About
As the NHS adopts increasingly sophisticated digital tools, including AI-driven software, EPMA modules, and EPR systems, it is vital that clinicians, informatics professionals, and safety officers know how to report potential safety concerns. The MHRA’s Yellow Card Scheme, traditionally used for medicines and devices, now plays a growing role in the oversight of digital health technologies. This Learning Program is designed to demystify the Yellow Card Scheme for those working with or overseeing AI health tech, EPMA systems, and clinical software. You’ll learn how to recognise when a feature, such as an AI diagnostic tool, risk calculator, or prescribing algorithm, may be classed as a medical device, and what your responsibilities are in terms of reporting, governance, and patient safety. Through practical examples, regulatory guidance, and hands-on tools, this course will build your confidence in identifying, evaluating, and reporting risks associated with digital and AI-driven health technologies.
You can also join this program via the mobile app. Go to the app