In Silico World D9.1 Legal and ethical inventory

Elisabetta Biasin, Anton Vedder
2022 Zenodo  
Executive Summary: The present Deliverable 'D9.1 – Legal and Ethical Inventory', part of Work Package 9 'Ethical and Legal Framework' of the In Silico World project, provides an overview of the core pieces of legislation and ethical principles that are relevant to the In Silico project, and thus, in silico trials. The analysis finds the following areas of legislation are of relevance: Privacy and Data Protection: The data processed for in silico trials entail the processing of personal data of
more » ... ndividuals (notably, patients) in healthcare settings. As a consequence, privacy and data protection legislation becomes relevant. Privacy and data protection are distinct fundamental rights enshrined in the European Union's (EU) treaties. The core and directly applicable regulation concerning the processing of personal data is the General Data Protection Legislation (GDPR). Other important data protection initiatives are undertaken by the Council of Europe and the Organisation for Economic Co-operation and Development (OECD). Data Governance: In healthcare and in silico trials, the sharing of data across healthcare facilities may be considered a key factor for the development, testing, and validation of in silico models. The European legislator's and national Member States' growing interest in regulating data sharing has resulted in a new and rapidly evolving framework concerning the governance of data. The current EU legal framework on data governance includes the Open Data Directive, the Free Flow of Non-Personal Data Regulation, and the Data Governance Act. In addition to these, two legislative proposals are expected to radically change data sharing in the healthcare sector: the Data Act and the European Health Data Space. Clinical Trials: The legislation and regulatory documentation concerning clinical trials are relevant to the very essence of in silico trials. On [...]
doi:10.5281/zenodo.7104078 fatcat:l33zbizyzjg2jlfpj35eqvuume