Quality, Research, and Quality, Research, and Public Health (QRPH)Public Health (QRPH)

IHE North America Webinar Series 2009IHE North America Webinar Series 2009

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AgendaAgenda

QRPH Domain OverviewQRPH Domain Overview Published Profile Updates: CRD*Published Profile Updates: CRD* New Profiles: DSC, MCH, RPENew Profiles: DSC, MCH, RPE White Paper: NBSWhite Paper: NBS Test ToolingTest Tooling Showcase DemonstrationsShowcase Demonstrations ’’09/’10 Schedule09/’10 Schedule Q & AQ & A

* NOTE: Update to 2008 IHE QRPH Webinar @ * NOTE: Update to 2008 IHE QRPH Webinar @ www.ihe.net/Events/webinars2008.cfm#7www.ihe.net/Events/webinars2008.cfm#7

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IHE Quality, Research, and Public HealthIHE Quality, Research, and Public Health

IHE-QRPH CharterIHE-QRPH Charter

The Quality, Research, and Public Health The Quality, Research, and Public Health (QRPH) domain addresses the infrastructure (QRPH) domain addresses the infrastructure necessary to share information relevant for necessary to share information relevant for quality improvement, clinical trials, and public quality improvement, clinical trials, and public health reporting between health care records health reporting between health care records in the physicians office or hospital and other in the physicians office or hospital and other entities.entities.

NOTE: NOTE: Formed in 2005 & sponsored by HIMSS & ACCEFormed in 2005 & sponsored by HIMSS & ACCE

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QRPH Domain QRPH Domain Overview

IHE QRPH MissionIHE QRPH Mission

The IHE Quality, Research, and Public Health Domain will apply the proven, Use Case drivenUse Case driven IHE processes to:

– DeliverDeliver the technical frameworktechnical framework for the IHE-QRPH domain profiles and white papers;

– Test conformanceTest conformance of IHE-QRPH profile implementations via ConnectathonsConnectathons; and

– Demonstrate Demonstrate marketable solutions at public trade public trade showsshows.

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QRPH Domain OverviewQRPH 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:QRPH Profile Primary Objectives:

Ultimately providing improved – … safety, quality of care & workflow efficiency

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QRPH Profile DevelopmentQRPH Profile Development

• 2006-2007 Initial Framework Development2006-2007 Initial Framework Development– Patient-level Export of Quality Data

• 2008/2009 Development Cycle2008/2009 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 Cycle2009/2010 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

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CRD UpdateCRD Update

CRD Profile UpdateCRD Profile Update

Clinical Research DocumentClinical Research Document

Trial ImplementationTrial Implementation

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Clinical Research DocumentClinical Research Document• UpdateUpdate

– 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]

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Clinical Research DocumentClinical Research Document• UpdateUpdate

– 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: NOTE: Update to 2008 IHE QRPH Webinar @ Update to 2008 IHE QRPH Webinar @ www.ihe.net/Events/webinars2008.cfm#7www.ihe.net/Events/webinars2008.cfm#7

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DSCDSC

DSC ProfileDSC Profile

Drug Safety ContentDrug Safety Content

Trial ImplementationTrial Implementation

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Drug Safety ContentDrug Safety Content• PurposePurpose

– 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)

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Drug Safety ContentDrug Safety Content• GoalGoal

– 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.

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Drug Safety ContentDrug Safety Content• Out of ScopeOut of Scope

– Queries on multiple patients

– Support for Pseudonymization of patient data

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Drug Safety ContentDrug Safety Content

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Drug Safety ContentDrug Safety Content• E2B ME2B 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.

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Drug Safety ContentDrug Safety Content• E2B ME2B 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.

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MCHMCH

MCH ProfileMCH Profile

Mother and Child HealthMother and Child Health

Trial ImplementationTrial Implementation

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Mother and Child HealthMother and Child Health• PurposePurpose

– 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

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Mother and Child HealthMother and Child Health• GoalGoal

– 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.

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Mother and Child HealthMother and Child Health• Out of Scope IncludesOut 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.

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Mother and Child HealthMother and Child Health

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Mother and Child HealthMother and Child Health

• Both content profiles contain information pertaining to two persons. – The Health at Birth Summary (HBS) Header shall

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) Header shall include only the newborn as a patientRole element while his parents are participant elements.

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RPERPE

RPE ProfileRPE Profile

Retrieve Protocol for ExecutionRetrieve Protocol for Execution

Trial ImplementationTrial Implementation

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Retrieve Protocol for Execution• PurposePurpose

– 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.

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Retrieve Protocol for Execution• GoalGoal

– Simplify a healthcare site’s participation in clinical research by integrating workflow from the research protocol into the work processes of patient care.

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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:

1. Protocol Definition Manager2. Protocol Executor3. Protocol State Manager

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Retrieve Protocol for Execution

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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.

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Newborn ScreeningNewborn Screening

White PaperWhite Paper

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Newborn Screening• PurposePurpose

– 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

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Newborn Screening• Target AudienceTarget 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

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QRPH - TestingQRPH - Testing

Test Tooling SupportTest Tooling Support

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Profile Conformance TestingProfile 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 testing infrastructure that supports effective industry consensus standards development processes and provides the U.S. healthcare IT industry and federal activities with robust conformance and interoperability testing capabilities

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Profile Conformance TestingProfile Conformance Testing

IHE and NIST are collaborating to test vendor implementations as defined across the IHE-QRPH profiles.

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Profile Conformance TestingProfile Conformance Testing

Tooling is being developed to: Increase test comprehensiveness and qualitySupport both conformance and interoperability

testingEstablish a framework for IHE-QRPH covering

increasing complexity and technologies over the next five years

Support for virtual connectathons, actual connectathons and to enable year round testing

Remain in alignment with the IHE-QRPH road- map

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QRPH & Meaningful UseQRPH & Meaningful Use

US Meaningful Use of An EHRUS Meaningful Use of An EHR

– Improve quality, safety, efficiency, and reduce health disparities

– Improve population and public health

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QRPH - ShowcaseQRPH - Showcase

HIMSS ShowcaseHIMSS Showcase

Where we get to show off !!Where we get to show off !!

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Why use IHE QRPH profiles?Why use IHE QRPH profiles?

• Many Stories – One Big Showcase

• Cultivating Innovation

• Borderless Scenarios

HIMSS ShowcaseHIMSS Showcase

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HIMSS ’09 IHE Showcase SponsorsHIMSS ’09 IHE Showcase Sponsors

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Why use IHE QRPH profiles?Why use IHE QRPH profiles?

• 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)

QRPH profiles will enable…QRPH profiles will enable…

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2009 Important Dates2009 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)

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For Further InformationFor Further Information

• Web: Web: www.ihe.net/Technical_Framework/index.cfm#qualitywww.ihe.net/Technical_Framework/index.cfm#quality

• Wiki: Wiki: wiki.ihe.net/index.php?title=Qualitywiki.ihe.net/index.php?title=Quality%2C_Research_and_Public_Health%2C_Research_and_Public_Health

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