In Silico World D9.4 Validation and recommendations for lawmakers and policymakers

Executive Summary The present deliverable, ‘D9.4—Validation and recommendations for lawmakers and policymakers’, is part of Work Package 9, ‘Ethical and Legal Framework’ (WP9) of the In Silico World (ISW) project. This report is based on previous research carried out throughout the ISW project, including ‘D9.1—Legal and Ethical Inventory’, ‘D9.2—In-depth analysis of legal and ethical requirements’, and D9.3, ‘Implementation guidance and guidelines’. The first and second deliverables assessed the core legislation and ethical principles relevant to In Silico Trials. The third deliverable provided guidelines on the ethical and legal aspects of In Silico Trials for researchers and end users. This fourth deliverable offers legal recommendations for the European Union’s (EU) legislature, regulators and policymakers. It builds on the previously identified areas of investigation, i.e. data governance and privacy, medical devices and medicinal products, and artificial intelligence, and, in light of the project experience, offers policy recommendations. These recommendations, further detailed throughout the report, are recapitulated as follows: Recommendations to EU legislature, regulators and policymakers Data Governance and Privacy 1. Provide data protection guidance on the use of synthetic data 2. Support in silico and health stakeholders complying with forthcoming EHDS opt-out requirements Medical Devices and Medicinal Products 3. Clarify the regulatory pathways for modelling and simulation and In Silico Trials for medical devices 4. Incorporate In Silico Trials in the binding text of the EU pharmaceutical reform Artificial Intelligence 5. Ensure the smooth interaction between the AI Act and medical laws This report follows a recommendatory method. It represents the third and last step of the research conducted within ISW WP9, which is dedicated to analysing the ethical and legal framework for In Silico Trials. The present report, grounded on the analysis carried out in D9.1, D9.2, and D9.3, is the final report of ISW WP9. It concludes the legal and ethical research of the In Silico World project.