Linked2Safety · A NEXT-GENERATION, SECURE LINKED DATA MEDICAL INFORMATION SPACE FOR SEMANTICALLY-INTERCONNECTING ELECTRONIC HEALTH RECORDS AND CLINICAL TRIALS SYSTEMS ADVANCING PATIENTS SAFETY IN CLINICAL RESEARCH

The vision of the proposed Linked2Safety project is to advance clinical practice and accelerate medical research, to improve the quality of healthcare, benefiting public health, and to enhance patients' safety; by providing pharmaceutical companies, healthcare professionals and patients with an innovative semantic interoperability framework, a sustainable business model, and a scalable technical infrastructure & platform for the efficient, homogenized access to and the effective, viable utilization of the increasing wealth of medical information contained in the EHRs deployed and maintained at regional and/or national level across Europe, dynamically interconnecting distributed patients data to medical research efforts, respecting patients' anonymity, as well as European and national legislation.The 36-month Linked2Safety project with the developed reference architecture, data protection framework, common EHR schema, lightweight semantic model and integrated platform will facilitate the scalable and standardized semantic interlinking, sharing and reuse of heterogeneous EHR repositories, which will provide healthcare professionals, clinical researchers and pharmaceutical companies experts with a user-friendly, sophisticated, collaborative decision-making environment for:a.\tanalyzing all the available data including the genetic, environmental and medical history of subjects that exhibit adverse events occurring in the frame of clinical trials, based on the clinical care information existing in the specific patients' EHR, leading to the identification of the phenotype and genotype factors that are associated with specific adverse events and thus having direct impact on the patient safety through the early detection of potential patient safety issues.b.\twide identification and selection of patients for clinical trials, though the seamless and standardized linking with heterogeneous EHR repositories, providing advice on the best design of clinical studies