SaluS Whitepaper

Abstract

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 exchange EHR data; implementing semantic interoperability
solutions enabling meaningful interpretation of the exchanged EHR data;
implementing security and privacy mechanisms and open source toolsets ensuring
that clinical information is shared in an ethical and safe way and providing a novel
exploratory analysis framework for open-ended temporal pattern discovery for safety
studies on top of disparate, distributed, heterogeneous EHR Systems.

SaluS Website
SaluS Whitepaper

Social