Electronic health records (EHRs) provide a huge but still under-utilized source of information on the real world use of medicines. Although EHRs are primarily utilized for patient care, they also contain a broad range of clinical information highly relevant for safety analysis. EHR data available in clinical care systems can clearly complement and strengthen existing post-marketing safety studies based on data from spontaneous reporting systems. Relative to spontaneous reports, EHRs cover extended parts of the underlying medical histories, include more complete information on potential risk factors, and are not restricted to patients who have experienced a suspected Adverse Drug Events (ADEs).
The SALUS project is exploring new ways of accessing and analyzing data found in Electronic Health Records to provide an infrastructure that enables the execution of safety studies for mining and analyzing real-time patient data. In this way, patient safety can be ensured through early detection of rare adverse events; the pharmaceutical industry can provide faster medication innovation by decreasing time to market for new, safe and effective drugs, and at the same time the load of overwhelmed medical practitioners can be reduced.
SALUS aims to 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
SRDC is the coordinator of the SALUS Project; hence the primary role of SRDC is to coordinate the administrative activities and ensure that the project is on track with the harmony of all project partners. Apart from coordination, SRDC is the main responsible of the design of the SALUS architecture together with the integration of different tools and components.
|2.||European Institute for Health Records||France|
|3.||The Uppsala Monitoring Centre (UMC)||Sweden|
|5.||AGFA Healthcare N.V.||Belgium|
|6.||Electronic Record Services BV||Netherlands|
|7.||Lombardia Informatica S.p.A.||Italy|
|8.||Institut National de la Sante et de la Recherce Medical||France|
|9.||Technische Universitaet Dresden||Germany|
|10.||F. Hoffmann-La Roche AG||Switzerland|