Work Package 5 (WP5)

Lead: University of Vienna (UNIVIE)
Partners: Fraunhofer (FH)

WP5 develops the legal and ethical framework to ensure COMMUTE operates within regulatory requirements while maintaining meaningful patient and stakeholder involvement throughout the project lifecycle.
 

Main objectives

1. Governance & Stakeholder Engagement – Establish a Legal and Ethical Advisory Board and organize workshops with patients, healthcare professionals, regulators, and other stakeholders to guide project implementation and develop recommendations.
2. Legal Compliance & Data Protection – Support GDPR compliance and data governance across the consortium, including establishing data protection roles, coordinating relevant agreements, and operating a Legal and Ethical Helpdesk as a centralized contact point for partners.
3. Regulatory Mapping & Risk Assessment – Conduct comprehensive regulatory mapping across key EU digital regulations and perform Data Protection Impact Assessments to identify risks, propose mitigation measures, and ensure appropriate safeguards are in place.
4. Research & Integration – Investigate emerging legal and ethical questions related to AI regulation, data protection, and fundamental rights implications of the decision support system, while facilitating ongoing dialogue to integrate ethical perspectives across all Work Packages.
    

Work accomplished and ongoing

Legal & Ethical Advisory Board (LEAB)
A multidisciplinary advisory board comprising experts in health law, data protection, AI ethics, clinical governance, and patient advocacy was established at project onset. The LEAB provides external oversight, participates in patient engagement workshops, and delivers strategic guidance to ensure COMMUTE upholds the highest legal and ethical standards throughout development.

Patient Engagement Workshops
WP5 has organized two patient involvement workshops and two more events are planned:

• 1st COMMUTE panel and workshop (University of Vienna, November 2024): Predictive Medicine and Patient Rights: Balancing Risks and Benefits for Individuals and Society (recording available)
• 2nd COMMUTE panel and workshop (University of Luxembourg, November 2025): AI-driven Predictive Medicine in Alzheimer's and Parkinson's: Ethical and Legal Challenges to the Future of Clinical Authority

Ethics-by-Design Approach
Building on the European Commission's guidelines for trustworthy AI, WP5 has conducted systematic research on ethical and legal challenges in predictive medicine, including:

• Analysis of existing guidelines and expert opinions on high-risk diagnostics with socio-psychological impact
• Review of legislation and regulatory aspects of digital health applications in neurological research
• Ethics assessment examining the deployment of AI risk-models for Alzheimer's and Parkinson's prediction
• Evaluation of medical interventions and long-term impacts on vulnerable and resilient populations

Collaboration & Knowledge Exchange
WP5 will organize a joint symposium with peer projects from the same EU call to exchange strategies and determine the generalizability of COMMUTE's legal and ethical guidance framework.

Dissemination activities
WP5 presented COMMUTE at the workshop for the 3rd Health, Law, and Technology Symposium (HELT 2025) which took place on 24 April 2025 in Brussels. COMMUTE presentation explored how advancements in AI and Big Data Analytics can be harnessed to improve disease diagnoses and treatment in a legally and ethically responsible manner.

Project Outcomes
WP5 will deliver comprehensive recommendations to guide the responsible development and deployment of the COMMUTE recommender system, ensuring transparency, trustworthiness, and regulatory compliance while protecting patient rights.

Download Deliverable 5.1