SALUS Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety Studies


Before being admitted to the market, new drugs have to go through clinical studies where their effectiveness as well as adverse drug events are examined. These studies enclose several thousand participants in various steps, still, not all possible adverse drug events can be examined systematically. Hence, drugs are also being observed after licensing regarding their reliability. These observations are based primarily on voluntary information on adverse drug events by the treating doctors. This is considered to be insufficient, however, because only a relatively small part of the occurring problems is reported. The reason for these low rates refers to the fact that doctors are already exposed to heavy workload and reporting newly recognised adverse drug events is time-consuming.


The EU- founded project SALUS "Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety Studies" aims at developing and testing software tools which allow recognizing, reporting and tracking cases with adverse drug events. This is done with the help of data which are grasped electronically within medical care and are stored, e.g., in a hospital information system. Besides, the SALUS system has to automatically mediate between the data formats which are used for the observation of adverse drug events so that the use of clinical data for recognizing and reporting adverse drug events with a minimum of additional effort for doctors and nursing staff can be implemented.
The OFFIS R&D department of Health is developing innovative components for the data integration (linking hospital information systems) based on common communication standards used in medicine (e.g., IHE profiles, HL7, CDA), as well as algorithms for data analysis (statistical evaluation of the anonymous data for identifying likely cases of adverse drug effects). The system is tested at the University Medical Centre Carl Gustav Carus in Dresden and used in the context of a regional health network in Lombardy (Italy).

Building the Semantic Interoperability Architecture Enabling Sustainable Proactive Post Market Safety Studies

Erturkmen, Gokce B. Laleci and Dogac, Asuman and Yuksel, Mustafa and Hussain, Sajjad and Declerck, Gunnar and Daniel, Christel and Sun, Hong and Depraetere, Kristof and Colaert, Dirk and Devlies, Jos and Krahn, Tobias and Thakrar, Bharat and Freriks, Gerard and Bergvall, Tomas and Sinaci, Ali Anil; 005 / 2012

Potenzial von Linked Data zur automatisierten Detektion bekannter unerwünschter Arzneimittelwirkungen

Krahn, Tobias; Gudenkauf, Stefan; Müller, Frerk; Appelrath, H.-Jürgen; GMDS 2014: 59. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V.; 09 / 2014

Sekundärnutzung klinischer Patientenakten – Semi-automatische Detektion von Medikamentennebenwirkungen

Krahn, Tobias and Müller, Frerk and Eichelberg, Marco and Hein, Andreas and Appelrath, Hans-Jürgen; e-Health 2014 - Informationstechnologien und Telematik im Gesundheitswesen; 001 / 2014

Transparenz unerwünschter Arzneimittelwirkungen

Krahn, Tobias and Saß, David and Appelrath, H.-Jürgen; 10 / 2013

Detektion unerwünschter Arzneimittelereignisse - Transparenzsteigerung in der Versorgungsforschung

Krahn, Tobias and Müller, Frerk and Appelrath, H.-Jürgen; 08 / 2013

Adverse Drug Event Notification System - Reusing clinical patient data for semi-automatic ADE detection

Krahn, Tobias; Eichelberg, Marco; Gudenkauf, Stefan; Laleci Erturkmen, Gokce B.; Appelrath, Hans-Jürgen; Computer-Based Medical Systems (CBMS), 2014 IEEE 27th International Symposium on; 2014

Adverse Drug Event Notification on a Semantic Interoperability Framework

Krahn, Tobias; Eichelberg, Marco; Müller, Frerk; Gönül, Suat; Laleci Erturkmen, Gokce B.; Sinaci, A. Anil; Appelrath, Hans-Jürgen; Stud Health Technol Inform; 2014

European Institute for Health Records
WHO Collaborating Centre for International Drug Monitoring
AGFA Benelux
Electronic Record Services
Lombardia Informatica
INSERM Institut national de la santé et de la recherche médicale
Uniklinikum Carl Gustav Carus der TU Dresden
Hoffmann- La Roche Ltd.


Start: 31.01.2012
End: 30.01.2015