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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ONC Needs to Address HTI-1’s Burdens on Healthcare Providers, Health IT Developers

By David Bucciferro, Chair, EHR Association

While the EHR Association has long supported the goals of ONC’s proposed rule to advance interoperability, improve transparency, and support further access, exchange, and use of EHI, we have several serious concerns about the impact HTI-1 (ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule) will have on the industry if finalized as proposed. 

Among the most significant are the insufficient implementation timeframes associated with various concepts included in HTI-1 and a failure to accurately consider the significant burden compliance would place on both provider organizations and health IT developers. Vendors need more time than proposed in HTI-1 to accommodate the substantial lift required to deliver safe, compliant, and high-quality versions of their certified products – 18-24 months is the commonly accepted necessary timeframe – while providers need sufficient time to implement, test and become proficient on that upgraded software. 

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Standards will Make or Break Efforts Toward ePA

By Janet Campbell (Epic), EHRA Public Policy Leadership Workgroup Vice Chair

This is part two in a four-part series examining the need for ePA, the barriers presented by the current environment, necessary capabilities, and functionality, and the EHR Association’s policy recommendations. Part one can be read here.

Streamlining the electronic prior authorization (ePA) process will require significant coordination and standardization across multiple domains within individual healthcare organizations, across dozens of health plans covering their patients, and across the health IT tools in use by every participant in the process.

Progress is being made by various stakeholders in terms of standards development. Notably, the Coverage Requirements Determination (CRD), Documentation Templates and Rules (DTR), and the Prior Authorization Support (PAS) implementation guides – all a part of the Da Vinci Project’s efforts to understand functional requirements, build consensus on a technical approach, pilot, and iterate – have resulted in significant progress toward the enablement of highly automated prior authorization workflows.

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The USCDI Curation Process: Why Stratify?

By John Travis and members of the EHRA Information Blocking Task Force 

In our last blog on the United States Core Data for Interoperability (USCDI), the focus was on USCDI as the policy ground for advancing federal interests for promoting high impact needs for health data, and USCDI’s import as a certification specification impacting developers of Certified Health Information Technology (CHIT). In this blog, we focus on how the evolution and curation of USCDI impacts the efforts of health IT developers and implementers to “stay current.” 

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The Balance Challenge for Policy in Progressing the U.S. Core Data for Interoperability (USCDI)

By John Travis and members of the EHRA Information Blocking Task Force

 

With publication of the 21st Century Cures Act: Interoperability, Information Blocking , and ONC’s Certified Health IT program final rule (Cures Act Final Rule), the Office of the National Coordinator for Health IT (ONC) worked to implement important provisions of the 21st Century Cures Act (Cures Act) for nationwide interoperability. The initial proposal from ONC addressing the Trusted Exchange Framework and Cooperative Agreement (TEFCA), which was also required by the Cures Act, created a central role for the U.S. Core Data for Interoperability (USCDI) in federal health IT policy, and it is important to consider what that role will be in the national policy framework. Will the USCDI push the industry beyond where it would go on its own by being progressive in its version expansion? Will it affirm and codify an extension of the current state, adhering to a principle of expansion based on supporting pre-requisites of already established interoperability standards? Or something in between?

In recent deliberations of the USCDI Task Force of the Health Information Technology Advisory Committee (HITAC), the Federal Advisory Committee established under the Cures Act, this tension point has come to light. The members of the task force seem to have two perspectives on the matter. 

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An EHR Perspective on the Consumer-Focused API/App Landscape

By Hans Buitendijk
EHRA Executive Committee member
Chair, Interoperability & Standards Workgroup

kevin-grieve-712217-unsplashONC’s 2015 Certification Edition for EHRs began supporting consumer access to their health data beyond patient portals. Open APIs were required to enable consumer Apps to access data from the Common Clinical Data Set. Because at the time there were no standards sufficiently mature to establish as a base, the requirement allowed for access by any means as long as the technical specifications, including terms and conditions, were made publicly available to enable App developers to write their Apps on top of these APIs.

A lot has happened since then.
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