1. EU-US eHealth/Health IT Cooperation Initiative Interoperability of EHR Work Group November 25, 2013 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 Finalize Pre and Post Conditions15 minutes Finalize Data Exchange Diagrams and Tables15 minutes Review Data Elements20 minute Next Steps/Questions5 minutes 3

5. Meeting Times – NOTE TIME CHANGE NEXT WEEK 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 NOTE: We will resume our normal meeting schedule Wednesday December 4th from 10:00am - 11:00am (ET)/3:00pm - 4:00pm (GMT)/4:00pm - 5:00pm (CET)/ 5:00pm - 6:00pm (EET).

6. General Announcements To participate in our weekly webinars, please visit the EU-US eHealth Collaboration Wiki Homepage: http://wiki.siframework.org/EU- US+eHealth+Cooperation+Initiative http://wiki.siframework.org/EU- US+eHealth+Cooperation+Initiative 5 Note: Please check the meeting schedule weekly to get the most up-to- date meeting information

7. Participating in the DAF IHE Standards Workgroup To join IHE as a member, visit: http://www.ihe.net/Join_IHE_Application/ http://www.ihe.net/Join_IHE_Application/ To join the DAF IHE/S&I Joint Work Group every Monday at 10:00 AM (EST) see the webinar details below: Meeting Number: 921 745 495 Meeting Password: meeting ------------------------------------------------------- To join this meeting ------------------------------------------------------- 1. Go to https://himss.webex.com/himss/j.php?J=921745495&PW=NYjU3ODhkOGM1https://himss.webex.com/himss/j.php?J=921745495&PW=NYjU3ODhkOGM1 2. Enter the meeting password: meeting 3. Click "Join Now". 4. Follow the instructions that appear on your screen to join the teleconference. ------------------------------------------------------- To only join the teleconference ------------------------------------------------------- To receive a call back, provide your phone number when you join the meeting, or call the number below and enter the access code. Call-in toll-free number (US/Canada): 1-866-469-3239 Call-in toll number (US/Canada): 1-650-429-3300 Access code:921 745 495 6

8. Join the EU-US eHealth/Health IT Cooperation Initiative 7 We encourage all members to “sign up” for the initiative. By joining, this ensures you stay up-to-date with the work being done, communications and any initiative activities Simply complete the EU-US MOU Project Signup Form on the Wiki Page: http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Sign+U p http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Sign+U p

9. Submit Your Bio Submitted biographies are now posted on the Wikipage http://wiki.siframework.org/Interoperability+of+EHR+W ork+Group#Work Group Members http://wiki.siframework.org/Interoperability+of+EHR+W ork+Group#Work Group Members 8

10. Archived Meeting Materials 9 Visit the “Materials” tab and select “Past Meetings” from the drop down menu to access all archived meeting materials http://wiki.siframework.org/Project+Meeting+Artifacts. http://wiki.siframework.org/Project+Meeting+Artifacts

11. Preparing for Meetings 10 Given our timeline and the amount of material to cover please ensure you are up-to-date with all of the activities of the interoperability work group – Visit the “Past Meetings” section of the wikipage for the latest interoperability meeting materials and recordings http://wiki.siframework.org/Project+Meeting+Artifacts. http://wiki.siframework.org/Project+Meeting+Artifacts – If you have questions, need help or want a quick update please feel free to reach out to any member of the support team – We will have little or no time to review what was covered the week prior in order to make our deadlines and deliverables FIRST MILESTONE: Completed Use Case by December 4th (with consensus completed by December 18th)

12. Use Case Development Timeline 11 DateInputsDiscussionOutputs 11/13/13 Updated scope based on comments Comments that need further discussion Finalize Scope Discuss Assumptions, Actors, and Roles Assumptions, Actors, and Roles to be posted for comments Data exchange diagrams and tables and pre and post conditions to be posted for comments 11/20/13 Updated Assumptions, Actors, and Roles based on comments Updated data exchange diagrams/tables and pre and post conditions Comments that need further discussion Review and update  Data exchange diagrams  Data exchange tables  Pre and Post Conditions Data exchange diagrams, data exchange tables, pre and post-conditions to be posted for comments 11/25/13 Updated data exchange diagrams, data exchange tables, pre and post-conditions based on comments Comments that need further discussion Draft data element tables Review and finalize  Data exchange diagrams  Data exchange tables  Pre and Post Conditions Begin review of draft data element tables Finalized  Data exchange diagrams  Data exchange tables  Pre and Post Conditions Draft data element tables to be posted for comments 12/04/13 Updated data element tables based on comments Comments that need further discussion Review and finalize data element tablesFinalized data element tables 12/11/13 Draft use case with all sections completed End to end review of draft use case Updated use case based on end to end comments and ready for consensus posting 12/18/13 Consensus comments mapped into the use case Review consensus comments and finalize use case Approved use case

13. Use Case Discussion Today’s discussion: – Pre and Post Conditions – Data Exchange diagrams and tables – Data Elements Goals for today: – Reach consensus pre and post conditions – Reach consensus on data exchange diagrams and tables – Begin review of data elements

14. Pre and Post Conditions: Patient Mediated Pre-conditions: – Patient PHR is able to create and send the patient summary – Provider EHR is able to receive, display and retain the patient summary – The National Contact Point is able to determine authorization for data sharing, transform message structure, provide data mapping, code translation and text translation. Post-conditions: – The Patient PHR has created and sent the patient summary – The National Contact Point has determined authorization for data sharing, transformed message structure, provided data mapping, code translation and text translation. – The provider EHR has received and retained the patient summary and stored the data 13

15. Pre and Post Conditions: Patient Facilitated Pre-conditions: – Provider 1 EHR is able to receive and process the patient request to send the patient summary – Provider 1 EHR is able to create and send a patient summary – The National Contact Point is able to determine authorization for data sharing, transform message structure, provide data mapping, code translation and text translation. – Provider 2 EHR is able to receive, display and retain a patient summary – Provider 2 EHR is able to create and send a patient summary – The National Control Point is able to? – Provider 1 EHR is able to receive, display and retain a patient summary Post-conditions: – Provider 1 EHR has processed the patient request – Provider 1 EHR has created and sent the patient summary to Provider 2 EHR – The National Contact Point has determined authorization for data sharing, transformed message structure, provided data mapping, code translation and text translation. – Provider 2 EHR has received and retained the patient summary from Provider 1 and stored the data – Provider 2 EHR has sent the patient summary to Provider 1 EHR – The National Control Point has? – Provider 1 EHR has received the patient summary from Provider 2 and stored the data 14

16. Pre and Post Conditions: Provider to Provider Pre-conditions: – Provider 1 EHR is able to receive and process a request from Provider 2 to send the patient summary – Provider 1 EHR is able to verify consent – Provider 1 EHR is able to create and send a patient summary – The National Contact Point is able to determine authorization for data sharing, transform message structure, provide data mapping, code translation and text translation. – Provider 2 EHR is able to receive, display and retain a patient summary – Provider 2 EHR is able to create and send a patient summary – The National Contact Point is able to determine authorization for data sharing, transform message structure, provide data mapping, code translation and text translation. – Provider 1 EHR is able to receive, display and retain a patient summary Post-conditions: – Provider 1 EHR has processed the request from Provider 2 EHR – Provider 1 EHR has created and sent the patient summary to Provider 2 EHR – The National Contact Point has determined authorization for data sharing, transformed message structure, provided data mapping, code translation and text translation. – Provider 2 EHR has received and retained the patient summary from Provider 1 and stored the data – Provider 2 EHR has created and sent the patient summary to Provider 1 HER – The National Contact Point has determined authorization for data sharing, transformed message structure, provided data mapping, code translation and text translation. – Provider 1 EHR has received and displayed the patient summary from Provider 2 and stored the data 15

17. epSOS to C-CDA CCD Mapping In support of Use Case

18. Vision – per MOU between EU and US Compare the data/document structures used in the US and EU by comparing the consolidated CDA (C-CDA) and the exchange standards used in epSOSDecember 20, 2013 Compare existing US and EU vocabularies, terminologies and clinical models to identify areas of overlap and commonality 17 Source: “HHS-EC Roadmap Executive Summary – Draft – 2013-02-19 CONNECT updates” Note: –Comparison is limited to Use Cases in current initiative. –

19. Vision – Objective - Goals Vision: –Ability to electronically transmit and use Clinical Summary (=Patient Summary) documents between US and EU: syntactic and semantic interoperability Objective: –Develop 1-to-1 mapping with core (=limited=constrained) information required to be included in Clinical Summary: Data Elements + Vocabularies(=values). Goals (divided in phases): –Phase 1: Map Header and Sections information –Phase 2: Map Data Element within each section –Phase 3: Map Vocabularies associated with data elements 18

20. Candidate for comparative analysis: Clinical Summary Form Health Level Seven Consolidated Clinical Document Architecture Release 1.1 (July 2012) –CDA R2 C-CDA R1.1 –http://www.hl7.org/implem ent/standards/product_brie f.cfm?product_id=258http://www.hl7.org/implem ent/standards/product_brie f.cfm?product_id=258 Focus: –CCD template (within C- CDA) epSoS (Patient Summary Form) –CDA R2 NE (May 2005) –HL7 IG: CDA R2-CCD (April 1, 2007) –http://www.epsos.eu/http://www.epsos.eu/ Focus: –Appendix II epsos_revised_data- set_25april2013.pdf USEU

21. Use Case Mapping Use case mapping will be at the section/category level and NOT at the detailed data element level Detailed data element mapping will be done in the harmonization phase 20

22. Syntactic Interoperability – Gap Analysis Compare –Document and data structures used in the US and EU Objective –Focus on Patient Summary Document (aka. Continuity of Care Document) –Propose set of mutually agreed upon and constrained: Document templates Metadata Data elements –Cardinality: [0..1], [1..*]…etc –Optionality: R (required), R2 (required if known), O (optional) –Data Type: Coded (CD), Free text (STR)…etc

23. Example: Document Structure standard C-CDA R1.1 (CCD Template) For Patient Summary Form (CCD) identify common/required: –Document format (e.g. XML) –Structural constraints (e.g. using HL7 CDA) –Minimum set of metadata (e.g. document ID, author, patient info) –Minimum required sections (e.g. Procedures, Medications…) –Minimum set of data elements (e.g. Procedure code, Procedure date) –Document structure attributes/vocabularies (e.g. Section Name such as “Current Medications” can be encoded using LOINC) (C-CDA CCD Patient Summary Form) (C-CDA CCD Patient 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] XML file format

24. Semantic Interoperability – Gap Analysis Compare –existing US and EU vocabularies, value sets and clinical models to identify areas of overlap and commonality Goal –Focus on vocabularies and value sets for Patient Summary Document (aka. Continuity of Care Document, CCD) –For Patient Summary Form Data Elements, propose set of mutually agreed upon and constrained: Coding Systems Code subsets (=Value Sets) from specified Coding Systems –Perform mapping where appropriate (e.g. if due to government/local policies specific coding system must be used)

25. Example: procedureCodes for Cesarean Section Identify permissible coding system(s): –SNOMED-CT –ICD-10-PCS –ICD-9-CM (legacy) identify codes that identify cesarean section procedure within each coding system (aka. Value Sets): –SNOMED-CT 177142005Elective upper segment cesarean section (procedure) 236986001Emergency upper segment cesarean section (procedure) 84195007Classical cesarean section (procedure)CPT –ICD-10-PCS 10D00Z0Extraction of Products of Conception, Classical, Open Approach –ICD-9-CM 74.0Classical cesarean section

26. Phase 1: Map header and sections Header –Header of the Patient Summary information contains general data about the document such as author of document, patient information, confidentiality settings…etc) Sections (body) –Body of Patient Summary contains patient-specific information organized in sections such as Medication section, Problems/Diagnosis/section, Allergy sections…etc Note: –Information (individual data elements) may be organized (grouped) in a different way in EU and US! 25

27. Phase 1: EU Sections (epSoS) 26 Section Name Information (data elements) within section

28. 27 Phase 1: USA Sections (C-CDA CCD)

29. 28 EU: epSoS USA: C-CDA CCD

30. Mapping - process Mapping maintained in Google Spreadsheet –Document updated in real time –Document publicly available –Document is machine processable! = can be imported into database for quick analysis. Production –After mapping is completed, information from spreadsheet will be transferred (packaged) in agreed upon format such as Word document, PDF document…etc 29

31. Use Case Development Timeline 30 DateInputsDiscussionOutputs 11/13/13 Updated scope based on comments Comments that need further discussion Finalize Scope Discuss Assumptions, Actors, and Roles Assumptions, Actors, and Roles to be posted for comments Data exchange diagrams and tables and pre and post conditions to be posted for comments 11/20/13 Updated Assumptions, Actors, and Roles based on comments Updated data exchange diagrams/tables and pre and post conditions Comments that need further discussion Review and update  Data exchange diagrams  Data exchange tables  Pre and Post Conditions Data exchange diagrams, data exchange tables, pre and post-conditions to be posted for comments 11/25/13 Updated data exchange diagrams, data exchange tables, pre and post-conditions based on comments Comments that need further discussion Draft data element tables Review and finalize  Data exchange diagrams  Data exchange tables  Pre and Post Conditions Review and update draft data element tables Finalized  Data exchange diagrams  Data exchange tables  Pre and Post Conditions Draft data element tables to be posted for comments 12/04/13 Updated data element tables based on comments Comments that need further discussion Review and finalize data element tablesFinalized data element tables 12/11/13 Draft use case with all sections completed End to end review of draft use case Updated use case based on end to end comments and ready for consensus posting 12/18/13 Consensus comments mapped into the use case Review consensus comments and finalize use case Approved use case

32. Next Steps 31 Prepare for our next meeting Continue submitting your bios NOTE: Interoperability of EHR Work Group will meet at our normally schedule time next week Wednesday December 4 th from 10:00am - 11:00am (ET)/4:00pm - 5:00 pm (CEST)

33. Interoperability Support Leads 32 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 – Emily Mitchell, emily.d.mitchell@accenturefederal.comemily.d.mitchell@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

34. Questions 33

35. 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 Reference Materials – http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Reference+Materials http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Reference+Materials 34