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

Pre-approval clinical trials cannot guarantee that drugs will not have serious side effects after they are marketed. Post-approval drug safety data studies aim to address this problem, however, their effectiveness is started to be discussed especially after recent examples of drug withdrawals. This is due to the fact that, current post market safety studies largely depend on the submission of spontaneous case reports where underreporting is a major problem. The need for a more proactive approach is apparent, where safety data from multiple sources are actively monitored, linked and analyzed. Effective integration and utilization of electronic health records (EHR) can help to improve post-market safety activities on a proactive basis. SALUS aims to facilitate this through providing functional interoperability profiles and supporting open source toolsets enabling EHR systems and clinical research systems to communicate and * The research leading to these results has received funding from the European Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no ICT-287800, SALUS Project (Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety