Artificial Intelligence for Biomedicine and Healthcare

ONC0263C EU Fundamental Rights, Health and AI

EU Fundamental Rights, Health and AI

Academic year 2024/2025

Sommario del corso

• Course objectives
• Results of learning outcomes
• Program
• Course delivery
• Learning assessment methods
• Suggested readings and bibliography
• Teaching tools
• Course card

Course objectives

The course aims at providing the basic knowledge of legal aspects associated with the production, elaboration and use of biomedical data in the wider context of EU law for the protection of fundamental rights, namely right to health and data protection

Results of learning outcomes

The completion of the course shall entail the knowledge of the right to health and data protection in the EU legal framework for the protection of fundamental rights. A specific competence will be developed with reference to legal aspects of use of biomedical data for research and therapy purposes.

Program

MODULE 1 - Introductory elements

1. Technology, Law and Health: preliminary assessment of a critical relationship
2. From Internet to Big Data to Artificial Intelligence: the regulatory problem

MODULE 2 – Regulating AI in the broader context of HR protection

1. International and EU human rights law: an overview
2. The European human rights approach to data protection and artificial intelligence: in particular the elaboration AI Act
3. AI, healthcare and the right to the enjoyment of the highest attainable standard of physical and mental health
4. AI, biomedicine and the right to participate and enjoy the benefits of scientific progress and its applications

MODULE 3 - Introduction to EU actions in the field of health and data protection

1. Introduction to EU law
2. Development of EU actions in health
3. Development of EU actions in data protection
4. Overview of EU law instruments dealing with health products and technology

 
MODULES 4 and 5 - GDPR and healthcare

1. Introduction to the General Data Protection Regulation (GDPR)
2. Health data in the GDPR
3. Data subjects’ rights
4. Rules on the processing of health data

MODULE 6: European Health Data Space

1. Background and objectives of the EHDS
2. Data sharing and processing in the EHDS

MODULES 7 and 8: Health and the AI Act 

1. Introduction to the AI Act: the risk-based approach
2. Use of AI and challenges to patients’ rights
3. The AI act and its relation with healthcare
4. Regulating the use of AI in healthcare in the EU legal context: the interaction between different EU instruments

 
MODULE 9 - Dealing with health data in AI in practice: case-studies

Course delivery

The course is composed by frontal lessons (40 hours).

The final part of the course also envisages some practical activity on case-studies.

Learning assessment methods

The assessment of learning will take place by means of a written examination reserved to attending students. For other students the assessment will be oral, to be prepared on the materials made available through the moodle (Syllabus)

Relevant bibliographic references and reading materials will be made available on the Moodle webpage of the course.

• Teaching material
• Exams and finals
• Class schedule
• Go to Moodle
• Register for the course
• Enrolled students
• Invia email agli studenti registrati
• Export table