A FHIR-Based eConsent App for the Digital Hospital

Research projects with humans is a highly regulated field that is currently undergoing rapid changes due to developments in eHealth and mHealth. While a patients data and samples must be thoroughly protected, they are also an invaluable source for fundamental and cutting edge research. There are processes in place to obtain a patient's consent for the use of their data and samples for research. These approaches could be more flexible, user-friendly and modernised. There is a high demand among all parties for a unified, yet differentiated, dynamic and personalised eConsent. An Android app has been developed that brings any existing consent form to mobile devices, including the integration of the process into existing hospital IT using established data standards, such as FHIR and the ResearchStack open source framework.The app is user-tested and shown to work in a hospital setting. Lack of eIdentification and legal drawbacks were determined as the main obstacles for immediate implementation.