22/09 - EUCROF presented at EMA/GCP IWG workshop on AI in Clinical Research

"EUCROF presented at EMA/GCP IWG workshop on AI in Clinical Research"

Fiona Maini represented EUCROF at a two day workshop with the EMA/GCP IWG on AI in Clinical Research. Fiona presented on Ethical and Trustworthy AI and the draft proposal on the new EU AI Act coming in. Fiona was invited to present given her expertise in this area having been a member of the EU AI Alliance for almost 3 years and so having seen these guidelines and regulations evolve during that time. There will be a recording posted in due course, but a summary of the session is as follows:-


Ethical Guidelines for Trustworthy AI – Key ethical aspects when implementing AI


This session discusses the EU Alliance on Ethical Guidelines on Trustworthy AI. The aim of the Guidelines is to define AI and promote Trustworthy AI. Trustworthy AI has been characterised as having three components, which should be met throughout the system's entire life cycle, 1) lawful, 2) ethical, and 3) robust. The guidelines put forward a set of 7 key requirements that AI systems should meet in order to be considered trustworthy including; human oversight, technical robustness, safety, privacy and data governance, transparency, diversity, social and environmental wellbeing, accountability.

The new proposal on a regulation for AI lays out a legal framework to ensure the ethical use of AI in the EU.