Onderzoek naar de specificaties en realiseerbaarheid van een notificatie/medical vigilance informatiesysteem voor de Inspectie voor de Gezondheidszorg

Abstract

Based on a request of the "Inspectie voor de Gezondheidszorg" LGM (laboratory for Medicines and Medical Devices of the RIVM) and TNO evaluated the requirements for and feasibility of a system for notification and medical vigilance. A prerequisit for this study was the optimum use of existing databases and experiences. The evaluation resulted in a concept based on the "multi layer networking" principle. The concept makes optimum use of the existing systems with minimum expenses. In the analyses the obvious necessity to be in line with European developments has been a major item. For this reason intensive participation in European developments through specific experts is considered essential.