In silico trials consist of the virtual testing of medical devices and medicinal products. They may help support the regulatory approval process of a medical product and, in general, the whole lifecycle of the medical product. The present document “Implementation guidance and guidelines”, part of the “Ethical and Legal Framework’ of the In Silico World project, offers guidelines on the ethical and legal aspects of In Silico Trials for researchers and end users.
The report builds on the previous reports ‘“Legal and Ethical Inventory” and ‘“In-depth Analysis of Legal and Ethical Requirements”, which assessed the core pieces of legislation and ethical principles relevant to In Silico Trials. It contains twelve main recommendations concerning the areas of legislation already identified in previous works:
- privacy
- data protection and data governance
- medical devices and medical products
- artificial intelligence
- ethics
Short and descriptive recommendations are provided for each of them, access the full document!
