Case study
Building consensus on synthetic data with the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) needed regulatory consensus on synthetic data before it could set policy on its use in medicines and medical device pathways. No shared standards existed, and reaching agreement meant aligning regulators, industry and legal experts who don’t typically agree quickly.
PHG Cambridge (as PHG Foundation) was commissioned to convene that process. We ran a series of expert workshops that tested and refined points of consensus, resulting in a Consensus Statement now informing MHRA policy, alongside a report on whether synthetic health data qualifies as personal data. We took the same approach on the MHRA’s AI Airlock programme, facilitating a workshop on post-market monitoring for AI system failures, and we continue to support the MHRA on synthetic data protocols for clinical trials.
Our role: independent, structured facilitation that turns complex, contested questions into regulatory outputs a public body can act on.
