1. EU-US eHealth/Health IT Cooperation Initiative Interoperability of EHR Work Group January 29, 2014 0

2. 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

3. 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

4. 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

5. 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

6. General Announcements To join our weekly webinars, visit the EU-US eHealth Collaboration Wiki Homepage for the latest meeting information: http://wiki.siframework.org/EU-US+eHealth+Cooperation+Initiative http://wiki.siframework.org/EU-US+eHealth+Cooperation+Initiative 5 To subscribe to our mailing list, simply complete the EU-US MOU Project Signup Form: http://wiki.siframework.org/EU- 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 http://wiki.siframework.org/Interoperability+of+EHR+Work+Group #Work Group Members and e-mail your bio and photo (optional) to Gayathri Jayawardena at gayathri.jayawardena@esacinc.com http://wiki.siframework.org/Interoperability+of+EHR+Work+Group #Work Group Membersgayathri.jayawardena@esacinc.com To access current and archived meeting materials, visit the Project Meeting Artifacts section: http://wiki.siframework.org/Project+Meeting+Artifac ts http://wiki.siframework.org/Project+Meeting+Artifac ts

7. 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

8. 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)

9. Mapping Sub-Work Group Artifacts 8 To access archived meeting materials (e.g. presentation and video), visit the Project Meeting Artifacts section: http://wiki.siframework.org/Project+Meeting+Artifacts http://wiki.siframework.org/Project+Meeting+Artifacts Please review the epSOS/C-CDA Header Data Element Spreadsheet and submit comments through the online comment form located here: https://docs.google.com/spreadsheet/ccc?key=0AiAfdYPeAnM- dG1mczY3dXN4WEl5eEpYVE5fV0pFWUE&usp=drive_web#gid=11 https://docs.google.com/spreadsheet/ccc?key=0AiAfdYPeAnM- dG1mczY3dXN4WEl5eEpYVE5fV0pFWUE&usp=drive_web#gid=11

10. CEN/ISO 13606 EHR-Communication Gerard Freriks 25-01-2014 EU-USA

11. © CEN/ISO 13606 Association 13606 Developments –ISO standard since 2008 - 2010 –20 year developments in EU projects, Good European/Electronic Health Record –ISO Renewal process is underway –Designed using ISO 18308 Requirements for an EHR System Architecture –2 precursor trial standards –Harmonised with ContSys, HISA 10

12. © CEN/ISO 13606 Association 13606 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

13. © CEN/ISO 13606 Association CEN/ISO 13606 Scope: EHR-Communication –This part of ISO 13606 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 10746-1[13]. This part of ISO 13606 is not intended to specify the internal architecture or database design of EHR systems. 12

14. © CEN/ISO 13606 Association CEN/ISO 13606 New Scope: –From EHR-Communication to –Information Viewpoint for Interfaces 13

15. © CEN/ISO 13606 Association CEN/ISO 13606 13606 5 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

16. © CEN/ISO 13606 Association CEN/ISO 13606 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

17. © CEN/ISO 13606 Association CEN/ISO 13606 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

18. © CEN/ISO 13606 Association 17 CEN/ISO 13606

19. © CEN/ISO 13606 Association 18 CEN/ISO 13606

20. © CEN/ISO 13606 Association 19 CEN/ISO 13606

21. © CEN/ISO 13606 Association 20 CEN/ISO 13606

22. © CEN/ISO 13606 Association CEN/ISO 13606 21 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.

23. © CEN/ISO 13606 Association Archetype Editor epSOS PS Template 22

24. © CEN/ISO 13606 Association Archetype Editor epSOS PS Template 23

25. © CEN/ISO 13606 Association 24

26. © CEN/ISO 13606 Association 25

27. © CEN/ISO 13606 Association 26

28. © CEN/ISO 13606 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

29. 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

30. Mapping Review/Validation: Resources and Process All harmonization/mapping work is done on Google spreadsheet: – Link: https://docs.google.com/spreadsheet/ccc?key=0AiAfdYPeAnM- 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

31. 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

32. 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

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

34. 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

35. 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.

36. Interoperability of EHR Project Support Team 35 US Point of Contacts – Mera Choi, Mera.Choi@hhs.govMera.Choi@hhs.gov – Jamie Parker, jamie.parker@esacinc.comjamie.parker@esacinc.com – Gayathri Jayawardena, gayathri.jayawardena@esacinc.comgayathri.jayawardena@esacinc.com – Amanda Merrill, amanda.merrill@accenturefederal.comamanda.merrill@accenturefederal.com – Mark Roche, mrochemd@gmail.commrochemd@gmail.com – Virginia Riehl, virginia.riehl@verizon.netvirginia.riehl@verizon.net EU Point of Contacts – Benoit Abeloos, Benoit.ABELOOS@ec.europa.eu Benoit.ABELOOS@ec.europa.eu – Frank Cunningham, frank.cunningham@ec.europa.eufrank.cunningham@ec.europa.eu – Catherine Chronaki, chronaki@gmail.comchronaki@gmail.com

37. Questions 36

38. Initiative Resources EU-US Wiki Homepage – http://wiki.siframework.org/EU- US+eHealth+Cooperation+Initiative http://wiki.siframework.org/EU- US+eHealth+Cooperation+Initiative Join the Initiative – http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Sign+Up http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Sign+Up EU-US Initiative Reference Materials – http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Reference+Materials http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Reference+Materials Interoperability of EHR Homepage – http://wiki.siframework.org/Interoperability+of+EHR+Work+Gr oup http://wiki.siframework.org/Interoperability+of+EHR+Work+Gr oup 37