21015 - PRIVACY, ETHICS AND REGULATIONS IN THE APPLICATION OF AI - SEMINAR
Department of Law
Course taught in English
Go to class group/s: 48
Course Director:
FRANCESCO PAOLO PATTI
FRANCESCO PAOLO PATTI
Mission & Content Summary
MISSION
Privacy, ethics, and regulation are foundational concepts in today’s data-driven society, especially in the health sciences. As digital technologies evolve, so do the legal and moral challenges around personal data, artificial intelligence, and automated decision-making. This course introduces to the core principles of European regulatory frameworks, particularly the GDPR and the AI Act, with an emphasis on their application in healthcare and biomedical research.
The goal is to equip students in the Data Analysis for Health Sciences program with the ability to understand and critically evaluate regulatory and ethical issues arising from the use of personal data and AI systems in health-related contexts. By the end of the course, students will have developed interdisciplinary competencies to navigate privacy, compliance, and ethical challenges in digital health innovation.
CONTENT SUMMARY
Part I – EU legislation shaping AI in healthcare
· Framing of the European Health Data Space (EHDS)
· Existing Legislation
· Legal relevance for research and practice
Part II – Fundamentals of EU Legislation on Data Protection and Governance
· GDPR
· Data Governance Act
· Data Act
Part III – The Deployment of AI in Healthcare
· AI Act
· Product Liability Directive
· Case scenarios
Intended Learning Outcomes (ILO)
KNOWLEDGE AND UNDERSTANDING
At the end of the course student will be able to...
- Describe the main principles and structure of the GDPR, including key concepts such as personal data, lawful processing, consent, and data subject rights.
- Explain the aims, scope, and major mechanisms of the proposed EU AI Act, with specific emphasis on high-risk AI applications in healthcare.
- Identify the ethical challenges and dilemmas related to the use of personal data and AI-based systems in health sciences, including issues of bias, accountability, and transparency.
- Recognize the roles of different actors involved in data governance in the health domain, including data controllers, processors, supervisory authorities, and health professionals.
APPLYING KNOWLEDGE AND UNDERSTANDING
At the end of the course student will be able to...
- Analyze real-world scenarios in health research and practice to determine compliance with GDPR and AI Act requirements.
- Assess potential risks related to privacy and ethics in digital health initiatives and suggest mitigation strategies in line with EU regulatory frameworks.
- Apply principles of data protection by design and ethical AI development to hypothetical health-based data projects.
- Communicate regulatory and ethical considerations effectively in interdisciplinary teams and to non-specialist audiences, using clear and accessible language.
Teaching methods
- Lectures
- Competitions/Hackathons
DETAILS
A case study involves the detailed examination of a concrete example drawn from real-world practice, regulatory challenges, or policy developments in digital health. Students analyze factual contexts, applicable legal frameworks, and ethical implications, and apply course concepts to evaluate compliance, assess risks, or propose responsible solutions. In these sessions, students actively engage with real or hypothetical scenarios involving GDPR or AI applications in healthcare settings, fostering practical understanding and critical thinking relevant to emerging regulatory and ethical issues.
Assessment methods
| Continuous assessment | Partial exams | General exam | |
|---|---|---|---|
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x |
ATTENDING STUDENTS
tbd
NOT ATTENDING STUDENTS
tbd
Teaching materials
ATTENDING AND NOT ATTENDING STUDENTS
Reading and materials uploaded on Bboard for students.
Last change 17/11/2025 11:37