Ethical and legal aspects of in silico trials. An interview with Elisabetta Biasin

Elisabetta Biasin is a Doctoral Researcher in Law at the KU Leuven Centre for IT & IP Law (CiTiP), Transatlantic Technology Law Forum Fellow at the Stanford Law School and External Expert on Data Protection on Big Data and Real World Data at the European Medicines Agency. She investigates the notion of accuracy in data protection as part of her doctoral project “Reconsidering the conceptualisation of accuracy as a principle of data processing”.

I studied Law at the University of Trento Faculty of Law, where I graduated in 2016 with a Research Thesis on Network Neutrality. In 2015, I worked as a Junior Assistant at the Bolzano Criminal Court (Italy). In 2016, I worked as a Policy Intern at European Digital Rights (EDRi) – while conducting my research on Network Neutrality. After, I worked as a Legal Advisor at Deloitte Legal Italy. There, I was involved in Privacy and Data Protection compliance programmes for large organisations, public bodies, and SMEs in the sectors of healthcare, public administration, manufacturing, and road infrastructures.

Her research at CiTiP started in 2018 with an interest in eHealth, AI, privacy, data protection, cybersecurity and medical devices law. Among the many projects in which she is involved, Elisabetta Biasin also participates in In Silico World, where she studies the ethical and legal aspects concerning the use of modelling and simulation in healthcare, with a focus on ‘in silico’ clinical trials, medical device software and healthcare artificial intelligence.

This is your first approach to in silico medicine, we would like to know the reason behind this choice.

It is, indeed, my first approach to in silico medicine, but not my first study of the related regulatory matters. I have been researching eHealth law for quite some time now. As soon as I realised how important In Silico is for the future of medical devices, clinical trials, and biomedical ethics, I wanted to be involved.

From a legal and ethical perspective, in silico is an exciting field of research. Ethical aspects range, for example, from informed consent to the right to know (or not to know) about incidental findings of predictive medicine, to fairness, transparency, and inclusiveness in clinical trials.

Legal challenges include the regulation of AI in healthcare, privacy and data protection aspects of personalised medicine, data governance mechanisms for health data sharing, non-discrimination, and equal access to healthcare – to name a few. Therefore, although it might not seem obvious, In silico trials are also a crucial domain for ethical and legal studies!


You recently published the paper “Why accuracy needs further exploration in data protection”. Tell us more about it and how it impacts the In Silico World project.

We often hear about the ‘diagnostic accuracy’ of healthcare algorithms and their predictions or the need to ensure data accuracy in existing data sets. Often technical or even policy discussions evolve the need to ‘balancing’ accuracy with fairness, or reconcile it with the need for data minimisation. I believe that the concept of accuracy will have more and more importance in the years to come, and that is why it deserves further investigation in research.

That is why I started researching it and its meaning in AI and privacy and data protection law. For example, at the moment, I am questioning the possible effects of a low or even an excessive level of accuracy (could it lead to discrimination or misrepresentation? Could it entail an invasion of privacy?). These are my current research questions; I hope to share my findings soon.

Many researchers today are convinced that modeling and simulation is the real game-changer for the healthcare industry, what do you think?

In silico has the potential to bring tremendous benefits for individuals and society as a whole – and I am thinking about the development of medical devices to access medicines. In the future, assessing devices through in silico could, for example, supplement or even balance evidence generated through human or animal experimentation.

From the perspective of the law, more work is needed in order to find the suitable regulatory pathways for in silico trials at the EU level. I believe these must go hand in hand with core values such as sustainable AI and innovation, the respect of the precautionary principle, as well as patients’ and individuals’ fundamental rights.

The In Silico World consortium released the “Legal and Ethical Inventory” document, which is part of the ‘Ethical and Legal Framework’, and provides an overview of the core pieces of legislation and ethical principles that are relevant to the In Silico project, and thus, in silico trials.

This analysis, produced by Elisabetta Biasin from our partner Ku Leuven, can be accessed here.