Quality, Research, and Public Health (QRPH)

1. Quality, Research, and Public Health (QRPH) IHE North America Webinar Series 2009

2. Agenda • QRPH Domain Overview • Published Profile Updates: CRD* • New Profiles: DSC, MCH, RPE • White Paper: NBS • Test Tooling • Showcase Demonstrations • ’09/’10 Schedule • Q & A • * NOTE: Update to 2008 IHE QRPH Webinar @ www.ihe.net/Events/webinars2008.cfm#7

3. IHE Quality, Research, and Public Health IHE-QRPH Charter The Quality, Research, and Public Health (QRPH) domain addresses the infrastructure necessary to share information relevant for quality improvement, clinical trials, and public health reporting between health care records in the physicians office or hospital and other entities. • NOTE: Formed in 2005 & sponsored by HIMSS & ACCE

4. QRPH Domain Overview IHE QRPH Mission The IHE Quality, Research, and Public Health Domain will apply the proven, Use Case driven IHE processes to: • Deliver the technical framework for the IHE-QRPH domain profiles and white papers; • Test conformance of IHE-QRPH profile implementations via Connectathons; and • Demonstrate marketable solutions at public trade shows.

5. QRPH Domain Overview Heterogeneity – … coexistence in a multi-vendor & multi-modality world, leveraging shared infrastructure Semantic Interoperability – … from the sensor to the EHR to the secondary use of data Real-time Availability – … facilitating more timely clinical decisions QRPH Profile Primary Objectives: Ultimately providing improved – … safety, quality of care & workflow efficiency

6. QRPH Profile Development • 2006-2007 Initial Framework Development • Patient-level Export of Quality Data • 2008/2009 Development Cycle • White Paper: Performance Measurement Data Element Structured for EHR Extraction • Retrieve Form for Data Capture (RFD) • Clinical Research Data Capture (CRD) • 2009/2010 Development Cycle • Update to Clinical Research Data Capture (CRD) • Drug Safety Content (DSC) • Mother and Child Health (MCH) • Retrieve Protocol for Execution (RPE) • White Paper: Newborn Screening

7. CRD Update CRD Profile Update Clinical Research Document Trial Implementation

8. Clinical Research Document • Update • Changed name from Clinical Research Data Capture to Clinical Research Document (still CRD) • Extended the Form Filler’s capability and provides for an additional Archive CRD Data transaction which reuses the Provide and Register Set transaction [ITI-15]

9. Clinical Research Document • Update • Provide the ability to send additional data containing context information and workflow information from a Form Filler to a Form Manager to facilitate the selection and pre-population of the requested form. • NOTE: Update to 2008 IHE QRPH Webinar @ www.ihe.net/Events/webinars2008.cfm#7

10. DSC DSC Profile Drug Safety Content Trial Implementation

11. Drug Safety Content • Purpose • Provide a more efficient way to move data through the drug safety reporting system • Routine output of usual clinical care processes • Maintain data fidelity • Timely reporting • Reduce the number of data translations • Provide elements identified within the US efforts under the Healthcare Information Technology Standards Panel (HITSP)

12. Drug Safety Content • Goal • Describe content and format to be used within the Pre-population Data transaction described within the Retrieve Form for Data Capture (RFD) Integration Profile. • Support a standard set of data for reporting 75 adverse drug safety events. • References the ability to convert this output into the ICH E2B M standard.

13. Drug Safety Content • Out of Scope • Queries on multiple patients • Support for Pseudonymization of patient data

14. Drug Safety Content

15. Drug Safety Content • E2B M • Guide for using a Form Manager to crosswalk an individual case safety report CCD structure into a standard used for routine reporting by regulatory agencies, including: • Food and Drug Administration (FDA) in the United States • European Medicines Agency (EMEA) • Ministry of Health Labour and Welfare (MHLW) in Japan • HealthCanada.

16. Drug Safety Content • E2B M • Ongoing harmonization efforts by HL7, ISO and CEN and ICH • Align reporting data elements within the E2B standard, moving from the existing E2B M to E2B R3. • Modify the messaging requirements as the Individual Case Safety Report (ICSR) R3.

17. MCH MCH Profile Mother and Child Health Trial Implementation

18. Mother and Child Health • Purpose • Provide two content profiles: • Health at Birth Summary (HBS) – summary of information impacting the newborn’s health status evaluation • Child Growth Summary (CGS) – child’s developmental (medical and social conditions) information

19. Mother and Child Health • Goal • Describe the contents to be used in automating the submission of the child and maternal health information to public health agencies. • Use transactions and content modules defined in other IHE profiles such as Request Form for Data Capture (RFD) to provide interoperable data exchange.

20. Mother and Child Health • Out of Scope Includes • A form archiver actor must be considered. When forms are partially filled, the data source actor should have the possibility to store this form and complete it later. • The appropriate risk assessment must guide the security considerations when implementing this profile. • When an MCH Content Creator and Content Consumer are grouped with actors from IHE integration profiles (e.g. XDS, XDR), then the Security Considerations for the integration profiles will be used when implementing the MCH profile.

21. Mother and Child Health

22. Mother and Child Health • Both content profiles contain information pertaining to two persons. • The Health at Birth Summary (HBS) Headershall include only the mother as a patientRole element while the father and the newborn will be represented via participant elements. • The Child Growth Summary (CGS) Headershall include only the newborn as a patientRole element while his parents are participant elements.

23. RPE RPE Profile Retrieve Protocol for Execution Trial Implementation

24. Retrieve Protocol for Execution • Purpose • Provide an automated mechanism for EHRs to retrieve a complex set of clinical research instructions (or a protocol) from a formally expressed research protocol to execute within the EHR.

25. Retrieve Protocol for Execution • Goal • Simplify a healthcare site’s participation in clinical research by integrating workflow from the research protocol into the work processes of patient care.

26. Retrieve Protocol for Execution • RPE works in the space between the EHR and the clinical research system (EDC). Three actors participate in automating the workflow: • Protocol Definition Manager • Protocol Executor • Protocol State Manager

27. Retrieve Protocol for Execution

28. Retrieve Protocol for Execution RPE is an early adopter of the workflow automation standard Business Process Execution Language (BPEL) applied to formal protocol representation and execution in an EHR.

29. Newborn Screening White Paper

30. Newborn Screening • Purpose • Identify the needs for interoperability between public health and clinical information systems, specifically for: • Newborn bloodspot screening (NBS) • Newborn hearing screening (NHS) • Inform future development of integration and content profiles • Contribute to the national and international HIT standardization efforts for public health

31. Newborn Screening • Target Audience • Public health and clinical professionals involved in the NBS and NHS programs • Electronic Health Record Systems (EHR-S) vendors • Public health information systems vendors • Members of US and international HIT standard development, harmonization, and certification entities

32. QRPH - Testing Test Tooling Support

33. Profile Conformance Testing NIST has the following mission in regards to Health IT Interoperability Standards: • Ensure health IT standards are complete and robust and • Establish a health IT standards testinginfrastructure that supports effective industry consensus standards development processes and provides the U.S. healthcare IT industry and federal activities with robust conformance and interoperabilitytesting capabilities

34. Profile Conformance Testing • IHE and NIST are collaborating to test vendor implementations as defined across the IHE-QRPH profiles.

35. Profile Conformance Testing Tooling is being developed to: • Increase test comprehensiveness and quality • Support both conformance and interoperability testing • Establish a framework for IHE-QRPH covering increasing complexity and technologies over the next five years • Support for virtualconnectathons, actual connectathons and to enable year round testing • Remain in alignment with the IHE-QRPH road- map

36. QRPH & Meaningful Use US Meaningful Use of An EHR • Improve quality, safety, efficiency, and reduce health disparities • Improve population and public health

37. QRPH - Showcase HIMSS Showcase Where we get to show off !!

38. Why use IHE QRPH profiles? HIMSS Showcase • Many Stories – One Big Showcase • Cultivating Innovation • Borderless Scenarios

39. HIMSS ’09 IHE Showcase Sponsors

40. Why use IHE QRPH profiles? QRPH profiles will enable… • Simplified standards-based export of data for quality improvement, public health monitoring, and clinical trials • Multi-vendor product integration testing @ Connectathons • Visibility of products with care providers and peer technology organizations in Showcases • Path to programs such as the U.S. National Health Information Network (NHIN)

41. 2009 Important Dates • 2009.09.30 Connectathon Registration Due • 2009.09.30 Showcase Registration Due • 2009.11.01 Virtual Connectathon Complete • 2010.01.11-15 2010 Connectathon (Chicago) • 2010.03.01-04 2010 HIMSS Showcase (Atlanta)

42. For Further Information • Web: www.ihe.net/Technical_Framework/index.cfm#quality • Wiki: wiki.ihe.net/index.php?title=Quality%2C_Research_and_Public_Health