be addressed – including some previously raised by the EHR Association that have yet to be adequately addressed by ASTP and other regulatory agencies.

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