Preston Lee, Abhishek Singh Dhadwal, Martha Kaiser, Soroush Dianaty, Eric Lott, Gagandeep Singh, Darwyn Chern, Jason Walonoski, Adela Grando
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引用次数: 0
Abstract
Background: Protecting sensitive health information, particularly substance use data, is essential to preserving patient trust, improving care engagement, and ensuring compliance with federal confidentiality laws such as 42 CFR Part 2. Manual segmentation of sensitive data remains burdensome and error-prone, creating a need for scalable, automated, and patient-centered data segmentation technologies.
Objectives: The objective of this study is to evaluate the technical effectiveness, scalability, and computational performance of SHARES, an open-source data segmentation platform based on HL7 Fast Healthcare Interoperability Resources (FHIR), designed to support patient-directed, granular control over sharing sensitive substance use-related health information.
Methods: We generated 11,519 synthetic FHIR patient records using Synthea and conducted physician-led classifications of 1,848 unique clinical terms contained in those patient records. These classifications were used to assign code-category-confidence rules applied by the SHARES segmentation engine. We deployed the SHARES platform in simulation environments to label and segment substance use-related data using varying confidentiality thresholds. We benchmarked throughput, scalability, and computational performance across large FHIR datasets, and measured segmentation accuracy via physician manual review.
Results: Physicians categorized 232 data items as substance use or "maybe" substance use data elements. The SHARES segmentation engine processed 197.6 million FHIR resources across 11 confidentiality thresholds. Overall, 17 million data items (8.64%) were flagged as sensitive. SHARES achieved a throughput of 10.36 patient bundles per second, or approximately 18,909 FHIR resources per second, on a commodity laptop. A full segmentation run on 11,519 patients had a cost of under one cent.
Conclusion: This study demonstrates the feasibility and scalability of automated, rule-based data segmentation within a FHIR-native architecture, using a physician-derived sensitivity construct for substance use as an applied test case. SHARES offers high-throughput, low-cost classification performance, and supports auditability and deterministic decision-making, which are key strengths for compliance with 42 CFR Part 2. Future enhancements will incorporate clinical quality language (CQL)-based logic to better reflect real-world clinical reasoning and contextual data interpretation.
背景:保护敏感的健康信息,特别是物质使用数据,对于维护患者信任、改善护理参与和确保遵守联邦保密法(如42 CFR Part 2)至关重要。手动分割敏感数据仍然是繁重且容易出错的工作,因此需要可扩展的、自动化的、以患者为中心的数据分割技术。目的:本研究的目的是评估SHARES的技术有效性、可扩展性和计算性能。SHARES是一个基于HL7快速医疗互操作性资源(FHIR)的开源数据分割平台,旨在支持以患者为导向的、对共享敏感物质使用相关健康信息的粒度控制。方法:我们使用Synthea生成了11,519例合成FHIR患者记录,并对这些患者记录中包含的1,848个独特临床术语进行了医生主导的分类。这些分类用于分配由SHARES分割引擎应用的代码-类别-置信度规则。我们在模拟环境中部署了SHARES平台,使用不同的机密阈值标记和分割与物质使用相关的数据。我们对大型FHIR数据集的吞吐量、可扩展性和计算性能进行了基准测试,并通过医生手动审查测量了分割的准确性。结果:医生将232项数据分类为物质使用或“可能”物质使用数据元素。SHARES分割引擎跨越11个机密性阈值处理了1.976亿FHIR资源。总的来说,1700万个数据项(8.64%)被标记为敏感数据。在一台商用笔记本电脑上,SHARES实现了每秒10.36个病人包的吞吐量,或每秒大约18,909个FHIR资源。对11,519名患者进行完整的分割,成本低于1美分。结论:本研究证明了在fhir本地架构中自动化、基于规则的数据分割的可行性和可扩展性,使用医生衍生的物质使用敏感性构建作为应用测试案例。SHARES提供了高吞吐量、低成本的分类性能,并支持可审计性和确定性决策,这是符合42 CFR Part 2的关键优势。未来的增强功能将包括基于临床质量语言(CQL)的逻辑,以更好地反映现实世界的临床推理和上下文数据解释。
期刊介绍:
ACI is the third Schattauer journal dealing with biomedical and health informatics. It perfectly complements our other journals Öffnet internen Link im aktuellen FensterMethods of Information in Medicine and the Öffnet internen Link im aktuellen FensterYearbook of Medical Informatics. The Yearbook of Medical Informatics being the “Milestone” or state-of-the-art journal and Methods of Information in Medicine being the “Science and Research” journal of IMIA, ACI intends to be the “Practical” journal of IMIA.