Future Developments of Medical Informatics from the Viewpoint of Networked Clinical Research Interoperability and Integration
Future Developments of Medical Informatics from the Viewpoint of Networked Clinical Research Interoperability and Integration
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DOI：
10.3414/me9137
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发表时间：
2009-01-01
影响因子：
1.7
通讯作者：
Kuchinke, W.
中科院分区：
文献类型：
--
作者：
Ohmann, C.;Kuchinke, W.
目的：为了为未来的发展做好准备，如支持快速创新转移和个性化医学概念，基础研究、临床研究和医疗服务的互操作性是必不可少的，本文的目的是概述发展情况，指出问题领域，并明确未来的要求。方法：本文描述和评价了最近和正在进行的与网络化临床研究的互操作性和集成有关的大规模活动。主要内容包括：一般IT概念的必要性、开放源码/开放社区方法、临床研究中对eSource的接受、电子健康记录和电子数据捕获的互操作性以及技术和语义互操作性标准的协调和衔接。结果：已经建立了国家基础设施和计划，以提供一般IT概念来指导软件工具(如TMF、caBIG、NIHR)的规划和开发。通过开放获取、开放数据、开放通信和开放源码软件实现的透明度所描述的开放研究的概念在临床研究基础设施发展(如caBIG、ePCRN)中正变得越来越重要。与此同时，在临床研究中使用eSource的愿景和规则是可用的，有可能改善电子健康记录和电子数据捕获之间的互操作性(例如，CDISC ESDI、eClinic Forum/PhRMA EDC/eSource Taskforce)。有几个小组制定了用户要求、用例和技术框架，以推进这些问题(例如NHIN Slipstream项目、EHR/CR项目、国际基础结构、水利和环境工程学院)。为了实现技术和语义上的互操作性，现有标准(如CDISC)必须协调和衔接。为了提供语义上的互操作性(例如，由HL7、CDISC和FDA共同领导的HL7 RCRIM，或覆盖CDISC、HL7、FDA、NCI的Bridg)和提供核心数据收集领域集(CDASH)，已经组成了主要联盟。结论：未来10年医学信息学的基本任务将是发展和实施包容的IT概念，大力支持开放社区和开放源码方法，在临床研究中接受eSource，毫不妥协地保持标准化的连续性和技术标准的桥梁，以及电子健康记录系统的广泛使用。
Objectives: To be prepared for future developments, such as enabling support of rapid innovation transfer and personalized medicine concepts, interoperability of basic research, clinical research and medical care is essential, It is the objective of our paper to give an overview of developments, indicate problem areas and to specify future requirements.Methods: In this paper recent and ongoing large-scaled activities related to interoperability and integration of networked clinical research are described and evaluated. The following main topics are covered: necessity for general IT-conception, open source/open community approach, acceptance of eSource in clinical research, interoperability of the electronic health record and electronic data capture and harmonization and bridging of standards for technical and semantic interoperability.Results: National infrastructures and programmes have been set up to provide general IT-conceptions to guide planning and development of software tools (e.g. TMF, caBIG, NIHR). The concept of open research described by transparency achieved through open access, open data, open Communication and open source software is becoming more and more important in clinical research infrastructure development (e.g. caBIG, ePCRN). Meanwhile visions and rules for using eSource in clinical research are available, with the potential to improve interoperability between the electronic health record and electronic data capture (e.g. CDISC eSDI, eClinical Forum/PhRMA EDC/eSource Taskforce). Several groups have formulated user requirements, use cases and technical frameworks to advance these issues (e.g. NHIN Slipstream project, EHR/CR-project, IHE). In order to achieve technical and semantic interoperability, existing standards (e.g. CDISC have to be harmonized and bridged. Major consortia have been formed to provide semantical interoperability (e.g. HL7 RCRIM under joint leadership of HL7, CDISC and FDA, or BRIDG covering CDISC, HL7, FDA, NCI) and to provide core sets of data collection fields (CDASH).Conclusions: The essential tasks for medical informatics within the next ten years will now be the development and implementation of encompassing IT conceptions, strong support of the open community and open source approach, the acceptance of eSource in clinical research, the uncompromising continuity of standardization and bridging of technical standards and the widespread use of electronic health record systems.