NHS England Data Sharing Remote Audit: LA-SER Europe Limited

Purpose

This report records the key findings of a remote data sharing audit of LA-SER Europe Limited (LE), a Certara company, between 13 and 16 May 2024.  It provides an evaluation of how LE and its Processors conform to the requirements of:

• the data sharing framework contract (DSFC) CON-280098-H3R8C-v2.02

• the data sharing agreement (DSA) DARS-NIC-682048-S9P4H-v1.2

• the organisations’ own policies, processes and procedures

This DSA covers the provision of the following datasets:

The Controller is LE and the Processors are Certara France and Microsoft UK.  Microsoft UK do not have access to the data and only provide cloud hosting services.

LE (a Certara company) requires access to NHS England data for the purpose of the following research project: Clinical and economic burden of graft versus host disease in allogeneic stem cell transplant recipients in England, a retrospective cohort study.

The interviews during the audit were conducted through video conferencing.

This is an exception report based on the criteria expressed in the Data Sharing Audit Guide version 4.0. 

Audit type and scope

Data recipient’s acceptance statement

LE has reviewed this report and confirmed that it is accurate.

Data recipient’s action plan

LE will establish a corrective action plan to address each finding shown in the findings table in section 2. The Audit Team will validate this plan and the resultant actions at a post audit review with LE to confirm the findings have been satisfactorily addressed. The post audit review will also consider the outstanding evidence at which point the Audit Team may raise further findings.

The Audit Team has identified 2 opportunities for improvement in section 3 which are provided for reference only and will not be followed up as part of any post audit review.

The following tables identify the 3 observations and 1 opportunity for improvement raised as part of the audit.

Use of data

LE confirmed that the datasets were only being processed and used for the purposes defined in the DSA and were not being linked with another dataset.

Data location

LE confirmed that processing and storage locations, including disaster recovery and backups, of the datasets were limited to the locations shown in the following table.  These locations conform with the territory of use defined in section 2c of the DSA.

Backup retention

The duration for which data may be retained on backup media is:

The audit was based upon a sample of the data recipient's activities, as observed by the Audit Team. The findings detailed in this audit report may not include all possible nonconformities which may exist. In addition, as the audit interviews were conducted through a video conference platform, certain controls that would normally be assessed whilst onsite could not be witnessed.

NHS England has prepared this audit report for its own purposes. As a result, NHS England does not assume any liability to any person or organisation for any loss or damage suffered or costs incurred by it arising out of, or in connection with, this report, however such loss or damage is caused. NHS England does not assume liability for any loss occasioned to any person or organisation acting or refraining from acting as a result of any information contained in this report.