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

2. 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

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 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

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. 8 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 Only Time in Years Quantity of Electronic Patient Health Data Pre-Launch Clinical Development Drug Launch Legend: = Highly controlled Clinical Trial Data 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 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

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