Case Report from the EHR4CR Project—A European Survey on Electronic Health Records Systems for Clinical Research

Andreas Schmidt has been an eHealth systems leader since 2009. He is involved in projects evaluating opportunities around electronic health record patient level data for F Hoffmann La Roche Pharma Product Development. He has held various roles in clinical development including cardiac safety, business development, and information management at Novartis Pharma AG and Ciba-Geigy AG in the past 20 years. With more than 10 years of working in public healthcare, Andreas has extensive experience in medical diagnostics and treatment, scientific research, and patient care. Objective: The Electronic Health Records for Clinical Research (EHR4CR) project aims to deliver a new technological platform and business model to enable the re-use of patient information from electronic health records (EHRs) for clinical research in Europe. An EU electronic survey (e-survey) was conducted to identify opportunities and issues pertaining to the development and implementation of cost-effective EHR4CR clinical services. Methods: The EU e-survey was conducted in two waves: with participating stakeholders from the public and private sectors involved in the EHR4CR consortium, and with non-participating informed stakeholders. Results: The results confirm a high interest in re-using EHR data for clinical research with the objective of optimizing drug development efficiency and access to innovative medicines in Europe. Key challenges include privacy protection, systems interoperability, patient acceptance, and ethical considerations. Conclusions: The re-use of EHR data for clinical research represents a unique opportunity. This survey highlights the importance for the EHR4CR platform and business model to address the respective needs and incentives of relevant stakeholders to provide sustainable EHR4CR solutions in Europe.