1. EU-US eHealth/Health IT Cooperation Initiative Interoperability of EHR Work Group December 18th, 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 Use Case Discussion40 minutes Use Case Acceptance10 minutes Next Steps5 minutes 3

5. Meeting Times…CHANGES 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 We will be canceling the December 25 th Workgroup Call We will meet again Tuesday December 31 st, 2013 same time

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. Join the EU-US eHealth/Health IT Cooperation Initiative 6 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

8. 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 7

9. Archived Meeting Materials 8 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

10. Preparing for Meetings 9 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)

11. 10 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 exchange diagrams, data exchange tables, pre and post conditions and data element tables based on comments Comments that need further discussion Review and finalize  Data exchange diagrams  Data exchange tables  Pre and Post Conditions  Data element tables Finalized  Data exchange diagrams  Data exchange tables  Pre and Post Conditions  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 final comments 12/18/13 Final comments mapped into the use case Review final comments and finalize use case Workgroup Accepted use case Use Case Development Timeline

12. Agenda for today Template discussion User Story: – Data sent from emergency room provider – Terminology: Patient Summary vs Clinical Summary Assumptions: Verification of authorization In Scope: Data Elements section wording In Scope: Translation In Scope: Additional Clinical Data Additional Comments 11

13. Use Case Acceptance NameCountryYesYes with Comments No with Comments Larry GarberUSX Barry RobsonUS and EnglandX David TaoUSX Homer PapadopoulosGreeceX Rachelle BlakeIsraelX Jakir Hossain Bhuiyan Masud BangladeshX Alexander BerderGreeceX 12

14. Template discussion The current Use Case has the following requirements: – Ability to send images – Discharge summary should be sent to the home provider including chief complaint Main focus of EU US collaboration is the CCD and epSOS specification Templates beyond CCD and epSOS are out of scope – Therefore a discharge summary template is out of scope – Therefore X-Ray/CAT scan/etc. imaging template is out of scope One option would be to use the clinical summary to provide information to the patient’s home provider on the emergency room visit 13

15. User Story Comments: Data sent from ER Provider? (1/2) 14 When the patient receives care in the other country and that provider sends something back, are they sending just the summary of care they provided or are they taking that patient summary and inserting information into it? Larry: Summary of Care they Provided Barry: A record should have the fullest possible and latest information. The question thus is really about whether it is updated by inserting information at the point of the treatment event, or whether it is joined later, and for timeliness, at the point of treatment event is indicated. But treatment can involve taking samples as tests which may take some time to process by labs etc., so it is both

16. When the patient receives care in the other country and that provider sends something back, are they sending just the summary of care they provided or are they taking that patient summary and inserting information into it? David: The question is not very clear. Yes, the provider is sending the summary of care he/she provided. Not clear what "taking that patient summary and inserting information into it" means. If the question means "Is the provider allowed to insert additional information beyond the standard summary of care?" then the answer should be yes. The receiver should, at a minimum, be able to display the entire document narrative (assuming it is CDA), even parts that were not "expected." However, it should not be assumed that the receiver can consume discrete data from additional unexpected sections or entries. Rachelle: My understanding is that that the patient is not inserting information but is sending just the summary (of care). I think that the quality and relevance of what might be inserted by the patient will be so variable in its reliability from patient to patient that it's best not to start with this. Alexander: I propose the second (updated clinical summary), they are taking the patient summary and inserting new information in the respective sections so that semantic interoperability can be verified 15 User Story Comments: Data sent from ER Provider? (2/2)

17. User Story Comments: Terminology Mark: Patient Summary refers specifically to a form within epSOS, so we should use the term “original and transformed clinical summary” to refer to the data we’re sending and receiving, instead of “original and transformed patient summary” 16

18. Assumptions: Verification of authorization (1/2) Comments on added assumption, “in any scenario where data is received from the NCP, a receiving entity, whether Patient PHR or a Provider EHR, will have the responsibility to verify authorization.” Rachelle: I don't understand this question. If the National Contact Point is always the intermediary, I assume that verification of authorization should be very clear and straightforward Larry: no, except for the patient-mediated case Barry: They should have the authority codes, but that code, by prior patient consent, can include access by a broad range of authorized providers to cover emergency situations. An authority code can in a sense be a set of codes for various circumstances 17

19. Assumptions: Verification of authorization (2/2) Comments on added assumption, “in any scenario where data is received from the NCP, a receiving entity, whether Patient PHR or a Provider EHR, will have the responsibility to verify authorization.” Alexander: Authorization means at least two major steps: – 1. authentication of healthcare provider at the country of treatment (each country has it own rules) - epSOS rules could apply there – 2. patient consent should be given from the country of origin - XACML could be a technical solution for handling more complex patient consent scenarios If no NCP is present from the US side there is a problem in implementing both of those steps. possible remedies: – 1. establish in the US an NCP by using openNCP provided by epSOS and apply US rules on it – 2. Hardcode in an API fashion (REST? HL7 FIHR?) the needed rules for very specific scenarios of handling healthcare provider authentication and patient consent rules (all other Note: The Use Case assumes whatever security and privacy requirements the EU has will be met in some way by the US receivers of data. 18

20. In Scope Changes In scope items Pre-Mark Comments In scope items Post-Mark Comments Preserve original text in original language

21. In Scope: Translation Feedback from Mark Roche: We would need to significantly alter the standards in scope in order to meet these translation requirements, as they currently stand. Currently, we have ‘Chief Complaint’ as the scope of translation. Chief complaint is within a discharge summary. However, this information uses a different template than the US CCD (CDA R2) that we have specified for this initiative. Chief complaint is in text form not data form, which is difficult to translate in a medical setting, even through an existing EU NCP. Colloquialisms are commonly used to express systems, which are difficult to translate to a different language. 20

22. Additional Comments Barry: Evidently we are "locked into" a CDA/CCD epSOS route if we are to proceed at this speed, but care must be taken so that other approaches can with appropriate authorization translate to and from the content, i.e. submit and subscribe. David Tao: p. 10 says "This process will be conducted only with the consent of the patient." Yet "break the glass" is in scope, and some break-the-glass scenarios involve a patient who is unconscious or otherwise unable to give consent. I suggest rewording to say "This process will be conducted only with the consent of the patient or where necessary in break-the-glass scenarios, per applicable policies.“ Homer: A description of the terms EHR, EMR and PHR in the document would help. This would assist eg the reader to clarify in Fig 3 and 5 the role of NCP between PHR and EHR. Homer: NCP acts as a communication gateway and establishes trust in the Trusted Domain and should not be considered as a necessity. The role of NCP is unnecessary in cases where an international health care company has established health care units both in EU and US and has to serve its own customers or in cases where different health care providers have established other trust relationships between them.

23. Additional Comments cont. Rachelle: Page 9 - first line in "working definition' for national contact point. I would add "EU" between “each participating" so that it reads "each participating EU Country" as you later clarify that there is no such ting in the US Rachelle: In the table describing the scenario beginning page 11, I think the description is misleading as in no case does the data ever go directly from the PHR or EMR to the receiver - it is always mediated by the NCP and that is clearly reflected in the diagrams. so the wording should be consistent with the diagram. Having said that - in real life I can't really envision a situation where if the patient can access his PHR on his phone, he would send it to the NCP rather than sharing it directly with the provider on the spot. Rachelle: Just to make the functional requirements charts a bit easier to understand, I suggest that we label the first part "prior to Clinical care Provision, and the second half "post clinical care provision". Also when the chart moves to another page the subheadings (actor, role, etc.) should be repeated

24. Alexander: It is a good start up document. User Story 3 seems the closest one to EU regulation and Directive 24/11/EC without applying EU regulation it is impossible to regulate and secure data transfer without creating an information management jungle where providers are not authenticated and patient consent is not properly addressed (it is a must based upon EU data protection law. until now patient give consent separately to each provider since no data transfer is done. now this has to be changed taking into account the data privacy rule of EU). As a consequence the need for a national (or regional) contact points is needed to create the needed circle of trust for successful data exchange (technically, legally, semantically, organizationally). Additional Comments cont.

25. Next Steps: Discussion of SDS/Harmonization What is the primary deliverable of this initiative? – Constrained form of CCD There are more data elements in CCD than in epSOS currently However, CCD has significantly less vocabulary than epSOS – Could US encode something that epSOS already has? EU is already using LOINC, SNOMED, etc. – Gap Analysis will help inform recommendations to HL7 CCD and epSOS – Implementation Guide: structured around mapping 24

26. In the meantime... 25 Prepare for our next meeting Continue submitting your bios Attend the next Interoperability of EHR Work Group meeting Tuesday December 31st from 10:00am - 11:00am (ET)/4:00pm - 5:00 pm (CEST)

27. Interoperability Support Leads 26 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

28. Questions 27

29. 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 28