EU-US eHealth/Health IT Cooperation Initiative Interoperability of EHR Work Group January 29,

Meeting Etiquette Participants automatically enter the webinar in “listen only” mode. The organizer will then unmute all participants. We ask if you are not speaking to manually mute yourself NOTE: VoIP participants have the ability to “Mute” themselves by clicking on the green microphone. However, if you would like to speak, only you can unmute yourself. If you are dialing in using a telephone and NOT using the VoIP you MUST dial the audio pin in order for the organizer to unmute you – if you do not use the audio pin and just push # when prompted the Organizer cannot unmute you

Meeting Etiquette CONTINUED If you are calling from a telephone, please do not put your phone on hold. If you need to take a call, hang up and dial in again when you have completed your other call This meeting is being recorded Another reason to keep your phone or your VoIP on mute when not speaking Use the “Chat” or “Question” feature for questions, comments and items you would like the moderator or other panelists to know. 2

Agenda TopicTime Allotted General Announcements5 minutes Recap: Mapping Sub-Work Group10 minutes Presentation: Gerard Freriks (Netherlands)25 minutes C-CDA CCD to epSoS PS Mapping Update10 minutes HL7 WGM Update5 minutes Next Steps/Questions5 minutes 3

Meeting Times 4 Washington, DC 10:00am (ET) Washington, DC 10:00am (ET) London 3:00pm/15:00 (GMT) London 3:00pm/15:00 (GMT) Germany 4:00pm/16:00 (CET) Germany 4:00pm/16:00 (CET) Athens 5:00pm/ 17:00 (EET) Athens 5:00pm/ 17:00 (EET) Interoperability of EHR Work Group meets every Wednesday

General Announcements To join our weekly webinars, visit the EU-US eHealth Collaboration Wiki Homepage for the latest meeting information: To subscribe to our mailing list, simply complete the EU-US MOU Project Signup Form: US+MOU+Roadmap+Project+Sign+Uphttp://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Sign+Up To submit a brief biography of yourself (150 words or less), review the criteria listed at #Work Group Members and your bio and photo (optional) to Gayathri Jayawardena at #Work Group To access current and archived meeting materials, visit the Project Meeting Artifacts section: ts ts

Mapping Sub-Work Group Purpose Mapping Sub-Work Group was launched yesterday (Tuesday, January 28) and will continue for 8 consecutive weeks This work group will continue our current epSOS-CCDA mapping efforts for the EU-US Interoperability Informative Guide 6

7 Washington, DC 9:00am (ET) Washington, DC 9:00am (ET) London 2:00pm/14:00 (GMT) London 2:00pm/14:00 (GMT) Germany 3:00pm/15:00 (CET) Germany 3:00pm/15:00 (CET) Athens 4:00pm/ 16:00 (EET) Athens 4:00pm/ 16:00 (EET) Mapping Sub-Work Group Meeting Time Every Tuesday for 8 Consecutive Weeks (Next meeting: February 4, 2014)

Mapping Sub-Work Group Artifacts 8 To access archived meeting materials (e.g. presentation and video), visit the Project Meeting Artifacts section: Please review the epSOS/C-CDA Header Data Element Spreadsheet and submit comments through the online comment form located here: dG1mczY3dXN4WEl5eEpYVE5fV0pFWUE&usp=drive_web#gid=11 dG1mczY3dXN4WEl5eEpYVE5fV0pFWUE&usp=drive_web#gid=11

CEN/ISO EHR-Communication Gerard Freriks EU-USA

© CEN/ISO Association Developments –ISO standard since –20 year developments in EU projects, Good European/Electronic Health Record –ISO Renewal process is underway –Designed using ISO Requirements for an EHR System Architecture –2 precursor trial standards –Harmonised with ContSys, HISA 10

© CEN/ISO Association History –CDA is subset –CIMI RM is subset –Selected by EU as one of the Base Standards in Europe –Used by: England, Sweden, Spain, Andalusia, Ireland Kind of used by: CIMI, Australia, Slovenia, Slowakia, Australia, 11

© CEN/ISO Association CEN/ISO Scope: EHR-Communication –This part of ISO specifies the communication of part or all of the electronic health record (EHR) of a single identified subject of care between EHR systems, or between EHR systems and a centralized EHR data repository. –This part of the multipart series, ISO13606, is an information viewpoint specification as defined in ISO/IEC [13]. This part of ISO is not intended to specify the internal architecture or database design of EHR systems. 12

© CEN/ISO Association CEN/ISO New Scope: –From EHR-Communication to –Information Viewpoint for Interfaces 13

© CEN/ISO Association CEN/ISO part standard: –Part 1: Reference Model –Part 2: Archetype interchange specification (Archetype Object Model) –Part 3: Reference archetypes and Term Lists –(Part 4: Patient Mandate (PMAC)) –Part 5: Interface specification 14

© CEN/ISO Association CEN/ISO Paradigms –Message paradigm: Implementation guide, IHE profile and testing is necessary –Two Level Model Paradigm (Reference Model, AOM -> Archetypes Supports model driven approach No need for Implementation guide and no need for IHE Profile and testing 15

© CEN/ISO Association CEN/ISO Reference Model –Represents the global characteristics of health record components, –how they are aggregated, and the context information required to meet ethical, legal and provenance requirements. –This model defines the set of classes that form the generic building blocks of the EHR. –It reflects the stable characteristics of an electronic health record, –and would be embedded in a distributed (federated) EHR environment as specific messages or interfaces (as specified in Part 5). 16

© CEN/ISO Association 17 CEN/ISO 13606

© CEN/ISO Association 18 CEN/ISO 13606

© CEN/ISO Association 19 CEN/ISO 13606

© CEN/ISO Association 20 CEN/ISO 13606

© CEN/ISO Association CEN/ISO Archetype –the formal definition of prescribed combinations of the building-block classes defined in the Reference Model for particular clinical domains or organizations. –An archetype is a formal expression of a distinct, domain-level concept, expressed in the form of constraints on data whose instances conform to the reference model. –For an EHR_Extract, as defined in this part of ISO 13606, an archetype instance specifies (and effectively constrains) a particular hierarchy of RECORD_COMPONENT sub-classes, defining or constraining their names and other relevant attribute values, optionality and multiplicity at any point in the hierarchy, the data types and value ranges that ELEMENT data values may take, and other constraints.

© CEN/ISO Association Archetype Editor epSOS PS Template 22

© CEN/ISO Association Archetype Editor epSOS PS Template 23

© CEN/ISO Association 24

© CEN/ISO Association 25

© CEN/ISO Association 26

© CEN/ISO Association Archetype Editor Characteristics Reference Model independent (incl CDA) Output formats: Various Tree views HTML Mock-up screen MindMap HTML table view Excel Schematron Generated XML data instantiations Can be integrated with Terminology server Mapping: Creation of mappings from and to other (proprietary) formats Execution of those mappings Integration with Artefact library manager 27

Phases of Harmonization 28 (Clinical Summary Form) (Clinical Summary Form) (document ID, author, patient ID…) (document ID, author, patient ID…) [Body] [Procedures] (Colonoscopy) [Gastroscopy] [CABG] … (Colonoscopy) [Gastroscopy] [CABG] … [Current Medications] … [ASA] [Warfarin] [CABG] [ASA] [Warfarin] [CABG] Phase 1 Section level mapping between epSOS and CCD Phase 2 Header’ Data Element mapping Phase 3 Sections’ Data Element mapping Phase 4 Value Set mapping Completed Remaining Data Granularity and Complexity

Mapping Review/Validation: Resources and Process All harmonization/mapping work is done on Google spreadsheet: – Link: dG1mczY3dXN4WEl5eEpYVE5fV0pFWUE&usp=drive_web#gid=11https://docs.google.com/spreadsheet/ccc?key=0AiAfdYPeAnM- dG1mczY3dXN4WEl5eEpYVE5fV0pFWUE&usp=drive_web#gid=11 – Access: anyone with link – Privileges: “View and Comment” – everyone with link (the one above) “Edit” – selected – EU: one designated XML/epSoS PS subject matter expert – US: Mark Roche (for now) » Above may be reviewed/updated as project continues Review Process: – Review/validate mapping outcomes after each phase with community – Review points: Mapping completeness Mapping accuracy Mapping gaps 29

Mapping Sub-Workgroup 30 Goal: The mapping SWG will continue our current epSOS-CCDA mapping efforts for the EU-US Interoperability Informative Guide Kick-off meeting took place on January 28 th Overview of Meeting: Reviewed Section Level Mapping Introduced Data Element Header Mapping Homework: Review Header Data Element Mapping Note: Header Mapping will be posted to the google doc by COB Friday 1/31 Next meeting: February 4 th, 2014 Meeting Time: Tuesdays 9 AM – 10 AM EST / 2 PM – 3 PM GMT (UTC) Note: As mapping sections are completed, they will be presented to the full workgroup for review and comment

Homework: Review Phase 2, Header’ Data Element Mapping 1.Are template names and OIDs correct? 2.Are all Header Data Elements (DE) listed? 3.Are DE names correct? 4.Are X-Path Statements correct? 5.Are requirements (R,R2,O) correct? 6.Are Data Types correct? 6.Is mapping complete (within header)? 7.Is mapping accurate (correct)? 8.Are there mapping gaps (Exists in epSoS PS but not in C- CDA CCD and vice versa)? 9.Is mapping clear and unambiguous? 10.What is missing? 31

Homework: Review Phase 2, Header’ Data Element Mapping Review google doc Demonstrate how to comment 32

Updates from HL7 33 EU PSS: Presented to Structured Documents WG and US Realm Task Force Balloting: Balloting timelines are currently being updated; confirming standards strategy with leadership SDO’s to consider engaging: HL7, ISO, JIC, CEN Deliverables: Mapping IG (Transformation guide) Renamed to “Informative Guide: Analysis for Harmonized EU US Patient Summary Exchange” Comparative analysis between C-CDA CCD and epSOS Value Set Mapping Longer term objective: Harmonized template for Patient Summary Trillium Bridge Alignment: Continue collaboration with Trillium Bridge

Preparing for Next Meeting 34 Next meeting will be on Wednesday, February 5, 2014 at 10:00 am (ET)/5:00 pm (EET) Please attend the next Mapping Sub-Work Group on Tuesday, February 4, 2014.

Interoperability of EHR Project Support Team 35 US Point of Contacts – Mera Choi, – Jamie Parker, – Gayathri Jayawardena, – Amanda Merrill, – Mark Roche, – Virginia Riehl, EU Point of Contacts – Benoit Abeloos, – Frank Cunningham, – Catherine Chronaki,

Questions 36

Initiative Resources EU-US Wiki Homepage – US+eHealth+Cooperation+Initiative US+eHealth+Cooperation+Initiative Join the Initiative – US+MOU+Roadmap+Project+Sign+Up US+MOU+Roadmap+Project+Sign+Up EU-US Initiative Reference Materials – US+MOU+Roadmap+Project+Reference+Materials US+MOU+Roadmap+Project+Reference+Materials Interoperability of EHR Homepage – oup oup 37