The project | Linked2Safety

The central piece for healthcare and public health is information. Electronic Health Records (EHRs) contain an increasing wealth of medical information has the potential to significantly advance medical research, personalized healthcare, as well as health policies formulation, providing society with additional benefits within a global health perspective, with applications ranging from disease prevention and genetics to surveillance and epidemiologic studies. Healthcare Organizations and the pharmaceutical industry in Europe both share a common goal, to deliver the best possible personalized treatments and innovative medicines to improve patient outcomes. The industry believes that technological advances and broad implementation of EHRs in Europe can achieve this goal and accelerate clinical research.

The above highlights the need for the development of an advanced environment for clinical research that enables seamless, secure and consistent integration of clinical care information in EHR with information in clinical trial systems, which will facilitate a) the early detection of patients’ safety issues, b) the identification of adverse events and c) the identification of a suitable critical mass of patients to participate in small (Phases II and III) or larger scale (Phase IV) clinical trials.

Within this requirement formulation, we argue that recent innovations in the Semantic Web research, e.g. semantic interoperability efforts and Linked Data technologies, can support the development of an extensible, scalable architecture that will facilitate the semantic interlinking between spatially distributed clinical care information sources, electronic patients’ health
records and clinical trials systems for gathering and sharing adequate knowledge to support decision making in medical and clinical research. These technologies will be empowered by a common shared infrastructure (including ontologies and common medical vocabularies, as well as health care record structures, and medical logic representations), mapping and alignment tools, patients’ data privacy, anonymity, security and authorized access techniques, for exposing, sharing, and connecting pieces of healthcare, medical and clinical data, information, and knowledge. The utilization and deployment of the aforementioned technologies for addressing semantic and technical interoperability of EHR/PHR and EDC repositories will result in an interoperability framework, which will allow homogenized, standardizedaccess to distributed patients data and clinical information resources.