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

1. EU-US eHealth/Health IT Cooperation InitiativeInteroperability of EHR Work Group November 25, 2013

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.

4. Agenda

5. Meeting Times – NOTE TIME CHANGE NEXT WEEK Interoperability of EHR Work Group meets everyWednesday Washington, DC 10:00am (ET) • 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). London 3:00pm/15:00 (GMT) Germany 4:00pm/16:00 (CET) Athens 5:00pm/17:00 (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 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/ • 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=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

8. Join the EU-US eHealth/Health ITCooperation Initiative • 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+Up

9. Submit Your Bio • Submitted biographies are now posted on the Wikipagehttp://wiki.siframework.org/Interoperability+of+EHR+Work+Group#Work Group Members

10. Archived Meeting Materials • 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.

11. Preparing for Meetings • 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. • 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

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

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

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

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 epSOS December 20, 2013 • Compare existing US and EU vocabularies, terminologies and clinical models to identify areas of overlap and commonality 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

20. Candidate for comparative analysis: Clinical Summary Form US EU • Health Level Seven Consolidated Clinical Document Architecture Release 1.1 (July 2012) • CDA R2 C-CDA R1.1 • http://www.hl7.org/implement/standards/product_brief.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/ • Focus: • Appendix II epsos_revised_data-set_25april2013.pdf

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

22. Syntactic Interoperability – Gap Analysis • Compare • Document and data structuresused in the US and EU • Objective • Focus on Patient Summary Document (aka. Continuity of Care Document) • Propose set of mutually agreed uponand 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 standardC-CDA R1.1 (CCD Template) XML file format <clinicalDocument> (C-CDA CCD Patient Summary Form) <header> (document ID, author, patient ID…) <component> [Body] • 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) <section> [Procedures] <entry> (Colonoscopy) <procedureCode> <procedureDate> <…> <entry> [Gastroscopy] <entry> [CABG] … <section> [CurrentMedications] <entry> [ASA] <entry> [Warfarin] <entry> [CABG] <section>… <entry>

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 uponand 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 • 177142005 Elective upper segment cesarean section (procedure) • 236986001 Emergency upper segment cesarean section (procedure) • 84195007 Classical cesarean section (procedure)CPT • ICD-10-PCS • 10D00Z0 Extraction of Products of Conception, Classical, Open Approach • ICD-9-CM • 74.0 Classical cesarean section

26. Phase 1: Map headerand 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!

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

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

29. 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

31. Use Case Development Timeline

32. Next Steps • 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 4thfrom 10:00am - 11:00am (ET)/4:00pm - 5:00 pm (CEST)

33. Interoperability Support Leads • US Point of Contacts • Mera Choi: Mera.Choi@hhs.gov • Jamie Parker: jamie.parker@esacinc.com • Gayathri Jayawardena, gayathri.jayawardena@esacinc.com • Amanda Merrill, amanda.merrill@accenturefederal.com • Emily Mitchell, emily.d.mitchell@accenturefederal.com • Mark Roche, mrochemd@gmail.com • Virginia Riehl, virginia.riehl@verizon.net • EU Point of Contacts • Benoit Abeloos, Benoit.ABELOOS@ec.europa.eu • Frank Cunningham, frank.cunningham@ec.europa.eu • Catherine Chronaki, chronaki@gmail.com

34. Questions

35. Resources • EU US Wiki Homepage • http://wiki.siframework.org/EU-US+eHealth+Cooperation+Initiative • Join the Initiative • http://wiki.siframework.org/EU-US+MOU+Roadmap+Project+Sign+Up • Reference Materials • http://wiki.siframework.org/EU-US+MOU+Roadmap+Project+Reference+Materials