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标准同步:实现医疗保健真实研究语义互操作性的五项原则。

Standards in sync: five principles to achieve semantic interoperability for TRUE research for healthcare.

作者信息

Facile Rhonda, Chronaki Catherine, van Reusel Peter, Kush Rebecca

机构信息

CDISC, Brussels, Belgium.

HL7 Europe, Brussels, Belgium.

出版信息

Front Digit Health. 2025 Jun 5;7:1567624. doi: 10.3389/fdgth.2025.1567624. eCollection 2025.

Abstract

The effective and meaningful exchange of data is pivotal for patient care, informed decision-making, and advancements in research and technology. This opinion piece explores the critical role of semantic interoperability (SI) in ensuring meaningful health data sharing across diverse systems. Emphasizing the imperative of synchronizing the use of data standards, we address the challenges posed by disparate data formats and underscore the impact on patient outcomes. International, harmonized standards are presented as a cornerstone for achieving SI, while the drawbacks of proprietary standards are examined. Case studies, including the complementary use of International Organization for Standardization (ISO), Health Level Seven Fast Healthcare Interoperability Resources (HL7 FHIR), and Clinical Data Interchange Standards Consortium (CDISC) standards, offer practical insights. We offer here five simple principles [reuse existing standards where possible, avoid mapping, implement standards at the start of a project, participate in standards development activities with standards development organizations (SDOs), and work toward harmonization of standards across SDOs] for achieving semantic meaning in support of Trustworthy, Reusable, Understandable data Elements (TRUE) research data for healthcare. We hope to provide a view to a future where standards are in sync and the proposed five principles are deployed globally to ensure the conduct of trustworthy research for the sake of improving health outcomes for all.

摘要

有效的数据交换对患者护理、明智的决策以及研究与技术的进步至关重要。这篇观点文章探讨了语义互操作性(SI)在确保不同系统间有意义的健康数据共享方面的关键作用。我们强调了同步使用数据标准的必要性,阐述了不同数据格式带来的挑战,并强调了其对患者治疗结果的影响。国际统一标准被视为实现语义互操作性的基石,同时我们也审视了专有标准的弊端。案例研究,包括国际标准化组织(ISO)、卫生信息标准化组织快速医疗保健互操作性资源(HL7 FHIR)和临床数据交换标准协会(CDISC)标准的互补使用,提供了实际见解。我们在此提出五条简单原则[尽可能复用现有标准、避免映射、在项目启动时实施标准、与标准制定组织(SDO)参与标准制定活动以及努力实现各SDO间标准的协调统一],以实现语义意义,支持用于医疗保健的可信、可复用、易懂数据元素(TRUE)研究数据。我们希望描绘出这样一个未来景象:标准相互协调,所提出的五条原则在全球范围内得到应用,以确保开展可信研究,从而改善所有人的健康状况。

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