Trillium-II initiative on scaling up use of patient summaries in Europe and globally Progress on International Patient Summary Standard
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
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. 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. 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. 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
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
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
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HL7 Asia 2017
August 18, 2017
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
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. 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. 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. 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. 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 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
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. 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. 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. 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. 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. 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
23. 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
27. right and enabler of safe
care.
stakeholder groups to identify
needs
key enablers and success
educational and training material
28. • Quality assurance
• Health goals
• Early warnings
Can we use patient summaries to unlock patient data?
30. 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
31. 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
32. 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
34. August 18, 2017 HL7 Asia 2017
Evaluate
Bridge
HarmonizeGuide
eHealth
DSI
Hinweis der Redaktion
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.