Transcript QuantumEnterprises, Inc.

Health-Care Information Systems
Development:
Lesson learned from a Systems
Integration Perspective
Gururajan R. Rao, Ph.D.
Quantum Enterprises, Inc.
1
2015/7/18
Common health-care systems integration issues
Laboratory
Information
Systems
Patient Record
Management
Systems
Compounds, Protocols
and discovery drugs
databases
Drug
Submission
Management
Systems
Diagnostic
Imaging Systems
(PACS)
• Need to deal with a plethora of
processes, groups and systems that fulfill
a specific departmental objective
• For a specific objective such as
generation of New Drug Application
documents, content & meta-data needs to
be seamless exchanged across these
systems
Worldwide Drug
Marketing and
Monitoring Systems
Clinical Trials
Systems
Hospital Information
Management Systems
eCTD Compliant
Systems
Post Drug Submission
Tracking Systems
2
Manufacturing,
Packaging and
Labeling Systems
Non-Clinical Data
Management
Systems
2015/7/18
Common health-care systems integration issues
Most systems have different business and/or
application owners
•
Critical systems not under the purview of an
enterprise-wide architecture or framework – (for
seamless meta-data/content exchange, document
tracking, design of new systems, etc.)
•
Business/application owners resistant to the
idea of a Common Information Infrastructure due
to fear of loosing control (for system re-design,
etc.)
•
3
2015/7/18
Common health-care systems integration issues
•
Where is a document or content in the enterprise?
• No generic document and/or content
tracking variables assigned across systems
Heterogeneous systems information flow
contributes to additional manual/adhoc automation
processes required to deliver on-time results.
•
•‘Power-users’
assume control of adhoc automation,
with no regard for common goals or format for
seamless metadata/content exchange
4
2015/7/18
Common health-care systems integration issues
• Need for “Real-time results” - eliminating effects
of time/distance. Example:
• NDA submission system in NJ
• Clinical trials being conducted in New
Zealand (NZ) and India for a specific drug
• Site monitors in NZ, India and US need
access to the most current protocol related
patient documents updated with most current
trial data to make decisions
Batch Uploads, downloads on laptop, etc. can be
avoided
5
2015/7/18
Common health-care systems integration issues:
Lessons learned

Need a Common Information Infrastructure (CII)
– worldwide: A single, authoritative, flexible and
well-designed enterprise-wide information
architecture that integrates critical meta-data,
content, related systems and groups for seamless
information exchange without loss of semantics
and business objectives across time-zones.
6
2015/7/18
Common health-care systems integration issues:
Lessons learned
 CII data model should be shared by systems
with common enterprise attributes (system name,
discipline, document_type, subtype, document
classification, dosage forms, data classification,
etc.)
CII security model (configurable) should be
shared by participating applications – minimizes
proprietary data ownership of systems and
provides dynamic ‘as-needed’ access to users.
7
2015/7/18
Common health-care systems integration issues:
Lessons learned
 Active working groups comprised of
business and technology champions - to
provide analysis and on-going knowledge
updates required to sustain CII and system
integration efforts
Institutionalize the CII with formal
enterprise-wide architecture and participating
system rules, common APIs, communication
and escalation channels, etc. that MUST be
followed by groups,
8
2015/7/18
Healthcare systems collaboration: FDA data
submission standards
Regulatory Agencies: FDA
HL7
Industry Standards
Common Pharma Disciplines
eCTD
Clinical
Non-Clinical
Regulatory
Pkg& Labeling
Manufacturing
Pharmacovigilance
Support/SOP
21CFR Part11
Resources
Management
External Agencies
Communication
Management
Knowledge
Management
Software/
Technology
Management
Legacy
Systems
eSubmissions
Collaboration
Authoring
Hospitals
LIMS
SAS: Analysis
Disease Management
Specific Divisions
Compounds
Metadata Mgmt
Partners
Hospitals
Drug Discovery
Clinical Trials
External
Collaborators
Vendors
Trial Centers
Drug partner
collaboration systems
9
Multi-center
trials
2015/7/18
Common health-care systems integration issues:
Sample enterprise - architecture design
Web-based Systems and Application Configuration layer
Common configurable
system attributes
Object/System
GOAL
Configurable
Processes, task attributes
User-Interface
Features/design
Shared, publishing
management
Shared meta-data and
taxonomy management
Shared, configurable
security templates User & Group
Group Tasks &
PROCESSES
Mgmt (Clusters)
RENDITION/
WATERMARK
Configurable
Business Services
Define
SERVICES
Application layer
Content Mgmt Module
Clinical Trial Module
App 1
App 2
eCTD
App 4
Pharmacovigilance
App n
Core technology layer
Content Management
System
10
Database Management
System
Network Technology
Web Technology
2015/7/18
Thank you and Questions
11
2015/7/18