Ethical justification of post-market monitoring of medical AI

Background

Article 72 of the EU AI Act suggests post-market monitoring is a way of ensuring that AI tools used in high-risk contexts, such as medicine, remain safe, ethical and efficient even after their deployment. In May 2025, the UK NICE recommended that DERM (https://www.nice.org.uk/guidance/hte24), a new AI skin cancer detection system, could be provisionally used in the NHS. Post-deployment monitoring over three years aims to gather information regarding the tool’s safety, efficacy and effectiveness.

Although post-market monitoring (equivalent to phase 4 clinical trial) of medical technologies (e.g. drugs) is not a new practice, the specific characteristics of AI tools as epistemic tools (Alvarado 2023) raise important questions regarding the ethical appropriateness of this validation method for medical AI. The project will use DERM as its case study, and will seek to critically analyse and ethically evaluate post-release monitoring processes for medical AI tools.

research experience, research methods and skills training

Research experience in using practical ethics methods (theoretical methods, empirical data collection and analysis methods), skills in developing ethical frameworks in research ethics. Training in academic writing and presentations.

FIELD WORK, SECONDMENTS, INDUSTRY PLACEMENTS AND TRAINING

Fieldwork for empirical data collection in NHS Trust(s) where DERM is deployed, and in policy bodies such as MHRA and NICE.

PROSPECTIVE STUDENT

The ideal candidate will have an undergraduate degree in philosophy or social science and Master’s degree in bioethics.