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Il lavoro di armonizzazione tra CEN 13606, openEHR
e HL7
Dr Dipak KalraCentre for Health Informatics and Multiprofessional Education
(CHIME)University College [email protected]
Drivers for the EHR
• Manage increasingly complex clinical care• Connect multiple locations of care delivery• Support team-based care• Deliver evidence-based health care• Improve safety
• reduce errors and inequalities• reduce duplication and delay
• Improve cost effectiveness of health services• Underpin population health and research• Empower and involve citizens • Protect patient privacy
Point of care delivery
Continuing care (within the institution)
Long-term shared care (regional national, global)
TeachingResearch
Clinical trials
explicit consent
EducationResearch
EpidemiologyData mining
de-identified
+/- consent
Public healthHealth care management
Clinical audit
implied consent
Holistic requirements• Empowering and respecting• Educating • Supporting diverse cultures and
professions• Capable of evolution
Clinical data life-cycle
Citizen in the community
Governance requirements• Faithfulness• Completeness• Medico-legal integrity• Standards conformance• Consistent semantics• Privacy management
In a generated medical summary
List of diagnoses and procedures
Procedure Appendicectomy1993
Diagnosis Acute psychosis2003
Diagnosis Meningococcal meningitis1996
Procedure Termination of pregnancy1997
Diagnosis Schizophrenia2006
Can we safely interpret a diagnosis without its context?
Clinical interpretation context
Emergency Department
“They are trying to kill me” Symptoms
Reason for encounter Brought to ED by family
Mental state exam Hallucinations
Delusions of persecution
Disordered thoughts
Management plan Admission etc.....
Diagnosis Schizophrenia
Working hypothesis Certainty
Seen by junior doctor
Junior doctor,emergency situation,a working hypothesis
soschizophrenia is not a
reliable diagnosis
Clinical trials,functional genomics,
public health databasesEHR repositories
Clinical devices,instruments
Clinical applications
Decision support, knowledge managementand analysis components
Mobile devices
Personnel registers,security services
The virtual EHR
Date: 1.7.94
WhittingtonHospital
Healthcare Record
John Smith DoB: 12.5.46
Shared logical EHR
Shared domain knowledge
Clinical trials,functional genomics,
public health databasesEHR repositories
Clinical devices,instruments
Clinical applications
Decision support, knowledge managementand analysis components
Mobile devices
Personnel registers,security services
The role of EHR interoperability standards
Date: 1.7.94
WhittingtonHospital
Healthcare Record
John Smith DoB: 12.5.46
openEHR
ISO/EN 13606
EHR archetypes
Logical EHR architectural components
Logical EHR model
Persistenceservices
Access control and privilege management services
Auditservices
Standards conformant interfaces (esp. ISO/EN 13606)
Query and retrieval Data entry and validation
Archetype and terminology services
Links with other components: HISA EN12967
Workflow, guidelines
Clinicalapplications
Persons,resources
Finance, billing
Comms& security
Terminology
Onlineknowledge
Learningresources
virtual EHR
Standard
Interfaces
Research and interoperability standardsEU and Australian R&D projects
EHR quality and interoperability requirements
EHR reference models
Open source reference implementations
Archetype authorship and governance
Early archetype approach
Archetype formalism and tools
Richer EHR models
1995 pre-standard
1999 pre-standard
2007-9 ISO/EN 13606
+ implementation guide
Ongoing evaluation & refinement
CEN/ISO 13606 EHR Communications Standard• A means to exchange part or all of a patients EHR
• between heterogeneous systems• within a federation of distributed EHR systems
• Meets published EHR requirements • 15 years of R&D and 2 past CEN EHR standards
• Five part standard1. information model2. archetype model3. term lists4. security5. service interfaces
Parts of ISO/EN 13606
• Part 1: Reference Model• comprehensive, generic model for communicating part or all of an EHR
• Part 2: Archetype Specification• constraint-based approach for defining clinical “business objects” that are
built from the Reference Model - adopted from openEHR
• Part 3: Reference Archetypes and Term Lists• initial set of archetypes mapping to other relevant standards• vocabularies for the Part 1 model
• Part 4: Security• measures to support access control, consent and auditability of EHR
communications
• Part 5: Interface specification• message and service interfaces to enable EHR and archetype
communication
Compositions Set of entries comprising a clinical care session or document e.g. test result, letter
EHR Extract Part or all of the electronic health record for one person, being communicated
Folders High-level organisation of the EHRe.g. per episode, per clinical speciality
Sections Headings reflecting the flow of information gathering, or organising data for readability
Clusters Multipart entries, tables,time series,e.g. test batteries, blood pressure, blood count
Elements Element entries: leaf nodes with valuese.g. reason for encounter, body weight
Data values Date types for instance values e.g. coded terms, measurements with units
Entries Clinical “statements” about Observations,Evaluations, and Instructions
Contextual building blocks of the EHR
EN 13606-1 Reference Model
EN 13606-1 Reference Model
Harmonisation with HL7 and IHE
• HL7• Meets the Infrastructure requirements of the EHR Functional
Model• An 13606-1 conformant R-MIM has been designed• Detailed cross-mapping to Clinical Document Architecture• Collaboration on archetype and template specifications• Contributed to the Clinical Statement model design• An HL7 13606 Implementation Guide is being developed
• IHE XDS specification• contributed to architecture and metadata• mapping to registry metadata• So XDS can store and share 13606 EHR Extract data
13606-1 R-MIM (draft)
the patient
family & carers
Date: 1.7.94
WhittingtonHospital
Healthcare Record
John Smith DoB: 12.5.46
13606-4: Potential users of EHR data
Clinical team
Research team
Teachingteam
Publisher, the press
Health service
Research funder
Public health
The public
Healthcareorganisation
Clinicalgovernance
Professionalorganisation
Commercialorganisation
Policies for EHR access need to specify:• Which institutions should normally have access • If certain teams or specialities should have privileged
access • If particular users should be excluded, or given wide
access• If consent has been granted for teaching, specific
research or generic research
EHR communication needs to ensure that such consent specifications are represented and communicated in a standardised way
13606-4: Communicating EHR access consent
0..*
ACCESS_POLICY
policy_id [1]: IIauthor [1]: IIdate_committed [1]: TSprevious_version [0..1]: IIeffective_start [0..1]: TSeffective_end [0..1]: TS
ATTESTATION
time [1]: TSperformer [1]: IIproof [0..1]: EDfunction [0..1]: CV
TARGET
rc_ids [0..1]: SET<II>archetype_ids [0..1]: SET<II>time_period [0..1]: IVL<TS>other_criteria [0..1] SET<String>
NOTE:If no target criteria are specified this policy applies to the whole EHR_EXTRACT
REQUEST
functional_roles [0..1]: SET<CS_FUNC_ROLE>structural_roles [0..1]: SET<CV>functional_responsibilities [0..1]: SET<CV>clinical_settings [0..1]: SET<CS_SETTING>specialities [0..1]: SET<CV>parties [0..1]: SET<II>other_characteristics [0..1]: SET<String>
NOTE:If no requestor characteristics are specified this policy applies to all requests
MAX_SENSITIVITY_CONSTRAINTS
access [1]: INTwrite [0..1]: INTmodify [0..1]: INTcommunicate [0..1]: INTversion_history [1]: BLother_constraints [0..1]: SET<String>
NOTE:The INT value corresponds to one of the values of CS_SENSITIVITY and matches the values of the sensitivity attribute of RECORD_COMPONENT
1..*
0..*
1
policy_attestation
EHR_target
request_characteristicsaccess_rules
13606-4: “Who has been looking at my record?”
Towards consistency of meaning
The EHR Reference Model• standardises the way of representing and sharing
the clinical and medico-legal contexts• helps to ensure that EHR data can be interpreted
longitudinally and internationally
BUT...• ...Part 1 cannot on its own ensure the consistency or
completeness of the clinical content, or define how terminology is used
• Part 2 standardises Archetypes for this purpose
What is an openEHR/13606 Archetype?• A formal sharable model of a clinical domain concept
• e.g. “blood pressure”, “discharge summary”, “fundoscopy”
• Uses classes defined in an EHR Reference Model• allows data quality constraints to be placed on the organisation
and content of record entries
• Can be published and shared within a clinical community, or globally
• May be mapped to the specific information in each clinical (EHR) system
• Defines a systematic EHR target for decision support queries
openEHR / 13606 Archetypes: a shared library of clinical data structures
openEHR / 13606 Archetypes: a shared library of clinical data structures
Ocean Informatics Archetype Editor
University of Linköping Archetype Editor
Ocean Informatics Archetype Finder
University of Manchester MoST plugin to bind archetype nodes to SNOMED CT
Ocean Informatics Template Composer
UCL archetype-driven clinical applications and portal
A growing library of archetypes
Next challenges for archetypes
• Clinical communities need to be fostered• to contribute domain expertise into the design of archetypes• to champion professional consensus on organising EHRs
• EHR Archetypes need to be quality assured• since they will direct the ways in which clinical data is captured,
processed and communicated
• EuroRec is partnering the openEHR Foundation in developing • governance practices for archetype development • quality criteria and editorial policies by which certified libraries of
EHR Archetypes can be recognised
Conclusion: the 13606 EHR Communications standard• defines a logical model for the core EHR
• supporting interoperability between heterogeneous systems• providing a common view across message paradigms
• meets published EHR requirements• draws on 15 years of significant R&D
• including multi-national implementation experience
• draws on two generations of CEN EHR standard• is being translated into an HL7 v3 RMIM • incorporates openEHR archetypes for sharing
semantic structures• offers a framework for sharing disclosure consent
and access control information