New report on Synthetic Data for Development of AI

Christopher Yau has contributed as a member of the expert working group to a new report “The Synthetic Data for Development of AI as a Medical Device” now available via PHG Foundation:

“Synthetic data is artificially generated data that reflects the properties and relationships found in real data. While synthetic data can play an important role in AIaMD development, its use in regulatory submissions introduces specific considerations, especially when it constitutes a substantial part of the evidence package.

The Synthetic Data for Development of AI as a Medical Device (AIaMDs) report, produced by the Medicines and Healthcare products Regulatory Agency (MHRA) and the PHG Foundation, outlines these considerations, building on and complementing existing regulatory guidance. This marks an important and exciting first step for manufacturers and notified bodies collectively navigating this evolving landscape. The report provides crucial groundwork, though more work is required to move past these preliminary ideas.”