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HIMSS Interoperability Showcase New Directions in Life Sciences Theater Presentation Supporting Physician Reporting of Adverse Reactions and Public Health Threats. Speakers. Tim Morris Centers for Disease Control and Prevention

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  1. HIMSS Interoperability ShowcaseNew Directions in Life SciencesTheater PresentationSupporting 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. SUBMIT SELECT FORM Clinical Trial AE MedWatch Public Health Surveillance GET FORM What Does The User See?

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

  7. RFD Value Proposition • Simplicity – RFD’s 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 Pharmacovigilance and Reporting of Adverse Events from the EHR / NHIN Portal • 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

  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

  13. Typical Safety Reporting Flow X X

  14. Ideal Safety Reporting Flow

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

  16. 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

  17. RFD in Support of Biosurveillance

  18. HIMSS Interoperability Showcase Demonstration Biosurveillance from the Clinical Workflow • 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

  19. 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

  20. 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 physician’s normal work flow • Facilitating physician decision-making • Use of standard terminology to capture inputs

  21. 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.

  22. 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 Form Report Later Do Not Report Submit Yes, Get Form

  23. Typical Public Health Reporting CDC reports results from surveillance activities and disseminates warnings and guidance when a potential outbreak is detected. 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.

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

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

  26. RFD Value Proposition • Simplicity – RFD’s 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

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