Contract Number: 287800
Project Acronym: SALUS
Project Name: Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety Studies
Priority: Objective ICT-2011.5.3 b) Tools and environments enabling the re-use of electronic health records
Total Cost (€): 5,077,781
Commission Funding (€): 3,325,966
Start Date: February 01, 2012
End Date: April 30, 2015
Funded By: This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 287800. It is being supported under eHealth Unit.

 

Objectives of the SALUS Project

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. There are prototype studies to monitor EHRs for simplifying ADE reporting, and also for signal detection by screening multiple EHRs, however these tools are directly built on top of EHR/EMR systems through proprietary interfaces. It is apparent that the promise of proactive, continuous monitoring of multiple sources cannot be achieved through such proprietary integrations. To facilitate wide scale proactive post market safety studies, there is a need for a new capacity enabling accessing the data locked in multiple different heterogonous EHR systems. In SALUS project, we aim to provide a standard-based interoperability framework that will enable execution of safety studies for mining and analyzing real-time patient data in communication with disparate heterogeneous EHR systems. SALUS will provide:

  • Functional interoperability profiles enabling exchange of EHRs
  • Semantic interoperability solutions enabling meaningful interpretation of the exchanged EHRs
  • Security and Privacy mechanisms ensuring EHRs are shared in an ethical and safe way
  • A novel framework for open-ended temporal pattern discovery for safety studies on top of EHR Systems
  • Implementation of high potential use cases enabling secondary use of EHRs for post market safety studies

Coordinator Contact Details

 

Dr. Gokce Banu Laleci Erturkmen
SRDC Software Research & Development and Consultancy Ltd.
Silikon Bina 1. Kat No: 14 ODTÜ Teknokent 06531 Çankaya/Ankara, Turkey

email: This email address is being protected from spambots. You need JavaScript enabled to view it.
homepage: www.srdc.com.tr
phone: +90 - 312 - 210 1763
fax: +90 - 312 - 210 18 37

 

 

 

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