Gazzarata R, Giannini B, Giacomini M
Department of Informatics, Bioengineering, Robotics and System Engineering (DIBRIS), University of Genoa, Via Opera Pia 13, 16145 Genoa, Italy
Healthropy s.r.l., Corso Italia 15/6, 17100 Savona, Italy
J Healthc Eng. 2017;2017. doi: 10.1155/2017/2190679.
The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the “Interoperable” Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the “Interoperable” Tier, the current solution actually covers the “Connected” Tier, due to local hospital policy restrictions.
临床数据交换标准协会下属的电子源数据交换小组提出了五种场景，以指导利益相关者开发用于捕获电子源数据的解决方案。第五种场景被细分为四个层级，以调整电子健康记录的功能来支持临床研究。为了开发一个属于“可互操作”层级的系统，作者决定采用面向服务的架构范式来支持技术互操作性，使用卫生信息交换标准第七版第3版消息并结合逻辑观测标识符名称和代码（LOINC）词汇表来确保语义互操作性，以及采用医疗保健服务规范项目标准来提供流程互操作性。所开发的架构增强了患者护理实践与医学研究之间的整合，允许两个医院信息系统和四个临床数据管理系统/临床登记处之间进行临床数据共享。其核心由一组通过标准化接口连接的标准化云服务组成，涉及客户端应用程序。该系统得到了医务人员的认可，因为它减少了临床试验管理的工作量。尽管这种架构可以实现“可互操作”层级，但由于当地医院政策限制，当前的解决方案实际上涵盖了“已连接”层级。
