Transcript Security & Privacy aspects of OpenClinica – the

Security & Privacy aspects of
OpenClinica – the CTMM-TraIT experience
Jacob Rousseau – TraIT, VU University Medical center
&
Marinel Cavelaars – TraIT, the Hyve
Version 0.5 21-05-2015
Content of presentation

Introduction CTMM / TraIT

Data-flows between applications

Hosting & operations

Privacy & security

Performance
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CTMM-TraIT
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Center for Translational Molecular Medicine - CTMM
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Translational Research IT - TraIT

Public partners, private partners, patient foundations
and charities

CTMM 2009-2015

TraIT Oct 2011 - 2016

CTMM merges with TI Pharma as of January 1st
2016
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TraIT partners
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TraIT applications & work-packages
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Statistics - OpenClinica
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Number of studies: 151
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Number of users: 900
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Number of unique sites: 157
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OpenClinica uptake
136 studies
157 sites
852 users
150
140
130
120
Number of Studies
110
100
90
80
Other multi-center
studies Dutch
UMC’s
70
60
50
Pre TraIT-effect
Multi-center
VUmc studies
40
30
20
10
July 2008
Start DeCoDe
OpenClinica
Q4
Q3
Q2
2015 - Q1
Q4
Q3
Q2
2014 - Q1
Q4
Q3
Q2
2013 - Q1
Q4
Q3
Q2
2012 - Q1
Q4
Q3
Q2
Q4
2011 - Q1
Q3
Q2
2010 - Q1
Q4
Q3
Q2
2009 - Q1
Q4
Q3
Q2
2008 - Q1
0
October 2011
Start TraIT
OpenClinica
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Number of visits per month to OpenClinica.nl
Number of Visits
since april 2014
1800
1600
1400
1200
Number of Visits
1000
800
600
400
200
0
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Source: AWStats
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TraIT: step by step guides
Web site: http://www.ctmm-trait.nl/
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Content of presentation

Introduction CTMM / TraIT

Data-flows between applications

Hosting & operations

Privacy

Security provisions

Performance
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Clinical Research data flows
All steps have
to be reviewed
for security
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OCDataImporter
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Developed by Cuneyt Parlayan, VUmc, CTMM-DeCoDe

Source:
https://github.com/cuneytparlayan/trait_open_clinica_upload_tool_2

Executable available via the TraIT service-desk

What does it do?
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Converts text (CSV) files to ODM taking subject, events, groups and
repeats into account
Automated mapping of columns to ODM-items
Creates SQL-insert files to create subjects and to schedule events
(not needed with improved web services)
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OCDataImporter
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Link to clinical or digital pathology image

Add a 'parameterized link' in the Excel-CRF in the
left/right column text:
<a
href="https://www.example.com:123/ContextRoot?images=/${
item['IMAGE_ID_ITEM_ID']}" target="_blank">Click here to
see this subjects slides in tEPIS</a>

Links to an image for which the review results must be
entered in the CRF
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Link to digital pathology image
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Schedule Appointment
Logis
 Developed by MEMIC, center for data- and information
management, Maastricht University Medical Center, Dirk
Veldman
 Date and time of visits entered in Logis; the
corresponding visit / event is scheduled in OpenClinica
using web services
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Export to Transmart
 OpenClinica (ODM) to ETL (csv) to tranSMART (I2B2)
Developed by Ward Blondé
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Content of presentation
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Introduction CTMM / TraIT

Data-flows between applications

Hosting & operation

Privacy & Security

Performance
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Hosting
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Hosting partner Vancis
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4 environments at Vancis
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Sandbox; for study & CRF development
Archive; for inactive studies
Acceptance; to solve technical problems
Production
Philips environments for technical R&D and
upload testing
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Deployment setup
Hosting provider Vancis
AJP
Apache
web
server
Tomcat
application
server
JDBC
Postgres
database
server
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Content of presentation

Introduction CTMM / TraIT

Data-flows between applications

Hosting & operations

Privacy & security

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Legislation
Technical measures
Process
Operational
Performance
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Legislation
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Legislation – National level
 Medical Research (Human Subjects) Act (Wet Medischwetenschappelijk Onderzoek bij mensen, WMO)
 Dutch Personal Data Protection Act (Wet Bescherming
Persoonsgegevens, WBP)
European level
 European Data Protection Directive - Directive 95/46/EC
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Future legislation
National Level

Mandatory to report data breaches to Dutch Data Protection Authority
(amendment to the WBP – ‘Meldplicht Data Lekken’)
European level

General Data Protection Regulation (GDPR)

Clear definition of responsibilities data processors and controllers
Challenges are:

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Data Protection Officer
Strict administration
Subject agreement (Informed Consent)
Right to be forgotten / right for erasure
Substantial fines
Amendments by Committee for Civil Liberties, Justice and Home Affairs
(LIBE)
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Technical measures
 Separation of modules in different Virtual Machines
 Separate Web-module (Apache Webserver)
 Separate access and performance logging
 Automatic redirect to /OpenClinica
 Separate location for static content of studies (e.g. images)
https://www.openclinica.nl/static/biomarkers/arthri
tis_skeleton_highlighted.jpg
 Possibility of load-balancing with multiple Tomcat instances
 Caching
 Avoid caching of secure content on disk using headers
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Technical measures

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
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Transport-layer encryption (HTTPS)
Access logging
Firewalls
Export logging for non-repudiation
Log retention
Two additional technologies:

Trusted Third Party & Single Sign-On
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Trusted Third Party - TTP
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Pseudonymisation of Subjects
 Encryption using symmetric keys; only source
(hospital) and TTP have keys
 One key per site or one key per study
 Two types of ID's:
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National Identification number (BSN)
Hospital Information System ID (HIS)
Various technical implementation strategies
tested:
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Client-side with Java-script
Client-side with Java Applet
Server-side ( for HIS-numbers only )
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Single Sign-On SAML 2.0
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Developed in cooperation with Daniel Pletea –
Philips and Paul van Dijk - SURFnet
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SAML (Security Assertion Markup Language)
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Only for authentication

Intended deployment (using OpenConext at
Vancis) with SURFconext / eduGAIN
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Processes
 User management
 PI is responsible to remove user from study if he / she is no
longer active
 Periodical reminders for studies to verify if users are still
active or affiliated
 User administration via the TraIT service-desk
 Password expiration
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Processes
 Checks on directly identifiable information before study
is promoted from sandbox to production
 SQL scripts to scan database for directly identifiable
information
 Standard Operating Procedures
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Operations
 Standard operating procedures for administrative
personnel
 Periodic review of vulnerabilities in components (e.g.
US-CERT)
 Secure connections to servers for administrative
operations
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Content of presentation

Introduction CTMM / TraIT

Data-flows between applications

Hosting & operations

Privacy & security

Performance
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Number of users
per hour
20
18
16
14
12
Number of users
per hour
10
8
6
4
2
0
From 27th of March to 4th of May
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Monitoring
 Tools at hosting-provider (e.g. Nagios) to monitor
availability
 Periodic database scripts to register number of users
logged-in (performance)
 AWStats for statistics (performance)
 Selenium-scripts deployed at 2 sites to register the
duration of common user actions (performance)
 Presentation: CRF Performance and System Scalability
by Annelies Rotte gives all details on performance
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Final words
 Privacy / security / risk assessments must have on-going
attention
 Due care and due diligence
 Multi-faceted: technology, legislation, operations,
development
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Thanks

OpenClinica LLC: Alicia Goodwin, Cal Collins, Krikor Krumlian, Ben Baumann
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The Hyve: Marinel Cavelaars, Kees van Bochove
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Trial Data Solutions: Gerben-Rienk Visser, Annelies Rotte
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CTMM: Jan-Willem Boiten
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NKI: Gerrit Meijer, Gwen Dackus
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VUmc: Henk Verheul, Jeroen Beliën, Rene Breet, Cuneyt Parlayan, Ward Blondé, Rinus
Voorham, Sander de Ridder
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Philips: Wim van der Linden, Daniel Pletea, Cees de Jonge
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Memic: Alfons Schroten, Dirk Veldman, Robert Klinkenberg
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Netherlands eScience Center: Rita Azevedo, Ruud Ross
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Maastro: Johan van Soest, André Dekker
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Vancis: Kees Louwen, Marcel Bunte, Auke Abbekerk
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SURFnet: Paul van Dijk
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