Il lavoro di armonizzazione tra CEN 13606, openEHR e HL7
Dr Dipak Kalra Centre for Health Informatics and Multiprofessional Education (CHIME) University College London [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 Clinical data life-cycle
Point of care Citizen in the delivery community
Teaching explicit consent Research Clinical trials
Continuing care (within the institution)
Education Public health Research de-identified implied consent Health care management Epidemiology +/- consent Clinical audit Data mining
Long-term shared care (regional national, global)
Governance requirements Holistic requirements • Faithfulness • Empowering and respecting • Completeness • Educating • Medico-legal integrity • Supporting diverse cultures and • Standards conformance professions • Consistent semantics • Capable of evolution • Privacy management In a generated medical summary
List of diagnoses and procedures 1993 Procedure Appendicectomy 1996 Diagnosis Meningococcal meningitis 1997 Procedure Termination of pregnancy 2003 Diagnosis Acute psychosis 2006 Diagnosis Schizophrenia
Can we safely interpret a diagnosis without its context? Clinical interpretation context
Emergency Department Seen by junior doctor Reason for encounter Brought to ED by family Symptoms “They are trying to kill me” Junior doctor, Mental state exam Hallucinationsemergency situation, a working hypothesis Delusions of persecutionso schizophrenia is not a Disorderedreliable thoughts diagnosis Diagnosis Schizophrenia Certainty Working hypothesis Management plan Admission etc..... The virtual EHR
Clinical trials, Decision support, functional genomics, EHR repositories knowledge management public health databases and analysis components
Date: 1.7.94
SharedWhittington logical Hospital EHR Healthcare Record
John Smith Personnel registers, SharedDoB: 12.5.46 domain security services knowledge Mobile devices
Clinical Clinical devices, applications instruments The role of EHR interoperability standards
Clinical trials, Decision support, functional genomics, EHR repositories knowledge management public health databases and analysis components
openEHRDate: 1.7.94 Whittington Hospital ISO/ENHealthcare Record 13606 John Smith Personnel registers, DoB: 12.5.46 security services EHR archetypes Mobile devices
Clinical Clinical devices, applications instruments Logical EHR architectural components
Persistence services
Logical EHR model
Archetype and terminology services
Access control and privilege management services Audit services Query and retrieval Data entry and validation
Standards conformant interfaces (esp. ISO/EN 13606) Links with other components: HISA EN12967
Workflow, guidelines Learning Comms resources & security
Standard Online virtual Persons, knowledge EHR resources Interfaces
Finance, Terminology billing Clinical applications Research and interoperability standards
EU and Australian R&D projects
1995 pre-standard EHR quality and interoperability requirements EHR reference models Early archetype approach 1999 pre-standard
Richer EHR models 2007-9 ISO/EN 13606 Archetype formalism and tools Archetype authorship and governance + implementation guide Open source reference implementations 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 standard 1. information model 2. archetype model 3. term lists 4. security 5. 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 Contextual building blocks of the EHR
Part or all of the electronic health record EHR Extract for one person, being communicated
High-level organisation of the EHR Folders e.g. per episode, per clinical speciality
Set of entries comprising a clinical care Compositions session or document e.g. test result, letter
Headings reflecting the flow of information Sections gathering, or organising data for readability
Clinical “statements” about Observations, Entries Evaluations, and Instructions
Multipart entries, tables,time series, Clusters e.g. test batteries, blood pressure, blood count
Element entries: leaf nodes with values Elements e.g. reason for encounter, body weight
Date types for instance values Data values e.g. coded terms, measurements with units 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) 13606-4: Potential users of EHR data
Clinical team Clinical Teaching governance team
Healthcare Research organisation the patient team
Date: 1.7.94
Whittington Hospital
Health Healthcare Record Research
service John Smith funder DoB: 12.5.46
family & carers Publisher, Public the press health
Commercial Professional organisation organisation The public 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
ACCESS_POLICY ATTESTATION policy_id [1]: II author [1]: II policy_attestation 1..* time [1]: TS date_committed [1]: TS performer [1]: II previous_version [0..1]: II proof [0..1]: ED effective_start [0..1]: TS function [0..1]: CV effective_end [0..1]: TS EHR_target
0..* TARGET rc_ids [0..1]: SET
NOTE: If no target criteria are specified this policy applies to the whole EHR_EXTRACT 0..* REQUEST functional_roles [0..1]: SET
NOTE: If no requestor characteristics are specified this policy applies to all requests 1 MAX_SENSITIVITY_CONSTRAINTS access [1]: INT write [0..1]: INT modify [0..1]: INT communicate [0..1]: INT version_history [1]: BL other_constraints [0..1]: SET
NOTE: The INT value corresponds to one of the values of CS_SENSITIVITY and matches the values of the sensitivity attribute of RECORD_COMPONENT 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