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Trillium-II initiative on scaling up use of patient summaries in Europe and globally Progress on International Patient Summary Standard

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Trillium-II initiative on scaling up use of patient summaries in Europe and globally Progress on International Patient Summary Standard

  1. 1. Trillium-II initiative on scaling up use of patient summaries in Europe and globally Progress on International Patient Summary Standard Catherine Chronaki Secretary General, HL7 Foundation euoffice@HL7.org Funded under H2020-72745
  2. 2. 2 HL7 Foundation: who we are.. August 18, 2017HL7 Asia 2017 HL7 the best and most widely-used eHealth standards since 1986 HL7 v2, Clinical Document Architecture, HL7 FHIR 19 National Affiliates in Europe (~38 wordwide) European HL7 foundation established in 2010 European Funded Research Projects eHGI, Antilope, Semantic Healthnet, Trillium Bridge, Expand, Trillium-II PHC34: ASSESS CT, OpenMedicine, eStandards Annual HL7 in Europe Newsletter Website: www.HL7.eu eHealth policy & Research eHealth stakeholders group; mHealth Guidelines; ENISA expert group EFMI council (2012-): MIE, STC EFMI Board (2016) eHealth Week SDO Joint Initiative Council HL7 Vision: A world in which everyone can securely access and use the right health data when and where they need it.
  3. 3. What is CEF TRANSPORT € 26.25 bn ENERGY € 5.85 bn TELECOM Broadband € 170 m Digital Service Infrastructures € 970 m * CEF Regulation (REGULATION (EU) No 1316/2013) The Connecting Europe Facility (CEF) is a regulation that defines how the Commission can finance support for the establishment of trans-European networks to reinforce an interconnected Europe. * - 100 m Juncker Package CEF Telecom Guidelines The CEF Telecom guidelines cover the specific objectives and priorities as well as eligibility criteria for funding of broadband networks and Digital Service Infrastructures (DSIs). CEF Work Programme Translates the CEF Telecom Guidelines in general objectives and actions planned on a yearly basis. HOW IS IT REGULATED?
  4. 4. 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
  5. 5. 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
  6. 6. Moving to CEF August HL7 Asia 2017
  7. 7. 7 eStandards – eHealth Standards and Profiles in Action for Europe & Beyond Vision of the global eHealth ecosystem  people have navigation tools for safe and informed health care  interoperability assets fuel creativity, entrepreneurship, and innovation eStandards will:  nurture digital health innovation  strengthen Europe’s voice & impact  enable co-creation and trusted provider-user relationships Base Standards Use Case based Standards Sets Assurance and Testing Live Deployment Feedback and Maintenance Tooling and Education Forums and Monitoring eStandards HL7 Asia 2017 August 18, 2017
  8. 8. 8 Innovation is where standards are most needed: to unlock data for trust & flow Today: Massive health data accumulated in silo EHR systems serving documentation purposes. We need to move from passive documentation to active use of information and knowledge creation: activation! Patient summaries defined at the macro level: cross-border exchange for emergency or unplanned care at a national level. Need to address communities and individuals! Standards and profiles address a predefined exchange of information. Need flexible use of available content and structure, recognizing national, regional or local jurisdictions trust & flow! Shaping the future: Focus on the top level: systems of innovation! Systems of record – documentation systems -EHRs Systems of differentiation – profile based data exchange Systems of innovation – unlock data and user experience + + - - C h a n g e G o v e r n a n c e HL7 Asia 2017 August 18, 2017
  9. 9. Adoption at scale calls for the collaborative use of standards eStandards has developed recommendations for increased collaboration: • Provide better linkage to professional guidelines • Put more emphasis on clinical information models • Accommodate a reliable mix of patient and provider generated data • Provide more regulatory clarity on the use of standards • Strive for coherence between terminology initiatives • Facilitate compliant localization and adaptation of standards • Provide open access tools and testing data for deployment of standards • Encourage the use of standards sets in procurement • Put in place a governance and maintenance process for standards sets 26 June 2017 eStandards Roadmap Presentation 9 Most importantly, eHealth standards need to answer the needs of the digital age.
  10. 10. 10 What do we need to make digital health work with standards and interoperability? Co-create to make it real using standards Governance to make it scale for large-scale deployment Alignment to make it flourish in a sustainable way Initial areas of work: chronic diseases, rare disease networks, medication identification, patient summaries HL7 Asia 2017 August 18, 2017
  11. 11. Findings Which are the strategic long term benefits of SNOMED-CT?  Robust maintenance process.  Maps to user interface terminologies.  Ease the reuse of data.  Standardization of EHR contents. Which enablers for semantic interoperability could be identified?  End user satisfaction and usability tools.  Awareness raising and education on terminology implementation and use.  Terminology bindings to information models.  Clear context of use for relevance and effectiveness.  Semantic infrastructure supporting terminology services.  Policies, governance, and operational management of terminologies. Which are the key challenges for SNOMED-CT introduction?  Need for further evidence  Market maturity  License policy and costs  Knowledge investment, terminology maintenance  Lack of expertise  Actual and perceived complexity Which are best-practice approaches to the introduction of SNOMED CT and other terminologies?  Step-wise, use case based incremental approach  International collaboration strategy and stakeholder engagement  Impact assessment on the business architecture August 18, 2017HL7 Asia 2017
  12. 12. AssessCT - recommendations o Any decision about adoption of terminological resources, including SNOMED CT, must be part of a wider, coherent and priority driven strategy for optimising the benefits of semantic interoperability in health data, and of the overarching eHealth strategy of the European Union and its Member States. o SNOMED CT is the best available core reference terminology for crossborder, national and regional eHealth deployments in Europe. o SNOMED CT should be part of an ecosystem of terminologies, including international aggregation terminologies (e.g., the WHO Family of Classifications), and user interface terminologies, which address multilingualism in Europe and clinical communication with multidisciplinary professional language and lay language. o The adoption of SNOMED CT should be realised incrementally rather than all at once, by developing terminology subsets that address the interoperability requirements for priority use cases and expanding these sets over a number of years. o Mechanisms should be established to facilitate and coordinate European Member State cooperation on terminology and semantic interoperability, including common areas of governance across national terminology centres, eHealth competence centres (or equivalent national bodies). o See: www.assess-ct.eu August 18, 2017HL7 Asia 2017
  13. 13. PHC-34 643796 13 Meeting the global challenge of unique identification of medicinal products Core goals  Univocal identification of a  prescribed medicinal product  for human use in  cross-border healthcare by a  dispensing community pharmacist  in another Member State than that in which the prescription was issued.  Substitution Policy context – xBorder HC Directive  A patient “purchases” a medicinal product in another Member State than that in which the prescription was issued  Not healthcare provided in the context of REGULATION (EC) No 883/2004 on the coordination of social security systems  Not only “medicinal products” – we also deal with prescriptions identifying an active ingredient, or a set of products (cluster)  Patient initially pays (“purchases”) from own pocket
  14. 14. PHC-34 643796 14 PhP MP Package • ... • PCID (GTIN) • ... • Substances • Strength • Dose Form • ... • Country • MAH • MPCode • ... Identifier = PhPID Identifier= MPID Identifier=PCID PhP MP Package • ... • PCID (GTIN) • ... • Substances • Strength • Dose Form • ... • Country • MAH • MPCode • ... Identifier = PhPID Identifier= MPID Identifier=PCID How would this work? Common data structure Centrally defined attribute values Use of common data values across borders: When an identifier is specified in one place, it can be mapped to the common structure in any other country. The prescribed package ID (PCID) can be identified in country B, but the package/product is not available there. However, it can be mapped to the underlying PhPID, which in turn can be mapped to medicinal products available. Enable safe and informed dispensing “Is packaged as” “Is produced as” Source: José Costa Teixeira August 18, 2017 HL7 Asia 2017
  15. 15. 15 August 18, 2017HL7 Asia 2017 Several viewpoints inform the creation of roadmap elements Identification of Needs taking perspectives into account Necessary Artefacts and components part of the EIF Actions to be taken Trust & Flow  Knowledge innovation  Information exchange  Data capture  Generic Requirements  State of the Art  Development Needs Phases in the Health Informatics Standards Life Cycle Base Standards Use Case based Standards Sets Assurance and Testing Live Deployment Feedback and Maintenance Tooling and Education Forums and Monitoring eStandards
  16. 16. 16 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
  17. 17. 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.”
  18. 18. Comparison of EHR summaries and the International Patient Summary bottom line Allergies Medications Problems Pregnancy History Expected date of delivery Vaccinations Social History Medical Devices Vital Signs Blood group ProceduresAllergies Problems Immunizations Procedures (surgical ) Functional Status (autonomy / invalidity) Results (blood group ) Social History Observations (lifestyle history ) Vital signs (blood pressure ) Medications Pregnancy history (expected date of delivery ) Advance Directives Encounters Family History Payers CCDPS Plan of Care (therapeutic recommendations )Medical Devices and Implants • Same base Standard (HL7 CDA) • Different philosophy: capture vs continuity of care • Different IGs: C-CDA/CCD (US realm) vs epSOS IG • Different technical approach: Open vs Closed Template
  19. 19. The IPS Project: the HL7 Int. CEN/TC 251 agreement (April, 2017) August 18, 2017 HL7 Asia 2017 HL7 Int. CEN/TC 251 agreement (April, 2017) Implementable 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
  20. 20. The IPS Project: the policy role… August 18, 2017 HL7 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
  21. 21. Compliance / Traceability The IPS «world» Requirements Design Implementation CEN prEN Conformance Products ART DECOR®; Forge; .. HL7 CDA IG HL7 FHIR IG EU PS Guidelines August 18, 2017 HL7 Asia 2017 The Patient Summary for Unscheduled, Cross- border Care IPS: Guidance for European Implementation Technical Specification CEN prTS
  22. 22. innovative collaborative community • empower • support • advance • enhance • improve August 18, 2017 HL7 Asia 2017 Reinforcing the Bridges and Scaling up EU/US Cooperation on Patient Summary Mission
  23. 23. Standards Organizations: Health Systems and Associated Competence centers: Dissemination and Networking: Development and Evaluation: Third parties
  24. 24. Emergency •Emergency response teams August 18, 2017 HL7 Asia 2017 Trillium II touches the person (through our mobile – the hub) and the community by focusing on data
  25. 25. right and enabler of safe care. stakeholder groups to identify needs key enablers and success educational and training material
  26. 26. • Quality assurance • Health goals • Early warnings Can we use patient summaries to unlock patient data?
  27. 27. OHI Objectives of the OHI Initiative • Increase the efficiency and effectiveness of the Olympic Medical Services functional program through the integration of interoperable healthcare information technology • Demonstrate to the world that the international adoption and implementation of standards-based interoperable healthcare information technology directly impacts: – Better health of the “Olympic Population” (athletes, coaches/staff, volunteers, family & spectators) – Improved health outcomes through availability of, and secure access to, appropriate information at the right place, audience and time – Reduction of total time for diagnosis and treatment – Reduction of waste of human and system resources – Improved care coordination, quality, safety, efficiency, population health 30
  28. 28. OHI Athlete Cardiac Event Twenty-four-year-old Jamaican athlete Tasha Morris collapsed on the track while competing in the Women’s 100 Meter event at the London2012 Olympic Games, showing symptoms of dizziness, light-headedness, and a pounding in the chest area. OHI Interoperability Use Cases* Olympic Family Member GI Event George Carson, the 56-year-old father of Canadian Olympic swimmer Brian Carson, exhibited an episode of acute abdominal pain while watching his son’s final heat in the 200 Meter Butterfly event at Rio2016 31 Benefits to Interoperability at the Olympic Games  Faster response between onset of symptoms and treatment  Fewer diagnostic tests required (elimination of redundancy), reducing both time and costs  Improved quality of treatment, based on access to more complete clinical information  Improved patient safety, especial with respect to medication errors  Closed loop of clinical information: from patient to clinician and back to the patient * Use Case details in slide NOTES Source: Mike Neusam
  29. 29. OHI Industry Support 32 Healthcare Information and Management Systems Society SNOMED International Standards Development Organizations • ISO/TC215 – Worldwide standards for Health Informatics • Joint Initiative Council – collaborative of international health IT SDO’s • IHE International – world leader in healthcare interoperability standards • HL7 - standards for the exchange, integration, sharing, and retrieval of electronic health information • GS1 – world leader in identification standards Source modified: Mike Neusam
  30. 30. Deploy or Die! Joi Ito, Head MIT Media Lab
  31. 31. August 18, 2017 HL7 Asia 2017 Evaluate Bridge HarmonizeGuide eHealth DSI

Editor's Notes

  • In order to achieve smart, sustainable and inclusive growth and to stimulate job creation in line with the objectives of the Europe 2020 Strategy,
    in the transport, telecommunications and energy sectors.
  • Systems of record – SQL / CDA/CCD /
    Systems of differentiation – IHE Profiles / PCHA/Continua Profiles
    Systems of innovation – FHIR / OpenEHR Archetypes
  • To develop, deliver, test and deploy standards sets which are properly adapted to a dynamic healthcare system, we need a constant flow of interaction between three types of activities:

    Co-creation between all relevant stakeholders
    to make it real using standards

    A supportive and appropriate governance system
    to make it scale toward large-scale deployment

    The flexibility to adapt and align as needs and requirements change
    to make it stay in a sustainable way
  • Robust maintenance process. Experts participating in the first revision workshop and EU/US workshop suggested that the evaluation should take into account that IHTSDO assures a transparent and robust maintenance process.
    Maps to user interface terminologies. Several projects e.g. CMT (Kaiser Permanente), NLMC (UK), Dutch Thesaurus for diagnoses reported in workshops suggest that SNOMED CT in fact, can play an infrastructure role supporting mapping of national or local user interface terminologies to clinical language.
    Easy reuse of data. Stakeholder questionnaires, focus groups, workshops, and case studies suggest that as a reference terminology SNOMED CT may facilitate interoperability and reuse of data across domains and jurisdictions ensuring data quality and traceability across the patient trajectory.
    Standardization of EHR contents. Stakeholder responses and the Canadian questionnaire support that adoption of SNOMED CT as a reference terminology may contribute to standardization of eHealth systems.
  • ISO IDMP defines a set of attributes and their relations to identify different levels of products.
    It harmonizes the concepts and the data elements (attributes)
    It is ready for adoption and manufacturers are adhering.
    How does this help in cross-border identification?
  • Trillium Bridge concluded a gap analysis comparing the implementation guides for epSOS and CCD-CCD and managed to identify the shared clinical elements: problems, medications, allergies. It also triggered the creation of interoperability assets: terminology prototype, transformer, and also an account of differences in the IHE profiles in EU and US on patient identity and document query retrieve.
    Several validation activities where carried out in EU/US Marketplace, HIMSS, IHE Europe, eHealth Week.
    Finally it led to a key transversal recommendation, and 20 thematic ones. The key recommendation is advance an international patient summary standard to enable people to access and share their health information for emergency or unplanned care anywhere and as needed. At a minimum the IPS should include innumication, allergies, medications, clinical problems, past operations and implants.
  • The role of the EC and Member state on creating the basis for the (international) Patient Summary ; for supporting their development and promoting the uinternational standardization activities
  • Let’s focus on the content..

    CEN prEN: The Patient Summary for Unscheduled, Cross-border Care

    The IPS project works for assuring the compliance and the traceability i order implementable specification actually fullfill the business requirement

    From deployment perpsctive the IPS project is aware about the importance of the conformance (assessment) and any kind of conformance support to implementers
  • Use Case #1: Athlete Cardiac Event
     
    Twenty-four-year-old Jamaican athlete Tasha Morris collapsed on the track while competing in the Women’s 100 Meter event at the London2012 Olympic Games, showing symptoms of dizziness, light-headedness, and a pounding in the chest area. Medical personnel treating her at the stadium clinic securely accessed the IOC’s Electronic Health Record (EHR) system to retrieve demographic information about Tasha as provided from the athlete registration/accreditation system, and performed an authorized query for any additional health information available from other sources. The Jamaican OC’s EHR system responded to the query with a list of patient summary documents sorted by date, and the latest document was retrieved and displayed within the IOC’s EHR, showing allergies, medications and medical conditions including a history of supra-ventricular arrhythmia.
     
    Tasha was transferred by ambulance to the Olympic Polyclinic, where she was administered oxygen and medications to treat her symptoms. An ECG and basic lab tests confirmed the patient was in Atrial Fibrillation, and needed treatment at a higher-level of care. Tasha was transferred by ambulance to Leeds General Infirmary’s Cardiac Centre.
     
    The hospital was able to access Tasha’s records from the IOC’s EHR via their Hospital Information System, and retrieve the originating patient summary document, together with information from the Polyclinic including ECG image, lab results, and medications administered. It was determined that Tasha required a Cardio-Version procedure, which was immediately performed.
     
     
    Use Case #2: Olympic Family Member Acute GI Event
     
    George Carson, the 56-year-old father of Canadian Olympic swimmer Brian Carson, exhibited an episode of acute abdominal pain while watching his son’s final heat in the 200 Meter Butterfly event at Rio2016. Medical treatment was immediately provided, and included the lookup and retrieval of George’s basic demographic data provided to the IOC’s Electronic Health Record system by the Olympic Accreditation system. As part of the Olympic “family”, George had voluntarily provided a medical summary along with his registration to the Canadian Olympic Committee’s registration/EHR system, and this record was found and retrieved by the attending physician in Rio. Along with medications and allergies, George had documented that he had been suffering from an intermittent occurrence of Crohn’s Disease.
     
    Diagnostics provided at the event clinic and subsequently at the Olympic Polyclinic, included an Upright Abdominal X-Ray, which showed that a Perforated Bowel had caused the acute attack. Requiring immediate surgery, George was transferred by ambulance to the Hospital Universidade de Rio de Janeiro, where an emergency Colostomy was performed. All George’s EHR data, including his Canadian records as well as physician notes and digital images from the Polyclinic, were accessed by the hospital through their own Hospital Information System’s participation in the integrated network.
     
    George was released from the hospital 2 days later. George’s hospital EHR records, including surgical notes and digital images, were transferred back to the IOC’s EHR, and also to the Canadian OC’s EHR, along with antibiotic medication data that had been prescribed and dispensed to George for long-term follow-up.

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