HeLDEn Academic Courses

EHLB is the first course in Italy open to students at the Departments of Law and Information Engineering, successfully established at the HI under the ELaTe Module since the a. y. 2021-2022, within the framework of the M.Sc. Degree «Biomedical Engineering». Conceived as an experiment in cross- fertilization among teachers and learners, this course offers students critical knowledge and skills in the field of healthcare innovation. To develop a common language among participants from different scientific and educational backgrounds, classes are held together by a law professor and a professor of biomedical engineering. Case-study analysis and discussions in class are employed to analyse the technical and normative issues concerning the development of an advanced medical device. Students who enroll in this class are distributed in small teams, under the tutorship of post-doc researchers. Each team is assigned a case study and team members are asked to identify and discuss the different scientific, technological, and regulatory issues that arise along the innovation cycle, to come up with solutions as much as possible “built in” the application.

The applied teaching methodology is highly innovative by the standards of the Italian academy, where cross-disciplinary teaching is relatively rare even in scientific education and is never offered on a regular basis.

ELAB is a new course, to be established at the Department of Biology within the framework of the international M.Sc. Degree «Biotechnologies and Applied Artificial Intelligence for Health». In this activity we will address the fundamental ethical and legal questions of A.I. applications in biomedicine: the tension between informed consent procedures, medical liability, and ‘black-box’ algorithms; how data safety and transparency requirements vary, depending on the applications’ tasks and the risks; the potential for discrimination and unfairness inherent to some machine-learning applications; the risks for patients privacy, beyond the patient-doctor relationship; the problem of data ownership. The response of legal systems to these concerns will be analyzed with a comparative approach and a specific focus on the law and policies of the European Union.

Students attending the EHLB and the ELAB classes will earn an in-depth understanding of the process of development, testing, marketing, post-market surveillance of advanced medical devices and A.I. based health applications within the EU legal framework, thereby fostering the introduction of an EU angle into educational curricula who do not normally consider EU studies. The skills obtained will enable participants to: (a) reduce liability risks and ensure compliance with relevant regulations, standards, and Responsible Research and Innovation (RRI) requirements; (b) embed ethical and legal considerations in the whole innovation cycle: from basic research to clinical application; (c) adopt risk management and intellectual property rights (IPRs) protection strategies. This new kind of combined expertise will greatly improve the students’ attitude to teamwork and give them a significant edge on the labor market.