Legal and ethical review of in silico modelling

The development of in silico models for personalised medicine in the EU requires lawful and ethical data integration. The ultimate use of these models will also require the use of information in these automated systems in a fair and transparent way, which respects patients’ rights.
This report therefore surveys the legal landscape for health data integration, and the challenges which arise when information is re-used to develop analytical or predictive models, which are then re-applied to a patient population. Particular attention is paid to the nature and role of consent in data integration and use within in silico models. Consent has a role within the Clinical Trials Regulation, the General Data Protection Regulation, and more broadly as authorising the use of private or confidential information. It also has key limitations, particularly when it cannot easily be revoked, or where it is not sufficient to allow significant decisions to be made in the context of automated processing.