FDP AI tool at centre of regulatory row

A federated data platform AI discharge tool hailed as “potentially transformational” by Wes Streeting is at the centre of a spiralling regulatory row, HSJ  can reveal.

The main concerns centre around whether the tool had been classified as a medical device by the Medicines and Healthcare Products Regulatory Agency, given that it was generating patient discharge summaries that, if incorrect, could impact continuity of care.

There have also been concerns about the information governance implications of using patient data to develop and validate the tool and whether this was being considered as direct care.

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Source: HSJ, 15 December 2025