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

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

3. 3 Background | MoU It started with a Memorandum of Understanding 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

4. 4 Background | Vision The MoU vision set the framework for progress “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

5. 5 From the MoU, a roadmap was created to help guide the work of both work streams 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 Background | Roadmap

6. 6 Background | Strategy To reach this vision two high priority work streams were established 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.

7. “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” 7 Background | Interoperability of EHR’s The Interoperability work stream aims to…

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

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

10. 10 Step 1: Outline Scope Statement Using the MOU and the roadmap, we developed the foundation of our work through a 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 http://wiki.siframework.org/Interoperability+of+EHR+Work+Group

11. Step 2: Select Scenario & User Stories 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 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 Mediated2. Patient Facilitated3. Provider-Provider Scenario 11

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

13. 13 Step 4: Harmonization Analysis of EU and US standards for clinical summary information 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

14. 14 Step 4: Harmonization (cont.) Analysis of EU and US standards for clinical summary information (cont.) CategoryEUUS Template Name:Patient Summary (PS) Continuity of Care Document (CCD) Base Standard:HL7 CDA 2.0 Pub. Date:April 2007July 2012 AcronymepSoS PS v1.4C-CDA R1.1 CCD

15. 15 (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 Mapping work - PHASES Step 4: Harmonization (cont.)

16. 16 Step 4: Harmonization (cont.) Mapping Outcomes: Observations 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

17. 17 Step 4: Harmonization (cont.) Mapping Outcomes: Observations (cont.) Code Systems and Value Sets (code system subsets): – Code system same but different code subsets used (typical for SNOMED CT and HL7 codes) – Code system different AND codes have different granularity (one to many maps). Examples of differences in coding systems: CategoryEUUS Patient Summary (PS) Continuity of Care Document (CCD) Problems/Diseases:ICT-10-CMSNOMED CT Medications:ATCRxNorm VaccinesSNOMED CTCVX

18. Value Sets: – epSoS (EU):9,529 codes (ICD-10-CM) – CCDA (US):16,443 codes (SNOMED CT) – epSoS  SNOMED CT Analysis performed: – Mapped epSoS disease codes to C-CDA problem codes – Used ICD-10-to-SNOMED CT maps developed by IHTSDO Mapping table contains mapping variables such as mapPriority and mapGroup that can be adjusted from relaxed to 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) 18 Step 4: Harmonization (cont.) Mapping Outcomes: Value Sets (VS) for Problem/Disease Codes

19. Observations: – SNOMED CT more granular 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 19 Step 4: Harmonization (cont.) Mapping Outcomes: Value Sets (VS) for Problem/Disease Codes ICD-10-CM codes: SNOMED CT codes associated with ICD-10 code: 7%1 6%2 5%3 15%4-9 7%10-19 3%20-49 1%50-99 1%~100-350 55%No maps ICD-10-CM codes: SNOMED CT codes associated with ICD-10 code: 11%1 7%2 5%3 14%4-9 3%10-19 1%20-49 1%50-99 <0.05%>100 58%No maps Relaxed  Strict 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 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. 20 Example 1: Relaxed vs. Strict Rules Step 4: Harmonization (cont.) Mapping rule: relaxed (#360) Mapping rule: strict (#3) Constraining mapping variables from relaxed-to strict limited display of SNOMED CT codes for a given ICD-10-CM code.

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

22. 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 significantly reduce 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 no associated 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 Step 4: Harmonization (cont.) Mapping Outcomes: Value Sets (VS) for Problem/Disease Codes 22

23. 23 Step 4: Harmonization (cont.) Comparative Analysis White Paper 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 data and associated vocabulary subsets that would constitute a new, International Patient Summary document, based on HL7 CDA R2.0 standard

24. 24 Step 4: Harmonization (cont.) International (Harmonized) Patient Summary template 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

25. 25 Step 5: Pilot Testing The Harmonization work will be validated through 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

26. 26 Recap of Activities The Interoperability work stream continues to progress towards the MOU vision 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

27. 27 How to get involved? Link to EU initiative: http://wiki.siframework.org (EU-US eHealth Cooperation initiative link on the left hand side)http://wiki.siframework.org 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 http://wiki.siframework.org/EU- US+MOU+Roadmap+Project+Sign+Up

28. 28 Questions

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