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written about our belief that smart deregulation, a core policy priority of the current administration, can eliminate outdated or redundant regulatory requirements that are of limited value to patients, providers, and developers.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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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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Part Two: Privacy & Consent Management Landscape and Challenges to Scale

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

In Part One of this two-part blog series, we introduced the challenges in today’s privacy and consent management landscape and discussed different approaches for rules management. In Part Two, we put forth a proposed roadmap for establishing the necessary framework for privacy and consent management. 

A Roadmap for a Complex Infrastructure

Defining the critical components and standards, and establishing the necessary infrastructure is no small undertaking. It is not sufficient to simply have standards on how to communicate any tags, such as HL7 DS4P for documents, FHIR Security Labels for FHIR resources, and the ARV segment for HL7 v2. Not only that, but more is needed when v2, CDA, or FHIR are used to communicate data that must have tags beyond the data itself to enable evaluation of rules by the receiving system. This is especially true when data can be exchanged in many other formats and ways, including proprietary formats, and when sensitivity is based on the context of multiple data elements that, on their own, would not be considered sensitive, as well as when a patient’s data sharing rules may not involve a well-defined set of data values.

The $64,000 question is, how can we make progress? 

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Part One: Privacy & Consent Management Landscape and Challenges to Scale

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

As health data flows more widely and automatically across providers, payers, patients, public health, researchers, and others, automated tools to filter for data that is not authorized to be shared have become imperative.  

To date, relatively simple and coarse methods have been deployed where large data sets are excluded from exchange:

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Success of ONC’s Health IT Strategic Plan Rests on Realistic Expectations, Regulatory Timelines

By Stephanie Jamison (Greenway Health), Chair, and William Hayes, M.D. (Trubridge), Vice Chair, EHR Association

With its Draft 2024-2030 Federal Health IT Strategic Plan, ONC seeks to enhance individual and community health through improved healthcare experiences, advanced research and innovation, and integrated health data systems – important goals the EHR Association finds commendable provided the path taken to achieve them is paved with realistic expectations and timelines for regulations targeting them.

In many ways, the mission and vision laid out by ONC in its strategic plan echoes the objectives of our member companies; namely, advancing the quality and efficiency of care through innovative, interoperable health IT adoption and use. However, our enthusiastic support is tempered by concerns over the potential for too-aggressive compliance timelines and expectations that are beyond the reach of EHR and other health IT developers and the provider organizations utilizing these tools – concerns we shared in our response to ONC’s call for feedback on the Draft Federal Health IT Strategic Plan. 

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EHRs are Prioritizing Data Usability with Help from The Sequoia Project and AHIMA

By Didi Davis, Vice President of Informatics, Conformance & Interoperability with the Sequoia Project

When folks talk about interoperability, the conversation is usually focused on the “why” or the “how” for health information exchange. The Sequoia Project, in partnership with AHIMA and health IT organizations participating in the Data Usability Taking Root Movement, is expanding the dialogue to “what” data is exchanged, and how we can ensure it is accurate, complete, usable, and in alignment with current regulations.

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