Transcript Content

Disease & Treatment Registry
Thru The Web,
The Way Forward
Dr. Lim Teck Onn
Ms Lim Jie Ying
Clinical Research Centre,
Hospital Kuala Lumpur
Ministry Of Health
Malaysia
www.crc.gov.my
Content
• CRC and Disease Registers
• Traditional operation vs web-based
operation
• Pros and Cons
• Minimizing security risk of Web based
operation (Ms Lim Jie Ying)
We do 4 types of clinical research
1. Clinical Trials.
2. Clinical Registers /Epidemiological and
Health outcomes research
3. Clinical Economics Research
4. Evidence based medicine
Disease Registers in CRC
1. National Renal Registry
2. National Cancer Registry
3. National Cataract Surgery Registry
4. National Neonatal Registry
5. National Mental Health Registry
6. National HIV/AIDS Treatment Registry
7. National Transplant Registry
8. In the pipeline: CKD (GN/SLE), CVD (Stroke,
AMI, Angioplasty) Rheumatic (RA)
Purpose of Disease Registry
1. Quantify disease burden (morbidity and mortality)
and its geographic and temporal trends.
2. Early warning of rapid increase in disease
incidence eg in infectious disease.
3. Identify sub-groups most at risk of disease.
4. Identify potential risk factors of disease.
5. Evaluate treatment programme / Clinical audit
6. Evaluate control and prevention programme.
7. Facilitate research, eg disease aetiology, Rx
effectiveness, outcomes research, prognosis
Epidemiological vs Treatment Register
Uses of Registry data
1.
2.
3.
4.
5.
6.
7.
Disease epidemiology
Treatment availability & accessibility
Outcomes research
Technology assessment
Clinical economics
Clinical audit
Support clinical trial/ clinical research
Data capture and reporting
A core function of
a Disease Registry
Traditional Operation vs
Web-based Operation
SITE
Report
data
(paper)
SDP
No data
return
SITE
Internet
EDC
Return
processed
data
Data Processing
CRC
Report
only
No
prim.
data
USERS
CRC
Real time
analysis &
Data
report
Reporting
Internet
USERS
Online
data
access
Process comparison
Traditional operation
Web Application
Site reports data in the form of CRF Site reports data electronically via
to CRC
electronic data capture
CRC does not return data to site
unless requested by site
Data processed are returned
electronically
CRC provides annual report to user
Real time analysis and availability
of reports
No data accessible by user
Online data access of data by user
Pros and Cons (1)
Traditional operation
Web Application
High cost of transmission of paper
CRF to CRC by SDP
No cost of transmission of paper CRF
to CRC by SDP
Incurs cost of printing CRF
(continuous)
Incurs cost of developing the web
application (one-off)
Data only available annually when
report is out
Instantaneous availability of latest
data for online review at all time
Data entry personnel at CRC keys in
data based on paper CRF received
Electronic (remote) data capture, data
entry by SDP personnel
Lower short term cost of client server
application development, high cost of
infrastructure planning
High short term cost of web
application development,
infrastructure planning
Report only analysable annually
(based on clean data)
Real time analysis of report (based on
uncleaned data)
Pros and Cons (2)
Traditional operation
Web Application
Authorised researcher has to send in
Ease of access to data for purpose of
request to CRC to gain access to data, research by authorised researcher
time consuming
Less security risk – enclosed system
within CRC network
High security risk – physical security,
data security, user access security, etc
SDP has to send in request to CRC to
review own centre’s data, time
consuming
SDP may verify own centre’s data
easily
Data entry personnel are trained to do Disparate way of entering data among
data entry in similar manner
SDPs
High efficiency
Efficiency – unknown until its
operational
Pros and Cons (3)
Traditional operation
Incurs cost of employment of data
entry personnel at CRC
Web Application
Does not incur cost of employment of
data entry personnel at CRC
Authorised user (CRC’s registry
Authorised user may run the
manager, data entry personnel) may
application anywhere with Internet
only run the application within CRC’s access at all time
entity
Software has to be installed at the
workstations for data entry
No installation of software is required
We think the pros outweigh the
cons.
But what about the security risk?
Ms Lim Jie Ying
Risks (1)
Trad
Web
Authentication –
– someone may impose as the
owner of the web site and direct
user to non-appropriate web site
– someone who knows the user
name and password of a user may
easily gain access to the system
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Risks (2)
Trad
Web
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Access control
– Non authorised user may view,
edit, add or delete data that he/she is
not authorised to
–When user left the application idle
and leaves the PC, someone else
who happened to pass by may easily
access the application if it is not
locked
Risks (3)
Trad
Web
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Data without protection
– Unauthorised people who gained
access to the entire database may
have access to all data
– Packet ‘Sniffing’ by nonauthorised people
Unable to identify what
alterations has been made, who
made it, when was it made
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Risks (4)
Trad
Web
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Physical insecurity
– Anyone who gain access to the
data storage area has access to data
External source of damage
– Hackers
– Disgruntled users
Risks (5)
Virus attack
Trad
Web
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Disaster
– Flood
– Fire
– Theft
– Power break down
Technological Mechanisms to
Counter Security Risk
•
•
•
•
•
•
Authentication
Access control
Encryption
Audit trail
Physical security
Control of external communication links
and access
• System backup and disaster recovery
Authentication (1)
• Authentication is a process of verifying the
identity of an entity that is the source of a
request or response for information in a
computing environment
• Categories:
– Web Application owner authentication
– User authentication
Authentication (2)
• Web application owner authentication
– VeriSign’s Server ID apply state of the art SSL
(Secure Sockets Layer) technology to conduct an
authenticated, strongly encrypted online transaction.
– VeriSign ensures:
• the web site belongs to NRR and not an
impostor’s
• Message privacy - information cannot be
viewed if it is intercepted by unauthorized
parties.
Authentication (3)
• User authentication is based on two criteria:
– Something that user know
• User ID and Password – user is required to change
password every 3 months and the password cannot
be reused within 3 cycles.
– Something that user have
• Mobile phone authentication
Authentication (4)
• Mobile phone authentication
– Eg. Mobile phone authentication. After user logs
in using UserID and password, server sends an
SMS containing additional password to user’s
mobile phone. User then types in the additional
password before gaining access to system
Mobile Phone Authentication
Access control
• Only authorized users, for authorized
purposes, can gain access to a system
• Authorised users are grouped into Access
Control List
• User’s rights are assigned based on role
• User session management – when user left
the application idle for more than 15
minutes, the application will be logged off
automatically
Encryption
•
•
•
Definition: convert ordinary language into code so as to be
unintelligible to unauthorized parties.
Field encryption for PHI (Personal Health Information) such
as Name, IC within SQL database
Data transmission and synchronisation encrypted
Data Centre
Internet
asdadadada5gsdafAsdjkn2543550nasdafasjfl5kjhfasfl5345l23
asdlkjldkjasjdalkdjladjl34435347593757asdkas6324sadadaad
VPN 128-bit connection
DTRU
Audit trail
• Audit trail on
– Information access – to allow identification of unauthorised
access to system / network
– data manipulation when users create, modify or delete
records
• Tracks the following
Who made the change
User ID and name
When was change made
date and time
What change was made
value change (previous to
current value)
Why was change made
reason, eg. data entry, data
edit
Physical and Environmental Security 1
• Physical security entails appropriate controls to prevent
unauthorised people from gaining access so that they cannot
tamper with or derive information from the equipment
• Access to data centre is limited to authorised personnel
only. Access to data centre will only be granted if the person
is in the authorised list, identification information is
presented and password is correct. Staffs within data centre
are authenticated using biometrics technology.
• Access to DTRU office is secured by access card system
and each personnel has limitation of accessible area/room
• Workstation will be logged off if left idle for 5 minute.
• Web application will be logged off if left idle for 15 minutes
Physical and Environmental Security 2
• Access card system, Fire and alarm system, data
storage space
Physical and Environmental Security 3
Web Application Infrastructure Layout
Control of external Communication
Links and Access (1)
• Firewall - acts as a sentry (guard)
that filters out ‘insecure’ traffic
from the Internet to ensure the
security of an internal network in
DTRU.
• Intrusion Detection System (IDS) built into firewall to detect and
block suspicious activities.
• Segmented network - User
workstations are physically and
logically separated from the servers.
Thus, compromised workstations
can be isolated from the servers and
thus minimising damage.
Control of external Communication
Links and Access (2)
• Antivirus
– TrendMicro Antivirus Installed on all
workstations and servers
– Daily virus signature update
– Real-time scan and cannot be disabled.
• Patch Management
– Automatically download, deploy and
install latest approved patches to all servers
and workstations without any user
interaction.
– Ensure that latest patches are applied to
operating systems.
System Backup and
Disaster Recovery
• Backup
– Daily, weekly and monthly backup of
data to tapes.
– Weekly and monthly backup tapes
stored offsite to ensure business
continuity if anything happens.
– Automatic schedule of backup
conducted at night using Veritas Backup
software.
7- Day backup
Tape Loader
• Disaster Recovery – Data may be recovered from backup
tapes. Security consultant works with CRC team to prepare
Business Continuity Plan Procedure.
Organizational Practice
• Security and confidentiality policies
– Prepared by CIS team of CRC with joint effort of Security
Consultant
– Each CRC staff has to sign Non Disclosure Agreement
• Information security officers (ISO)
– To enforce policies
– To ensure staffs abide by the policies
– Responsibilities include but not limited to: Personnel security, IT
security, Physical & environmental Security, Information Processing
Practices, Business Continuity Management
• Education and training programs
– Awareness training program on information security for all CRC
personnel is held every month.
– Ongoing emphasis
• Sanction
– Sanction for breaches of confidentiality
Thank You