1. eHR Clinical data repository and pharmacovigilance
Suzanne Markel-Fox
12 October 2007

2. Discussion points eHR systems Pharmacovigilance and surveillance
Penetration of eHR systems
Characteristics of health information technology systems
Standards and interoperability
Pharmacovigilance and surveillance
Post-marketing surveillance
Passive (spontaneous reporting)
Active surveillance
Automated (computer database)
Manual chart review
Observational studies, secondary analysis and registries

3. Penetration of eHR Ambitious regional and national goals for eHealth
EU Commission plan for eHealth
UK Connecting for Health
US Office of National Coordinator
Australia HealthConnect
Obstacles to meeting those goals
Organisational/cultural approaches to health care delivery
Limited interoperability of eHealth systems
Lack of regulation and fragmentation of eHealth market
Privacy and information security concerns
Investment required (cost, time, effort)

4. Standards and interoperability
Standard data structure
eHR designs vary widely
New certification requirements cross-reference ISO/TC215, HL7, CCHIT and other eHealthcare standards
Master Patient Index is essential
Not all systems use a unique identifier
Some regional systems create a system-specific synthetic identifier
Interoperability* is key
Technical/functional interoperability = “point to point flow of information”
Process interoperability is another way of talking about workflow management
Semantic interoperability = the successful communication of meaning
Semantic interoperability is at the very core of health care information exchange
NB: Breaking news on 8 Oct from HL7: Brazil is focusing on CCHIT, HL7 and ISO specifications for eHR standards
RIDE (support of COM 356), ISO/TC215, CEN 251, HL7
Interoperability = the ability to communicate and exchange data accurately, effectively, securely, consistently with different information technology systems, software applications & networks in various settings, so that clinical & operational purpose & meaning are preserved and unaltered (Halamka, 2007)

5. eHR systems
There are many components to an eHR system, some of which are broadly available and many of which are far less common. For example, a 2004 Health Information Network Europe (HINE) survey of European hospitals found that nearly 100% had patient registry and billing (and a master patient index), 18% had a computerised ordering system, but that only 2% had ePrescribing and clinical decision support.

6. Postmarketing surveillance
Spontaneous reporting
AERS, VAERS (physician, consumer reporting)
CIOMS, ICH safety reporting requirements
Active surveillance
Manual chart review: better at detecting symptom-related mild adverse events
Automated (computerised) surveillance: better for reporting drug interactions and laboratory-based changes
Disease-state registries: focused on improvement of care
Observational studies, secondary data analysis
Exploratory analyses
Disease modelling

7. ICU-based severe sepsis patient e-registry network
Global sharing of clinical data (38 countries)
To improve treatment decision making and outcomes
Electronically connecting physicians globally
Remove technology barriers
Resolve coordination issues
Manage privacy requirements
Objectives
Provide ‘real-time’ reports for participating institutions
Allow sites to compare their experience to the corresponding provincial, national, and worldwide aggregate
Benefits
On-demand access to track outcomes and improve performance
Standardisation of definitions 7 guidelines
Courtesy of A. Impicciche, Eli Lilly & Co 2

8. eHRs Can Improve Access & Usability of Clinical Care Data
9/18/2019
eHRs Can Improve Access & Usability of Clinical Care Data
Clinical Trials:
Data are high integrity due to validation, but are sourced from limited patient populations
Post-launch Clinical Care:
Today, data from payers & providers are lower quality, fragmented, and challenging to access
Providing Clinical Research requirements for eHRs has the potential to make Clinical Care data higher quality, more easily accessible, and more useful for safety, outcomes, and other types of analyses.
eHRs
TODAY
Fragmented
Limited accessibility
Limited populations
Narrow uses
FUTURE?
Easily aggregated
Broad access
National coverage
Many applications
Clinical Care Data: Availability & Access
Mix of efficacy, safety, and commercial data with multiple uses
This slide shows how eHRs could transform pharmacovigilance
Improved signal detection
Longitudinal data provide long-term safety data
Control groups within provider system allow for better signal:noise testing
Increased medication safety via enhanced surveillance of real-time data
More targeted post-marketing studies
Modeling and simulation using secondary data
Routine part of the drug development process
Legend:
= Highly controlled Clinical Trial Data
Quantity of Electronic
Patient Health Data
Drug Launch
Pre-Launch Clinical Development
= Clinical Care Data from Patients, Payers, & Providers 8
Courtesy of Pfizer Health Informatics
Time in Years
Graph Is For Illustrative Purposes Only 8

9. backup

10. AMIA Secondary Data Panel Recommendations*
Increase the transparency of data use and public awareness. Secondary use of health data must be conducted and managed solely through the use of open and transparent processes
Focus ongoing discussions on data access, use, and control (not “ownership”)
Continue discussions on privacy policy and security with regard to the secondary use of health data
Increase public awareness efforts on the benefits and challenges associated with the secondary use of health data
Create a taxonomy of the secondary use of health data
Address increasingly difficult current and evolving questions related to the secondary use of health data in a comprehensive manner
Focus national and state attention on the secondary use of health data *