Leveraging Big Data to improve healthcare decision making

This research explores the balance between on the one hand the opportunities presented by routinely collected data and artificial intelligence, and on the other hand the legal and ethical risks that could be encountered. It analyses whether the current legal framework has correctly defined and reflected this balance, or whether on the contrary changes are desirable in order to open up opportunities, or rather to mitigate potential risks. The research will in general focus on EU law, with an additional focus on Belgian law where a topic is a responsibility of the European member states, or where interesting developments have occurred at a national level. Where significant, a comparative analysis may be made with French, German, Dutch or American law. The scope of this research is limited to medicinal products and medical devices for human use. Hence, rules for products intended for veterinary use or for use in agriculture shall be excluded. Also the legislation applicable to herbal products is excluded from the scope of this research. It will be further assessed whether biological medicinal products and substances of human origin are relevant to be included in this research.