The aim of the project is to establish EU-wide standards for the use of ‘in silico modelling’ (including software developed through artificial intelligence) in healthcare. ‘Personalised medicine’ is treatment tailored to a particular patient. This ‘personalisation’ case be achieved by running their medical records through a computer ‘model,’ such as software that helps doctors diagnose patients, or recommend treatment.
The legal and ethical Work Package focuses on data protection, patients’ rights and research ethics. The objectives of the work package are to:
1. Map and analyse European and international data protection and clinical trials regulation in the area of data protection, biomedical research (including clinical trials), and patients’ rights relevant for collaborative research for heterogeneous data integration and data driven in silico models.
2. Evaluate legal and ethical challenges and explore possibilities for collaborative research for heterogeneous data integration and data driven in silico models
3. In collaboration with the other WP’s and external stake holders: Develop recommendations which are compliant with the current legal and ethical framework and provide a sustainable back bone for collaborative research for heterogeneous data integration and data driven in silico models.
The project began in 2019, and is due to complete its recommendations in 2021-22. An international stakeholder workshop will be held in late 2021/early 2022, at which point this page will be updated.