Looking Ahead at 2024

By Stephanie Jamison (Greenway Health), Chair, EHR Association

Last year ended with a bang as ONC issued the HTI-1 final rule and officially opened the doors to TEFCA by designating the first five QHINs. It was a small taste of what’s to come in 2024, and the EHR Association will be busy ensuring our members’ voices are heard at the state and federal levels as the regulatory wheel continues to spin.

Even as EHR developers and providers begin work on HTI-1 compliance, ONC is already moving forward with plans for the HTI-2 proposed rule, which is expected to focus on public health, patient engagement, and information sharing. The EHR Association will work closely with ONC and other stakeholders to voice concerns, provide recommendations, and educate on issues impacting our membership.

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Concerns Grow over Ambiguity of USCDI Data Classes

By Hans Buitendijk (Oracle) Ex Officio Member, EHRA Executive Committee

As USCDI and USCDI+ expand, we see an increase in ambiguities in their data definitions that are creating increased challenges for programs and health IT required to support USCDI as intended. It’s of particular concern for certified health IT developers, as the ambiguity gap raises questions about what support is actually required, as HL7 FHIR US Core and HL7 CDA C-CDA specifications are used to certify to supporting USCDI.

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Timeline to Comply:  EHR Developers Face a Complex Regulatory Compliance Landscape

By the EHR Association Public Policy Leadership Workgroup

Leading the digital transformation of the healthcare industry, electronic health records (EHRs) and health information technology (IT) play a pivotal role in streamlining patient care and improving healthcare outcomes. This transformation comes with a host of regulatory and compliance requirements that EHR and health IT developers must navigate – this timeline highlights the challenges and complexities of a portion of the upcoming projects.

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How Not to Lose $1 Million: Preparing for OIG’s Information Blocking Enforcement

Guest post by Alya Sulaiman and James A. Cannatti III, Partners with McDermott, Will & Emery LLP

On Sept. 1, 2023, the HHS Office of Inspector General (OIG) began enforcing rules against information blocking in healthcare – authority it was granted under the 21st Century Cures Act – putting certified health IT developers, HINs, and HIEs at risk of civil monetary penalties (CMPs) of up to $1 million for each confirmed violation. (Ultimately, healthcare providers will also be subject to disincentives for information blocking not yet published by HHS.) The EHR Association’s membership is committed to preventing information blocking and supporting efforts to share electronic health information (EHI) to better patient care. Part of that is arming impacted health IT developers with as much information as possible to help them – and by extension, their customers – comply with current and future regulations to help protect themselves from potentially crippling penalties.

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HTI-1 Patient Requested Restrictions Risks Negative Unintended Consequences

By David Bucciferro, Chair, EHR Association

In previous installments of this five-part blog series on the EHR Association’s concerns with ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule (HTI-1), we discussed our overarching concerns, as well as concerns specific to the Insights Condition program, transition to USCDI v3, and Decision Support Interventions (DSI) and Predictive Models. In this blog, we take a closer look at our issues with the proposed Patient Requested Restrictions provisions.

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HTI-1 Falls Short with DSI and Predictive Decision Support Proposals

By David Bucciferro, Chair, EHR Association

In other installments of this five-part blog series on the EHR Association’s issues with ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule (HTI-1), we discussed our overarching concerns, as well as concerns with the Insights Condition program, transition to USCDI v3, and Patient Requested Restrictions. In this installment, we examine the considerable issues we have identified with provisions related to Decision Support Interventions (DSI) and Predictive Models.

According to ONC, the existing scope and structure of the Health IT Certification Program are to enhance transparency around predictive decision support, with requirements to make transparent information regarding the authorship, bibliographic, and other kinds of “source attribute” information for evidence-based decision support and linked referential interventions. Noting that AI/ML in healthcare “is often best considered a form of decision support or ‘augmented intelligence’,” ONC says its goal with the proposed rule related to DSI and predictive models is to update the existing decision support criterion to directly include predictive decision support, inclusive of ML technologies.

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