May 12-14, 2014

1. May 12-14, 2014 Dr. Doug Fridsma EU-US eHealth/Health IT Cooperation Initiative Interoperability of EHR Work Group

2. Agenda • Background • Memorandum of Understanding • Vision • Roadmap • Strategy • Interoperability of EHR’s • Progress to date • Methodology • How to get involved

3. Background | MoU In December 2010, the European Commission and the US Dept. of Health and Human Services signed a Memorandum of Understanding (MOU) to • Help facilitate more effective uses of eHealth/Health IT • Strengthen their international relationship • Support global cooperation in the area of health related information and communication technologies. Interoperability of EHRs It started with a Memorandum of Understanding

4. Background | Vision “To support an innovative collaborative community of public- and private-sector entities working toward the shared objective of developing, deploying, and using eHealth science and technology to empower individuals, support care, improve clinical outcomes, enhance patient safety and improve the health of populations.” Vision The MoU vision set the framework for progress

5. Background | Roadmap • Scope of Roadmap • Defines a cooperative action plan to produce deliverables aligned with the goals outlined in the MoU, with a specific emphasis on the following two areas: • international interoperability of Electronic Health Records information, to include semantic interoperability, syntactic interoperability, patient and healthcare provider mediated data exchange (including identification, privacy and security issues surrounding exchange of health data); and • cooperation around the shared challenges related to eHealth/health IT workforce and eHealth proficiencies. • Trillium Bridge Coordination • Integrates relevant Trillium Bridge work with the EU/US Interoperability work stream From the MoU, a roadmap was created to help guide the work of both work streams

6. Background | Strategy • eHealth/Health IT Interoperability: • accelerate progress towards the widespread deployment and routine use of internationally recognized standards that would support transnational interoperability of electronic health information and communication technology; and • eHealth/Health IT Workforce Development: • identify approaches to achieving a robust supply of highly proficient eHealth/health IT professionals and assuring health care, public health, and allied professional workforces have the eSkills needed to make optimum use of their available eHealth/health information technology. Equally, we will identify and address any competency and knowledge deficiencies among all staff in healthcare delivery, management, administration and support to ensure universal application of ICT solutions in health services. To reach this vision two high priority work streams were established

7. Background | Interoperability of EHR’s “Accelerate progress towards the widespread deployment and routine use of internationally recognized standards that would support transnational interoperability of electronic health information and communication technology” The Interoperability work stream aims to…

8. Background | Goal Syntactic Interoperability • Harmonize the formats for how information is • Structured • Semantic Interoperability • Identify and align a subset of commonly used • vocabularies and terminologies Empower individuals through patient-mediated data exchange, addressing privacy and security issues • Patient Mediated Data Exchange The goal of this work stream is three-fold

9. Background | Progress to Date Harmonize EU/US syntax and semantics Validate through Pilot testing Create Workgroup Charter and Scope Statement Collect scenarios and select user stories Develop Use Case based on user stories The S&I Framework model is being used to support the Interoperability work stream

10. Step 1: Outline Scope Statement • Scope Statement: • Working to accelerate and advance the progress of eHealth/health IT interoperability standards and interoperability implementation specifications for the unambiguous semantic interpretation of clinical data that meet high standards for security and privacy protection and fidelity (faithful to the source) for the international community and for the enhanced care quality and safety of the patient. • Working toward shared objective to support an innovative collaborative community of public- and private-sector entities, including suppliers of eHealth solutions, working toward the shared objective of developing, deploying, and using eHealth science and technology to empower individuals, support care, improve clinical outcomes, enhance patient safety and improve the health of populations. • http://wiki.siframework.org/Interoperability+of+EHR+Work+Group Using the MOU and the roadmap, we developed the foundation of our work through a Scope Statement…

11. Step 2: Select Scenario & User Stories • Scenario • Patient has traveled outside of their normal geographic location. This could be from the US to the EU, or EU to US • Patient requires emergency care and visits an emergency room in the location that they have traveled to. The emergency room staff require information on the patient’s health care • The patient is discharged from the emergency room and returns to their home for follow-up care from their customary provider • 1. Patient Mediated • 2. Patient Facilitated • 3. Provider-Provider We defined one scenario containing three user stories. Each user story represents a different way in which the patient can control the flow of his/her information

12. Provider to Provider Exchange Patient Mediated Exchange Patient Mediated Exchange Step 3: Use Case Development Patient travels abroad and requires emergency care from foreign Provider… Patient requests customary provider to send data to emergency room provider Customary provider authorizes data to be sent Data translated from patient language to foreign language Provider sends request for patient data from customary provider Customary provider authorizes release Data translated from patient language to foreign language to customary provider Patient sends data to emergency room provider through mobile application Data translated from patient language to foreign language Provider to Provider Exchange Patient Mediated Exchange Patient Mediated Exchange Patient authorizes emergency room to send electronic summary of care to customary provider Data translated to patient language Customary provider incorporates into patient EHR Emergency room provides electronic summary of care Data translated to patient language Patient incorporates data into application, the cloud, or hard copy Emergency room provides electronic summary of care Data translated to patient language Patient forwards summary of care to customary provider Patient is discharged and requires follow-up care in home country…

13. Step 4: Harmonization • Mapping SWG of EU and US experts was created • Compared clinical (patient) summary templates between epSOS and C-CDA standards. • Analyzed • Document structure • Data elements • Value sets/Vocabularies • Comparative Analysis outcomes will be presented in a White Paper Analysis of EU and US standards for clinical summary information

14. Step 4: Harmonization (cont.) Analysis of EU and US standards for clinical summary information (cont.)

15. Step 4: Harmonization (cont.) <clinicalDocument> (Clinical Summary Form) <header> (document ID, author, patient ID…) Completed Data Granularity and Complexity <component> [Body] <section> [Procedures] <entry> (Colonoscopy) <procedureCode> <procedureDate> <…> <entry> [Gastroscopy] <entry> [CABG] … <section> [CurrentMedications] <entry> [ASA] <entry> [Warfarin] <entry> [CABG] <section>… <entry> Remaining 15 Mapping work - PHASES

16. Step 4: Harmonization (cont.) • Document Section: • Both standards have 13 sections (e.g. Medications, Problems, Immunization, etc.) • C-CDA CCD has 3 sections that epSoS does not have: • Advance Directives • Encounters • Family History • Data Elements (DEs): • Some required DEs in epSoS are optional in C-CDA CCD and vice versa Mapping Outcomes: Observations

17. Step 4: Harmonization (cont.) • Code Systems and Value Sets (code system subsets): • Code system samebut differentcode subsets used (typical for SNOMED CT and HL7 codes) • Code system differentAND codes have different granularity(one to many maps). • Examples of differences in coding systems: Mapping Outcomes: Observations (cont.)

18. Step 4: Harmonization (cont.) Mapping Outcomes: Value Sets (VS) for Problem/Disease Codes • Value Sets: • epSoS (EU): 9,529codes (ICD-10-CM) • CCDA (US): 16,443codes (SNOMED CT) • epSoS SNOMED CT • Analysis performed: • Mapped epSoSdisease codes toC-CDA problem codes • Used ICD-10-to-SNOMED CT maps developed by IHTSDO • Mapping table contains mapping variables such as mapPriorityand mapGroup that can be adjusted from relaxedto strict. • Generally, relaxed rules will display more SNOMED CT matches for a given ICD-10-CM code, while strict rule will display less matches (see next slides)

19. Step 4: Harmonization (cont.) Mapping Outcomes: Value Sets (VS) for Problem/Disease Codes Relaxed  Strict • Observations: • SNOMED CT moregranular than ICD-10-CM codes • In ~90% cases, a single ICD-10-CM code had more than one SNOMED CT code mapped (see table to the right) • >50% of ICD-10-CM codes had no associated SNOMED CT code • Generally, relaxed rules will produce more SNOMED CT codes for a (one) given ICD-10-CM code, while strict rule will produce less matches Interpretation example: In 7% of all epSoS disease codes, a single (one) ICD-10-CM codes has between 10 and 19 associated (mapped) SNOMED CT codes in C-CDA Problem Value Set

20. Step 4: Harmonization (cont.) Mapping rule: relaxed (#360) Constraining mapping variables from relaxed-to strict limited display of SNOMED CT codes for a given ICD-10-CM code. Mapping rule: strict (#3) Example 1: Relaxed vs. Strict Rules

21. Step 4: Harmonization (cont.) Constraining mapping variables from relaxed-to strict did not significantly limit display of SNOMED CT codes for a given ICD-10-CM code. Mapping variables: relaxed (#258) Mapping variables: strict (#184) Example 2: Relaxed vs. Strict Rules

22. Step 4: Harmonization (cont.) Mapping Outcomes: Value Sets (VS) for Problem/Disease Codes • Conclusions: • More specific ICD-10-CM codes will have a smaller number of associated SNOMED CT codes than less specific ICD-10-CM codes. • Even the strictest application of a map rule (variables) does not significantlyreduce in all cases the number of SNOMED CT codes associated with a given ICD-10-CM code. • Conversion from epSoS Disease codes to C-CDA Problem codes is unlikely to be entirely automated process because: • 10% or less epSoS codes have a single (one) associated C-CDA problem codes. • >50% epSoS codes have noassociated C-CDA problem codes • ~40% epSoS codes have more than one associated C-CDA problem codes • Conversion from C-CDA Problem codes to epSoS Disease codes poses other challenges: • Since SNOMED CT is more granular than ICD-10-CM codes, transcoding will invariably lead to loss of granularity in clinical information

23. Step 4: Harmonization (cont.) • Purpose: • To summarize outcomes of document structure, data elements and value sets between Patient (Clinical) Summary document in the EU and the US • Goal: • To identify minimally required clinical dataand associated vocabulary subsetsthat would constitute a new, InternationalPatient Summarydocument, based on HL7 CDA R2.0 standard Comparative Analysis White Paper

24. Step 4: Harmonization (cont.) • The Mapping work concluded that a universal Patient Summary template and global vocabulary subsets would best address requirements and support harmonization across the standards • A template WG will launch in mid-May and focus on developing the international template International (Harmonized) Patient Summary template

25. Step 5: Pilot Testing • Pilot recruitment has begun • Pilot efforts will begin in September 2014 • Please reach out if you are interested in participating as a pilot project The Harmonization work will be validated through Pilot Testing

26. Recap of Activities • COMPLETED • Interoperability Use Case • Detailed mapping of epSOS Patient Summary and C-CDA CCD • FUTURE WORK • Continue collaboration with Trillium Bridge • Standards balloting in September • Pilot test • IN PROGRESS • Comparative Analysis White Paper • International/Harmonized Patient Summary template • Collaboration with Trillium Bridge The Interoperability work stream continues to progress towards the MOU vision

27. How to get involved? • Link to EU initiative: http://wiki.siframework.org(EU-US eHealth Cooperation initiative link on the left hand side) • Project Charter, Meeting Schedules, Minutes, Reference Materials, Use Case, and all Announcements are posted on the Wiki page • Join the project and the project mailing list: http://wiki.siframework.org/EU-US+MOU+Roadmap+Project+Sign+Up

28. Questions

29. Contacts • ONC Contacts: • Doug Fridsma: Doug.Fridsma@hhs.gob • MeraChoi: Mera.Choi@hhs.gov • Project Management Team: • Jamie Parker: jamie.parker@esacinc.com • Virginia Riehl: virginia.riehl@verizon.net • Amanda Merrill: amanda.merrill@accenturefederal.com • Clinical and Technical Contact: • Mark Roche: mrochemd@gmail.com For more information on the EU-US Interoperability work