Towards a Code of Conduct for the re-use and integration of Virtual Human Twins: analysis of the legal landscape and identification of legal and ethical challenges

This deliverable D6.2 is designed as an in-depth analysis of the essential elements to be considered when proceeding towards establishing a Code of conduct, with the aim of serving as a compliance-enabler and an accountability tool under the General Data Protection Regulation, for the re-use and integration of Virtual Human Twins in healthcare. D6.2 focuses on two primary objectives: (i) assisting all stakeholders composing the VHT ecosystem in identifying the key legal and regulatory challenges that need to be overcome for ensuring compliance with various applicable regulations, and (ii) offering specific recommendations with the aim of helping European policymakers to better identify and remove the obstacles, detected within the complex and multi-layered legal framework, that currently hinder a wider adoption of VHTs and Europe’s global leadership in this field. To this end, the following document first analyzes the current EU general regulatory and policy scenario in the AI and data-driven landscape, exploring the outcomes of some significant public initiatives carried out with the same scope of outlining the applicable barriers to scientific and technological innovation. Secondly, it sets out a comprehensive state-of-the-art on data anonymization, data pseudonymization and Privacy-Enhancing Technologies, both from a technical and a legal perspective, highlighting the key role that synthetic data may play in the future. Subsequently, all – already in force or forthcoming – EU regulations with major impacts on the VHT ecosystem are comprehensively investigated, including: the General Data Protection Regulation (providing a practical focus on some of EDITH’s specific use cases); the European Health Data Space; the Artificial Intelligence Act; the Data Governance Act and the Data Act; the Clinical Trial Regulation; the Medical Device Regulation and the In Vitro Diagnostic medical devices Regulation. Following this extensive analysis, Intellectual Property Rights management profiles are put under the magnifier lens, first focusing on copyright and database protection, trade secrets, and patentability, and finally also assessing innovative open-source approaches and licensing frameworks. Section 11 evaluates the main ethical implications and challenges stemming from both the generation and the use of VHT, to ensure social license and wide acceptability under strict ethical frameworks based on internationally recognized principles and values. Additionally, section 12 is dedicated to a summary of the main outcomes of the significant amount of work on technical standards which has been carried out during the EDITH CSA. Finally, some brief conclusions are drawn both with regard to: the need to move towards a Code of Conduct dedicated to the Virtual Human Twin, with the double aim of: setting out a framework of rules tailored to the specific needs and challenges of this groundbreaking technology; enhancing clarity and harmonization as to how regulations governing data, AI and data-driven digital models are to be implemented across Member States; the steps and initiatives which need to be taken by EU policymakers to address and mitigate the major barriers outlined in this document and to adequately benefit from the profound transformative impact on Europe’s healthcare systems potentially implied by a growing uptake of VHTs, which could act in all Member States as growth-enhancing expenditure within the EU new economic governance framework.