eHR Clinical data repository and

pharmacovigilance

Suzanne Markel-Fox

12 October 2007

Discussion points eHR systems

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

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)

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

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)

eHR systems

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

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

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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

eHRs Can Improve Access & Usability of Clinical Care Data

Graph Is For Illustrative Purposes OnlyTime in Years

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Pre-LaunchClinical Development

Drug Launch

Legend:

= Highly controlled Clinical Trial Data

eHRsTODAY•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

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.

= Clinical Care Data from Patients, Payers, & Providers

Courtesy of Pfizer Health Informatics

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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

*http://www.amia.org/inside/initiatives/healthdata.asp