An in-depth analysis of legal and ethical requirements

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.

This “In-depth analysis of legal and ethical requirements” is part of the “Ethical and Legal Framework” of the In Silico World project, and assesses the core pieces of legislation and ethical principles identified in the “Legal and Ethical Inventory“. The use of in silico solutions requires an analysis of the legal and ethical aspects and of where the regulatory framework stands at the moment. The report analyses the following areas of legislation – and identifies some key issues – relevant to the In Silico World project and, thus, for in silico trials:

  • Privacy and data protection: from health data to synthetic data to data ownership
  • Data sharing: with an overview of the EHDS, DGA and Data Act and their relevance to health, data altruism and secondary use of data
  • Medical devices and medicinal products: the current pathways and state of the art of regulations for in silico trials in the EU
  • Artificial Intelligence regulation (since in silico trials entail the use of AI)

The report, produced by Elisabetta Biasin from our partner KU Leuven with the contribution of the University of Bologna, also includes some thoughts stemming from the principles of Biomedical Ethics as applied to in silico trials.

Access the full document here.