This section about legal and ethical aspects in Cancer Image Europe is specifically designed for the Management user profile, which includes the following categories: ELSI and IPR experts, professional societies, patients’ associations, infrastructures (EDIC/ERIC), government representatives and data protection authorities.

It provides a foundational overview and is primarily intended to raise awareness about the platform’s ethical and legal aspects.

Learning Objectives

For Ethical Representatives
(Data Protection Authorities, ELSI, IPR Experts, Government Representatives, EDIC/ERIC):

  • Provide information on the platform’s functionalities, supporting DPOs and ethics committees

  • Understand the platform’s commitments to ethics, privacy and safeguarding patients’ rights

  • Understand the specific requirements for operating within the European Health Data Space (EHDS)

  • Identify projects that do not meet mandatory compliance standards

  • Understand emerging ethical concerns related to AI

  • Distinguish AI-based projects to assess whether they fall under ethical or experimental categories as per the Medical Device Regulation

For Patients’ Associations:

  • Understand the platform’s commitments to ethics, privacy and patients’ rights

  • Be informed about the secondary use of health data for research, in line with GDPR compliance

  • Gain transparency on how data is used, reviewed and the potential benefits of the platform

In contrast a dedicated legal and ethical training course, which is mandatory for all user categories, is provided by the consortium and is far more detailed and specifically tailored to the responsibilities and needs of the following user profiles:

  • Data Holders – Focused on GDPR compliance, anonymization, data federation processes, and ethical data governance

  • Software Providers – Covering legal and ethical requirements for tool integration and regulatory compliance

  • Data Users – Addressing ethical use of data and AI, transparency obligations, patient consent, and responsibilities under the European Health Data Space (EHDS)

This in-depth training ensures that each profile is equipped with the necessary knowledge and guidance to operate responsibly within the Cancer Image Europe ecosystem.