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