{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T01:56:54Z","timestamp":1772243814107,"version":"3.50.1"},"reference-count":0,"publisher":"IOS Press","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2011]]},"abstract":"<jats:p>The paper describes the design of a module that manages Serious Adverse Events (SAEs) reporting within a Clinical investigation on Medical devices. This module is integrated in a Medical Device Information System (MEDIS) that collects data and documents exchanged between applicants and the National Competent Authority during the clinical investigation lifecycle. To improve information sharing among different stakeholders and systems MEDIS design and developed were based on the HL7 v.3 standards. The paper provides a conceptual model on SAEs based on HL7 RIM that underlines Medical Device characteristics.<\/jats:p>","DOI":"10.3233\/978-1-60750-806-9-834","type":"book-chapter","created":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T03:47:32Z","timestamp":1740109652000},"source":"Crossref","is-referenced-by-count":0,"title":["Serious Adverse Event Reporting in a Medical Device Information System"],"prefix":"10.3233","author":[{"family":"Pecoraro Fabrizio","sequence":"additional","affiliation":[]},{"family":"Luzi Daniela","sequence":"additional","affiliation":[]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","User Centred Networked Health Care"],"original-title":[],"deposited":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T04:39:34Z","timestamp":1740112774000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.medra.org\/servlet\/aliasResolver?alias=iospressISSNISBN&issn=0926-9630&volume=169&spage=834"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011]]},"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/978-1-60750-806-9-834","relation":{"is-cited-by":[{"id-type":"doi","id":"10.3389\/fphar.2021.754858","asserted-by":"object"}]},"ISSN":["0926-9630"],"issn-type":[{"value":"0926-9630","type":"print"}],"subject":[],"published":{"date-parts":[[2011]]}}}