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).