Ethical and Legal

EDITH grounds its technological path on EU applicable legislation, including, in particular, Privacy and Data Protection, Artificial Intelligence, as well as In silico Clinical Trial and Medical Device related laws. Special attention has been paid to some key upcoming, or recently adopted, developments such as the Data Governance Act, the Data Act, and the European Health Data Space, to ensure that EDITH’s roadmap to Virtual Human Twin (VHT) outlines new requirements and an advanced regulatory guidance for reinforcing healthcare and medical research stakeholders’ accountability. Leveraging on EDITH partners multi-sectoral expertise, all major hurdles deriving from the current legal framework, which may prevent, or slow down the progress and uptake of a compliant, secure, ethically compatible and privacy-preserving VHT ecosystem, is examined to propose improvements and compliance streamlining. Therefore, issues like cross-border health data sharing, reuse of medical data, pseudonymization and benefits of specific privacy-enhancing technologies (such as federated learning, synthetic data, and secure multi-party computation) to foster security and boost citizens’ trust will all be included in the roadmap.

The concept of ‘Code of Conduct’ implies a triple step by any concerned industry: first creating awareness, then self-examination and, last, setting of sector-tailored and self-imposed high compliance standards. In the case of EDITH, the definition of conduct rules represents a statement of intent. Drawing inspiration from this novel accountability tool put forward in the General Data Protection Regulation (Articles 40 and 41), aiming to pave the way to an easier and more homogeneous application of the applicable legal obligations, EDITH outlines a prospective guidance suggesting innovative regulatory trails and industry-specific technological and legal measures to overcome current hurdles for sharing and reusing health data. Best practices outlined within EDITH will be transposed into possible legal, although elective, commitments to enhance compliance by stakeholders and strengthen general trust in Virtual Human Twin (VHT) by AI developers, technology providers, end-users (particularly healthcare professionals and patients), regulatory agencies, and Health Technology Assessment (HTA) bodies.