1. September, 2005 HIMSS Interoperability Showcase New Directions in Life Sciences Theater Presentation Supporting Physician Reporting of Adverse Reactions and Public Health Threats

2. Speakers Tim Morris Centers for Disease Control and Prevention Director of Shared Services, National Center for Public Health Informatics (NCPHI) Michael Ibara Pfizer, Inc. Head of Pharmacovigilance Information Management Dixie Baker SAIC Chief Technology Officer

3. Inconvenience Constrains Reporting Reporting adverse events and notifiable diseases and conditions interrupts the normal routine of providing care and imposes a burden on providers – greatly decreasing the probability that these events and conditions will be reported. Not part of normal routine Not available at point of recognition Duplicate data entry High nuisance factor

4. A Potential Solution: Retrieve Form for Data-Capture (RFD) Provides standard way to: Retrieve a form from an external source, Display and use the form, Submit the collected information, and Archive a copy of the submitted form… All within the context of a local application Many-to-many integration – a single application can retrieve forms from many external sources

5. What Does The User See? GET FORM SELECT FORM Clinical Trial AE MedWatch Public Health Surveillance SUBMIT

6. Form ArchiverForm ReceiverForm Manager How Does RFD Do This? Archive Form (ITI-d) Retrieve Form (ITI-a) Submit Form (ITI-c) Clinical Repository Invoke Form Filler Prepopulate Form EHR Application Extended UI GET FORM Health System / Physician Portal RFD Extension EHR Application RFD Form Filler Form Source Form Recipient Form Archival

7. RFD Value Proposition Simplicity – RFDs simple components ease integration with clinical applications Convenience – RFD enables providers to fulfill reporting obligations without interrupting their normal work flow Interoperability – Adherence to open standards helps facilitate data exchange and semantic interoperability

8. Example Use Cases Pharmacovigilance Reporting of adverse reactions to drugs Clinical trials Post-marketing Biosurveillance (in cooperation with CDC) Reporting of suspected and confirmed cases of notifiable diseases and conditions

9. RFD in Support of Pharmacovigilance

10. HIMSS Interoperability Showcase Demonstration Demonstrate the technical feasibility of providing a seamless way for physicians to submit high-quality adverse event reports Demonstrate the use of the EHR and also the use of a portal (e.g., the National Health Information System) as primary data sources Stimulate additional thought / work in this area Pharmacovigilance and Reporting of Adverse Events from the EHR / NHIN Portal

11. Safety Reporting In the US the spontaneous reporting system relies on volunteer reports to track safety of marketed medicines Two of the most important limitations of the current system are underreporting and sparse data Increasing the number of high-data-quality reports of adverse events can have a direct beneficial effect on public safety To achieve this we must: Lower the burden of reporting on physicians and other health care professionals, and Raise the quality of the data in the report

12. Pharmacovigilance (Drug Safety) Scenario Team: Pfizer, Sentrx/Relsys, Allscripts Standard(s): XForm, HL7 ICSR, E2B(M/R3) Scenario: Physician/investigator, using an EHR or the NHIN portal, discovers a suspected adverse drug event and summons a data-capture form from the drug manufacturer or Regulator to provide information on the event and allow for submission back to the Regulator and manufacturer

14. Typical Safety Reporting Flow X X

15. Ideal Safety Reporting Flow

16. Form ArchiverForm ReceiverForm Manager How Does RFD Do This? Archive Form (ITI-d) Retrieve Form (ITI-a) Submit Form (ITI-c) Clinical Repository Invoke Form Filler Prepopulate Form EHR Application Extended UI GET FORM RFD Form Filler Company / FDA / etc. Company / FDA / 3 rd Party Company / FDA / etc. Health System / Physician Portal RFD Extension EHR Application

17. Interaction of Biopharma and HIT… Increase in the quality, number and timeliness of spontaneous reports Better and more rapid assessment of reports Solution can be applied universally Direct impact on public health

18. RFD in Support of Biosurveillance

19. HIMSS Interoperability Showcase Demonstration Demonstrate the technical feasibility of providing a seamless way for physicians to submit standards-based case reports from their desktops Demonstrate the integration of XForms-based surveillance instruments with EHR applications, using the IHE RFD profile Stimulate additional thought & work in this area Biosurveillance from the Clinical Workflow

20. Foundational Work CDC Interchangeable Data-Collection Instruments (IDI) work reported at HIMSS 2006 Forms are constructed using reusable XML fragments Standard data model & schema Standard PHIN terminology bound to questions W3C XForms standard provides multiple benefits Forms run on any platform that supports the standard – browser based, application, or client-server Model-view-controller separation allows for local customization of presentation Off-line and on-line data collection – important for outbreaks! Integration of public-health business rules (e.g., skip patterns, cross-field validation) Integrated form submittal No scripting – faster form creation

21. Public Health Reporting In the US, cases are reported to local public health, often using faxed paper forms Effective public health surveillance, detection, and response require timely and consistent reporting Reporting from the point of care, using standards- based, electronic forms, offers potential for earlier detection and more complete epidemiological profile Effective point-of-care public health reporting requires: Integrating reporting with the physicians normal work flow Facilitating physician decision-making Use of standard terminology to capture inputs

22. Biosurveillance Scenario Team: SAIC, CDC, IBM, Allscripts, Cerner, SAS, University of Washington Standard(s): XForms, XML, HTML/XHTML, PHIN Vocabulary Standards Scenario: Patient from local homeless shelter visits clinic and reports symptoms of tuberculosis. Suspecting TB, the physician performs TB skin test and chest x-ray, with results further raising her suspicions of TB. Physician prescribes 4 anti-TB medications and arranges for a respite bed at the shelter. Physician collects sputum specimen and sends it to the lab for confirmation.

23. You have ordered two or more anti-tuberculosis drugs for your patient, so you need to report this suspected case to the public health department. Do you want to report this now? Yes, Get FormReport LaterDo Not Report Yes, Get Form Submit

24. Notifiable diseases and conditions typically are reported to local public health agencies using faxed paper forms. Local agencies send some of the data on to the State, which sends an even smaller subset on to the CDC. CDC reports results from surveillance activities and disseminates warnings and guidance when a potential outbreak is detected. Typical Public Health Reporting

25. Clinical Repository Physician records suspected disease in patients EHR and orders treatment. As physician signs order, EHR application retrieves public health case reporting form. When physician submits the form, appropriate data elements are sent to public health agencies. Potential outbreaks are detected earlier, enabling public health to respond sooner. Ideal Public Health Reporting

26. How Does RFD Do This? Archive Form (ITI-d) Retrieve Form (ITI-a) Submit Form (ITI-c) Clinical Repository Invoke Form Filler Prepopulate Form EHR Application Extended UI GET FORM RFD Form Filler State Public Health CDC Local Public Health Form Archiver Form Receiver Form Manager Health System / Physician Portal RFD Extension EHR Application

27. RFD Value Proposition Simplicity – RFDs simple components ease integration with clinical applications Convenience – RFD enables providers to fulfill reporting obligations without interrupting their normal work flow Interoperability – Adherence to open standards helps facilitate data exchange and semantic interoperability