Certifying and Securing a Trusted Environment for Health Informatics Research dataDr Jonathan Monk, Director of IT, University of Dundee

1/11/2016

Health Informatics Centre

dundee.ac.uk/hic

Dr Jonathan MonkDirector of IT

University of Dundee

Certifying and Securing a Trusted Environment for Health Informatics

Research data

Health Informatics Centre

dundee.ac.uk/hic

1. Overview of Health Informatics2. Research Data Management

Platform3. Safe Haven Architecture4. ISO27001 Certification

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Overview of HealthInformatics

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Geographic - Tayside And Fife Population of Scotland Time Period 1972 - 2016

Electronic Medical Data Coverage

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Parents

Conception

Birth

Early Life

Childhood

Adulthood

Late Life

DeathResearch Datasets

• GoDARTS Diabetes – 18K - Case/Controls• TASC FORCE – 5000 - MRA Volunteers• POPADAD – 1200 - Diabetes with no CVD• TRACE RA – 3200 - Rheumatoid Arthritis/UK

Pre-consented Cohorts SHARE – 100+K Generation Scotland – 20K

SMR02Maternity & Neonate

Walker48,00 Births (1952-1966)

Health Care Data Primary Care : Community Prescribing Secondary Care : Out Patient Visits, Hospital Admissions, Accident & Emergency, Cancer Register, Psychiatric Episodes. Diagnostics : Radiology Events, Cardiology & Vascular Labs, Bowel Screening Laboratory - Biochemistry, Haematology, Immunology, Microbiology, Virology Diabetes Surveillance - BP,BMI, Smoking Alcohol, Amputations, Ulcers Diabetic Retinal Images – DRS Retinopathy Image Library (Go DARTS Population)

Disease Registers• TARDIS Respiratory Disease• SDCRN – Scottish Dementia Network• SCI Diabetes• Epilepsy

Child Health Pre-School/SchoolSIRS/CHSP

Register OfDeaths

Data

For

Lin

kage

Existi

ng R

esea

rch

Stu

dies

Phenotypic Data Available

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Data Linkage Through Family Generations

2004 - Community Prescribing (Dispensed)

2016

1986 - Acute Hospital Admission Tayside

1975 - Births and Neonatal Record

1986 - Laboratory ( Biochemistry, Haematology, Immunology, Microbiology)

1994 - Radiology Records

1952

Walker Dataset1952 – 66

48,000 Dundee Births

BabiesMothers Fathers

1980 – Cancer Register

1990 – Diabetes Records

Cohort participants episodes recorded in dataset

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Controls Ratio : 3:1 Match on Age, Sex, SIMD

Feasibility Searches

Inclusion: Health Board : Tayside Status : Alive Conditions : Type 2 Diabetes Age: >= 65 Prescribed : Insulin > 2yrs

Exclude: Prescribed: Statins

Researcher Supplies Search CriteriaMatches

570K

450K

120K

70K

9210

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Demography

GRO ECHO

There was a 22% overall reduction in

all cause mortality

with β blocker use 

Prescribing TARDIS

Biochemistry

Microbiology

Haematology

Case Study # 1 - β blockers:Their Effect in Managing Chronic Obstructive Pulmonary Disease (COPD)

Setting Tayside, Scotland (2001–2010)Population 5977 patients aged >50 years with a diagnosis of COPD.

BMJ. 2011; 342: d2549. 10.1136/bmj.d2549 P.M Short, S.I.W Lipworth, D.H.J Elder, S. Schembri, B.J. Lipworth.

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Hospital admission

sGRO

More than 400 lives are being lost each year because breast cancer patients fail to take the full course

of the drug Tamoxifen due to "intolerable" side-effects 

Prescribing

Br J Cancer. 2008 December 2; 99(11): 1763–1768. 10.1038/sj.bjc.6604758 McCowan, J Shearer, P T Donnan, J A Dewar, M Crilly, A M Thompson and T P Fahey

Researcher SuppliedCohort

Cancer patients from a Ninewells clinic

Case Study #2: Tamoxifen adherence:Relationship to Mortality in Women with Breast Cancer

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Research Data Management Platform (RDMP)‘Optimizing and Augmenting the Research Data Supply Chain`

Labs

SMR01

Prescribing

Raw Data Data Import Databases Custom Extractions & Export Formats

RDMP

Labs

SMR01

Prescribing

Raw Data Data Import Structured Database Extraction + Export

Data LoadEngine

ResearchData Warehouse

Validate

Clean

Catalogue Quality Checks

Project XData Marts

Validate

Clean

Catalogue Quality Checks

Project YData Marts

Validate

Clean

Catalogue Quality Checks

Data Extraction Engine

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Data Set 1

Data Set 6

Data Set 2

Data Set 3

Data Set 4

Data Set 5

Data Set 1 Pseudo-CHI

Data Set 2Pseudo-CHI

Data Set 6Pseudo-CHI

Data Set 3Pseudo-CHI

Data Set 4Pseudo-CHI

Data Set 5 Pseudo-CHI

CHI and All Identifiable

Data

Data Set 1 Project -CHI

Data Set 4Project -CHI

NHS Network University Network

Data Repository Function of Safe Haven Analytic Platform of Safe Haven

Virtual Environment – no data leaves

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• Extraction takes minutes• Data released is standardised – the same regardless of Data Analyst that

completes the work• A history is recorded of all changes to data over time• Data released now will be in the same format as in 5 years from now• Metadata has been added• Methods for transforming and validations have been added across all data sets• Tools to manage and explore the data are available to Data Management team

and researchers• Audit and Logging all automated• Major work towards integration of image and genomic data

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Health Informatics Centre

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• Standard restrictive VDI solution• VMWare View / Horizon

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• AppVolumes used for Applications• Bring Your Own License• Lots of Application Variations!

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• There are many types of ISO Certification.• We have 27001:2013 – Certificate

Number: 2016/2269• ISO 27001:2013 is a specification for an

information security management system (ISMS). An ISMS is a framework of policies and procedures that includes all legal, physical and technical controls involved in an organisation's information risk management processes.

What is ISO27001?

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Why ISO27001 certification?• Independent set of standards – so rather than constantly having to think

what documents and processes we should have in place and reinventing the wheel, ISO gives us this!

• Gives confidence to other organisations we work with e.g. NHS, main University.

• Reduces other documentation requirements for governance, as we can just reference ISO documentation.

• Improves the working practices of HIC. This has been particularly the case with our hardware infrastructure.

• Key towards Scottish Government Safe Haven Accreditation.

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Scottish Government Safe Haven Accreditation

• 27001 standard controls PLUS some additional ones specific to Safe Havens.

• Reviewed by Scottish Government eHealth.

• Documentation Required:• Risk Assessment Doc• Mapping of Controls

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Scope“The provision of data to researchers via safe haven environment, secure patient recruitment, data collection using software tools, data entry, the development and operation of web based applications and all assets underpinning the provision of those services from the locations of HIC premises at Ninewells Hospital and data centres within the University of Dundee Campus”

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ISMS Controls Status with Statement of Applicability and Gaps

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ISO Controls – Made up of HIC specific ones and University/NHS general controls

University of Dundee Security Policies

University of Dundee HR Policies and Procedures (and NHS where

appropriate as we have honorary contracts)

HIC HR Procedures/Training/Policies

HIC Security Policies

A7: Human Resource SecurityA5: Information Security Policies A6: Organisation of Information security

University of Dundee Security Policies

HIC Security Policies, SOPS, Procedures, Work Instructions and Service

Descriptions

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Document Types and ReviewStatic & Formally Approved:HIC Exec & HIC Information Governance Committee

• Policies

• Standard Operating Procedures (SOPs)

• Risk Management Doc

• Information Security Management System (ISMS) Manual

• Business Continuity Plan

Just HIC Exec

• Procedures

Working Documents (technical):Relevant Technical Manager

• Service Descriptions

• Work Instructions

• Asset and Responsibility Matrix

• Disaster Recovery Plans

• Infrastructure Diagrams

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Structure of Docs in Box Become aware of an improvement of our current procedure

Take a copy of Procedure from “Live” folder and move to “Under Development”.

Draft change using tracked changes.Ask Technical Manager to review.

Technical Manager moves the doc they have approved to “Awaiting Approval Folder” and asks for it to be included in

HIC Exec Meeting Agenda for review.

If approved at HIC Exec either formally approved or sent to HIC Information Governance Committee for additional

formal approval (if document type requires)

Approved doc is moved to “Live” folder by HIC Admin

Procedure Changes

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Infrastructure comprised UoD, HIC & NHS

University of Dundee Network NHS NetworkHIC Managed Hardware

HIC Managed Hypervisor ClusterHIC Managed Operating Systems

HIC Managed Applications

UoD HardwareUoD Hypervisor

UoD OSUoD Applications

HIC and UoD use identical platform technology and share locationsHardware & responsibility for management varies depending on specificity

University of Dundee Data Centres NHS Locations

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Timelines• Help from University’s Information Security Officer (Graham McKay)

to get us up to the required standard. • Passed our Stage 1 audit of our documentation in June 2015.• Passed our Stage 2 audit of our systems (do we do what we say we do

in our documentation) in Jan 2016.• Passed second Stage 2 audit July 2016• Now have full audits every 6 months for the next 3 years!

Health Informatics Centre

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Phil Appleby

Jim Galloway

Chris Hall

Duncan Heather Emily Jefferson

Claire Jones Gordon McAllister

Keith Milburn Leandro Tramma

Donald Scobbie

Thomas Nind Guney Hanedan

Graham McKay

Many thanks to the people that did all the work!

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Questions?