Assurance roles in dynamic healthcare related consent

Offentlig prosjektsammendrag

Informed consent forms the basis for many healthcare activities. When a patient agrees to undergo a treatment, receive a diagnostic test, or to have their health data processed for a particular purpose, they must be informed about what that means for them as a patient, along with any potential benefits and risks. Traditionally, this consent has been collected via paper forms, which are largely static and difficult to modify should a patient wish to change their preferences. Moreover, patients do not have oversight over what they have consented to, and don’t have a full register of who is processing their health data and for which purposes. Some hospitals have begun experimenting with dynamic consent, where patients record their preferences via a web interface or mobile app where they can view and update their consent preferences. These consent preferences are then propagated to other IT systems within the hospital, to ensure that when health data is analyzed that it is done so in accordance with the wishes of the patient. In spite of the potential benefits of dynamic consent, these systems are not widely adopted. One of the reasons for this is a lack of trust in the system and its implementation. How can the hospital, doctors, and patients know that the software is secure, fit-for-purpose, and operated and maintained in a responsible manner? This project will develop an assurance framework for dynamic consent systems. It will consist of a structured and impartial method for describing how these consent systems are built, how they function, and how they are used in a broader clinical context. It will identify and evaluate risks, and will provide a systematic method for assessing claims about the safety, suitability, and performance of these systems. This project will test this framework with real-life use-cases, and develop this concept into an assurance service, allowing hospitals to implement dynamic consent in a safe and responsible way.