FOI release

AI Assisted Discharge Summary (AADS)

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2026/00965

Received 27 August 2026

Published 1 October 2026

Request

This is a request for information under the Freedom of Information Act 2000. I would like to request information on the AI Assisted Discharge Summary (AADS) tool that’s hosted on the Federated Data Platform (FDP). This tool was piloted at Chelsea and Westminster Hospital NHS Foundation Trust and was recently certified by the MHRA as a Class I medical device (GMDN Code: 61087) for official use as an NHS tool. 1) In the latest minutes from the NHS England Data Transformation Check and Challenge Group, published in April 2026, it was reported that “The group reviewed the FDP action log and noted progress across several areas. It was confirmed that the DPIA for the AI Assisted Discharge Summary remained on track but could not be finalised until the product reaches pilot stage” Can you please provide me with the DPIA for the AADS. Source for Q 1: https://www.england.nhs.uk/long-read/tra... 2) Can you please provide me with the registration/certification date for the AADS device by the MHRA? Can you also please provide me with the dates the tool was being oficially piloted at Chelsea and Westminster. 3) In regards to the self certification of the AADS the manufacturer would have compiled technical documentation, implemented a Quality Management System (QMS) and created a Declaration of Conformity. The manufacturer must also must prove their device meets the Essential Requirements (ERs) of the UK Medical Devices Regulations 2002. Can you please provide me with this technical documentation, including the Quality Management System (QMS) documentation which may consist of policies, standard operating procedures, risk assessments, approval procedures, decision logs, software validation, and post-market surveillance procedures. Can you also please provide me with the Declaration of Conformity, and the proof that the manufacturer met the Essential Requirements (ERs) of the UK Medical Devices Regulations 2002.

Response

See attached

Documents

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.