Luzi Daniela, Pecoraro Fabrizio, Mercurio Gregorio, Ricci Fabrizio L
Institute of Research on Population and Social Policies (IRPPS), National Research Council, 00100 Rome, Italy.
Stud Health Technol Inform. 2009;150:162-6.
Clinical investigations (CIs) are carried out to demonstrate safety and efficacy of new Medical Devices (MDs). The presence of many stakeholders participating in CIs makes it necessary to develop a common standard language to achieve semantic interoperability among systems and organizations. In Italy the National Research Council is carrying out a project supported by Ministry of Health aiming to develop an information system (MEDIS) that manages MD clinical investigations. In order to develop a flexible and interoperable system, MEDIS design has been based on the application of HL7 (Health Level 7) v.3 standards. This paper presents the results of the MEDIS design: the MD DAM based on HL7 RIM.
开展临床研究（CI）以证明新医疗器械（MD）的安全性和有效性。众多利益相关者参与临床研究，这使得有必要开发一种通用的标准语言，以实现系统和组织之间的语义互操作性。在意大利，国家研究委员会正在开展一个由卫生部支持的项目，旨在开发一个管理医疗器械临床研究的信息系统（MEDIS）。为了开发一个灵活且可互操作的系统，MEDIS的设计基于HL7（健康级别7）v.3标准的应用。本文介绍了MEDIS设计的成果：基于HL7 RIM的医疗器械数据模型（MD DAM）。
