International Patient Summary Workshop

1. International Patient Summary Worshop HL7 Asia Meeting Catherine Chronaki Secretary General, HL7 Foundation euoffice@HL7.org Funded under H2020-72745

2. 2 Mission: build the best most widely used HIT standards History: Since 1987 HL7 grows exponentially - demand outstrips capacity, HL7 v3, HL7 CDA, 40+ WGs, 50+ standards products in use; HL7 is supported by over 35 national/regional Affiliates and members in over 55 countries 1997: first national affiliate on board/ IHIC conference 2004: HL7 CDA is adopted 2009: HL7 International, USA on the International Council 2010: HL7 International Foundation in Europe established 2012: 25 years youth celebration with FHIR, HL7 Asia 2013: HL7 makes standards available under free license HL7 Leads HIT Standards development since 1987 1987 1997 2004 2009 2010 2012 2013

3. 3 HL7 CDA in Finland CDA R1 was used in regional information systems for information sharing CDA R2 was selected for national eHealth infrastructure (~2005) Kanta services: National EPR archive, ePrescription centre, national code server, etc. Transport using HL7 v3 Medical Records Messages (in future: also IHE infrastructure) CDA R2 localized implementation guides in Finland for: ePrescription (prescriptions, dispensations) EPR core dataset = patient summary, providers, diagnoses and concerns, procedures, examinations, results, service events, aids, blood group, functional status, medical certificates, queuing, follow-ups, goals, risks, nursing core dataset including summaries lab, medication, imaging reference and report, referral and discharge, scanned documents, dental records Use of CDA in national ePrescription IGs made it easier to study, understand and comply with the international ePrescription specifications According to epSOS experience from the National Insurance Institute (Kela)

4. HL7 CDA legacy in ELGA: patient summaries in Austria Information Curtesy of Dr Stefan Sabutsch, Chair HL7 Austria

5. 5 HL7 CDA in ELGA The ELGA GmbH is responsible for defining nation-wide HL7 CDA Implementation Guides in Austria. The process of creating HL7 CDA Implementation Guides was intense: 3 years of harmonization work in working groups Inclusive process including Austrian stakeholders Resulted in nation-wide harmonized and detailed technical specifications and Implementation Guides Discharge Summary (Physician) Discharge Summary (Nurse) Laboratory report Radiology report All documents are available from http://www.elga.gv.at/index.php?id=28 (German language only).

6. 6 Global IHE Implementation Guides in the Austrian context Use of International standards is a fundamental requirement for ELGA IHE profiles are adapted to Austrian demands Why was it impossible to adopt as is the IHE specifications? Austrian constraints demanded changing parts of templates working group experts considered better alternatives. What type of changes? stricter or relaxed options of CDA Level 3 entries based on value-sets for code-lists New content template that matched perfectly the Austrian needs.

7. 7 ELGA discharge summaries Physician and Nursing discharge summary parts separate CDA documents and Implementation Guides (IGs) relevant information is responsibity of Physician or Nurse both accessible in ELGA by both parties. Austrian Health Record (ELGA) includes documents that follow the ELGA Implementation Guides. Organizations must upgrade the information systems to conform to ELGA IGs to connect to ELGA Three ELGA Interoperability Levels (EIS) to enable quick & easy connection of providers, min data quality The ELGA legislation act mention that in the future the Austrian MoH will enforce interoperability levels through ordinances.

8. 8 ELGA Interoperability levels (EIS) EIS “Basic” / “Structured” minimum requirement coded information for document registry, access control system. medical content may be unstructured data, e.g. embedded PDF object. CDA documents conform to the Common Implementation Guide (IG) and CDA Header-constraints in Specialized IGs EIS “STRUCTURED” indicates that the human readable content of an embedded PDF meets the requirements of Specialized IGs EIS “Enhanced” further to EIS “Basic/Stractured” documents have to additionally follow the CDA Body constraints of Specialized IG Unstructured content is not allowed in this level. CDA Body is generally structured in CDA 2 sections, may contain CDA L3 elements EIS “Full support” further to EIS “Enhanced” CDA documents conform to CDA Body constraints of Specialized IGs Additional CDA Level 3 entries are required in most of the sections.

9. 9 Patient summaries in ELGA ELGA to serve as platform for Patient summary Patient Summary could be automatically created out of existing documents in ELGA discharge summary lab+radiology report Requirements for ELGA patient summaries all ELGA documents in EIS “full support” more documents types to a complete patient summary. If these basic prerequisites are not fulfilled, an automatically generated patient summary remains wishful thinking…

10. HL7 CDA in Germany Slides Curtesy of: Kai Heitmann Past Chair HL7 Germany

11. Sciphox (sky-fox) Project (DE) • Introduction of CDA in the year 2000+ in Germany, as a cooperation between general practitioners and hospitals • Lead later in 2005 to the first CDA R2 Discharge Letter definition – With ~ 15 vendors involved – Large show case, implementations • Was input to similar definitions in Austria (national infrastructure ELGA) and Switzerland around 2008-2010

12. German Discharge Letter Genesis, influence, cooperation Courtesy of Alexander Mense, Stefan Sabutsch, Bernd Blobel, modified 2005 2014

13. ART-DECOR Tool • DECOR – Data Elements, Codes, OIDs and Rules • ART – Advanced Requirement Tooling Internet: art-decor.org

14. Patient Summaries in Japan Information Curtesy of Massaki Hirai

15. Patient Summaries in Japan • HL7 CDA has been adopted in Japan • HL7 Japan work on summary standard using CDA. • no paper base summary standard in Japan. • Many researchers have tried to develop the standard but they are not yet success. • Current approach is that the standard is using narrative part and automatically generated contents.

16. Patient Summaries in the EU

17. European Patient Summary Guideline (based on epSOS)

18. CEF eHealth DSI (eHDSI) eHealth DSI Deploying Countries PS eP Austria Croatia Cyprus Czech Republic Estonia Finland France Germany Greece Hungary Ireland Italy Luxembourg Malta Portugal Sweden Switzerland What is the eHealth DSI? • Services and Infrastructure using ICTs that enable cross border Healthcare services. Tools and services using ICTs that can improve cross border Healthcare services. • Tools and services using HL7 and other standards that can improve interoperability cross border Healthcare services. • Use Cases: • Patient Summary, provides access to health professional to verified key health data of a patient during an unplanned care encounter while abroad • ePrescription, enables patients to receive equivalent medication treatment while abroad to what they would receive in their home country

19. eHDSI Communities OPERATIONS Audit Framework TF Test Framework TF SEMANTIC Coordination WG Organisation WG Architecture WG Semantics WG TECHNICAL STEERING COMMITTEE TECHNICAL COMMITTEE SMP/SML TF Non-Repudiation DEVELOPERS eHDSI Operation Communities Legend: TF: Task Force WG: Work Group

20. Moving to CEF August HL7 Asia 2017

21. The IPS Project: the HL7 Int. CEN/TC 251 agreement (April, 2017) August 18, 2017HL7 Asia 2017 HL7 Int. CEN/TC 251 agreement (April, 2017) Implementabl e Applicable for global use Extensible and open Sustainable Vision •“In order to further the care for citizens across the globe, we agree to collaborate on a single, common International Patient Summary (IPS) specification that is readily usable by all clinicians for the (cross-border) unscheduled care of a patient.” Scope •“The IPS specification shall focus on a minimal and non- exhaustive Patient Summary, which is specialty-agnostic and condition-independent, but still clinically relevant.” IPSPrinciples

22. August 18, 2017HL7 Asia 2017 class Products Initiatives_fund EUPS Guidelines eHDSI PS IGIPS CDA IG EN European PSOrganization:: CEN/TC 251 Organization:: HL7 Internatonal Organization::EC Project::CEN IPS Project::eHDSI Project::JAseHN Issue: Potential Gap. Undefined process Issue: Potential Gap. Undefined process isResponsibleFor provideInputs Funds isResponsibleFor «trace» Funds isResponsibleFor refine useAsInput implement isProgressivelyHarmonizedWith Funds contributeTo «trace» Source: Giorgio Cangioli

23. Compliance / Traceability August 18, 2017HL7 Asia 2017 Requirements Design Implementation CEN prEN Conformance Products ART DECOR®; Forge; .. HL7 CDA IG HL7 FHIR IG EU PS Guidelines The Patient Summary for Unscheduled, Cross- border Care IPS: Guidance for European Implementation Technical Specification CEN prTS

24. Patient summaries in the USA

25. US Meaningful Use: Consolidated-CDA/CCD 170.205(a)3 Consolidated CDA (C-CDA): Standardized representation of the Consult Note, Diagnostic Imaging Report, Discharge Summary, History and Physical, Operative Note, Procedure Note, Progress Note, and Continuity of Care Document (CCD). 170.205(h) CDA Guide for Quality Reporting Document Architecture, Category I 170.205(i) CDA Guide for Reporting to Central Cancer Registries 170.205(k) CDA Guide for Quality Reporting Document Architecture, Category III (QRDA-III) § 170.205 Content exchange standards and implementation specifications for exchanging electronic health information.

26. Kaiser Permanente overview 06/03/2018 eStandards Roadmap Presentation - PS for Emergency or Unplanned care 26

27. Kaiser Permanente overview August 24, 2017 Hangzhou, China Building a global community for digital health innovation: the role of patient summaries 27

28. 28 Patient summaries: our navigator in the health and social care ecosystem Think of the Patient summary as a window to a person’s health or personal dashboard: Medications, allergies, vaccinations problems and procedures, labs, diagnostic imaging recent or planned Encounters, implantable devices advance directives “Bring the Power of Platforms to Health Care” using data to drive: [Bush & Fox, HBR November 2016] administrative automation networked knowledge resource orchestration Think of appointments, technology, and productivity  virtual and f2f just-in-time appointments HL7 Asia 2017 eStandards need to • help build trust • unlock the power of health data • facilitate decision support • navigate the health system August 18, 2017

29. Achievements of Trillium Bridge 2013-2015 • Gap Analysis - Compared patient summary specifications in EU/US - Shared clinical elements: problems, medications, allergies • Interoperability Assets - Established a terminology prototype CTS-2 service: http://extension.phast.fr/STS_UI - Developed Patient summaries Transformer: http://informatics.mayo.edu/trillium-bridge - Identified Gaps in EU/US IHE profiles Patient Identity & Document Query/Retrieve • Validation activities: 4 EU countries/ Kaiser Permanente - EU/US Marketplace; HIMSS 2015; IHE Connectathon 2015, eHealthWeek14,15 • Feasibility study: - Reflected upon standards, cross-vendor integration, incentives, clinical research, security and privacy, innovative business models, education Recommendation: “Advance an International Patient Summary (IPS) standard to enable people to access and share their health information for emergency or unplanned care anywhere and as needed. At minimum the IPS should include immunizations, allergies, medications, clinical problems, past operations and implants.”

30. 30 IPS is out for ballot! August 18, 2017HL7 Asia 2017

31. 31 Example Patient Summary August 18, 2017HL7 Asia 2017

32. © 2016 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Sections  Medications (Statements, (relevant) ceased and current) (entries defined) (R)  Problem list (Concerns) (entries defined) (R)  Allergies and Intolerances (entries defined) (R)  History of Procedures (operations, interventions, implants procedure,..) (entries defined) (R)  Medical Devices (implanted devices) (entries defined) (R) 32

33. © 2016 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Sections  Immunizations (entries defined)  Results (including imaging, Path. Lab; Clinical Path;…) (entries defined)  Past history of illnesses (entries defined – entry optional ?) 33

34. © 2016 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Sections  Functional Status (Autonomy/Invalidity)  Plan of care  Social History  Pregnancy (expected day of delivery)  Advance Directive  (Vital Signs) 34

36. © 2016 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. What is Data Provenance?  The term “provenance” refers to attributes about the origin of health information at the time it is first created and tracks the uses and permutations of the health information over its lifecycle.  http://wiki.siframework.org/Data+Provena nce+Pilots+Executive+Summary 36 From “Data Provenance Initiative Launch”

38. © 2016 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Type of Patient Summary  Related to the previous topic  Do we want to keep track of information that describe the “context” of creation of the PS ?  Single vs Multi Encounter;  Single vs Multi organization;  Clinical act VS automatic collection VS mixed mode (see also provenance) 38

39. © 2016 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Type of Patient Summary  In epSOS/eHDSI (only the third item is actually handled with a simplified approach)  automatic collection => author device  Provider => author human  Mixed => both  Do we want to do more ?  In case how ? 39

41. © 2016 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Header  clinicalDocument.effectiveTime : different level of precision  Different type of adddress  US city and street line required  EU at least one element in the AD is required  US no mixed content, (neither for EU even if not specified  ) 41

42. © 2016 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Header  US raceCode (SHALL); sdtc:raceCode (MAY); ethnicGroupCode (SHALL); sdtc:ethnicGroupCode (MAY); not used or prohibited in EU  There are specific information required or suggested for the EU PS…  How we would like to proceed ? 42

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