Integrating the Healthcare Enterprise International

1. Integrating the Healthcare EnterpriseInternational Webinar Series 2013

2. Cardiology Domain Update Tom Dolan, Philips Healthcare Chris Melo, Philips Healthcare Harry Solomon, GE

3. Cardiology Domain Update Agenda Domain & Committee Overview Domain Profiles & Technical Frameworks New and existing profiles highlights for 2014 connectathon Profiles in development Overview of other Profiles developed How to Participate? IHE International Membership Planning & Technical Committees Q&A Session

4. Cardiology Domain Overview Scope: interoperability in the in-patient and ambulatory cardiology practice Sponsors: American College of Cardiology, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society Established 2003 Close working relationship with other IHE domains Radiology Patient Care Coordination IT Infrastructure Patient Care Devices Quality, Research and Public Health

5. Cardiology Domain – Key Trends Co-ordination across transitions of care Consistent use of HL7 Clinical Document Architecture across all clinical domains Registries and quality-improvement programs Profiling of standard data elements for both clinical and secondary use Proliferation of Electronic Health Record Systems in both the in-patient and ambulatory environments Need better bi-directional integration with imaging

6. Cardiology Domain - Current Focus Discrete data capture and codification profiles leveraging clinical guidelines and C-CDA: 2013/14 Registry Submission Content (RSC) 2012 Cath Report Content (CRC) 2011 Cardiac Imaging Report Content (CIRC) 2013/14 Electrophysiology Report Content (EPRC) Align cardiology workflow with best practice in general imaging: Cath/Echo/Nuclear-Medicine/ECG specializations to existing imaging workflow and evidence gathering profiles. Displayable Reports (DRPT) Image Enabled Office (IEO)

7. Profiles highlighted for 2014 connectathon

8. Image-Enabled Office Bi-directional integration of medical imaging equipment and office EHR Not limited to cardiology – applies to orthopedics, women’s health, gastroenterology, even primary care Ambulatory office EHRs, mini-PACS (or cloud PACS), imaging modalities Supports the 2014 Meaningful Use criteria for EHR with imaging TRIAL Profiles & Technical Frameworks Workflow in the ambulatory environment

9. Image-Enabled Office (IEO) Workflow

10. TRIAL Image-Enabled Office Leverages in-patient workflow concepts to minimize impact on imaging devices, but adapted to use with office EHR (EHR-S) EHR – PACS image display integration using Web technologies Integrated EHR-System is an optional integration of an EHR with the image “order filler” (scheduling and management) function Can be implemented with 3rd party software components without having to expose internal order transactions Agnostic to EHR and PACS deployment technology (on-site, hosted, SaaS, cloud, etc.)

11. TRIAL Profiles & Technical Frameworks Cath Procedure Reporting • “Cath Report Content” profile defines anHL7 CDA structured report (XML) to facilitate consistency, accuracy, and semantic interoperability of Diagnostic Cath, Angiography, and PCI procedure reports and findings • Based on “ACC/AHA 2008 Cardiac Catheterization Report Prototype” and “ACC-NCDR CathPCI Registry v4.4 Coder’s Data Dictionary” • Affected systems include: Cardiovascular Information Systems, EHR systems, cardiac cath lab analysis and reporting workstations • Aligned with HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation, Release 1.1 DSTU • Related links: • http://wiki.ihe.net/index.php?title=Cath_Report_Content • http://www.ihe.net/Technical_Framework/upload/IHE_CARD_Suppl_CRC.pdf • http://www.ihe.net/Technical_Framework/index.cfm#cardiology <ClinicalDocument xmlns=“urn:hl7-org:v3”> <typeId extension=”POCD_HD000040” root=”2.16.840.1.113883.1.3”/> <templateId root=“1.3.6.1.4.1.19376.1.4.1.1.2”/> <id root=“” extension=“”/> <code code=“18745-0” displayName=“Cardiac catheterization study report” codeSystem=“2.16.840.1.113883.6.1” codeSystemName=“LOINC”/> <title>Cardiac Catheterization Report</title> <effectiveTime value=“201207231245”/> <confidentialityCode code=“N” displayName=“Normal” codeSystem=“2.16.840.1.113883.5.25” codeSystemName=“Confidentiality”/> <componentOf> <encompassingEncounter> <id extension=“IHE-CardtemplateId” root=“1.3.6.1.4.1.19376.1.4.1.3.1”/> <effectiveTime value=”20120723”/> <code code=“1234097013” codeSystem=“2.16.840.1.113883.6.96” codeSystemName="SNOMED CT" displayName="Diagnostic Coronary Angiography“>

12. TRIAL Cath Report Content (CRC) • Based on >100 discrete cath & PCI procedure data elements, fully modeled using non-proprietary SNOMED, LOINC, and DICOM terminologies • Is not a direct specialization of any existing HL7 CDA document template ID. However, some parts were based on: • IHE Cardiology CIRC content profile • HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation, Release 1.1 DSTU -July 2012 (C-CDA) Procedure Note. • Allows structured representation of lesions, coronary anatomy and devices • Supports data import into longitudinal patient tracking databases • First step to wider secondary use of report data (outcomes research, quality metrics and quality improvement) • Leverages HL7 CDA capability for both human readable narrative and robust XML-encoded data elements.

13. HL7 CDA and C-CDA CDA is the schema for those documents The HL7 Clinical Document Architecture (CDA) is a document markup standard that specifies the structure and semantics of “clinical documents” for the purpose of exchange. HL7 Clinical Document Architecture Release 2 is a HL7 V3 normative standard. C-CDA defines a set of CDA documents The HL7 Consolidated CDA is an Implementation Guide which specifies a library of templates and details their use for a set of specific clinical document types. HL7 C-CDA Release 1.1 is an HL7 DSTU.

14. HL7 Consolidated CDA (C-CDA) HL7 Implementation Guides for CDA Release 2: IHE Health Story Consolidation, DTSU Release 1.1 – US Realm It contains a library of CDA templates incorporating and harmonizing previous efforts from HL7, IHE, and HITSP Consolidates previous document templates into a single library and resolves conflicts and ambiguities. It includes 9 CDA document types Continuity of Care Document (CCD) / HITSP C32 History and Physical Note Discharge Summary Consultation Note Diagnostic Imaging Report Procedure Note Operative Note Progress Note Unstructured Document (non-XML body) It includes all required CDA templates in the Final Rules for Meaningful Use Stage 1 and can support Meaningful Use Stage 2 requirements.

15. Cath Report Content (CRC) General – context, use cases, and actors Header elements Section content modules Entry content modules Vocabulary constraints and value sets

16. CRC- Context Clinical Reports for cardiology procedures recorded in a Cardiac Catheterization Laboratory, including: Diagnostic Catheterization Angiography PCI Does not include imaging studies, EP procedures, and non-cardiology procedures (e.g. peripheral angiography). It is assumed that there is a DICOM Study associated with the exam. If there is not a DICOM Study, this report content may not be appropriate. There are no constraints on the narrative text and figures that the cardiologist could include in the report document, although there are requirements on minimum data elements reflecting expert consensus (ACC-NCDR Cath PCI data elements).

17. Cath Report - Summary Narrative form of the summary information including the major highlights from each section: • Patient demographics • History and Physical • Procedures and Interventions • Findings and Results • Equipment • Complications • Notes • Key images and graphics

18. Cath Report – Pre-procedure Documents the key elements from the information gathered prior to the cath procedure being performed, including: • Patient demographics • Medical, family, and social history • Allergies • Known problems and symptoms • Current medications • Physical exam and vital signs • Prior procedures and interventions • Pre-procedure results

19. Cath Report - Procedure Documents the key elements from the information gathered during the cath procedure including: • Procedures performed • Equipment used • Medications administered • Anatomical locations addressed • Specimens obtained • Complications

20. Cath Report – Results and Interpretations Documents the key results, including measurements, findings, and observations, for the cath procedure performed, including: • Anatomical measurements • Cardiac functional measurements • Device related measurements • Diagnoses • Additional notes

21. CRC– Use Cases Compile and Transfer Report of Cardiac Cath Lab Procedure with Use of ACC-NCDR Cath/PCI Data Elements This use case addresses the generation and transfer of a cardiac cath lab report based on the NCDR CathPCI Registry v4.4 Coder’s Data Dictionary data elements. Perform Discrete Data-analysis on Procedure Report Content The goal of this use case is to assist data collection for comparative and research purposes. Based on a report generated in the previous use case an advanced medical data analysis system collects discrete data from multiple patients and their procedure, e.g., for cardiac Clinical Decision Support or for advanced lifetime patient records. Review Procedure Report This is a secondary use-case addressed by this profile involves the direct human use of the procedure report. In most practical cases this will be: The referring physician who instigated/ordered the procedure, and other healthcare providers who manage subsequent patient care activities. Another person involved in downstream clinical or administrative data processing e.g., someone validating/source-checking for QA the original report as part of JCAHO audits, or pre-submission checking on the original reporting data against the case-data imported in the ACC-NCDR Cath/PCI registry-submission application.

22. CRC– Actors and Options Actors: Content Creator and Content Consumer Content Creator Create a CRC document populating the required header elements, sections, and entry content modules Group with a Time Client actor to synchronize its clock Content Consumer Receive and process a CRC document, parsing the relevant header elements, sections, and entries Implement the View option, the Discrete Data Import option, or both If implements the Document Import or Section Import options, must also implement the View option Options:

23. CRC – Relationship with other Profiles Other Content Profiles Cardiac Imaging Report Content (CIRC) Profile – in Trial Implementation Electrophysiology Report Content (EPRC) Profile – currently under development Registry SubmissionContent (RSC) Profile – Cath/PCI - currently under development Actor Required Grouping Consistent Time (CT) – for Legal Authentication timestamp to be accurate Cross Profile Considerations – grouping of Content Creator/Content Consumer with actors of workflow profiles that manage interchange of clinical data Displayable Reports (DRPT) - to exchange the CRC content between Report Creator and Report Manager Cross-enterprise Document Sharing (XDS), Cross-enterprise Document Media Interchange (XDM), Cross-enterprise Reliable Interchange (XDR), Cross-enterprise Document Sharing for Imaging (XDS-I), and Cross-enterprise Reliable Document Interchange for Imaging (XDR-I) - to exchange the CRC content Cross Enterprise Portable Data for Imaging (PDI) - to exchange the CRC content via removable media. Retrieve Form for Data Capture (RFD) - to use the CRC content for pre-population of data entry Document Digital Signature (DSG) – to allow digital signing of the CRC content

24. CRC – Relationship to C-CDA CRC is realm agnostic – so it can be specialized for deployments Deviates from C-CDA (US Realm) by not specifying format of addresses, telcoms, names, NPI Utilizes documentation style of C-CDA for defining constraints Where constraints defined in C-CDA were not modified, the constraint remains as the C-CDA constraint identifier (e.g., CONF:5361). If only the value set was modified, then the constraint is considered unchanged. Where constraints defined in C-CDA were modified, the original constraint ID is also modified by appending “-CRC” (e.g., CONF:5253-CRC). Modifications could include changes in the cardinality. Where new constraints were introduced, a new constraint identifier was defined (e.g., CONF:CRC-xxx) Use of C-CDA Sections and Entries If there are no new or modified constraints for a section or entry or if only the value sets are constrained, then the definition of the section or entry is considered unchanged from the C-CDA definition and the C-CDA template IDwill be used. These unchanged sections/entries are referenced directly from the C-CDA specification and are not included in this specification. If there are new or modified constraints for a section or entry, then that section or entry is assigned a new IHE Card specific template ID.

25. CRC – Header Elements code - is selected from a value set specific for Cath lab reporting. recordTarget – identifies the patient whose health information is described in this clinical document for the procedure. author – represents the creator(s) of the clinical document content. custodian – represents the organization that is in charge of maintaining the clinical document. legalAuthenticator – identifies the single person legally responsible for the document. This profile does not support the exchange of preliminary unapproved procedure reports. authenticator – identifies participants that attest to the accuracy of the information in the clinical document. There may be one for each cath procedure performed (e.g. diagnostic cath and PCI). inFulfillmentOf – represents orders that are fulfilled by this clinical document. For CRC, the order/id is the Accession Number used in the DICOM imaging data. authorization – contains information about patient consents for the procedure(s) and for the anesthesia. componentOf – contains information about the encompassing encounter for the clinical procedures documented in this report. This includes the clinical setting (location and organization). It also allows for the referring provider(s), an attending physician and a responsible physician to be identified. documentationOf/serviceEvent – represents the main cath procedure that is being documented. This also documents the primary performer (potentially one for the diagnostic cath and one for the PCI) and any assistants involved in the procedures.

26. CRC – Section Content Modules (21 total) Unchanged sections (14) Allergies Family History Social History Physical Exam Vital Signs Planned Procedure Procedure Indications Anesthesia Medications Administered Procedure Specimens Taken Procedure Disposition Complications Postprocedure Diagnosis DICOM Object Catalog New sections (2) Document Summary Includes a summary of most significant aspects of the procedures in a narrative form. It is a condensed form of the full narrative report whose structure has no constraint. Key Images – Cardiac Contains narrative description of and references to DICOM Image Information Objects that illustrate the findings of the procedure reported. Specialized sections (5) Medical History – Cardiac Adds support for coded problem observation and procedures. Pre-Procedure Results – Cardiac Adds support for results in external documents. Procedure Description – Cardiac Adds support for device specific observations and identification of lesions. Procedure Results – Cardiac Adds support for lesions. Plan of Care – Cardiac Includes specialized Plan of Care Activity Act with elements.

27. CRC – Entry Content Modules Unchanged entry content modules (~35) New entry content modules (3) Lesion Observation – identifies a lesion of interest, identified by a global ID and one or more target sites Procedure Device Organizer – Cardiac – contains a set of observations related to a device used during a procedure Device Observation – represents observations made of devices used during a procedure Specialized entry content modules (6) Problem Observation – Cardiac Extends the Problem Observation Entry with an entryRelationship for a Severity Observation Result Organizer – Cardiac Extends to support references to external documents for results Result Observation – Cardiac Extends to support an entryRelationship to a Severity Observation Plan of Care Activity Act – Cardiac Extends to support code, statusCode, and effectiveTimeelements Procedure Results Organizer – Cardiac Extends to include entryRelationship to a Lesion Observation Procedure Activity Procedure – Cardiac Extends to support entryRelationship to a Procedure Device Organizer and a Lesion Observation

28. CRC – Vocabulary Constraints Result observation constraints – defines complete sets of elements for observations, including codes and allowed values Value sets provided for Cath specific concept domains Cardiac Problems/Concerns Body Site Cardiovascular Family History Contrast Agents Classes for Adverse Reactions Cardiac Lab Results Vital Sign Results Procedure Indications Contrast Agents • Cardiac Activity Procedures • Drug Classes and Specific Cardiac Drugs • Rx Recommendations • Procedure Findings Types • Postprocedure Diagnoses • Supported File Types • Complications

29. TRIAL Intravascular Imaging New Supplement in 2013 – target for Japan connectathon Intravascular Imaging Option to CATH Workflow Addresses use case to workflow to change a modality during the procedure Requires support for Intravascular Optical Coherence Tomography (OCT) SOP classes Option for Image Manager/Archive and Image Display Actors Image Manager/Archive actors must store the following SOP Classes Intravascular Optical Coherence Tomography Image Storage – For Presentation Intravascular Optical Coherence Tomography Image Storage – For Processing Image Displays have to provide the functionality to display Intravascular Optical Coherence Tomography Image Storage – For Presentation objects http://www.ihe.net/Technical_Framework/upload/IHE_CARD_Suppl_IVI_Option_for_Cath_Workflow.pdf

30. Current work in progress

31. TRIAL Electrophysiology Report Content (EPRC) New Supplement target for 2015 connectathon This proposal is targeted at the completion of the original 2011-2012 proposal for a cardiac electrophysiology report content profile. Leverages the Cardiac EP Key Data Elements white paper published in 2011: http://www.ihe.net/Technical_Framework/upload/IHE_CARD_WP_Cardiac_EP_Key_Data_Elements_Rev1-0_PC_2011-08-05.pdf A CDA implementation guide for an EP procedure report will bring the benefits of structured reports to the EP lab. This is a critical first step to a profile that uses the EP procedure clinical report as pre-population data for submission to a registry. This new profile will leverage the existing CIRC and CRC content profiles.

32. TRIAL Registry Submission Content (RSC) New Supplement target for 2015 connectathon Develop a CDA implementation guide for data elements to be submitted to registries, including NCDR Cath/PCI registry. Leverages the C-CDA codification and structuring done in CRC profile, expanded to capture the additional information needed for NCDR Registry submission. Authoring of profile led by the ACC-NCDR organization. Aims to make the rich registry data collection needs from multiple clinical/administrative sources more efficient for Registry participants. Aligns data content for Registry collection with emerging best-practice in wider clinical data exploitation initiatives.

33. Technical Framework Overview

34. Profiles & Technical Frameworks • Overview • IHE Technical Frameworks • Final Text: Current version 5.0 • Trial Implementation: Supplements • http://www.ihe.net/Technical_Framework/index.cfm#cardiology • Brief descriptions of Profiles developed by Cardiology Domain • http://wiki.ihe.net/index.php?title=Profiles#IHE_Cardiology_Profiles FINAL TRIAL

35. Profilesaligned with IHE Radiology workflow Scheduled and unscheduled cardiac imaging exams, including multimodality Management of data, demographic and procedure identifiers Cardiovascular Information Systems, PACS, imaging and waveform modalities: X-ray and hemo (cath lab), Echo, Nuclear imaging analysis and reporting workstations Consistent, robust workflow minimizes manual procedure management tasks Cardiac Catheterization Workflow Echocardiography Workflow Stress (ECG + imaging)Workflow Evidence Documents (cardiology specialization) Displayable Reports Workflow Intravascular Imaging Option for Cardiac Catheterization Workflow Profiles & Technical Frameworks Workflow in the in-patient environment FINAL TRIAL

36. Image-Enabled Office Bi-directional integration of medical imaging equipment and office EHR Not limited to cardiology – applies to orthopedics, women’s health, gastroenterology, even primary care Ambulatory office EHRs, mini-PACS (or cloud PACS), imaging modalities Supports the 2014 USA Meaningful Use criteria for EHR with imaging TRIAL Profiles & Technical Frameworks Workflow in the ambulatory environment

37. TRIAL Profiles & Technical Frameworks Reporting Report Content • Cardiac Imaging Report Content (CIRC) • CDA structured report (XML) to facilitate consistency, accuracy, and semantic interoperability of imaging findings • Based on ACC/AHA 2008 Key Data Elements for Cardiac Imaging • Cath Report Content (CRC) • CDA structured report (XML) to facilitate consistency, accuracy, and semantic interoperability of cardiac cath and PCI procedure reports and findings • Based on ACC/AHA 2008 Cardiac Catheterization Report Prototype and ACC-NCDR CathPCI Registry v4.4 Coder’s Data Dictionary Displayable Report Workflow (DRPT) Cardiology reports typically include lots of graphics Addresses workflow between a reporting application and the departmental info system and/or the EMR Possible report archiving to PACS Report format may be PDF or HL7 CDA Applicable to other clinical domains!

38. Retrieve ECG for Display Access to ECGs from everywhere in the hospital Resting ECGs, HolterECGs ECG Management Systems, EMRs, workstations Simplified and standardized Web-based access to ECGs; No need for ‘printed ECGs’ Resting ECG Workflow Multi-system workflow for the most common cardiology exam Scheduled/unscheduled, post-exam reconciliation Cardiovascular Information Systems, ECG Management Systems, ECG devices and workstations, PACS and imaging workstations, EMRs Components and workflow shared with imaging Profiles & Technical Frameworks ECG Workflow FINAL TRIAL

39. Patient Care Coordination Medical Summary ED Referral IT Infrastructure XDS, ATNA, Consistent Time PIX, PDQ, PAM Retrieve Form for Data Capture Profiles & Technical Frameworks Cardiology Relevant Profiles in Other Domains Radiology Scheduled Workflow (CT/MR/NM) Nuclear Medicine Image (cardiac) Evidence Documents, Key Image Note Portable Data for Imaging, XDS-I, Import Reconciliation Patient Care Devices Implantable Device - Cardiac - Observations Device Enterprise Communication Waveform Content Message

40. Domain organization

41. IHE Cardiology Planning Committee Contact Information Secretary Paul Dow pdow@acc.org Co-Chair Alan Katz, MD alan.katz@chsli.org Co-Chair David Slotwiner, MD dslotwin@nshs.edu Committee’s wiki page http://wiki.ihe.net/index.php?title=Cardiology_Planning_Committee • Responsibilities • Identifying priority issues for the cardiology community • Liaison to sponsor organizations • Soliciting and developing IHE Profile Proposals • Now soliciting proposals! • Evaluation of Technical Committee work • Marketing IHE Cardiology profiles to user community

42. IHE Cardiology Technical Committee Contact Information Secretary Paul Dow pdow@acc.org Co-Chair Tom Dolan tom.dolan@philips.com Co-Chair Antje Schroeder aschroeder@siemens.com Committee’s wiki page http://wiki.ihe.net/index.php?title=Cardiology_Technical_Committee • Responsibilities • Development of IHE Profiles and white papers • Maintenance of IHE Cardiology Technical Frameworks • Liaison with other IHE domains • Support for Planning Committee marketing

43. How to Participate in IHE Cardiology? IHE International Membership is Free. Apply for IHE International Organizational Membership Visit: www.ihe.net/apply Approved monthly by IHE International Board Review IHE's 400+ Organizational Members Participate in IHE Domains & Committees IHE Organizational Members only 12 Clinical and Operational Domains Each Domain has one planning and one technical committee Non-members participate in comment periods and implement IHE Technical Frameworks

44. How to Participate in IHE Cardiology? • IHE’s Profile Development Cycle Committee work typically follows the IHE Profile Cycle Annual cycle ~18 months from profile proposal to Connectathon Each IHE domain has its own independent schedule Opportunities for IHE members and non-members to participate in cycle

45. IHE Profiles Drafted & Revised Test at IHE Connectathons • Publish in IHE’s Product Registry • Trial • Implementation • Posted Published For Public Comment months 12-18 Demonstrateat a or ACC / HRS / ESC … IHE Technical Framework Supplement Developed months 5-11 Profile Selection by Committees Install Interoperable products in Clinical Settings worldwide IHE Improves, Safety, Quality and Efficiency inClinical Settings IHE Call for Proposals Opens months 1-4

46. Thank you for your attention Questions?

47. Backup

48. Learn More about IHE International • Important Links and Information Sign up for the IHE International News Email secretary@ihe.net Apply for IHE International’s Free Membership Visit: www.ihe.net/apply