IBD Registry. All rights reserved ibdregistry.org.

uk
Information governance
Richard Driscoll
IBD Registry. All rights reserved ibdregistry.org.uk
Overview
Legal Framework for the Registry
Secure data processing
Patient Consent
Caldicott Guardian approval
Scotland, Wales and Northern Ireland
IBD Registry. All rights reserved ibdregistry.org.uk
Overview
Legal Framework for the Registry
Collaborative sets Registry policies
BSG is legally responsible
Local data remains locally owned
Ethics approval not required for Registry data
IBD Registry. All rights reserved ibdregistry.org.uk
DATA SAFE HAVEN
IBD Registry. All rights reserved ibdregistry.org.uk
Health & Social Care Information
Centre (HSCIC)
(accredited data safe haven)

Validates data files
(demographics & clinical data)

Verifies the patients identities

Allocates Registry identifier

Converts the patient identifiable data into a
dataset with demographic categories

Forwards data from other datasets
annually
e.g. Death, cancer, HES data etc.

IBD Registry PMS
(InfoFlex software platform,
data held on hospital servers)
Clinical staff processing
patient identifiable data.

Hospital or GI Dept IBD
database in current use
(on Trust servers)
Clinical staff processing
patient identifiable data.
Legacy IBD database
(on PC in hospital)
Clinical staff holding
patient identifiable data
Overview of registry data-flow & pseudonymisation in England
Web Portal access
(Registry data set,
future audit data or
research data)
Patient identifiable data
IBD Registry web server
hosted by InTechnology
(an N3-approved company)











Web-portal databases
Separate database for each
Trust or Research Project
Patient identifiable data encrypted
and accessed only by Trust users
Registry staff do not have access
All export through NHS Network to HSCIC.
N3
The Registry Database for research and audit

Anonymised
data file from
HSCIC
Output files
To HSCIC for
anonymisation
Local Trusts
ibd registry, 2014
IBD Registry. All rights reserved ibdregistry.org.uk
Secure data processing
Using NHS IT systems and standards
(e.g. N3)
Using NHS Data safe havens
For processing patient identifiable data
For linking to other NHS data sets
To reassure Trust management and IT
IBD Registry. All rights reserved ibdregistry.org.uk
Patient consent
Opt out system for 2014 and 2015
Written consent required from 2016
Registry will provide a pack
Posters
Approved patient information leaflet
Approved consent form
Consent recorded on PMS and web portal
IBD Registry. All rights reserved ibdregistry.org.uk
IBD Registry. All rights reserved ibdregistry.org.uk
Caldicott Guardian approval
Information for CG in the Registry Pack
Registry team will support with any queries
raised
CG has to sign an authorisation form
before data can be submitted
IBD Registry. All rights reserved ibdregistry.org.uk
Scotland, Wales and N Ireland
We are applying in all three countries to
set up an equivalent system and following
the same principles.
IBD Registry. All rights reserved ibdregistry.org.uk