Il lavoro di armonizzazione tra CEN 13606, openEHR e HL7

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