Laleci Erturkmen Gokce Banu, Sinaci Ali Anil, Namli Tuncay, Boonstra Machteld J, Lekadir Karim, Gkontra Polyxeni, Chronaki Catherine, Facile Rhonda, Baker Rebecca, Kush Rebecca
SRDC Software Research & Development and Consultancy Corporation, Ankara, Türkiye.
Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Amsterdam, Netherlands.
Front Med (Lausanne). 2024 Nov 7;11:1481551. doi: 10.3389/fmed.2024.1481551. eCollection 2024.
The European Health Data Space (EHDS) initiative was launched to create a unified framework for health data exchange across Europe. Central to this initiative is the European Electronic Health Record Exchange Format, designed to achieve interoperability of electronic health record data across Europe. Despite these advancements, the readiness of current guidelines and implementations, such as the European Patient Summary, to support secondary use in clinical research, particularly in cardiology, remains underexplored.
This study aims to evaluate the European Patient Summary guidelines and their implementations, specifically the HL7 FHIR International Patient Summary Implementation Guide, to determine their suitability for secondary use in clinical research. The focus is on identifying gaps and extensions needed to enhance the utility of the European Patient Summary for building artificial intelligence models in assisting heart failure management.
We selected two European Union-funded research projects, DataTools4Heart and AI4HF, that aim to reuse electronic health record data to develop artificial intelligence models for personalized decision support services for heart failure patients. We analyzed their clinical use cases and the specific data items required, and we compared these with the current European Patient Summary guidelines and provided a detailed gap analysis indicating similarities and required extensions. In our gap analysis, we also compared the needs of DataTools4Heart and AI4HF with the HL7 FHIR International Patient Summary Implementation Guide to assess the extensions needed to support clinical research.
The EHDS is a transformative initiative to establish a European health data ecosystem that supports healthcare delivery and clinical research. Our comparative analysis demonstrates that, with minor extensions, these guidelines have significant potential to facilitate access to electronic healthcare record data for the secondary use, particularly in training AI models. We advocate for the adoption of an International Patient Summary format as a semantically interoperable core set of data elements, which will enhance global clinical research efforts and improve patient outcomes through precision medicine.
欧洲健康数据空间（EHDS）倡议旨在创建一个统一的框架，用于欧洲范围内的健康数据交换。该倡议的核心是欧洲电子健康记录交换格式，旨在实现欧洲各地电子健康记录数据的互操作性。尽管取得了这些进展，但当前的指南和实施措施，如欧洲患者摘要，在支持临床研究（尤其是心脏病学领域）的二次使用方面的准备情况仍未得到充分探索。
本研究旨在评估欧洲患者摘要指南及其实施情况，特别是HL7 FHIR国际患者摘要实施指南，以确定其在临床研究中二次使用的适用性。重点是识别增强欧洲患者摘要在构建人工智能模型以辅助心力衰竭管理方面的效用所需的差距和扩展。
我们选择了两个由欧盟资助的研究项目，即DataTools4Heart和AI4HF，它们旨在重新利用电子健康记录数据来开发用于心力衰竭患者个性化决策支持服务的人工智能模型。我们分析了它们的临床用例和所需的特定数据项，并将这些与当前的欧洲患者摘要指南进行了比较，并提供了详细的差距分析，指出了相似之处和所需的扩展。在我们的差距分析中，我们还将DataTools4Heart和AI4HF的需求与HL7 FHIR国际患者摘要实施指南进行了比较，以评估支持临床研究所需的扩展。
EHDS是一项变革性倡议，旨在建立一个支持医疗保健提供和临床研究的欧洲健康数据生态系统。我们的比较分析表明，只需进行少量扩展，这些指南就有很大潜力促进获取电子医疗记录数据以用于二次使用，特别是在训练人工智能模型方面。我们主张采用国际患者摘要格式作为一组语义上可互操作的数据元素核心集，这将加强全球临床研究工作，并通过精准医学改善患者预后。
