A medical device domain analysis model based on HL7 RIM.
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.
Luzi
Daniela
D
Institute of Research on Population and Social Policies (IRPPS), National Research Council, 00100 Rome, Italy. d.luzi@irpps.cnr.it
Pecoraro
Fabrizio
F
Mercurio
Gregorio
G
Ricci
Fabrizio L
FL
D004864:Equipment and Supplies; D008962:Models, Theoretical; D012985:Software Design; D013673:Technology Assessment, Biomedical / Q000379:methods*