ENTRUST D1.3 Legal and Ethical Issues and Guidelines

Deliverable D1.3, Legal and Ethical Issues and Guidelines outlines the legal framework and ethics policy adopted by the ENTRUST project to ensure compliance with EU legislation, ethical assurance, and inclusivity. It integrates findings from workshops, surveys, and earlier deliverables to address key concerns in data protection, cybersecurity, and trust in Connected Medical Devices (CMDs). The analysis emphasises ethical issues related to evidence measures and trustworthiness in CMDs, ensuring alignment with current medical standards. By embedding ethical principles and regulatory alignment, ENTRUST provides a robust framework for secure, trustworthy CMDs that meet societal needs.