Patientendossier - europäische Konzepte · eHealth Competence Center University Hospital...

Patientendossier - europäische Konzepte

Bernd Blobel

eHealth Competence Center

University Hospital Regensburg

Jahrestagung der HL7 Benutzergruppe Schweiz

18. Oktober 2012, Olten, Schweiz eHCC


Bernd Blobel, PhD, FACMI, FACHI, FHL7

Head, eHealth Competence Center, University Hospital Regensburg, Germany Past-Chair HL7 Germany Past-Chair, IMIA Working Group “Standards in Health Care Informatics Chair, EFMI Working Groups “EHR” and “Security, Safety and Ethics Chair, CEN/ISSS eHealth Standardization Focus Group Chair, German Health Informatics Standards Committee Head of the German Delegation to ISO and CEN Past-Chair, GMDS Working Groups “Standards for Interoperability and EHR” Co-Chair ,GMDS Working Group “Data Protection in Health Information Systems” Chair, GDD Working Group “Security and Privacy in Health and Welfare”


18. Oktober 2012, Olten, Schweiz


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Interoperability Challenge


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Observation

Interpretation Action

Data

Information

Observation

Diagnosis Therapy

Knowledge

Consent

HP or HCE Action Patient


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Interoperability Level Instances

Technical interoperability Technical plug&play, signal- & protocol

compatibility

Structural interoperability Simple EDI, envelopes

Syntactic interoperability Messages, clinical documents, agreed

vocabulary

Semantic interoperability Advanced messaging, common

information models and terminology

Organizations/Service

interoperability Common business process

Interoperability Levels


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Requirements for Achieving Interoperability and Harmonization

• Openness, scalability, flexibility, portability

• Distribution at Internet level

• Standard conformance

• Service-oriented / semantic interoperability

• Consideration of timing aspects of data and information exchanged

• Lawfulness

• User acceptance

• Appropriate security and privacy services

Model-Driven Architecture


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Model

A model is a partial representation of reality. It is

restricted to attributes the modeller is interested

in. Defining the pragmatic aspect of a model, the

interest is depending on the addressed audience,

the reason and the purpose of modelling the

reality and using the resulting model for a certain

purpose and for a certain time instead of the

original. Therefore, the model as a result of an

interpretation must be interpreted itself.


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Electronic Health Records


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Definitions (according to ISO TR 20514 Health

informatics - Electronic health record – Definition, scope and

context ) (1/2) EHR A repository of information regarding the health status of a subject of care, in computer processable form. An EHR provides the ability to share patient health information between authorized users of the EHR and the primary role of the EHR in supporting continuing, efficient and quality integrated health care. EHR system The set of components that form the mechanism by which electronic health records are created, used, stored, and retrieved. It includes people, data, rules and procedures, processing and storage devices, and communication and support facilities.


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Definitions (according to ISO TR 20514 Health informatics -

Electronic health record – Definition, scope and context ) (2/2)

EHR architecture

A model of the generic features necessary in any electronic healthcare record in order that the record may be communicable, complete, a useful and effective ethico-legal record of care, and may retain integrity across systems, countries, and time.

In general, a system’s architecture defines its components, their

functionalities and relationships.


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EHR Types

• Organization-centric EHR

• Personally moderated EHR

• Personal Health Record (PHR)

• Legal EHR

• Centralized EHR

• Distributed EHR


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Requirements the EHR must meet: ISO 18308 after Kalra

The EHR shall preserve any explicitly

defined relationships between different

parts of the record, such as links between

treatments and subsequent complications

and outcomes. The EHR shall preserve the original data

values within an EHR entry including code

systems and measurement units used at

the time the data were originally

committed to an EHR system. The EHR shall be able to include the

values of reference ranges used to

interpret particular data values. The EHR shall be able to represent or

reference the calculations, and/or

formula(e) by which data have been

derived. The EHR architecture shall enable the

retrieval of part or all of the information in

the EHR that was present at any particular

historic date and time. The EHR shall enable the maintenance of

an audit trail of the creation of,

amendment of, and access to health

record entries.


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Currently, three streams for specifying and implementing advanced EHR architectures, which partially have their roots in existing systems, in traditional thoughts and methodologies as well as in specific domain-languages and modelling languages:

Data approach (data representation)

Concept approach (concept/knowledge representation)

Process/service approach (business process / service representation)


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• An alternative structure of current approaches with analogue methodologies and modelling languages under implementation focus is: Communication focus (message) Document focus (clinical document) Business process focus (application)

• According to the time dimension, following structure can be proposed:

Episode focus (EHR extract) Life-long record focus (EHR service)

• Because of their rational roots and driving factors, all those approaches have

their right to exist at least temporarily. Therefore, they exist also practically in co-existence or concurrency. The three approaches develop continuously, thereby showing some convergence.


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18. Oktober 2012, Olten, Schweiz eHCC16 August 2007 14

Direct vs. Indirect EHR Access Model

• “National (regional) switchpoint” – E.g. Netherlands, Greece – Requires central client (patient), provider, and organizational

registries – Query/response paradigm used to retrieve discrete data versus

• Central respository(ies) – E.g. (Canadian/UK/Finland) – Requires central registries as above – Discrete results uploaded to central/regional registries – Centralized legal record in Finland


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EHR Approaches


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EHR Approaches after HIMSS

Wales Germany England

The Netherlands Denmark

Canada

New Zealand


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EHR Projects and Standards

• ISO TC 215 TS 18308, TR 20514

• CEN EN 12967 „Health Information System Architecture“

• CEN EN 13606 „EHR Communication“

• openEHR

• GEHR

• IHE RID: Retrieve Information for Display

• IHE XDS: Cross-enterprise Clinical Document Sharing

• G-CPR

• ASTM CCR

• HL7 RIM & CDA, EHR-S Functional Model, EHR-S Interoperability Model, CCD

• HARP

• DICOM SR: Structured Reporting

• WADO: Web Access to DICOM Persistent Objects

• EuroRec, ProRec Centers

• MML: The Medical Mark-up Language


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Archetype Object Model 1.5 (after Beale)


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ADL Archetype Structure (after Beale)


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CIMI Core Reference Model (after CIMI)

class CIMI Core Reference Model

COMPOSITION

+ category :CODED_TEXT

+ language :CODE_PHRASE

+ territory :CODE_PHRASE

CONTENT_ITEM

ENTRY

+ language :CODE_PHRASE

SECTION

ARCHETYPED

+ archetype_id :ARCHETYPE_ID

+ template_id :TEMPLATE_ID [0..1]

+ rm_version :String

LOCATABLE

+ name :TEXT

+ uid :UID_BASED_ID [0..1]

+ archetype_node_id :String

LINK

+ meaning :TEXT

+ target :EHR_URI

+ type :TEXT

ITEM

+ null_flavor :CODED_TEXT [0..1]

ELEMENTCLUSTER

+ structure_type :CODE_PHRASE [0..1]

DATA_VALUE

PARTICIPATION

+ function :TEXT

+ mode :CODED_TEXT

+ time :DATE_TIME [0..1]

PARTY_PROXY PARTY_SELF

PATHABLE

+value

0..1

+provider

0..1 +subject 1..1

+items

*..*+content

*..*

+composer

1..1

+data 1..*

1

+items

1..*

+other_participation

0..*

+performer

1..1

+archetype_details

0..1

+links

*..*

+participations *


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CIMI Hierarchical Representation (after CIMI)

ELEMENT

Name: Problem Diagnosis Name

Meaning: 404684003|Clinical finding|

Parent-child-link: 246090004|Associated finding|

Value: ϵ ProbDiag_RefSet

CLUSTER

Name: Location Details

Meaning: 123037004|Body structure|

Parent-child-link: 363698007|Finding site|

ELEMENT

Name: Body Site

Meaning: 123037004|Body structure|

Parent-child-link: 363698007|Finding site|

Value: ϵ BodyStructure_RefSet

ELEMENT

Name: Laterality

Meaning: 182353008|Side|

Parent-child-link: 272741003|Laterality|

Value: ϵ Side_RefSet

ELEMENT

Name: Severity

Meaning: 272141004|Severities|

Parent-child-link: 246112005|Severity|

Value: ϵ Severity_RefSet

ELEMENT

Name: Finding Context

Meaning: 410514004|Finding context value|

Parent-child-link: 408729009|Finding context|

Value: ϵ FindingContext_RefSet

CLUSTER

Name: Problem Diagnosis

Meaning: 243796009|Situation with explicit context|

CLUSTER

Name: Associated Problem Diagnosis

Meaning: 404684003|Clinical finding|

Parent-child-link: 246090004|Associated finding|


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Header

Document Information

Encounter

Service Actors

Service Targets

Body

Structured (Narrrative) Text, Coded Entries

CDA Document

The CDA Header & Body (after Heitmann)


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Medical Logic Modules (after HL7)

• General layout

maintenance: slotname: slotbody;; slotname: slotbody;; … library: slotname: slotbody;; … knowledge: slotname: slotbody;; … end:


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Overview on the CIMI Project (after CIMI)


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National EHR Approaches


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Strategy

• Some countries start with an infrastructure project (Germany, Austria, partially the Netherlands)

• Some countries focus on the record/repository (Austria)

• Some countries focus on a solutions architecture (Canada, Germany)


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National EHR Strategy Examples

England: National Programme for IT (NPfIT)

Australia: HealthConnect, NEHTA

Canada: Infoway, EHRS Blueprint

USA: National Health Information Infrastructure (NHII), EHRVA

Germany: bIT4health, eGK, eGA

Taiwan: National Health Information Exchange Platform

France: DMP (Dossier Medical Personnel)

The Netherlands: AORTA

Wales: IHR/LLR within the “Informing Healthcare Program” (IHC)

… and probably 60+ other countries


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International Programs and Budgets Examples

• Health Infoway ( Canada)

• By 2007, the government of Canada had invested $1.6 billion CAD

in Infoway. By March, 2008, Infoway had committed nearly than

$1.5 billion CAD in co-investment within the jurisdictions. 50%

pop. have EMR

• Health Connect (Australia)

• NEHTA has received $160 AUD million in funding. All pts have

EMR anytime

• Ctr. for Interoperable EHR (Korea )

• 1.1 bill. USD by 2010 for universal EMR


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International Programs and Budgets Examples

• National Program for IT ( UK)

• The National Programme for IT (NPfIT) was initiated in 2003 and was

originally budgeted to be £6.0 billion over 10 years, but the National Audit

Office estimates the figure to be £12.4bn over 10 years and other officials

have been recently quoted in papers as estimating the figure to be close to

£20.0 billion. Objective: IT infrastructure for safe and efficient health

information transfer

• National Health Information Infrastructure ( USA)

• 86.5 mill. USD 2005, 125mill. USD 2006 for universal EMR. Within ARRA,

more 40 billion US $ will be spent to provide a PHR to every American.


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ELGA Project (after Sauermann, changed)

Medical reports to be designed in CDA format:

– Discharge summary

– laboratory and radiology reports

– data segments for medication

CDA level 2, partly 3

First trials in 2008

International standards mandated

Approach:

Preparation of a process choreography, accompanying measures, preparation of test beds

„Picking up“ all involved parties for realizing a joint, coordinated

process


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(after Hyppönen)


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(after Hyppönen)


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18. Oktober 2012, Olten, Schweiz eHCC33

VISION

eHealth and eWelfare

space 2020 LPWR

Users

Primary users

Secondary users

- context

- purpose

Legislation

Regulations

Requirements (dynamic, context aware)

- Need to know

- Restrictions

- Rights

- Permissions

- Obligations

- Confidentiality

person

Use

control

Audit

- consent

- opt-out

- ….

after Pekka Ruotsaleinen


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Granular

context, purpose,

security policy,

semantics

at time of creation

At granular

Granular context, purpose,

security policy,

semantics

at time of creation

Information source 1

Information source n

Subject of information

Dynamic context

aware permission

opt-out in this context

and for requested purpose

Personal security policy

E

T

H

I

C

S

R

E

G

U

L

A

Y

I

O

N

S

Primary requester

Environment,

context, need to

know,

permission to

access,

role

Request

Context, purpose,

objects to access

LPWR

Access and

Disclose mana-

gement

output

Event log

Secondary user

Environment,

context, need to

know,

permission to

access,

role



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Requirements

for the LPWR

Available general

models:

-Information models

-Inf. system models

Health care specific

models:

-Information models

-inf. system models

Model:

- Information model for the

LPWR

- Infrastructure model

- Model for trusted use

Requirements

for

infrastructure



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EHRS Blueprint Key Definitions: EHR Solution

36

The EHR Solution is a combination of people, organizational entities, business processes, systems, technology and standards that interact and exchange clinical data to provide high quality and effective healthcare.


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EHRS Blueprint Key Definitions: EHR Infostructure

37

The EHR Infostructure is a collection of common and reusable components in the support of a diverse set of health information management applications. It consists of software solutions for the EHR, data definitions for the EHR and messaging standards for the EHR.


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Key EHRS Architecture Concepts

EHR SOLUTION (EHRS)

EHR INFOSTRUCTURE (EHRi)

EHR Viewer Point of Service

Application Point of Service

Application

EHRS

Locator

Longitudinal Record Services

Health Information Access Layer

Ancillary

Data &

Services

Health

Information

Data

Warehouse

EHR

Data &

Services

Registries

Data &

Services


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EHR Infostructure: Conceptual Architecture

JURISDICTIONAL INFOSTRUCTURE

Ancillary Data

& Services Registries Data

& Services

EHR Data

& Services

Data

Warehouse

Outbreak

Management

PHS

Reporting

Shared

Health Record

Drug

Information

Diagnostic

Imaging Laboratory

Health

Information

POINT OF SERVICE

Hospital, LTC,

CCC, EPR

Physician

Office EMR EHR Viewer

Physician/

Provider

Business

Rules

EHR

Index

Message

Structures

Normalization

Rules

Security Mgmt

Data Privacy Data Configuration

Physician/

Provider

Physician/

Provider

Lab System

(LIS)

Lab Clinician

Radiology

Center

PACS/RIS

Radiologist

Pharmacy

System

Pharmacist

Public Health

Services

Public Health

Provider


HIAL Communication Bus

Common Services

Client

Registry

Provider

Registry

Location

Registry

Terminology

Registry


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CROSS-JURISDICTIONAL INFOSTRUCTURE

EHR Infostructure: EHRS Locator Data

• EHRi Client ID (resolved ECID) • CR instance ID (OID root) • EHRi instance ID (which instance of an EHRi) • EHRi URI (the URI to access the HIAL) • Optimized for performance

– Information type (drug, lab, DI) (derived from HL7 act classes)

– First created date – Last updated date

EHR SOLUTION (EHRS)


EHR Viewer

Point of

Service

Application

Point of

Service

Application

Ancillary

Data &

Services

Health

Information

Data

Warehouse

EHR

Data &

Services

Registries

Data &

Services



EHR SOLUTION (EHRS)


EHR Viewer

Point of

Service

Application

Point of

Service

Application

Ancillary

Data &

Services

Health

Information

Data

Warehouse

EHR

Data &

Services

Registries

Data &

Services



JURISDICTIONAL INFOSTRUCTURE

POINT OF SERVICE

EHRS

Locator


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English EHR Architecture

• England’s EHR - the Spine - acts as a central Summary Record (CDA-based, ebXML) consists of the Spine Directory, Demographics Services, the Summary Care Record and adapters and is not an EHR. It contains only a small percentage of the information held in primary and secondary care systems.

• The English envisioned EHR contains a new network infrastructure as well as national applications that will utilize the EHR (e.g., electronic transfer of prescriptions, electronic outpatient scheduling).

• The EHR portion (the Care Record Service) includes three components:

– Personal Demographics Service (PDS),

– Summary Care Record (patient's clinical information, such as allergies and adverse reactions to medicine),

– Secondary Uses Service (SUS), which uses data from patient records to provide anonymised and pseudonymised business reports and statistics for research, planning and public health delivery.


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English EHR Architecture (after Department of Health)

• The NHS turns between detailed information models on the one hand and extended terminology to include information models.

• The result is the Logical Record Architecture (LRA) for Health and Social Care in England.

– A generic model designed to work with the SNOMED CT terminology

– Domain models, derived directly from the Generic Model and terminology, designed to meet specified uses

– A catalogue of the requirements/uses for data, whether for direct care of patients or secondary uses, including analysis


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LRA Modelling (after Department of Health)

LRA

Repository

Technical Model Artefact

Development

Select existing or model new SNOMED CT

terminology bound ELEMENTs and (terminology

neutral) ENTRYs to satisfy Candidate Data

Element Definitions and Information Descriptions

ELEMENTS

ENTRYs

Output

Interface Artefact Model

Development

Select existing or create new Data Element

Definition and Refined Technical Model

constraints of ELEMENTs and ENTRYs; select

existing or create new Query Specifications.

Data Element

Definitions

Refined

Technical Model

Query

Specifications

Output

LRA Technical Modelling

Domain and Analysis Scoping

Review and Establish Requirements, Determine

Information and Process Concepts

Requirements

Catalogue

Stakeholder

Information View

Stakeholder

Business Model

Output

Logical Analysis

Modelling, Detailed Definitions, and Traceability

of Requirements, Pathways, and Information

Concepts

Information

Analysis Model

Use Case Model

Business

Process Model

Output

LRA Analysis

Identify Existing and/or New Requirements for

Data Element Definitions, Queries,

and Data Aggregation Models

Information

Descriptions

Query

Functionality

Candidate Data

Element Definitions

Output

LRA Knowledge Modelling


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The record structure


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LRA Core Components (after Department of Health)

• SNOMED CT terminology Description Logic

• BS/ISO/EN13606 Electronic Health Record for Communications object model

• HL7 Data Types (draft ISO)

• UCUM Units of Measure


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The LRA Base Elements (after Department of Health)

Element

Observation Activity Relationship

Property

Finding

Investigation

Substance

Activity

General Activity


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Logical Care Record Model

The 5 Layers for Analysis of Care Records

Query (constraint ) Specifications

Classification / Grouping Rules (logic)

Human focused Business Rules

Business focused Requirements

Current Data Dictionary

Current Data Model


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Logical Record

Architecture

Pathways

Metrics Other dataset developments

Social care

LRA Requirements (after Department of Health)


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LRA Content Development (after Department of Health)

Use case

Elaboration

Design

Construction

Requirement

Elaboration

Design

Construction

Metadata

Registry

Purpose

& scope

Library

Imple

men

tation

cycle

Sta

ndard

s

Develo

pm

ent

cycle


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18. Oktober 2012, Olten, Schweiz eHCCTerminology and archetypes Templates and forms

Use case

Elaboration

Design

Construction

Requirement

Elaboration

Design

Construction

Metadata

Registry

Purpose

& scope

Library

Local National


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DMP: a French national eHealth record

DMP (Dossier Médical Personnel) will be:

a private medical file digitalised aimed at favouring coordination, quality and continuity of care;

a file shared by Healthcare professionals (HCP) but under the holder's control (i.e. The patient manages its access, the holder can hide documents...)

not a substitute for professional files of HCP in ambulatory care or in Hospital

accessed through :

• Web Portal for holder's

• Only through professional application for Healthcare professionals to maximize ergonomy and avoid time-consuming change of application

consisting of data (structured or not) signed by the author (at first only by the HCP)


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DMP: A health record needing adequate protection

As a health record, the DMP needs to be:

• Available – Opens 7/24 – Availability 99,9% (total amount of interruption of 8 hours a year)

• Protective of data integrity and confidentiality

– Protected communications (SSL) – Restrictive access to a DMP (eSafe, HCP rights defined by law) – Separation of trusted services (authentication) and data housing

– Good level authentication

* Caisse des Dépôts et Consignations is a state-owned financial institution that performs public-interest missions on behalf of France’s central, regional and local governments.


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DMP: A record used by numerous actors


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Dutch Design of the Architecture, Basic Infrastructure, for Healthcare after NICTIZ, 2002


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Dutch eHealth Activities Scheme after NICTIZ, 2004


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Turkey National EHR Approach

• Development of an Adaptor for automatically transforming National Health Information System (NHIS)of Turkey“Transmission Schema” instances to HL7 CDA R2 conformant EHRs

• Development of a Terminology Server based architecture enabling automatic mappingof the local coded terms that appear in the NHIS Transmission Schema instancesto international counterparts

• Development of an Adaptor for automatically transforming CDA conformant NHIS Transmission Schema instances to CEN EN 13606 conformant EHRs


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The Architecture of the Transformation Environment for National Health Information System (NHIS) of

Turkey after Assuman, 2008


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Healthcare System Vison for Croatia after Blazona, 2007


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German Approach

• There are two streams in the German EHR approach:

– An architecture-centric, intelligent, adaptive solution specifications based on international standards and partially borrowed from the Cnadian EHR-S Blueprint, launched by the Federal Ministry for Economy and realized by the eHCC

– An set of pilots more or less independent from international standards and international experiences, launched by the Federal Ministry for Health and realized by different hospital trusts, Fraunhofer Institutes and others


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German EHR Architecture

Registries Common Services EHR System

Health Data Warehouse


Communication Bus Common Services

Connector Connector Connector Connector

Application 1 Application 2 EHR Viewer

Resource Locator Service


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eHealth Components (Logical View)

Policy

Services

Client

Services

Application

Services

Audit

Services

PMI EHR

Systeme

Dir./Reg.

Services

ID CA

Services

ACA

Services PKI

Terminology

Services

Gesundheitskarte

Name Zeile 1

Name Zeile 2

Name der Krankenkasse

123456789 A123456789

Kassennummer Versichertennummer

Knowledge

Services

Ontology

Services


Bernd Blobel





Thank you for your attention!

Prof. Dr. rer. nat. habil Bernd Blobel


University of Regensburg Medical Center Franz-Josef-Strauss-Allee 11

D-93042 Regensburg, Germany

Email: [email protected]

Phone: +49-941-944 6769

Fax: +49-941-944 6766

http://www.ehealth-cc.de

mailto:[email protected]



http://www.ehealth-cc.de/



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